(38 days)
Not Found
No
The description focuses on the physical and optical components of a surgical light, with no mention of AI or ML capabilities for image analysis, decision support, or automated control beyond basic light adjustments. The "computercalculated optical system" refers to the design of the optics, not an AI/ML algorithm.
No
The device is a surgical light used for illumination, not for treating a condition, disease, or injury.
No
The device is a surgical light, intended to illuminate the surgical field. It is not designed to diagnose any condition or disease.
No
The device description explicitly lists hardware components such as lamp housing, LED modules, optical, electrical, and mechanical components, cables, and a sterilizable handle sleeve. It also describes a physical suspension system and keypads for operation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to illuminate the patient's body and surgical field. This is a direct interaction with the patient's body for visualization during procedures.
- Device Description: The description details a surgical light system with LEDs, optical components, and mechanical arms for positioning. It focuses on providing light for surgical and examination purposes.
- Lack of IVD Characteristics: There is no mention of analyzing samples taken from the human body (like blood, urine, tissue, etc.) or providing information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples from the human body to provide diagnostic information. This surgical light does not fit that description.
N/A
Intended Use / Indications for Use
The surgical light Mach LED 2MC is intended to illuminate the on the patient's body with a high intensity, shadow-free and "cold" light.
The Mach LED 2MC lighting system is designed for illuminating an examination area and surgical field at the hospital and doctor's practice.
Product codes (comma separated list FDA assigned to the subject device)
FSY
Device Description
The surgical light Mach LED 2MC is intended to illuminate the operation site on the patient's body with a high intensity, shadow free and "cold" light.
The Mach LED 2MC 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-colored LEDs: warm white, cold white, green and red. The four different colors are merged inside the lamp head by a computercalculated optical system with light guide and facetted lenses.
The 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 surgical light Mach LED 2MC will be marketed with merging of light fields, light intensity control, color temperature adjustment and integrated laser pointer.
Available accessories for the Mach LED 2MC lighting systems are as follows:
- Camera module
- Remote control of 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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's body / operation site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital and doctor's practice.
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)
Performance testing was conducted to verify that Mach LED 2MC meet the requirements for Medical Electrical Equipment as defined in the relevant standards for Medical electrical equipment and the EN 61000 group.
The accessories are identical to those used with the predicate device.
The risk analysis method used to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA). The design verification test methods used are the same as those submitted for the predicate device 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.
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
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2014
Dr. Mach GmbH & Company KG % Gudrun Busch, Ph.D. Dr. Busch Regulatory Strategy GmbH Fehmarnstrasse 31 Norderstedt, Schleswig-Holstein 22846 Germany
Re: K140461
Trade/Device Name: Mach LED 2MC Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical Lamp Regulatory Class: Class II Product Code: FSY Dated: February 27, 2014 Received: March 5, 2014
Dear Dr. Busch:
This letter corrects our substantially equivalent letter of April 3, 2014.
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 mav 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
1
Page 2 - Dr. Gudrun Busch
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 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K 1 4046 I
Device Name Mach LED 2MC
Indications for Use (Describe)
The surgical light Mach LED 2MC is intended to illuminate the on the patient's body with a high intensity, shadow-free and "cold" light.
Type of Use (Select one or both, as applicable)
[図] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
. :
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Image /page/3/Picture/1 description: The image shows a logo for "Dr. Mach Medizinische Leuchten + Technik". The logo is in black and white and features a stylized font. There is a drawing of a medical examination light.
APR 0 9 2014
510(k) Summary for Mach LED 2MC
as required by section 807.92(c)
| Submitter | Dr. Mach GmbH & Co.KG |
|---|---|
| Flossmannstrasse 28 | |
| 85560 Ebersberg | |
| Germany | |
| Contact Person | Rainer Adams |
| Technical Director | |
| Phone: +49 8092 209330 | |
| Fax: +49 8092 209350 | |
| Preparation Date | February 14, 2014 |
| Trade Name | Mach LED 2MC |
| Common Name | Surgical Lamp |
| Classification Name | Surgical Lamp |
| Regulation 21 CFR 878.4580, Class II | |
| Product Code: FSY | |
| Predicate Device | Mach LED MC |
| Surgical lamp | |
| 510(k) No. K093010, April 1, 2010 |
Dr. Mach GmbH & Co KG Summary Mach LED 2MC
Page 1 of 3
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Image /page/4/Picture/1 description: The image shows the logo for Dr. Mach Medzinische Leuchten + Technik. The logo features the name "Dr. Mach" in a bold, stylized font, with the words "Medzinische Leuchten" and "+ Technik" underneath in a smaller font. To the left of the text is a drawing of a surgical light.
Device Description
The surgical light Mach LED 2MC is intended to illuminate the operation site on the patient's body with a high intensity, shadow free and "cold" light.
The Mach LED 2MC 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-colored LEDs: warm white, cold white, green and red. The four different colors are merged inside the lamp head by a computercalculated optical system with light guide and facetted lenses.
The 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 surgical light Mach LED 2MC will be marketed with merging of light fields, light intensity control, color temperature adjustment and integrated laser pointer.
Available accessories for the Mach LED 2MC lighting systems are as follows:
- Camera module
- Remote control of 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 .
5
Image /page/5/Picture/1 description: The image shows a logo for "Dr. Mach Medizinische Leuchten + Technik". The logo is in black and white and features the text "Dr. Mach" in a stylized font. Below the name is the text "Medizinische Leuchten + Technik" in a smaller font. To the left of the text is a drawing of a medical examination light.
Intended Use
The Mach LED 2MC lighting system is designed for illuminating an examination area and surgical field at the hospital and doctor's practice.
The intended use is identical to the intended use of the predicate device Mach LED MC, K093010.
Technological characteristics Comparison
The Mach LED 2MC has the same technological characteristics (design, materials, chemical composition, energy source) as the predicate device. The Mach LED 2MC and the predicate device Mach LED MC are both based on the LED (light-emitting diode) technology.
For the new device, the number of LEDs was reduced. Therefore, dimensions of the light head diameter, the illumination depth, and the light intensity have been reduced accordingly.
| Technical Parameter | New Device | Predicate Devices | ||
|---|---|---|---|---|
| Mach LED 2MC | Mach LED 3MC | Mach LED 5MC | ||
| Number of LEDs | 84 | 112 | 160 |
Non-clinical data
Performance testing was conducted to verify that Mach LED 2MC meet the requirements for Medical Electrical Equipment as defined in the relevant standards for Medical electrical equipment and the EN 61000 group.
The accessories are identical to those used with the predicate device.
The risk analysis method used to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA). The design verification test methods used are the same as those submitted for the predicate device submission.
Clinical data
No clinical data is required for this device classification submission.
Conclusions
The modifications incorporated into the Mach LED 2MC design arc minor (change in number of LEDs). Based on the information provided hercin it is concluded from the performed testing that the device is as safe, as effective, and performs as well as the predicate devices.