Pulse Oximeters - Premarket 
Notification Submissions [510(k)s] 
Guidance for Industry and  
Food and Drug Administration 
Staff 
 
Document issued on: March 4, 2013  
 
This document supersedes Non-invasive Pulse Oximeter General Guidance 
Document, September 7, 1992 
The draft of this document was issued on July 19, 2007. 
 
 
For questions regarding this document contact Neel Patel at 301-796-5580 or 
neel.patel@fda.hhs.gov.  
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Office of Device Evaluation 
Division of Anesthesiology, General Hospital,  
Infection Control, and Dental Devices 
Anesthesiology and Respiratory Devices Branch 
  Contains Nonbinding Recommendations 
 
 
Preface 
 
 
Public Comment 
 
 
You may submit written comments and suggestions at any time for Agency consideration to the 
Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, (HFA-305), Rockville, MD, 20852.  Submit electronic comments to 
http://www.regulations.gov.  Identify all comments with the docket number listed in the notice of 
availability that publishes in the Federal Register.  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 e-mail request to 
dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 301-
827-8149 to receive a hard copy.  Please use the document number (1605) to identify the 
guidance you are requesting. 
 
  Contains Nonbinding Recommendations 
 
 
Table of Contents 
1.  INTRODUCTION................................................................................................................... 1 
2.  SCOPE ..................................................................................................................................... 1 
3.  DEVICE DESCRIPTION ...................................................................................................... 2 
4.  DEVICE PERFORMANCE................................................................................................... 4 
4.1  ACCURACY OF PULSE OXIMETERS............................................................................................................... 4 
4.2  ALARMS ...................................................................................................................................................... 8 
4.3  DISPLAY VALUES, OUTPUTS, AND INDICATORS ............................................................................................. 8 
4.4  SATURATION PULSE INFORMATION SIGNAL .................................................................................................. 9 
5.  SOFTWARE INFORMATION ............................................................................................. 9 
6.  ELECTRICAL, MECHANICAL, AND ENVIRONMENTAL SAFETY ......................... 9 
7.  ELECTROMAGNETIC COMPATIBILITY ...................................................................... 9 
8.  BIOCOMPATIBILITY .......................................................................................................... 9 
9.  CLEANING, DISINFECTION, AND STERILIZATION ................................................ 10 
9.1  REUSE INSTRUCTIONS AND VALIDATION ................................................................................................ 10 
9.2  STERILIZATION DOCUMENTATION ......................................................................................................... 10 
10. LABELING ........................................................................................................................... 10 
10.1  INTENDED USE ......................................................................................................................................... 11 
10.2  INSTRUCTIONS FOR USE .......................................................................................................................... 11 
10.3  DEVICE SPECIFICATIONS ......................................................................................................................... 11 
10.4  PACKAGE LABELING ............................................................................................................................... 12 
11. SUBMISSIONS FOR REPROCESSED SINGLE-USE SENSORS ................................. 12 
11.1  IDENTIFICATION OF COMPONENTS AND USES ........................................................................................ 13 
11.2  PERFORMANCE TESTING ......................................................................................................................... 13 
11.3  CLEANING METHODS AND VALIDATION INFORMATION ........................................................................ 13 
11.4  DISINFECTION AND/OR STERILIZATION VALIDATION INFORMATION ................................................... 14 
11.5  DEVICES NOT PROVIDED STERILE .......................................................................................................... 14 
11.6  DEVICES PROVIDED STERILE .................................................................................................................. 14 
APPENDIX  LIST OF REFERENCES .................................................................................. 15  Contains Nonbinding Recommendations 
 
 
Pulse Oximeters - Premarket Notification 
Submissions [510(k)s] 
 
Guidance for Industry and  
Food and Drug Administration Staff 
 
 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on 
this topic.  It does not create or confer any rights for or on any person and does not operate to 
bind FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the appropriate number listed on the title page of this 
guidance.  
 
1.  Introduction  
FDA has developed this guidance document to assist industry in preparing premarket notifications 
(510(k)s) for pulse oximeters.  These devices are intended for non-invasive measurement of the 
arterial blood oxygen saturation and pulse rate.   
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.  
 
