(15 days)
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.
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.
This section will describe the acceptance criteria and the study that proves the M3 Surgical Light meets the acceptance criteria.
The provided 510(k) summary for the MAVIG M3 Surgical Light does not contain a study explicitly designed to "prove" the device meets specific acceptance criteria in the way a clinical or performance study for a diagnostic AI device would. Instead, this 510(k) submission establishes substantial equivalence to a predicate device (CHROMOPHARE X 65, K024132).
For a surgical lamp, acceptance criteria typically fall under performance standards outlined in recognized standards (e.g., IEC standards for medical electrical equipment) or internal company specifications related to illumination intensity, shadow reduction, heat radiation, color temperature, mechanical stability, and safety. The 510(k) process focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Given the nature of the provided document, the "acceptance criteria" can be inferred from the comparison made to the predicate device and the general performance characteristics expected of a surgical light. "Reported device performance" would be derived from the description of the M3 and its comparison to the predicate.
Here's an attempt to structure the information based on the provided document, acknowledging the limitations for a device of this type in a 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a surgical lamp, the "acceptance criteria" are implicitly tied to the performance of the predicate device and general safety/effectiveness requirements for surgical lights. The "reported device performance" is descriptive rather than quantitative, focusing on features and comparative benefits.
| Acceptance Criteria (Inferred from Predicate Equivalence & Device Type) | Reported M3 Device Performance |
|---|---|
| Illumination Intensity (High) | Realizes a high illumination intensity (with its advanced technology of R96 light technology). |
| Shadow-free Illumination | Intended to illuminate locally the operating site... with a high intensity, shadow-free, "cold" light. |
| Reduced Heat Radiation | Realizes a high illumination intensity with a lower heat radiation. |
| Operability / Maneuverability | Incorporates easy-to-move swivel arms. |
| Light Source Type & Redundancy | 3 halogen bulbs 24V/50W (Predicate: 2 discharge lamps with automatic switch-over function). This difference is presented as not negatively affecting safety/effectiveness. |
| Reflector System | Multi-reflector system with 3 glass reflectors, specially coated heat protection filter (Predicate: One-reflector system with polygon reflector). |
| Lighting Field Size Adjustment | Duo-Focus Technology: Allows a bigger setting range of the light field size (suitable for very small and deep wound areas). (Predicate: Not available). This is highlighted as an enhancement to usefulness. |
| Modularity / Expandability | Optional video camera or video preparation is available. Can be combined with other lights provided by MAVIG. |
| Safety and Effectiveness | Substantially equivalent to the surgical light CHROMOPHARE X 65. Any difference has no negative effect on safety or effectiveness and actually enhances the usefulness. |
Since this is a 510(k) for a medical device (surgical lamp) and not an AI or diagnostic device, the subsequent requested points regarding study details are largely
not applicable or cannot be determined from the provided 510(k) summary document directly because it focuses on substantial equivalence rather than a detailed performance study with human readers or AI algorithms.
Here's an analysis for each point:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: For a surgical light, there isn't a "test set" in the context of diagnostic data or images. Performance is typically assessed through engineering tests, adherence to standards, and user feedback, not data analysis with a test set. The 510(k) does not mention any specific test set data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: As there is no "test set" in the diagnostic sense, there were no experts establishing ground truth for data for this device type within the scope of a 510(k) summary of this nature. Performance validation for medical devices like surgical lamps involves technical specifications and compliance with recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: There is no diagnostic "test set" or adjudication method described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable / Not Provided: This device is a surgical lamp, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers or AI assistance would not be relevant or performed for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: This device is a surgical lamp, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: For a surgical light, "ground truth" isn't established in the same way as for diagnostic devices. Performance is typically validated against technical specifications, optical measurements (e.g., illuminance, color rendering, depth of field), and safety standards. The document doesn't detail these validation methods but implies they were performed to support substantial equivalence.
8. The sample size for the training set
- Not Applicable / Not Provided: This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: This device is not an AI/ML algorithm, so there is no training set or associated ground truth.
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KO63333
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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 (+49 89) 420 96 -0 (+49 89) 420 96 -200 fax e-mail info@mavig.com
Christian Stoian CEO Christian.stoian@mavig.com phone (+49 89) 420 96 -233
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. +49/89/42096-0 Fax +49/89/42096-200 EMail: info@mavig.com
P.O. Box 820362 81803 Munich
..
Stahloruberring 5 81829 Müncher
HypoVereinsban BLZ 70020270 1620225300 HYVEDEMI
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 5: page 1 of 2
.. . . . . . . . . . .
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$\not=$
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-reflectorsystem with 3glass reflectors,specially coatedheat protectionfilter | One-reflector systemwith polygon reflector |
| Light Source | 3 halogen bulbs24V/50W | 2 discharge lampswith automatic switch-over function |
| Duo-FocusTechnology | Allows a biggersetting range ofthe light field size(suitable for verysmall and deepwound 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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):
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. +49/89/42096-0 Fax.+49/89/42096-200 EMail: info@mavig.com 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
§ 878.4580 Surgical lamp.
(a)
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.(b)
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.