BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS

K070582 · C.R. Bard, Inc. · EZL · Dec 7, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070582
• Device Name: BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS
• Applicant: C.R. Bard, Inc.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Dec 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Bardex® Temperature-Sensing Foley Catheter, when connected to a Bard CritiCore® or Urotrack 224 Monitor, or other 400-Series Temperature Monitors, is intended for use in the drainage and/or collection and/or measurement of urine and in conjunction with an electronic urine monitor for the monitoring of core body temperature, in degrees Fahrenheit and degrees Celsius.

Device Story

Two-way silicone Foley catheter with embedded thermistor in third lumen; available uncoated, lubricious-coated, or silver/lubricious-coated. Used for urinary drainage and core body temperature monitoring. Connects to 400-series temperature monitors (e.g., Bard CritiCore, Urotrack 224). Thermistor senses temperature; signal transmitted to external monitor for display in Fahrenheit/Celsius. Used in clinical settings by healthcare professionals. Provides continuous core temperature data to assist clinical decision-making and patient management.

Clinical Evidence

Bench testing only. Device performance verified against ASTM F623-99 standard and FDA guidance for conventional and antimicrobial Foley catheters.

Technological Characteristics

Two-way silicone Foley catheter; thermistor sensing element; 400-series monitor compatibility. Materials: silicone, optional lubricious coating, optional silver coating. Standards: ASTM F623-99. Sterilization: not specified.

Indications for Use

Indicated for patients requiring urinary drainage, collection, or measurement, and concurrent core body temperature monitoring via an electronic urine monitor.

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® Latex-Free Temperature-Sensing Foley Catheter (K003289)

Submission Summary (Full Text)

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K070582
DEC -

## SECTION 5 BARDEX® TEMPERATURE-SENSING FOLEY CATHETER 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

#### A. SUBMITTER INFORMATION:

| Submitter's Name | C.R. Bard, Inc.<br>Bard Medical Division<br>8195 Industrial Blvd.<br>Covington, GA 30014 |
|------------------------------------|------------------------------------------------------------------------------------------|
| Contact Person: | Skip Rimer |
| Contact Person's Telephone Number: | 770-784-6160 |
| Contact Person's Fax: | 770-784-6419 |
| Date of Preparation: | January 10, 2007 |

#### B. DEVICE NAME:

| Trade Name(s): | Bardex® Latex-Free Temperature-Sensing Foley<br>Catheter, Bardex® Lubri-Sil® Temperature-<br>Sensing Foley Catheter, and Bardex® Lubri-Sil®<br>I.C. Temperature-Sensing Foley Catheter |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Temperature-sensing Foley catheter |
| Classification Product Code: | EZL – Catheter, Retention Type, Balloon<br>21 CFR 876.5130 |
| Subsequent Product Code: | MJC – Catheter, Urological (Antimicrobial) and<br>Accessories<br>21 CFR 876.5130 |

#### C. PREDICATE DEVICE NAME:

Trade Name(s): Bardex® Latex-Free Temperature-Sensing Foley Catheter, Bardex® Lubri-Sil® Temperature-Sensing Foley Catheter, and Bardex® Lubri-Sil® I.C. Temperature-Sensing Foley Catheter

#### D. DEVICE DESCRIPTION:

The Bardex® Temperature-Sensing Foley Catheter is a two-way silicone Foley Catheter with a thermistor embedded in the third lumen. The catheters will be available uncoated, with a lubricious coating or with a silver and lubricious coating.

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### SECTION 5 BARDEX® TEMPERATURE-SENSING FOLEY CATHETER 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

#### E. INTENDED USE:

The Bardex® Temperature-Sensing Foley Catheter, when connected to a Bard CritiCore® or Urotrack 224 Monitor, or other 400-Series Temperature Monitors, is intended for use in the drainage and/or collection and/or measurement of urine and in conjunction with an electronic urine monitor for the monitoring of core body temperature, in degrees Fahrenheit and degrees Celsius.

#### F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:

The subject device, Bardex® Temperature-Sensing Foley Catheter, has the same intended use, design and fundamental scientific technology as the predicate device.

#### G. PERFORMANCE DATA SUMMARY:

The Bardex® Temperature-Sensing Foley Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as the predicate (#K003289). Performance and functional testing standards are based on the FDA "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters" dated September 12, 1994 and ASTM F623-99, "Standard Performance Specification for Foley Catheter."

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized representation of an eagle with three wavy lines emanating from its head, symbolizing health, services, and human needs. The eagle is facing to the right.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C.R. Bard, Inc. % Mr. Robert Mosenkis President Citech 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K070582

Trade/Device Name: Bardex® All-Silicone Temperature-Sensing Foley Catheter

DEC 7 2007

Regulation Number: 21 CFR 876.5130

Regulation Name: Urological catheter and accessories

Regulatory Class: II

Product Code: EŽL

Dated: November 20, 2007

Received: November 21, 2007

Dear Mr. Mosenkis:

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.

the same of the same of the states of the states

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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 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 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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# SECTION 4 BARDEX® TEMPERATURE-SENSING FOLEY CATHETER INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Bardex® All-Silicone Temperature-Sensing Foley Catheter, Bardex® Lubri-Sil® Temperature-Sensing Foley Catheter, and the Bardex® Lubri-Si1® I.C. Temperature-Sensing Foley Catheter

Indications for Use:

The Bardex® Temperature-Sensing Foley Catheter, when connected to a Bard CritiCore® or Urotrack 224 monitor, or other 400-series Temperature Monitors, is intended for use in the drainage and/or collection and/or measurement of urine and in conjunction with an electronic urine monitor for the monitoring of core body temperature, in degrees Fahrenheit and degrees Celsius.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

| CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

OR

Prescription Use (Per 21 CFR 801.109)

Nancy Brogdon

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

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1/2/96)

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