Contains Nonbinding Recommendations 
 
Conventional Foley Catheters  
Performance Criteria for Safety and 
Performance Based Pathway 
______________________________________________________________________________ 
Guidance for Industry and 
Food and Drug Administration Staff 
 
Document issued on August 14, 2020. 
 
The draft of this document was issued on September 19, 2019 
 
For questions about this document, contact the DHT3B: Division of Reproductive, Gynecology 
and Urology Devices at 301-796-7030. 
 
 
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-1651. 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 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number 19010 and complete title of the guidance in the request. 
 
2 
  Contains Nonbinding Recommendations 
Conventional Foley Catheters  
Performance Criteria for Safety and 
Performance Based Pathway
 
______________________________________________________________________________ 
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 
This guidance provides performance criteria for conventional Foley catheters in support of the 
Safety and Performance Based Pathway.1 Under this framework, submitters planning to submit a 
510(k) using the Safety and Performance Based Pathway for Foley catheters will have the option 
to use the performance criteria proposed in this guidance to support substantial equivalence, 
rather than a direct comparison of performance of the subject device to that of a predicate device. 
 
For the current edition of the FDA-recognized standard(s) referenced in this document, see the 
FDA Recognized Consensus Standards Database.2 For more information regarding use of 
consensus standards in regulatory submissions, please refer to the FDA guidance titled 
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices.3   
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys 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 guidance means that something is suggested or 
recommended, but not required.  
 
                                                 
1 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-
based-pathway  
2 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm  
3 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices  
3 
  Contains Nonbinding Recommendations 
II.  Scope/Device Description 
The Foley catheters that are the subject of this guidance are intended for the drainage and/or 
irrigation of the urinary tract. These devices are Class II and are regulated under 21 CFR 
876.5130 with the product code EZL (Catheter, Retention Type, Balloon).  
 
Intended Use/Indications for Use: 
Drainage is accomplished by inserting the catheter through the urethra into the bladder. The 
catheter is retained by use of a balloon inflated in the bladder, which is attached to the distal end 
of the catheter. The devices are single-use and indwelling time should be 30 days or less.  
 
Device Design Characteristics: 
The French sizes within the scope of this guidance include sizes 12 through 26 with a retention 
balloon volume no greater than 30 cm3. Two lumen catheters are included within the scope of 
this guidance. Three lumen catheters, catheters treated to enhance their lubricity, suprapubic 
catheters, and antimicrobial catheters are outside the scope of this guidance.  
 
General guidance that is beyond the scope of this safety and performance guidance document 
(e.g., labeling recommendations) regarding submission of a 510(k) for Foley catheters can be 
found in FDAs guidance document Guidance for the Content of Premarket Notifications for 
Conventional and Antimicrobial Foley Catheters.4 
 
FDA may determine, on a case-by-case basis, that additional data are necessary to evaluate 
whether the device is appropriate for the Safety and Performance Based Pathway. In situations 
where you determine that additional testing outside of those identified in this guidance are 
necessary to determine whether the device is appropriate for the Safety and Performance Based 
Pathway, we would encourage sponsors to submit a Pre-Submission5 to engage in discussion 
with FDA prior to submission of the 510(k). 
 
III.  Testing Performance Criteria 
If your device is appropriate for submission through the Safety and Performance Based Pathway, 
and you choose to use that option, you do not need to provide direct comparison testing against a 
legally marketed predicate device to demonstrate substantially equivalent performance 
characteristics. To ensure that the performance criteria outlined in this guidance remain 
contemporary and take into account relevant data from recent clearances, FDA recommends that 
you provide a results summary for all tests evaluated in addition to the other submission 
information (e.g. Declaration of Conformity (DoC)) identified for each test or evaluation below.  
Unless otherwise identified in the submission information sections below, test information such 
as  results summary, test protocols, or complete test reports should be submitted as part of the 
                                                 
4 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-
premarket-notifications-conventional-and-antimicrobial-foley-catheters  
5 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program 
4 
  Contains Nonbinding Recommendations 
510(k) as described in FDAs guidance Safety and Performance Based Pathway.6 For additional 
information regarding the submission of non-clinical bench testing information, please see 
FDAs guidance Recommended Content and Format of Non-Clinical Bench Performance 
Testing Information in Premarket Submissions.7 
 
Mechanical Testing 
 
1.  Test name: Dimensional Analysis 
Methodology: FDA currently-recognized version of American Society for Testing and 
Materials (ASTM) F623 Standard Performance Specifications for Foley Catheters  
Performance Criteria: The label French size should correspond with the following 
actual diameters of the catheter tip, shaft, and balloon within tolerances as identified in 
test #6, Balloon Size and Shaft Size.  
 
