Contains Nonbinding Recommendations
Arthroscopy Pump Tubing Sets 
Intended for Multiple Patient Use - 
Premarket Notification (510(k)) 
Submissions 
Guidance for Industry and          
Food and Drug Administration Staff
Document issued on December 23, 2021.
The draft of this document was issued on January 28, 2020.
For questions about this document, contact OHT6: Office of Orthopedic Devices/DHT6C: 
Division of Restorative, Repair, and Trauma Devices at (301) 796-5650.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health  Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration 
to https://www.regulations.gov. Submit written comments to the Dockets Management Staff, 
Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 
20852. Identify all comments with the docket number FDA-2019-D-5606. Comments may 
not be acted upon by the Agency until the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet. You may also send an email request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number 1500066 and complete title of the guidance in the request. Contains Nonbinding Recommendations
Table of Contents
I. Introduction and Scope ................................................................................................................................ 1
II. Definitions ................................................................................................................................................... 2
III. Premarket Submission Recommendations ................................................................................................... 5
A. Indications for Use .................................................................................................................................... 5
B. Device Description .................................................................................................................................... 5
(1) Backflow-Prevention (One-way) Valve ......................................................................................... 5
(2) Connectors ...................................................................................................................................... 5
(3) Tubing............................................................................................................................................. 6
(4) Pump ............................................................................................................................................... 6
C. Risk Management ...................................................................................................................................... 7
D. Biocompatibility ........................................................................................................................................ 7
E. Sterility ...................................................................................................................................................... 8
F. Reprocessing ............................................................................................................................................. 9
G. Pyrogenicity .............................................................................................................................................. 9
H. Shelf Life and Packaging ........................................................................................................................ 10
I. Mitigation of Cross-Contamination Risk ................................................................................................ 11
(1) Device Design............................................................................................................................... 11
J. Non-Clinical Performance Testing .......................................................................................................... 12
(1) Bench Testing ............................................................................................................................... 13
(2) Backflow-Prevention Valve Testing ............................................................................................. 13
(3) Microbial Ingress Testing ............................................................................................................. 17
K. Labeling ................................................................................................................................................... 18 Contains Nonbinding Recommendations
Arthroscopy Pump Tubing Sets 
Intended for Multiple Patient Use - 
Premarket Notification (510(k)) 
Submissions
Guidance for Industry and        
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page. 
I. Introduction and Scope
This guidance document provides recommendations for 510(k) submissions for arthroscopy 
pump tubing sets intended for multiple patient use. These devices are designed to deliver 
irrigation fluid to the surgical site, such as knee, shoulder, hip, elbow, ankle, and wrist joint 
cavities, during arthroscopic procedures. 
In arthroscopic procedures, clinicians often use a single source of irrigation fluid for multiple 
patients without replacing the source of irrigation fluid or replacing or reprocessing the irrigation 
tubing system between patients. This practice may increase the risk of cross-contamination 
between patients and subsequent iatrogenic infection, because the irrigation system can become 
contaminated with patient fluids that travel back through the irrigation tubing (a phenomenon 
hereafter referred to as backflow). FDA has received reports of backflow of patient fluids 
which raises the question of potential for disease transmission when using irrigation and tubing 
systems in such a manner on multiple patients. 
This guidance outlines the device design considerations, risk mitigation strategies, and testing 
recommendations for arthroscopy pump tubing sets intended for multiple patient use. This 
guidance document also clarifies the terminology used to describe arthroscopy pump tubing sets 
intended for multiple patient use.   
The scope of this document is limited to Class II, arthroscopy pump tubing sets classified under 
the following regulation:
1 Contains Nonbinding Recommendations
21 CFR 888.1100 Arthroscope.
An arthroscope is an electrically powered endoscope intended to make visible the interior 
of a joint.  The arthroscope and accessories also is intended to perform surgery within a 
joint.
Devices that supply arthroscopic irrigation are found under product code HRX and require 
premarket notification (510(k)). These irrigation devices may be part of an arthroscopy pump 
system or marketed separately as accessories to arthroscopy pump systems.
While FDA believes the recommendations listed below serve as rigorous risk mitigation 
strategies for reducing the risk of cross-contamination between patients, it should be noted that 
the only way to eliminate the risk of cross-contamination from multiple patient use is to utilize 
single patient use arthroscopy pump tubing sets. 
For the current edition of the FDA-recognized consensus standard(s) referenced in this 
document, see the FDA Recognized Consensus Standards Database.1 For more information 
regarding use of consensus standards in regulatory submissions, refer to the FDA guidance titled 
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices.2  
The contents of this document do not have the force and effect of law and are not meant to bind 
the public in any way, unless specifically incorporated into a contract. This document is intended 
only to provide clarity to the public regarding existing requirements under the law. FDA 
guidance documents, including this guidance, should be viewed only as recommendations, unless 
specific regulatory or statutory requirements are cited. The use of the word should in Agency 
guidance means that something is suggested or recommended, but not required. 
