(52 days)
This device is intended to be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The ULK-H and ULT-H lamps each contain a number of quartz bulbs with ceramic coatings that when heated emits infrared radiation with wavelengths from 8 to 40 microns (8.000 to 40.000 nanometers).
The provided text is a 510(k) summary for an infrared lamp, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data in the format requested. Therefore, much of the requested information is not available in the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
This information is not available in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence based on technological characteristics and intended use, rather than presenting specific performance metrics against pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance:
This information is not available. The 510(k) summary does not mention any clinical study or test set involving human subjects to evaluate the device's performance against specific pain relief claims.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available. Since no test set or clinical study is described, there's no mention of experts establishing ground truth.
4. Adjudication method for the test set:
This information is not available. As no test set is described, there is no adjudication method mentioned.
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:
This information is not available. The device is an infrared lamp, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not available. This is not an algorithmic device.
7. The type of ground truth used:
This information is not available. No clinical study data is presented.
8. The sample size for the training set:
This information is not available. The device is an infrared lamp, and there is no mention of a "training set" in the context of device development or evaluation for this type of medical device.
9. How the ground truth for the training set was established:
This information is not available. Similar to the above, there is no training set for this type of device.
Summary of what is available from the 510(k) document:
- Device Name: TLC Infrared Lamp (Models ULK-H and ULT-H)
- Intended Use/Indications for Use: Temporary relief of minor muscle and joint pain and stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation where applied, and relaxation of muscles. May also help muscle spasms, minor sprains and strains, and minor muscular back pain.
- Predicate Device: Model CGO-222B TDP infrared lamp (cleared in K020851).
- Technological Characteristics Comparison (basis of substantial equivalence):
- TLC Lamp: Quartz bulbs with ceramic coatings, emitting infrared radiation with wavelengths from 8 to 40 microns (8,000 to 40,000 nanometers).
- Predicate Device: Metal ceramic-coated plate, emitting infrared radiation with wavelengths from 1 to 25 microns (1,000 to 25,000 nanometers).
The 510(k) process primarily relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing indications for use, technological characteristics, and performance data if available and necessary. For devices like infrared lamps, the demonstration often focuses on the physical properties and safety rather than extensive clinical efficacy studies with ground truth establishment in the way an AI diagnostic tool would require.
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NOV 2 0 2003 510(k) Summary
This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the Medical Devices User Fee Act of 2002.
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- The sponsor of this premarket notification is:
George Works President TLC Marketing Inc. 12407 MoPac Ex. N Suite 100-413 Austin, TX 78758
- The sponsor of this premarket notification is:
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The submitter is: 2. Robert J. Mazzaferro Manager RegTech Solutions, LLC Consultant for TLC Marketing Inc. 11 Dellcastle Court Montgomery Village, MD 20886
This summary was prepared on September 29, 2003. -
The name of the device is the TLC Infrared Lamp in two models, Whole Body 3. Model ULK-H and the Topical Model ULT-H. These devices may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
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The above device is substantially equivalent to the Model CGO-222B TDP 4. infrared lamp and the other models that were cleared in K020851.
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న్. The ULK-H and ULT-H lamps each contain a number of quartz bulbs with ceramic coatings that when heated emits infrared radiation with wavelengths from 8 to 40 microns (8.000 to 40.000 nanometers).
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The technological characteristics of the device are similar to those of the predicate 6. device which has a metal ceramic-coated plate which when heated emits infrared radiation with wavelengths from 1 to 25 microns (1,000 to 25,000 nanometers).
K0 33035
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Image /page/1/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 symbol featuring three human profiles facing to the right, with flowing lines above them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2003
TLC Marketing, Inc. C/o Mr. Robert J. Mazzaferro Manager RegTech Solutions, LLC 11 Dellcastle Court Montgomery Village, Maryland 20886
Re: K033035
Trade/Device Name: TLC Models ULK-H and ULT-H Infrared Lamps Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: September 29, 2003 Received: September 29, 2003
Dear Mr. Mazzaferro:
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 10 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 mav 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. Robert J. Mazzaferro
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,
Miriam C. Provost
to 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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510(k) Number (if known):
Device Name: Infrared Lamp
Indications for Use:
This device is intended to be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K633035
§ 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.