The Isolux Ilc OptiLux LED Illuminator is indicated for use in transmitting light for illumination purposes from an LED source via a fiber optic cable and attached to either an endoscope, surgical head light or other tools that contain in providing illumination to body cavities during examinations or surgical procedures.

Device Description

Not Found

AI/ML Overview

The provided documents are a 510(k) clearance letter and an Indications for Use statement for the "OptiLux LED Illuminator." These documents, from the FDA, confirm the device's regulatory clearance and its intended use but do not contain any information regarding acceptance criteria, device performance studies, or data about the device's accuracy or efficacy.

Therefore, I cannot fulfill your request for information on the following:

A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
Sample size used for the test set and the data provenance: Not available.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
Adjudication method for the test set: Not available.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The OptiLux LED Illuminator is a physical device for illumination, not an algorithm. Therefore, this type of study is not applicable, and no information about it would be found here.
The type of ground truth used: Not applicable and not available.
The sample size for the training set: Not applicable and not available.
How the ground truth for the training set was established: Not applicable and not available.

The documents primarily focus on:

The FDA's determination of substantial equivalence to a predicate device.
The regulatory classification of the device (Class II).
The indications for use: "transmitting light for illumination purposes from an LED source via a fiber optic cable and attached to either an endoscope, surgical head light or other tools that contain in providing illumination to body cavities during examinations or surgical procedures."

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 21, 2016

Isolux LLC c/o Mr. Dave Yungvirt Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, NJ 07041

Re: K163185

Trade/Device Name: OptiLux LED Illuminator Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: HBI Dated: November 10, 2016 Received: November 14, 2016

Dear Mr. Yungvirt:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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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/Resourcesfor You/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,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K163185

Device Name OptiLux LED Illuminator

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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
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FORFDAUSEONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1114)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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Regulation Number and Section

§ 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.