II. Definitions
For the purposes of this guidance, FDA provides the following definitions for terms used to 
describe arthroscopy pump systems and tubing sets. We provide additional explanations for these 
terms in Figure 1. We recommend that arthroscopy pump tubing set manufacturers adopt similar 
definitions in both the labeling and in 510(k) submissions to ensure consistency in the use and 
premarket review of these devices. 
FDA is defining both terms single-use device and disposable to refer to a device that is used 
on a single patient during a single procedure and then discarded. A single procedure performed 
on one patient, hereafter referred to as a patient use, may include multiple insertions of an 
arthroscope that is connected to an arthroscopy pump system and associated tubing into the 
patient. 
1 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. 
2 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices.
2 Contains Nonbinding Recommendations
 24 Hour Use or Day Use: The use of a device for 24 hours with no reprocessing between 
patient uses. A device labeled 24 Hour Use or Day Use implies multi-patient use.
 Backflow-Prevention Valve: The valve that is intended to prevent the proximal irrigation 
system from being contaminated by backflow of fluids from the patient (see Figure 1). 
When multiple valves are present in the irrigation system, the backflow-prevention valve is 
the one closest to the patient. The backflow-prevention valve may also be referred to as a 
one-way valve. 
 Consumable: A device that is intended to be discarded or replaced after use, with no 
reprocessing. Consumable devices include all single-use devices (see definition below) and 
the subset of multi-patient use devices that are discarded after a specified time period (e.g., 
24 hours).
 Cross-contamination: The transfer of potentially harmful substances or disease-causing 
microorganisms from one patient to another patient.
 Irrigation Fluid: Fluid used to irrigate the surgical site during arthroscopic procedures by use 
of an arthroscopy pump system. Commonly, the irrigation fluid used is saline.
 Irrigation System: The irrigation fluid container (e.g., saline bag) and associated tubing, 
valves, and connectors used with the irrigation fluid for irrigation of the surgical site during 
arthroscopic procedures. The irrigation system may be subdivided into the following 
components: 
o  Distal Irrigation System: All components of the irrigation system between the 
patient (e.g., distal tubing) and the distal (patient-side) connector, including the 
backflow-prevention valve. In arthroscopy tubing sets intended for multi-patient 
use, the distal irrigation system is typically discarded after use in each patient 
(i.e., single-use).
o  Proximal Irrigation System: All components of the irrigation system between the 
source of irrigation fluid (e.g., saline bag) and the proximal (pump-side) 
connector.  In arthroscopy tubing sets intended for multi-patient use, the proximal 
irrigation system is typically used in multiple patients (i.e., multi-patient use) for a 
specified duration or number of uses and then discarded.
 Multiple Patient Use (Multi-Patient Use) Device: A device that is intended to be used on 
multiple patients, either with reprocessing (for reusable devices) or without reprocessing (for 
consumable devices) between patient uses.
 Reprocessing: Validated processes used to render a medical device fit for a subsequent 
single use on another patient after it has been previously used or contaminated. These 
processes are designed to remove soil and contaminants by cleaning and to inactivate 
microorganisms and viruses by disinfection or sterilization. For guidance regarding 
3 Contains Nonbinding Recommendations
reprocessing of reusable medical devices, please see Reprocessing Medical Devices in 
Health Care Settings: Validation Methods and Labeling.3
 Reusable Medical Device: A device intended for repeated use, either on the same or
different patients, with appropriate cleaning and disinfection or sterilization between uses.
 Single-Use Device (SUD) or Disposable Device: A single-use device, also referred to as a
disposable device, is intended for use on one patient during a single procedure. It is not
intended to be reprocessed (cleaned and disinfected or sterilized) and used on the same
patient in a different procedure or on another patient.
Figure 1. Example configuration of an Arthroscopy Pump Tubing Set for Multiple Patient Use. While not 
all arthroscopic pump tubing sets may exhibit this configuration, this example illustrates several of the critical 
terms used in this guidance document. A backflow-prevention (one-way) valve divides the irrigation system into 
a single-use distal irrigation system and a multi-patient use proximal irrigation system. 
3 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-health-
care-settings-validation-methods-and-labeling. 
4 Contains Nonbinding Recommendations
III. Premarket Submission Recommendations
A. Indications for Use
Arthroscopy pump tubing systems that have been designed and validated for multiple patient use 
should include this information in the indications for use statement, along with the maximum 
validated use time (e.g., 24 Hour Use) or use lives (Up to 8 Procedures).
B. Device Description
We recommend you identify your device by the applicable regulation number and product code 
indicated in Section I above and include the information described below. 