2.  Scope 
The scope of this document is limited to the Class II devices, Oximeter and Ear oximeter, 
classified under the following regulations:  
 
21 CFR 870.2700  Oximeter (product codes: DQA (Oximeter) and NLF (Oximeter, 
Reprocessed)) 
An oximeter is a device used to transmit radiation at a known wavelength(s) through blood 
and to measure the blood oxygen saturation based on the amount of reflected or scattered 
radiation.  It may be used alone or in conjunction with a fiberoptic oximeter catheter. 
 
  1  Contains Nonbinding Recommendations 
 
 
This guidance does not address oximeters in product codes MUD (tissue saturation 
oximeter), NMD (reprocessed tissue saturation oximeter), or MMA (fetal pulse oximeter). 
 
21 CFR 870.2710  Ear Oximeter (product code: DPZ (Ear oximeter))  
An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) 
through blood in the ear.  The amount of reflected or scattered light as indicated by this 
device is used to measure the blood oxygen saturation. 
 
These classification regulations group together all oximeters intended to measure blood oxygen 
saturation.  The regulations at 21 CFR 870.2700 and 870.2710 include devices using reflectance, 
transmittance, and fiber optic technologies, which are collectively referred to as pulse oximeters 
for the purpose of this guidance.  The terms transmittance and reflectance refer to the sensor 
geometry and are not related to the principles of pulse oximetry and how the light is absorbed by 
hemoglobin. 
 
This guidance document pertains to non-invasive pulse oximeters to measure arterial blood 
oxygen saturation (SpO2) and pulse rate based on the amount of transmitted, reflected and 
scattered light through various application sites (including, but not limited to finger, ear, foot, 
hand, forehead, back, and nose). These devices are limited to prescription use. These pulse 
oximeters may be continuous or spot-checking devices and either stand-alone or multi-parameter 
modules.  These devices are typically labeled with a general indication for non-invasive 
measurement of blood oxygen saturation.  A manufacturer that wishes to seek a specific clinical 
indication for use of a pulse oximeter, for example to screen for or diagnose a disease or 
condition, should submit clinical safety and effectiveness data to support the specific indication.  
A clinical evaluation of a new intended use of a legally marketed device may require an 
Investigational Device Exemption (IDE) under 21 CFR Part 812 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Howto 
MarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm) before the clinical study is 
initiated.  Should an IDE be necessary, FDA suggests that manufacturers take advantage of the 
Pre-Submission Program (see Draft Guidance for Industry and FDA Staff Medical Devices:  
The Pre-Submission Program and Meetings with FDA Staff, issued  July 13, 2012,1 which when 
final will represent FDAs current thinking on this topic) to obtain input from FDA on their study 
plan.   
 
3.  Device Description  
We recommend you identify your device by the applicable regulation number and product code 
indicated in Section 2 above and include the information described below. 
 
Intended Use  
We recommend you clarify if the device [and accessories] is intended: 
                                                 
1 Web addresses for all guidance documents referenced within can be found in the List of References at the end of 
this document.  
  2  Contains Nonbinding Recommendations 
 
 
  as a stand-alone device or a multi-parameter module; 
  for use in spot-checking or continuous monitoring;  
  for single use or multi-use; 
  for out-of-hospital transport; or  
  for home use.  
 
Device Design  
We recommend you identify and describe: 
  scientific principles underlying how the device achieves its intended use, i.e., the theory 
of operation (e.g. functional oxygen saturation or fractional oxyhemoglobin); 
  sensor configuration/geometry and recommended application sites;  
  design features; e.g., functions, alarms.  In general, pulse oximeters intended for 
continuous monitoring should include high and low SpO2 and pulse rate alarms; 
  all patient interface accessories; e.g., patient cable, extender cables, sensors, bandages; 
  whether the device will be provided sterile; and 
  whether the device is a reprocessed single-use device. 
 
We recommend you include high-level drawings, diagrams, or photographs of your device that 
can help explain the function or highlight new features that may affect safety and effectiveness, 
for example, changes to a sensor. 
 
