(362 days)
To provide infrared light energy that penetrates the skin to promote increased blood flow and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles and relief from pain resulting in improved range of motion
The devices are a family (models) of infrared lamps having the same indication for use and equivalent technology. The units are electrical and mechanical designs for use and convenience of users to provide topical heating. Heat is generated by LEDs (light emitting diodes) at 940 nm wavelength.
The provided 510(k) summary for the LightWave™ Infrared Photon Stimulator, Models LW10D and LW30D, does not contain information regarding traditional acceptance criteria or a study designed to prove device performance against such criteria in the context of diagnostic accuracy, which is typical for AI/ML devices.
Instead, this submission focuses on establishing substantial equivalence to predicate devices for infrared lamps and demonstrating safety and performance in terms of heating capabilities to justify its intended use for temporary pain relief. Therefore, many of the requested categories related to AI/ML device studies (like sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this particular document.
Here's an attempt to answer the questions based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Substantial Equivalence and Safety) | Reported Device Performance |
|---|---|
| Indications for Use: Promote increased blood flow and circulation, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. Promote relaxation of muscles and relief from pain resulting in improved range of motion. | Stated to have the "same indications for use as the predicate devices". "Design has been tested and verified to raise the skin temperature adequately to effect the indications for use." |
| Technological Characteristics: Use light emitting diodes (LEDs) to convey heat energy to the skin, operating at 940nm wavelength. | "All are based on the mode of operation that light emitting diodes convey heat energy to the skin. The device LEDs all operate at 940nm." Specific wavelengths, number of LEDs, output power, and treatment areas are provided and compared to predicates. |
| Safety: Device operates safely, potential hazards are mitigated. Electrical safety and skin temperature rise safely. | "A Risk Analysis was performed on all models using EN1441. Potential hazards are identified and have been mitigated by design and labeling." "The devices were tested for performance and found to raise skin temperature safely when used following the manufacturer's instructions." "Adapters to convert 110V power to 9V or 12V are UL listed to assure user safety." |
| Performance: Raise skin temperature adequately to effect the indications for use. | "The design has been tested and verified to raise the skin temperature adequately to effect the indications for use." |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission describes a physical device (infrared lamp) and its substantial equivalence to predicate devices, not an AI/ML diagnostic system. There is no "test set" in the context of AI/ML performance evaluation. The "testing" mentioned refers to non-clinical performance and safety testing of the physical hardware.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth for an AI/ML diagnostic test set was established.
4. Adjudication method for the test set:
- Not applicable.
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:
- Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
7. The type of ground truth used:
- Not applicable. The "ground truth" for this device relates to its ability to emit infrared light, safely raise skin temperature, and the known physiological effects of heat on pain and circulation. This is established through established scientific principles and non-clinical testing, not expert consensus on diagnostic images or pathology.
8. The sample size for the training set:
- Not applicable. There is no AI/ML model that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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Ko24027
510(k) Summary Infrared Lamp, Models LW10D and LW30D
Skytech Enterprises, Inc. 2425 N.W. 69th Street Vancouver, WA 98665 360-699-6194 Telephone 360-699-6197 Fax Douglas Greene, Chairman
Prepared 11/25/02 by: L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279 Telephone 303-530-4774 Fax
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Device: LightWave™ Infrared Photon Stimulator, Models, LW10D and LW30D
Common Name: Infrared Lamp
Classification: 890.5500, 89 ILY, Class II
SE Predicates:
- a) C&H International K020851, Infrared Heating Lamp TDP Heat Lamp
- b) BioScan, Inc. K993684, Infrared Lamp Spinal Pad
Device Description:
The devices are a family (models) of infrared lamps having the same indication for use and equivalent technology. The units are electrical and mechanical designs for use and convenience of users to provide topical heating. Heat is generated by LEDs (light emitting diodes) at 940 nm wavelength. .