Submissions should include a description of all device components integral to the multiple 
patient use tubing sets, including those listed below and any other design features intended to 
reduce the risk of backflow for allowing multiple patient use. We recommend that you also 
provide illustrative schematics and/or engineering drawings of each device component, identify 
important design features, compare the similarities/differences of those features to legally 
marketed devices, and identify any applicable FDA-recognized consensus standards. 
(1) Backflow-Prevention (One-way) Valve
We recommend that a description of the basic function and specifications of the 
backflow-prevention valve include the following:
 Maximum flow rate
 Reverse flow rate during closing of the valve and leakage under back pressure
 Pressure differentials for valve opening and closing
 Cracking pressure, i.e, the pressure required to open the valve
 Maximum back pressure, i.e., the maximum back pressure the valve can withstand
before failure
 Valve design and mechanism for preventing backflow of fluids
 Materials of construction, including chemical formulation and identification of any
color additives, lubricants, bonding agents, plasticizers, or other additives (e.g., ink,
dyes, markings, radiopaque materials) and their amounts
 Non-pyrogenicity and sterility status
(2) Connectors
We recommend that a description of all connectors used in the device include the 
following:
 Connector types (e.g., Luer lock, slip fit, other screw types)
5 Contains Nonbinding Recommendations
 Types of configurations
 Proximal and distal end configuration:
o  Shape
o  Location
o  Diameter of any outlets or ports
o  Duration of use for each end configuration (multi-patient use or single-use)
 Physical dimensions:
o  Inner diameter
o  Outer diameter
o  Length
o  Width
 Connection/reconnection mechanism of action
 Connector performance criteria/specifications (e.g., to prevent leakage or maintain 
sterility)
 Non-pyrogenicity and sterility status
 Materials of construction, including chemical formulation and identification of any 
color additives, lubricants, bonding agents, plasticizers, or other additives (e.g., ink, 
dyes, markings, radiopaque materials) and their amounts
 Any other unique physical features and specifications
(3)  Tubing
We recommend that a description of the tubing include the following:
 Configuration of all tubing sets
 Identification of the functions of each tubing component (e.g., inflow line, suctioned 
waste line)
 Identification of parts mechanically stressed during normal operation by peristaltic 
rollers, tubing clamps, etc.
 Identification of proximal and distal tubing components, and the duration of use for 
each tubing component (multi-patient use or single-use)
 Physical dimensions:
o  Inner diameter
o  Outer diameter
o  Length 
 Non-pyrogenicity and sterility status
 Materials of construction, including chemical formulation and identification of any 
color additives, lubricants, bonding agents, plasticizers, or other additives (e.g., ink, 
dyes, markings, radiopaque materials) and their amounts
 Any other relevant physical or performance specifications
(4)  Pump
We recommend that you provide any relevant physical, performance, or safety 
specifications of the arthroscopy pump(s) intended to be used with the tubing sets that 
6 Contains Nonbinding Recommendations
would aid in the understanding of the tubing set functionality. For example, it is 
recommended that you describe the following aspects of the pump(s):
 The pump manufacturer and model number as well as the 510(k) number for
previously cleared pumps
 Minimum and maximum flow rates
 Safety features designed to monitor pressure in the system and prevent over-
pressurization or reverse flow, including their mechanism of action
 Mechanism for connection of the tubing sets to the pump
 Pump mechanism of action to create fluid flow
 Pump pressure head vs. flow curves to characterize the pump capability for given
levels of back pressure
 Any other flow or pressure specifications
 Any other operating elements that may affect pressure or flow, such as gravity vs.
suctioned outflow, elevated irrigation fluid bags, or pressure drops caused by
attachment of arthroscopic instruments, and any control functions to react to those
pressure or flow changes
C. Risk Management
We recommend that you apply accepted risk management principles, such as those described in 
the currently recognized version of ISO 14971: Medical devices  Application of risk 
management to medical devices, while conducting the risk analysis as part of your design 
controls required in 21 CFR 820 during the development of your device. We recommend that 
you submit risk management information that identifies hazardous situations, estimates the risks 
(e.g., risks of device malfunction, adverse tissue reaction, infection, use error, extravasation), 
describes risk control measures and overall residual risk specific to your device. Certain 
verification and validation testing performed as a result of these activities should be provided (as 
described in Sections D through J).
D. Biocompatibility
Significance:  Arthroscopy pump tubing sets contain patient-contacting materials, which, when 
used for their intended purpose (i.e., contact type and duration), may induce a harmful biological 
response.   
Recommendation:  You should determine the biocompatibility of all patient-contacting materials 
present in your device. If your device is identical in composition and processing methods to 
arthroscopy pump tubing sets with a history of successful use, you may reference previous 
testing experience or the literature, if appropriate. For some device materials, it may be 
appropriate to provide a reference to either a recognized consensus standard, or to a Letter of 
Authorization (LOA) for a device Master File (MAF). You should refer to the following FDA 
webpage for additional information on using device MAFs: https://www.fda.gov/medical-
devices/premarket-approval-pma/master-files.
