TEMPERATURE DIAGNOSTIC ACCESSORY

K973764 · New Star Lasers, Inc. · GEX · Dec 31, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973764
• Device Name: TEMPERATURE DIAGNOSTIC ACCESSORY
• Applicant: New Star Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2

Intended Use

The Temperature Diagnostic Accessory is intended for use as a sensing device to measure and display the temperature of the treatment area during procedures with the ND-130 Laser.

Device Story

Temperature Diagnostic Accessory functions as a temperature detector for laser surgery. Device inputs thermal data from the treatment area; transforms signals into a temperature reading; displays output on a control panel for the laser operator. Used in clinical settings by physicians or trained laser operators during ND-130 Laser procedures. Output provides real-time thermal monitoring to assist the operator in managing the treatment area temperature, potentially enhancing procedural safety.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Temperature detector/sensor; provides control panel readout of treatment area temperature. Designed as an accessory for the ND-130 Laser system.

Indications for Use

Indicated for use as a temperature sensing and display device for the treatment area during procedures involving the ND-130 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

• Fiber Tipped Protection System accessory (K912703)

Submission Summary (Full Text)

{0}------------------------------------------------

K973064

## Attachment I 510(K) Summary Temperature Diagnostic Accessory

This 510(K) Summary of safety and effectiveness for the Temperature Diagnostic Accessory is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

| Applicant: | New Star Lasers | DEC 31 1997 |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Address: | 11802 Kemper Road<br>Auburn, CA 95603 | |
| Contact Person: | Nina Davis | |
| Telephone: | [phone]<br>[phone] | |
| Preparation Date: | 10-1-97 | |
| Device Trade Name: | Temperature Diagnostic Accessory | |
| Common Name: | Temperature Diagnostic Accessory | |
| Classification Name: | Instrument, Surgical, Powered, laser<br>79-GEX<br>21 CFR 878-4810 | |
| Legally Marketed Predicate Device: | Fiber Tipped Protection System accessory cleared for market<br>as part of the Optica 60 Nd: YAG Laser System, Mfg. by<br>Xintec Corp., Oakland, CA Cleared under 510(K) #<br>K912703 | |
| Description of the Temperature Diagnostic<br>Accessory | The Temperature Diagnostic Accessory is a temperature<br>detector which will provide the laser operator with a control<br>panel read out of the temperature of the treatment area. | |
| Intended use of the Temperature<br>Diagnostic Accessory | The Temperature Diagnostic Accessory is intended for use<br>as a sensing device to measure and display the temperature<br>of the treatment area during procedures with the ND-130<br>Laser. | |
| Nonclinical Performance Data: | None | |
| Clinical Performance Data: | None | |
| Conclusion: | The Temperature Diagnostic Accessory is substantially<br>equivalent to other existing automatic temperature<br>measuring accessories. | |
| Additional Information: | None requested at this time | |

{1}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dave Hennings, M.S. President New Star Lasers, Incorporated 11802 Kemper Road Auburn, California 95603

Re: K973764

Trade Name: Temperature Diagnostic Accessory Regulatory Class: II Product Code: GEX Dated: October 1, 1997 Received: October 2, 1997

DEC 3 1 1997

Dear Mr. Hennings:

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 (OS) 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

Image /page/1/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wing shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle emblem.

{2}------------------------------------------------

Page 2 - Mr. Hennings

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,

toole

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

{3}------------------------------------------------

## INDICATION FOR USE STATEMENT

K973764 510(k) Number:

Device Name: New Star Temperature Diagnostic Accessory Indications for Use:

The Temperature Diagnostic Accessory is intended for use as a sensing device to measure and display the temperature of the treatment area during procedures with the ND-130 Laser.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

tocoeep o

Prescription Use (per 21 CFR 801.109)

OR

Over-the-Counter Use ------