CHROMOPHARE X 65

K024132 · Berchtold Holding GmbH · FSY · Mar 21, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K024132
• Device Name: CHROMOPHARE X 65
• Applicant: Berchtold Holding GmbH
• Product Code: FSY · General, Plastic Surgery
• Decision Date: Mar 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

The CHROMOPHARE® X 65 is intended to be used to provide used to provide visible illumination of the surgical field or the patient.

Device Story

CHROMOPHARE® X 65 is a ceiling-mounted surgical lamp used in operating rooms to provide visible illumination of the surgical field. It utilizes gas-discharging lamps to achieve high illumination intensity while minimizing heat radiation. The device features swivel arms for positioning, an auto-switching mechanism that activates a secondary lamp upon failure of the primary lamp, and an easily exchangeable lamp cartridge. Optional configurations include a CCD video camera and an "EndoLite" version for endoscopic procedures. The device is operated by surgical staff to provide clear visualization of the patient's body during surgery, facilitating clinical decision-making through improved visibility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Surgical lamp utilizing gas-discharging lamps for illumination. Features include swivel arm mounting, automatic lamp switching, and modular lamp cartridges. Optional integrated CCD video camera and endoscopic lighting mode (EndoLite). Ceiling-mounted form factor.

Indications for Use

Indicated for providing high intensity, shadow-free, "cold" light to illuminate the operating site on a patient's body 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.

Predicate Devices

• BERCHTOLD CHROMOPHARE® D650 (K965130)

Submission Summary (Full Text)

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K024132

## 510(k) Summary

| Submitter: | BERCHTOLD Holding GmbH<br>Ludwigstaler Str. 25<br>D-78532 Tuttlingen Germany | MAR 21 2003 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Jörg Schneider<br>Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] | |
| Preparation Date: | December 02, 2002 | |
| Trade Name: | CHROMOPHARE® X 65 | |
| Common Name: | Surgical lamp | |
| Classification Name: | Light, Surgical, Ceiling Mounted | |
| Device Description: | The new BERCHTOLD CHROMOPHARE® X 65 surgical light<br>is suitable for all types of surgical procedures.<br>With the use of `gas-discharging lamps in the new light<br>BERCHTOLD realizes a higher illumination intensity with a<br>lower heat radiation.<br>The light incorporates easy-to-operate swivel arms auto<br>switching on the second lamp in case of failure of the main<br>lamp and an easy-to-exchange lamp cartridge. Also an optional<br>CCD-video-camera is available and a special version<br>with "EndoLite" for endoscopical working.<br>The light could be combined with other BERCHTOLD lights. | |
| Intended Use of<br>the Device: | The CHROMOPHARE® X 65 is intended to be used to provide<br>used to provide visible illumination of the surgical field or the<br>patient. | |
| Substantial Equivalence: | The BERCHTOLD CHROMOPHARE® X65 is substantially<br>equivalent to the surgical light BERCHTOLD<br>CHROMOPHARE® D650 (K965130).<br>Any difference that exists between the CHROMOPHARE®<br>D650 and the X 65 has no negative effect on safety or efficacy<br>and actually enhances the usefulness in the chosen<br>application. | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2003

Mr. Jörg Schneider Regulatory Affairs Berchtold Holding GmbH Ludwigstaler Str. 25 Tuttlingen, Germay D-78532

Re: K024132

Trade/Device Name: CHROMOPHARE® X65 Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSY Dated: February 13, 2003 Received: February 19, 2003

Dear Mr. Schneider:

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. Jörg Schneider

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 to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Sincerely yours,

Mark N Millerson

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 K024132

## INDICATION FOR USE

The surgical light BERCHTOLD CHROMOPHARE® X65

is intended to illuminate locally the operating site on the patient's body

with a high intensity, shadow free, "cold" light.

for Mark N. Melluson

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

510(k) Number K0241132