7 Contains Nonbinding Recommendations
Differences in formulation, processing, sterilization, or device surface properties (e.g., submicron 
or nanoscale components) that could affect biocompatibility of the final product may warrant 
additional biocompatibility testing. 
If you are unable to identify a legally marketed predicate device with similar location/duration of 
contact and intended use that uses the same materials as used in your device, we recommend you 
conduct and provide a biocompatibility risk assessment. The assessment should explain the 
relationship between the identified biocompatibility risks, the information available to mitigate 
the identified risks, and any knowledge gaps that remain. You should then identify any 
biocompatibility testing or other evaluations that were conducted to mitigate any remaining risks. 
We recommend that you follow FDAs guidance Use of International Standard ISO 10993-1, 
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk 
management process,4 which identifies the types of biocompatibility assessments that should 
be considered and recommendations regarding how to conduct related tests. 
Per ISO 10993-1: Biological evaluation of medical devices  Part 1: Evaluation and testing 
within a risk management process and Attachment A of FDAs guidance on ISO 10993-1, 
arthroscopy pump tubing sets are external-communicating devices in contact with 
tissue/bone/dentin for a limited contact duration. Therefore, the following endpoints should be 
addressed in your biocompatibility evaluation: 
 cytotoxicity;
 sensitization;
 irritation or intracutaneous reactivity;
 acute systemic toxicity; and
 material mediated pyrogenicity.
E. Sterility
Significance:  Arthroscopy pump tubing sets indirectly contact tissue and bone and should be 
adequately sterilized to minimize infections and related complications.    
Recommendation:  For arthroscopy pump tubing sets labeled as sterile, we recommend that you 
provide information for the final device in accordance with FDAs guidance Submission and 
Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices 
Labeled as Sterile.5
4 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-
1-biological-evaluation-medical-devices-part-1-evaluation-and.
5 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-
information-premarket-notification-510k-submissions-devices-labeled.
8 Contains Nonbinding Recommendations
F. Reprocessing
Significance: If any of the components or accessories (e.g., arthroscopic instruments, etc.) of the 
arthroscopic pump tubing system are reused, they should be adequately cleaned, disinfected and 
sterilized between uses to minimize infections and prevent device degradation. 
Recommendation: Validated instructions on how to reprocess a reusable device or single-use 
device that is provided non-sterile to the user are critical to ensure that a device is appropriately 
prepared for its initial and subsequent uses. We also recommend that you apply principles of 
human factors and usability engineering, which include risk management focused on user 
interactions, to the development and validation of appropriate reprocessing instructions to 
support safe and effective use of the device.  
As required under Section 3059 of the 21st Century Cures Act (Pub. L. 114-255), 82 FR 26807 
was published on June 9, 2017,6 which states that sponsors are required to provide reprocessing 
validation data and validated reprocessing instructions in 510(k) submissions for devices under 
product code HRX that possess design features which may pose a challenge to adequate 
reprocessing. For recommendations regarding the development and validation of reprocessing 
instructions in your proposed device labeling, refer to FDAs guidances Reprocessing Medical 
Devices in Health Care Settings: Validation Methods and Labeling7 and Applying Human 
Factors and Usability Engineering to Medical Devices.8
G. Pyrogenicity
Significance:  Pyrogenicity testing is used to help protect patients from the risk of febrile 
reaction due to gram-negative bacterial endotoxins and/or chemicals that can leach from a 
medical device (e.g., material-mediated pyrogens). 
Recommendation:  To address the risks associated with the presence of bacterial endotoxins, 
arthroscopy pump tubing sets should meet pyrogen limit specifications by following the 
recommendations outlined in FDAs guidance Submission and Review of Sterility Information 
in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.9 You should 
also follow the recommendations in Guidance for Industry: Pyrogen and Endotoxins Testing: 
Questions and Answers.10 To address the risks associated with material-mediated endotoxins, 
follow the recommendations in FDAs guidance Use of International Standard ISO10993-1, 
6 Available at https://www.federalregister.gov/documents/2017/06/09/2017-12007/medical-devices-validated-
instructions-for-use-and-validation-data-requirements-for-certain-reusable. 
7 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-health-
care-settings-validation-methods-and-labeling.
8 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-
usability-engineering-medical-devices.
9 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-
information-premarket-notification-510k-submissions-devices-labeled. 
10 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pyrogen-and-endotoxins-testing-
questions-and-answers. 
9 Contains Nonbinding Recommendations
'Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk 
management process.11
For devices intended to be labeled as non-pyrogenic, we recommend that both bacterial 
endotoxins and material-mediated pyrogens be addressed.
