A Prospective Multicenter, Open Label, Non-Randomized, Cross-Over Study Evaluating the Use of the Tablo Hemodialysis System In-Center and In-Home by Subjects With End Stage Renal Disease (ESRD) Who Are on Stable Dialysis Regimens
Phase: NA
Conditions: End Stage Renal Disease
Sponsor: Outset Medical

Outset Medical 
 
CONFIDENTIAL 
TABLO Clinical Study 
Page 1 of 40 
Study# 2014-01 
Amendment 9, dated January 9, 2020 
DOC-0000876, Rev 11 
 
 
Confidential and Proprietary 
Nothing herein is to be disclosed without the expressed written consent of Outset Medical. 
 
TABLO 
(The EvAluation of TaBlo In-CLinic and In-HOme) 
Study # 2014-01 
 
A Prospective Multicenter, Open Label, Non-Randomized, Cross-Over Study Evaluating the Use of the 
Tablo Hemodialysis System In-Center and In-Home by Subjects with End Stage Renal Disease (ESRD) 
who are on Stable Dialysis Regimens. 
 
 
 
 
Principal Investigator 
TABLO Clinical Study: 
 
Troy Plumb, MD 
983040 Nebraska Medical Center 
Omaha, NE 68198-3040 
402.559.9227 
 
 
 
 
Sponsor/Study Monitor/Data 
Monitoring/Data 
Management/Data Analysis: 
 
Chad Hoskins 
VP, Commercial and Corporate Strategy 
Outset Medical, Inc. (Outset) 
1830 Bering Drive, San Jose, CA 95112, USA 
 
 
 

Outset Medical 
 
CONFIDENTIAL 
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1 
PROTOCOL SYNOPSIS ...............................................................................................5 
2 
BACKGROUND ..........................................................................................................9 
3 
STUDY OBJECTIVE ...................................................................................................10 
3.1 
Device and Study Rationale ......................................................................................... 10 
4 
DEVICE DESCRIPTION ..............................................................................................10 
4.1 
Tablo™ Hemodialysis System Overview ....................................................................... 10 
4.2 
Principle of Operation ................................................................................................. 10 
4.3 
Proposed Indications For Use ...................................................................................... 11 
4.4 
Device Instructions...................................................................................................... 11 
4.4.1 
Medical Informatics ............................................................................................. 11 
4.4.2 
Device Set-up ....................................................................................................... 11 
5 
STUDY ENDPOINTS .................................................................................................13 
5.1 
Evaluation of Efficacy .................................................................................................. 13 
5.2 
Evaluation of Safety .................................................................................................... 14 
5.3 
Secondary Outcome Measure ..................................................................................... 14 
5.4 
Other Data and Analyses ............................................................................................. 14 
6 
STUDY DESIGN ........................................................................................................14 
6.1 
Overview .................................................................................................................... 14 
6.2 
Efforts to Minimize Bias .............................................................................................. 15 
6.3 
Blinding and Randomization ........................................................................................ 15 
6.4 
Clinical Events Committee ........................................................................................... 16 
7 
SUBJECT SELECTION ................................................................................................16 
7.1 
Study Population ......................................................................................................... 16 
7.2 
Informed Consent ....................................................................................................... 16 
7.3 
Subject Privacy ............................................................................................................ 17 
7.4 
Inclusion Criteria ......................................................................................................... 17 
7.5 
Exclusion Criteria ........................................................................................................ 17 
7.6 
Subject Discontinuation and Replacement .................................................................. 18 
8 
STUDY PROCEDURES ..............................................................................................19 
8.1 
Baseline Evaluation ..................................................................................................... 19 
8.2 
1-week Run-in ............................................................................................................. 20 
8.3 
Treatment Period 1 (In-Center) ................................................................................... 21 

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8.4 
Transition Period (In-Center/In-Home dialysis treatment) ........................................... 21 
8.5 
Treatment Period 2 (In-Home dialysis treatment)........................................................ 22 
8.6 
Weekly Visits during the In-Center and In-Home Treatment Periods ........................... 22 
8.7 
Laboratory Assessments ............................................................................................. 23 
8.8 
Device Malfunction ..................................................................................................... 23 
8.9 
Subject Assessment .................................................................................................... 23 
8.10 
Device Water and Dialysate Testing ......................................................................... 23 
9 
ADVERSE EVENT REPORTING ..................................................................................24 
9.1 
Adverse Event Definitions ........................................................................................... 24 
9.1.1 
Adverse Event (AE): .............................................................................................. 24 
9.1.2 
Serious Adverse Events (SAEs) .............................................................................. 24 
9.1.3 
Additional Treatment Observations (ATOs) .......................................................... 24 
9.1.4 
Unanticipated Adverse Device Effects (UADEs) ..................................................... 24 
9.1.5 
Primary Safety Endpoint ....................................................................................... 26 
9.2 
Recording Adverse Events ........................................................................................... 26 
9.2.1 
Adverse Event Categorization............................................................................... 26 
9.2.2 
Other Adverse Events ........................................................................................... 27 
9.2.3 
Determination of the Relationship ....................................................................... 27 
9.2.4 
Determination of Adverse Events (Clinical Events Committee, CEC) ...................... 28 
9.3 
Reporting Requirements of SAEs or UADEs ................................................................. 28 
10 
RISKS and BENEFITS .............................................................................................28 
10.1 
Potential Risks ......................................................................................................... 28 
10.1.1 
Procedure Risks .................................................................................................... 28 
10.2 
Risk Management Procedures ................................................................................. 29 
10.3 
Potential Benefits .................................................................................................... 30 
11 
STATISTICAL METHODS AND CONSIDERATIONS ..................................................30 
11.1 
Data Sets Analyzed .................................................................................................. 30 
11.1.1 
Intent to Treat Population (ITT) ............................................................................ 30 
11.1.2 
Per Protocol Population (PP) ................................................................................ 30 
11.2 
Safety Population .................................................................................................... 30 
11.3 
Analysis of Primary Endpoint ................................................................................... 30 
11.4 
Analysis of Weekly Standardized Kt/V ...................................................................... 31 

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11.5 
Analysis of Secondary Endpoint ............................................................................... 31 
11.6 
Analysis of Adverse Events ....................................................................................... 31 
11.7 
Interim Analysis ....................................................................................................... 32 
11.8 
Sample Size Analysis ................................................................................................ 32 
12 
STUDY RECORD MANAGEMENT ..........................................................................32 
12.1 
Source Documentation ............................................................................................ 32 
12.2 
Data Collection and Case Report Form Completion .................................................. 33 
12.3 
Case Report Forms (CRF) and Device Data Storage................................................... 33 
12.4 
Device Accountability .............................................................................................. 33 
12.5 
Missing Data ............................................................................................................ 33 
12.6 
Data Processing ....................................................................................................... 33 
13 
TRAINING ............................................................................................................34 
13.1 
Site Training ............................................................................................................ 34 
13.2 
Monitoring .............................................................................................................. 34 
13.2.1 
Site Monitoring Procedures .................................................................................. 34 
13.3 
Compliance ............................................................................................................. 34 
13.3.1 
Site Compliance ................................................................................................... 34 
13.3.2 
Protocol Deviations .............................................................................................. 35 
14 
QUALITY CONTROL and ASSURANCE ...................................................................35 
14.1 
Selection of Sites and Investigators .......................................................................... 35 
14.2 
Financial Disclosure ................................................................................................. 36 
14.3 
Institutional Review Board Protocol and Informed Consent Approvals ..................... 36 
14.4 
Protocol Amendments ............................................................................................. 36 
14.5 
Confidentiality ......................................................................................................... 36 
14.6 
Study Administration ............................................................................................... 36 
14.6.1 
Pre-Study Documentation Requirements ............................................................. 36 
14.6.2 
General Investigator Responsibilities .................................................................... 37 
14.6.3 
Record Retention ................................................................................................. 37 
14.6.4 
Criteria for Suspending/Terminating a Study Center ............................................. 38 
14.6.5 
Publication Policy ................................................................................................. 38 
APPENDIX A: Subject Study Flow ..................................................................................39 
APPENDIX B: Schedule of Assessments .........................................................................40 

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1 
PROTOCOL SYNOPSIS 
Title 
A Prospective, Multicenter, Open Label, Non-randomized, Cross-Over Study 
Evaluating the Use of the Tablo Hemodialysis System In-Center and In-Home by 
Subjects with End Stage Renal Disease (ESRD) who are on stable dialysis regimens.  
Study Device 
The Tablo Hemodialysis System (The Tablo System) 
Study Design 
This is a prospective, multicenter, open label, non-randomized, cross-over study.  
Subjects will be enrolled in the trial for approximately 21 weeks and will use the 
Tablo™ Hemodialysis System for their dialysis treatments for all study phases, 
according to the schedule outlined in four periods as follows:   
• Run-in– Subjects undergo study staff administered dialysis treatment 4 
times/week for 1 week In-Center.   
• Treatment Period 1, In-Center – Subjects undergo study staff administered 
dialysis treatment 4 times/week for 32 treatments (approximately 8 weeks) 
In-Center.  Subjects are expected to undergo no more than 4 complete 
treatments per week during this treatment period.  
• In-Home Transition– Subjects undergo device training for the study, perform 
self-care dialysis 4 times/week for approximately 4 weeks, and are assessed 
for stability in the new care environment.  
• Treatment Period 2, In-Home – Subjects undergo self-care dialysis treatment 
4 times/week for 32 treatments (approximately 8 weeks) In-Home.  Subjects 
are expected to undergo no more than 4 complete treatments per week 
during this treatment period.   
• Follow-Up---Subjects treatment modality will be followed for up to 5 years 
post study completion.  
Study Objective 
To evaluate the Tablo Hemodialysis System when used In-Center by trained 
individuals and In-Home by trained Subjects. 
Enrollment 
This study will enroll up to 50 Subjects to result in 30 evaluable Subjects at 10-20 
sites in the U.S. 
Primary Efficacy Endpoint 
Delivery of a standardized weekly Kt/V of greater than or equal to 2.1. 

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Primary Safety Endpoint 
The primary safety endpoint will be calculated using the mean number of adverse 
events from the pre-specified list observed during a dialysis interval:   
1. Serious Adverse Event:  any serious adverse event that: 
o 
Results in death, 
o 
Is life-threatening, 
o 
Requires hospitalization or prolongs existing hospitalization, 
o 
Requires intervention to prevent permanent impairment or 
damage, or 
o 
Results in persistent or significant disability/incapacity. 
2. Allergic Reaction:  Type A, anaphylactoid or Type B dialyzer reactions to 
dialyzer, blood tubing or chemical disinfectant. 
3. Blood Loss:  blood loss resulting in hemodynamic compromise that leads 
to death, transfusion or fluid resuscitation with greater than 1 liter of 
crystalloid IV fluids. 
4. Hemolytic Reaction:  hemolytic reactions due to disinfectant exposure, 
dialysate temperature, mechanical failure or other device related causes. 
5. Infection: any infection related to catheter, its tunnel or exit site, AV 
fistula, or AV graft. 
6. Intra-Dialysis Event: a significant clinical event such as loss of 
consciousness, cardiac arrest, or seizure caused by device failure.  
7. Vascular Access Complication: defined as AVF or AVG clotting during the 
dialysis procedure, bleeding for more than 30 minutes post-dialysis for 3 
consecutive sessions, difficulty with vascular access resulting in inability 
to initiate or complete dialysis treatments or complications related to 
hemodialysis catheters (not including reduced blood flow in catheter or 
TPA or catheter exchange). 
8. Pyrogenic Reaction: onset of objective chills (visible rigors) and fever 
(oral temperature greater than or equal to 37.5 degrees Celsius) in a 
Subject who was afebrile and who had no recorded signs or symptoms of 
infection before treatment. 
Secondary Outcome 
Measure 
The ultrafiltration (fluid removal) value as reported by the device will be 
within 10% of the expected fluid removal based on the UF prescription and 
the Tablo Console fluid removal algorithm. 

