MAQUET LUCEA LED® Surgical Light Systems are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.

Device Description

MAQUET LUCEA LED® Surgical Light Systems have been developed in order to provide MAQUET EUGEAEED Surgied Lightnology. An innovative design combined with a functional shape offers an efficient product to the surgical staff. functional shape oners an cindical provide hights provide high quality illumination Designed for minor ourgory, without any compromises on the major enhancements offered by MAQUET surgical lights. The LUCEA LED® Surgical Lights are well-suited for installation in surgical suites, examining rooms, doctor's surgeries and external consultations.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the LUCEA LED® Surgical Light System:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices for a surgical light system. As such, it does not present quantifiable acceptance criteria for specific performance metrics in the way a diagnostic AI device's summary might. Instead, the "acceptance criteria" are implied by conformance to various medical device standards, and the "reported device performance" is the claim of meeting these standards.

Acceptance Criteria (Implied)	Reported Device Performance
Conformance to electrical safety standards (UL 60601-1)	Test data supports conformance to UL 60601-1, 1st Edition, 2006-04-26
Conformance to particular safety standards for luminaires (IEC 60601-2-41)	Test data supports conformance to IEC 60601-2-41:2000
Conformance to general requirements for basic safety and essential performance (IEC 60601-1)	Test data supports conformance to IEC 60601-1:1988 + A1:1991 + A2:1995
Conformance to electromagnetic compatibility standards (IEC 60601-1-2)	Test data supports conformance to IEC 60601-1-2:2007
Conformance to FCC regulations for radio frequency emissions (FCC Part 15)	Test data supports conformance to FCC Part 15
Equivalence in intended use and features to predicate devices	The device is "similar to the predicate devices" with described modifications, and considered "safe and effective when used as intended."

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

This document does not describe a "test set" in the context of an AI device's performance evaluation (e.g., a set of images or cases). The testing described is engineering and regulatory compliance testing for a physical medical device (a surgical light). Therefore, concepts like sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in the way they would be for an AI algorithm.

The testing involved evaluating the physical device against the listed standards. The "data provenance" for this type of testing is typically the testing laboratory or manufacturer's internal quality assurance processes.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For a surgical light system, "ground truth" as it relates to expert consensus on medical findings is not relevant. The device's performance is objectively measured against engineering and electrical safety standards.

4. Adjudication Method

Not applicable. This is not a study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, this document does not mention or describe an MRMC comparative effectiveness study. This type of study is typically conducted for diagnostic or AI-powered devices to assess the impact of AI on human reader performance.

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

Not applicable. The LUCEA LED® Surgical Light System is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is defined by established engineering standards, product specifications, and regulatory requirements. The device's performance is measured against these objective, quantifiable benchmarks. For example, light intensity is measured in lumens, color temperature in Kelvin, and electrical safety against specific resistance and leakage current limits.

8. The Sample Size for the Training Set

Not applicable. The LUCEA LED® Surgical Light System is a physical medical device, not an AI model that requires training data.

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

Not applicable. As described above, there is no AI training set for this device.

Summary

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K 11 3679

JAN 1 2 2012

510(k) Summary As required by section 807.92

LUCEA LED® Surgical Light System

Submitter's Name & Address	MAQUET S.A.S.Parc de LimèreAvenue de la Pomme de PinCS 10008 Ardon45074 Orléans - Cedex 2France
Submitter of this submission	Ms. Marie-Françoise CabelDirector, Quality and Regulatory AffairsMaquet S.A.SPhone: +33 238 25 88 72Email: marie-francoise.cabel@maquet-sa.fr
Applicant Correspondent	Ms. Whitney TörningDirector, Regulatory AffairsMaquet Inc.45 Barbour Pond DriveWayne, NJ 07470Phone: 973-709-7994Fax: 973-973-807-9210Email: whitney.torning@maquet.com
Date prepared	December, 9th 2011
Proprietary Name	LUCEA LED® Surgical Light System
Common Name	Surgical Light
Device product codes	FTD (light, surgical) for ceiling and wall-mounted modelsFSS (light, surgical, floor standing) for floor standing models
Device classification	Class II, acording to regulation number 21 CFR 878.4580
Predicate Device identification