H.  Shelf Life and Packaging 
Significance:  Shelf life testing is conducted to support the proposed expiration date through 
evaluation of the package integrity for maintaining device sterility and/or evaluation of any 
changes to device performance or functionality.
Recommendation:  With respect to package integrity for maintaining device sterility, you should 
provide a description of the packaging, including how it will maintain the devices sterility, and a 
description of the package integrity test methods, but not the package test data. We recommend 
that package integrity test methods include simulated distribution and associated package 
integrity, as well as simulated (and/or real-time) aging and associated seal strength testing, to 
validate package integrity and shelf life claims. We recommend you follow the methods 
described in the FDA-recognized series of consensus standards AAMI/ANSI/ISO 11607-1: 
Packaging for terminally sterilized medical devices  Part 1: Requirements for materials, sterile 
barrier systems and packaging and AAMI/ANSI/ISO 11607-2: Packaging for terminally 
sterilized medical devices  Part 2: Validation requirements for forming, sealing and assembly 
processes.
With respect to evaluating the effects of aging on device performance or functionality, shelf life 
studies should evaluate the critical device properties to ensure it will perform adequately and 
consistently during the entire proposed shelf life. To evaluate device functionality, we 
recommend that you assess each of the bench tests described in Section III.J (Non-Clinical 
Performance Testing) and repeat, using aged devices, all tests that evaluate design components 
or characteristics that are potentially affected by aging.
We recommend that you provide a summary of the test methods used for your shelf life testing, 
results and the conclusions drawn from your results. If you use devices subject to accelerated 
aging for shelf life testing, we recommend that you specify the way in which the devices were 
aged. We recommend that you age your devices as per the currently FDA-recognized version of 
ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical 
Devices and specify the environmental parameters established to attain the expiration date. For 
devices or components containing polymeric materials or coatings, you should conduct testing 
on real-time aged samples to confirm the results of the accelerated aging study. This testing 
should be conducted in parallel with 510(k) review and clearance with results documented to file 
in the design history file (i.e., complete test reports do not need to be submitted to FDA).
11 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-
10993-1-biological-evaluation-medical-devices-part-1-evaluation-and. 
10 Contains Nonbinding Recommendations
I.  Mitigation of Cross-Contamination Risk
Significance: Without proper mitigation strategies, backflow of patient fluids through the 
irrigation system of arthroscopic tubing sets can increase the risk of cross-contamination between 
patients and subsequent iatrogenic infection.
Recommendation: The risk of cross-contamination from multiple patient use of arthroscopy 
pump tubing sets can be mitigated by a combination of device design, labeling, proper device 
handling and performance testing, as described below. While FDA believes the 
recommendations listed below serve as rigorous risk mitigation strategies, it should be noted that 
the only way to eliminate the risk of cross-contamination from multi-patient use is to utilize 
single patient use arthroscopy pump tubing sets.  
Manufacturers of arthroscopy pump tubing sets intended for multiple-patient use must establish 
and maintain procedures for validating the design of their device, which shall ensure that the 
device conforms to defined user needs and intended uses (21 CFR 820.30(g)). FDA interprets 
this to require manufacturers to validate the design, including instructions for use and associated 
claims, of such devices to ensure that the device can be safely and effectively used as intended. 
Therefore, we recommend you provide information in your 510(k) submission addressing the 
following items:
(1)  Device Design
a.   Prevention of Backflow to the Proximal Irrigation System
We recommend that the device design include at least one backflow-prevention valve 
or other feature that prevents the backflow of fluids into the irrigation system. 
Consideration should be given to redundant design/safety features for backflow 
prevention or reduction (e.g., a critical length of tubing that may reduce the potential 
for contaminated fluid to reach the backflow-prevention valve, pump mechanisms to 
prevent reverse flow). This valve or other feature should be tested with quantitative 
chemical and/or microbiological assays to demonstrate that it is capable of preventing 
the backward flow of fluids and contamination of the irrigation system by 
microorganisms, as described below in Section III.J.(2) (Backflow-Prevention Valve 
Testing). 
In the absence of a backflow-prevention valve or other feature demonstrated to 
prevent backflow and contamination, the irrigation system is not appropriate for 
multi-patient use and should instead be discarded after every patient use to reduce the 
risk of patient infection. 
b.  Components of the Distal Irrigation System 
Currently, some multiple patient use device designs include separation of the tubing 
sets into a distal single-use component (with respect to the irrigation fluid source) that 
11 Contains Nonbinding Recommendations
includes a backflow-prevention valve, and a proximal Day Use component that 
does not include the backflow-prevention valve. 
It should be noted that the risk of cross-contamination cannot be completely 
eliminated with multi-patient use tubing, even when a backflow-prevention valve is 
used. FDA is not aware of any methods for assuring complete prevention of 
contamination of the backflow-prevention valve. Therefore, it is recommended that 
all device components in the distal irrigation system, including the backflow-
prevention valve, be discarded after every patient use. 
c.  Components of the Proximal Irrigation System 
Manufacturers may wish to indicate proximal irrigation system components for use in 
multiple patients over a certain time period (e.g., 24 hours), and then to be discarded. 
