The CHROMOPHARE® E 668 is intended to be used to provide visible illumination to the surgical field of the patient. The surgical lights BERCHTOLD CHROMOPHARE® E 668 is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.

Device Description

The new BERCHTOLD CHROMOPHARE® E 668 surgical light is suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in this light, BERCHTOLD realizes high illumination intensity with a lower heat radiation and less pattern variation compared to previous generations of BERCHTOLD products. The light features easy-to-operate swivel arms. Each light functions with an optional integrated CCD video camera and/or with upward "EndoLite" and/or with downward "GuideLite" for endoscopic procedures. The lights could be combined among each other.

AI/ML Overview

The provided text describes a 510(k) summary for the BERCHTOLD CHROMOPHARE® E 668 surgical lamp. The submission focuses on demonstrating substantial equivalence to a predicate device (BERCHTOLD CHROMOPHARE® E 558), rather than a study proving the device meets specific acceptance criteria for a novel AI or diagnostic system.

Therefore, many of the requested elements (like sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from this type of regulatory submission as they pertain more to performance studies of diagnostic or AI-driven devices.

However, I can extract the acceptance criteria based on the comparison to the predicate device and the conformity to relevant standards.

1. A table of acceptance criteria and the reported device performance

For a substantial equivalence submission like this, the "acceptance criteria" are implicitly established by the characteristics of the predicate device and relevant performance standards. The new device is accepted if its performance characteristics are substantially equivalent to the predicate and conform to identified standards, without raising new questions of safety or effectiveness.

Characteristic / Acceptance Criteria (Predicate E 558)	Reported Device Performance (New Device E 668)	Met/Not Met (Substantially Equivalent)
Intended use: Illumination of the operating site on a patient's body	Same	Met
Input power: 120V, 1-phase lines, 60Hz	Same	Met
Protection against electrical shock: Class I	Same	Met
Diameter of light body: 568mm	638mm	Met (Difference assessed not to alter safety/efficacy)
Diameter of reflectors: 36x35mm, 36x40mm	48x35mm, 48x40mm	Met (Increased number, assessed not to alter safety/efficacy)
Lamp technology: Light Emitting Diode	Same	Met
Reflector: 72 individual reflectors	96 individual reflectors	Met (Increased number, assessed not to alter safety/efficacy)
Power consumption of bulb: <2.5W each	Same	Met
Light/heat filter technology incl. UV light filter mechanism: None	Same	Met
Color rendering Index Ra: 94	Same	Met
Color temperature: 3600K, 4000K, 4500K, 5000K	Same	Met
Central illuminance (at 1m): 70000 - 140000lux	80000 - 160000lux	Met (Increased range, assessed not to alter safety/efficacy)
Light field diameter: 140 - 285mm	150 - 290mm	Met (Increased range, assessed not to alter safety/efficacy)
Depth of illumination: 805mm	850mm	Met (Increased, assessed not to alter safety/efficacy)
Total irradiance E₀: 442 W/m²	600 W/m²	Met (Increased, assessed not to alter safety/efficacy)
UV-irradiance (≤400nm): 0 W/m²	Same	Met
Light focusing mechanism: Pressure Sensitive Handgrip	Same	Met
Life time of bulb: 20000h	Same	Met
Reusable steam sterilizable lamp handle: Yes	Same	Met
Additional light controls in separate wall box: Standard	Same	Met
Ambient Illumination for minimally invasive surgeries: Optional upward "EndoLite" and/or downward "GuideLite"	Same	Met
CCD video camera located in sterilizable lamp handle: Optional feature	Same	Met
Conforms to IEC 60601-2-41:2001 (performance)	Conforms to IEC 60601-2-41:2001 (performance)	Met
Conforms to IEC 60601-1 (electrical safety)	Conforms to IEC 60601-1 (electrical safety)	Met
Conforms to IEC 60601-1-2 (electrical safety)	Conforms to IEC 60601-1-2 (electrical safety)	Met

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not involve a "test set" in the context of an AI or diagnostic device. The evaluation is based on device specifications and adherence to international safety and performance standards for surgical lamps. No patient data or clinical study data (retrospective or prospective) from any country of origin is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no "ground truth" establishment by experts for a test set in this device submission. The device is a surgical lamp, and its performance is validated against engineering specifications and international standards, not against expert interpretation of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no test set or adjudication method described for this type of device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical light, not an AI or diagnostic system. Therefore, no MRMC comparative effectiveness study was performed or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a surgical light, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The "ground truth" for this device's performance is established by its engineering specifications and its ability to meet the requirements of recognized international standards (IEC 60601-2-41, IEC 60601-1, IEC 60601-1-2) for safety and performance of surgical lights.

