(87 days)
The Solid State Procedure Headlight is indicated for providing illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.
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.
This submission describes a medical device, the "Solid State Procedure Headlight," and its comparison to a predicate device. However, it does not contain a study that presents specific acceptance criteria and detailed device performance data in a way that would allow for a complete answer to all parts of your request.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for performance specifications (e.g., light intensity, beam uniformity, color temperature, etc.) nor does it report specific device performance data against such criteria. Instead, it refers to general safety standards and an overall statement of effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC60601-1, IEC60601-1-2, IEC60825-1 (Safety) | "The system will be certified to the following general safety standards..." |
| Performs within design parameters and intended environment | "Completed design reviews and testing ensures that the Solid State Procedure Headlight System performs within the environment(s) for which is to be marketed." |
| Safety and Effectiveness | "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." |
| Substantial Equivalence to Predicate Device | FDA letter states: "we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission mentions "design reviews and testing" but does not detail the nature of these tests, the number of units tested, or the type of data collected.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The device is an illumination tool, not an imaging or diagnostic AI device that would typically rely on expert-established ground truth for its performance evaluation in this context. The evaluation described here focuses on safety standards and functional comparisons to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable given the type of device and the evaluation described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not relevant for this device. This is a spotlight/headlamp, not an AI-powered diagnostic tool. There is no AI component or "human readers" in the context of interpretation of images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study in the context of an algorithm is not applicable as this device is an illumination tool and does not contain an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. The assessment of this device is based on its ability to provide illumination and meet safety standards, as well as being substantially equivalent to a predicate device. "Effectiveness" is determined by its ability to fulfill its intended purpose (providing illumination) rather than making a diagnostic determination that requires a ground truth standard.
8. The sample size for the training set
This information is not provided and is not applicable for this type of device. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for this type of device.
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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 RoadSkaneateles 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-PoweredCommon/Usual Name - Solid State Procedure HeadlightProprietary 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.
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Summary of Safety:
The system will be certified to the following general safety standards:
| IEC60601-1 | Medical Electrical Equipment, Part 1: General requirementsfor Safety, Amendment 1, and Amendment 2 |
|---|---|
| IEC60601-1-2 | Medical Electrical Equipment, Part 1: General requirementsfor safety 2: Electromagnetic Compatibility - Requirementsand 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.
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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.
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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
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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
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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
§ 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.