CHROMOPHARE E 778 AND E 558

K083066 · Berchtold Holding GmbH · FSY · Oct 30, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K083066
• Device Name: CHROMOPHARE E 778 AND E 558
• Applicant: Berchtold Holding GmbH
• Product Code: FSY · General, Plastic Surgery
• Decision Date: Oct 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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 Story

Surgical lights providing high-intensity, shadow-free, "cold" illumination to operating sites. Input: electrical power (120V, 60Hz). Transformation: LED-based light generation via multiple individual reflectors (168 for E 778; 72 for E 558) to produce adjustable color temperatures (3600K-5000K). Output: visible light directed at the surgical field. Used in clinical/surgical settings; operated by surgical staff via pressure-sensitive handgrips for focusing. Optional features include integrated CCD video cameras and "EndoLite"/"GuideLite" ambient lighting for endoscopic procedures. Benefits include reduced heat radiation and lower pattern variation compared to previous metal halide technology. Healthcare providers use the light to visualize the surgical site; output directly facilitates surgical performance by ensuring clear, shadow-free visibility.

Clinical Evidence

Bench testing only. Device conforms to IEC 60601-2-41:2001 (surgical lamp performance) and IEC 60601-1/IEC 60601-1-2 (electrical safety). No clinical data provided.

Technological Characteristics

LED-based surgical lighting. E 778: 168 reflectors; E 558: 72 reflectors. Color temperature: 3600K, 4000K, 4500K, 5000K. Power: <2W per LED. Pressure-sensitive handgrip focusing. Class I electrical safety. Reusable steam-sterilizable handles. Optional integrated CCD camera and ambient lighting modules. No UV irradiance.

Indications for Use

Indicated for local illumination of 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® E 655 (K080857)

Submission Summary (Full Text)

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

# 510 (k) Summary

Image /page/0/Picture/1 description: The image contains a sequence of handwritten digits. The digits appear to be '1083066'. The numbers are written in a cursive style, with some connections between the digits. The image has a white background, and the digits are written in black ink.

OCT 3 0 2008

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

- Contact Person: Silke Goral Regulatory Affairs Phone: [phone] Fax: [phone] [e-mail]
- 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.

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

### 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 device<br>CHROMOPHARE® E 655 | New devices | |
|----------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| | | CHROMOPHARE® E 778 | CHROMOPHARE® E 558 |
| Intended use | Illumination of the operating<br>site on a patient's body | Same | Same |
| Input power | 120V, 1- phase lines, 60Hz | Same | Same |
| Protection against<br>electrical shock | Class I | Same | Same |
| Diameter of light body | 649mm | 763mm | 568mm |
| Diameter of reflectors | Polygon reflector: 520mm | 84 reflectors: 35mm<br>84 reflectors: 40mm | 36 reflectors: 35mm<br>36 reflectors: 40mm |
| Number of mirrored<br>reflector 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 of<br>bulb | 72W | <2W each | <2W each |
| Light / heat filter<br>technology incl. UV light<br>filter mechanism | ThermoSorb® | None | None |
| Color rendering Index Ra | 94 | same | same |
| Color temperature | 4300°K | 3600K, 4000K, 4500K,<br>5000K | 3600K, 4000K, 4500K,<br>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 the<br>reserve bulb | Yes | No | No |
| Bulb replacement indicator | Yes | No | No |
| Reusable steam<br>sterilizable lamp handle | Yes | Same | Same |
| Additional light controls in<br>separate wall box | Standard | Same | Same |
| Ambient illumination for<br>minimally invasive<br>surgeries | Optional upward "EndoLite" | Optional upward "EndoLite"<br>and/or downward "GuideLite" | Optional upward "EndoLite"<br>and/or downward "GuideLite" |
| CCD video camera located<br>in 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.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle's head is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### 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.

{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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/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

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

# 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