In order to confirm that such components are acceptable for this type of use, 
performance data to support use in multiple patients over the proposed time duration 
should be provided to demonstrate that the backflow-prevention valve or other feature 
in the distal irrigation system adequately prevents backflow into the proximal 
irrigation system, and provides adequate mitigation against the risk of cross-
contamination between patients. See Section III.J below for additional information 
regarding recommended performance testing. Alternatively, the proximal irrigation 
system should be discarded after every patient use.
d.  Reusable Devices used with the Irrigation System 
While tubing components of the distal and proximal irrigation system are not 
typically reusable, the irrigation system may be used with devices and/or accessories 
(e.g., arthroscopic instruments, etc.) that are reusable. Any reusable devices should be 
designed to withstand multiple cleaning and sterilization cycles. Manufacturers 
should provide reprocessing validation data for reusable device components in their 
510(k) submissions and provide clear, comprehensive instructions for reprocessing 
these components after every patient use. See Section III.F above for additional 
information regarding reprocessing.
J.  Non-Clinical Performance Testing
Significance: Non-clinical performance testing is conducted to demonstrate that the device 
performs as intended and that all labeling statements, including identification of multi-patient use 
(e.g., 24 Hour Use, Up to 8 Procedures), are appropriately validated. 
Recommendation:  We recommend that non-clinical performance testing of arthroscopy pump 
tubing sets intended for multiple patient use include bench testing, backflow-prevention valve 
testing, and microbial ingress testing, as described below. 
12 Contains Nonbinding Recommendations
For all performance testing you perform, we recommend that you provide complete test reports. 
For information on recommended content and format of complete test reports for non-clinical 
bench performance testing in premarket submissions, refer to FDAs guidance, Recommended 
Content and Format of Test Reports for Non-Clinical Bench Performance Testing in Premarket 
Submissions.12
(1)  Bench Testing
We recommend that you conduct all testing under simulated use conditions, including use 
of a compliance model to simulate the joint, a wet environment simulating fluids being 
administered, and other conditions affecting operation, such as periodic changes in flow 
and pressure triggered by use of suction equipment. We recommend that you evaluate 
your device compared to a similar legally marketed device,13 using clinically relevant 
worst case simulated static and dynamic forces to the failure point of the components. We 
also recommend that you describe how you determined the worst case conditions used in 
your testing.
Your testing should address the following:
a)  Cycle testing of connections, with inspection for mechanical damage and fluid 
leakage
b)  Evaluation of tubing performance on new versus end-of-life devices to 
demonstrate the maintenance of tubing integrity after the intended use life of the 
device, including:
i.  Pressure and flow control performance 
ii.  Correct operation of over-pressurization safety features that may be 
affected by loss of tubing integrity 
(2)  Backflow-Prevention Valve Testing
Testing should be conducted to verify that the backflow-prevention valve(s) used in the 
irrigation system are effective to prevent contaminated fluid from the surgical site from 
entering into the irrigation system during the clinical procedure (i.e., backflow). We 
recommend that the testing be performed with both a microbiological and chemical 
marker to investigate the potential for backflow in the system. 
Your testing should address the following:
12 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-format-
non-clinical-bench-performance-testing-information-premarket. 
13 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-
substantial-equivalence-premarket-notifications-510k.
13 Contains Nonbinding Recommendations
a)  Assessment of the volume of fluid that would backflow from the surgical site to 
the backflow-prevention valve and the time it would take for the backflow of fluid 
to reach the valve if backflow conditions were to occur 
b)  Investigation of the length of tubing that may reduce the risk of backflow of fluids 
at the surgical site from reaching the backflow-prevention valve
c)  Investigation of the device pump properties that may reduce the risk of backflow 
of fluids at the surgical site from reaching the backflow-prevention valve. You 
should determine the maximum back pressure experienced by the backflow-
prevention valve.  
d)  Investigation of the potential for regurgitation on valve closing and the volume of 
fluid that may backflow upon regurgitation. You should determine the closing 
volume and leakage volume. 
