RIGHT ANGLE LASER FIBERS

K954597 · Trimedyne, Inc. · GEX · Mar 11, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K954597
• Device Name: RIGHT ANGLE LASER FIBERS
• Applicant: Trimedyne, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Right Angle Laser Fiber and Optilase Lasers are indicated for a wide variety of surgical uses including incision, excision, resection, vaporization, ablation, coagulation, and hemostasis for the treatment of benign prostatic hyperplasia (BPH) and other urological conditions. Viewing scopes, which can be either flexible or rigid, may be used for visualization during laser procedures.

Device Story

System comprises Right Angle Laser Fiber (3m buffered quartz fiber, tip, connector) and Optilase Nd:YAG laser (continuous-wave source, aiming beam, adjustable power). Used in urological surgery; operated by physicians. Laser energy delivered via fiber through flexible or rigid viewing scopes to prostate tissue. Enables incision, excision, resection, vaporization, ablation, coagulation, and hemostasis. Clinical benefit: minimally invasive treatment of BPH compared to traditional resection.

Clinical Evidence

Prospective, controlled, well-matched study comparing visual laser ablation of the prostate (VLAP) using the subject devices to transurethral resection of the prostate (TURP). Data concluded the devices are safe and effective for BPH treatment.

Technological Characteristics

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

Indications for Use

Indicated for patients with benign prostatic hyperplasia (BPH) and other urological conditions requiring surgical incision, excision, resection, vaporization, ablation, coagulation, or hemostasis.

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 Right Angle Laser Fiber (K944204)
• Trimedyne Optilase Nd:YAG Laser Systems (K922497)
• Trimedyne Optilase Nd:YAG Laser Systems (K932883)

Submission Summary (Full Text)

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k954597

Trimedyne

MAR 11 1996

# Summary of 510(k) Safety and Effectiveness Information

## Trimedyne® Right Angle Laser Fibers and

## Optilase® Nd:YAG Laser System Models 1000, 4000, and 1000-100 (PL100)

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 92719-7001
714/559-5300
714/559-1330 (facsimile)

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

Summary Date:
October 2, 1995

### II. Device Name

Right Angle Laser Fibers:

Proprietary: Not yet selected
Common: Laser fiber
Classification: Accessory to Laser-powered Instrument (unclassified)

Optilase Lasers:

Proprietary:
- Optilase® Model 1000 Nd:YAG Laser System
- Optilase® Model 4000 Nd:YAG Laser System
- Optilase® PL100 Model 1000-100 Nd:YAG Laser System

Common: Neodymium Yttrium Aluminum Garnet (Nd:YAG) laser system
Classification: Laser-powered Instrument

### III. Predicate Device

The predicate devices for the intended use are various configurations of the Trimedyne Right Angle Laser Fiber cleared under 510(k) number K944204 and the Trimedyne Optilase Nd:YAG Laser Systems cleared under 510(k) numbers K922497 and K932883.

TRIMEDYNE, INC.
2801 BARRANCA ROAD
P.O. BOX 57001, IRVINE, CA 92619-7001
714 559-5300, FAX [phone]
800 33 5271

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## IV. Device Description

The Right Angle Laser Fiber is a fiber optic Nd:YAG energy delivery system consisting of: a 3 meter length of buffered quartz fiber, a tip which allows delivery of laser energy, and a fiber optic connector.

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

## V. Intended Use

The Right Angle Laser Fiber and Optilase Lasers are indicated for a wide variety of surgical uses including incision, excision, resection, vaporization, ablation, coagulation, and hemostasis for the treatment of benign prostatic hyperplasia (BPH) and other urological conditions.

Viewing scopes, which can be either flexible or rigid, may be used for visualization during laser procedures.

## VI. Technological Characteristics

There are no technological characteristics differences between the devices cleared under this 510(k) and the predicate devices with regard to the intended use.

## VII. Nonclinical Tests

No nonclinical tests were submitted in this Premarket Notification.

## VIII. Clinical Tests

A prospective, controlled and well-matched study was undertaken to compare visual laser ablation of the prostate (VLAP) to transurethral resection of the prostate (TURP).

## IX. Conclusions Drawn from Testing

The clinical data show that the Trimedyne Right Angle Laser Fibers and Optilase Nd:YAG Laser Systems are safe and effective for treatment of Benign Prostatic Hyperplasia (BPH).