We recommend that you compare your device with a legally marketed predicate device (include 
the 510(k) number, if available) and provide information to show how your device is similar to 
and different from the predicate.  Side by side comparisons, whenever possible, are desirable, for 
example, using a tabular format as shown below.  For each identified difference, please provide 
further discussion of the difference compared to the predicate and why this difference will not 
significantly affect safety or effectiveness.  
 
Table 1. Example Comparison of New and Predicate Devices 
Description  Your Device  Predicate Device 
Intended patient population, such as 
   
neonate, infant, pediatric, adult 
Intended application site, such as 
   
finger, ear, foot, hand, forehead, back, 
nose 
Performance Specifications (including 
   
use under motion and low perfusion 
conditions, if applicable, and any 
indices or signals provided to the user) 
  3  Contains Nonbinding Recommendations 
 
 
Safety Specifications (e.g., electrical, 
   
mechanical, environmental) 
Features (e.g., alarms, display and 
   
indicators, modes)  
 
4.  Device Performance 
We recommend the device undergo performance testing as described in ISO 80601-2-61:2011 
Medical Electrical Equipment  Part 2-61: Particular requirements for basic safety and 
essential performance of pulse oximeter equipment or equivalent method.  This should include, 
but not be limited to, testing identified in Sections 4.1  4.4 below. 
4.1  Accuracy of Pulse Oximeters 
We recommend that you conduct the testing described in Clause 201.12.1 of ISO 80601-2-
61:2011 or equivalent methods. 
 
An oximeter operates as a system composed of a sensor, any extender or interface cable, and 
a specific oximeter monitor or module.  We recommend you validate each system through 
appropriate testing, inspection, or analysis. 
 
Grouping Sensors for Testing 
It may be appropriate to group certain sensors for testing if they are of similar design or 
equivalent performance.  We consider sensors to be of similar design if they contain identical 
materials and electro-optical components and have equivalent sensor characteristics (e.g., 
location of use).  If you choose to group sensors for testing based on their similar design, we 
recommend you indicate that all sensors within each group contain identical materials and 
electro-optical components and describe the rationale for grouping.  Generally, we believe 
that clip and adhesive sensors should not be grouped based on similar design because they 
differ in form, fit, and functional specifications.  If you choose to group sensors for testing 
based on equivalent performance, we recommend you provide valid scientific evidence and 
statistical analysis to demonstrate that the results of testing are poolable.   
 
Incorporating an Original Equipment Manufacturers Cleared Technology 
If your device incorporates an Original Equipment Manufacturers (OEM) oximeter that is 
legally marketed for the same intended use, we recommend you provide the following in lieu 
of accuracy studies:  
  the 510(k) numbers for the submissions where each combination of oximeter, sensor, 
and cable were cleared for use together; and 
  testing that demonstrates that SpO2 and pulse rate values calculated by the OEM 
system are not corrupted during communication to your host device. 
 
We recommend you conduct the above verification on the bench using a functional tester (see 
ISO 80601-2-61:2011 Section 201.3.209 for the definition and appropriate uses of a 
  4  Contains Nonbinding Recommendations 
 
 
functional tester) to span the range of saturation and pulse rate values to assure 
communication between the component and the host module.   
 
Modifications to Oximeter Systems that Require a New 510(k) 
In accordance with 21 CFR 807.87(g), a pulse oximeter system  that has undergone a 
significant change or modification (from its currently cleared configuration) that could 
significantly affect the safety or effectiveness of the device requires a new 510(k).  To 
decide when to submit a new 510(k) for a change to an existing device, we recommend you 
refer to the FDA guidance titled Deciding When to Submit a 510(k) for a Change to an 
Existing Device (K97-1), issued January 10, 1997.  FDA generally considers any one of the 
following modifications to be significant as they may have the potential to affect safety or 
effectiveness:  
  significant electro-optical sensor modifications (e.g., component or bandage material 
in the light path, extensive re-design where a device is miniaturized); or 
  significant SpO  algorithm modifications.  
2
 
We recommend you conduct in vivo (i.e., clinical) studies to determine the accuracy of SpO  
2
(under laboratory and any labeled operating conditions (e.g., motion)) for new and modified 
systems.  FDA will always consider alternatives to in vivo testing when the proposed 
alternatives are supported by an adequate scientific rationale.  For example, when changes or 
modifications made do not affect the optical chain or signal processing path, then additional 
clinical studies may not be needed. 
 
