The PORGES™ Silicone prostatectorny catheter is a balloon catheter of the retention type, commonly called THE FORGES " Silkone prosidioning outhere is a banetransparent silicone elastomer with a radiopaque a Toley datable 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 Shall. One laimer is for araning halas to anyth a third lumen, it is used in conjunction with the first lumen for the ballow with other water in used for inflation and deflation of the balloon. The distal end has opposite eye holes, which are used for drainage.
Nominal balloon inflation volumes are 15 to 30 cm³ or 30 to 50 cm³ with the 15 to 30 cm³ balloon being used Nominal banoon innation for normal usage, and 30 to 50 cm³ when a larger balloon is indicated.
to head of outher in place rehaft, are an connecting funnel and a Luer activated valve of which the colour varies according to the size of the catheter.
This product is available in sizes 18 Fr to 24 Fr, with DUFOUR, DELINOTTE, COUVELAIRE or standard tip. Total length of all catheters : 42 cm. One catheter has an open tip to fit over a guide wire.

AI/ML Overview

The provided document is a 510(k) summary for the PORGES™ Silicone prostatectomy catheter, which is a medical device and not an AI/ML-driven device. Therefore, the questions related to AI/ML device performance, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable.

However, I can extract the acceptance criteria for the device based on the provided text.

The device's performance requirements are assessed against the FDA "Guidance for the content of premarket notifications and functional testing of conventional and anti-reflux Foley catheters" dated September 12, 1994, and/or PORGES's own testing/acceptance criteria.

Here's a table based on the provided text, outlining the acceptance criteria (i.e., the performance requirements the device must meet) and what the document reports about the device performance regarding these criteria. It's important to note that the document generally states the device meets or passes these criteria, but it does not provide specific numerical outcomes or detailed results of the tests in this 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Requirements from Section J.7)	Reported Device Performance
Flow rate through the drainage lumen.	The PORGES™ Silicone prostatectomy catheter meets this performance requirement.
Balloon to rupture when inflated to the claimed balloon volume and held under conditions approximating the usage environment for a period of seven days.	The PORGES™ Silicone prostatectomy catheter meets this performance requirement. (Implied that the balloon does not rupture under these conditions).
Being distorted and pulled through the bladder outlet.	The PORGES™ Silicone prostatectomy catheter meets this performance requirement. (Implied that the device performs adequately without problematic distortion).
Maintenance of balloon inflation to fill volume over an extended time.	The PORGES™ Silicone prostatectomy catheter meets this performance requirement.
Manufacturing tolerances for catheter tip, balloon and shaft diameters.	The PORGES™ Silicone prostatectomy catheter meets this performance requirement.
Deflate reliability (to within 4 Fr. sizes of the labelled shaft size, as applicable, including the time for such deflation) for a catheter submerged seven days.	The PORGES™ Silicone prostatectomy catheter meets this performance requirement.
Shaft tensile strength and tip adherence.	The PORGES™ Silicone prostatectomy catheter meets this performance requirement.
Balloon burst.	The PORGES™ Silicone prostatectomy catheter meets this performance requirement.
Biocompatibility testing per ISO 10993-1.	The PORGES™ Silicone prostatectomy catheter passes biocompatibility testing per ISO 10993-1.

Since this is a traditional medical device (catheter) and not an AI/ML product, the remaining questions are not directly applicable. However, I will address them to explicitly state why they are not relevant in this context.

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical, sterile, single-use medical device. Performance is evaluated through physical and material tests, not typically with "test sets" in the context of data. The document does not specify general "data provenance" but mentions testing according to FDA guidance and/or PORGES internal criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on image interpretation) is not relevant for the physical performance testing of a catheter. The "ground truth" here is compliance with established engineering and safety standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve disagreements among human reviewers in clinical data analysis for AI/ML. The performance of this device is assessed against predetermined physical and material specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI algorithm, so MRMC studies or human-with-AI vs. without-AI comparisons are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, the "ground truth" is adherence to established mechanical, material, and biocompatibility standards (e.g., ASTM F 623-89, ISO 10993-1, and internal PORGES criteria).

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable. As there is no training set for an AI/ML model, "ground truth" for it is not established.

Summary

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DEC 2 0 2001

(

ection J: 510(k) Sur

ORGES™ Silicone prostatectomy catheter 510(k) submission Origin : Regulatory Affairs

Image /page/0/Picture/3 description: The image is a black and white logo for "PORGES". The logo consists of the word "PORGES" in a bold, sans-serif font, with a horizontal line above and below the word. Above the word is a symbol that resembles a key or a stylized letter "P". The symbol consists of a circle with a dot in the center, connected to a vertical line that splits into two lines at the bottom.

