TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001

K011693 · Trumpf Medical Systems, Inc. · FSY · Jun 13, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K011693
• Device Name: TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
• Applicant: Trumpf Medical Systems, Inc.
• Product Code: FSY · General, Plastic Surgery
• Decision Date: Jun 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The Trumpf surgical lights are intended to locally illuminate an operating or examination area of the patient's body with high intensity light.

Device Story

Trumpf Surgical Light models (301, 501, 701, 1001) provide high-intensity local illumination for surgical or examination areas. Devices feature halogen lamps in varying housing diameters (300-1000 mm) with ceiling, wall, or mobile configurations. Models 501, 701, and 1001 include a 635 nm laser pilot (<1 mW) to mark the center of the light field, activated during repositioning and remaining on for two seconds after movement stops. Model 1001 includes an anti-drift system using magnetic brakes that engage when the light is stationary and release upon contact with the handle. Operated by surgical staff in clinical/OR settings. Output is visual illumination; laser pilot assists in precise light field positioning. Benefits include improved visualization of small operating areas and stable, drift-free positioning.

Clinical Evidence

Bench testing only. Conformance to IEC 60601-2-41 (Particular Requirements for the safety of surgical luminaries) and IEC 601-1/EN 60601-1 (General requirements for safety) was demonstrated. No clinical data provided.

Technological Characteristics

Halogen lamp-based surgical luminaries. Configurations: ceiling, wall, or mobile. Features: laser pilot (635 nm, <1 mW) and magnetic brake anti-drift system (Model 1001). Standards: IEC 60601-2-41, IEC 601-1/EN 60601-1. Connectivity: None (standalone).

Indications for Use

Indicated for local illumination of operating or examination areas of the patient's body during surgical or examination 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.

Predicate Devices

• Drager Sola Surgical Light (K984611)

Submission Summary (Full Text)

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## 510(k) Summary of Safety & Effectiveness

Trumpf Medical Systems, Inc. Submitter 415 Jessen Lane Wando, SC 29492 Mr. William Apperson Contact President and CEO [phone] Fax: [phone] [e-mail] May 7, 2001 Date Device Trade Name: Trumpf Surgical Light . Common Name: Surgical Light, Examination Light Classification: 21 CFR 878.4580 - Surgical Light - Class II ● Product Code FSY ● Drager Sola Surgical Light legally marketed under 510(k) premarket Predicate Device notification K984611. The Trumpf surgical lights are intended to locally illuminate an operating or Indications for Use examination area of the patient's body with high intensity light. Device Four models of the Trumpf surgical lights will be available: 301, 501, 701 and 1001. The versions differ in the diameter of the lamp housing (300 mm, Description 500 mm, 700 mm and 1000 mm, respectively). All lights are equipped with one or two halogen lamps and are available in either ceiling-mounted ("D") or wall-mounted ("W") configurations. The Model 301 is also available in a floor standing/mobile ("S") configuration. The lights may be mounted individually, but more typically are mounted as two- or three-unit aggregates.

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011693

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## 510(k) Summary of Safety & Effectiveness, Continued

An optional laser pilot is available on the Models 501, 701 and 1001. The Device laser pilot exactly marks the center of the light field. This makes it easier for Description, the user to focus the light field with precision even if the operating area is continued very small. Whenever the operating light is moved/repositioned, the laser pilot is activated. When the operating light comes to a standstill, the laser pilot continues to be in operation for another two seconds. The laser pilot can be deactivated via the control panel. The laser wavelength is 635 nm with a nominal output power of < 1 mW. The Model 1001 is also equipped with an anti-drift system. As soon as the light comes to a standstill, it will be fixed in position by built-in magnetic brakes. The brakes are automatically released whenever the handrail surrounding the light (or central handle) is touched. The technological characteristics of the Trumpf Surgical Light are the same as Technological the predicate device, the Drager Sola Surgical Light. The physical Characteristics characteristics, performance specifications, materials, dimensions and all other characteristics of the Trumpf surgical lights are identical to the Sola surgical lights. Test Data Test data to support the conformance to: IEC 60601-2-41 Standard - Particular Requirements for the safety of . surgical luminaries and luminaries for diagnosis, First edition 2000-02 IEC 601-1/EN 60601-1 Medical electronic equipment, Part 1, General . requirements for safety, and software testing demonstrates that the lights perform as intended and are safe and effective. Based on the information provided herein and the 510(k) "Substantial Conclusion Equivalence" Decision Making Process Chart, we conclude that the Trumpf Surgical Light is substantially equivalent to the predicate device, the Drager Sola Surgical Light under the Federal Food, Drug and Cosmetic Act.

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Public Health Service

JUN 1 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Trumpf Medical Systems, Inc. c/o Mr. Kent Donohue Senior Staff Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle, North Carolina 27709

Re: K011693

Trade/Device Name: Trumpf Surgical Light Models 301, 501, 701 and 1001 Regulation Number: 878.4580 Regulatory Class: II Product Code: FSY Dated: May 30, 2001 Received: May 31, 2001

Dear Mr. Donohue:

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 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). 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 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 - Mr. Kent Donohue

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 nothloate 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 11 you desire specific dains and on the devices), please contact the Office of Compliance at additionally 607.10 for in in 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsible free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark N Milkersen

elia 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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## Indications for Use

510(k) Number: k 011613

Device Name: Trumpf Surgical Lights Models 301, 501, 701 and 1001

Indications for Use:

The Trumpf surgical lights are intended to locally illuminate an operating or examination area of the patient's body with high intensity light.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use '/ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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(Division Sign Off)

Division of General, Restorative and Neurological Devices

510(k) Number K011693

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