The CHROMOPHARE® E 778 and E 558 is intended to be used to provide visible illumination to the surgical field of the patient. The surgical lights BERCHTOLD CHROMOPHARE® E 778 and E 558 are 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 778 and E 558 surgical lights are suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in these lights, 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 510(k) summary for the BERCHTOLD CHROMOPHARE® E 778 and E 558 surgical lights does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/ML-driven medical devices.

This document describes a traditional medical device (surgical lamps) seeking substantial equivalence to a predicate device. The performance data provided are technical specifications of the surgical lights themselves, not a medical "performance" in the sense of diagnostic accuracy or clinical outcome that would require a study with a test set, ground truth, or expert review.

Therefore, many of the requested details are not applicable or cannot be extracted from this document.

However, I can extract the "acceptance criteria" in the context of device specifications and the "study" (referring to the testing against standards) as best as possible from the provided text.

Acceptance Criteria and Device Performance for BERCHTOLD CHROMOPHARE® E 778 and E 558 Surgical Lights

The acceptance criteria for the BERCHTOLD CHROMOPHARE® E 778 and E 558 surgical lights are primarily defined by their compliance with recognized international standards for medical electrical equipment and the direct comparison of their technical specifications to a predicate device. The "study" proving the device meets these criteria refers to the testing conducted to demonstrate conformance to these standards and the tabulated comparison to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the technical specifications of the predicate device and the specified performance standards. The "Reported Device Performance" column reflects the new device's compliance or its specific values where applicable.

Acceptance Criterion (Based on Predicate/Standard)	CHROMOPHARE® E 778 (New Device Performance)	CHROMOPHARE® E 558 (New Device Performance)
Safety and Electrical Standards
Conforms to IEC 60601-1 (Electrical Safety)	Conforms	Conforms
Conforms to IEC 60601-1-2 (EMC)	Conforms	Conforms
Protection against electrical shock (Class I)	Same as predicate (Class I)	Same as predicate (Class I)
Surgical Lamp Performance Standards
Conforms to IEC 60601-2-41:2001 (Surgical Lamps)	Conforms	Conforms
Illumination Characteristics
Color rendering Index Ra (>= 94 predicate)	Same (94)	Same (94)
Central illuminance (at 1m)	80000 - 160000lux (Same as predicate)	70000 - 140000lux
Light field diameter	140 - 285mm	140 - 285mm
Depth of illumination	690mm	805mm
Total Irradiance Ee	505W/m²	442W/m²
UV- irradiance (≤400nm)	0	0
Other Technical Specifications
Lamp technology	Light Emitting Diode	Light Emitting Diode
Life time of bulb (>= 5000h predicate)	20000h	20000h
Light focusing mechanism	Pressure Sensitive Handgrip	Pressure Sensitive Handgrip

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the context of clinical/diagnostic performance. The "test set" for this device would refer to sample units of the manufactured surgical lights that underwent laboratory testing to verify compliance with the specified standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-41). The document does not specify the number of units tested.
Data Provenance: The testing data would be generated from laboratory tests conducted on the physical devices. The country of origin for the data is not explicitly stated but would presumably be Germany, where BERCHTOLD Holding GmbH is located, or a certified testing laboratory. The data is prospective in the sense that it describes the performance of the newly manufactured devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is not a device that generates diagnostic output requiring expert interpretation for ground truth. The "ground truth" for a surgical light is its adherence to physical performance specifications (e.g., illuminance, color temperature, safety standards).

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method (like 2+1, 3+1) is relevant for evaluating the performance of a surgical light's physical specifications or compliance with engineering standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC study is not relevant for this type of medical device. This is not an AI/ML device, nor one where human readers interpret output.

6. Standalone (Algorithm Only) Performance Study

No. This is not an algorithmic device. Performance is determined by the physical properties and operation of the surgical light.

7. Type of Ground Truth Used

The "ground truth" for this device is the defined technical specifications outlined in international standards (e.g., IEC 60601-2-41) and the predicate device's performance. Measured physical parameters of the surgical light (e.g., central illuminance, irradiance, color rendering index) are compared directly against these established values/ranges.

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set is used.

