The 2-way PORGES™ FOLYSIL™ silicone Foley catheter is used for urethral urinary catheterisation for short term drainage of vesical urines. Only straight 2-way PORGES™ FOLYSIL™ silicone Foley catheter with a maximum 15 ml balloon volume may be used in a supra-pubic way (except the grooved catheters). The 3-way PORGES™ FOLYSIL™ silicone Foley catheter is used for urethral urinary catheterisation to allow short term drainage of the vesical urines, irrigation/injection following surgery.

Device Description

The PORGES™ FOLYSIL™ silicone Foley catheter is of the retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate the balloon with sterile water. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. Sterile water is used for inflation of the balloon. The distal end has opposite eye holes, which are used for drainage. On the Tiemann tip there is one hole. Straight cylindrical, "over the guide wire" and Tiemann tips are available versions of this product. On the opposing end of the shaft, are a connecting funnel and a Luer activated valve. This product is available in sizes 12 Fr to 24 Fr, smooth and profile (grooved) shafts. Profile shafts provide drainage channels along the shaft length.

AI/ML Overview

PORGES™ FOLYSIL™ silicone Foley catheter - Acceptance Criteria and Study Details

The provided document describes the acceptance criteria and testing for the PORGES™ FOLYSIL™ silicone Foley catheter, primarily referencing the FDA "Guidance for the content of premarket notifications for conventional and antimicrobial Foley catheters" dated September 12, 1994, and ASTM F 623-89.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Requirement	Reported Device Performance
Flow rate through the drainage lumen	Device meets performance requirements via testing.
Resistance of the balloon to rupture (claimed volume, 7 days usage environment)	Device meets performance requirements via testing.
Resistance of inflated balloon to distortion/pull-through from bladder outlet	Device meets performance requirements via testing.
Maintenance of balloon inflation to fill volume over extended time	Device meets performance requirements via testing.
Manufacturing tolerances for catheter tip, balloon, and shaft diameters	Device meets performance requirements via testing.
Ability of inflated catheter (7 days submerged) to reliably deflate to ≤ 4 Fr. sizes of labeled shaft size, including deflation time	Device meets an applicable performance requirement via testing.
Shaft tensile strength	Device meets performance requirements via testing.
Tip adherence	Device meets performance requirements via testing.
Balloon burst	Device meets performance requirements via testing.
Biocompatibility (per ISO 10993-1)	Device passes biocompatibility testing per ISO 10993-1.

Note: The document only states that the device "meets the following performance requirements per testing conducted," implying all items listed are successfully met. Specific quantitative performance values are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each individual test. It broadly states that "testing conducted according to ASTM F 623-89, when appropriate, and/or PORGES testing/acceptance criteria" was performed.

Data Provenance: The studies were conducted by PORGES S.A. based on established US FDA guidance and ASTM standards. The country of origin for the data is implicitly France, where PORGES S.A. is located, and the testing was conducted as part of their 510(k) submission to the US FDA. The studies are prospective in the sense that they were conducted specifically for the submission to demonstrate compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable. The device is a physical medical device (catheter), and the "ground truth" for its performance is established through physical and mechanical testing against predefined engineering and biocompatibility standards, not through expert consensus on interpretation.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data interpretation (e.g., medical images). The testing involves objective physical measurements and adherence to specified performance limits.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This section is not applicable. The device is a physical medical device (catheter), not an AI algorithm intended for diagnostic interpretation that would involve human readers. Therefore, an MRMC study and AI assistance effect size are not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This section is not applicable. The device is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for the device's performance is based on:

Established engineering standards: Specifically, ASTM F 623-89, which details test methods for Foley catheters.
Biocompatibility standards: ISO 10993-1, which outlines biological evaluation of medical devices.
FDA guidance: The "Guidance for the content of premarket notifications for conventional and antimicrobial Foley catheters" dated September 12, 1994, provides the framework and specific performance expectations.
Internal PORGES testing/acceptance criteria: These would likely be derived from or in alignment with the above external standards and guidance.

These standards define objective, measurable physical and material properties that the device must exhibit to be considered safe and effective for its intended use.

8. Sample Size for the Training Set

This section is not applicable. The device is a physical medical device, not an AI algorithm requiring a training set of data.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable, as there is no training set for a physical medical device.

