MILLENNIUM GOLD

K992090 · Skytron, Div. the Kmw Group, Inc. · FSY · Sep 8, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992090
• Device Name: MILLENNIUM GOLD
• Applicant: Skytron, Div. the Kmw Group, Inc.
• Product Code: FSY · General, Plastic Surgery
• Decision Date: Sep 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

The Millennium Gold Series Surgical light is intended to be used by medical personnel for the purpose of illuminating surgical sites.

Device Story

Millennium Gold Series Surgical Light provides illumination for surgical sites; operated by medical personnel in clinical/surgical settings. Device functions as a surgical light source to enhance visibility during procedures. Output is visible light directed at the surgical field to assist healthcare providers in performing medical tasks. Benefits include improved visualization of anatomy and surgical site, facilitating clinical decision-making and procedural accuracy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Surgical light system; intended for illumination of surgical sites. Technical specifications and materials are consistent with standard surgical lighting equipment. No software or complex algorithm components described.

Indications for Use

Indicated for illumination of surgical sites by medical personnel during surgical procedures.

Regulatory Classification

Identification

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 8 1999

Ms. Kari Ogreen Executive Secretary Skytron A Division of the KMW Group, Inc. 5000 36th Street, S.E. P.O. Box 888615 Grand Rapids, Michigan 49588

Re: K992090

> Trade Name: Millennium Gold Series Surgical Light Regulatory Class: II Product Code: FSY Dated: June 14, 1999 Received: June 21, 1999

Dear Ms. Ogreen:

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

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Page 2 - Ms. Kari Ogreen

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 vours,

scolle
C. Colin M. Wittwer, Ph.D., M.D.

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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Kaasoaa SIO(K) MUNBER (IF KNOWN) : MILLENIUM GOLD SERIES SURGICAL LIGHT DEVICE NAME:

INDICATIONS FOR USE:

The Millennium GoTd Series Surgical light is intended to be used
and the form the surporal of illuminating surgical The Millennium Gold Series Surgical Fight for the minuting surgical
by medical personnel for the purpose of illuminating surgical sites.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

.

Prescription Use
*
(Per 21 CFR 801.109)
OR
Over-The-Counter-Us
(Optional Format

(Division Sign-Off)
Division of General Restorative Devices K942080

510(k) Number