RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)

K964585 · Trimedyne, Inc. · GEX · Apr 17, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964585
• Device Name: RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)
• Applicant: Trimedyne, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These devices are intended for use with any holmium laser (with a compatible connector) for its cleared applications.

Device Story

Fiber optic energy delivery device; near-contact fixed laser fiber in stainless steel shaft; attaches to Omni Multiuse Handpiece via quick-connect mechanism. Used in clinical settings by physicians; delivers laser energy for cleared holmium laser applications. Enables steam sterilization and reuse through minor material and configuration modifications compared to predicate devices.

Clinical Evidence

No clinical data submitted. Bench testing included sterilization, mechanical, biological, and performance studies.

Technological Characteristics

Fiber optic energy delivery; stainless steel shaft; quick-connect mechanism; steam sterilizable; compatible with holmium lasers.

Indications for Use

Indicated for use with holmium lasers for cleared applications; patient population not specified.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Trimedyne Omni Switchtip System
• Tapertip Endfiring Multiuse Handpieces

Submission Summary (Full Text)

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K 964585

Trimedyne

APR 17 1997

# Summary of 510(k) Safety and Effectiveness Information

Trimedyne® Multiuse Switchable Tips

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

I. Submitter Information: Trimedyne, Inc.
P.O. Box 57001
Irvine, CA 92619-7001
714/559-5300
714/559-1330

Contact Person: Susan H. Gamble
Director, Regulatory Affairs & Quality Assurance

Summary Date: November 14, 1996

II. Device Name

Proprietary: Resposable OmniTip™ Switchable Tips

Common: Laser Fibers

Classification: Accessories to Laser-Powered Instrument (unclassified)

III. Predicate Device

The predicate devices are the Trimedyne Omni™ Switchtip System and Tapertip™ Endfiring Multiuse Handpieces.

IV. Device Description

The Multiuse Switchable Tip is a fiber optic energy delivery device consisting of a near-contact fixed laser fiber contained in a stainless steel shaft; it attaches to the Omni™ Multiuse Handpiece through a quick-connect mechanism.

V. Intended Use

These devices are intended for use with any holmium laser (with a compatible connector) for its cleared applications.

VI. Technological Characteristics

The devices differ from their predicate devices due only to the incorporation of minor materials and configuration changes which allow for steam sterilization/reuse.

VII. Nonclinical Tests

The devices were subjected to a series of tests; these tests included sterilization, mechanical, biological, and performance studies.

TRIMEDYNE, INC.

J:\FDA\510K\REUSE2\ST-REUSE.DOC 14-Nov-96

2801 BARRANCA ROAD, IRVINE, CA 92714

714 559-5300, FAX [phone]

800 733-5273

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VIII. Clinical Tests

No clinical tests were submitted in this Premarket Notification.

IX. Conclusions Drawn from Testing

The devices are biocompatible, perform as intended, and have acceptable mechanical properties when used according to their labeling.

J:FDA1510KREUSE2ST-REUSE.DOC 14-Nov-96