(64 days)
The ISOLUX America's Surgical Headlight is indicated for illumination purposes from an illuminator to a headlight to aid in providing illumination to body cavities during examinations or surgical procedures.
Not Found
The provided document is a 510(k) Pre-market Notification letter from the FDA to Isolux America regarding their ISOLUX Fiber Optic Surgical Headlight. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed devices, indicating that it does not require new efficacy or safety studies to be approved for market. Therefore, the detailed information requested regarding specific acceptance criteria, performance data, sample sizes, expert qualifications, adjudication methods, or comparative effectiveness studies is not present in this regulatory correspondence.
The document primarily covers:
- Device Name: ISOLUX Fiber Optic Surgical Headlight
- Regulatory Class: II
- Product Code: FST
- FDA Determination: Substantially equivalent to pre-amendments devices.
- Indications for Use: "illumination purposes from an illuminator to a headlight to aid in providing illumination to body cavities during examinations or surgical procedures."
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8 1999 JUL
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stuart L. McGhee Vice President Isolux America 1479 Railhead Boulevard Naples, Florida 34110
K991572 Re:
Trade Name: ISOLUX Fiber Optic Surgical Headlight Regulatory Class: II Product Code: FST Dated: May 4, 1999 Received: May 5, 1999
Dear Mr. McGhee:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Stuart L. McGhee
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K991572
Device Name: '' ISOLUX Surgical Headlight
Indications for Use:
The ISOLUX America's Surgical Headlight is indicated for ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ illumination purposes from an illuminator to a headlight to aid in providing illumination to body cavities during examinations or surgical procedures.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | |
|---|---|
| OR Over-The-Counter Use | X |
| (Division Sign-Off) | (Optional Format 1-2-96) |
| Department of General Restorative Devices | |
| 510(k) Number | K991572 |
§ 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.