If a clinical study is needed to demonstrate substantial equivalence, i.e., conducted prior to 
obtaining 510(k) clearance of the device, the study must be conducted under the 
Investigational Device Exemptions (IDE) regulation, 21 CFR Part 812.  Generally, FDA 
believes pulse oximeters addressed by this guidance document are non-significant risk 
devices; therefore, the study would be subject to the abbreviated requirements of 21 CFR 
812.2(b).  Please see the FDA Guidance titled, Significant Risk and Nonsignificant Risk 
Medical Device Studies, issued January 2006.  In addition to the requirements of Section 21 
CFR 812.2(b), sponsors of such trials must comply with the regulations governing 
institutional review boards (21 CFR Part 56) and informed consent (21 CFR Part 50).  
 
4.1.1  In vivo testing for SpO  accuracy under laboratory conditions 
2
We recommend you follow Clause 201.12.1.101.2 and Annex EE.2 of ISO 80601-2-
61:2011 Procedure for invasive laboratory testing on healthy volunteers, or equivalent 
method to validate the SpO  accuracy specifications of your pulse oximeter system by 
2
comparing each value from your system and a simultaneous value from co-oximetry of an 
arterial blood sample.  We recommend you submit a detailed clinical report for this 
testing.  Your report should describe the device configuration tested and include the 
following: 
  test apparatus used, including means for arterial catheterization and blood 
sampling, means for recording SpO  values, and means for delivering medical 
2
  5  Contains Nonbinding Recommendations 
 
 
grade oxygen-nitrogen mixtures of varying fractional inspired oxygen (FiO ) 
2
levels; 
  inclusion and exclusion criteria; 
  number of subjects; 
  number of samples taken per subject; 
  specific conditions of testing, including laboratory conditions, subject motion, low 
pulse amplitude; 
  type and frequency of motion for testing under motion conditions, if applicable; 
  criteria and methods for determining stability of reference arterial blood oxygen 
saturation (SaO ) at the pulse oximeter sensor site; 
2
  desaturation profile, including target saturation plateaus and ranges; and 
  formula used for determination of root mean square difference (A ).  (See 
rms
Clause 201.12.1.101.2.2 of ISO 80601-2-61:2011 for recommended formula.) 
 
We recommend you conduct the study described in Clause 201.12.1.101.2 and Annex 
EE.2 of ISO 80601-2-61:2011 on 10 or more healthy subjects that vary in age and gender.  
Your data should include 200 or more data points (paired observations: pulse oximeter, 
co-oximeter).  These data should be distributed as described in Annex EE.2.3.4(g).   
 
Your study should have subjects with a range of skin pigmentations, including at least 2 
darkly pigmented subjects or 15% of your subject pool, whichever is larger. 
 
We recommend you provide a line listing, a Bland-Altman plot, error plots (i.e., SaO  
2
versus (SpO -SaO ) for both individual test subjects and all subjects pooled), and 
2 2
rationale for any points excluded from analysis.  Please include population mean bias 
( ), between-subject variance ( 2), within-subject variance (2), and upper 95% and 
0 
lower 95% limits of agreement.  Please provide this information as outlined in Section 3 
of Agreement Between Methods Of Measurement With Multiple Observations Per 
Individual by Bland and Altman.2  If you note that the plots show noticeable outliers, 
please provide the following:  
  a discussion of the state of health, subject characteristics, test setup, test 
procedure, and any other factors that may have affected these data points; and 
  a discussion of how the outlier(s) do not raise safety and performance concerns 
regarding the accuracy of the device.  
 
