VAPORMAX

K050412 · Trimedyne, Inc. · GEX · Mar 14, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050412
• Device Name: VAPORMAX
• Applicant: Trimedyne, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The VAPORMAX is intended for surgical use including: incision, excision, vaporization, ablation, and coagulation of soft tissue. The VAPORMAX is indicated for use with any cleared Holmium:YAG 2.1 micrometer laser with a compatible connector for that laser's cleared indications for use.

Device Story

VAPORMAX is a single-use, disposable, side-firing fiber optic energy delivery device. It functions as an accessory to cleared Holmium:YAG (2.1 micrometer) lasers. The device transmits laser energy to soft tissue to perform incision, excision, vaporization, ablation, and coagulation. It is intended for use by surgeons in clinical settings. The device is designed to operate at higher power levels (up to 100 watts) compared to previous Trimedyne side-firing fibers. The surgeon directs the fiber tip to the target tissue; the laser energy delivered through the fiber facilitates the surgical procedure. The device provides a mechanical means for energy delivery, enabling the physician to perform precise tissue management.

Clinical Evidence

No clinical data were submitted in this Premarket Notification.

Technological Characteristics

Single-use, disposable, side-firing fiber optic energy delivery device. Compatible with Holmium:YAG 2.1 micrometer lasers. Designed for operation at laser power levels up to 100 watts.

Indications for Use

Indicated for surgical incision, excision, vaporization, ablation, and coagulation of soft tissue when used with cleared Holmium:YAG 2.1 micrometer lasers.

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 Side Firing Fibers (K915223, K992230, K022655)
• Lumenis DUOTOME SIDELITE (K011703, K990947)

Submission Summary (Full Text)

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KOSO412

MAR 1 4 2005

### VAPORMAX™ Side Firing Fiber

This summary of 510(k) safety and effectiveness information is being submitted in This Summary of 5 r 6 r requirements of SMDA 1990 and 21 CFR 807.92.

| I. Submitter Information: | Trimedyne, Inc.<br>15091 Bake Parkway<br>Irvine, CA 92618<br>949-951-3800 |
|---------------------------|---------------------------------------------------------------------------|
| Contact Person: | Glenn Yeik<br>President and COO |
| Summary Date: | 4 March 2005 |

#### II. Device Name

| Proprietary: | VAPORMAX TM |
|-----------------|----------------------------------------|
| Common: | Laser Fiber |
| Classification: | Accessory to Laser-Powered Instrument: |

#### III. Predicate Device

The predicate devices for the VAPORMAX Side Firing Fiber are:

- Trimedyne Side Firing Fibers cleared under 510(k)s K915223, K992230 and . K022655; and
- Lumenis DUOTOME SIDELITE™ believed to have been cleared under K011703 . and/or K990947.

#### Device Description IV.

The VAPORMAX is a single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers.

#### Intended Use V.

The VAPORMAX is intended for surgical use including: incision, excision, vaporization, ablation, and coagulation of soft tissue.

The VAPORMAX is indicated for use with any cleared Holmium:YAG 2.1 micrometer laser with a compatible connector for that laser's cleared indications for use.

#### Technological Characteristics VI.

The VAPORMAX differs from the current Trimedyne side firing devices in that it can be used at laser powers up to 100 watts, rather than 40-60 watts.

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#### Nonclinical Data VII.

No nonclinical data were submitted in this Premarket Notification.

#### Clinical Data VIII.

No clinical tests were submitted in this Premarket Notification.

#### Conclusions Drawn From Testing IX.

The VAPORMAX performs as intended and has acceptable mechanical properties when used in accordance with its labeling.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three wavy lines representing its wings. The eagle is facing left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2005

Trimedyne, Inc. c/o Mr. Morten S. Christensen Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050

Re: K050412 Trade/Device Name: VaporMAXTM Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 4, 2005 Received: March 7, 2005

Dear Mr. Christensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device within we reviewed your becamed the device is substantially equivalent (for the indications forcreneed above and have sure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or to commerce prior to may 20, 2012 - 12:00 accordance with the provisions of the Federal Food, Drug. de nees mat have been require approval of a premarket approval application (PMA). and Cosmetic For ( 100) rate the device, subject to the general controls provisions of the Act. The r va may) are severy and 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I editar Batales and 2008.
Comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quand provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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# Page 2 - Mr. Morten S. Christensen

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wif anow you to ocgin mailing of substantial equivalence of your device to a legally premaired 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), please if you desire speeme at 75th as a 100 - 10-0115. Also, please note the regulation entitled. Contact the </rive of Come to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Smail other general information of 90% Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Coress http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A Milliken

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: VAPORMAX™

## Indications for Use:

The VAPORMAX is intended for surgical use including: incision, excision, vaporization, ablation, and coagulation of soft tissue.

The VAPORMAX is indicated for use with any cleared Holmium:YAG 2.1 micrometer laser with a compatible connector for that laser's cleared indications for use.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR |
|-------------------------------------------------|---|--------|
|-------------------------------------------------|---|--------|

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Milliken

Division of General, Restorative, and Neurological Devices

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**510(k) Number**