(136 days)
Not Found
Not Found
No
The summary describes a simple headlamp for illumination and does not mention any AI or ML components or functionalities.
No
The device is a headlamp used for illuminating a surgical field, not for treating a disease or condition.
No
The Headlamp HL2000 is used for illuminating a surgical field, which is a therapeutic or procedural function, not a diagnostic one. It aids the doctor by providing light during surgery rather than gathering information or identifying conditions.
No
The device description explicitly states it is a "Headlamp HL2000" and describes physical components like a "headlamp" and a connection to a "remote light source," indicating it is a hardware device.
Based on the provided information, the Headlamp HL2000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to illuminate a surgical field. This is a direct medical intervention/aid during a procedure, not a test performed on samples taken from the body.
- Device Description: The description details a headlamp worn by a doctor to provide light. This is a physical device used externally.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
IVDs are devices used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Headlamp HL2000 does not fit this definition.
N/A
Intended Use / Indications for Use
The Headlamp HL2000 has indicated use in the following situations:
There is a requirement for illuminating a surgical field. .
· There is a requirement for munimaling on and The doctor wears this device on hishler end to the headlamp. The headlamp contains a end to a remote light source and the other end to the headlamp contains a End to a remote inght source and the carcular spot and illuminates the surgical field.
Product codes
FSR
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4335 Operating headlamp.
(a)
Identification. An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.(b)
Classification. (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
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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 emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 11 2000
Mr. Robert Allman Senior Project Leader Angiolaz, Inc. P.O. Box 556 Industrial Park Bellows Park, Vermont 05101
Re: K994362 Trade Name: HeadLamp, HL2000 Regulatory Class: II Product Code: FSR Dated: March 7, 2000 Received: March 7, 2000
Dear Mr. Allman:
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 (QS) 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. Robert Allman
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,
Dianne R. Lochner.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page__________________________________________________________________________________________________________________________________________________________________________ o (
510(k) Number (il known):_K 994362
Device Name: HEADLAMP HL2000____
Indications For Use:
Device Name: HeadLamp, HL2000 Indications for use:
The Headlamp HL2000 has indicated use in the following situations:
There is a requirement for illuminating a surgical field. .
· There is a requirement for munimaling on and The doctor wears this device on hishler end to the headlamp. The headlamp contains a
end to a remote light source and the other end to the headlamp contains a End to a remote inght source and the carcular spot and illuminates the surgical field.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| Anne R. Lochner (Division Sign-Off) Division of General Restorative Devices 510(k) Number: K994362 | |
|---|---|
| -- | --------------------------------------------------------------------------------------------------------------------------------------- |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) | |
| OR | Over-The-Counter Use |
| (Optional Format 1-2-96) |