· MAQUET POWERLED™ Surgical Light System – 510(k) No. K070442

· MAQUET BLUE 30 & 80 Surgical Light System (ceiling mounted) 510(k) No. K954169
· MAQUET BLUE 80 Hospital Light System (floor standing) 510(k) No. K970886

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MAQUET S.A.S. FDA 510(K) Summary
Device: LUCEA LED® Surgical Light System

113679

Device description:

functional shape oners an cindical provide hights provide high quality illumination Designed for minor ourgory, without any compromises on the major enhancements offered by MAQUET surgical lights.

The LUCEA LED® Surgical Lights are well-suited for installation in surgical suites, examining rooms, doctor's surgeries and external consultations.

The LUCEA LED® product family is available in the following versions:

Device name	Device Description
WALL MOUNTED VERSIONS
LCA 50 WALL	LUCEA LED 50 SURGICAL LIGHT, WALL MOUNTED VERSION WHICH INCLUDES A LUCEA 50LIGHTHEAD, A WALL ERGODISC SUSPENSION AND A POWER SUPPLY KIT
LCA 100 WALL	LUCEA LED 100 SURGICAL LIGHT, WALL MOUNTED VERSION WHICH INCLUDES A LUCEA 100LIGHTHEAD, A WALL ERGODISC SUSPENSION AND A POWER SUPPLY KIT
CEILING MOUNTED VERSIONS
LCA DUO 50	LUCEA LED DUO 50 SURGICAL LIGHT, CEILING MOUNTED, WHICH INCLUDES TWO LUCEA 50LIGHTHEADS - UNLIMITED ROTATION ON CENTRAL AXIS, ERGODISC SUSPENSION
LCA 50	LUCEA LED 50 SURGICAL LIGHT, CEILING MOUNTED, WHICH INCLUDES A LUCEA 50 LIGHTHEAD -UNLIMITED ROTATION ON CENTRAL AXIS, ERGODISC SUSPENSION
LCA 100 V	LUCEA LED 100 SURGICAL LIGHT, CEILING MOUNTED, WHICH INCLUDES A LUCEA 100LIGHTHEAD - UNLIMITED ROTATION ON CENTRAL AXIS, ERGODISC SUSPENSION, VIDEOPREWIRING
LCA DUO 100 V	LUCEA LED DUO 100 SURGICAL LIGHT, CEILING MOUNTED, WHICH INCLUDES TWO LUCEA 100LIGHTHEADS - UNLIMITED ROTATION ON CENTRAL AXIS, ERGODISC SUSPENSION, VIDEOPREWIRING
LCA DUO 100+50 V	LUCEA LED 100+50 V SURGICAL LIGHT, CEILING MOUNTED, WHICH INCLUDES A LUCEA 100LIGHTHEAD WITH VIDEO PREWIRING AND A SATELLITE LUCEA 50 - UNLIMITED ROTATION ONCENTRAL AXIS, ERGODISC SUSPENSION
MOBILE VERSIONS
LCA 50 MOBILE	LUCEA LED 50 SURGICAL LIGHT, MOBILE VERSION WHICH INCLUDES A LUCEA 50 LIGHTHEAD, AMOBILE STAND INCLUDING THE POWER SUPPLY
LCA 50 MOBILE B	LUCEA LED 50 SURGICAL LIGHT, MOBILE VERSION WHICH INCLUDES A LUCEA 50 LIGHTHEAD, AMOBILE STAND INCLUDING THE POWER SUPPLY AND A BATTERY PACK
LCA 100 MOBILE	LUCEA LED 100 SURGICAL LIGHT, MOBILE VERSION WHICH INCLUDES A LUCEA 100 LIGHTHEAD,A MOBILE STAND INCLUDING THE POWER SUPPLY
LCA 100 MOBILE B	LUCEA LED 100 SURGICAL LIGHT, MOBILE VERSION WHICH INCLUDES A LUCEA 100 LIGHTHEAD,A MOBILE STAND INCLUDING THE POWER SUPPLY AND A BATTERY PACK

