(87 days)
46003
Not Found
No
The description focuses on basic illumination and mechanical adjustments, with no mention of AI/ML terms or functionalities.
No
The device provides illumination for general exams and minor procedures, which aids in diagnosis and treatment but does not directly provide therapy.
No
The device is a portable headlight for illumination during general exams, foreign body removal, and minor suturing, not for diagnosing medical conditions.
No
The device description explicitly states it consists of a light source and a headband, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for providing illumination for general exams, foreign body removal, and minor suturing. These are all procedures performed on the patient, not on samples taken from the patient.
- Device Description: The description details a light source and headband, which are external tools used during a physical examination or procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing conditions based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Solid State Portable Headlight is indicated for providing a portable, battery powered illumination for performing general exams, foreign body removal, and minor suturing.
Product codes
FSR
Device Description
This product consists of a light source that is held in place by a comfortable, adjustable and consumable Terrycloth headband with Velcro adjustments. The range of adjustability accommodates the majority of users. The portable Headlight is small, light weight and adjustable in both pointing direction and illuminated spot size. The Solid State Portable Headlight is indicated for providing a portable, battery powered illumination for performing general exams, foreign body removal, and minor suturing.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Completed design reviews and testing ensures that the Solid State Portable 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
46003
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
Image /page/0/Picture/1 description: The image shows the numbers 49 and K031549. The number 49 is written in a handwritten style at the top of the image. Below it, the alphanumeric string K031549 is also handwritten, with the 'K' being a capital letter.
"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 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Portable Headlight
Proprietary Name - Solid State Lamp [LED] Headlight |
| Predicate Device: | 46003, Direct Focusing Headlight manufactured by Welch Allyn
Inc. Skaneateles Falls, New York |
Device Description, intended Use & Effectiveness:
This product consists of a light source that is held in place by a comfortable, adjustable and consumable Terrycloth headband with Velcro adjustments. The range of adjustability accommodates the majority of users. The portable Headlight is small, light weight and adjustable in both pointing direction and illuminated spot size. The Solid State Portable Headlight is indicated for providing a portable, battery powered illumination for performing general exams, foreign body removal, and minor suturing.
Technological Characteristics:
See attachment "III" for a comparison of the Solid State Portable 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 Portable 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 a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the logo is a symbol that looks like three stylized waves or lines. The logo is black and white and appears to be of a government organization.
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: K031549
Trade/Device Name: Solid State Lamp (LED) 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.
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
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications For Use:
The Solid State Portable Headlight is indicated for providing a portable, battery powered illumination for performing general exams, foreign body removal, and minor suturing.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
OR
Over-The-Counter Use __
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
(Optional Format 1-2-96)
K031549 510(k) Number_