LUXSCOPE by LUXTEC CORP. | FDA 510(k) Summary

This document is an FDA 510(k) clearance letter for the LuxScope device, dated November 21, 1997. It confirms that the device is substantially equivalent to legally marketed predicate devices.

Based on the provided document, the following information regarding acceptance criteria and study details cannot be found:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance
If a standalone (algorithm only without human-in-the-loop performance) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

This letter primarily focuses on the FDA's determination of substantial equivalence based on the provided 510(k) submission, confirming that the device can be legally marketed. It does not contain details of specific performance studies or the acceptance criteria used in such studies, which would typically be found in the original 510(k) submission itself, not the clearance letter.

The relevant information from the document is:

Trade Name: LuxScope
Regulatory Class: II
Product Code: HQF
Indications for Use: The LuxScope is indicated for panretinal photocoagulation and ablation of the ciliary processes.

Summary

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized representation of a human figure. The emblem is composed of three curved lines that form the shape of a person's head and torso. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 21 1997

Mr. Joseph Ress *Authorized Representative Luxtec Corporation C/O Medical Device Regulatory Consultants 45 Pontiac Road Newton, Massachusetts 02168

K973193 Re:

Trade Name: Luxscope .. Regulatory Class: II Product Code: HQF Dated: August 24, 1997 Received: August 25, 1997

Dear Mr. Ress:

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. 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 -

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 (OS) 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

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

Page 2 - Mr. Ress

not affect any obligation you might have under sections 531 through 542 of the Act for 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

to seefa

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

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

STATEMENT FOR INDICATIONS FOR USE

Page 1 of 1

510(K) Number: K973193

Device Name: LuxScope

Indications for Use:

The LuxScope is indicated for panretinal photocoagulation and ablation of the ciliary processes.

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

Concurrance of CDRH, Office of Device Evaluation (ODE)

Perscription Use YES

Over-The-Counter Use NO

padelfs

(Division Sign-Off) Division of General Restorative Devices 73193 10 510(k) Number

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.