SILICONE ANTIBACTERIAL FOLEY CATHETER

K971627 · Rochester Medical Corp. · MJC · Jan 13, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K971627
• Device Name: SILICONE ANTIBACTERIAL FOLEY CATHETER
• Applicant: Rochester Medical Corp.
• Product Code: MJC · Gastroenterology, Urology
• Decision Date: Jan 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Silicone Antibacterial Foley catheter is intended for short term use to provide continuous urinary bladder drainage in adult males and females requiring catheterization for surgical procedures, monitoring urine output, management of incontinence, and voiding dysfunction. The catheter has been shown to provide a statistically significant reduction in the incidence of catheter acquired bacterial urinary tract infection during the first 5 days of catheterization. This device is not intended to be used as a treatment for active urinary tract infections.

Device Story

Standard Foley catheter; silicone elastomer construction; nitrofurazone-impregnated coating on external surface and inner lumen. Used for continuous urinary bladder drainage; inserted by clinicians in surgical or clinical settings. Retention balloon (5 or 10 cc) secured via Luer valve. Nitrofurazone coating provides antibacterial activity against specific uro-pathogens to reduce incidence of catheter-associated urinary tract infections (CAUTI) during first 5 days of use. Clinical benefit: statistically significant reduction in bacterial CAUTI rates compared to conventional silicone catheters for short-term (≤5 days) catheterization.

Clinical Evidence

Single-site, randomized, double-blind, controlled trial (n=344; mean age 56; 68% male). Compared nitrofurazone-coated catheter to conventional silicone catheter. Primary endpoint: incidence of CAUTI. Results: 3-fold reduction in bacterial CAUTI for patients catheterized ≤7 days (2.4% vs 6.9%). Statistically significant difference in survival curves for first 5 days (p=0.007). Hazard ratio trend reversed after day 5 (p=0.03). Bench testing confirmed compliance with ASTM 623-89 and successful elution profile.

Technological Characteristics

Silicone elastomer construction; nitrofurazone-impregnated coating. Available in 12, 18, 20 Fr sizes; 5 or 10 cc balloon capacity. 16-inch length. Complies with ASTM 623-89. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for adult males and females requiring short-term continuous urinary bladder drainage for surgical procedures, urine output monitoring, incontinence management, or voiding dysfunction. 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

• C.R. Bard Corp. Bardex® I.C. Foley Catheter (K910318)
• American Pharmascal Co. Antimicrobial Foley Catheter (K871429)
• Rochester Medical All Silicone Foley Catheter (K896053)

Submission Summary (Full Text)

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K97162 1-12

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

JAN 13 1998

Richard D. Fryar Submitter and Contact Person Rochester Medical Corporation

Classification Name: Urological catherer Name of the Device Common/Usual Name: Foley catheter Proprietary Name: Rochester Medical Corporation Silicone Antibacterial Foley Catheter

## Predicate Device

The predicate devices for purposes of substantial equivalence are the C.R. Bard Corp. Bardex® I.C. Foley Catheter (K910318), the American Pharmascal Co. Antimicrobial Foley Catheter (K871429) and the Rochester Medical All Silicone Foley Catheter (K896053).

#### Intended Use of the Device

The Silicone Antibacterial Foley Catheter is intended for short term use to provide continuous urinary bladder drainage in adult males and females requiring catheterization for surgical procedures, monitoring uring output, management of incontinence, and voiding dysfunction. The catheter has been shown to provide a statistically significant redution in the incidence of catheter acquired bacterial urinary tract infection during the first 5 days of catheterization. This device is not intended to be used as a treatment for active urinary tract infection.

#### Device Description

The catherer consists of a standard configuration Foley catheter with a drainage lumen that exits through two drainage eyes on the proximal end. A retention balloon is located near the proximal catheter tip. The retention balloon is filled thru a second lumen with a Luer valve that extends from a side arm on the distal end of the catherer to the balloon. The catherer is coated with nitrofurazone impregnated siliconc on the outside surface and inner lumen. It is available in 12, 18 and 20 Fr sizes. All French sizes are provided in a 16 inch length with a 5 or 10 cc size balloon.

