RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS

K970422 · Trimedyne, Inc. · GEX · Apr 21, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970422
• Device Name: RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS
• Applicant: Trimedyne, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Right Angle Laser Fibers and Optilase Lasers are indicated for a wide variety of surgical uses including incision, excision, resection, vaporization, ablation, coagulation and hemostasis. In addition, they are indicated for coagulation of soft tissue for prostatectomy in the treatment of benign prostatic hyperplasia (BPH).

Device Story

System consists of Optilase Nd:YAG laser energy sources and UroGold/UroMax right angle fiber optic delivery systems. Laser energy delivered via quartz fiber to target tissue; used for incision, excision, resection, vaporization, ablation, coagulation, and hemostasis. Specifically used for prostatectomy in BPH treatment. Operated by physicians in surgical settings. Output is continuous wave laser energy; clinical effect is thermal tissue destruction/coagulation. Higher power (60W) compared to previous 40W standard; intended to provide viable alternative to transurethral resection of the prostate (TURP).

Clinical Evidence

Limited clinical study evaluated Visual Laser Ablation of the Prostate (VLAP) at 60 watts. Data compared to historical study of 40-watt VLAP versus TURP. Results indicate 60-watt VLAP is a viable alternative to TURP.

Technological Characteristics

Continuous wave Nd:YAG laser system; 3-meter buffered quartz fiber delivery system; fiber optic connector; adjustable power output; aiming beam.

Indications for Use

Indicated for surgical incision, excision, resection, vaporization, ablation, coagulation, and hemostasis, including coagulation of soft tissue for prostatectomy in patients with benign prostatic hyperplasia (BPH).

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

• K954597

Submission Summary (Full Text)

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APR 21 1997

# Trimedyne

K970422

## Summary of 510(k) Safety and Effectiveness Information

Trimedyne® Right Angle Laser Fibers and Optilase® Lasers for the Treatment of BPH at 60 watts of Laser Power

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: February 3, 1997

### II. Device Name

Proprietary:
Optilase® Model 1000 Nd:YAG Laser System
Optilase® Model 4000 Nd:YAG Laser System
Optilase® PL100 Model 1000-100 Nd:YAG Laser System
UroGold™ Right Angle Laser Fibers
UroMax™ Right Angle Laser Fibers

Additional proprietary names may be used for other Right Angle Laser Fiber configurations.

Common: Laser-powered Instrument
Laser Fiber

Classification: Nd:YAG Laser System
Accessory to Laser-powered Instrument - Not Classified

### III. Predicate Device

The predicate devices are those cleared under 510(k) K954597.

### IV. Device Description

The Optilase laser systems are continuous wave Nd:YAG energy sources equipped with an aiming beam, adjustable power output, and a fiber optic connector.

The Right Angle Laser Fibers are fiber optic Nd:YAG energy delivery systems consisting of: a three meter length of buffered quartz fiber, a tip which allows delivery of laser energy, and a fiber optic connector.

TRIMEDYNE, INC.
2801 BARRANCA ROAD, IRVINE, CA 92714

J:\FDA\510K\60WATT.BPH60WSUB.DOC 3-Feb-97
714 559-5300, FAX [phone]
800 733-5273

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V. Intended Use

The Right Angle Laser Fibers and Optilase Lasers are indicated for a wide variety of surgical uses including incision, excision, resection, vaporization, ablation, coagulation and hemostasis. In addition, they are indicated for coagulation of soft tissue for prostatectomy in the treatment of benign prostatic hyperplasia (BPH).

VI. Technological Characteristics

There are no technological differences between these devices and those cleared under K954597.

VII. Nonclinical Tests

No nonclinical tests were submitted in this Premarket Notification.

VIII. Clinical Tests

A limited clinical study was undertaken to provide information related to Visual Laser Ablation of the Prostate (VLAP) with 60 watts of laser power. These data were compared to data obtained from an earlier study in which VLAP at 40 watts of laser power was compared to TURP.

IX. Conclusions Drawn from Testing

The results of the comparative data submitted in this Premarket Notification demonstrate that VLAP, whether it be performed at 40 watt or 60 watt treatment parameters, is a viable alternative to TURP.

J:FDA1510K160WATT.BPH160WSUB.DOC 3-Feb-97