(57 days)
The Medical Illumination International Inc. 150 - 300 Watt Medical Fiberoptic Light Source with Headlight is indicated for use in transmitting light for illumination purposes from an illuminator (150 - 300 Watt Lamp) to various instruments such as a Headlight, providing illumination in body cavities during examinations or minimal invasive surgical procedures.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical fiberoptic light source with illuminating headlights. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This type of document is a regulatory approval, not a scientific study report.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. The document primarily focuses on the substantial equivalence determination to a predicate device for regulatory purposes.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of an eagle with its wings spread, represented by three curved lines.
JAN 1 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mike Alcala Manager, Quality Assurance and Regulatory Approval Medical Illumination International, Inc. 547 Library Street San Fernando, California 91340
Re: K053227
Trade/Device Name: 150 – 300 Watt Medical Fiberoptic Light Source Illuminating Headlights Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FST Dated: January 6, 2006 Received: January 6, 2005
Dear Mr. Alcala:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Alcala
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millhouser
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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VII Statement of Indications for Use
510(k) Number (if known): K053227
150 - 300 Watt Medical Fiberoptic Light Source Illuminating Device Name: Headlights.
Indications for use:
The Medical Illumination International Inc. 150 - 300 Watt Medical Fiberoptic Light Source with Headlight is indicated for use in transmitting light for illumination purposes from an illuminator (150 - 300 Watt Lamp) to various instruments such as a Headlight, providing illumination in body cavities during examinations or minimal invasive surgical procedures.
Prescription Use YES_ and / or Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_ につらろ222
§ 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.