POWERLED SURGICAL LIGHT SYSTEM

K070442 · Maquet S.A. · FSY · Mar 16, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070442
• Device Name: POWERLED SURGICAL LIGHT SYSTEM
• Applicant: Maquet S.A.
• Product Code: FSY · General, Plastic Surgery
• Decision Date: Mar 16, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Indications for Use

The POWERLED™ Surgical Lights are intended to be used to provide visible illumination of the surgical area or the patient. An "LED inside" feature is available which produces lower intensity levels of ambient light, intended for minimally invasive surgery, procedures and examination. An added optional patented automatic head recognition system feature is available to reduce the heat projected on to the surgeon's head, and to compensate for loss of illumination due to an obstacle in front of the cupola.

Device Story

POWERLED™ Surgical Light System provides visible illumination for surgical areas/patients; utilizes LED light source. Features include "LED inside" ambient light mode for minimally invasive procedures and optional automatic head recognition system. Head recognition system detects obstacles in front of light cupola to compensate for illumination loss and reduce heat projection onto surgeon's head. Device configurations include ceiling-mounted units with single/double forks, optional flat screen mounts, and video pre-wiring. Operated by surgical staff in clinical/OR settings. Benefits include improved visualization, reduced heat exposure for surgeons, and maintained illumination during obstructions.

Clinical Evidence

No clinical data required for this device classification; bench testing only.

Technological Characteristics

LED-based surgical luminaire; ceiling-mounted configurations. Features ambient light mode (5 levels) and optional automatic head recognition. Complies with UL 60601-1, CSA C22.2 No. 60601.1, IEC 60601-2-41, and EN 60601-1-2. Electromagnetic compatibility per FCC Part 15. Software classified as Minor Level of Concern.

Indications for Use

Indicated for providing visible illumination of the surgical area or patient during surgery, procedures, and examinations. Includes ambient light mode for minimally invasive applications. No specific patient population restrictions stated.

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

• ALM X'TEN® (X10) Surgical Light System (K040735)

Submission Summary (Full Text)

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KO70442

# 510(k) SUMMARY

# POWERLED™ Surgical Light System

MAR 1 6 2007

| Submitted by: | Getinge USA, Inc. (as MAQUET S.A.'s US Agent)<br>1777 E Henrietta Road<br>Rochester, NY 14623-3133 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kevin M. Tompkins<br>Quality Analyst<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date prepared: | February 13, 2007 |
| Proprietary Name: | POWERLED™ Surgical Light System |
| Common Name: | Surgical Light |
| Device Classification: | Surgical Lamp (78 FSY) |
| | Class II, as listed per 21 CFR 878.4580 |
| Predicate Device: | ALM X'TEN® (X10) Surgical Light System (K040735) |

### Description of Device:

The POWERLED™ Surgical Light System is a new product designation intended to identify a family of surgical lights that will use a similar set of design principles as the ALM X'TEN® (X10) Surgical Light Systems.

The POWERLED™ Surgical Light provides a broadened set of features and options that include LEDs as the main light source as well as an added optional automatic head recognition system feature as a result of this redesign effort.

The POWERLED™ Product Family currently has multiple configurations available, as shown within Table 1.

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# MAQUET S.A. FDA 510(k) Summary
Device: POWERLED™ Surgical Light System

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### Table 1:

| Article code | Alias Code | Description |
|---------------|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| ARD568411110C | PWD70SF | POWERLED SURGICAL LIGHT, PWD70SF, CEILING MOUNTED, ONE POWERLED CUPOLA INCLUDING AMBIENT LIGHT (LEDINSIDE FUNCTION), SINGLE FORK, 1150MM SA SUSPENSION |
| ARD568411210C | PWD77SF | SAME AS PWD70SF, TWO POWERLED CUPOLAS |
| ARD568411511C | PWD70SFXS09 | SAME AS PWD70SF, AND ONE FLAT SCREEN (<9KG) |
| ARD568411512C | PWD70SFXS21 | SAME AS PWD70SF, AND ONE FLAT SCREEN (<21KG) |
| ARD568411513C | PWD70SFXD24 | SAME AS PWD70SF, AND TWO FLAT SCREENS |
| ARD568413110C | PWD70SFV | SAME AS PWD70SF AND VIDEO PREWIRING |
| ARD568413210C | PWD77SFV | SAME AS PWD77SF AND VIDEO PREWIRING |
| ARD568413251C | PWD77SFVXS09 | SAME AS PWD77SF, VIDEO PREWIRING AND ONE FLAT SCREEN (<9KG) |
| ARD568413252C | PWD77SFVXS21 | SAME AS PWD77SF, VIDEO PREWIRING AND ONE FLAT SCREEN (<21KG) |
| ARD568413253C | PWD77SFVXD24 | SAME AS PWD77SF, VIDEO PREWIRING AND TWO FLAT SCREENS |
| ARD568413258C | PWD77SFSC07 | SAME AS PWD77SF AND ONE CAMERA SUPPORT UNIT |
| ARD568413511C | PWD70SFVXS09 | SAME AS PWD70SF, VIDEO PREWIRING AND ONE FLAT SCREEN (<9KG) |
| ARD568413512C | PWD70SFVXS21 | SAME AS PWD70SF, VIDEO PREWIRING AND ONE FLAT SCREEN (<21KG) |
| ARD568413513C | PWD70SFVXD24 | SAME AS PWD70SF, VIDEO PREWIRING AND TWO FLAT SCREENS |
| ARD568411110C | PWD70SFR | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568411210C | PWD77SFR | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568411511C | PWD70SFR XS09 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568411512C | PWD70SFR XS21 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568411513C | PWD70SFR XD24 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568413110C | PWD70SFVR | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568413210C | PWD77SFVR | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568413251C | PWD77SFVR XS09 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568413252C | PWD77SFVR XS21 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568413253C | PWD77SFVR XD24 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568413258C | PWD77SFR SC07 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568413511C | PWD70SFVR XS09 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568413512C | PWD70SFVR XS21 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568413513C | PWD70SFVR XD24 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568421110C | PWD70DF | POWERLED SURGICAL LIGHT, PWD70DF, CEILING MOUNTED, ONE POWERLED CUPOLA INCLUDING AMBIENT LIGHT (LEDINSIDE FUNCTION), DOUBLE FORK, 850MM SA SUSPENSION |
| Article code | Alias Code | Description |
| ARD568421210C | PWD77DF | SAME AS PWD70DF, TWO POWERLED CUPOLAS |
| ARD568421511C | PWD70DFXS09 | SAME AS PWD70DF, AND ONE FLAT SCREEN (<9KG) |
| ARD568421512C | PWD70DFXS21 | SAME AS PWD70DF, AND ONE FLAT SCREEN (<21KG) |
| ARD568421513C | PWD70DFXD24 | SAME AS PWD70DF, AND TWO FLAT SCREENS |
| ARD568423110C | PWD70DFV | SAME AS PWD70DF AND VIDEO PREWIRING |
| Article code | Alias Code | Text EN |
| ARD568423210C | PWD77DFV | SAME AS PWD77DF AND VIDEO PREWIRING |
| ARD568423251C | PWD77DFVXS09 | SAME AS PWD77DF, VIDEO PREWIRING AND ONE FLAT<br>SCREEN (<9KG) |
| ARD568423252C | PWD77DFVXS21 | SAME AS PWD77DF, VIDEO PREWIRING AND ONE FLAT<br>SCREEN (<21KG) |
| ARD568423253C | PWD77DFVXD24 | SAME AS PWD77DF, VIDEO PREWIRING AND TWO FLAT<br>SCREENS |
| ARD568423258C | PWD77DFSC07 | SAME AS PWD77DF AND ONE CAMERA SUPPORT UNIT |
| ARD568423511C | PWD70DFVXS09 | SAME AS PWD70DF, VIDEO PREWIRING AND ONE FLAT<br>SCREEN (<9KG) |
| ARD568423512C | PWD70DFVXS21 | SAME AS PWD70DF, VIDEO PREWIRING AND ONE FLAT<br>SCREEN (<21KG) |
| ARD568423513C | PWD70DFVXD24 | SAME AS PWD70DF, VIDEO PREWIRING AND TWO FLAT<br>SCREENS |
| ARD568421110C | PWD70DFR | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568421210C | PWD77DFR | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568421511C | PWD70DFR XS09 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568421512C | PWD70DFR XS21 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568421513C | PWD70DFR XD24 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568423110C | PWD70DFVR | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568423210C | PWD77DFVR | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568423251C | PWD77DFVR<br>XS09 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568423252C | PWD77DFVR<br>XS21 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568423253C | PWD77DFVR<br>XD24 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568423258C | PWD77DFR SC07 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568423511C | PWD70DFVR<br>XS09 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568423512C | PWD70DFVR<br>XS21 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |
| ARD568423513C | PWD70DFVR<br>XD24 | SAME AS ABOVE WITH HEAD RECOGNITION SYSTEM |

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## MAQUET S.A. FDA 510(k) Summary
Device: POWERLED™ Surgica! Light System

.. . .

