APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE

K971498 · Applied Medical Resources · EZB · May 5, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971498
• Device Name: APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE
• Applicant: Applied Medical Resources
• Product Code: EZB · Gastroenterology, Urology
• Decision Date: May 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 1

Indications for Use

The Applied Medical Laparoscopic Guidewire is intended to assist the physician in navigation, placement and exchange of laparoscopic and general surgical instrumentation.

Device Story

Device: Applied Medical Laparoscopic Guidewire; radiopaque body with flexible, tapered tip. Function: assists physician in navigation, placement, and exchange of laparoscopic and general surgical instrumentation. Usage: clinical setting; operated by physicians. Benefit: facilitates access and visibility during surgical procedures.

Clinical Evidence

Bench testing only. Mechanical and biocompatibility tests performed to verify functional/structural integrity and material safety.

Technological Characteristics

Radiopaque body; flexible, tapered tip. Materials comparable to predicate devices. Dimensions include various lengths.

Indications for Use

Indicated for use by physicians to assist in the navigation, placement, and exchange of laparoscopic and general surgical instrumentation.

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

• Applied Medical Urological Guidewire (K944135/A)
• Cook Urological Guidewire (K880100)

Submission Summary (Full Text)

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K971498

## APPENDIX VIII

## MAY - 5 1997 510(k) SUMMARY

| 510(k) NUMBER: | PENDING |
|----------------------|---------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Applied Medical Resources Corporation<br>26051 Merit Circle, Unit# 103<br>Laguna Hills, California 92653<br>(71) 582-6120 |
| CONTACT PERSON: | Howard V. Rowe |
| DATE OF PREPARATION: | April 22, 1997 |
| NAME OF DEVICE: | Applied Medical Laparoscopic Guidewire |
| CLASSIFICATION NAME: | Urological Catheter and Accessories, 21CFR<br>876.5130. |
| TRADE NAME: | Not Determined |

SUMMARY STATEMENT:

The Applied Medical Laparoscopic Guidewire is intended to assist the physician in navigation, placement and exchange of laparoscopic and general surgical instrumentation. The Applied Medical Laparoscopic Guidewire is substantially equivalent in function, physical configuration and materials to the Applied Medical Urological Guidewire approved under K944135/A and a guidewire marketed by Cook Urological under K880100. The Applied Medical Laparoscopic guidewire and the predicate devices have a radiopaque body with a flexible, tapered tip allowing ease of access and visibility during placement. Differences include a change of indicated use and a selection of different lengths.

Mechanical and biocompatibility tests were performed to verify functional and structural integrity and material safety. All testing has demonstrated that the Applied Medical Laparoscopic Guidewire is comparable to the predicate device and introduces no new safety and effectiveness issues when used as indicated.

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