We recommend an A  specification in conformance with Clause 201.12.1.101.1 of ISO 
rms
80601-2-61:2011.  We recognize that accuracy is, among other things, a function of 
patient characteristics, application site and sensor geometry.  The table below outlines the 
typical A  between measured values (SpO ) and reference values (SaO ) under normal 
rms 2 2
conditions ranging from 70% to 100% SpO . 
2
                                                 
2 See Bland and Altman. Agreement between methods of measurement with multiple observations per individual. 
Journal of Biopharmaceutical Statistics (2007) vol. 17 pp. 571-582. 
  6  Contains Nonbinding Recommendations 
 
 
 
Table 3.  Typical Arms Specification by Sensor Type 
Sensor Type  A  
rms
Transmittance, wrap and clip   3.0 % 
Ear clip   3.5 % 
Reflectance   3.5 % 
 
4.1.2  In vivo testing for SpO  accuracy for neonates 
2
If your device is intended for use with neonates, we recommend you report performance 
of neonatal sensors on adult subjects as described in Section 4.1.1.  Adult subjects are 
acceptable in this case due to the uncertainty of determining the accuracy of sensors 
intended for use in neonates.  If the neonatal sensor is new or significantly changed 
compared to the predicate device, we recommend you provide testing on additional 
convenience arterial samples (See Annex EE.4.1, Invasive testing on patients, of ISO 
80601-2-61:2011) collected on neonates to verify safe form, fit, and function (clinical 
performance).  
 
We recognize that neonatal clinical studies are more representative of the intended use 
than controlled laboratory studies in adults, that there will be inherently greater noise in 
the measurement of neonatal oxygen saturation values, and that convenience samples in 
this population may be clustered around 90% SaO .  Nonetheless, we recommend you 
2
provide data on a sufficient number of neonatal subjects and samples.  We recommend 
that you justify the sample size and SaO  range of data collected.  
2
 
4.1.3  Testing for SpO  accuracy for oximeters making motion 
2
performance claims  
We recommend testing in accordance with Clause 201.12.1.102 of ISO 80601-2-61:2011. 
One recommended approach is to use the methods described in Section 4.1.1 
incorporating subject motion. We recommend including a description of the 
characteristics of each motion including amplitudes, types, and frequencies of motion 
selected for testing in your test report. 
 
4.1.4  Testing for SpO  accuracy under low perfusion for oximeters 
2
making low perfusion performance claims  
We recommend testing in accordance with Clause 201.12.1.103 of ISO 80601-2-61:2011.  
One recommended method is to verify the SpO  accuracy under low perfusion conditions 
2
in vitro using a functional tester, set to the signal amplitude defined as low perfusion for 
the system (e.g., 0.3% modulation).   
 
  7  Contains Nonbinding Recommendations 
 
 
4.1.5  Testing for Pulse Rate Accuracy claims 
We recommend testing in accordance with Clause 201.12.1.104 of ISO 80601-2-61:2011.  
One recommended method is to test your system on the bench (using a functional tester) 
at the lowest pulse amplitude that the oximeter specifies as normal.  
 
4.1.6  Testing for Pulse Rate Accuracy for oximeters labeled with 
motion performance claims 
We recommend testing in accordance with Clause 201.12.1.102 of ISO 80601-2-61:2011.  
One potential approach is to use the methods described in Section 4.1.5 incorporating 
motion. We recommend including a description of the characteristics of each motion 
including amplitudes, types, and frequencies selected for testing. 
 
4.1.7  Testing for Pulse Rate Accuracy for oximeters labeled with low 
perfusion performance claims 
We recommend testing in accordance with Clause 201.12.1.103 of ISO 80601-2-61:2011.  
A recommended approach is to use the methods described in Section 4.1.5 with a 
functional tester, set to the signal amplitude defined as low perfusion for the system (e.g., 
0.3% modulation).   
4.2  Alarms 
We recommend you address the requirements of Clause 208 of ISO 80601-2-61:2011 or an 
equivalent method for visual and audible indicators and alarms of the monitor and any remote 
alarm unit. 
4.3  Display values, outputs, and indicators 
We recommend you provide appropriate (e.g. clinical, bench) testing all of the data outputs, 
measurement values, and indicators that the device incorporates and displays on the monitor 
(e.g., perfusion index, signal strength, pulse amplitude).  We recommend the test procedure 
include:  
  the test method,  
  the objectives of the testing,  
  the equipment used, the tests specifications,  
  the standards to which conformance is demonstrated,  
  the pass/fail criteria, and  
  the summary of the results including an analysis explaining the significance of the 
results.   
 