## Technological Characteristics

The catheter described in the 510(k) has similar technological and performance characteristics to the predicate devices. The catheter is manufactured entirely from silicone elastomer. The predicate devices are manufactured from silicone elastomer or latex. The device is supplied in French sizes from 12 to 20 with 5 or 10 cc capacity balloons. The predicate devices are available in French sizes ranging from 8 to 30 French with 3, 5 10 and 30 cc balloons. All of the devices are supplied sterile for single use. The C.R. Bard Corp. Bardex® I.C. Foley Catheter and American Pharmaseal Co. Antimicrobial Foley Catheter provide antibacterial activity through the use of a silver or silver oxide coating or impregnation of the catheter

Rochester Medical Corporation Silicone Antibacterial Foley Catheter Section 510(k) Notification Summary of Safety and EMcacy Puge 1 of 2 Junuary 8, 1998

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Tel: [phone]

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K971627 2 - 2

materials. The Rochester Medical Silicone Antibacterial Foley Catheter provides antibacterial activity by coating the catheter with nitrofurazone.

#### Testing and Test Results

Test results indicated that the Silicone Antibacterial Foley Catheter meets the requirements of ASTM 623-89 Standard Specification for Foley Catheters. Simulated use testing shows that the elution profile of the antibacterial agent from the catheter is reproducible and the agent is released at bacteriocidal levels. There has been no evidence that the catheter materials or performance are degraded with ageing. Samples of Silicone Antibacterial Foley Catheter passed Cytotoxicity, USP Systemic Toxicity, Subchronic Toxicity, Intracutancous Injection, Muscle Implant Study, Sensitization Study. Pyrogenicity and Hemolysis. Mutagenicity testing indicated some mutagenic changes.

#### In-vitro studies

In vitro studies have shown that nitrofurazone impregnated catherer segments have antibacterial activity against clinical isolates of uro-pathogens including Coagulase-negative staphylococci, S. aureus, Enterococcus spp., C. Minutissimum, E. Coli, Enterobacter spp., and Klebstella spp. Gram-negative bacilli including Serratia spp., Proteus spp., and Pseudomonas spp. were not inhibited by nitrofurazone impregnated catheter segments. Nitrofurazone is not effective against yeast and fungi.

#### Clinical studies

A single site randomized, double-blind, controlled clinical trial was conducted to compare the antibacterial properies of the Silicone Antibacterial Catheter (nitrofurazone impregnated) to a Conventional Silicone Catheter. During the eleven month trial, a total of 344 patients (68% men, 32% women) mecting the study evaluation criteria were enrolled (mean age = 56 years, range 18 to 91) and the incidence of catheter associated urinary tract infection (CAUTI) during catheterization was recorded.

For patients with catheters inserted for 7 days or less (91.9% of population, median = 3 days), the group receiving the Silicone Antibacterial Catherer had an approximate threefold reduction in the rate of bacterial CAUTI compared to the Conventional Silicone Catheter group (2.4% vs. 6.9% incidence). The difference in actuarial survival curves for time until the occurence of bacterial CAUTI between the two groups was found to be statistically significant (p = 0.007, Kaplan-Mcicr survival, Breslow logrank statistic) for the first 5 days of use.

However, the trend in the hazard ratio over time to bacterial CAUTI between the antibacterial catheter and standard catherer was found to be statistically significantly increasing (P=0.03 Wald Chi Square Statistic) for the 7 days of use, resulting in the reversal of the hazard ratio in favor of the standard catheter from the 6th day.

Rochester Medical Corporation Silicone Antibacterial Foley Catheter Section 510(k) Notification Summary of Safety and Efficacy Page 2 of 2 January 8, 1998

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 1 3 1998

Re: K971627

Rochester Medical Silicone Antibacterial Foley Catheter Dated: December 5, 1997 Received: December 8, 1997 Regulatory class: II 21 CFR §876.5130/Product code: 78 MJC

Mr. Richard D. Fryar Vice President of Research and Development Rochester Medical Corporation One Rochester Medical Drive Stewartville, Minnesota 55976

Dear Mr. Fryar:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration. "

If your device is classified (see above) into either class II (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Pederal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions; or _ other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone]-01-[phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

William Yu
Lillian Yiu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if Known):

Silicone Antibacterial Foley Catheter Device Name: _ Rochester Medical Corporation

Indications for Use:

#### INTENDED USE

The Silicone Antibacterial Foley catheter is intended for short term use to provide continuous urinary bladder drainage in adult males and females requiring catheterization for surgical procedures, monitoring urine output, management of incontinence, and voiding dysfunction. The catheter has been shown to provide a statistically significant reduction in the incidence of catheter acquired bacterial urinary tract infection during the first 5 days of catheterization. This device is not intended to be used as a treatment for active urinary tract infections.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert D. Sattler
(Division Sign Off)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number K971627

OR

Prescription Use _ (Per 21 CFR 801.109)

Over-The-Counter-Use

(Optional Formal 1-2-96)