Table 1 Foley Catheter French Size Designation 
French Size  Outside Diameter, in. (mm) 
12  0.157 (4.0) 
13  0.171 (4.3) 
14  0.184 (4.7) 
15  0.197 (5.0) 
16  0.210 (5.3) 
17  0.223 (5.7) 
18  0.236 (6.0) 
19  0.249 (6.3) 
20  0.262 (6.7) 
21  0.276 (7.0) 
22  0.289 (7.3) 
23  0.302 (7.7) 
24  0.315 (8.0) 
25  0.328 (8.3) 
26  0.341 (8.7) 
 
Performance Criteria Source: For French sizes - ASTM F623 (2019) Standard 
Performance Specifications for Foley Catheters 
Additional Considerations: Conventional Foley catheters typically have an even 
numbered French size.  
Submission Information: DoC  
 
2.  Test name: Flow Rate 
Methodology: ASTM F623 Standard Performance Specifications for Foley Catheters 
                                                 
6 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-
based-pathway  
7 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-
and-format-non-clinical-bench-performance-testing-information-premarket  
5 
  Contains Nonbinding Recommendations 
Performance Criteria: Catheters with French size 14-26 should have a minimum 
average flow rate of 100 cm3/min. French size 12 catheters should have a minimum 
average flow rate of 70 cm3/min. 
Performance Criteria Source: ASTM F623 (2019) Standard Performance 
Specifications for Foley Catheters 
Additional Considerations: ASTM F623 does not provide a criterion for French size 13 
catheters as conventional Foley catheters typically have an even numbered French size. 
Submission Information: DoC 
 
3.  Test name: Balloon Integrity (Resistance to Rupture) 
Methodology: ASTM F623 Standard Performance Specifications for Foley Catheters 
Performance Criteria: The inflated balloon should inflate easily with distilled or 
deionized water to the labeled volume without showing any evidence of breakage 
throughout the test period. Any catheter whose balloon has burst during or after filling up 
to the time of examination of the balloon, are considered to have failed the test. Any 
catheter whose balloon does not burst but which deflates during the test because of some 
form of leakage should be considered an invalid test item.  
Performance Criteria Source: ASTM F623 (2019) Standard Performance 
Specifications for Foley Catheters 
Submission Information: DoC 
 
4.  Test name: Inflated Balloon Response to Traction 
Methodology: ASTM F623 Standard Performance Specifications for Foley Catheters. 
Performance Criteria: The entire balloon of the catheters with a labeled French size 14 
through 26 should not pass into or through the funnel barrel with a size of 28Fr.  
Performance Criteria Source: ASTM F623 (2019) Standard Performance 
Specifications for Foley Catheters 
Additional Considerations: Labeled French size 12 catheters are not expected to pass 
this testing.  
Submission Information: DoC 
 
5.  Test name: Balloon Volume Maintenance 
Methodology: ASTM F623 Standard Performance Specifications for Foley Catheters. 
Performance Criteria: The catheter should maintain its volume throughout the test.  
Performance Criteria Source: ASTM F623 (2019) Standard Performance 
Specifications for Foley Catheters 
Submission Information: DoC 
 
6.  Test name: Balloon Size and Shaft Size  
Methodology: ASTM F623 Standard Performance Specifications for Foley Catheters. 
Performance Criteria: The proximal catheter tip, the balloon, and the shaft should 
measure within the tolerances on diameter shown below in comparison to the labeled 
French size: 
 
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  Contains Nonbinding Recommendations 
Table 2 Foley Catheter Dimensional Tolerances 
Material Type  Tip Tolerance  Shaft  Balloon Size, Maximum 
Tolerance  As Received,  Deflated, 
Uninflated  After 
Immersion 
Latex and  1  +2,-1  3  4 
coated latex 
All silicone  1  1  4  4 
Others  1  1  3  4 
 
Performance Criteria Source: ASTM F623 (2019) Standard Performance 
Specifications for Foley Catheters 
Submission Information: DoC 
 
7.  Test name: Deflation Reliability (Failure to Deflate)  
Methodology: ASTM F623 Standard Performance Specifications for Foley Catheters 
Performance Criteria: The balloon should deflate to no less than four French sizes of 
the labeled French size within 15 minutes or be otherwise manipulated to effect drainage 
within this time-period.  
Performance Criteria Source: ASTM F623 (2019) Standard Performance 
Specifications for Foley Catheters 
Submission Information: DoC 
 
Sterilization (devices labeled as sterile) and Reprocessing (end-user sterilized) Validation 
 
