(64 days)
Not Found
None
No
The summary describes a surgical headlight for illumination, with no mention of AI, ML, image processing, or data analysis capabilities.
No
The device is a surgical headlight used for illumination during examinations or procedures, not for treating a disease or condition.
No
The device is described as a surgical headlight for illumination during examinations or surgical procedures, which is a therapeutic or assistive function, not a diagnostic one.
No
The device description and intended use clearly describe a physical surgical headlight system, which includes hardware components for illumination. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for illumination during examinations or surgical procedures. This is a direct interaction with the patient's body for visualization, not for testing samples taken from the body.
- Device Description: While the description is "Not Found," the intended use clearly points to a physical device used on or near the patient.
- No mention of IVD characteristics: There is no mention of analyzing samples (blood, tissue, etc.), reagents, or any other typical components of an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical headlight does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
FST
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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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Page 1 of -1
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.
대표 이용 시 경기 : 100
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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 |