PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX

K021856 · Porges S.A. · EYB · Oct 17, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K021856
• Device Name: PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX
• Applicant: Porges S.A.
• Product Code: EYB · Gastroenterology, Urology
• Decision Date: Oct 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The PORGES™ Ureteral catheters are used for ureteral catheterisation: - drainage catheters: straight catheters with bevel, olive or cylindrical tip, elbowed catheter with olive tip - . catheters for retrograde ureteropyelography (R.U.P.): Chevassu, cone or Braasch - interventional catheters: flush, open straight, open elbowed. The appropriate guide-wire size for each catheter is shown on the box.

Device Story

Single-lumen ureteral catheter; medical-grade radiopaque polymer; sizes 03 FR to 12 FR; optional removable metal or polymer stylet for straightening during insertion; silicone stop ring on stylet for tip positioning. Used by physicians for ureteral drainage, retrograde ureteropyelography, or interventional procedures via Seldinger guide-wire. Catheter provides access to ureter; facilitates fluid drainage or contrast medium delivery. Benefits include improved procedural access and patient management during urological interventions.

Clinical Evidence

Bench testing only. No clinical data. Substantial equivalence demonstrated through mechanical/physical testing including flow rate, tensile strength, tear strength of bulbs, and passage of contrast medium. Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Single-lumen catheter; medical-grade radiopaque thermoplastic (PVC, polyamide, polyurethane, or PEBA); graduated every cm along 50 cm; sizes 03-12 FR. Features include various tip configurations (bevel, olive, cylindrical, Chevassu, cone, Braasch, open straight/elbowed). Optional removable stylet. Sterile, single-use. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients requiring ureteral catheterization for drainage, retrograde ureteropyelography (R.U.P.), or interventional procedures (e.g., placement over a guide-wire).

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

• Bard Flexible Tip Ureteral catheter (K950300)
• PORGES pre-amendment range of ureteral catheters
• C.R. Bard Inc. Urological Division's currently marketed ureteral catheter line

Submission Summary (Full Text)

{0}------------------------------------------------

# OCT 1 7 2002

Section J: 510(k) Sum

#### Ref. US021A41.DOC

Origin : Regulatory Affairs

Image /page/0/Picture/4 description: The image is a logo for Porges. The logo consists of a stylized symbol above the word "PORGES". The symbol is a circle with a line extending down from the center, ending in a small circle. The word "PORGES" is in a bold, sans-serif font.

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 Boursidière<br>92357 Le Plessis Robinson - France |
| Contact person: | Mr Bernard ISMAEL<br>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: | February, 2002 |

#### J.2. Device name

| Classification name: | Catheter, ureteral, gastro-urolog |
|----------------------|-----------------------------------|
| Common / Usual name: | Ureteral catheters |
| Proprietary name: | PORGES™ Ureteral catheters |

#### J.3. Predicate devices

The PORGES™ Ureteral catheters are substantially equivalent to the PORGES™ pre-amendment range of ureteral catheters, C.R. Bard Inc. Urological Division's currently marketed ureteral catheter line and Bard Flexible Tip Ureteral catheter (K950300). PORGES S.A., is not aware of any information suggesting that C.R. Bard Inc. ureteral catheters are not legally marketed. Ureteral catheters may also be referic catheters, both denominations being equally used within the medical profession.

#### J.4. Description of the Device

The PORGES™ Ureteral catheters consist of a single lumen catheter in medical grade radiopaque polymer, graduated every cm along 50 cm, and fitted with either a metal or a polymer removable stylet or no stylet. The stylet allows straightening of the catheter for easier insertion. A wax knob is added on the external end of the stylet for easy retreat of the coudé tip catheters are fitted with a silicone stop ring on the stylet between the catheter and the wax knob to hold the renal tip of the stylet away from the catheter's renal tip.

The ureteral catheters are available with different types of renal tips and in sizes ranging from 03 FR to 12 FR.

The preamendment devices have been designed for R.U.P. (retrograde ureteropyelography).

PORGES has validated the following uses for the new range of ureteral catheters :

- . drainage
- R.U.P. (= retrograde uretero pyelography) .
- interventional ("per operating") use with a Seldinger guide wire (not supplied)

The predicate devices Bard® Flexible Tip ureteral catheters (K950300) and C.R. Bard's currently marketed devices are designed for the same intended use.