We recommend that you provide detailed test methods for your study, which includes 
each of the following items:
a)  Discussion of all conditions (i.e., pressure, volumes, fluid flow conditions, user 
handling, pressure changes occurring with the use of arthroscopic instruments, 
tubing lengths, overall time of test) that increase the potential for backflow of 
fluid into the system and a justification that the conditions of your testing 
maximize the potential for backflow of fluids through the system
b)  Rationale for worst case parameters and clinical relevance of testing and 
parameters (e.g., if simulation of a certain joint is chosen, an explanation should 
be provided as to why the set-up and parameters are considered worst case for 
potential backflow)
c)  Appropriate controls, including a positive control of forced/confirmed backflow 
and a negative control
d)  Pressures/conditions that are relevant to the critical valve parameters described in 
Section III.B, above, and worst case clinical use of the device, including: 
i.  Worst case parameters for pressure in terms of both critical valve failure 
and backflow/leakage should be considered, which may not be the same 
pressure parameters 
ii.  Pressure cycling, with a justification of the clinical relevance for the 
number of cycles and length of time per cycle chosen
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iii.  Common errors, such as possible incorrect installation of the tubing set or 
blockage of the outflow should be considered as potential worst case 
situations for testing
e)  Description of the fluid volume, flow rate, pressure settings, and valve opening 
and closing characteristics used at each stage in the testing and their clinical 
relevance
f)  Description of the irrigation fluid used in the testing and its clinical relevance
i.  All irrigation fluids intended to be used with the device, as identified in 
the labeling, should be included in your testing, or a justification provided 
for why the irrigation fluid tested represents all other fluids that may be 
used with the device 
ii.  Fluid chemical properties (e.g., wetting agents and other fluid properties 
that may affect flow)
g)  Relevant simulation of multi-patient use (e.g., 24 Hour Use) tubing vs. single-use 
tubing, including an explanation of the number of each tubing set configurations 
tested and their associated time of testing; simulation of multi-patient use (e.g., 24 
Hour Use) tubing should also include testing of stagnant flow conditions under 
minimum backpressure
h)  For microbiological testing of the backflow-prevention valve, your protocol 
should include:
i.  Amount and identity of the challenge organism(s)
ii.  Rationale for the chosen challenge microorganisms 
  We recommend that you include both bacteriophages and bacteria 
in your microbiological testing to represent viral and bacterial 
challenges, respectively.  
 
  For bacterial testing, we recommend that you include both Gram-
positive and Gram-negative bacteria that may be common causes 
for joint infections and include at least one motile species of 
bacteria, such as Pseudomonas aeruginosa or Escherichia coli.
iii.  Methods used to prepare the challenge organisms
  We recommend that each challenge organism be prepared and 
tested separately.
iv.  Method of device contamination/inoculation 
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v.  Rationale for the inoculum volume and concentrations
vi.  Time, temperature, humidity level, and culture procedures for collection of 
samples from contaminated device, volume of sample aliquot measured, 
and rationale for the location of sample collection from the contaminated 
device
vii.  Type of environment in which the study was conducted (e.g., biological 
safety cabinet vs. non-sterile bench), a rationale for selection, and its effect 
on results 
viii.  Limit of detection and limit of quantitation of the microbiological method
  Assays should be sensitive enough to detect small numbers of 
microbes, e.g., less than 10 colony forming units (CFU).
i)  For testing of the backflow-prevention valve with a chemical marker (e.g., dye), 
your protocol should include:
i.  Marker concentration 
ii.  Diluent used
iii.  Consideration for the use of wetting agent (e.g., Triton X-100, propylene 
glycol)
  If a wetting agent is used, a rationale for the wetting agent chosen 
and its concentration should be provided. 
iv.  Limit of detection and limit of quantitation of the assay
j)  Investigation and discussion of the potential for false negatives that may occur if 
microbes/dye markers that have penetrated the backflow-prevention valve are 
flushed out when the pressure at the simulated joint site is reduced
  
i.  Your protocol should be designed to eliminate the potential for false 
negatives, which can provide a false sense of security regarding the safety 
of your device.  
k)  Explanation of how any microbiological or dye test can evaluate the risk from 
expected clinical contaminants, including viral blood borne pathogens
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(3)  Microbial Ingress Testing 
A connector that facilitates connection/reconnection of sterile device components may 
increase the patients risk of infection, because these features allow the entry of 
microorganisms into the sterile fluid path. We recommend that you conduct microbial 
ingress testing on these device components. This testing is intended to simulate repeated 
connection/reconnection of the devices connector components.
Microbial ingress testing should simulate the use of the device in a clinical setting, i.e., 
the number of microbial challenges in the study should approximate the greatest number 
of user interactions with the connection site that would be expected clinically. The testing 
should demonstrate that the disinfection procedures you use are effective.
We recommend that you provide a detailed protocol for your study, which includes the 
following:
a)  Study procedures for the subject device
b)  Amount and identity of challenge organisms commonly associated with 
contaminated arthroscopic devices (i.e., two Gram-negative and two Gram-
positive organisms) 
c)  Methods used to prepare the challenge organisms
i.  We recommend that each challenge organism be prepared and tested 
separately.
d)  Method of device contamination/inoculation for all device sites inoculated
e)  Description of all sites inoculated and rationale for site selection (we recommend 
that, at minimum, the sites include the position immediately adjacent to the fluid 
flow path)
f)  Rationale for the number of challenge microorganisms used as inoculum (it is 
recommended that you use a minimum of 103 CFU per device) and that each 
organism be tested separately)
g)  Connection/reconnection procedure
h)  Time, temperature, humidity level, and related culture procedures 
i)  Type of environment in which the study was conducted, a rationale for selection, 
and its effect on results (e.g., if a biological safety cabinet is used, is it 
representative of actual risks incurred when connections are made under actual 
clinical use conditions?)
