(45 days)
The Headlight is indicated for use in transmitting illumination to a body cavity or surgical procedure.
Not Found
I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for the IsoLED AC-Powered LED Headlight System, indicating that the device has been found substantially equivalent to a predicate device.
It includes:
- Device name: IsoLED AC-Powered LED Headlight System
- Regulation Number and Name: 21 CFR 878.4580, Surgical lamp
- Regulatory Class: Class II
- Product Code: FST
- Indications for Use: "The Headlight is indicated for use in light transmitting illumination and body cavity illumination procedures."
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Information on MRMC comparative effectiveness studies or standalone performance.
- Training set details.
Therefore, I cannot fulfill your request based on the provided text.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Isolux LLC % Intertek Testing Services NA, Inc. Mr. Daniel W. Lehtonen 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
SEP 2 4 2010
Re: K102266
Trade/Device Name: IsoLED AC-Powered LED Headlight System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FST Dated: August 09, 2010 Received: August 10, 2010
Dear Mr. Lehtonen:
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
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Page 2 - Mr. Daniel W. Lehtonen
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); 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/CDRHQffices/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 Dan Rum
Dec or
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
2 4 2010
SEP
510(k) Number (if known):
IsoLED LED Ac-Powered Device Name: Indications For Use:
Isolux IIc IsoLED LED Ac-Power The Headlight is indicated for use in light to transmitting illumination an tED body Co arriller procedu
Headlisht
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C
Page 1 of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R of Ogden for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102266
§ 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.