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Inclusion Criteria 
1. Subject has provided informed consent and has signed a Health 
Insurance Portability and Accountability Act of 1996 (HIPAA) compliant 
authorization statement. 
2. Subject is at least 18 years and less than 75 years of age. 
3. Subject has end stage renal disease (ESRD) adequately treated by 
maintenance dialysis achieving a Kt/V ≥ 1.2 and has been deemed stable 
for at least three months by his/her treating nephrologist.  
4. Subject has a well-functioning and stable vascular access that allows a 
blood flow of at least 300 ml/min. 
5. Subject understands the nature of the procedures and the requirements 
of the study protocol, including home-based dialysis. 
6. Subject is willing and able to comply with the protocol requirements and 
return to the treatment center for all required treatments and clinical 
evaluations. 
7. Subject has identified an individual to be trained and available as needed.  
The identified individual must be considered competent in the use of the 
device by the prescribing physician. 
8. Subject has a documented psychosocial evaluation by a qualified social 
worker, treating physician or home hemodialysis nurse.  
9. Subject has no childbearing potential or has a negative pregnancy test 
within 7 days prior to the start of the first study treatment and will be 
utilizing medically acceptable means of contraception during the study 
period. 

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Exclusion Criteria 
1. Subject is unable to read English or Spanish. 
2. Subject has dementia or lacks capacity for self-care. 
3. Life expectancy less than 12 months from first study procedure. 
4. Subject unable to understand or cooperate with hemodialysis nurse and 
dialysis care team. 
5. Subject has a documented history of non-adherence to dialysis therapy 
that would prevent successful completion of the study. 
6. Subject has had a recent major cardiovascular adverse event within the 
last 3 months. 
7. Subject has New York Class III or IV Congestive Heart Failure, or ejection 
fraction less than 30%.  
8. Subject has a persistent pre-dialysis sitting systolic blood pressure less 
than 100 mmHg despite medical therapy. 
9. Subject has symptomatic intra-dialytic hypotension requiring medical 
intervention in two of their last three treatments. 
10. Subject has an active infection requiring antibiotics within last 7 days.  
11. Subject with fluid overload due to intractable ascites secondary to liver 
cirrhosis. 
12. Subject has uncontrolled blood pressure (e.g. sustained/persistent pre-
dialysis systolic blood pressure greater than 180 mmHg despite maximal 
medical therapy in two of the last three treatments). 
13. Subject is intolerant to heparin. 
14. Subject is seroreactive for Hepatitis B Surface Antigen. 
15. Subject has an active, life-threatening, rheumatologic disease. 
16. Subject has a history of adverse reactions to dialyzer membrane material. 
17. Subject is participating in another investigative drug or device clinical 
study related to Home Hemodialysis which conflicts with the execution of 
this study.   
18. Subject is expected to receive an organ transplant during the course of 
the study. 
19. Subject has a life-threatening malignancy actively receiving treatment 
that would prevent successful completion of the study protocol. 
20. Any other documented condition that the Investigator feels would 
prevent the Subject from successful inclusion in the study. 
 
 

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2 
BACKGROUND 
End-Stage Renal Disease (ESRD) has become a major public health problem and is associated with 
considerable co-morbidity and mortality.  Currently, routine hemodialysis is the most prevalent treatment 
for ESRD and it is typically conducted in a dialysis outpatient facility.1  These patients must typically travel 
three times a week to the outpatient clinic and sit for hours while being dialyzed.  The realities of 
outpatient dialysis facilities render more frequent dialysis less practical for most patients, providers and 
caregivers.  
In recent years a significant body of evidence has emerged establishing the clinical, social and economic 
benefits of more frequent dialysis.2,3,4,5,6 Frequent dialysis is challenging in a clinic-based delivery model 
due to a variety of reasons (e.g. travel three times/week), which has led to a growing interest within the 
dialysis community to shift hemodialysis therapy to persons’ homes.  In-Home treatment allows for more 
frequent dialysis sessions, which more closely mimics the natural function of the kidneys. 
Additionally, home hemodialysis (HHD) also offers numerous medical advantages over conventional In-
Center hemodialysis.  Studies have demonstrated improved blood pressure control, reductions in use of 
hypertension medication7 and improvements in left ventricular function.8   Improved control of 
hyperphosphatemia,9 improvements in quality of sleep including patient reported quality of rest, 
decrease in episodes of apneic episodes, and decrease in restless leg syndrome severity have also been 
reported.10  Most importantly, improvements in overall patient survival rates have been shown with more 
frequent but shorter dialysis times,11 which are best met by HHD. 
A continuum of renal replacement therapies ranging from wearable artificial kidneys to better home 
hemodialysis technologies are in development, but many of the technologies are unproven or will take 
many years to mature. The Outset philosophy has been to couple the proven mechanisms of today’s In-
Center hemodialysis with targeted technology innovation that will bring the benefits of frequent 
hemodialysis to more patients.   
 
1 Lacson, E. Jr et al. Survival with three-times weekly in-center nocturnal versus conventional       hemodialysis. J. Am. 
Soc. Nephrol. 23, 687–695 (2012). 
2 Charra, B. et al. Long thrice weekly hemodialysis: the Tassin experience. Int. J. Artif. Organs 27, 265–283 (2004). 
3 Chertow, G. M. et al. In-center hemodialysis six times per week versus three times per week. N. Engl. J. Med. 363, 
2287–2300 (2010). 
4 Evans, R. W. et al. The quality of life of Subjects with end-stage renal disease. N. Engl. J. Med. 312, 553–559 (1985). 
5 Woods, J. D., Port, F. K., Stannard, D., Blagg, C. R. & Held, P. J. Comparison of mortality with home hemodialysis and 
center hemodialysis: a national study. Kidney Int. 49, 1464–1470 (1996). 
6Nitsch, D. et al. Outcomes in Subjects on home haemodialysis in England and Wales, 1997–2005: a comparative cohort 
analysis. Nephrol. Dial. Transplant. 26, 1670–1677 (2011). 
7 Lee, H. et al. Cost analysis of ongoing care of patients with end-stage renal disease: the impact of dialysis modality 
and dialysis access. Am. J. Kidney Dis. 40, 611–622 (2002). 
8 Kjellstrand, C. M. et al. Short daily haemodialysis: survival in 415 patients treated for patient-years. Nephrol. Dial. 
Transplant. 23, 3283–3289 (2008). 
9 Kraus, M. et al. A comparison of center-based vs. home-based daily hemodialysis for patients with end-stage renal 
disease. Hemodial. Int. 11, 468–477 (2007) 
10 Paoletti, E. et al. The worsening of left ventricular hypertrophy is the strongest predictor of sudden cardiac death in 
haemodialysis patients: a 10 year survey. Nephrol. Dial. Transplant. 19, 1829–1834 (2004). 
11 Block, G. A., Hulbert-Shearon, T. E., Levin, N. W. & Port, F. K. Association of serum phosphorus and calcium × 
phosphate product with mortality risk in chronic hemodialysis patients: a national study. Am. J. Kidney Dis. 31, 607–617 
(1998). 

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3 
STUDY OBJECTIVE 
To evaluate the Tablo Hemodialysis System when used In-Center by trained individuals and In-Home by 
trained Subjects. 
3.1 Device and Study Rationale 
The Tablo™ Hemodialysis System (System) makes hemodialysis more accessible to ESRD Subjects through 
meaningful improvements in usability.   
4 
DEVICE DESCRIPTION 
The Tablo™ Hemodialysis System is a self-contained hemodialysis system (Hemodialysis System or 
System), intended for acute and chronic dialysis therapy with or without ultrafiltration, in an acute or 
chronic care facility. The System is modular in design and contains two components: 1) the Tablo™ 
Console (Console), a single module consisting of multiple fluidic systems that perform the activities of a 
Water Purification System (WPS) and a conventional Dialysis Delivery System (DDS), and 2) the Tablo™ 
Cartridge (Cartridge), consisting of a single-use blood tubing set attached to an Organizer. A disposable 
Cartridge is inserted onto the front panel of the Console for each dialysis treatment. 
 
4.1 Tablo™ Hemodialysis System Overview 
Incoming water is pretreated in the Sediment and Carbon Filtration subsystem a. This pre-treated water 
then passes through the Reverse Osmosis (RO) system where polyamide thin-film composite membranes 
purify the incoming water. This process reduces the levels of chemical and microbial contaminants, 
producing water for dialysis meeting AAMI/ANSI/ISO 13959 limits. After cycling through the WPS, the 
purified water enters the Dialysis Delivery System.  
 
The Dialysis Delivery System de-aerates the treated water, then proportions and mixes in acid and 
bicarbonate concentrates. The resulting dialysate fluid passes through an ultrafilter to assure the dialysate 
meets the AAMI/ANSI/ISO 11663 limits for microbial contaminants. During routine use, both heat and 
chemical disinfections are utilized throughout both the Water Purification System and the Dialysis 
Delivery System to maintain water quality. Heat disinfection and chemical disinfection are performed at 
defined intervals to reduce the microbial burden that may occur in the fluid path and components. 
 
The Cartridge, consisting of a single-use disposable blood tubing set attached to an Organizer, draws 
blood from the Subject through interaction with a peristaltic pump, and passes the blood through a 
dialyzer before returning the treated blood to the Subject. The disposable Cartridge is provided sterile. 
Therefore, neither the blood tubing set nor Organizer is treated with heat or chemical disinfectant. 
 
4.2 Principle of Operation 
During treatment, the water purification system produces dialysis-quality water, which is delivered to the 
Dialysis Delivery System where the water is mixed with the proportioned concentrates. The resulting 
dialysate passes through the ultrafilter and enters the dialyzer.  
Within 24 hours following treatment the Tablo Console performs a heat disinfection cycle, during which 
the fluid path components of both the water purification system and the Dialysis Delivery System are 
heated. After the heat disinfection cycle is completed, the Console shuts down and any residual hot water 
in the Console cools. The Console performs a pre-treatment cycle before the next treatment begins during 
which the entire fluid path is flushed with freshly purified water. 
 
In addition to post-treatment heat disinfection, a chemical disinfection cycle is performed periodically. 
During this cycle, a peracetic acid type of disinfectant (e.g. Peracidin) disinfects the fluid path. After the 
chemical disinfection, the fluid path is rinsed until no detectable residual peracetic acid is present (as 

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determined by conductivity measurements). After rinsing the chemical disinfectant, another heat 
disinfection cycle is performed as previously described.  The complete disinfection cycle concludes when 
the Console shuts down and any remaining water cools. Prior to the next treatment, the user is prompted 
by the user interface to perform a water test to ensure no residual disinfectant remains. 
 
