KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C

K990500 · The Kendal Co. · EZL · Sep 28, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990500
• Device Name: KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
• Applicant: The Kendal Co.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Sep 28, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kendall Coude Foley catherer is a urological catherer designed with a bent tip to provide transurethral access to the obstructed bladder in the male patient for irrigation and uring drainage.

Device Story

Sterile, single-use urological catheter; natural rubber latex construction; features bent tip and 5cc or 30cc balloon. Used in hospital settings by clinicians for transurethral access to obstructed bladders in male patients. Facilitates irrigation and urine drainage. Device provides mechanical access; no electronic or software components.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO-10993. Functional/mechanical testing performed per ASTM F623-89, including flow rates, balloon integrity, traction response, volume maintenance, and deflation reliability.

Technological Characteristics

Natural rubber latex construction; bent tip design; 5cc or 30cc balloon; 12-24 French sizes. Complies with ASTM F623-89 standard performance specifications for Foley catheters. Biocompatible per ISO-10993.

Indications for Use

Indicated for male patients requiring transurethral access to an obstructed bladder for irrigation and urine drainage.

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

• Bardex Lubricath Coude Foley Catheter (K910195)

Submission Summary (Full Text)

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SEP 2 8 1999

K990500

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## II. 510(k) SUMMARY

| Submitted by: | The Kendall Company<br>15 Hampshire Street<br>Mansfield, MA 02048 |
|----------------------|-------------------------------------------------------------------|
| Contact Person: | Paul W. Evans<br>[phone] |
| Date Prepared: | January 31, 1999 |
| Proprietary Name: | Kendall Ultramer Coude Foley Catheter |
| Common Name: | Coude Foley Catheter |
| Classification Name: | Urological Catheter and accessories (21 CFR §876.5130(h)) |
| Predicate Device: | Bardex Lubricath Coude Foley Catheter<br>510(k) #K910195 |

#### Description of the Device:

The Kendall Ultraner Coude Foley Catheter is a sterile, single use unological catheter composed of natural rubber latex with a 5 cc or 30cc balloon and designed with a beat tip to provide transurethral access to an obstructed bladder, for purposes of irrigation and urine drainage. The Coude catheter is exclusively used in the male patient, typically in a hospital secting. The Kendall Ultramer Coude Foley Catheters will be marketed in 12-24 French sizes.

### Intended Use of the Device:

The Kendall Coude Foley catherer is a urological catherer designed with a bent tip to provide transurethral access to the obstructed bladder in the male patient for irrigation and uring drainage.

### Technological Characteristics:

The Kendall Ultramer Coude Foley Catherer is equivalent to the referenced predicate device in that they are fabricated from similar materials, have the same function, equivalent indications for use, and similar overall design.

#### Nonclinical resting:

Biocompatibility resting was performed on the Kendall cather, following ISO-10993 Biological Evaluation of Medical Devices. The testing found that the Materials used in the Kendall Coude Foley Catheter are biocompatible.

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4.

Fur. tional/mechanical testing was performed to determine flow rates, balloon integrity, inflated balloon response to traction, balloon volume maintenance, balloon size and shaft size, and deflation reliability. The testing found the Kendall Coude catheter to meet ASTM F623-89 Standard Performance Specifications for Foley Catheters. The testing also verified equivalence to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 1999

Mr. Paul W. Evans Director, Regulatory Affairs The Kendall Company 15 Hampshire Street Mansfield, MA 02048

Re: K990500 Kendall Ultramer Coude Foley Catheter Dated: September 9, 1999 Received: September 10, 1999 Regulatory Class: II 21 CFR §876.5130/Procode: 78 EZL

Dear Mr. Evans:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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, isting 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809,10 for in vitto diagnosic devices), piease contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CART Daniel J. Scheidt, M.D.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# VII. INDICATIONS FOR USE STATEMENT

K 990500 510(k) Number: Kendall Coude Foley Catheter Device Name: _

Indications for Use: The Kendall Coude Foley Catheter is a urological catheter designed with a bent tip to provide transurethral access to the obstructed bladder in the male patient for irrigation and urine drainage.

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Concurrence of CDRD, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR §801.109) | <div>✓</div> |
|-------------------------------------------|--------------|
| OR Over-The Counter Use | |

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K990500 |
|---------------|---------|
|---------------|---------|