Please also note Clause 201.12.4 of ISO 80601-2-61:2011 Protection against hazardous 
output for considerations regarding data update period and signal inadequacy. 
  8  Contains Nonbinding Recommendations 
 
 
4.4  Saturation pulse information signal 
If your device includes a variable-pitch auditory information signal to indicate the pulse 
signal, we recommend the pitch change follow Clause 201.103 of ISO 80601-2-61:2011 or 
equivalent method. 
 
5.  Software Information 
Please refer to Guidance for the Content of Premarket Submissions for Software Contained in 
Medical Devices, issued May 11, 2005, for a discussion of the software documentation that we 
recommend you provide.  Please refer to the guidance General Principles of Software 
Validation, issued January 11, 2002, for software development practices.  FDA generally 
considers pulse oximeters to be of Moderate level of concern for the purposes of software 
review. 
 
If the device includes off-the-shelf software, we recommend you provide the additional 
information as recommended in the guidance, Off-the-Shelf Software Use in Medical Devices, 
issued September 9, 1999.      
 
6.  Electrical, Mechanical, and Environmental Safety 
We recommend you follow safety testing for Type BF or CF applied part as referenced in ISO 
80601-2-61:2011.  Specifically, we recommend you address the requirements of Clauses 201.4 to 
201.11 and 201.13 to 201.16 of ISO 80601-2-61:2011. 
 
7.  Electromagnetic Compatibility 
Electromagnetic compatibility (EMC) is the ability of a device to operate properly in its intended 
environment of use without introducing excessive electromagnetic disturbances into that 
environment.  We recommend you address the requirements of Clauses 201.17 and 202 of ISO 
80601-2-61:2011.  
 
8.  Biocompatibility 
We recommend that you provide a list of the patient-contacting materials in your device. You 
should evaluate the biocompatibility of the patient-contacting materials as described in the FDA 
guidance on the Use of International Standard Organization (ISO) Standard ISO-10993, 
Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, issued May 1, 1995.  
We consider pulse oximeters devices with prolonged contact duration due to the potential for 
cumulative use.  We consider the components that contact the patient to be surface contacting 
components with skin contact.  We recommend testing include:   
  irritation or intracutaneous reactivity; 
  sensitization; and 
  cytotoxicity.   
  9  Contains Nonbinding Recommendations 
 
 
 
Materials are considered identical if they have the identical chemical formulation and identical 
manufacturing processes.  If identical materials are used in a predicate device with the same type 
and duration of patient contact, you may identify the predicate device in lieu of performing 
biocompatibility testing.   
 
9.  Cleaning, Disinfection, and Sterilization 
We recommend you provide information on cleaning, disinfection, and sterilization for all pulse 
oximeters intended for reuse (both single patient and multi-patient). 
 
9.1  Reuse Instructions and Validation 
For pulse oximeter systems and accessories intended for reuse, we recommend you evaluate 
the instructions for cleaning and, as appropriate, disinfection or sterilization. 
 
If the device is intended to be cleaned, high-level disinfected, or sterilized by the user for 
multiple use, we recommend you demonstrate that the device can be cleaned, high-level 
disinfected, or sterilized according to the instructions provided in the device labeling; and 
that afterwards, the device continues to perform as intended.     
 
In order to demonstrate that the labeled cleaning and disinfection or sterilization methods 
achieve the desired results, refer to the FDA guidance, Labeling Reusable Medical Devices 
for Reprocessing in Healthcare Facilities, issued April 1996, for additional 
recommendations. 
 
9.2   Sterilization Documentation 
If the pulse oximeter system or accessories are provided sterile, we recommend you include 
the documentation described in Updated 510(k) Sterility Review Guidance K90-1, issued 
August 30, 2002. 
 
You should also provide a description of the packaging system and the method used to 
validate that the packaging maintains sterility, but not the validation data itself (for more 
information on packaging testing, see ANSI/AAMI/ISO 11607-1-2:2006 Packaging for 
terminally sterilized medical devices  Parts 1 and 2).  We recommend you identify the 
proposed shelf life and provide testing of aged samples to demonstrate that the sterility and 
device functionality are maintained over the expected shelf life. 
 