Summary

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510 (k) Summary

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OCT 3 0 2008

Submitter: BERCHTOLD Holding GmbH Ludwigstaler Straße 125 D- 78532 Tuttlingen Germany

Contact Person: Silke Goral Regulatory Affairs Phone: 0049 7461 181-155 Fax: 0049 7461 181-8155 Silke.Goral@BERCHTOLD.biz
Preparation Date: September 17, 2008
Trade Name: CHROMOPHARE® E 778 CHROMOPHARE® E 558
Common Name: Surgical lamp
Classification Name: Light, Surgical, Ceiling mounted

Predicate Device: BERCHTOLD CHROMOPHARE® E 655 (K080857)

The new BERCHTOLD CHROMOPHARE® E 778 and E 558 surgical Device Description: lights are suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in these lights, 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.

Intended Use of the device: The CHROMOPHARE® E 778 and E 558 is intended to be used to provide visible illumination to the surgical field of the patient. Indications for Use: The surgical lights BERCHTOLD CHROMOPHARE® E 778 and E 558 are intended to illuminate locally the operating

site on the patient's body with a high intensity, shadow free, "cold" light.

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Summary of technological characteristics compared to the predicate device:

The BERCHTOLD CHROMOPHARE® E 778 & E 558 are substantially equivalent to the surgical lights BERCHTOLD CHROMOPHARE® E 655 (K080857). Similarities and differences are tabulated below. Any differences between the CHROMOPHARE E 778 / E 558 and the predicate device do not alter the safety or efficacy of the device.

	Legally marketed deviceCHROMOPHARE® E 655	New devices
		CHROMOPHARE® E 778	CHROMOPHARE® E 558
Intended use	Illumination of the operatingsite on a patient's body	Same	Same
Input power	120V, 1- phase lines, 60Hz	Same	Same
Protection againstelectrical shock	Class I	Same	Same
Diameter of light body	649mm	763mm	568mm
Diameter of reflectors	Polygon reflector: 520mm	84 reflectors: 35mm84 reflectors: 40mm	36 reflectors: 35mm36 reflectors: 40mm
Number of mirroredreflector elements	720	None	None
Lamp technology	Metal halide discharging	Light Emitting Diode	Light Emitting Diode
Reflector	single-piece polygon reflector	168 individual reflectors	72 individual reflectors
Power consumption ofbulb	72W	<2W each	<2W each
Light / heat filtertechnology incl. UV lightfilter mechanism	ThermoSorb®	None	None
Color rendering Index Ra	94	same	same
Color temperature	4300°K	3600K, 4000K, 4500K,5000K	3600K, 4000K, 4500K,5000K
Central illuminance (at 1m)	80000 - 160000lux	same	70000 - 140000lux
Light field diameter	170 - 280mm	140 - 285mm	140 - 285mm
Depth of illumination	1300mm	690mm	805mm
Total Irradiance Ee	560W/m²	505W/m²	442W/m²
UV- irradiance (≤400nm)	2.0W/m²	0	0
Light focusing mechanism	Rotating of Handle	Pressure Sensitive Handgrip	Pressure Sensitive Handgrip
Life time of bulb	5000h	20000h	20000h
Automatic switching to thereserve bulb	Yes	No	No
Bulb replacement indicator	Yes	No	No
Reusable steamsterilizable lamp handle	Yes	Same	Same
Additional light controls inseparate wall box	Standard	Same	Same
Ambient illumination forminimally invasivesurgeries	Optional upward "EndoLite"	Optional upward "EndoLite"and/or downward "GuideLite"	Optional upward "EndoLite"and/or downward "GuideLite"
CCD video camera locatedin sterilizable lamp handle	Optional feature	Same	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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2008

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

K083066 Re:

Trade/Device Name: CHROMOPHARE® E 778 CHROMOPHARE® E 558 Regulation Number: 21 CFR 878.4580

Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSY Dated: October 13, 2008 Received: October 15, 2008

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.

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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) 276-0120. 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.

Mark M. Milliman

Mark N. Melkerson 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 (if known):

Device Name:

CHROMOPHARE® E 778 CHROMOPHARE® E 558

Indications for Use:

The surgical lights BERCHTOLD CHROMOPHARE® E 778 and E 558 are

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) _

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil Redfern for uxm

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

510(k) Number K083066

Page 5 of 22

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.