4.3 Proposed Indications For Use 
The Tablo™ System is indicated for use in patients with acute and/or chronic renal failure, with or without 
ultrafiltration, in an acute or chronic care facility.  Treatments must be administered under physician's 
prescription, with a trained individual available as needed who is considered competent in the use of the 
device by the prescribing physician. The Tablo™ System is also indicated for use in the home.  
4.4 Device Instructions 
A comprehensive User Manual for the Tablo Console and Instructions for Use for the Tablo Cartridge, 
including warnings and precautions, has been created.  Please refer to the most current version for 
complete details on preparation and procedural use of the device.   
4.4.1 
Medical Informatics 
USB flash drives connected directly to the Tablo™ Hemodialysis Console will capture individual treatment 
details.   Treatment data captured will include, but is not limited to, prescription details, blood pressure 
readings, heparin infusion data (from the heparin pump), changes to treatment parameters, total fluid 
removed during treatment, and alarms and errors.  This data may also be collected via wireless 
capabilities. 
Note: If a heparin bolus is prescribed for the Subject to be administered prior to the initiation of 
treatment, the dosage amount will not be saved to the USB drive and will need to be manually recorded 
in the Subject’s medical record and transcribed to the case report form. 
4.4.2 
Device Set-up 
4.4.2.1 
Initial Device Set-up 
The Tablo Console must be connected to an incoming water source, an outgoing drain line, and an 
electrical outlet.  Additional instructions on the Console set-up can be found in the User Manual. 
4.4.2.2 
Supplies for Dialysis Therapy 
Prior to beginning set-up for each dialysis treatment, the clinical site personnel (In-Center) and/or the 
Subject (In-Home), should collect the following supplies: 

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Supplies provided by Outset 
General Supplies provided by the Dialysis Center 
• 
1 Container of Acid Concentrate (red label) 
• 
1 Container of Bicarbonate Concentrate (blue 
label) 
• 
1 Tablo Cartridge (blood tubing set) 
• 
1 Commercially Available Dialyzer  
• 
1 USB flash drive for prescription upload and 
treatment data capture 
• 
1-2 Saline Bags (Subject dependent) 
• 
Heparin (per Subject’s prescription) 
• 
Dialysis Needles 
• 
Syringes for heparin pump and initial heparin 
dose 
Note: the syringe for use with the heparin 
pump should be one of the following types: 
Beckton Dickinson 10ml, Terumo 10ml, or 
Kendall Monoject 12ml 
• 
Cleaner for vascular access site 
• 
Gauze pads and tape for vascular access 
• 
Gloves, mask and safety glasses 
• 
Biohazard box and bag 
• 
Chlorine Test Kit 
4.4.2.3 
Prescription for Dialysis Therapy 
Subject prescription details will be uploaded to the Tablo™ Console using a Subject specific USB flash 
drive. Before treatment can begin, the user must validate the prescription details via a user interface 
confirmation screen (Table 1).  The user interface will allow treatment to begin only after the prescription 
is verified.  Tablo’s prescription screen includes two “on/off” options, including use of the heparin pump 
and the ability to capture standing blood pressure readings in addition to the required sitting blood 
pressure readings.   
 
Table 1: Prescription Details 
Subject Settings 
Treatment 
Settings 
Dialysate Settings 
Blood Pressure 
Settings 
Heparin Settings 
• Estimated Dry 
Weight 
• Access Type 
• Blood Clot Time 
(defaulted to 3 
min.) 
• Saline Bolus 
Volume (defaulted 
to 100 ml) 
• Blood Flow 
Rate 
• Length of 
Treatment 
• Concentrate Type 
• Sodium Setting 
• Bicarbonate 
Setting 
• Potassium Setting 
• Dialysate 
Temperature 
• Dialyzer Type 
• Standing Blood 
Pressure 
(on/off) 
• Blood Pressure 
Frequency 
• Heparin Pump 
(on/off) 
• Heparin Flow Rate 
• Heparin Stop Time 
• Heparin 
Concentrate 
• Heparin Syringe 
Type 
4.4.2.4 
Heparin Dosing for Dialysis Therapy 
If an initial heparin bolus is prescribed for treatment with the Tablo™ Hemodialysis System, then a heparin 
dose will be manually delivered to the Subject with a syringe prior to commencement of treatment.  
Heparin dosing during dialysis treatment may be delivered manually or automatically using the heparin 
pump.   Heparin therapy during dialysis treatment will be prescribed according to institutional practices 
and at the discretion of the Investigator.  To optimize therapy, it is suggested that Subjects receive a 
heparin bolus of 30 units/kg at the start of treatment, followed by 15 units/kg hourly.  For arterial, 
venous, fistula or graft Subjects heparin administration should be discontinued 30 minutes before the end 
of treatment. 

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4.4.2.5 
System Interfaces 
The user will interact with multiple system interfaces when using the Tablo™ Console.  All interfaces 
described are through the Tablo touchscreen.  A summary of each interface is described below: 
1. Pre-Treatment Mode (Set-Up) - The user interface employs a checklist approach to guide users 
through the sequence of steps in “pre-treatment mode”, including (1) connection of the 
concentrate containers, Tablo™ Cartridge, dialyzer, saline, and heparin, (2) verification of the 
Subject prescription settings, (3) Subject pre-treatment vitals, (4) system priming, (5) water 
chlorine test, and (6) Subject vascular access.  Preparation for treatment via this mode can be 
accessed in the user interface via the Home Screen “Get Started” button. 
2. Treatment Mode (During Dialysis) - Treatment mode covers the dialysis therapy process from 
initial blood flow from the Subject to the extracorporeal circuit through to final blood return to 
the Subject after treatment completion.  The user interface employs a single main treatment 
progress screen which monitors blood pressure and pulse measurements, saline bolus delivery, 
fluid removal (ultrafiltration) and blood pump cessation, and changes to treatment settings.  
Additionally, the main treatment screen tracks treatment time.  A secondary user interface 
screen monitors additional treatment information like arterial and venous pressure readings and 
a log of blood pressure and pulse readings.  The treatment mode user interface also includes 
confirmation screens for delivering a saline bolus, stopping fluid removal, and stopping the blood 
pump.  Additionally, the user interface guides the user to save changes to treatment settings and 
to replace a saline bag. 
3. Post-Treatment Mode - The user interface also employs a checklist approach to guide users 
through the sequence of steps in “post-treatment mode”, including (1) disconnection of the 
Subject blood lines, (2) access site closure, (3) Subject post-treatment vitals, and (4) 
disconnection and disposal of the concentrate containers, Tablo Cartridge, dialyzer, saline, and 
heparin from the Tablo™ Console.  The Tablo™ Console can be programmed to automatically 
begin a heat disinfection cycle. 
4. Maintenance Mode - The user interface employs a checklist approach to guide users through the 
sequence of steps for periodic maintenance activities, including (1) heat disinfection, (2) chemical 
disinfection with a water test, (3) carbon filter replacement, (4) sediment filter replacement, and 
(5) ultrafilter replacement.  The user interface is designed to automatically remind users when a 
maintenance activity is required.  Additionally, the maintenance functions can be accessed in the 
user interface via the Home Screen “Maintenance” button. 
5 
STUDY ENDPOINTS 
5.1 
Evaluation of Efficacy  
The primary effectiveness endpoint is the delivery of a standardized weekly Kt/V of greater than or equal 
to 2.1.  The standardized weekly Kt/V value will be computed by the Sponsor and included in the study 
database from laboratory data provided/recorded by the site via the Case Report Forms (CRFs). 
This analysis will be based on the Intent-to-Treat (ITT) population (section 11.1.1) with a supportive 
analysis for the Per-Protocol (PP) population (section 11.1.2). 
 
 

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5.2 
Evaluation of Safety 
The primary safety endpoint will be calculated using the mean number of adverse events from the pre-
specified list observed during a dialysis interval as follows: 
1. Serious Adverse Event:  any serious adverse event that: 
• 
Results in death, 
• 
Is life-threatening, 
• 
Requires hospitalization or prolongs existing hospitalization, 
• 
Requires intervention to prevent permanent impairment or damage, or 
• 
Results in persistent or significant disability/incapacity. 
2. Allergic Reaction:  Type A, anaphylactoid or Type B dialyzer reactions to dialyzer, blood tubing or 
chemical disinfectant. 
3. Blood Loss:  blood loss resulting in hemodynamic compromise that leads to death, transfusion or 
fluid resuscitation with greater than 1 liter of crystalloid IV fluids. 
4. Hemolytic Reaction:  hemolytic reactions due to disinfectant exposure, dialysate temperature, 
mechanical failure or other device related causes. 
5. Infection: any infection related to catheter, its tunnel or exit site, AV fistula, or AV graft. 
6. Intra-Dialysis Event: a significant clinical event such as loss of consciousness, cardiac arrest, or 
seizure caused by device failure.  
7. Vascular Access Complication: defined as AVF or AVG clotting during the dialysis procedure, 
bleeding for more than 30 minutes post-dialysis for 3 consecutive sessions, difficulty with 
vascular access resulting in inability to initiate or complete dialysis treatments or complications 
related to hemodialysis catheters (not including reduced blood flow in catheter or TPA  or 
catheter exchange). 
8. Pyrogenic Reaction: onset of objective chills (visible rigors) and fever (oral temperature greater 
than or equal to 37.5 degrees Celsius) in a Subject who was afebrile and who had no recorded 
signs or symptoms of infection before treatment. 
A dialysis interval is defined as the start of one dialysis treatment until the start of the next dialysis 
treatment.  The primary safety analysis will be performed on the Intent-to-Treat (ITT) population. 
5.3 
Secondary Outcome Measure 
The ultrafiltration (fluid removal) value as reported by the device will be within 10% of the expected fluid 
removal based on the UF prescription and the Tablo Console fluid removal algorithm. 
5.4 
Other Data and Analyses 
Baseline and demographic characteristics will be summarized for all Subjects.  Continuous variables will be 
displayed via summary statistics (mean, median, sample size, standard deviation, minimum, and 
maximum).  Categorical variables will be summarized via counts and percentages.  In addition, summary 
statistics will be computed on the number of pre-specified adverse events per dialysis interval for each 
treatment period.  The same summary statistics will be calculated by treatment period for the rate of pre-
specified adverse events per 100 dialysis treatments.  Concomitant medications that may affect the study 
endpoints will also be collected and analyzed.  These include, but are not limited to, blood thinners, 
diuretics, hypertensives and iron supplements. 
6 
STUDY DESIGN 
6.1 
Overview 
This is a prospective, multicenter, open label, non-randomized, cross-over study.  Subjects will be enrolled 
in the trial for approximately 21 weeks during which time Subjects will use the Tablo™ Hemodialysis 

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System for dialysis treatments in all study phases.  There are four periods during which the Tablo System 
will be utilized; run-in, treatment period 1, training/transition and treatment period 2. 
• Run-in – Subjects will undergo dialysis treatment 4 times/week for 1 week In-Center.  Treatments will 
be administered by study staff.   
Confirmation of study eligibility will be assessed after the Subject completes this one-week run-in 
period. 
• Treatment Period 1, In-Center – Subjects will undergo dialysis treatment 4 times/week for 32 
treatments (approximately 8 weeks) In-Center.  Treatments will be administered by study staff. 
Subjects are expected to undergo no more than 4 complete treatments per week during this 
treatment period. 
Subjects are considered enrolled in the study if they meet all inclusion and exclusion criteria and have 
started the first study treatment during the first treatment period. 
• In-Home Transition– Subjects will undergo device training for the study, then perform self-care 
dialysis 4 times/week for approximately 4 weeks.   Treatments performed during the first portion will 
be completed In-Center under supervision.  Treatments performed during the second portion will be 
completed In-Home.  This second portion will assess subject stability in a new care 
environment.  Supervision will be at the discretion of the Investigator. 
• Treatment Period 2, In-Home – Subjects will undergo self-care dialysis treatment 4 times/week for 
32 treatments (approximately 8 weeks) In-Home.  Subjects are expected to undergo no more than 4 
complete treatments per week during this treatment period. 
 
• Follow-Up---Subjects treatment modality will be followed for up to 5 years post study 
completion. 
 
