(184 days)
The Mach LED MC lighting system is designed for illuminating an examination area and surgical field at the hospital and doctor's practice.
The surgical light Mach LED MC is intended to illuminate the operating site on the patient's body with a high intensity, shadow-free and "cold" light.
The surgical light Mach LED MC is intended to illuminate the operating site on the patient's body with a high intensity, shadow-free and "cold" light.
This light system can be added to the ceiling mounted suspension system supporting the horizontal arms and spring arms. The horizontal arms can be rotated horizontally with 360°, the spring arms can be rotated horizontally with 360° and moved vertically with 50° downwards and 45° upwards. The light system is operated by a keypad on the lamp head or, by special request of the customer, by a keypad on the wall.
The Mach LED MC consists of lamp housing, LED modules, optical -/electrical and mechanical components, one sterilizable handle sleeve as well as the cables.
One LED-module consists of 4 different-coloured LED's: warm white, cold white, green and red. The four different colours are merged inside the lamphead by a computer-calculated optical system with light quide and facetted lenses.
The surgical light Mach LED MC will be market with merging of light intensity control, colour temperature adjustment and integrated laser pointer.
Available accessories for the Mach LED MC lighting systems are as follows:
- Camera module
- Remote control for camera module
- Remote control with network interface for camera module
- Single monitor yoke for flat panel monitors
- Double monitor yoke for flat panel monitors
- Instrument trays
- Trays for CRT monitors
- 24V DC battery backup support
- Low profile wall control unit
- Sterilizable handle sleeves
The provided document pertains to a 510(k) summary for a surgical lamp, the Mach LED MC. This type of device does not involve AI or algorithms, and therefore, many of the requested details about acceptance criteria, study design for AI performance, ground truth, and training sets are not applicable.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative performance metrics in a defined table. Instead, the device's performance is demonstrated by meeting general regulatory standards for medical electrical equipment.
| Acceptance Criteria Category | Reported Device Performance (Compliance) |
|---|---|
| Electrical Safety | Complies with EN 60601-1 |
| Specific Requirements for Surgical Luminaires | Complies with EN 60601-2-42 |
| Electromagnetic Compatibility (EMC) Emissions | Complies with EN 55015 |
| Electromagnetic Compatibility (EMC) Immunity | Complies with EN 61000-4 |
| Illumination Quality | "high intensity, shadow-free and "cold" light" (Qualitative) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. Performance testing was likely conducted on a single or a limited number of device units. This is not a study involving patient data.
- Data Provenance: Not applicable, as this is hardware performance testing, not data-driven. The testing was conducted by third-party laboratories (TÜV SÜD Product Service and mikes-testingpartners GmbH).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for hardware performance is defined by the technical specifications and standards (e.g., specific lux levels, color temperature ranges, safety limits).
4. Adjudication method for the test set
Not applicable. Performance testing against established standards (EN 60601 series, EN 55015, EN 61000-4) typically involves direct measurement and comparison with predefined limits, not expert adjudication.
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. This is a surgical lamp, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not have an algorithm in the context of AI or data processing for diagnosis/decision-making.
7. The type of ground truth used
The ground truth used for this device is based on established international and European standards for medical electrical equipment (EN 60601-1, EN 60601-2-42, EN 55015, EN 61000-4). These standards define objective, measurable parameters for safety and performance.
8. The sample size for the training set
Not applicable. There is no AI model or algorithm being trained for this device.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or algorithm being trained for this device.
Summary of Study:
The study conducted for the Mach LED MC was a non-clinical performance data testing to verify that the device meets the requirements for Medical Electrical Equipment as defined in the following standards:
- EN 60601-1 (General requirements for basic safety and essential performance)
- EN 60601-2-42 (Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis)
- EN 55015 (Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment)
- EN 61000-4 (Electromagnetic compatibility (EMC) - Testing and measurement techniques)
The testing was performed according to external procedures at TÜV SÜD Product Service and mikes-testingpartners GmbH. No clinical data was required or submitted for this device classification. The conclusion was that the device met these requirements.
