The surgical lights BERCHTOLD CHROMOPHARE® F 628 and F 528 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® F 628 and F 528 surgical lights are suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in combination with reflector technology, 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 in-light video camera and/or with upward "EndoLite" and/or with downward "GuideLite" for endoscopic procedures. The lights could be combined among each other or with other CHROMOPHARE devices, on ceiling mounted, wall mounted and floorstand configurations.

AI/ML Overview

This looks like a 510(k) summary for a surgical lamp, not an AI/ML device. Therefore, many of the requested fields related to AI/ML device studies, such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment for AI models, are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard)	Reported Device Performance (Compliance)
IEC 60601-2-41:2001 (Performance of Surgical Lamps)	Conforms to specifications; all requirements met; achieved specified desired values per product design specifications.
IEC 60601-1 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance)	Conforms to specifications; testing conducted for mechanical and electrical safety.
IEC 60601-1-2 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests)	Conforms to specifications; testing conducted for mechanical and electrical safety.

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

Test Set Sample Size: Not applicable. This device is a surgical lamp, and its performance was evaluated through engineering and product testing against established standards, not through a clinical test set with patient data.
Data Provenance: Not applicable. The testing described is hardware-level performance validation against industry standards.

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

Not applicable. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts on a dataset. For a surgical lamp, performance is assessed against technical specifications and safety standards, not expert-labeled data.

4. Adjudication Method for the Test Set:

Not applicable. There was no 'test set' in the AI/ML sense, and thus no adjudication method for expert disagreement. Performance was evaluated against objective technical standards.

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 is for AI/ML devices. The CHROMOPHARE® F 628 and F 528 are surgical lamps and do not involve human readers or AI assistance in their function. Clinical testing was not required or utilized.

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

Not applicable. This is for AI/ML algorithms. The device is a physical surgical lamp.

7. The Type of Ground Truth Used:

Not applicable in the AI/ML context. The "ground truth" for this device's performance is adherence to the technical specifications outlined in IEC 60601-2-41:2001, IEC 60601-1, and IEC 60601-1-2. These standards define objective, measurable performance characteristics like illumination intensity, shadow reduction, heat radiation, electrical safety, and mechanical integrity.

8. The Sample Size for the Training Set:

Not applicable. There is no training set for a surgical lamp.

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

Not applicable. There is no training set for a surgical lamp.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The study that proves the BERCHTOLD CHROMOPHARE® F 628 and F 528 surgical lamps meet their acceptance criteria is a technical and performance testing study conducted in accordance with international standards.

Standards Applied:
- IEC 60601-2-41:2001: This standard specifically governs the safety and essential performance of surgical luminaires and luminaires for diagnosis. The document states that "Testing was conducted in accordance with this standard to support substantial equivalence. The F [device] has complied... all requirements of the performance standard and achieved specified desired values per the product design specifications."
- IEC 60601-1: This is the general standard for medical electrical equipment, covering basic safety and essential performance. The devices "were subjected to testing in accordance with IEC 60601-1... for mechanical and electrical safety."
- IEC 60601-1-2: This collateral standard addresses electromagnetic disturbances (EMC) for medical electrical equipment. The devices "were subjected to testing in accordance with... IEC 60601-1-2 for mechanical and electrical safety."
Conclusion: The tests demonstrated that the new devices meet all the requirements of these standards, ensuring their safety and performance are equivalent to, or surpass, that of the predicate device (BERCHTOLD CHROMOPHARE® E 668, K090378). The "Performance Comparison Summary" explicitly states that the device conforms to IEC 60601-2-41:2001 and "achieved specified desired values per the product design specifications." Clinical testing was explicitly not required or utilized for this submission.

Summary

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K120392 162

FEB 1 6 2012

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510 (k) Summary

Submitter:

BERCHTOLD Holding GmbH Ludwigstaler Straße 125 D- 78532 Tuttlingen Germany

Contact Person:

Volker Hornscheidt Regulatory Affairs 0049 7461 181-374 Phone: 0049 7461 181-8374 Fax: Volker.Hornscheidt@BERCHTOLD.biz

Preparation Date:

November 18, 2011

Trade Name:

November 18, 2011

CHROMOPHARE® F 628 CHROMOPHARE® F 528

Surgical lamp Common Name:

Light, Surgical, Ceiling mounted Classification Name:

Predicate Device:

Device Description:

BERCHTOLD CHROMOPHARE® E 668 (K090378)

Intended Use of the device:

Indications for Use:

The CHROMOPHARE® F 628 and F 528 are intended to be used to provide visible illumination to the surgical field of the patient.

The surgical lights BERCHTOLD CHROMOPHARE® F 628 and F 528 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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K120392 2 of 2

Technological Characteristics Comparison Summary:

The BERCHTOLD CHROMOPHARE® F 628 and F 528 have the same technological characteristics ﻣﻤﺴﺎ as the predicate BERCHTOLD CHROMOPHARE® E 668 (K090378). Following is a summary of the technological characteristics of the new device in comparison to those of the predicate device. The input power is the same; the protection against electrical shock is the same; the lamp technology is the same, the power consumption per sources is comparable; the color rendering index is slightly higher, the color temperature is the same, the focusing mechanism is the same; the use of sterilizable and disposable handles is the same; the control system via wall boxes is the same; and ombient illumination and in-light camera system capabilities are the same. The predicate device and the new F 628 and F 528 utilize differing materials in construction, such as a composite frame for the new device versus an all-aluminum housing for the predicate devices were subjected to testing in accordance with IEC 60601-1 and IEC 60601-1-2 for mechanical and electrical safety, just as the predicate device. Any technological differences between the F 628 and F 528, and the predicate device do not affect the safety and efficacy, or alter the intended use.

Performance Comparison Summary:

This device conforms to IEC 60601-2-41:2001 specifications for performance of surgical lamps. Testing was conducted in accordance with this standard to support substantial equivalence. The F rooting has conceed as did the predicate device, all requirements of the performance standard and achieved specified desired values per the product design specifications. Clinical testing was not required or utilized to support substantial equivalence.

Substantial Equivalence Conclusion and Determination:

Based on the summarized technological characteristic similarities and differences, in conjunction with the testing conducted to support conformity to IEC 60601-2-41:2001 and performance data tabulated in detail within this submission per FDA "Guidance Document for Surgical Lamp 510(k)s", the CHROMOPHARE F 628 and F 528 are found to be substantially equivalent to the identified predicate device.

Conformity 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 medical device and electrical safety.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

FEB 1 6 2012

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

Re: K120392

Trade/Device Name: Chromophare® F 628 Chromophare® F 628 Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSY Dated: February 06, 2012 Received: February 08, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Mr. Jeff D. Rongero

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eric L. Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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® F 628 CHROMOPHARE® F 528

Indications for Use:

The surgical lights BERCHTOLD CHROMOPHARE® F 628 and F 528 are

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

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

X Prescription Use (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 R.P. Ogden for MXA

(Division Sign-Off)

Division of Surgical. Orthopedic, and Restorative Devices

. 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.