 
 
Figure 1:  Study Design 
Data collected during Treatment Period 1 and Treatment Period 2 will be used to assess the primary 
endpoints. 
In the event a subject undergoes more than 4 complete treatments per week, during Treatment Period 1 
and Treatment Period 2, the additional treatment(s) will be reported as a protocol deviation per Section 
13.3.2.   
6.2 
Efforts to Minimize Bias 
To maintain a balanced population in the study, no single Investigational Site will be permitted to enroll 
more than 30% of the entire study population.  
6.3 
Blinding and Randomization 
This study is a prospective, multicenter, open label, non-randomized, cross-over study comparing In-
Center and In-Home hemodialysis performance using the Tablo™ Hemodialysis System.  Both Subjects and 

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attending clinicians will know the System delivering dialysis treatments, therefore, blinding is not 
required.   
Each Subject will serve as his or her own control in terms of treatment period comparisons (In-Center 
versus In-Home), and as such, randomization procedures are not required. 
6.4 
Clinical Events Committee 
In order to minimize bias, an independent Clinical Events Committee (CEC) will assess clinical events to 
determine the following: 
• Confirm whether or not the event should be included as one of the 8 pre-specified adverse 
events (defined in Section 9.1.5) that will be analyzed as the Primary Safety Endpoint for the 
study. 
• Event was related to the device as defined in Section 9.2.3. 
• Event was related to the dialysis procedure and is considered an additional treatment 
observation (ATO) as defined in Section 9.1.3.  These adverse events are generally associated 
with dialysis and are a consistent with the Subject’s established history on dialysis. 
• Event was related to a pre-existing condition. 
7 
SUBJECT SELECTION 
7.1 
Study Population 
Subjects with a diagnosis of end stage renal disease (ESRD) who meet the inclusion and exclusion criteria 
will be eligible for participation in this study.  The eligibility criteria for the TABLO study are designed to 
capture diverse Subjects, such as those patients who are currently undergoing In-Center, In-
homehemodialysis, or peritoneal dialysis. In addition, Subjects with all vascular access types are eligible 
for the study and may include catheters, grafts, and fistulas.  Potential study candidates should be 
screened for eligibility according to the study inclusion and exclusion criteria.   
To be considered enrolled in the study, the Subject must meet all inclusion and exclusion criteria and have 
started the first study treatment during the first treatment period.   
7.2 
Informed Consent 
IMPORTANT:  The Code of Federal Regulations requires that the consent form signed by the Subject 
must be dated at the time consent is given.  Also, medical records must contain documentation that 
informed consent was obtained prior to participation in a study.  (21 CFR Parts 50 and 812) 
The Investigator may determine whether potential Subjects are interested in participating in an 
investigation, but shall not request the written informed consent of any Subject to participate, and shall 
not allow any Subject to participate before obtaining Institutional Review Board (IRB) and FDA approval.  
The consent process shall begin before care is altered beyond the scope of a routine comprehensive 
examination for the purpose of participating in this study. 
All Subjects in this research study should be completely informed about the purpose, duration, and 
pertinent details of the study.  The informed consent process must be documented using a written form 
that has been approved by the IRB and includes all Basic Elements of Informed Consent and pertinent 
Additional Elements (21 CFR Part 50.25).   
The Investigator must keep the original signed copies of all consent forms in the Subject’s medical records 
and provide a copy to each Subject. 

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Appendix A outlines the screening and enrollment process and illustrates the point where informed 
consent should be obtained. 
7.3 
Subject Privacy 
In accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), all Subjects 
should be informed of potential uses and disclosures of their medical information for research purposes, 
and their rights to access information about them by covered entities.  Each Investigator will follow the 
procedures for securing HIPAA compliance as directed by their respective IRB or Privacy Board, and to 
obtain written authorization to use and disclose Subject information for all clinical research and research 
involving questioning of the Subject’s or Subjects’ physician(s).  Per individual site procedures, this 
authorization may be included as part of the Subject informed consent form. 
7.4 
Inclusion Criteria  
Subjects must meet ALL of the inclusion criteria to be enrolled in the study. 
1. Subject has provided informed consent and has signed a Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) compliant authorization statement. 
2. Subject is at least 18 years and less than 75 years of age. 
3. Subject has end stage renal disease (ESRD) adequately treated by maintenance dialysis achieving 
a Kt/V ≥ 1.2 and has been deemed stable for at least three months by his/her treating 
nephrologist.  
4. Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 
ml/min. 
5. Subject understands the nature of the procedures and the requirements of the study protocol, 
including home-based dialysis. 
6. Subject is willing and able to comply with the protocol requirements and return to the treatment 
center for all required treatments and clinical evaluations. 
7. Subject has identified an individual to be trained and available as needed.  The identified 
individual must be considered competent in the use of the device by the prescribing physician. 
8. Subject has a documented psychosocial evaluation by a qualified social worker, treating 
physician or home hemodialysis nurse.  
9. Subject has no childbearing potential or has a negative pregnancy test within 7 days prior to the 
start of the first study treatment and will be utilizing medically acceptable means of 
contraception during the study period. 
7.5 
Exclusion Criteria  
If ANY of the exclusion criteria are met, the Subject is excluded from the study. 
1. Subject is unable to read English or Spanish. 
2. Subject has dementia or lacks capacity for self-care. 
3. Life expectancy less than 12 months from first study procedure. 
4. Subject unable to understand or cooperate with hemodialysis nurse and dialysis care team. 
5. Subject has a documented history of non-adherence to dialysis therapy that would prevent 
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6. Subject has had a recent major cardiovascular adverse event within the last 3 months. 
7. Subject has New York Class III or IV Congestive Heart Failure, or ejection fraction less than 30%.  
8. Subject has a persistent pre-dialysis sitting systolic blood pressure less than 100 mmHg despite 
medical therapy. 
9. Subject has symptomatic intra-dialytic hypotension requiring medical intervention in two of their 
last three treatments. 
10. Subject has an active infection requiring antibiotics within last 7 days.  
11. Subject with fluid overload due to intractable ascites secondary to liver cirrhosis. 
12. Subject has uncontrolled blood pressure (e.g. sustained/persistent pre-dialysis systolic blood 
pressure greater than 180 mmHg despite maximal medical therapy in two of the last three 
treatments). 
13. Subject is intolerant to heparin. 
14. Subject is seroreactive for Hepatitis B Surface Antigen. 
15. Subject has an active, life-threatening, rheumatologic disease. 
16. Subject has a history of adverse reactions to dialyzer membrane material. 
17. Subject is participating in another investigative drug or device clinical study related to Home 
Hemodialysis which conflicts with the execution of this study.   
18. Subject is expected to receive an organ transplant during the course of the investigation. 
19. Subject has a life-threatening malignancy actively receiving treatment that would prevent 
successful completion of the study protocol. 
20. Any other documented condition that the Investigator feels would prevent the Subject from 
successful inclusion in the study. 
7.6 
Subject Discontinuation and Replacement 
Every Subject should remain in the study until completion of the required follow-up period.  Subjects may 
voluntarily withdraw from the study at any time with or without reason and it will not have any negative 
impact on subsequent treatment. Conceivable reasons for Subject discontinuation may include, but are 
not limited to, the following: 
• 
Subject Withdrawal: Subject participation in this clinical study is voluntary.  The Subject may 
choose to discontinue participation (refuse all subsequent testing) at any time without loss of 
benefits or penalty.  
• 
Discontinuation:  Subject participation may be discontinued by the Subject or Investigator 
because of a treatment modality change, organ transplant, transfer, death or prolonged 
hospitalization. 
• 
Investigator Termination: The Investigator may terminate the Subject’s participation without 
regard to the Subject’s consent if the Investigator believes it is medically necessary. 
• 
Exclusion Criterion Discovered After Enrollment: A small number of Subjects may be enrolled 
despite meeting an exclusion criteria due to timing of study required clinical procedures. This will 
be documented by the study personnel on the Case Report Form (CRF), and will be considered a 
protocol deviation.  

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• 
Lost-to-Follow-up: If the Subject fails to complete eight consecutive treatments, regardless of 
whether or not they fall into a single treatment period or a total of up to eight missed 
treatments, consecutive or not,  per period, but has not formally withdrawn from the study, he 
or she will be considered lost-to-follow-up.  The data from this Subject is still eligible for the 
intent to treat dataset.  Site personnel should make all reasonable efforts to locate and 
communicate with the Subject, at each contact time point, including: 
o 
A minimum of two telephone calls to contact the Subject should be attempted.  Each 
attempt should be recorded in the Subject’s medical record, including date, time, and initials 
of site personnel attempting the contact. 
o 
If telephone calls are unsuccessful, a certified letter should be sent to the Subject. 
If the above-mentioned attempts at communicating with the Subject are unsuccessful, the 
Subject will be considered lost-to-follow-up.   
NOTE: If the Subject can be contacted, study treatments will resume at the point when the last 
treatment was conducted. 
In all cases, the reason(s) for withdrawal, if given, must be recorded on the appropriate CRF and in the 
Subject's medical record.  If more than one reason is cited for withdrawal, study personnel must identify 
the most significant reason and record this reason on the CRF.  Investigators must also report all Subject 
withdrawals to their IRB as defined by their institutions’ procedures.  Subjects who withdraw or are 
withdrawn from the study, or are lost to follow-up may be replaced.  
8 
STUDY PROCEDURES 
8.1 
Baseline Evaluation  
The baseline evaluation will include, but is not limited to, the following testing and assessments, and will 
be conducted prior to initiating the Run-In period per Appendix B: 
• 
Documentation of consent 
• 
Demographics (Sex, Age, Ethnicity, Race) 
• 
Physical Examination 
• 
Medical History (including history of vascular access) 
• 
Hemodialysis prescription (e.g., equipment,  number of times dialyzed per week, and whether in-
home or in-clinic settings) 
• 
Laboratory Values 
o 
Documentation of Laboratory values for 3 months prior to Run-In. 
o 
Laboratory Testing (hematology and chemistry) as needed* 
• 
Assessment of kinetics 
• 
Routine signs and symptoms  
• 
Concomitant medications 
* If the subject has had lab work within two weeks of the run-in period that contains all of the protocol 
specified tests, a repeat lab draw at baseline is not necessary.   

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If, after completion and review of the above data, the Subject appears to be a good candidate for study 
enrollment and is assessed as being able to perform self-care, the Investigator will proceed with the run-
in period using the Tablo Hemodialysis System. 
8.2 
1-week Run-in  
The 1-week run-in period will include, but is not limited to, the following testing, procedures, and 
assessment per Appendix B: 
• 
Subject’s Dialysis Prescription Settings 
• 
Pre-dialysis vitals, including body weight, temperature, blood pressure, and heart rate (pulse) 
• 
Number of dialysis sessions completed 
• 
Post-Dialysis body weight 
• 
Assessment of Kinetics 
• 
Concomitant Medications 
• 
Assessment of dialysis interval adverse events (if any) 
• 
Final assessment of Subject eligibility 
All treatments will be performed using the Tablo™ Hemodialysis System.  Dialysis personnel, trained on 
the use of the device, will input the dialysis prescription as detailed below: 
The dialysis prescription will include: 
• 
Access blood flow (set between 300 and 400 ml/min.)  
• 
Dialysate temperature (between 36 and 39 degrees Celsius adjustable by 0.5 degrees 
increments) 
• 
Composition of dialysate: potassium (limited to 2 mEq/dL versus 3 mEq/dL), bicarbonate (30 to 
40 mEq/L adjustable in 1 mEq/L intervals), sodium concentrations (135-145 mEq/L in 1mEq/liter 
increments)  
• 
Treatment length in minutes between 160 minutes and 240 minutes    
• 
Blood pressure parameters for ultrafiltration  
• 
Heparin dose and anticoagulation parameters  
Using established center protocols, and after adequate patient training for performing their own first 
cannulation, dialysis personnel will observe or perform: 1) the Subjects’ dialysis access (i.e., catheter, 
fistula or graft) preparation using In-Center aseptic technique, and 2) cannulation of the fistula or graft, or 
connection to a catheter.  Dialysis will then be initiated and ongoing monitoring of the Subject will be 
done per center protocol.  During treatment, vital signs, including blood pressure measurements and 
heart rate (pulse), will be collected every 30 minutes for the first hour, then hourly until the completion of 
the treatment.  
Post-treatment vitals, including body weight, temperature, blood pressure and heart rate (pulse), will also 
be collected.  
Each Subject will be prescribed dialysis therapy using the Tablo™ Hemodialysis System for four times per 
week with no inter-dialytic (end of treatment period to start of next treatment) period greater than 2 
days. No isolated ultrafiltration will be available on the device during the study.   