Note: additional model configurations are planned for development. These will incorporate MAQUET POWERLED™ lighthead subassemblies.

#### Intended Use:

The POWERLED™ Surgical Lights are intended to be used to provide visible illumination of the surgical area or the patient.

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MAQUET S.A. FDA 510(k) Summary Device: POWERLED™ Surgical Light System

An "LED inside" feature is available which produces lower intensity levels of ambient light, intended for minimally invasive surgery, procedures and examination.

An added optional patented automatic head recognition system feature is available to reduce the heat projected on to the surgeon's head, and to compensate for loss of illumination due to an obstacle in front of the cupola.

#### Non-clinical Comparisons to Predicate Device

The POWERLED™ Surgical Light (subject device) is similar to the predicate device with the following modifications:

- Modified light head design, updating its appearance and light source. .
- Change of power supply. .
- Modified LEDinside feature, updating its appearance using three LEDs. This . ambient light, used for minimally invasive surgery applications, has five light level adjustments.
- Added optional patented automatic head recognition system feature to reduce the . heat projected on to the surgeon's head, and to compensate for loss of illumination due to an obstacle in front of the cupola

#### Test Data:

The test data supports conformance to:

- UL 60601-1 Standard for Medical Electrical Equipment, Part 1: General Requirements . for Safety
- CSA C22.2 No. 60601.1 Medical Electrical Equipment, Part 1: General Requirements . for Safetv
- CSA C.22.2 No. 60601-2-41 Medical electrical equipment Part 2-41: Particular . requirements for the safety of surgical luminaires for diagnostics
- IEC 60601-2-41 Medical electrical equipment Part 2-41: Particular requirements for . the safety of surgical luminaires and luminaires for diagnostics
- EN 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety . - Collateral standard: Electromagnetic compatibility - Requirements and tests
- FCC Part 15 .
- Software used in the POWERLED™ Surgical Light was tested according to the . appropriate FDA Software Guidance Documents, per its determination as a Minor Level of Concern.

#### Clinical Data:

No clinical data is required for this device classification submission.

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MAQUET S.A. FDA 510(k) Summary
Device: POWERLED™ Surgical Light System

#### Conclusion:

The modifications incorporated into the POWERLED™ Surgical Light System design use those desired design features from ALM X'TEN® (X10) Surgical Light Systems. Based upon the information provided herein this 510(k) Premarket Notification, we conclude that POWERLED™ Surgical Light Systems are substantially equivalent to the predicate device(s) and are safe and effective when used as intended.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird-like figure, composed of multiple curved lines.

Public Health Service

MAR 1 6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Maquet S.A. % Getinge USA, Inc. Mr. Kevin M. Tompkins Quality Analyst 1777 East Henrietta Road Rochester, New York 14623

Re: K070442

Trade/Device Name: MAQUET POWERLED™ Surgical Light System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSY Dated: February 13, 2007 Received: February 15, 2007

Dear Mr. Tompkins:

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

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Page 2 - Mr. Kevin M. Tompkins

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.

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/industry/support/index.html.

Sincerely yours,

for
Mark N. Mellerson

ark N. erson 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): K

### Device Name: MAQUET POWERLED™ Surgical Light System

Indications for Use:

MAQUET POWERLED™ Surgical Light Systems are intended to be used to provide visible illumination of the surgical area or the נatient.

An "LED inside" feature is available which produces lower intensity levels of ambient light, intended for minimally invasive surgery, procedures and examination.

An added optional patented automatic head recognition system feature is available to reduce the heat projected on to the surgeon's: head, and to compensate for loss of illumination due to an obstacle in front of the supola.

Mark N. Mullerson

Division of General, Restorative, and Neurological Devices

510(k) Number K070442

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OFI

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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