(88 days)
No
The summary describes a standard surgical light with LED technology and dimmable intensity, with no mention of AI or ML capabilities.
No
This device is an operating light designed to illuminate a surgical area, not to provide therapy to a patient.
No
The device is an operating light designed for illumination during surgery and treatment, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical operating light utilizing LED bulbs, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "local illumination of the surgery and treatment area on the patient in operating and treatment rooms." This is a physical function performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description focuses on the physical characteristics of the light (LED bulbs, illumination intensity, color temperature) and its function as an operating light. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The device is clearly described as an operating light, which is a medical device used for illumination during surgical and treatment procedures. This falls under the category of general medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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
Product codes
FTD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating and treatment rooms
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 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/2 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is black and is underlined by a thin black line. The two dots above the "a" are also black.
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
1
.
Abbreviated 510(k) Polaris 100/200
Image /page/1/Picture/7 description: The image shows the word "Dräger" in a bold, sans-serif font. The "ä" in Dräger is represented by two dots above the letter "a". A horizontal line is present below the word, emphasizing the brand name.
Device Name
| Common Name: | Lamp, surgical |
|---|---|
| Legally Marketed Device | |
| Identification: | Polaris 100/200 |
| Regulation Number | 878.4580 |
| Regulation Description | Surgical Lamp |
| Regulation Medical Specialty | General & Plastic Surgery |
| Product Code | FTD |
| Class | 2 |
2
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
3
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.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a series of flowing lines, representing health and human services.
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
5
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
6
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