RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET

K963993 · Rusch, Inc. · FCM · Dec 17, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K963993
• Device Name: RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET
• Applicant: Rusch, Inc.
• Product Code: FCM · Gastroenterology, Urology
• Decision Date: Dec 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rüsch Simplastic Foley Catheterization Set contains: - one Rüsch Simplastic Foley Catheter - one pack of lubricating jelly. The Rüsch Simplastic Foley Catheter is intended to be used to pass fluids to and from the urinary tract. A pack of lubricating jelly is intended to assist insertion of the catheter through the urethra.

Device Story

Set includes polyvinyl chloride (PVC) Foley catheter and lubricating jelly packet. Catheter features radiopaque BaSO4-loaded PVC stripe, adhesive-bonded latex balloon, funnel-connected main lumen, and luer-activated valve. Available in 2-way/3-way formats, sizes 12-26 F.G., various hardnesses, balloon sizes, and tip/eye configurations. Used by clinicians to facilitate fluid passage to/from urinary tract; jelly assists urethral insertion. Device provides drainage/irrigation access for patient urinary management.

Clinical Evidence

Bench testing only. Performed per FDA Draft Guidance for Conventional and Antimicrobial Foley Catheters: drainage flow rate, balloon rupture resistance, pullout resistance, inflation maintenance, manufacturing tolerances, deflation performance, and ISO 10993 biocompatibility.

Technological Characteristics

Materials: Polyvinyl chloride (PVC) tube, BaSO4-loaded PVC radiopaque stripe, latex balloon. Adhesive bonding. Luer-activated valve. Sizes: 12-26 F.G. Sterilization: Not specified (standard medical device processing).

Indications for Use

Indicated for patients requiring urinary tract fluid drainage or irrigation. No specific age or gender restrictions stated.

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

• Rusch Simplastic Foley Catheter (Preamendment)
• Urotec/Franklin Soft Simplastic Catheters (K851684)
• Inmed Foley Catheterization Tray (K832363)

Submission Summary (Full Text)

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DEC 17 1996
RUSCH.
INTERNATIONAL
Group Regulatory Affairs
A Subsidiary of Teleflex Incorporated (USA)

Tall Pines Park
Jaffrey, NH 03452
[phone]
FAX [phone] or 6108

# 510(k) SUMMARY
[As required by 21 CFR 807.92]

## 1. Submitter and Contact Person
Neil R. Armstrong
Group Regulatory Affairs Manager
Rusch International
Tall Pines Park
Jaffrey NH 03452
Tel: [phone]
Fax: [phone]

## 2. Device Name
**Trade Name**
Rusch Simplastic Foley Catheterization Set

**Common Name**
Urological Catheter

**Classification Name**
Catheter, Urological 78 KOD
21 CFR 876.5130; Class II medical device

## 3. Comparison Devices
Rusch Simplastic Foley Catheter - Preamendment
Urotec/Franklin Soft Simplastic Catheters - K851684
Inmed Foley Catheterization Tray - K832363

## 4. Description of Device
The Rusch Simplastic Foley Catheterization Set contains a pack of lubricating jelly and a Rusch Simplastic Foley Catheter.

The Rusch Simplastic Foley Catheters used in the kit will be available:
- in 2 way and 3 way formats
- in various sizes from 12 - 26 F.G.
- in two hardnesses
- with various sizes of balloon
- with various tip and eye configurations.

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Common features of all the catheters are: a clear polyvinyl chloride tube, a radiopaque stripe of $\mathrm{BaSO_4}$ loaded PVC is fully encapsulated in the tube wall, a latex balloon attached by adhesive bonding, a funnel connected to the main lumen and a luer activated valve for filling and emptying the balloon.

## 5. Intended Use

The Rüsch Simplastic Foley Catheterization Set contains:

- one Rüsch Simplastic Foley Catheter
- one pack of lubricating jelly.

The Rüsch Simplastic Foley Catheter is intended to be used to pass fluids to and from the urinary tract. A pack of lubricating jelly is intended to assist insertion of the catheter through the urethra.

## 6. Summary of Technological Characteristics

The Rüsch Simplastic Foley Catheterization Set is manufactured from the same materials and by the same processes (including sterilization) as the Rüsch Simplastic Foley Catheter (preamendment) and Urotec/Franklin Soft Simplastic Catheters (K851684), and contains the same "gel" pack as the Inmed Foley Catheterization Tray (K832363).

Sterile catheters have been biocompatibility tested in accordance with ISO 10993 and the FDA "Blue Book Memo" #G95/1.

## 7. Summary of Performance Data

Laboratory bench testing has been completed to section #XI of the FDA "Draft Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters":

- drainage lumen flow rate
- balloon resistance to rupture
- pullout resistance of inflated balloon
- maintenance of balloon inflation over extended time
- manufacturing tolerances for tip, balloon and shaft
- deflation after period of inflation
- biocompatibility testing for patient contacting materials

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