PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL

K013172 · Porges S.A. · EZL · Dec 20, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K013172
• Device Name: PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
• Applicant: Porges S.A.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Dec 20, 2001
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

PORGES™ Silicone prostatectomy catheter is a sterile, single-use, disposable, retention-type balloon catheter. Constructed from transparent silicone elastomer with a radiopaque line; features a shaft with three lumens: one for drainage, one for balloon inflation/deflation, and one for irrigation/injection. Distal end includes opposite eye holes for drainage. Available in sizes 18 Fr to 24 Fr with various tip configurations (DUFOUR, DELINOTTE, COUVELAIRE, or standard); total length 42 cm. Used in clinical settings by healthcare professionals for post-prostatectomy management. The device is inserted into the urinary tract; the balloon is inflated (15-30 cm³ or 30-50 cm³) to secure the catheter in place. Provides drainage and hemostasis, facilitating post-operative recovery.

Clinical Evidence

Bench testing only. Performance evaluated per FDA 'Guidance for the content of premarket notifications and functional testing for conventional and antinational Foley catheters' (1994) and ASTM F 623-89. Testing included flow rate, balloon rupture resistance, balloon inflation maintenance, manufacturing tolerances, shaft tensile strength, tip adherence, and deflation reliability after seven-day submersion. Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Material: Silicone elastomer. Design: 3-way balloon catheter, 18-24 Fr, 42 cm length. Features: Radiopaque line, Luer-activated valve, multiple tip options. Connectivity: None. Sterilization: Sterile, single-use. Standards: ASTM F 623-89 (test methods), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for patients requiring short-term vesical urine drainage, post-surgical irrigation/injection and drainage, or hemostasis of the prostate area following prostate surgery.

Regulatory Classification

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).

Predicate Devices

• modified paediatric silicone catheter
• Bardex® All-silicone 3-way Foley catheter (BARD)

Submission Summary (Full Text)

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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: | [e-mail] |
| 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

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.

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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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