(88 days)
Polaris 100/200 lights are classified as operating lights in accordance with IEC 60601-2-41 and are intended to be used for the local illumination of the surgery and treatment area on the patient in operating and treatment rooms.
Double light
The combination of two operating lights as an operating light system enables the use in operating and treatment rooms.
Versions
-
Polaris 100 light
-
Polaris 200 light
The Polaris 100/200 light is designed for use in as an operating light. For the Polaris 100/200 light, LED bulbs are used.
The Polaris 100 light combines the illumination intensity of 48 white LED bulbs, the Polaris 200 light combines the illumination intensity of 66 white LED bulbs to form a homogeneous illumination volume of considerable illumination depth and low shadiness. A color temperature similar to natural light with good color rendering and dimmable illumination intensity ensure working conditions for surgical and treatment procedures.
The provided document is a 510(k) summary for the Dräger Polaris 100/200 surgical lamp. It does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML device performance or clinical trials as typically expected. Instead, it describes performance testing related to general medical electrical equipment standards.
However, I can extract information related to the performance testing that was conducted to verify the device's compliance with safety and effectiveness standards for a surgical lamp.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Performance testing was conducted to verify that the proposed Polaris 100/200 Surgical lamp meet the requirements for Medical Electrical Equipment as defined in IEC 60601-1 and IEC 60601-2-41."
It does not provide a table of specific numerical acceptance criteria (e.g., minimum illumination intensity, color rendering index, etc.) for each parameter from these standards, nor does it report the specific measured performance values for the Polaris 100/200 against those criteria. It only states that the device "meet the requirements."
An example of what such a table would look like if the information were available might be:
| Performance Characteristic (based on IEC 60601-2-41) | Acceptance Criterion | Reported Device Performance (Polaris 100/200) |
|---|---|---|
| Illumination Intensity (Ec) | X lux (e.g., ≥ 40,000 lux) | Met Requirement (specific value not provided) |
| Color Rendering Index (Ra) | Y (e.g., ≥ 85) | Met Requirement (specific value not provided) |
| Color Temperature (Tc) | Z K (e.g., 3000-6700 K) | Met Requirement (specific value not provided) |
| Depth of Illumination (L1+L2) | A mm | Met Requirement (specific value not provided) |
| Shadow Dilution | B % | Met Requirement (specific value not provided) |
| Electrical Safety (IEC 60601-1) | Compliance | Met Requirement |
| Electromagnetic Compatibility (IEC 60601-1) | Compliance | Met Requirement |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The performance testing described is likely type testing conducted on a sample of manufactured devices (e.g., one or more units of the Polaris 100 and Polaris 200) to confirm design compliance with standards, rather than a clinical study with a test set of data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided. For a surgical lamp, "ground truth" is typically established by objective measurements against engineering and performance standards (like IEC 60601-2-41) using calibrated equipment, not by expert consensus in the way it would be for diagnostic imaging or AI algorithms.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used for human expert review in diagnostic studies, not for the direct measurement of a physical device's performance against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic tools where human readers interpret medical images, often with and without AI assistance. The Dräger Polaris 100/200 is a surgical illumination device, not a diagnostic imaging tool or AI product.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone study was not done. This term applies to the performance of an AI algorithm independent of human interaction. The Polaris 100/200 is a physical surgical lamp, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for the performance testing of the surgical lamp would be based on objective measurements against established performance standards, specifically IEC 60601-1 (Medical Electrical Equipment general requirements) and IEC 60601-2-41 (Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis). These standards define measurable parameters (e.g., illumination levels, color temperature, color rendering, depth of field, shadow reduction, electrical safety) that the device must meet.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The Polaris 100/200 is a hardware device; it does not involve machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as there is no training set for this type of device.
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510(k) summary As required per CFR 21 807.92
General Company Information
| Submitters Name and Address: | Dräger Medical GmbH |
|---|---|
| Moislinger Allee 53-55, | |
| D-23542 Luebeck, Germany |
Manufacturer's Name and Address: Dräger Medical GmbH Moislinger Allee 53-55, D-23542 Luebeck, Germany
Establishment Registration Number:
9611500
Contact Person:
Mr. Ulrich Schroeder Moislinger Allee 53-55, D-23542 Luebeck, Germany Phone : 49 (451) 882-3648 Fax :49 (451) 882-3018 Email: Ulich.Schroeder@draeger.com
Alternate
Mrs. Beth Zis Draeger Medical Systems, Inc., 6 Tech Dr, Andover, MA 01810 Phone +1 (978) 3798255 Fax: +1 (978) 3798335 Email: beth.zis@draeger.com
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Abbreviated 510(k) Polaris 100/200
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Device Name
| Common Name: | Lamp, surgical |
|---|---|
| Legally Marketed DeviceIdentification: | Polaris 100/200 |
| Regulation Number | 878.4580 |
| Regulation Description | Surgical Lamp |
| Regulation Medical Specialty | General & Plastic Surgery |
| Product Code | FTD |
| Class | 2 |
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Device description:
The Polaris 100/200 light is designed for use in as an operating light. For the Polaris 100/200 light, LED bulbs are used.
The Polaris 100 light combines the illumination intensity of 48 white LED bulbs, the Polaris 200 light combines the illumination intensity of 66 white LED bulbs to form a homogeneous illumination volume of considerable illumination depth and low shadiness. A color temperature similar to natural light with good color rendering and dimmable illumination intensity ensure working conditions for surgical and treatment procedures.
Indications / Intended Use:
Polaris 100/200 lights are classified as operating lights in accordance with IEC 60601-2-41 and are intended to be used for the local illumination of the surgery and treatment area on the patient in operating and treatment rooms. Double light
The combination of two operating lights as an operating light system enables the use in operating and treatment rooms.
Versions
-
Polaris 100 light
-
Polaris 200 light
Legally marketed devices:
Drager is claiming substantial equivalence of its Polaris 100/200 surgical light to the Sola 700, Sola 500 from Dräger (K010724) and to the device iLED from Trumpf Medizin Systeme (K061317). - -
Technological Characteristics:
Performance testing was conducted to verify that the proposed Polaris 100/200 Surgical lamp meet the requirements for Medical Electrical Equipment as defined in IEC 60601-1 and IEC 60601-2-41
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Substantial Equivalence:
The proposed device Polaris 100/200 and all predicative devices have the similar intended use and they conform to the same particular standard: IEC 60601-2-41. In addition the iLED and the new Polaris 100/200 do use the same light source / technology: light emitting diodes (LED).
There are differences in design and operation but these do not alter the safety or efficacy of the device.
Dräger is claiming its Polaris 100/200 surgical light to be as safe, as effective, and performs as well as or better than the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 8, 2013
Drager Medical GMBH % Draeger Medical Systems, Incorporated Ms. Beth Zis Director, Regulatory Affairs 6 Tech Drive Andover, Massachusetts 01810
Re: K123776
Trade/Device Name: Polaris 100/200 Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FTD Dated: December 04, 2012 Received: December 10, 2012
Dear Ms. Zis:
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. Beth Zis
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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, FOR
Peter D. Rumm -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 Statement
Polaris 100/200 lights are classified as operating lights in accordance with IEC 60601-2-41 and are intended to be used for the local illumination of the surgery and treatment area on the patient in operating and treatment rooms.
Double light
The combination of two operating lights as an operating light system enables the use in operating and treatment rooms.
Versions
-
Polaris 100 light
-
Polaris 200 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)
Neil R Ogden 2013.03.08 11:00:35 -05'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number __ K123776
§ 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.