PERSONAL CATHETER

K970704 · Rochester Medical Corp. · GBM · Mar 13, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970704
• Device Name: PERSONAL CATHETER
• Applicant: Rochester Medical Corp.
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Mar 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The device is intended for use for urethral or intermittent catheterization. Device sizes are supplied for pediatric and adult male and female applications.

Device Story

Single lumen urethral/intermittent catheter; 2 or 4 drainage eyes on proximal tip; lengths 6.4 to 15.65 inches; French sizes 6 to 26. Used for bladder drainage; operated by clinicians or patients for self-catheterization. Manufactured from silicone elastomer; supplied sterile for single use. Provides drainage path for urine; facilitates bladder emptying.

Clinical Evidence

Bench testing only. Flow rates meet/exceed ASTM 623-89. Biocompatibility testing passed: MEM Cytotoxicity, Guinea Pig Sensitization (Maximization), Acute Intracutaneous Reactivity, Ames Genotoxicity, USP Systemic Toxicity, 2-week Muscle Implant, and Urinary Bladder Irritation.

Technological Characteristics

Material: Silicone elastomer. Design: Single lumen, 2 or 4 drainage eyes. Dimensions: 6.4-15.65 inch length, 6-26 French size. Standards: ASTM 623-89 (flow rates). Sterilization: Sterile, single-use.

Indications for Use

Indicated for urethral or intermittent catheterization 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 All Silicone Intermittent Catheter (K943851)
• Bard Urology Inc. Urethral Catheters

Submission Summary (Full Text)

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K970704

Rochester
MEDICAL

MAR 13 1997

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

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
Rochester Medical Corporation

## Name of the Device
Classification Name: Urological catheter
Common/Usual Name: Urethral or Intermittent catheter
Proprietary Name: Rochester Medical Corporation Personal Catheter™

## Predicate Device
The predicate device for purposes of substantial equivalence is the Rochester Medical All Silicone Intermittent Catheter which received marketing approval under K943851 and Bard Urology Inc. Urethral Catheters.

## Intended Use of the Device
The device is intended for use for urethral or intermittent catheterization. Device sizes are supplied for pediatric and adult male and female applications.

## Device Description
The catheter consists of a single lumen catheter with two or four drainage eyes on the proximal tip. The catheter is available in a combination of French sizes and lengths to accommodate pediatric and adult male and female applications. Available catheter lengths range from 6.4 to 15.65 inches and French sizes from 6 to 26 French.

## 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, plastic, latex or red rubber. The catheter is supplied with either two or four drainage eyes. The predicate devices are available with 1, 2 or 3 drainage eyes. The device is supplied in French sizes from 6 to 26. The predicate devices are available in French sizes from 6 to 26. The device is supplied in male and female lengths. The predicate devices are supplied in male and female lengths. All of the devices are supplied sterile for single use.

## Testing and Test Results
Test results indicated that flow rates of the Personal Catheter meet or exceed the requirements of ASTM 623-89 Standard Specification for Foley Catheters.

Samples of Personal Catheters were required to pass MEM Cytotoxicity, Sensitization Study in the Guinea Pig (Maximization Method), Acute Intracutaneous Reactivity, Genotoxicity (Ames Mutagenicity), USP Systemic Toxicity, Muscle Implant Study (2 week), and Urinary Bladder Irritation Study testing.

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