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MAQUET S.A.S. FDA 510(k) Summary FDA 510(K) Surfimaly
Device: LUCEA LED® Surgical Light System

K 113679

Intended Use:

MAQUET LUCEA LED® Surgical Light Systems are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.

Nonclinical Comparisons to Predicate Device

The LUCEA LED® Surgical Light (subject device) is similar to the predicate devices with the following modifications:

Modified light head design, updating its appearance: One primary lighthead (type . LUCEA 100) and one secondary lighthead (type LUCEA 50).
Added a mechanical focusing function in LUCEA 100 lightheads: Rotating the . central handle makes it possible to focus the light depending on the distance from the operating field
Added an optional zoom camera accessory integrated in LUCEA 100 lightheads to . / Rodod an optional be images, which may then be shared, saved or broadcast.
Added an optional infrared remote control accessory to control intensity of LUCEA . 50 and LUCEA 100 lightheads, as well as an optional zoom camera.
Added an optional triple-axis ceiling down tube which enable combinations of . LUCEA 50-100 surgical light systems with 2 other medical devices.

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MAQUET S.A.S. FDA 510(k) Summary Device: LUCEA LED® Surgical Light System

K113679

Test Data:

Test data support conformance to:

· UL 60601-1, 1st Edition, 2006-04-26 (Medical Electrical Equipment, Part 1: General Requirements for Safety, includes National Differences for USA)
· IEC 60601-2-41:2000, Medical electrical equipment Part 2-41: Particular IEC 00001-2-41:2000, Modioa. Shownaires and luminaires for diagnostics
IEC 60601-1:1988 + A1:1991 + A2:1995, Medical electrical equipment Part 1: General requirements for basic safety and essential performance
· IEC 60601-1-2:2007: General requirements for basic safety and essential ILC - 00001 - 2.2001. Standard: Electromagnetic compatibility - Requirements and tests
· FCC Part 15 (10) Code of Federal Regulations, Title 47 Telecommunication, 1 - Federal Communications Commission, Part 15 - Radio frequency Ghapter T = T ederar Oommanisations, limits and methods of measurement of radio disturbance characteristics of information technology equipment

Clinical Data:

No clinical data is required for this device classification submission.

Conclusion:

The modifications incorporated into the MAQUET LUCEA LED® Surgical Light System The mountcations incorporated into the the new MAQUET POWERLED™, BLUE 30 & 80, designs use those desired doolgh toatures . Based upon the information provided herein
and BLUE 80 Hospital Surgical Light Systems. Based upon the information in this bestems and BLOE ou Hospital Surgical Eight Oystems: Babea aportal Light Systems
this 510(k) Premarket Notification, we conclude that LUCEA LED® Surgical Light Systems this 310(K) Fremanel Notification, wo conside that as a is safe and effective when used as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is oriented towards the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

MAQUET S.A.S. % Ms. Whitney Torning Director, Regulatory Affairs 45 Barbour Pond Drive Wayne. New Jersey 07470

JAN 1 2 2012

Re: K113679

Trade/Device Name: MAQUET LUCEA LED® Surgical Light System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: NTN, FTD, FSS Dated: January 6, 2012 Received: January 9, 2012

Dear Ms. Torning:

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.

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

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Page 2 - Ms. Whitney Torning

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 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,

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):_K // 36 79

Device Name: MAQUET LUCEA LED® Surgical Light System

Indications for Use:

MAQUET LUCEA LED® Surgical Light Systems are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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)

Neil R. Oyler Sor nxm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113679

Page 1 of 1

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.