DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR

K071049 · Tyco Healthcare · EZL · Oct 16, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K071049
• Device Name: DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
• Applicant: Tyco Healthcare
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Oct 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. General drainage is accomplished by inserting the catheter through the urethra and into the urine bladder. The catheter is retained in the bladder by inflation of balloon. Drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

Device Story

Dover 100% Silicone Foley Catheter with Temperature Sensor; indwelling urinary catheter with integrated thermistor. Device inserted through urethra into bladder; retained via inflatable balloon. Facilitates urine drainage while simultaneously monitoring core body temperature. Used in clinical settings (OR, post-surgical units) by healthcare professionals. Output (temperature data) transmitted to compatible patient monitoring systems. Enables continuous core temperature tracking during procedures; assists clinical decision-making regarding patient thermal status.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design characteristics.

Technological Characteristics

100% silicone construction; integrated thermistor for temperature sensing; balloon retention mechanism; standard Foley catheter form factor; compatible with standard patient monitoring equipment.

Indications for Use

Indicated for patients requiring urinary bladder drainage and simultaneous core body temperature monitoring during surgical or post-surgical intervals.

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 Boulevard Rockville MD 20850

## T 16 2007

Dr. Wei Zhao Manager, Regulatory Affairs Tyco Healthcare The Kendall Company 15 Hampshire Street MANSFIELD MA 02048

Re: K071049

Trade/Device Name: Dover® 100% Silicone Foley Catheter with Temperature Sensor Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: August 27, 2007 Received: August 28, 2007

Dear Dr. Zhao:

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 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.

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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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 Brogdon

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

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Enclosure

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Tyco Healthcare/Kendall DOVER® 100% Silicone Foley Catheter with Temperature Sensor

## Indication for Use Statement

## 510 (k) Number (if known):

Device Name:

Tyco Healthcare/Kendall DOVER® 100% Silicone Foley Catheter with Temperature Sensor

## Indications for Use:

The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. General drainage is accomplished by inserting the catheter through the urethra and into the urine bladder. The catheter is retained in the bladder by inflation of balloon. Drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

Please DO NOT Write Below This Line - Continue On Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _X____ OR OVER-The -Counter Use __ (Per 21 CFR 801.109)

Valind Hennen

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