8. The sample size for the training set

Not applicable. This device is a physical surgical light, not a machine learning model. There is no training set in this context.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary

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

K090378

FEB 2 3 2009

510 (k) Summary

Submitter:

BERCHTOLD Holding GmbH Ludwigstaler Straße 125 D- 78532 Tuttlingen Germany

Silke.Goral@BERCHTOLD.biz

Contact Person:

Preparation Date:

February 06, 2009

Silke Goral

Phone:

Fax:

Regulatory Affairs

CHROMOPHARE® E 668 Trade Name:

Common Name:

Surgical lamp

Light, Surgical, Ceiling mounted Classification Name:

Predicate Device:

BERCHTOLD CHROMOPHARE® E 558 (K083066)

0049 7461 181-155

0049 7461 181-8155

Device Description:

Intended Use of the device:

Indications for Use:

The CHROMOPHARE® E 668 is intended to be used to provide visible illumination to the surgical field of the patient.

The surgical lights BERCHTOLD CHROMOPHARE® E 668 is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.

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

Summary of technological characteristics compared to the predicate device:

The BERCHTOLD CHROMOPHARE® E 668 is substantially equivalent to the surgical light BERCHTOLD CHROMOPHARE®E 558 (K083066). Similarities and differences are tabulated below. Any differences between the CHROMOPHARE E 668 and the predicate device do not alter the safety or efficacy of the device.

	Legally marketed deviceCHROMOPHARE® E 558	New deviceCHROMOPHARE® E 668
Intended use	Illumination of the operatingsite on a patient's body	Same
Input power	120V, 1- phase lines, 60Hz	Same
Protection againstelectrical shock	Class I	Same
Diameter of light body	568mm	638mm
Diameter of reflectors	36 reflectors: 35mm36 reflectors: 40mm	48 reflectors: 35mm48 reflectors: 40mm
Lamp technology	Light Emitting Diode	Same
Reflector	72 individual reflectors	96 individual reflectors
Power consumption ofbulb	<2,5W each	Same
Light / heat filtertechnology incl. UV lightfilter mechanism	None	None
Color rendering Index Ra	94	Same
Color temperature	3600K, 4000K, 4500K,5000K	Same
Central illuminance (at 1m)	70000 - 140000lux	80000 - 160000
Light field diameter	140 - 285mm	150 - 290mm
Depth of illumination	805mm	850mm
Total irradiance E₀	442 W/m²	600 W/m²
UV-irradiance (≤400nm)	0 W/m²	Same
Light focusing mechanism	Pressure Sensitive Handgrip	Same
Life time of bulb	20000h	Same
Reusable steamsterilizable lamp handle	Yes	Same
Additional light controls inseparate wall box	Standard	Same
Ambient Illumination forminimally invasivesurgeries	Optional upward "EndoLite"and/or downward "GuideLite"	Same
CCD video camera locatedin sterilizable lamp handle	Optional feature	Same

Performance Summary:

This device conforms to IEC 60601-2-41:2001 specifications for performance of surgical lamps. This device conforms to IEC 60601-1 and IEC 60601-1-2 for electrical safety.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is facing left and has a sleek, modern design. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Berchtold GmbH & Co. % Underwriters Laboratories, Inc. Mr. Jeff D. Rongero 12 Laboratory Drive Research Triangle Park, North Carolina 27709

FEB 2 3 2009

Re: K090378

Trade/Device Name: CHROMOPHARE® E 668 Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSY Dated: February 13, 2009 Received: February 17, 2009

Dear Mr. Rongero:

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.

{3}------------------------------------------------

Page 2 - Mr. Jeff D. Rongero

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

for
Mark N. Melkerson

Mark N. Melkerson A Director 10 Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name:

CHROMOPHARE® E 668

Indications for Use:

The surgical light BERCHTOLD CHROMOPHARE® E 668 is intended to

illuminate.locally the operating site on the patient's body with a high

intensity, shadow free, "cold" light.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR 21 CFR 801 Subpart C)

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

GDRH, Office of Device Evaluation (ODE) Concurr

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

6090378 510(k) Number

Regulation Number and Section

§ 878.4580 Surgical lamp.

(a)
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.(b)
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.