10. Labeling  
The premarket notification must include labeling in sufficient detail to satisfy the requirements of 
21 CFR 807.87(e).  Use the following suggestions for assistance in preparing labeling that 
  10  Contains Nonbinding Recommendations 
 
 
satisfies the requirements of 21 CFR 807.87(e).3  In addition, we recommend you conform to the 
labeling recommendations in Clause 201.7 of ISO 80601-2-61:2011.   
10.1  Intended Use 
The intended use should identify: 
  patient population(s); 
  spot checking or continuous monitoring; 
  application sites;  
  conditions of use such as motion and low perfusion, if applicable; 
  whether the device is intended for single use or reuse; and 
  environments of use. 
 
10.2  Instructions for Use 
As a prescription device, according to 21 CFR 801.109, the device is exempt from having 
adequate directions for lay use.  Nevertheless, we recommend you provide clear and concise 
instructions that delineate the technological features of your device and how it is used on 
patients.  Instructions should encourage local/institutional training programs designed to 
familiarize users with the features of the device and how to use it in a safe and effective 
manner.  We recommend you conform to Clause 201.7 of ISO 80601-2-61:2011 for 
information to be included in the instructions for use.  This includes but is not limited to:  
  all applicable safety information, warnings, cautions, and notes; 
  a description of your pulse oximeter system including the theory of operation 
(functional oxygen saturation or fractional oxyhemoglobin, etc.), sensor 
configuration/geometry, all features, alarms, and accessories;  
  an identification of whether the system and accessories are provided sterile or non-
sterile; 
  device setup and operation information; 
  instructions for the frequency of inspection of the application site for skin integrity; 
  instructions for the frequency of sensor relocation; and  
  device service and maintenance information, including cleaning and disinfection 
instructions for reusable pulse oximeters and accessories (please also see Section 9.1 
above). 
 
10.3  Device Specifications 
We recommend you conform to Clauses 201.7.9.2.1.101, 201.7.9.2.14.101, and 
201.12.1.101.1 of ISO 80601-2-61:2011 for reporting device specifications in the labeling.   
                                                 
3 Although final labeling is not required for 510(k) clearance, final labeling must comply with the requirements of 21 
CFR 801 before a medical device is introduced into interstate commerce.  In addition, final labeling for prescription 
medical devices must comply with 21 CFR 801.109.  Labeling recommendations in this guidance are consistent with 
the requirements of part 801. 
  11  Contains Nonbinding Recommendations 
 
 
The labeling should include a list of specifications including: 
  SpO  accuracy specification in the SpO  range of 70% to 100%; 
2 2
  a table with measured SpO  accuracy specification in the discrete SpO  ranges of 70% 
2 2
to 80%, 80% to 90%, and 90% to 100%;  
  graphical plot of all sampled data points; 
  pulse rate accuracy specification covering the entire pulse rate display range; 
  operating and storage temperature and humidity; 
  alarm limits and ranges; and 
  default settings. 
 
For the graphical plot, we recommend a plot of SaO  versus error (SpO   SaO ) with linear 
2 2 2
regression fit and upper 95% and lower 95% limits of agreement as discussed in Section 3 of 
Agreement Between Methods Of Measurement With Multiple Observations Per Individual 
by Bland and Altman.2  We recommend each sampled data point be identified per individual 
test subject.   
 
The labeling should identify the specific models of pulse oximeters with which the sensors 
were clinically validated and intended to be used. 
 
For new systems or major modifications to existing systems intended for use with neonates, 
we recommend you disclose the SaO  range and A  of the collected convenience samples 
2 rms
(see Section 4.1.2 above).  The specifications should include:   
  patient population characteristics of the neonate population tested; 
  number of subjects; and 
  number of data samples. 
 
10.4  Package Labeling 
We recommend you provide package labeling in your submission in accordance with Clause 
201.7.2.101 of ISO 80601-2-61:2011.  This includes but is not limited to whether the system 
is:  
  provided sterile or non-sterile; and 
  intended for single use or reuse. 
   
11. Submissions for Reprocessed Single-Use Sensors  
If your device includes a reprocessed single-use sensor, we recommend you provide the 
following information in addition to the information previously described in this guidance 
document:     
  electro-optical specifications of the reprocessed sensors; 
  means to ensure each reprocessed device meets these specifications; and 
  12  Contains Nonbinding Recommendations 
 
 
  tracking methods used to limit the number of reprocessing cycles. 
 