Ref. US1AB60A.DOC

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 Boursidière
	92357 Le Plessis Robinson - France
Contact person:	Mr Bernard ISMAEL
	Regulatory 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

Classification name:	Urological Catheter, Retention type, Balloon (78 EZ
Common / Usual name:	Prostatectomy catheter
Proprietary name:	PORGES™ Silicone prostatectomy catheter

J.3. Predicate devices

The PORGES™ Silicone prostatectorny catheter is substantially equivalent to the modified paediatric silicone The POTGES and to the Bardex® All-silicone 3-way Foley catheter from BARD.

J.4. Description of the Device

opposite eye nores, which are used for than ago.
Nominal balloon inflation volumes are 15 to 30 cm³ or 30 to 50 cm³ with the 15 to 30 cm³ balloon being used Nominal banoon innation for normal usage, and 30 to 50 cm³ when a larger balloon is indicated.

to head of outher in place rehaft, are an connecting funnel and a Luer activated valve of which the colour varies according to the size of the catheter.

varies according to the Sizes of the outloter.
This product is available in sizes 18 Fr to 24 Fr, with DUFOUR, DELINOTTE, COUVELAIRE or standard tip. Total length of all catheters : 42 cm. One catheter has an open tip to fit over a guide wire.

J.5. Intended use of the Device

The PORGES™ Silicone prostatectomy catheter is used for :

short term drainage of the vesical urines,
irrigation/injection and drainage following surgery,
after prostate surgery : hemostasis of the prostate area.

J.6. Technological characteristics

The PORGES™ Silicone prostatectory catheter has similar technological and performance characteristics to the predicate devices. The catheter is manufactured entirely from silicone elastomer as for the predicate to the producer to the eather is supplied in French sizes ranging from 18 to 24 and balloon capacities 15-30 cm to devices: The battletter to oupplied in French sizes from 6 to 26 balloon capacities from 1.5 cm 1.5 cm 1.5 cm 1.5 cm 1.5 cm 1.5 cm 1.5 cm 30 cm . The device is supplied in male length only. The predicate device is supplied in male and female lengths. All of the devices are supplied sterile for single use.

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Section J: 510(k) Sum

PORGES™ Silicone prostatectomy catheter 510(k) submission Origin : Regulatory Affairs

Image /page/1/Picture/2 description: The image is a logo for Porges. The logo consists of a stylized symbol above the word "PORGES". The symbol features a circle with a vertical line extending downwards from its center, ending in two parallel lines. The logo is black and white and is contained within a rectangular border.

Ref. US1AB60A.DOC

J.7. Testing and results

The PORGES™ Silicone prostatectorny catheter referenced in this submission is held to the same design, THE PORGES -- SMOUNE prostateority battleters currently manufactured. Performance performance manulaciure, and performanon and the FDA "Guidance for the content of premarket notifications and functional tooking otariaal old Foley catheters" dated September 12, 1994.

for conventional and antinitional Poly vatheter meets the following performance requirements per testing THE FONGES - Silleone prosidioson's baller Provinte, 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 Note: ASTMT - 020 00 - nower, the test methods described therein will also be utilised to test tri-lumen (3-way) catheters, balloon catheters equal to or larger than 30 cm³.

Flow rate through the drainage lumen .
r low taxe and 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;
ditions approximating the 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; .

Malitationing theration 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™ Silicone prostatectorny catheter passes biocompatibility testing per ISO 10993-1.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2001

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

Re: K013172

Trade/Device Name: Porges Silicone Prostatectomy Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessor: Regulatory Class: II Product Code: 78 EZL Dated: September 21, 2001 Received: September 24, 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 for associor 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 r ou may , increase 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 0011) war an an an 110 revel 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 predicate 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/dsmaldsmamain.html.

Sincerely yours,

Nancy C. Croghan

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 Stater

PORGES™ Silicone prostatectomy catheter 510(k) submission

Image /page/4/Picture/2 description: The image shows a close-up of a document with the words "Statement" and "Origin : Regulatory Affairs" printed on it. The text is in a clear, sans-serif font and appears to be part of a larger document. There is also a partial logo or symbol visible in the upper right corner of the image.

Ref. US1AB60A.DOC

Page 1 of 1

KO13172 510(k) Number (if known):

Device Name: PORGES™ Silicone prostatectomy catheter

Indications for use:

The PORGES™ Silicone prostatectomy catheter is used for :

short term drainage of the vesical urines, -
irrigation/injection and drainage following surgery,
infigurer.hijformate surgery : hemostasis of the prostate area.

(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)

Prescription Use

David A. Segerson

(Division Sign-OR
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013172

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.