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| Model | Number of LEDs | Output Power | Wavelength | Power Source | Light Pattern | Treatment Area | Battery Life | Recommended Treatment |
|---|---|---|---|---|---|---|---|---|
| LW10D | 9 | 20 mW | 940 nm | 9V DC battery or 110V AC/9V DC adapter | 145 Hz pulse | ~225 square mm | 6 hours continuous | 15 minutes |
| LW30D | 30 | 30 mW | 940 nm | 110V AC/9V DC adapter only (no battery) | 145 Hz pulse | ~900 square mm | 30 hours pulsing N/A | 10 minutes |
Tech Infrared Photon Stimulator Model Differentiati
ntended Lise:
If orovide intract light ears the skin o promote increased blood for and circulation, thereby, providing
emprary relef of minor musele ad join pain resulting n
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SE Comparison:
Comparative Information
:
| Model LW10D | Model LW30D | TDP Infrared LampsK020851 | The LightPatchK993684 |
|---|---|---|---|
| ILYSkytech | ILYSkytech | ILYC&H Intl.Houston, TX | ILYBioScan, Inc.Corrales, NM |
| Infrared lightenergy to promoteincreased bloodflow and circu-lation, providingtemporary relief ofminor muscle andjoint pain andstiffness, minorarthritis pain, andmuscle spasm.Promotesrelaxation ofmuscles and relieffrom pain resultingin improved rangeof motion. | Infrared lightenergy to promoteincreased bloodflow and circu-lation, providingtemporary relief ofminor muscle andjoint pain andstiffness, minorarthritis pain, andmuscle spasm.Promotes relaxationof muscles andrelief from painresulting inimproved range ofmotion. | Temporary relief ofminor muscle andjoint pain andstiffness, thetemporary relief ofminor joint painassociated witharthritis, the temporaryincrease in localcirculation whereapplied, and relaxationof muscles. Helpmuscle spasms, minorsprains, and minormuscular back pain. | Personal comfort,temporary relief ofminor aches and painsin muscles and joints.Aids in relaxation inmuscles, temporaryinfrared range andfreedom of motion,temporary minor painrelief, temporaryincrease in local bloodcirculation. |
| Yes | Yes | Yes | Yes |
| Yes | Yes | Yes | Yes |
| 9V DC battery or110V AC adapter,UL listed | 110V AC adapter(only), UL listed | 110V AC | 9V DC battery |
| 940 nm | 940 nm | 940 nm | 940 nm |
| ~225 square mm | ~900 square mm | ~1215 square mm | ~6500 square mm |
:
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510(k) Substantial Equivalence Rationale:
-
- The Skytech devices have the same indications for use as the predicate devices, TDP Infrared Lamp and the LightPatch.
- The same technological characteristics are used for this device and the two 2. predicates. All are based on the mode of operation that light emitting diodes convey heat energy to the skin. The device LEDs all operate at 940nm.
-
- The comparative information shown in this submission demonstrates substantial equivalence for indications for use, design, and mode of operation.
Nonclinical Data:
A Risk Analysis was performed on all models using EN1441. Potential hazards are identified and have been mitigated by design and labeling.
The devices were tested for performance and found to raise skin temperature safely when used following the manufacturer's instructions. The rise in skin temperature results in the indications for use.
Adapters to convert 110V power to 9V or 12V are UL listed to assure user safety.
Conclusions:
These infrared lamp models are designed, labeled, and verified for performance and safety. The design has been tested and verified to raise the skin temperature adequately to effect the indications for use. A Risk Analysis confirms the design process and final product design for consideration of potential hazards. The potential hazards have been adequately addressed and mitigated by the design or by labeling. Labeling covers the user instructions and warning statements for users.
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Image /page/5/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 & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring three wavy lines that resemble an abstract representation of the American flag.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2003
Skytech Enterprises, Inc. C/o Mr. Lewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, Colorado O 80301
Re: K024027
Trade/Device Name: Lightwave Infrared Lamps LW10D and LW30D Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: October 15, 2003 Received: October 21, 2003
Dear Mr. Ward:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments. or to commerce proc to May 20, 1978, the enoveance with the provisions of the Federal Food, Drug, devices mat have been rechtsined in quire approval of a premarket approval application (PMA). and Cosmetter (110) that Lo neview, subject to the general controls provisions of the Act. The Tou may, dierettle, mains of the Act include requirements for annual registration, listing of general controls profitation 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 If your device is elassinod tional 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 I lease be advised that I Drivisante a vour device complies with other requirements of the Act that I Dri has intact and regulations administered by other Federal agencies. You must or any I catal states and registanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Lat 007); adoling (Dr OS) regulation (21 CFR Part 820); and if applicable, the electronic ford in the quarty by wisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Lewis Ward
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and wy and finding of substantial equivalence of your device to a legally premance hotification. The 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 If you desire spocific acrios 101 your as (301) 594-4659. Also, please note the regulation entitled, Connact the Office of Comments to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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
Sincercly yours,
Mark N Millerm
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Initial 510(k):
Device Name:
Indications for Use:
Janf
To provide infrared light energy that penetrates the skin to promote increased 1 of provide and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles and relief from pain resulting in improved range of motion
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ision Sign-Off)
ision of General, Restorative
and Neurological Devices
Number. K024027
Prescription Use __ OR Over-the-Counter Use X
(Per 21 CFR 801.109)
4
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.