We recommend you provide complete reprocessing methods and validation data in accordance 
with the FDA guidance, Medical Device User Fee and Modernization Act of 2002, Validation 
Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical 
Devices, issued September 25, 2006.  This should include, but not necessarily be limited to the 
following information. 
 
11.1  Identification of Components and Uses 
We recommend you provide a detailed diagram of all the components of the sensors, and 
identify each component that will be replaced when the device or system is reprocessed and 
each component that will be retained.  In particular, we recommend you indicate whether the 
reprocessor will replace or save the laminate that encloses the optical components.   
 
11.2  Performance Testing  
We recommend you describe performance testing conducted to validate the performance of 
the reprocessed device, including: 
  clinical validation of SpO  accuracy as described in Section 4 above; 
2
  bench testing of pulse rate performance as described in Section 4 above; and 
  bench testing of SpO  and pulse rate performance as described in Section 4 above in 
2
accordance with Clause 5.3 of IEC 60601-1:2005.  
We recommend the performance testing for reprocessed sensors be assessed on worst-case 
basis (i.e., after the maximum number of times the sensor is intended to be reprocessed).  In 
addition, we recommend you simulate use of each sensor after each reprocessing cycle prior 
to conducting the testing recommended above. 
 
11.3  Cleaning Methods and Validation Information  
We recommend you provide point-of-use cleaning instructions for the healthcare facility (if 
used) in the device labeling. 
 
We recommend you provide incoming inspection instructions for device-cleaning 
technicians, including:   
  detailed acceptance/rejection criteria to control incoming raw materials for devices 
that are intended to be reprocessed; and 
  model sorting. 
 
We recommend you provide cleaning instructions to be used by the device cleaning 
technicians, including set points and ranges for cleaning methods (e.g., times, temperatures). 
 
We recommend you provide cleaning validation information, including: 
  methods that test worst case implementation of set points and ranges described above; 
  13  Contains Nonbinding Recommendations 
 
 
  predetermined cleaning endpoints and their scientific rationale; and 
  the adequacy of the proposed cleaning process as measured against the predetermined 
endpoints. 
 
11.4  Disinfection and/or Sterilization Validation Information  
We recommend you provide comprehensive disinfection and sterilization validation 
protocols and data, consistent with the intended use, indications, and performance 
characteristics described in your labeling. 
 
11.5  Devices Not Provided Sterile 
For devices labeled non-sterile, we recommend labeling include a general description of 
how the packaging materials adequately protect the devices during shipping and handling, 
including packaging validation protocols and data. 
 
11.6  Devices Provided Sterile 
For devices labeled sterile, we recommend you include the documentation described in the 
guidance Updated 510(k) Sterility Review Guidance K90-1, issued August 30, 2002. 
 
  14  Contains Nonbinding Recommendations 
 
 
Appendix  List of References 
For the most recent version of a guidance, check the CDRH guidance webpage at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/defaul
t.htm 
 
Draft Guidance for Industry and FDA Staff Medical Devices:  The Pre-Submission Program and 
Meetings with FDA Staff  
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm31
0375.htm 
 
Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1) 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm08
0235.htm 
 
Significant Risk and Nonsignificant Risk Medical Device Studies 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418. 
pdf 
 
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGui 
dance/GuidanceDocuments/ucm089543.htm 
 
General Principles of Software Validation; Final Guidance for Industry and FDA Staff 
http://www.fda.gov/Medical 
Devices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm 
 
Off-the-Shelf Software Use in Medical Devices 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm07
3778.htm 
 
Use of International Standard Organization (ISO) standard ISO-10993, "Biological Evaluation 
of Medical Devices Part 1: Evaluation and Testing 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm08
0735.htm 
 
Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities 
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocum
ents/UCM080268.htm 
 
Updated 510(k) Sterility Review Guidance K90-1 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm07
2783.htm 
 
  15  Contains Nonbinding Recommendations 
 
 
Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket 
Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGui 
dance/GuidanceDocuments/ucm071434.htm 
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