RESPOSABLE BARE FIBERS

K973172 · Trimedyne, Inc. · GEX · Feb 3, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K973172
• Device Name: RESPOSABLE BARE FIBERS
• Applicant: Trimedyne, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 3, 1998
• 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 pulsed Holmium: YAG 2.1 micrometer laser (with compatible connector) for incision, excision, resection, ablation, vaporization, coagulation and hemostasis.

Device Story

Resposable Holmium Bare Fibers are reusable fiberoptic energy delivery devices; consist of optical fiber, optionally housed in catheter, cannula, needle, or handpiece. Core diameters range 50-1000 microns; various distal tip configurations available. Used with pulsed Holmium: YAG 2.1 micrometer lasers for surgical procedures including incision, excision, resection, ablation, vaporization, coagulation, and hemostasis. Designed for reuse via steam and EtO sterilization. Operated by clinicians in surgical settings to deliver laser energy to target tissue.

Clinical Evidence

No clinical data submitted.

Technological Characteristics

Reusable fiberoptic energy delivery device; 50-1000 micron core diameter; compatible with pulsed Holmium: YAG 2.1 micrometer lasers; supports steam and EtO sterilization.

Indications for Use

Indicated for incision, excision, resection, ablation, vaporization, coagulation, and hemostasis using a pulsed Holmium: YAG 2.1 micrometer laser.

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 Disposable Holmium Bare Fibers

Submission Summary (Full Text)

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EB - 3 1998

# Summary of 510(k) Safety and Effectiveness Information

## Resposable Holmium Bare Fibers

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.

| 1. | Submitter Information: | Trimedyne, Inc.<br>P.O. Box 57001<br>Irvine, CA 92619-7001<br>714/559-5300<br>714/559-1330 |
|-----|------------------------|--------------------------------------------------------------------------------------------|
| | Contact Person: | Susan H. Gamble<br>Vice President, Regulatory Affairs & Quality Assurance |
| | Summary Date: | December 22, 1997 |
| 11. | Device Name | |
| | Proprietary: | Resposable Holmium Bare Fibers |
| | Common: | Laser Fiber |
| | Classification: | Accessories to Laser-Powered Instruments |

#### 111. Predicate Device

The predicate devices are the Trimedyne Disposable Holmium Bare Fibers.

#### IV. Device Description

The Resposable Holmium Bare Fibers are reusable fiberoptic energy delivery devices. These devices consist of an optical fiber which may or may not be contained in a catheter tube, cannula, needle, handpiece or handle. The fibers range from 50 to 1000 microns core diameter and will be offered with various distal tip configurations.

#### V. Intended Use

These devices are intended for use with any pulsed Holmium: YAG 2.1 micrometer laser (with compatible connector) for incision, excision, resection, ablation, vaporization, coagulation and hemostasis.

#### Technological Characteristics VI.

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

#### VII. Nonclinical Tests

No nonclinical test data were submitted in this Premarket Notification.

#### VIII. Clinical Tests

No clinical tests were submitted in this Premarket Notification.

### Conclusions Drawn from Testing IX.

Not applicable.

TRIMEDYNE, INC. 2801 BARRANCA ROAD P.O. Box 57001, Irvine, CA 92619-7001 714 559-5300, FAX [phone]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susan H. Gamble Vice President, Regulatory Affairs & Quality Assurance Trimedyne. Incorporated P.O. Box 57001 Irvine, California 92619-7001

FEB - 3 1998

K973172 Re:

> Trade Name: Resposable Holmium Bare Fibers Regulatory Class: II Product Code: GEX Dated: December 22, 1997 Received: December 23, 1997 .....

Dear Ms. Gamble:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895 .. A substantially equivalent determination assumes compliance with the .... current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for

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devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K973172

Device Name:

(

Resposable Holmium Bare Fibers

.

Indications for Use:

Incision, excision, resection, ablation, vaporization, coagulation and hemostasis.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (QDE)

A. Oleks

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Over-the-Counter Use _