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During the Run-In period, Investigators or their designee, may use other clinical assessment indicators to 
determine the Subject’s ability to perform self-care (including but not limited to, self-cannulation and 
assessment of the home environment).   Any issues which would prevent dialysis from being performed, 
or that would require a change in dialysis procedure will be communicated to Outset. 
If, after completion of the baseline evaluation and Run-In period, the Investigator determines the Subject 
meets all inclusion and exclusion criteria, the Subject will begin Treatment Period 1, In-Center dialysis 
using the Tablo Hemodialysis System. 
8.3 
Treatment Period 1 (In-Center) 
Investigators or their designee will perform routine pre-dialysis assessment of adverse events, infections, 
medication changes, and subject’s vitals including body weight, blood pressure, temperature, and heart 
rate (pulse).  Any issues which would prevent normal dialysis from being performed or that would require 
a change in dialysis procedure will be communicated with the study Sponsor.  
Dialysis personnel, trained on the use of the device, will perform device set-up, input the dialysis 
prescription and administer dialysis therapy In-Center during Treatment Period 1 according to the 
Investigator’s instruction. 
Prior to treatment, pre-dialysis vitals, including body weight, temperature, blood pressure, and heart rate 
(pulse), will be collected. Using established center protocols, dialysis personnel will observe or perform: 1) 
the Subjects’ dialysis access (i.e., catheter, fistula or graft) preparation using In-Center aseptic technique, 
and 2) cannulation of the fistula or graft, or connection to a catheter.  Dialysis will then be initiated and 
ongoing monitoring of the Subject will be done per center protocol. During treatment, vital signs, 
including blood pressure measurements and heart rate (pulse), will be collected every 30 minutes for the 
first hour, then hourly until the completion of the treatment. 
Post-treatment vitals, including body weight, temperature, blood pressure and heart rate (pulse), will also 
be collected. 
NOTE: Subjects are considered enrolled in the Study if they have met all inclusion and exclusion criteria 
and the first treatment during Treatment Period 1 has been started. 
Each Subject will be prescribed dialysis therapy for four times per week with no inter-dialytic (end of 
treatment period to start of next treatment) period greater than 2 days. No isolated ultrafiltration will be 
available on the device during the study.   
During therapy, each Subject is encouraged to limit food and water intake.  Subjects will document any 
alarms that occurred which required intervention (such as medication or saline administration or a change 
in treatment parameters), under what conditions they occurred, and final resolution.  A summary of alarm 
occurrence will be tabulated from data transmitted to Outset Medical. Subjects will also document any 
signs or symptoms that they experienced during treatment.   
8.4 
 Transition Period (In-Center/In-Home dialysis treatment) 
Over the four-week transition period, Investigational site personnel will confirm the Subject is stable in 
the new care environment, has been appropriately trained on the set up and use of the Tablo 
Hemodialysis System and has satisfactorily  completed the items of the patient skills assessment.  The 
Subject will be responsible for device set up and initiating therapy under the supervision of study 
personnel In-Center during the first portion.  The second portion of the transition period In-Home will be 
supervised at the discretion of the investigator.  
Prior to treatment, pre-dialysis vitals, including body weight, temperature, blood pressure, and heart rate 
(pulse), will be collected. Using established center protocols, the subject or identified trained individual 

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will: 1) prep Subject’s dialysis access (i.e., catheter, fistula or graft) using trained aseptic technique, and 2) 
perform cannulation of the fistula or graft, or connection to a catheter.  
Once all pre-treatment steps are complete, the Subject will initiate dialysis and monitor their treatment 
according to the center protocol.  During treatment, vital signs, including blood pressure measurements 
and heart rate (pulse), will be collected every 30 minutes for the first hour, then hourly until the 
completion of the treatment. 
Post-treatment vitals, including body weight, temperature, blood pressure and heart rate (pulse), will also 
be collected. 
During therapy, each Subject is encouraged to limit food and water intake.  Subjects will document any 
alarms that occurred which required intervention (such as medication or saline administration or a change 
in treatment parameters), under what conditions they occurred, and final resolution.  A summary of alarm 
occurrence will be tabulated from data transmitted to Outset Medical.  Subjects will also document any 
signs or symptoms that they experienced during treatment.   
Each Subject will be prescribed dialysis therapy for four times per week with no inter-dialytic (end of 
treatment period to start of next treatment period) period greater than 2 days. No isolated ultrafiltration 
will be available on the device during the study.   
8.5 
Treatment Period 2 (In-Home dialysis treatment) 
Subject will administer dialysis therapy at home during Treatment Period 2 according to the Investigator’s 
instruction.  After device setup, the Subject will take his/her pre-dialysis vitals, including body weight, 
temperature, blood pressure, and heart rate (pulse), and confirm the dialysis prescription. 
Using established center protocols, the subject or identified trained individual will: 1) prep Subject’s 
dialysis access (i.e., catheter, fistula or graft) using trained aseptic technique, and 2) perform cannulation 
of the fistula or graft, or connection to a catheter.  
Once all pre-treatment steps are complete, the Subject will initiate dialysis and monitor their treatment 
according to the center protocol.  During treatment, vital signs, including blood pressure measurements 
and heart rate (pulse), will be collected every 30 minutes for the first hour, then hourly until the 
completion of the treatment.   
Post-treatment vitals, including body weight, temperature, blood pressure and heart rate (pulse), will also 
be collected. 
During therapy, each Subject is encouraged to limit food and water intake.  Subjects will document any 
alarms that occurred which required intervention (such as medication or saline administration or a change 
in treatment  parameters), under what conditions the alarms occurred, and final resolution. A summary of 
alarm occurrence will be tabulated from data transmitted to Outset Medical.  Subjects will also document 
any signs or symptoms that they experienced during treatment.  . 
Each Subject will be prescribed dialysis therapy for four times per week with no inter-dialytic (end of 
treatment period to start of next treatment period) period greater than 2 days. No isolated ultrafiltration 
will be available on the device during the study.   
8.6 
Weekly Visits during the In-Center and In-Home Treatment Periods 
Weekly visits for each Subject will be conducted by a study staff member during Treatment Periods 1 (In-
Center) and 2 (In-Home).  During this weekly visit, signs and symptoms experienced by the Subject both 
since the last dialysis treatment as well as those experienced during dialysis treatments will be reviewed, 
as well as compliance to treatment time.  The study staff member will also review the definitions of 
adverse and serious adverse events and re-educate the Subject where necessary.   

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8.7 
Laboratory Assessments 
Each Subject will be required to provide approximately 120ml or 8 tablespoons of total blood for the 
duration of the trial to monitor the Subject’s blood chemistry. Samples will be collected as outlined in 
Appendix B. 
For weekly draws to calculate the Urea Reduction Ratio (URR) and thereby quantify dialysis treatment 
adequacy, collect approximately 54-57ml into Yellow top or serum separator tubes in increments of 3ml 
or 0.6 teaspoons for pre and post dialysis treatment BUN.   
For pre BUN, prior to connecting to Tablo or administering heparin bolus, fill appropriate tubes 
according to the standard of care. 
For post BUN, pull the sample at the conclusion of therapy by reducing the blood pump speed to 100 
ml per minute. Allow one minute to elapse at that blood flow rate, then collect the sample according 
to the standard of care.  
Additionally, at least twice during each treatment period (Treatment Period 1, In-Center and Treatment 
Period 2, In-Home), collect both chemistry and hematology, and iron indices as specified (see Appendix B 
for tests and timing). 
For chemistry, collect approximately  54-57ml into Tiger top or serum separator tubes in increments of 
3ml or 0.6 teaspoons, according to the standard of care.  
For hematology, collect approximately 12ml in Lavender top tubes in increments of 3ml or 0.6 teaspoons 
according to the standard of care. 
During visits when both Chemistry and CBC labs will be drawn, the recommended draw order is Tiger top 
or serum separator followed by Yellow top or serum separator.  All samples will be processed according 
to reference laboratory requirements.  No blood samples will be stored or used for permanent or 
immortal cell lines.   
8.8 
Follow Up 
Subjects’ treatment modialities will be followed for up to 5 years post study completion. 
8.9 
Device Malfunction 
Device malfunctions are instances where the device does not perform as intended.  During device set-up, 
treatment administration and post-treatment, site personnel and/or the Subject will be requested to 
inspect and identify any defective parts.  The study Investigator (or designee) will notify the Sponsor and 
comply with Sponsor procedures for returned goods.    
8.10 
Subject Assessment 
Each Subject will be asked to complete questions weekly regarding whether or not the device was easy to 
use, whether assistance was needed, and the length of recovery time required post treatment.  In 
addition, the Subject will be asked to complete a questionnaire regarding signs and symptoms 
experienced during each treatment (see section 9.2 Recording Adverse Events).   
 
8.11 
Device Water and Dialysate Testing 
During device installation in-center and in-home and monthly thereafter,  water and dialysate samples 
will be collected and tested.  Samples above the limits (≥100CFU/ml or ≥0.50 EU/ml for dialysate and ≥100 
CFU/ml or >0.25EU/ml for water) may be considered device failures.  If results are above the action limit 

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(≥50 CFU/ml or ≥0.50 EU/ml for dialysate and ≥50 CFU/ml or >0.25EU/ml for water) a chemical 
disinfection cycle will be run, a new sample will be drawn and new test results obtained. In addition, 
Sponsor will review the culture and disinfection logs and determine if the system should be removed from 
patient use.  If above the action limit upon retesting the device will be removed from use. 
9 
ADVERSE EVENT REPORTING 
9.1 
Adverse Event Definitions 
9.1.1 
Adverse Event (AE):  
An adverse event (AE) is any undesirable medical occurrence in a clinical study Subject, whether it is 
considered to be related to the device or not, that includes a clinical sign, symptom or condition. 
9.1.2 
Serious Adverse Events (SAEs)  
An AE is considered to be serious if it: 
• 
results in death; 
• 
is life-threatening; 
• 
requires Subject hospitalization or prolongation of existing hospitalization; 
• 
requires  intervention to prevent permanent impairment or damage;  
• 
results in persistent or significant disability/incapacity 
9.1.3 
Additional Treatment Observations (ATOs)  
Additional Treatment Observations (ATOs) are observations of interest that are not considered adverse 
events.  These observations will be recorded as measured.  These include, but are not limited to: 
• 
Blood pressure measurements 
• 
Phosphorous and potassium levels 
• 
Alarms that end treatment 
• 
Subjects feeling cold during treatment 
• 
Study Subject drop out 
• 
clinically significant alarms during treatment as reported by the Tablo Console 
o 
air in venous bloodline,  
o 
low systolic blood pressure, 
o 
high/low venous pressure, and  
o 
blood leak in dialyzer 
 
9.1.4 
Unanticipated Adverse Device Effects (UADEs) 
An unanticipated Adverse Device Effect means any serious adverse effect on health or safety or any life-
threatening problem or death caused by, or associated with, a device, if that effect, problem, or death 
was not previously identified in nature, severity, or degree of incidence in the investigational plan or 
application (including a supplementary plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of Subjects. 

