M3

K063333 · Mavig GmbH · FSY · Nov 21, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K063333
• Device Name: M3
• Applicant: Mavig GmbH
• Product Code: FSY · General, Plastic Surgery
• Decision Date: Nov 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The M3 lighting system is for illuminating an examination and surgical site on the patient in the clinic and doctor's office.

Device Story

M3 surgical light provides high-intensity, shadow-free, cold illumination for surgical and examination sites in clinics and doctor's offices. Device utilizes R96 light technology with three halogen bulbs (24V/50W) and a multi-reflector system featuring specially coated heat-protection filters. System includes easy-to-move swivel arms and an exchangeable lamp cartridge; optional video camera or video preparation available. Duo-Focus technology allows adjustment of light field size for deep or small wound areas. Operated by clinical staff to improve visibility during procedures; output is directed light. Device can be combined with other MAVIG lights.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Surgical lamp with multi-reflector system (3 glass reflectors) and heat protection filters. Light source: 3 halogen bulbs (24V/50W). Features Duo-Focus technology for light field adjustment. Ceiling-mounted with swivel arms. No software or electronic processing described.

Indications for Use

Indicated for local illumination of the operating site on the patient's body with high intensity, shadow-free, cold light 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

• Chromophare X65 (K024132)

Submission Summary (Full Text)

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KO63333

Image /page/0/Picture/1 description: The image shows the word "MAVIC" in a stylized, sans-serif font. The letters are bold and black, with a slightly rough or textured appearance. The "A" is represented by a triangle, and the "V" is formed by two diagonal lines meeting at a point. The "I" is a simple vertical line, and the "C" is a curved shape that is open on the left side.

FDA/CDRH/GDE/PH0

NOV 2 1 2006

2005 NOV -6 A 11:12

MAVIG GmbH · Postfach 820362 · 80803 München · Germany

## Section 5

R. R.

K-4U

## 510(k) SUMMARY

Type:

510k Submitter:

Contact Person:

Traditional

2

MAVIG GmbH Stahlgruberring 5 81829 Munich Bavaria Germany

phone [phone] ([phone] fax e-mail [e-mail]

Christian Stoian CEO [e-mail] phone [phone]

Preparation Date:

4th August 2006

Trade Name: мз Common Name: Classification Name: Class: Recommended Classification Regulation: Product Code: Panel:

Surgical Lamp Light, Surgical, Ceiling Mounted Class II 878.4580 FSY General & Plastic Surgery

Mavig GmbH Tel. [phone] Fax [phone] EMail: [e-mail]

P.O. Box 820362 81803 Munich

..

Stahloruberring 5 81829 Müncher

HypoVereinsban BLZ 70020270 1620225300 HYVEDEMI

Postbank München (BLZ 70010080) 71374-807 SWIFT-Code: PBNKDEFF700

1. .

:

Handelsregister München HFB-Nr. 76 403 Geschäftsführer Manfred Stoian Christian Stoian VAT-ID No . DE 811268845

SECTION 5: page 1 of 2

.. . . . . . . . . . .

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K063333

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Device Description: The M3 Surgical Light is suitable for all types of of surgical procedures. With its advanced technology of R96 light technology, the M3 realizes a high illumination intensity with a lower heat radiation. The light incorporates easy-to-move swivel arms, three halogen bulbs, and an easy-to-exchange lamp cartridge. Also an optional Video camera or video preparation is available. The lamp can be combined with other lights provided by MAVIG. Indications for Use of the Device: The surgical light M3 is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow-free, "cold" light. Intended Use of the Device: The M3 lighting system is for illuminating an examination and surgical site on the patient in the clinic and doctor's office. Predicate Device Chromophare X65, K024132. Substantial Equivalence: The M3 is substantially equivalent to the surgical light CHROMOPHARE X 65. Any difference that exists between the CHROMOPHARE X 65 and the M3 has no negative effect on safety or effectiveness and actually enhances the usefulness in the choosen application.

Main Difference to Predicate:

| | M3 | Chromophare X65 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Reflector System | Multi-reflector<br>system with 3<br>glass reflectors,<br>specially coated<br>heat protection<br>filter | One-reflector system<br>with polygon reflector |
| Light Source | 3 halogen bulbs<br>24V/50W | 2 discharge lamps<br>with automatic switch-<br>over function |
| Duo-Focus<br>Technology | Allows a bigger<br>setting range of<br>the light field size<br>(suitable for very<br>small and deep<br>wound areas) | Not available |

Mavio GmbH

landelsregister HEB-Nr 76 ANS Geschäftsführer Mantred Stoian Christian Stoiar

SECTION 5: page 2 of 2

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and human well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAVIG GmbH % Underwriters Laboratories, Inc. Mr. Jeffrey D. Rongero Senior Project Engincer 12 Laboratory Drive Research Triangle Park, North Carolina 27709

Rc: K063333

Trade/Device Name: M3 Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSY Dated: October 20, 2006 Received: November 6, 2006

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.

NOV 2 1 2006

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Page 2 - Mr. Jeffrey 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 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,

Mark A. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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MAVIC

MAVIG GmbH · Postfach 820362 · 80803 Munchen · Germany

Section 4

Indications for Use

510(k) Number (if known):

K063333

Device Name:

M3

Indications for Use:

The surgical light M3 is 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Device Evaluation (ODE)
Mark A. Millhessen

Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K063333

Mavig GmbH
Tel. [phone] Fax.[phone] EMail: [e-mail] P.O. Box 820362 81803 Munich Germany

Stahlgruberring 5 81829 München Germany

HypoVereinsbank (BLZ 70020270) 1820225300 SWIFT-Code: HYVEDEMM

Postbank München (BLZ 70010080) 71374-807 SWIFT-Code: PBNKDEFF700

Handelsregister München HFB-Nr. 76 403

Geschäftsführer Manfred Stoian Christian Stoian VAT-ID No..
DE 811268845

SECTION 4: page 1 of 1