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j)  Positive (non-disinfected device) and negative controls used in the study
k)  Validation (using microbiological techniques) of the disinfection procedures for 
connection and reconnection of the connector, as stated in your labeling
K.  Labeling
The premarket notification must include proposed labeling in sufficient detail to satisfy the 
requirements of 21 CFR 807.87(e). Proposed labels and labeling, sufficient to describe the 
arthroscopy pump tubing set, its intended use, and the directions for use must be provided. 
 
As prescription devices, arthroscopy pump tubing sets are exempt from having adequate 
directions for lay use required under section 502(f)(1) of the Federal Food, Drug and Cosmetic 
Act (FD&C Act) as long as the conditions in 21 CFR 801.109 are met. For instance, labeling 
must include adequate information for the intended user of the device, including indications, 
effects, routes, methods, frequency and duration of administration and any relevant hazards, 
contraindications, side effects, and precautions (21 CFR 801.109(d)). 
Labeling for arthroscopy pump tubing sets that identify multi-patient use (e.g., 24 Hour Use, 
Up to 8 Procedures) should be validated according to the recommendations described in 
Section III.J. Since the risk of cross-contamination cannot be completely eliminated with multi-
patient use tubing, labeling should inform users that there is a potential risk of cross-
contamination associated with re-use across multiple patients. 
The user manual should additionally include the following information: 
a)  Terminology that is consistent with the definitions provided in Section II, above;
b)  Clear instructions for installing the arthroscopy tubing system, including valves, 
connectors, and tubing, etc.; 
c)  Identification of the port/inlet to which each device component connects;
d)  Identification of compatible arthroscopy pump systems and arthroscopic 
instruments and accessories (or criteria to determine compatibility);
e)  Identification of all irrigation fluids intended for use with the device;
f)  Clear identification of the device or component that includes a backflow-
prevention valve or other backflow-prevention feature; 
g)  Directions for proper handling and associated practices to prevent backflow or 
contamination of the device (e.g., tubing containing backflow-prevention valve 
not to be placed in a horizontal or inverted direction, using sterile technique to 
handle the connectors); 
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h)  Directions to flush the irrigation system containing the multiple patient use tubing 
sets with irrigation fluid after each patient procedure (following removal of any 
tubing containing the backflow-prevention valve); 
i)  Identification of each device or component that is part of the proximal irrigation 
system or the distal irrigation system;
j)  Identification of the device as consumable or reusable;
i.  Consumable Device
  Identify the device as single-use device or 24-hour multi-patient 
use device, or clearly specify the maximum validated use life (e.g., 
Up to 8 procedures).
  Note: Multi-patient use devices used over a specified time period 
(e.g., 24 Hour Use) should not be labeled single-use or 
disposable.
 Consumable devices should not include reprocessing instructions.
 Labeling should include disposal instructions and should specify that 
the device should be discarded after every patient use for single-use 
devices, or after the maximum validated use life for multi-patient use 
devices (e.g., 24 hours for 24 Hour Use devices). The labeling should 
also instruct the user to discard the multi-patient use device 
components if any breach in sterility or potential for backflow occurs 
(e.g., improper handling of sterile connectors, pump warnings of 
excessive pressure in the joint during the case). 
Table 1 describes the appropriate actions for the various consumable 
irrigation system components. The table describes the recommended 
action that should be implemented to minimize risk, assuming that the 
irrigation system includes a backflow-prevention valve and performance 
data as described above has been provided.
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Table 1: Recommended Labeling and Actions for Consumable Device Components in Arthroscopy Pump Tubing 
Sets Intended for Multiple-Patient Use 
Consumable Device 
Recommended Labeling and Action 
Component
Label to include single-use device
Components of the Distal 
Irrigation System  Discard after every patient use
Label to include single-use device
Discard after every patient use
Components of the 
OR
Proximal Irrigation 
system 
Label to include 24-hour multi-patient use device
Discard after specified time period, e.g., 24 hours 
(multi-patient use without reprocessing between patient uses)
ii.  Reusable Device
 Identify the device as reusable. 
 The validated reprocessing instructions should indicate that the device 
is to be reprocessed after every patient use. Reprocessing instructions 
should be consistent with the recommendations described in the FDA 
guidance document entitled Reprocessing Medical Devices in Health 
Care Settings: Validation Methods and Labeling.14
14 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-
health-care-settings-validation-methods-and-labeling.
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