VOLISTA 400; VOLISTA 600

K130513 · Maquet S.A.S. · FTD · May 8, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K130513
• Device Name: VOLISTA 400; VOLISTA 600
• Applicant: Maquet S.A.S.
• Product Code: FTD · General, Plastic Surgery
• Decision Date: May 8, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

MAQUET TRIOP VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.

Device Story

TRIOP VOLISTA Surgical Light System provides LED-based visible illumination for surgical areas, diagnostics, and treatment. System comprises Volista 400 and 600 lightheads, configurable in ceiling-mounted arrays of one to three units. Features include optional integrated cameras and screen supports. Operated by surgical staff via a touch-screen interface to control on/off status, optical parameters, and camera functions. New suspension arms and mechanical connections facilitate positioning of lightheads and accessories. Used in surgical suites, examining rooms, and doctor's surgeries. Enhances visualization for clinicians during procedures.

Clinical Evidence

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

Technological Characteristics

LED-based surgical luminaire. Components: Volista 400/600 lightheads, suspension arms, touch-screen interface. Connectivity: Integrated camera/screen support. Standards: UL 60601-1, IEC 60601-2-41, IEC 60601-1, IEC 60601-1-2, FCC Part 15. Power: Medical electrical equipment.

Indications for Use

Indicated for providing visible illumination of the surgical area or patient during surgical operations, diagnostics, and treatment in surgical suites, examining rooms, doctor's surgeries, and external consultations.

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

• MAQUET POWERLED™ Surgical Light System (K070442)
• MAQUET LUCEA LED® Surgical Light System (K113679)

Submission Summary (Full Text)

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#### K130513

## 510(k) Summary As required by section 807.92

## TRIOP VOLISTA® Surgical Light System

| Submitter's Name & Address | MAQUET S.A.S.<br>Parc de Limère<br>Avenue de la Pomme de Pin<br>CS 10008 Ardon<br>45074 Orléans - Cedex 2<br>France |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of this submission | Ms. Marie-Françoise Cabel<br>Director, Quality and Regulatory Affairs<br>Maquet S.A.S<br>Phone: [phone]<br>Email: [e-mail] |
| Applicant Correspondent | Ms. Tosin Yedess<br>Regulatory Affairs Specialist II<br>Maquet Inc.<br>45 Barbour Pond Drive<br>Wayne, NJ 07470<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date prepared | February 26, 2013 |
| Proprietary Name | TRIOP VOLISTA® Surgical Light System |
| Common Name | Surgical Light |
| Device product codes | FTD<br>FSY |

Class II, acording to regulation number 21 CFR 878.4580 Device classification

# Predicate Device identification

- · MAQUET POWERLED™ Surgical Light System 510(k) No. K070442
- · MAQUET LUCEA LED® Surgical Light System 510(k) No. K113679

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

#### Device description:

MAQUET TRIOP VOLISTA® Surgical Light Systems have been developed in order to provide any operating room with LED technology. An innovative design combined with a functional shape offers an efficient product to the surgical staff.

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

The TRIOP VOLISTA® product family is composed by two different lightheads, Volista 400 and Volista 600.

The System is available on ceiling versions and may be composed by one, two or three lightheads, which can be every possible combination of VOLISTA 400 and VOLISTA 600:

| | .<br>T WANNELERSHIPENERS<br>E RESEARRESE I BEARLERSERVE<br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>A - A - A - A - A - A - A - A | | | | | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br><br>. | | | | | | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |
| A-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br>.<br><br><br> | | | | | | | | | | |

Accessories such as integrated cameras and screen supports can be included to the TRIOP VOLISTA® Surgical Light System.

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

#### Intended Use:

MAQUET TRIOP VOLISTA Surgical lights are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnosis and treatment.

#### Nonclinical Comparisons to Predicate Device

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

1) a minor redesign of the lighthead,

2) change in the type of camera (optional) that can be integrated to the lighthead,

3) a new type of suspension arms and mechanical connections that allows the users to easily place either a cupola or an accessory to the arms,

4) A touch-screen interface that allows the user to switch the lights on/off, control the optical parameters of the devices and the optional cameras.

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

#### 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 requirements for the safety of surgical 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 performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- · FCC Part 15 (10) Code of Federal Regulations, Title 47 Telecommunication, Chapter 1 - Federal Communications Commission, Part 15 - Radio frequency devices, Subpart B - Unintentional Radiators, 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 TRIOP VOLISTA® Surgical Light System designs use those design features from MAQUET POWERLED™ and MAQUET LUCEA LED® Surgical Light Systems. Based upon the information provided herein this 510(k) Premarket Notification, we conclude that TRIOP VOLISTA® Surgical Light Systems are substantially equivalent to the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

May 8, 2013

Maquet SAS % Maquet Medical Systems USA Ms. Tosin Yedess Regulatory Affairs Specialist II 45 Barbour Pond Drive Wayne, New Jersey 07470

Re: K130513

Trade/Device Name: TRIOP VOLISTA® Surgical Light System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FTD, FSY Dated: April 10, 2013 Received: April 11, 2013

#### Dear Ms. Yedess:

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

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#### Page 2 - Ms. Tosin Yedess

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/CDRH0ffices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours, FOR

# Peter DRumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices ) Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K130513

### Device Name: TRIOP VOLISTA® Surgical Light System

#### Indications for Use:

MAQUET TRIOP VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.

Prescription Use × (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)

Joshua C. Nipper -S
For

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130513

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