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9.1.5 
Primary Safety Endpoint 
This category includes the 8 pre-specified adverse events that will be analyzed as the Primary Safety 
Endpoint for the study: 
1. Serious Adverse Event:  any serious adverse event that: 
o 
Results in death, 
o 
Is life-threatening, 
o 
Requires hospitalization or prolongs existing hospitalization, 
o 
Requires intervention to prevent permanent impairment or damage, or 
o 
Results in persistent or significant disability/incapacity. 
2. Allergic Reaction:  Type A, anaphylactoid or Type B dialyzer reactions to dialyzer, blood 
tubing or chemical disinfectant. 
3. Blood Loss:  blood loss resulting in hemodynamic compromise that leads to death, 
transfusion or fluid resuscitation with greater than 1 liter of crystalloid IV fluids. 
4. Hemolytic Reaction:  hemolytic reactions due to disinfectant exposure, dialysate 
temperature, mechanical failure or other device related causes. 
5. Infection: any infection related to catheter, its tunnel or exit site, AV fistula, or AV graft. 
6. Intra-Dialysis Event: a significant clinical event such as loss of consciousness, cardiac arrest, 
or seizure caused by device failure.  
7. Vascular Access Complication: defined as AVF or AVG clotting during the dialysis procedure, 
bleeding for more than 30 minutes post-dialysis for 3 consecutive sessions, difficulty with 
vascular access resulting in inability to initiate or complete dialysis treatments or 
complications related to hemodialysis catheters (not including reduced blood flow in 
catheter or TPA  or catheter exchange). 
8. Pyrogenic Reaction: onset of objective chills (visible rigors) and fever (oral temperature 
greater than or equal to 37.5 degrees Celsius) in a Subject who was afebrile and who had no 
recorded signs or symptoms of infection before treatment. 
9.2 
Recording Adverse Events 
9.2.1 
Adverse Event Categorization  
Reported Adverse Events will be categorized into one of the following two categories: 
1. Primary Safety Endpoint:  This category includes the 8 pre-specified adverse events that will be 
analyzed as the Primary Safety Endpoint for the study. 
2. Other Adverse Events: This category includes all reported adverse events that meet the definition 
in Section 9. 
The proposed categorization will serve to focus reporting, adjudicating, and analysis efforts to those 
categories most relevant for demonstrating the investigational device’s relevant safety profile. 
It is the intention of the Sponsor that AE’s be collected in a uniform manner over the course of the study 
(independent of study arm) through the use of a Subject questionnaire.  The Subject will be asked to 
complete a questionnaire regarding signs and symptoms experienced during each treatment.  During 
regularly scheduled clinical follow-up visits during the trial, study staff will review the signs and symptoms 
noted by the Subject and provide education, as needed, on how they are documented.  The study staff 
will determine whether subject reported signs and symptoms meet the definition of an AE as specified in 
Section 9.  This approach attempts to eliminate any potential observed differences in AE rates between 
the study arms that are solely due to reporting sources or techniques. 
Prior to analysis, all adverse events (AEs) will be coded using the Medical Dictionary for Regulatory 
Activities (MedDRA). Based on these coded terms, treatment emergent AEs will be summarized by 
treatment period, by severity, relation to procedure and relation to device. 

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9.2.2 
Other Adverse Events 
The Investigator will monitor the occurrence of adverse events for each Subject during the course of the 
study. All AEs will be listed on the adverse event case report forms.  All pre-existing medical conditions 
and baseline dialysis stability signs and symptoms will be recorded on baseline case report forms for 
medical history and signs and symptoms.  
Starting with the first treatment during Treatment period 1 with the Tablo™ Hemodialysis System, any 
new event/experience that was not present at baseline, or worsening of an event present at baseline, is 
considered an adverse event.  Recorded Adverse Events will include, but are not limited to: 
• 
infections (other than those defined in the Primary Safety Endpoint),  
• 
hypotension,  
Note: Unchanged, chronic conditions are not adverse events and should not be recorded on the adverse 
event page of the CRF.   
Note:  Laboratory values that are abnormal will not be considered as adverse events unless medical 
intervention is required. Clinical laboratory data will be monitored and values that are outside of the 
normal ranges will be separately summarized by time point for each treatment period (In-Center and In-
Home).  During the In-Center treatment period, summary statistics (mean, standard deviation, median, 
range, n) on laboratory values collected will be computed on the raw data.  During the In-Home treatment 
period, summary statistics (mean, standard deviation, median, range, n) on laboratory values collected 
will be computed on the raw data.  Individual tables will be created for each laboratory panel and 
quantitative parameter combination.  In addition, a summary table will be created for each laboratory 
panel (hematology and chemistry) to display the number and percentage of subjects who have results 
that fall out of the normal ranges for each laboratory parameter by time point for each of Treatment 
Period 1 and 2. 
Adverse events will be monitored until they are adequately resolved or explained.  Should an adverse 
event be ongoing at the end of the Subject’s last study treatment the medical care plan for the Subject 
will be described and documented. 
9.2.3 
Determination of the Relationship 
Determination of whether there is a reasonable possibility that the investigational device caused or 
contributed to an AE is to be determined by the Investigator and recorded on the CRFs as not related, 
related or unknown.  Determination should be based on assessment of temporal relationships, biologic 
plausibility, association (or lack of association) with underlying disease, and presence (or absence) of a 
more-likely cause. 
Definitions for determination of the relationship include: 
Not Related:  Exposure to the investigational device has not occurred, or the occurrence of the adverse 
event is not reasonably related in time, or the adverse event is considered unlikely to be related to the 
use of the investigational device (biologically implausible). 
Related:  Exposure to the investigational device and the adverse event are reasonably related in time and 
the investigational device is more likely than other causes to be responsible for the adverse event, or is 
the most likely cause of the adverse event.   

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Unknown: Exposure to the device and the occurrence of adverse event cannot be reasonably determined 
to be unrelated to the device.  If the relationship is identified as unknown it will be treated as related to 
the investigational device.  
If any adverse event is considered related to the use of the investigational device, that event will be 
followed until resolution or until the Investigator determines the event to be chronic or stable.  
9.2.4 
Determination of Adverse Events (Clinical Events Committee, CEC) 
In order to ensure that events reported as AEs meet clinically recognized and accepted standards and are 
reported in a uniform manner across sites, AEs that have been assessed by the site Principal Investigator 
to be device related, severe in nature, and/or meets the definition of one the primary safety endpoint 
events, will be reviewed and adjudicated by a CEC.  Adjudication of reported adverse events will be 
performed by a multi-physician panel.  Adjudication will be done against the standard of whether a 
reasonable attending nephrologist would attribute the AE to one of the causes listed as part of the 
Primary Safety Endpoint above.  In the case of disagreement by the adjudication panel, determination will 
be made by majority vote.  The CEC also will confirm those reported events indicated as such, do indeed 
meet the Safety Endpoint criteria.  In addition, the CEC will periodically review all AEs, including those that 
are not included as a primary endpoint, to assess overall study safety. 
9.3 
Reporting Requirements of SAEs or UADEs 
The Investigator must report all SAEs or UADEs immediately upon awareness to Outset.  The site should 
contact the following person by telephone to provide the initial notification: 
Chad Hoskins 
 Vice President, Commercial and Corporate Strategy  
1830 Bering Drive 
San Jose, CA 95112 
choskins@outsetmedical.com 
415.254.3094 (cell) 
The Investigator must follow up the initial telephone notification by providing a written report by 
facsimile or mail describing the SAE or UADE to Outset.  This report may be accomplished by completing 
the AE CRF.  Any missing or additional relevant information concerning the SAE or UADE should be 
provided in the form of a written follow-up report. 
The Investigator is required to comply with applicable regulations regarding the notification of SAE/UADE 
to the reviewing IRB consistent with any IRB conditions of approval. 
10 
RISKS AND BENEFITS 
10.1 Potential Risks 
The potential risks and benefits of participation in this study are identified in the Subject Informed 
Consent Form (ICF) and are to be explained to the Subject and/or their legal representative prior to 
participating in the study.  It is not anticipated that there will be any additional risks to the Subject with 
use of the Tablo™ System that are different than those expected during routine dialysis procedures. 
10.1.1 Procedure Risks 
Potential adverse events that may be associated with a hemodialysis procedure include, but are not 
limited to, the following: 
• 
Abdominal pain 
• 
Epigastric fullness 
• 
Occult hemorrhage 
• 
Adynamic bone disease 
• 
Fatigue 
• 
Pain 
• 
Air embolism 
• 
Fever 
• 
Pericardial tamponade 

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• 
Allergic reaction 
• 
Fluid overload 
• 
Perspiration 
• 
Allergic skin reactions 
• 
Hallucinations 
• 
Pneumothorax 
• 
Aluminum toxicity 
• 
Headaches 
• 
Pruritus 
• 
Anaphylaxis  
• 
Heart palpitations 
• 
Pulmonary edema 
• 
Anemia 
• 
Hematoma 
• 
Restless leg syndrome 
• 
Angioedema 
• 
Hemolysis 
• 
Seizures 
• 
Anuria 
• 
Hemothorax  
• 
Septicemia 
• 
Anxiety 
• 
Hepatitis B 
• 
Sexual dysfunction 
• 
Arrhythmia 
• 
Hepatitis C 
• 
Shortness of Breath 
• 
Ascites  
• 
Urticaria 
• 
Sleep apnea  
• 
Atlanto-cervical spondylopathy 
• 
Hyperparathyroid bone disease  
• 
Slurred speech 
• 
Back pain 
• 
Hyperparathyroidism 
• 
Syncope 
• 
Bleeding complications from the 
use of blood thinners 
• 
Hypertension 
• 
Tetany 
• 
Bleeding from access 
• 
Hypoglycemia 
• 
Thrombocytopenia 
• 
Cerebrovascular disease 
• 
Hypotension 
• 
Thrombosis 
• 
Chest pain 
• 
Hypovolemia 
• 
Tremors 
• 
Chills/Rigors 
• 
Hypoxemia 
• 
Uremia 
• 
Chronic dementia 
• 
Ileus  
• 
Uremic encephalopathy 
• 
Circumoral paresthesia 
• 
Infection 
• 
Uremic neuropathy 
• 
Cold extremities 
• 
Inflammation  
• 
Vascular access complications 
• 
Colitis 
• 
Insomnia  
• 
Vascular calcification 
• 
Complement activation 
• 
Intracranial bleeding 
• 
Vomiting 
• 
Confusion 
• 
Iron deficiency  
• 
Weakness 
• 
Congestive heart failure 
• 
Ketoacidosis 
• 
Weight gain 
• 
Constipation 
• 
Lactic acidosis 
• 
Weight loss 
• 
Cough 
• 
Left ventricular hypertrophy 
• 
Wheezing  
• 
Cramps 
• 
Lipid abnormalities  
 
• 
Depression 
• 
Liver function abnormalities 
 
• 
Dialysis-associated neutropenia 
• 
Loss of consciousness 
 
• 
Dialyzer reaction 
• 
Malnourished 
 
• 
Diarrhea 
• 
Metabolic acidosis/alkalosis 
 
• 
Difficulty swallowing 
• 
Metabolic disorders  
 
• 
Digestion or absorption 
disorders 
• 
Monomeuropathies 
 
• 
Disequilibrium syndrome 
• 
Myocardial infarction 
 
• 
Dizziness 
• 
Nasal congestion 
 
• 
Edema 
• 
Nausea 
 
• 
Electrolyte Imbalance 
• 
Neutropenia 
 
There may be other potential risks that are unforeseen at this time. 
10.2 Risk Management Procedures 
Eligibility criteria have been selected that exclude Subjects who are at a higher risk for experiencing an 
anticipated adverse event in order to reduce the risks to Subjects who participate in this study.  In 
addition, Subjects enrolled in this study will receive their hemodialysis treatments by qualified dialysis 
center staff when undergoing treatments In-Center and will perform their own hemodialysis treatments 
after having completed device study training when performing treatments In-Home.   
Monitoring will take place throughout the course of treatment and adverse events will be recorded in the 
Subject’s charts and on Case Report Forms developed for the study. 

