SYMPACATH HYDROGEL COATED FOLEY

K964575 · Rusch Intl. · EZL · Feb 4, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964575
• Device Name: SYMPACATH HYDROGEL COATED FOLEY
• Applicant: Rusch Intl.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Feb 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is a urological catheter, which is a tubular device that is inserted through the urethra and is used to pass fluids to or from the urinary tract.

Device Story

Standard Foley catheter; hydrogel coating applied to surface. Coating activated by water contact; provides lubricity to facilitate urethral insertion. Used by clinicians in clinical settings for urinary drainage or irrigation. Benefits include reduced friction during insertion, potentially improving patient comfort.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to legally marketed predicate devices.

Technological Characteristics

Standard Foley catheter; hydrogel coating; water-activated lubrication; principle of operation identical to predicate devices.

Indications for Use

Indicated for patients requiring urinary catheterization for the passage of fluids to or from the urinary tract.

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

• Bard Biocath
• Bard Lubricath
• Curity Kendall Ultramer

Submission Summary (Full Text)

{0}

Rusch International
A Subsidiary of Teleflex Incorporated (USA)

Tall Pines Park
P.O. Box 532-7706
FAX [phone]

510(k) Summary

K964575
P192

1. Submitter Name, Address, and Date of Submission:

Miss Karenann J. Brozowski
Group Regulatory Affairs Director
Rusch International
Tall Pines Park
Jaffrey, NH 03452

FEB - 4 1997

Telephone: [phone]

Contact: Same as above.

2. Names of the Device, Common, Proprietary(if Known), and Classification.

Classification Name: Urological Catheter, Retention Type, Balloon
Proprietary Name: Rusch SympaCath™ Hydrogel Coated Foley Catheter
Common Name: Foley Catheter

3. Identification of the legally marketed device to which the submitter claims equivalence.

The Rusch International Hydrogel Coated Foley Catheter is equivalent to the Bard Biocath and Lubricath or the Curity Kendall Ultramer coated catheters.

4. Description of the Device:

The Rusch SympaCath Hydrogel Coated Foley Catheter is a standard foley catheter, which has been coated with a coating known as hydrogel. The purpose of the coating is to make the catheter slippery on insertion, post activation with water.

{1}

5964575
P2012

page 2

## 5. Intended Use of the Device:

This device is a urological catheter, which is a tubular device that is inserted through the urethra and is used to pass fluids to or from the urinary tract.

## 6. Summary of Technological Characteristics:

The following technological characteristics are the same or equivalent as predicate devices:

The coating is added to a standard foley catheter.

The coating is activated with contact with water, making the catheter slippery to ease insertion.

The design, material construction and principals of operation for the SimpaCath Hydrogel Foley Catheters are the same as the competitors.

sumhcl