8.  Test name: Sterilization (devices labeled as sterile) and Reprocessing (end-user 
sterilized) 
Methodology: FDA currently-recognized version of the following consensus standards 
(as applicable): 
  International Organization for Standardization (ISO) 17665-1 Sterilization of 
health care products  Moist heat  Part 1: Requirements for the development, 
validation, and routine control of a sterilization process for medical devices 
  ISO 11135-1 Sterilization of health care products  Ethylene oxide- Part 1: 
Requirements for development, validation, and routine control of a sterilization 
process for medical devices 
  ISO 11137-1 Sterilization of health care productsRadiationPart 1: 
Requirements for development, validation, and routine control of a sterilization 
process for medical devices 
  ISO 20857 Sterilization of health care products  Dry heat  Requirements for 
the development, validation and routine control of a sterilization process for 
medical devices 
  ISO 11607-1 Packaging for terminally sterilized medical devices  Part 1: 
Requirements for materials, sterile barrier systems and packaging systems 
  ISO 11607-2 Packaging for terminally sterilized medical devices  Part 2: 
Validation requirements for forming, sealing and assembly processes 
7 
  Contains Nonbinding Recommendations 
Performance Criteria: Validation testing should demonstrate the cleanliness and 
sterility of, or the ability to clean and sterilize to a sterility assurance level of 10-6, the 
device and device-specific instruments. You should provide a description of the 
packaging (sterile barrier system) and how it will maintain the devices sterility, and a 
description of the package test methods, but not package test data. 
Performance Criteria Source: FDAs guidance: 
  Submission and Review of Sterility Information in Premarket Notification 
(510(k)) Submissions for Devices Labeled as Sterile8 
  Reprocessing Medical Devices in Health Care Settings: Validation Methods and 
Labeling9 
Submission Information: If using an Established Category A sterilization method, you 
should provide the information described in Section V.A. of the FDA guidance 
Submission and Review of Sterility Information in Premarket Notification (510(k)) 
Submissions for Devices Labeled as Sterile; the validation data itself is not needed to 
demonstrate substantial equivalence.  
 
Biocompatibility Evaluation 
 
To identify the biocompatibility endpoints to include as part of your biocompatibility evaluation 
you should use Attachment A of CDRHs guidance Use of International Standard ISO 10993-1, 
Biological evaluation of medical devices  Part 1: Evaluation and testing within a risk 
management process,10 referred to in the rest of this document as the CDRH Biocompatibility 
Guidance for brevity. FDA considers the devices covered by this guidance to be categorized as 
External Communicating Devices with a prolonged tissue contact duration of >24 hours to 
30 days and you should assess the endpoints below per Attachment A of the CDRH 
Biocompatibility Guidance. 
  Cytotoxicity 
  Sensitization 
  Irritation or Intracutaneous Reactivity 
  Acute Systemic Toxicity 
  Material-Mediated Pyrogenicity (should be conducted to support devices labeled as 
"non-pyrogenic") 
  Sub-acute/Sub-chronic Toxicity 
  Genotoxicity 
  Implantation 
 
Rationale in Lieu of Testing: If the subject device is manufactured from the identical raw 
materials using identical manufacturing processes as a predicate device with the same type and 
duration of tissue contact, and any changes in geometry are not expected to impact the biological 
response, this is typically sufficient to establish substantially equivalent biocompatibility, if 
                                                 
8 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-
sterility-information-premarket-notification-510k-submissions-devices-labeled  
9 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-
devices-health-care-settings-validation-methods-and-labeling  
10 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-
standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and  
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  Contains Nonbinding Recommendations 
documentation such as that outlined in Attachment F of the CDRH Biocompatibility Guidance is 
also provided. 
 
Testing: If you determined that testing is needed to address some or all of the identified 
endpoints, FDA recommends that complete test reports be provided for all tests performed unless 
a declaration of conformity without supplemental information can be appropriately provided, per 
Attachment E of the CDRH Biocompatibility Guidance. Any test-specific positive, negative, 
and/or reagent controls should perform as expected, and protocol deviations should be 
thoroughly described and justified; however, note that certain protocol deviations may invalidate 
comparison to the performance criteria listed below and require submission of a Traditional, 
Special, or Abbreviated 510(k). 
 
9.  Test name: Biocompatibility endpoints (identified from CDRH Biocompatibility 
Guidance) 
Methodology: FDA currently-recognized versions of biocompatibility consensus 
standards 
Performance Criteria: All direct or indirect tissue contacting components of the device 
and device-specific instruments should be determined to have an acceptable biological 
response. 
Performance Criteria Source: The CDRH Biocompatibility Guidance 
Additional Considerations: For any biocompatibility test samples with an adverse 
biological response, the biocompatibility evaluation should explain why the level of 
toxicity seen is acceptable. Some comparison testing against a legally marketed predicate 
may be necessary (and is considered acceptable under the Safety and Performance Based 
Pathway) to support such a rationale as explained in the CDRH Biocompatibility 
Guidance. For standard biocompatibility test methods that include comparison device 
control samples, the legally marketed comparison device control samples should perform 
as expected, as specified above for the subject device samples.   
Submission Information: Refer to CDRH Biocompatibility Guidance 
9