ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR

K063442 · Degania Silicone , Ltd. · EZL · Mar 26, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K063442
• Device Name: ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
• Applicant: Degania Silicone , Ltd.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Mar 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

All Silicone Foley Catheter intended for urological use only. Foley Catheter 2-way: for routine drainage of the urinary bladder. Foley Catheter 3-way: for drainage of the urinary bladder and bladder irrigation. Foley Catheter with Temperature Sensor: for drainage of the urinary bladder and simultaneous monitoring of temperature. Prescription use only.

Device Story

All Silicone Foley Catheter; 2-way, 3-way, and temperature-sensing configurations. Device facilitates urinary bladder drainage; 3-way version allows irrigation; temperature-sensing version provides continuous bladder temperature monitoring. Used in clinical settings by healthcare professionals. Catheter inserted into bladder; provides drainage path; temperature sensor provides real-time thermal data to compatible monitoring equipment. Benefits include effective fluid management and non-invasive core temperature tracking.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

All-silicone construction; 2-way and 3-way configurations; integrated temperature sensor for specific models. Passive drainage and irrigation functionality.

Indications for Use

Indicated for patients requiring urinary bladder drainage, bladder irrigation, or simultaneous bladder drainage and temperature monitoring. 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).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## MAR 2 6 2007

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

Re: K063442

Trade/Device Name: All Silicone Foley Catheter, 2-Way, 3-Way and With Temperature Sensor Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: March 1, 2007 Received: March 1, 2007

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.

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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/0/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top, and the letters "FDA" are in the center. The word "Centennial" is below the letters. The text around the circle says "100 Years of Competence, Performance, and Trust". There are also three stars at the bottom of the circle.

Protecting and Promoting Public Health

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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.

This letter will allow you to begin marketing your device as described in your Section 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:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Brogdon

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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## Indications for Use

510(k) Number (if known): K063442

Device Name: Urinary Foley catheter

Indications for Use: All Silicone Foley Catheter intended for urological use only. Foley Catheter 2-way: for routine drainage of the urinary bladder. Foley Catheter 3-way: for drainage of the urinary bladder and bladder irrigation. Foley Catheter with Temperature Sensor: for drainage of the urinary bladder and simultaneous monitoring of temperature. Prescription use only.

Prescription Use I ONLY (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Derid A. Segerman

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number