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In addition, engineering testing has been performed on the Tablo™ System to help mitigate any risks to 
the Subjects due to product failure.  
Investigational device training will be conducted at each initiated study center and appropriate training 
records will be maintained.  
10.3 Potential Benefits 
There are no guaranteed additional benefits from participation in this study; however, dialysis with the 
Tablo™ System is expected to provide the Subject with the required urea clearance.  Information gained 
from the conduct of this study may be of no benefit to others with the same medical condition. 
11 
STATISTICAL METHODS AND CONSIDERATIONS 
The Statistical Analysis Plan (SAP) for the study will describe the data sets to be analyzed, the methods of 
analysis, and the specific analyses to be conducted in support of the study’s primary endpoints.  Those key 
elements are outlined below. 
11.1 
Data Sets Analyzed 
All Subjects who meet all of the Inclusion and Exclusion Criteria and who start the first study treatment 
during the first treatment period will be considered enrolled and will be included in the Intent-to-Treat 
Population (ITT). The primary effectiveness endpoint analysis will be based on the ITT population with a 
supportive analysis for the Per-Protocol population (PP).   
11.1.1 Intent to Treat Population (ITT) 
The ITT population will consist of all Subjects who are enrolled in the study.  The primary analysis set will 
be the ITT analysis set with no missing value imputation with a sensitivity analysis performed on the ITT 
with missing value imputation population.   
11.1.2 Per Protocol Population (PP) 
The PP population will consist of all Subjects who are enrolled in the study, have successfully completed at 
least 75% of their dialysis treatments, have at least one valid value of the primary effectiveness variable 
and have no major protocol deviations while enrolled in the study.  A successfully completed dialysis 
treatment is defined as one completed as prescribed by the physician.  A major protocol deviation is 
defined as any protocol deviation that affects the soundness of the data or a Subject’s rights.  Subjects to 
be excluded from the PP analysis set, and the reasons for their exclusion, will be determined and 
documented prior to statistical analysis.  These decisions will not be outcome-data driven.  
The analysis of the primary efficacy endpoint will be conducted on ITT and PP populations.   
11.2 
Safety Population 
The safety population will consist of all Subjects who are enrolled in the study. All safety analyses will be 
conducted on the safety population.   
11.3 
Analysis of Primary Endpoint 
The study is based on the primary endpoints for effectiveness and interval estimates of the safety of the 
device.  The study will be considered a success from a statistical standpoint if:  
1. Both primary analysis variables pass their respective hypotheses, i.e., Ha0 and Hb0 below are 
rejected in favor of Ha1 and Hb1, respectively, 
2. The rate of pre-specified adverse events per dialysis interval is estimated to be within the 
specified error of estimation for each treatment period. 

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11.4 
Analysis of Weekly Standardized Kt/V 
The following hypotheses will be tested at a one-sided α=0.025 level of significance: 
Ha0: µIC ≤2.1  vs. Ha1: µIC>2.1 
and 
Hb0: µIH ≤2.1  vs. Hb1: µIH>2.1 
where µIC is the treatment period mean weekly standardized Kt/V value for the In-Center arm and µIH is 
the treatment period mean weekly standardized Kt/V value for the In-Home arm.  This hypothesis will be 
tested using the Least Square Mean for the respective treatment period from a repeated measures 
analysis of variance (RMANOVA) containing terms for Subject, arm and time points (weeks) and using an 
AR(1) covariance structure.  
 
The weekly standardized Kt/V value will be calculated using the Leypoldt (Seminar in Dialysis, 17(2); 
March-April 2004) formula of: 
Standard Kt/V (stdKt/V) = 168*(1-exp(-Kt/V))/t/((1-exp(- t/V))/(Kt/V)+168/(N*t) -1) 
Where: N=number of treatments / week; t= treatment time in hours 
 
Summary statistics (mean, sample size, standard deviation, minimum, maximum, and median) will be 
computed on the weekly standardized Kt/V values for each treatment period. 
11.5 
Analysis of Secondary Endpoint   
The analysis of the secondary endpoint of ultrafiltration rate (UFR) will be conducted on ITT and PP 
populations.  The UFR will be calculated using the following method: 
UF Rate = (Fluid Removal Goal + Rinse Back Volume) / Treatment Duration 
 
Where,  
Fluid Removal Goal = Today’s Weight – Prescribed Estimated Dry Weight  
 
And, 
Rinse Back Volume = The volume of saline, 300mL, returned to the patient at the end of treatment. 
 
 
11.6 
Analysis of Adverse Events   
All study-emergent AEs occurring during the study sessions will be recorded and classified on the basis of 
MedDRA terminology for the ITT population.  Study-emergent AEs are those AEs with an onset on or after 
the date of first study treatment.  All study-emergent AEs will be categorized by study period (In-Center or 
In-Home), the number of Subjects reporting study-emergent AEs, severity, device relationship, and 
seriousness.  Serious adverse events (SAEs) will be listed by Subject. SAEs will be categorized by study 
period, severity, and device relationship. Each Subject will be counted only once within a category using 
the event with the greatest device relationship and greatest severity. 

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For each treatment period, a 95% confidence interval will be computed on the pre-specified adverse 
event rate per dialysis interval.  This confidence interval will be computed using the Least Square Mean 
for the respective treatment period from a generalized linear model containing terms for Subject, arm 
and time points (i.e., a repeated measures analysis using GEE) using a Poisson link function and AR(1) 
covariance structure . 
Summary statistics (mean, sample size, standard deviation, minimum, maximum, median) will be 
computed on the number of pre-specified adverse events per dialysis interval for each treatment period.  
The same summary statistics will be calculated by treatment period for the rate of pre-specified adverse 
events per 100 dialysis treatments.  
11.7 
Interim Analysis 
No formal statistical interim analyses will be conducted during this study.   
11.8 
Sample Size Analysis 
The estimated sample size for the trial was based on the safety endpoint and yields an estimate of the 
rate of pre-specified adverse events per 100 dialysis treatments in each treatment period (In-Center and 
In-Home use), to a margin of error of less than 1 event per 100 treatments.  With a two-sided =0.05, in 
order to construct a 95% confidence interval on the rate of pre-specified adverse events per 100 dialysis 
treatments with half-width less than 1 event per 100 treatments, the sample size required would be n=30 
Subjects with 4 dialysis intervals per week for a minimum of 8 weeks (i.e., 30 subjects with a minimum of 
32 treatments).  The sample size calculation was based on an asymptotic normal theory one sample test 
using variance estimates that included covariance terms for repeated measurements (4 dialysis intervals 
per week for 8 weeks) on each Subject with a block diagonal first order autoregressive (AR(1)) covariance 
structure. This sample size calculation assumed a standard deviation of 0.8 AEs per dialysis interval and a 
within Subject correlation of pre-specified AE counts of =.50. 
12 
STUDY RECORD MANAGEMENT 
For the study duration, the Investigator will maintain complete and accurate documentation, including 
but not limited to, medical records, study progress records, laboratory reports, CRFs, signed and dated 
informed consent forms, all correspondence with the IRB, Sponsor personnel/representatives, and other 
regulatory agencies, the protocol, and documentation for each deviation from the protocol, records of 
receipt, use, or disposition of each device, record of the exposure to the investigational device, adverse 
event records, information regarding Subject discontinuation or completion of the study, any other 
supporting data, and any other records that FDA requires to be maintained by regulation or by specific 
requirement. 
12.1 
Source Documentation 
Regulations require that an Investigator maintain information in the Subject’s medical records which can 
corroborate data collected on study CRFs. In order to comply with these regulatory requirements, at a 
minimum, the following information should be recorded in the Subject’s medical record: 
• 
Medical history and physical condition of the Subject prior to participation in the study sufficient 
to verify inclusion/exclusion criteria. 
• 
Dated and signed study progress or clinic notes on the day of entry into the study referencing the 
Tablo™ protocol number, site, Subject ID number assigned, and a statement that informed 
consent was obtained. 
• 
Dated and signed notes from each Subject’s weekly visit. 

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• 
All collected AE/SAEs and their resolution, including supporting documents such as discharge 
summaries and diagnostic test results. 
• 
Subject medical condition upon completion of or withdrawal from the study. 
Data recorded in the Subject’s medical records will be reviewed for verification of agreement with critical 
data on the CRFs as specified in the monitoring plan. The Investigator/Study personnel will allow the 
Sponsor (or designee) and appropriate regulatory authorities access to these records. If a non-study 
physician, at a non-study institution, sees a study Subject, a copy of the medical record for this 
unscheduled visit will be copied and placed in the Subject’s medical record and made available for review.  
12.2 
Data Collection and Case Report Form Completion 
All study data will be collected and recorded by authorized study personnel on the required Case Report 
Forms (CRFs). Identifiable Subject information will not be recorded in the CRFs. Subjects will be assigned 
unique study ID numbers. Only study site personnel directly involved with study and Sponsor monitors or 
designee(s) will have access to the documentation that links the study ID numbers to identifying Subject 
information. 
The CRFs will capture information relevant to the Subjects’ clinical presentation, medical history, 
laboratory values, and results of clinical and/or dialysis testing. Follow-up clinical data will include 
laboratory assessments, current medications, physician office visits, hospitalizations, and/or adverse 
events that have occurred since study enrollment or from the prior visit.  
The site Principal Investigators will be required to sign and date the completed CRFs on the appropriate 
page(s) to verify that he/she has reviewed the recorded data, and assures its accuracy and completeness. 
12.3 Case Report Forms (CRF) and Device Data Storage 
Prescription details, blood pressure readings, heparin infusion data, changes to treatment parameters, 
and total fluid removed during treatment will be captured on a Subject specific USB flash drive. Additional 
study information will be collected on standardized CRFs. Site numbers, Subject numbers and Subject 
initials will be used to track Subject information throughout the study. 
12.4 Device Accountability 
The Investigator shall maintain adequate records of the receipt, use, and disposition of the Investigational 
Device.  
12.5 
Missing Data 
All missing values within the treatment period will be imputed using a multiple imputation procedure 
(Markov Chain Monte Carlo (MCMC) method).  Parameter estimates and inferences for each treatment 
period will be based on the multiple imputations as described in Little and Rubin (2002).  For subjects who 
did not finish the study but have accumulated partial data for the primary effectiveness endpoint, missing 
data for Kt/V will be imputed by taking the average of the subject’s non-missing Kt/V responses.   
 
For all other endpoints, missing value imputation will be described in the Statistical Analysis Plan (SAP).  
12.6 
Data Processing 
Overall data management will be the responsibility of the study Sponsor.  All data will be managed in a 21 
CFR Part 11-compliant database. Data edit checks will be performed and the study sites will be queried as 
needed to ensure completeness and consistency of study data.  

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All above-mentioned tasks will be performed according to the Data Management Plan and Sponsor SOPs. 
Audits may be performed for quality assurance of procedures and data handling. 
13 
TRAINING 
13.1 Site Training 
The study Sponsor or its designee will conduct site training to develop a common understanding of the 
study objectives, clinical protocol, CRFs, study procedures and informed consent process. Site initiation 
may include Investigator(s), nurses and technicians, site research coordinator(s) and Sponsor 
representatives and/or designee(s). Training activities will include, but are not limited to, review of the 
clinical protocol including the study procedures, data collection procedures, adverse event reporting 
procedures, monitoring guidelines, and applicable regulatory requirements. All trained personnel will be 
required to sign a Training Log. 
Teleconferences and/or web-meetings may also be used throughout the study to train Investigators and 
other study personnel.  
Investigators and study site personnel will not be allowed to participate in the study until they have 
completed appropriate study training.  
13.2 Monitoring 
13.2.1 Site Monitoring Procedures 
All study monitoring activities will be managed and performed by the study Sponsor or designee. CRFs will 
be source-document verified according to the monitoring plan. These tasks will be performed according 
to relevant Sponsor SOPs.  
The number of monitoring visits and their duration will be conducted according to the monitoring plan. By 
verifying compliance, these activities will ensure: 
• The study is conducted in accordance with the study protocol, relevant Good Clinical Practice 
(GCP), and International Conference on Harmonization (ICH) guidelines, as well as in conjunction 
with 21 CFR Part 812, 50, 54, 56 and other applicable government regulations.  
• Adequate protection of the rights and safety of the informed Subjects involved in the study by 
thoroughly providing accurate and complete data. 
• Quality and integrity of the data. 
The frequency and scope of periodic site visits will be determined according to the monitoring plan, but at 
a minimum, shall occur at least once per year. Monitoring activities may include: review of informed 
consent and research authorization confirmation, regulatory document review, overall investigational 
plan adherence, GCP/ICH compliance, facility assessment, study staff assessment and additional study 
related functions that contribute to the safety of study Subjects and the integrity of study data.  
Investigators must provide adequate time and resources to the study protocol and will be available to the 
study monitor and/or designee via telephone, and in person during site visits.  The Investigator will also 
provide the study monitor with a suitable working environment for review of study-related documents.  
13.3 Compliance 
13.3.1 Site Compliance 
The study at the investigational site may be subject to an audit by the Sponsor or its designees for quality 
assurance purposes, as well as inspection by appropriate regulatory authorities. 

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In the event that an Investigator is contacted by a Regulatory Agency in relation to this study, the 
Investigator shall notify the study Sponsor immediately. The Investigator shall permit authorized 
representatives from appropriate regulatory authorities, at reasonable times and in a reasonable manner, 
to: 
• 
Enter and inspect any establishment where the device is held or records relating to the 
investigational device are kept, inspect and copy records relating to the investigational device 
use. 
• 
Inspect and copy records that identify Subjects upon notice that the Regulatory Agency has 
reason to suspect that adequate informed consent was not obtained, or that reports required to 
be submitted by the Investigator to the Sponsor or IRB have not been submitted or are 
incomplete, inaccurate, false, or misleading. 
The Investigator must provide the Sponsor with copies of all correspondence that may affect the review 
of the current trial (e.g. Form FDA 483, Inspectional Observations, and Warning Letters). The study 
Sponsor may provide any needed assistance in responding to regulatory audits. 
13.3.2 Protocol Deviations 
A deviation is defined as any departure from clinical study requirements, including those cited within 
International Conference Harmonization (ICH)/Good Clinical Practice (GCP) guidelines. Protocol deviations 
that affect the rights, safety, or welfare of human Subjects must be reported to the study Sponsor as soon 
as possible from the occurrence of the deviation. Major protocol deviations are defined as any protocol 
deviation that affects the soundness of the data or a Subject’s rights.   
Protocol deviations include, but are not limited to: 
• 
Appropriate informed consent was not obtained prior to performing any study-specific 
procedures (requires Sponsor notification within 24 hours) 
• 
Enrollment of a Subject who does not meet the study inclusion/exclusion criteria 
• 
Any deviation from the protocol 
• 
Failure to perform study procedures or performing clinical procedures outside of protocol 
requirements  
• 
Subjects receiving more than 4 complete treatments per week during Treatment Period 1 
and Treatment Period 2.    
Protocol deviations must be reported to the IRB per the institutional review board’s reporting 
requirements. The occurrence of protocol deviations will be monitored by the study Sponsor for 
evaluation of Investigator compliance to the study protocol, ICH/GCP guidelines, and regulatory 
requirements. Protocol deviations will be reviewed and evaluated by the study Sponsor on an ongoing 
basis.  
14 
QUALITY CONTROL AND ASSURANCE 
14.1 
Selection of Sites and Investigators 
The Sponsor will select Investigators who are qualified by training and experience to perform the 
procedures as required per protocol and to participate in the investigation of TABLO. A site selection 
process will be followed, including a qualification visit to each institution as necessary. Study sites will be 
selected based upon review of a recent site assessment, the qualifications of the Investigator, research 
infrastructure including personnel support and standard operating procedures, and the availability of 

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required equipment and supplies. In order to participate in the clinical study, the Investigator must 
provide a current Curriculum Vitae to validate his/her experience. 
14.2 
Financial Disclosure 
All Investigators must provide the Sponsor with documentation of financial interest related to Outset. 
Investigator’s must complete and provide Financial Disclosure in compliance with 21CFR 812.43 (c) (5) to 
the Sponsor during the approval process of the site. 
14.3 
Institutional Review Board Protocol and Informed Consent Approvals 
A sample Informed Consent form (ICF) will be provided for the study Investigator(s) to prepare for use at 
his/her site prior to participation in the study. The written Informed Consent documents should be 
prepared in the language(s) of the potential Subject population. The ICFs that are used should be in 
accordance with the current guidelines as outlined by the 21CFR Part 50, Good Clinical Practices (GCP) 
guidelines and the International Conference on Harmonization (ICH). 
The study Sponsor and reviewing IRB must first approve the language and the content within the 
Informed Consent form that is to be used by each study site. A copy of the proposed Informed Consent 
form, other written Subject information and any proposed advertising material must be submitted to the 
IRB for written approval. A copy of the written IRB approval of the protocol and Informed Consent form 
must be received by the study Sponsor before recruitment and enrollment of Subjects into the study. The 
written approval must identify the study, protocol version, and the date of approval. The Investigational 
site must submit to and, where necessary, obtain approval from, the IRB for all subsequent protocol 
amendments and changes to the Informed Consent Form prior to implementation.  
The Investigator will be responsible for obtaining annual IRB approval and renewal throughout the 
duration of the study. The Investigator and site personnel must forward copies to the Sponsor of all 
required correspondence with the IRB, including the annual and continuing review reports and IRB 
continuance of approval.  Copies of such correspondence should be filed in the Investigational site study 
files. Additionally, the Investigator will provide an IRB membership list or assurance number to the 
Sponsor annually. 
14.4 
Protocol Amendments 
This protocol will only be altered by written amendments from the study Sponsor. All significant protocol 
changes must receive written approval from appropriate Sponsor personnel and from the IRB prior to 
implementation at the study site. Upon IRB approval, the protocol amendment(s) will be distributed to all 
site study personnel and training will be performed as appropriate. 
14.5 
Confidentiality 
All information and data sent to Outset, and its authorized representatives, concerning Subjects or their 
participation in this study will be considered confidential. All data used in the analysis and reporting of 
this evaluation will be used in a manner without identifiable reference to the Subject. 
The Investigator will ensure that this study is conducted in full conformity with the current revision of the 
regulations and guidelines of FDA (21 CFR Part 812, 50, 54 and 56, and the relevant parts of the ICH 
Guidelines for Good Clinical Practice).  
14.6 
Study Administration 
14.6.1 Pre-Study Documentation Requirements 
Prior to Subject enrollment at any clinical site, the following documents must be provided to the Sponsor: 

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• 
A signed and dated Investigator Agreement 
• 
A copy of the IRB approval letter of the protocol and Informed Consent  
• 
A copy of the IRB approved Informed Consent Form 
• 
A copy of the signed and dated Curriculum Vitae of the Investigator 
• 
A signed and dated Financial Disclosure Form 
• 
A copy of the medical license of the Principal Investigator 
14.6.2 General Investigator Responsibilities 
In order to ensure that the protocol is conducted in compliance to applicable regulations, each site 
Investigator must: 
• 
Conduct the study in accordance with the study protocol, the signed Clinical Study 
Agreement, the International Conference on Harmonization (ICH) Guidelines for Good 
Clinical Practices and Title 21 of the U.S. Code of Federal Regulations (CFR) Parts 812, 50, 54, 
and 56.  
• 
Assure that the study is not commenced until IRB/EC approval has been obtained. 
• 
Complete all study related documents promptly. 
• 
Agree to participate in an appropriate training program prior to first Subject enrolled and as 
required by the Sponsor throughout the conduct of the study. 
• 
Sign and adhere to the Investigator Agreement / Financial Disclosure Form. 
• 
Assure that informed consent is obtained from each Subject prior to enrollment, using the 
IRB-approved Subject Informed Consent Form. Informed Consent must be obtained before 
conducting any study-specific tests or procedures (including activities to determine Subject 
eligibility for the study) and without any coercion of or undue influence of Subjects to 
participate.  
• 
Ensure adverse events are reported within the guidelines provided in this protocol. 
• 
Provide all required data and agree to source document verification of study data with 
Subject’s medical records. Allow study Sponsor staff and its authorized representatives to 
inspect and copy any documents pertaining to this clinical study. 
• 
Adhere to any institutional clinical care guidelines or protocols. 
• 
Comply with all required elements of this protocol (e.g., perform testing and follow-up as 
specified, especially during personnel transitions).  
14.6.3 Record Retention 
The Investigator agrees to maintain all essential study documents and source documentation, in original 
format, that support the data collected on the study Subjects in compliance with the ICH/GCP guidelines 
(the Investigator’s File, including signed Informed Consent forms and Subject-related materials) in a 
location that is secure and to which access can be gained if required.  
Documents must be retained for at least two years after (1) study completion, or (2) the study has been 
terminated by the Sponsor. These documents will be retained for a longer period of time by agreement 
with the Sponsor or in compliance with other regulatory requirements. When these documents no longer 
need to be maintained, it is the study Sponsor’s responsibility to inform the Investigator. The Investigator 
will take measures to ensure that these essential documents are not accidentally damaged or destroyed. 
If, for any reason, the Investigator withdraws responsibility for maintaining these essential documents, 

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custody must be transferred to an individual who will assume responsibility. The Sponsor must receive 
written notification of this custodial change.  
14.6.4 Criteria for Suspending/Terminating a Study Center 
The study Sponsor reserves the right to terminate the enrollment of Subjects at a study center at any time 
after the study initiation visit if no Subjects have been enrolled, if the site has multiple or severe protocol 
deviations without justification, or fails to follow remedial actions. Possible reasons for 
suspending/terminating a study center include: 
• 
Failure to obtain a written Informed Consent 
• 
Significant non-adherence to Subject inclusion/exclusion criteria 
• 
Repeated protocol deviations 
• 
Inability to sustain appropriate Subject enrollment rates 
• 
Repeated failure to complete case report forms in a timely manner 
• 
Investigator debarment by regulatory agencies 
• 
Disqualification or suspension by the IRB of this or another study 
In the event a study site is suspended, the Subjects already enrolled at these sites will continue to have 
protocol-designated follow-up despite termination of further enrollment at the site. 
14.6.5 Publication Policy 
The data and results from the study are the sole property of the Sponsor. Outset shall have the right to 
access and use all data and results generated during the clinical study. The Investigators will not use the 
study related data without the written consent of Outset for any other purpose than for study completion 
or for generation of a multi-center publication, such as in a peer-reviewed journal deemed appropriate by 
the Sponsor.  

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APPENDIX A: SUBJECT STUDY FLOW  
 

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APPENDIX B: SCHEDULE OF ASSESSMENTS  
Assessment 
 
Dialysis Treatment Week 
Study 
Exit 
Study Period 
Baseline 
Run-in 
In-Center Treatment Period 1 
Self-Care Transition 
In-Home Treatment Period 2 
 
Study Week 
1 
1 
2 
3 
4 
5 
6 
7 
8 
1 
2 
3 
4 
1 
2 
3 
4 
5 
6 
7 
8 
 
Informed Consent (≤90 days from Run-In Tx 1) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion /Exclusion Criteria Verification 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics/Medical/Vascular Access History 
(including assessment of historical lab values) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical Exam (≤90 days from Run-In Tx 1) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Concomitant Medications12 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Chemistry 2013 /CMP 
X14 
 
X 
X 
 
X 
X 
 
CBC15 
X15 
 
X 
X 
 
X 
X 
 
Iron Studies (TSAT, Ferritin, Transferrin) 
X15 
 
X 
 
X 
 
Pre and Post BUN sample collection (Kt/V)16 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Signs and Symptoms13 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Subject Evaluation of Device13 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Adverse Event13 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Study Completion 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
12Data for each of these Assessments will be recorded at every treatment. 
13Tests will include the following: Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Bilirubin (total and direct), Blood Glucose, Blood Urea Nitrogen 
(BUN), Calcium (Ca) in blood, Carbon Dioxide (Bicarbonate), Chloride, Creatinine, Phosphate in blood, Potassium in blood, Sodium in blood, and total serum protein. 
14 Additional testing at baseline is not required if lab data on file is within 2 weeks of the Run-In Period and includes all protocol required tests. 
15 CBC includes: White Blood Cells (WBC), Hemoglobin (HgB), Hematocrit (HCT), Mean Corpuscular Volume (MCV), and Platelets,  
16 Standard Kt/V (stdKt/V) = 168*(1-exp(-Kt/V))/t/((1-exp(- t/V))/(Kt/V)+168/(N*t) -1), where: N=number of treatments / week; t= treatment time in hours