K Number

Device Name

LUCEA LED SURGICAL LIGHT SYSTEM

Manufacturer

MAQUET SAS

Date Cleared

2012-01-12

(29 days)

Product Code

NTN FSS FTD

Regulation Number

876.1500

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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K070442, K954169, K970886

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard surgical light system and does not mention any AI or ML capabilities. The performance studies focus on electrical and safety standards, not algorithmic performance.

Therapeutic

No
The device is a surgical light system intended for illumination, not direct treatment or diagnosis.

Diagnostic

Yes

The 'Intended Use / Indications for Use' section explicitly states that the device is "intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment." This indicates its use in diagnostic procedures.

SaMD (Software as a Medical Device)

The device description clearly states it is a "Surgical Light System" and describes physical components and installation locations, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to provide visible illumination during surgical operations, diagnostics, and treatment. This is a physical function, not a diagnostic test performed on biological samples outside the body.
Device Description: The description focuses on providing illumination and being suitable for surgical and examination settings. It doesn't mention any analysis of biological samples.
Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is purely related to providing light for visualization.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

FTD, FSS, NTN

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

surgical area

Indicated Patient Age Range

Not Found

Intended User / Care Setting

surgical staff / surgical suites, examining rooms, doctor's surgeries and external consultations

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 capture 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.

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

No clinical data is required for this device classification submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K070442, K954169, K970886

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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 Limère
Avenue de la Pomme de Pin
CS 10008 Ardon
45074 Orléans - Cedex 2
France |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of this submission | Ms. Marie-Françoise Cabel
Director, Quality and Regulatory Affairs
Maquet S.A.S
Phone: +33 238 25 88 72
Email: marie-francoise.cabel@maquet-sa.fr |
| Applicant Correspondent | Ms. Whitney Törning
Director, Regulatory Affairs
Maquet Inc.
45 Barbour Pond Drive
Wayne, NJ 07470
Phone: 973-709-7994
Fax: 973-973-807-9210
Email: 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 models
FSS (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

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

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.

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.

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

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

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

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