COUDE/ OR TIEMANN

K103371 · Degania Silicone , Ltd. · EZL · Mar 11, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K103371
• Device Name: COUDE/ OR TIEMANN
• Applicant: Degania Silicone , Ltd.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Mar 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Coude Foley catheter / or Tiemann Foley Catheter/ is all silicone Foley catheter 2-way intended for urological use only. Indicated for routine drainage of the urinary bladder. Maximum recommended indwelling time is not more than 30 days.

Device Story

Coude Foley/Tiemann Foley catheter is a 2-way, all-silicone device designed for routine urinary bladder drainage. Used in clinical settings by healthcare professionals. Device inserted into urethra to facilitate urine flow; indwelling time limited to maximum 30 days. Provides continuous drainage for patients with urinary retention or other urological conditions requiring bladder management.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design comparison to predicate.

Technological Characteristics

All-silicone 2-way Foley catheter. Coude/Tiemann tip design. Intended for indwelling use up to 30 days.

Indications for Use

Indicated for routine drainage of the urinary bladder in patients requiring urological catheterization. Prescription use only.

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

• Degania Silicone, Ltd. (K063442)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human figures in profile, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Zoya Lee Regulatory Affairs Degania Silicone, Ltd. Degania BET Emek Hayarden 15130 ISRAEL

# MAR 1 1 2011

Re: K103371

Trade/Device Name: Coude Foley catheter / or Tiemann Foley catheter Regulation Number: 21 CFR 8876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: March 4, 2011 Received: March 4, 2011

Dear Ms. Lee:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting of medical device-related

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adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Hubert Lemur MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Document No : | Traditional 510(k) submission<br>K103371 | Predicate device<br>510(k) K063442 |
|--------------------------------------------------|------------------------------------------|------------------------------------|
| Version: 2 | COUDE/OR TIEMANN<br>CATHETER | Degania Silicone, Ltd |
| Replace: Special 510(k)<br>submission, version 1 | | |

## Indications for Use

## 510(k) Number K103371

Device Name: Coude Foley catheter / or Tiemann Foley catheter

#### Indications for Use:

Coude Foley catheter / or Tiemann Foley Catheter/ is all silicone Foley catheter 2-way intended for urological use only. Indicated for routine drainage of the urinary bladder.

Maximum recommended indwelling time is not more than 30 days.

Prescription Use ONLY (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices