| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
056
|
Date of Entry 06/07/2021
|
|
FR Recognition Number
|
9-132
|
| Standard | |
ASTM F623-19
Standard Performance Specification for Foley Catheter |
|
Scope/Abstract| This performance specification establishes performance requirements for the short-term utilization of a single-use, balloon-retention catheter, French s 12 through 26 inclusive, used by the medical professions for providing a means of bladder drainage by means of the urethra. The product is manufactured in various s and materials such as latex, silicone, rubber, and various polymers (as well as combinations of these) and is provided nonsterile for sterilization and sterile for single use only. Catheters whose surface has been chemically treated to effect biocompatibility or microbial properties may be tested to this specification. |
|
| Extent of Recognition
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §876.5130 |
Stylet, Ureteral
|
Class 1
|
EYA
|
| §876.5130 |
Catheter, Ureteral, Gastro-Urology
|
Class 2
|
EYB
|
| §876.5130 |
Catheter, Upper Urinary Tract
|
Class 2
|
EYC
|
| §876.5130 |
Adaptor, Ureteral Catheter
|
Class 1
|
EYI
|
| §876.5130 |
Holder, Ureteral Catheter
|
Class 1
|
EYJ
|
| §876.5130 |
Connector, Ureteral Catheter
|
Class 1
|
EYK
|
| §876.5130 |
Stylet For Catheter, Gastro-Urology
|
Class 1
|
EZB
|
| §876.5130 |
Catheter, Coude
|
Class 2
|
EZC
|
| §876.5130 |
Catheter, Straight
|
Class 2
|
EZD
|
| §876.5130 |
Catheter, Retention Type, Balloon
|
Class 2
|
EZL
|
| §876.5130 |
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
|
Class 2
|
FCM
|
| §876.5130 |
Catheter, Ureteral Disposable (X-Ray)
|
Class 2
|
FGF
|
| §876.5130 |
Catheter, Double Lumen Female Urethrographic
|
Class 2
|
FGH
|
| §876.5130 |
Catheter, Urethrographic, Male
|
Class 2
|
FGI
|
| §876.5130 |
Catheter, Ureteral, General & Plastic Surgery
|
|
GBL
|
| §876.5130 |
Catheter, Urethral
|
Class 2
|
GBM
|
| §876.5130 |
Accessories, Catheter, G-U
|
Class 2
|
KNY
|
| §876.5130 |
Catheter, Urological
|
Class 2
|
KOD
|
| §876.5130 |
Catheter, Urological (Antimicrobial) And Accessories
|
Class 2
|
MJC
|
| §876.5130 |
Kit, Catheter, Urinary (Exludes Hiv Testing)
|
Class 2
|
NWO
|
| §876.5130 |
Catheter Care Tray
|
Class 2
|
OHR
|
|
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters, Issued September 1994.
2. Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway, Guidance for Industry and Food and Drug Administration Staff, Issued August 2020.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
FDA Specialty Task Group (STG)
| ObGyn/Gastroenterology/Urology |
|
| *These are provided as examples and others may be applicable. |
|
|