Summary

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JAN 0 4 2002

tion J: 510(k) Summ

PORGES™ FOLYSIL™ silicone Foley catheter 510(k) submission

Ref. US1AA61A.DOC

Origin : Regulatory Affairs

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

J.1. Submitter's information

Submitter's name:	PORGES S.A.
Submitter's address:	Centre d'Affaires La Boursidière92357 Le Plessis Robinson - France
Contact person:	Mr Bernard ISMAELRegulatory Affairs Manager
Contact person's phone:	+ 33 1 46 01 32 06
Contact person's fax:	+ 33 1 46 01 32 56
Contact person's email:	bernard.ismael@porges.com
Date of preparation:	July 2001

J.2. Device name

Urological Catheter, Retention type, Balloon (78 EZL) Classification name: Foley catheter Common / Usual name: PORGES™ FOLYSIL™ silicone Foley catheter Proprietary name:

J.3. Predicate devices

The PORGES™ FOLYSIL™ silicone Foley catheter is substantially equivalent to the modified paediatric silicone Foley catheter from PORGES, silicone Foley catheters from ROCHESTER, Inc., Bardex® All-silicone 3-way Folev catheter from BARD and Oligon® Foley Catheter from IMPLEMED.

J.4. Description of the Device

J.5. Intended use of the Device

J.6. Technological characteristics

The PORGES™ FOLYSIL™ sillcone Foley catheter has similar technological and performance characteristics to the predicate devices. The catheter is manufactured entirely from silicone elastomer as for the predicate devices. The catheter is supplied in French sizes ranging from 12 to 24 and balloon capacities 5 cm to 30 cm³. The predicate devices are available in French sizes from 6 to 26 balloon capacities from 1.5 cm³ to 30 cm³. The device is supplied in male and female lengths. The predicate devices are supplied in male and female lengths. All of the devices are supplied sterile for single use.

J.7. Testing and results

The PORGES™ FOLYSIL™ silicone Foley catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those Foley catheters currently manufactured. Performance

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ection J: 510(k) Su

GES™ FOLYSIL™ silicone Foley

Ref. US1AA61A.DOC

Image /page/1/Picture/3 description: The image is a logo with the word "PORGES" written in bold, sans-serif font at the bottom. Above the word is a symbol that resembles a stylized lightbulb or a keyhole. The symbol consists of a circle with a vertical line extending downwards from its center, ending in a small circle. The logo is contained within a rectangular border.

Origin : Regulatory Affairs

and functional testing standards are based on the FDA "Guidance for the content of premarket notifications for conventional and antimicrobial Foley catheters" dated September 12, 1994.

The PORGES™ FOLYSIL™ silicone Foley catheter meets the following performance requirements per testing conducted according to ASTM F 623-89, when appropriate, and/or PORGES testing/acceptance criteria:

Note: ASTM F 623-89 excludes from the scope the catheters that have three lumens, balloons equal to or larger than 30 cm³, or shaft sizes smaller than 12 Fr or larger. Also excluded are catheters for paediatric and nonurethral catheterizations such as suprapubic cystostomy. However, the test methods described therein will also be utilised to test tri-lumen (3-way) catheters equal to or larger than 30 cm , and catheters size equal to or smaller than 12 Fr including paediatric catheters.

Flow rate through the drainage lumen .
Resistance of the balloon to rupture when inflated to the claimed balloon volume and held under . conditions approximating the usage environment for a period of seven days;
Resistance of the inflated balloon to being distorted and pulled through the bladder outlet; .
Maintenance of balloon inflation to fill volume over an extended time; .
Manufacturing tolerances for catheter tip, balloon and shaft diameters; .

Ability of an inflated catheter that has been submerged for seven days to deflate reliability to . within 4 Fr. sizes of the labelled shaft size, as applicable, including the time for such deflation;

. Shaft tensile strength and tip adherence;

Balloon burst. .
The PORGES™ FOLYSIL™ silicone Foley catheter passes biocompatibility testing per ISO 10993-1.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 4 2002

Mr. Bernard Ismael Regulatory Affairs Manager PORGES-C.A. La Boursidière 92357 Le Plessis Robinson CEDEX FRANCE

Re: K013174

Trade/Device Name: PORGESTM FOLYSIL™ Silicone Foley Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EZL Dated: December 20, 2001 Received: December 27, 2001

Dear Mr. Ismael:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed needicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section F: Indications for Use Statem

silicone Foley catheter 510(k) submissio

Origin : Regulatory Affairs

Image /page/4/Picture/3 description: The image is a black and white logo for "PORGES". The logo is inside of a rectangle. Above the word "PORGES" is a symbol that looks like a circle with a line going through the middle of it. The line has a small circle at the top.

Ref. US1AA61A.DOC

Page 1 of 1

013174 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: PORGES™ FOLYSIL™ silicone Foley catheter

Indications for use:

The 2-way PORGES™ FOLYSIL™ silicone Foley catheter is used for une matheterisation for short term drainage of vesical urines. Only straight 2-way PORGES™ FOLYSIL™ silicone Foley for short with a maximum 15 ml balloon volume may be used in a supra-pubic way (except the grooved catheters).

grooved batheoloj:
The 3-way PORGES™ FOLYSIL™ silkone Foley catheter is used for urethral urinary catheterisation to allow short term drainage of the vesical urines, irrigation/injection following surgery.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

(Optional Format 3-10-98)

Nancy C Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K013174

Prescription Use

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.