STELLAR SERIES SURGICAL LIGHTS WITH HERMES

K021585 · Skytron, Div. the Kmw Group, Inc. · FSY · Nov 13, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021585
• Device Name: STELLAR SERIES SURGICAL LIGHTS WITH HERMES
• Applicant: Skytron, Div. the Kmw Group, Inc.
• Product Code: FSY · General, Plastic Surgery
• Decision Date: Nov 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

The Stellar Series Surgical Lights are indicated for use with the Hermes OR Control Center (ORCC). A few examples of the more common surgical procedures are Cardiovascular, Ortho, Neuro, Cysto, Opthalmic, Plastics, Special Procedures, Delivery, Urology and general surgery. Users of the Stellar Series Surgical Lights with Hermes ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists,

Device Story

Stellar Series Surgical Lights integrate with Hermes OR Control Center (ORCC) to provide illumination during surgical procedures. Device functions as surgical lighting system controlled via ORCC interface. Used in operating rooms by surgeons and surgical staff. Provides high-intensity light for visualization of surgical field. Integration with ORCC allows centralized control of OR environment, potentially streamlining surgical workflow and improving visualization for clinical decision-making during procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Surgical lighting system designed for integration with Hermes OR Control Center (ORCC). Class II device (Product Code FSY, Regulation 878.4580).

Indications for Use

Indicated for use in surgical procedures including cardiovascular, orthopedic, neurological, cystoscopic, ophthalmic, plastic, delivery, urological, and general surgery. Intended for use by surgeons across various specialties including general, gynecological, cardiac, thoracic, plastic, orthopedic, ENT, and urological surgeons.

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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

00 Corporate Boulevard ockville MD 20850

**NOV 1 3 2002**

Skytron, Division The KMW Group, Inc Larry Perez VP Technical Services P. O. Box 888615 Grand Rapids, Michigan 49588-8615

Re: K021585

Trade/Device Name: Stellar Series Surgical Lights with Hermes Regulation Number: 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSY Dated: September 24, 2002 Received: September 25, 2002

Dear Mr. Perez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (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 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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Larry Perez

This letter will allow you to begin marketing your device as described in your Section 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 t proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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

Enclosure

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510(k) Number (if known):

TM Stellar Series Surgical Lights with Hermes Device Name:

Indications For Use:

The Stellar Series Surgical Lights are indicated for use with the Hermes OR Control Center (ORCC).

A few examples of the more common surgical procedures are Cardiovascular, Ortho, Neuro, Cysto, Opthalmic, Plastics, Special Procedures, Delivery, Urology and general surgery.

Users of the Stellar Series Surgical Lights with Hermes ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists,

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use__

Miriam C. Purret

(Optional Format 1-2-96)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K033535

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