(87 days)
49003
49003
No
The description focuses on basic illumination technology (LED) and mechanical adjustability, with no mention of AI/ML terms or functionalities.
No
Explanation: The device is described as a headlight that provides illumination to aid visualization during procedures. This function does not directly treat or prevent a disease or condition, which is the primary characteristic of a therapeutic device.
No
The device is described as "providing illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures." While it aids during diagnostic procedures, its function is illumination, not diagnosis. It does not perform any diagnostic function itself.
No
The device description clearly states it is a physical product with hardware components like an articulated projector, headband, and LED.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide illumination for visualization during procedures. This is a physical aid for the healthcare professional, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical device (headband, projector, LED) used for illumination. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
An IVD is a medical device used to perform tests on samples taken from the human body to provide information about a person's health, such as diagnosing a disease or monitoring a condition. This device is simply a tool for illumination during procedures.
N/A
Intended Use / Indications for Use
The Solid State Procedure Headlight is indicated for providing illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.
Product codes
FSR
Device Description
This product features an articulated projector that is mounted to a comfortable adjustable headband. The range of adjustability accommodates the majority of users. The actual source for the illumination is a high intensity white LED.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Completed design reviews and testing ensures that the Solid State Procedure Headlight System performs within the environment(s) for which is to be marketed. The safety testing complies with the indicated standards. Based on these results, and above referenced testing it is our determination that the device is safe, effective and performs within its design parameters as well as the legally marketed predicate device.
Key Metrics
Not Found
Predicate Device(s)
49003, Halogen Headlight manufactured by Welch Allyn, Inc.
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.
0
AUG 1 1 2003
K03154/8
"Abbreviated 510(k) SUMMARY" Summary of Safety and Effectiveness
| Submitter's Name & Address: | Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls, New York 13153 - 0220 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person & Telephone: | David Klementowski
(315) 685-4133 |
| Date Summary Prepared: | Monday, May 12th, 2003 |
| Device Name: | Classification Name - Headlamp, Operating, AC-Powered
Common/Usual Name - Solid State Procedure Headlight
Proprietary Name - LED Headlight |
| Predicate Device: | 49003, Halogen Headlight manufactured by Welch Allyn, Inc. |
Skaneateles Falls, New York.
Device Description, intended Use & Effectiveness:
This product features an articulated projector that is mounted to a comfortable adjustable headband. The range of adjustability accommodates the majority of users. The actual source for the illumination is a high intensity white LED. The Solid State Procedure Headlight is indicated for providing illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.
Technological Characteristics:
See attachment "III" for a comparison of the Solid State Procedure Headlight System to the predicate device.
1
Summary of Safety:
The system will be certified to the following general safety standards:
| IEC60601-1 | Medical Electrical Equipment, Part 1: General requirements
for Safety, Amendment 1, and Amendment 2 |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------|
| IEC60601-1-2 | Medical Electrical Equipment, Part 1: General requirements
for safety 2: Electromagnetic Compatibility - Requirements
and tests |
| IEC60825-1 | Safety of laser products, Part 1: Equipment classification,
requirements and user's guide |
Summary of Effectiveness:
Completed design reviews and testing ensures that the Solid State Procedure Headlight System performs within the environment(s) for which is to be marketed. The safety testing complies with the indicated standards. Based on these results, and above referenced testing it is our determination that the device is safe, effective and performs within its design parameters as well as the legally marketed predicate device. Welch Allyn, Inc. will not market this device if it does not completely meet its design intent and safety functions.
2
Image /page/2/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 & H. SERV. SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
AUG 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Klementowski Senior Manager Regulatory Affairs Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, New York 13153
Re: K031548
Trade/Device Name: Solid State Procedure Headlight Regulation Number: 21 CFR 886.4335 Regulation Name: Light, Headband, Surgical Regulatory Class: II Product Code: FSR Dated: May 12, 2003 Received: May 20, 2003
Dear Mr. Klementowski:
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.
3
Page 2 - Mr. David Klementowski
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Colin M. Wilson, Ph.D.
Celia M. Witten, Ph.D., M.D. ન્ડ Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): KO31548
Device Name: Solid State Procedure Headlight
Indications For Use:
The Solid State Procedure Headlight is indicated for providing illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V
ನ್ನ
OR
Over-The-Counter Use ________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Signature
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031548