ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER

K981612 · Rochester Medical Corp. · EZL · Jul 8, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981612
• Device Name: ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER
• Applicant: Rochester Medical Corp.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Jul 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

For urological use only.

Device Story

All-silicone Foley catheter; available in two-way, three-way (for irrigation), and radiopaque configurations. Device inserted into urethra for bladder drainage; three-way variant allows simultaneous irrigation. Used in clinical settings by healthcare professionals. Catheter features proximal drainage eye; balloon integrated into shaft via proprietary process. Available in French sizes 6-26; lengths 10.6-15.8 inches; balloon capacities 1.5cc-30cc. Sterile, single-use device. Benefits include biocompatible silicone construction, reducing potential for latex-related reactions compared to traditional rubber/latex catheters.

Clinical Evidence

Bench testing only. Device evaluated against ASTM F 623-89 Standard Specifications for Foley Catheters. Biocompatibility testing performed, including cytotoxicity, systemic toxicity, intracutaneous reactivity, muscle implantation with histopathology, sensitization, and irritation. All results were acceptable.

Technological Characteristics

Material: 100% silicone elastomer. Design: Double or triple lumen; integrated balloon. Dimensions: French sizes 6-26; lengths 10.6-15.8 inches; balloon capacities 1.5cc-30cc. Sterilization: Sterile, single-use. Standards: ASTM F 623-89 (with noted exceptions for tip/shaft diameter).

Indications for Use

Indicated for urethral catheterization for bladder drainage (two-way), bladder drainage and irrigation (three-way), and bladder drainage with radiopaque visualization (radiopaque) in pediatric and adult male and female patients.

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

• Rochester Medical Corporation All Silicone Foley Catheter (K896053)
• Rusch Foley Catheters
• Bard Urological Inc. Foley Catheters

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo for Rochester Medical. The logo includes a circle with a check mark through it, and the words "Rochester" and "MEDICAL" in bold letters. The image also includes the date "JUL - 8 1998" at the top. The logo is black and white.

K481612
P171

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION 14.0

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92,

| Submitter and Contact Person: | Mary M. Wilen<br>Rochester Medical Corporation |
|-------------------------------|-----------------------------------------------------------------------------|
| Name of the Device: | Classification Name: Urological Catheter |
| | Common/Usual Name: All Silicone Foley Catheter |
| | Proprietary Name: Rochester Medical Corporation All Silicone Foley Catheter |
| | ➤ Two-Way Foley Catheter |
| | ➤ Three-Way Foley Catheter |
| | ➤ Two-Way Radiopaque Foley Catheter |

### Predicate Device

The predicate device for purposes of substantial equivalence is the Rochester Medical Corporation All Silicone Folcy Catheter which receive matketing approval under K896053, Rusch Foley Catheters, and Bard Urological Inc. Foley Catheters.

# Intended Use of the Device

For urological use only.

# Device Description

The catherer consists of a double or triple lumen drainage eye on the proximal tip. The threeway cather has an additional eye for irrigation purposes. The two-way catheter is available with a radiopaque option. The catherer is available in a combination of French sizes, balloon capacties and lengths to accommodate pediative and adult male and female applications. Available catheter lengths range from 10.6 to 15.8, French sizes from 6 to 26 and balloon sizes 1.5cc to 30cc.

# Technological Characteristics

The catheter described in the 510(k) has similar technological and performance characteristics to the predicate devices. The cather is manufactured entirely from silicone elassomer. The predicate devices are manufactured from silicone elastomer, latex, rubber and red rubber. The device is supplied in French sizes ranging from 6 to 26 and balloon capacities 1.5cc to 30cc. The predicate devices are available in French sizes from 6 to 26 and balloon capacities 1.5cc to 75cc. The device is supplied in pediatric, male and female lengths. The predicate devices are supplied in pediative, male and female lengths. All of the devices are supplied sterile for single use.

# Testing and Results

Test results indicate that the Rochester Medical Corocration All Silicone Foley catherers meet the requirements of ASTM F 623-89 Standard Specifications for Foley Catheters with the exception of requirements 5.3 and 5.5 regarding catheter tip and shaft diameters. These exceptions are due to the proprietary manufacturing process that allows Rochester Medical to manufacture catheters with balloons that are incorporated into the cather than being applied during a secondary operation, the tip diameter is equivalent to the balloon diameter which complies with therefore is not considered clinically significant. Biocompatibility testing was completed on catherer samples including tests for: CCytotoxicity, Systemic Toxicity, Intractaneous Reactivity, Muscle Implantation with Histopathology, Sensitization and Irlritation. Results were acceptable for all tests.

Rochester Medical Corporation All Silicone Foley Catheter Section 510(k) Notification 07/07/98

One Rochester Medical Drive Stewartville, MN 55976

Image /page/0/Picture/17 description: The image shows a logo with the text "ISO 9001 CERTIFIED". The text "ISO 9001" is in bold and is placed in the center of the logo. The word "CERTIFIED" is placed below "ISO 9001". The logo is surrounded by a globe-like design.

Tel: [phone]

Fax: [phone]

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 1998

Ms. Mary M. Wilen Director of Clinical and Regulatory Affairs Rochester Medical One Rochester Medical Drive Stewartville, Minnesota 55976

Re: K981612

Rochester Medical Corporation All Silicone Foley Catheter Dated: May 1, 1998 Received: May 6, 1998 Regulatory Class: II 21 CFR 876.5130/Procode: 78 EZL

Dear Ms. Wilen:

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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (2) 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 Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 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 (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion 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] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.html".

Sincerely yours

Lillian Yin Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Page 1 of 1

510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________

Device Name: __All Silicone Two-Way Catheter, All Silicone Three-Way Foley Catheter, & Radiopaque Silicone Foley Catheter Rochester Medical Corporation

Indications for Use:

Two-Way Catheter: Urethral catheterization for bladder drainage.

Three -Way Catheter: Urethral catheterization for bladder drainage and bladder irrigation.

Radiopaque Catheter:

Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization.

INTENDED USE For urological use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Doler R Sathing/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 98 16 510(k) Number _

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter-Use ____________

(Optional Format 1-2-96)