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Image /page/0/Picture/0 description: The image shows the title page of a document. The title page includes the text "5.0 Traditional 510(k) Summary" and the logo for "Dr. Mach Medizinische Leuchten + Technik". The document is marked as page 1 of 2 and has the number K093010 written on it.
| Submitter: | Dr. Mach GmbH & Co.KGFlossmanstraße 2885560 EbersbergGermany | APR - 1 2010 |
|---|---|---|
| Contact Person: | Rainer AdamsTechnical DirectorPhone: +49 (0)8092-209330Fax: +49 (0)8092-209330 | |
| Preparation Date: | July 13, 2009 | |
| Trade Name: | Mach LED MC | |
| Regulation Number: | 21 CFR 878.4580 | |
| Regulation Name: | Surgical Lamp | |
| Regulatory Class: | Class II | |
| Product Code: | FSY |
Device Description:
The surgical light Mach LED MC is intended to illuminate the operating site on the patient's body with a high intensity, shadow-free and "cold" light.
This light system can be added to the ceiling mounted suspension system supporting the horizontal arms and spring arms. The horizontal arms can be rotated horizontally with 360°, the spring arms can be rotated horizontally with 360° and moved vertically with 50° downwards and 45° upwards. The light system is operated by a keypad on the lamp head or, by special request of the customer, by a keypad on the wall.
The Mach LED MC consists of lamp housing, LED modules, optical -/electrical and mechanical components, one sterilizable handle sleeve as well as the cables.
One LED-module consists of 4 different-coloured LED's: warm white, cold white, green and red. The four different colours are merged inside the lamphead by a computer-calculated optical system with light quide and facetted lenses.
The surgical light Mach LED MC will be market with merging of light intensity control, colour temperature adjustment and integrated laser pointer.
Available accessories for the Mach LED MC lighting systems are as follows:
- Camera module
- Remote control for camera module
- Remote control with network interface for camera module
- Single monitor yoke for flat panel monitors
- Double monitor yoke for flat panel monitors
- Instrument trays
File: 05 510(k) Summary_MC_rev01
Page 1 of 2
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- Trays for CRT monitors
- 24V DC battery backup support
- Low profile wall control unit
- Sterilizable handle sleeves
Intended Use:
The Mach LED MC lighting system is designed for illuminating an examination area and surgical field at the hospital and doctor's practice.
Indications for Use:
The surgical light Mach LED MC is intended to illuminate the operating site on the patient's body with a high intensity, shadow-free and "cold" light.
Predicate Device:
iLED (K061317), Trumpf Kreuzer Medizin System GmbH
Substantial Equivalence:
The Mach LED MC is substantially equivalent to the surgical light iLED. Any difference that exists between the iLED and the Mach LED MC has no negative effect on safety or effectiveness and actually enhances the usefulness in the choosen application.
Technological Characteristics Comparison:
Technological Characteristics of Subject Device are based on the same LED (light-emitting diode) technology as the Predicate Device. For detailed comparison of all functionalities of the subject device and the predicate devices refer to Chapt.12: Substantial Equivalent discussion.
Discussion according non-clinical performance data testing:
Performance testing was conducted to verify that Mach LED MC meet the requirements for Medical Electrical Equipment as defined in EN 60601-1, EN 60601-2-42, EN 55015 and EN 61000-4.
Discussion according clinical performance data testing:
No clinical data is required for this device classification submission.
Test Conclusions of non-clinical data:
Testing was performed according to external procedures. Performance testing and validation were done at TÜV SÜD Product Service and mikes-testingpartners GmbH. Please refer to Chapter 18 and Appendic C.
Dr. Hans-Jorg Kemper
General Manager
File: 05_510(k)_Summary_MC_rev01
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure with outstretched arms, possibly representing care or protection.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Dr. Mach GmbH & Co. KG % Rainer Adams Technical Director Flossmannstrasse 28 85560 Ebersberg, Germany
APR - 1 2010
Re: K093010
Trade/Device Name: Mach LED MC Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSY Dated: March 10, 2010 Received: March 30, 2010
Dear Rainer Adams:
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 - Rainer Adams
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/CDRH/CDRHOffices/ucm115809.htm fart 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/ResourcesforYou/Industry/default.htm.
Sincere
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):
Device Name:
Mach LED MC
Indications for Use:
The surgical light Mach LED MC is intended to illuminate the operating site on the patient s body with a high intensity, shadow-free and "cold" light.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dilko Jul for mxm
Division Sign-on
sion Sien-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093010
04_Indications_for_Use_Statement_MC_rev02.doc
i
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.