DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER

K042709 · Tyco Healthcare · EZL · Jan 18, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K042709
• Device Name: DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
• Applicant: Tyco Healthcare
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Jan 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The proposed device is 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 bladder. The catheter is retained in the bladder by inflation of balloon. Efficacy of the DOVER® Silver Temperature Sensing Foley Catheter in preventing urinount infection during the catheterization has not been established. This device is not intended to be used as a treatment for active urinary tract infection.

Device Story

Sterile, single-use, indwelling urinary drainage catheter; extruded from 100% vulcanized silicone; coated with lubricious hydrophilic polymer containing silver. Device inserted through urethra or suprapubic site into bladder; retained by inflated balloon. Integrated temperature sensor monitors body core temperature during surgical/post-surgical intervals. Output is temperature data for clinical monitoring. Used in clinical settings (OR, post-surgical units) by healthcare professionals. Device facilitates simultaneous urine drainage and core temperature tracking; aids clinical decision-making regarding patient thermal status.

Clinical Evidence

No clinical data. Bench testing only; biocompatibility testing performed per ISO 10993 standards.

Technological Characteristics

100% vulcanized silicone catheter; silver hydrogel hydrophilic coating. Integrated temperature sensor. Sterile, single-use. Biocompatibility per ISO 10993.

Indications for Use

Indicated for patients requiring urinary drainage/collection and simultaneous body core temperature monitoring during surgical or post-surgical intervals. Catheter is inserted via urethra or suprapubic placement and retained via balloon inflation. Not indicated for treatment of active urinary tract infections.

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

• DOVER® 100% Silicone Foley Catheter with Temperature sensor (K933400)
• DOVER® Silver Hydrogel Coated Silicone Foley Catheter (K024010)

Submission Summary (Full Text)

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

K042709
page 1 of 2

JAN | 8 2005

# 510(k) Summary

# Tvco Healthcare/Kendall DOVER® Silver Temperature Sensing Foley Catheter

In accordance with section 513(l) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:

Tyco Healthcare/Kendall 15 Hampshire Street Mansfield, MA 02048 Date Prepared: September 28, 2004

### 1. Contact Person

Wei Zhao Senior Specialist, Regulatory Affairs Tyco Healthcare/Kendall Telephone: [phone] Fax: [phone]

### 2. Name of Medical Device

| Classification Name: | Catheter, Retention Type, Balloon |
|-----------------------|-----------------------------------------------------------------------------|
| Common or Usual Name: | Urinary Drainage Silicone Foley Catheter<br>with Temperature Sensor |
| Trade Name: | Tyco Healthcare/Kendall DOVER® Silver Temperature<br>Sensing Foley Catheter |

### 3. Identification of Legally Marketed Device

The proposed DOVER® Silver Temperature Sensing Foley Catheter is identical in intended uses, function and mode of operation to the currently marketed DOVER® 100% Silicone Foley Catheter with Temperature sensor and DOVER® Silver Hydrogel Coated Silicone Foley Catheter. DOVER® 100% Silicone Foley Catheter with Temperature sensor was cleared for marketing under 510(k) K933400. DOVER® Silver Hydrogel Coated Silicone Foley Catheter was cleared for marketing under 510(k) K024010.

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

K042709
Page 2 of 2

# 4. Device Description

The Tyco Healthcare/Kendall DOVER® Silver Temperature Sensing Foley Catheter is a sterile, single use, indwelling urinary drainage catheter extruded from 100% vulcanized silicone material, The catheter is coated with a lubricious hydrophilic topcoat containing an inozoa dinother releasing polymer.

## 4. Device Intended Use

The proposed device is 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 bladder. The catheter is retained in the bladder by inflation of balloon. Efficacy of the DOVER® Silver Temperature Sensing Foley Catheter in preventing urinount infection during the catheterization has not been established. This device is not intended to be used as a treatment for active urinary tract infection.

# 5. Product Comparison

The proposed DOVER® Silver Temperature Sensing Foley Catheter is substantially equivalent to the Tyco healthcare/Kendall DOVER® 100% Silicone Foley Catheter with Temperature sensor as each product is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature. Also the proposed device is substantially equivalent to the Tyco healthcare/Kendall DOVER® Silver Hydrogel Coated Silicone Folect Catheter as each product has a Foley catheter with same silver hydrogel coating and is intended for use in the drainage/collection of urine from the urinary bladder.

### 6. Nonclinical Testing

Biocompatibility testing has demonstrated that the proposed device meets the requirements of guidelines presented in the 10993 ISO Standard, Part1, with the FDA modified matrix presented in memorandum G95-1.

End of Document

Confidential

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

JAN 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Wei Zhao Senior Regulatory Specialist Tyco Healthcare/Kendall 15 Hampshire Street MANSFIELD MA 02048

Re: K042709

Trade/Device Name: DOVER® Silver Temperature Sensing Foley Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EZL Dated: December 23, 2004 Received: December 27, 2004

Dear Ms. 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 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 elections as on product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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

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/cdrl/dsmaldsmamain.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

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

# Indication for Use Statement

510 (k) Number (if known):

# Device Name:

Tyco Healthcare/Kendall DOVER® Silver Temperature Sensing Foley Catheter

### 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

Tomil C. Lynn
(Division Sign-Off)

ion of Reproductive, Abdominal and Radiological Dev 510(k) Number