TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS

K960787 · Baxter Healthcare Corp · LJH · May 14, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960787
• Device Name: TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS
• Applicant: Baxter Healthcare Corp
• Product Code: LJH · Gastroenterology, Urology
• Decision Date: May 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Baxter’s line of irrigation sets are intended for delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cystoscopy, transurethral resection (TUR) and arthroscopic procedures.

Device Story

Irrigation sets deliver sterile solutions from fluid containers to surgical sites; used during bladder irrigation, cystoscopy, TUR, and arthroscopy. Device consists of tubing segments connecting fluid source to endoscope. Modification replaces natural rubber latex distal tubing with styrene ethylene butadiene styrene (SEBS) to eliminate latex protein sensitivity risks. Operated by clinicians in surgical/procedural settings. Output is controlled fluid flow to irrigation site. Benefits include improved patient safety via allergen-free material.

Clinical Evidence

Bench testing only. Biological/chemical reactivity assessed per ISO 10993-1 and USP Physicochemical tests. Functional performance validated via kink, pull, and pressure testing. No clinical data presented.

Technological Characteristics

Materials: SEBS tubing (replacing natural rubber latex). Design: Identical to predicate; dimensions unchanged. Energy: Passive fluid delivery. Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for patients undergoing bladder irrigation or endoscopic procedures, including cystoscopy, transurethral resection (TUR), and arthroscopic procedures, requiring delivery of irrigating solutions.

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

• Current Baxter Irrigation Sets

Submission Summary (Full Text)

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K960787
510(k) Premarket Notification
Irrigation Sets
MAY 14 1996

# 510(k) SUMMARY
Irrigation Sets

## Submitted by:

Mary Ellen Snyder
Baxter Healthcare Corporation
I.V. Systems Division
Rte. 120 and Wilson Road
Round Lake, IL 60073

## Date Prepared:

February 23, 1996

## Proposed Device:
Irrigation Sets with Modified Tubing Segment

## Predicate Devices:
Current Baxter Irrigation Sets

## Proposed Device Description:

Baxter’s line of irrigation sets are intended for delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cystoscopy, transurethral resection (TUR) and arthroscopic procedures. The subject of this submission is a material change in the distal tubing segment of the irrigation set from natural rubber latex to styrene ethylene butadiene styrene (SEBS). This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee joint. The change from latex to SEBS is being made to improve user safety by eliminating the potential for sensitivity reactions associated with natural rubber proteins.

## Summary of Technological Characteristics of New Device to Predicate Devices

The proposed irrigation sets are identical to current Baxter irrigation sets except for the material change from latex to SEBS in the tubing segment. The design and dimensions of the latex tubing segment will remain unchanged. Also, all other materials of the irrigation sets, as well as overall product design and intended use will remain unchanged.

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FEB 23 1996 50

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510(k) Premarket Notification
Irrigation Sets

# Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests

The biological and chemical reactivity of the new SEBS material has been assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. The material was found to be acceptable for its intended use.

Data regarding the functional performance of irrigation sets with the proposed SEBS tubing segment have been generated. Studies included kink testing, pull testing and pressure testing. Performance testing indicate that the proposed irrigation set meets or exceeds all functional requirements and support its suitability for use.

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