The PORGES™ Ureteral catheters are supplied sterile and for single use only.

#### J.5. Intended use of the Device

The PORGES™ Ureteral catheters are used for ureteral catheterisation:

- drainage catheters: straight catheters with bevel, olive or cylindrical tip, elbowed catheter with olive tip ●
- . catheters for retrograde ureteropyelography (R.U.P.): Chevassu, cone or Braasch

interventional catheters: flush, open straight, open elbowed. The appropriate guide-wire size for each catheter is shown on the box.

{1}------------------------------------------------

Section J: 510(k) Summa PORGES™ Ureteral catheters 510(k) submission

Ref. US021A41.DOC

Origin : Regulatory Affairs

Image /page/1/Picture/3 description: The image shows a logo with the word "PORGES" written in bold, block letters at the bottom. Above the word is a symbol that resembles a stylized key or a tuning fork. The symbol consists of a circle with a vertical line extending downwards from its center, ending in a small circle. The logo is enclosed in a rectangular border.

#### J.6. Technological characteristics

The PORGES™ Ureteral catheters have similar technological and performance characteristics to the predicate devices. The PORGES™ Ureteral catheters are similar as it concerns its materials to PORGES and C.R. Bard's currently marketed ureteral catheters and to the Bard Flexible tip ureteral catheter (K950300). All are made of medical grade thermoplastic material. The choice of either a polyvinyl chloride, polyamide, polyurethane or PEBA (polyether block amide) catheter or metal or polymer stylet may provide a slight difference in stiffness, which does not affect clinical properties, but may be preferred by practioners according to the method of use.

The polyvinyl chloride and polyamide mixtures which are used for the manufacturing of most PORGES Ureteral catheters are the same as those used since 1971 for the manufacturing of the PORGES preamendment devices.

The straight open tip of the interventional ureters allows placement over a quide-wire. The straight open tip is similar in performance as the straight whistle tip of both Porges' and Bard's currently marketed catheters.

#### J.7. Test Summary

The PORGES™ Ureteral catheters referenced in this submission are held to the same design, manufacture, and performance specifications as the predicate devices. Substantial equivalence of the devices with respect to functional performance has been demonstrated by mechanical/physical testing. The following tests have been performed :

- Flow rate
- Tensile strength .
- Tear strength of bulbs (Chevassu and cone-tip catheters)
- Passage of contrast medium

The PORGES™ Ureteral catheters have successfully passed biocompatibility testing per ISO 10993-1.

#### J.8. Conclusion.

The biocompatibility and mechanical/physical tests confirm the safety and effectiveness for these devices is assured and these devices perform as well as or better than the predicate devices.

{2}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the caduceus symbol.

## OCT 1 7 2002

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Re: K021856

Trade/Device Name: PORGES™ Ureteral Catheters Models ACN6xx, ACN5xx, AC5B, AC5C07, ACP5xx, ACP2xx, ACP3xx, ACP4xx, and ACP6xx Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EYB Dated: September 24, 2002 Received: October 7, 2002

Dear Mr. ISMAEL:

Mr. Bernard ISMAEL

PORGES S.A.

FRANCE

Regulatory Affairs Manager

Centre d'Affaires La Boursidière 92357 Le Plessis-Robinson Cedex

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.

{3}------------------------------------------------

Page 2

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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Croydon.

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

Enclosure

{4}------------------------------------------------

# Section F: Indications for Use Statement

PORGES™ Ureteral catheters 510(k) submission

Ref. US021A41.DOC

Origin : Requlatory Affairs

Image /page/4/Picture/4 description: The image is a logo for Porges. The logo features a stylized image of a key with a circular head. The word "PORGES" is written in bold, sans-serif letters below the key image. The logo is black and white and has a simple, modern design.

Page 1 of 1

510(k) Number (if known): K1021856

Device Name: PORGES™ Ureteral catheters

Indications for use:

The PORGES™ Ureteral catheters are used for ureteral catheterisation:

- drainage catheters: straight catheters with bevel, olive or cylindrical tip, elbowed catheter with olive tip
- catheters for retrograde ureteropyelography (R.U.P.): Chevassu, cone or Braasch -
- interventional catheters: flush, open straight, open elbowed. The appropriate quide-wire size for each catheter is shown on the box.

(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

IDivision Sign-Off) Division of Seproductive, Abdominal, and Padiciogical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________