(45 days)
The Dermatherm 100 is indicated for use to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.
See Attachment II
The provided document does not contain information regarding acceptance criteria or a study that proves the device meets specific performance metrics. Instead, it is a 510(k) summary and FDA clearance letter for the Dermatherm 100, an infrared heat lamp.
The key points from the document regarding performance and testing are:
- Non-clinical Performance Data: None
- Clinical Performance Data: None
- Conclusion: The Dermatherm 100 is substantially equivalent to other existing Heat Lamps in commercial distribution (specifically, the Warm-Lamp by Olympic Medical, cleared under K932881).
Therefore, based on the provided text, I cannot complete the requested tables and sections. The device's clearance was based on substantial equivalence to a predicate device, not on meeting specific acceptance criteria proven by a dedicated performance study as would be described for many AI/ML devices or novel technologies.
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APR - 3 1998
Kg80•607
Attachment I 510(K) Summary Dermatherm 100
This 510(K) Summary of safety and effectiveness for the Dermatherm 100 is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the Organization and content of a 510(K) summary. ﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ !
| Applicant: | New Star Lasers |
|---|---|
| Address: | 11802 Kemper RoadAuburn, CA 95603 |
| Contact Person: | Nina Davis |
| Telephone: | (530) 823-1434(530) 823-1446 FAX |
| Preparation Date: | 1-15-98 |
| Device Trade Name: | Dermatherm 100 |
| Common Name: | Infrared Heat Lamp |
| Classification Name: | Therapeutic DeviceProduct Code IL Y21CFR Regulation: 890.5500 |
| Legally Marketed Predicate Device: | Warm-Lamp is manufactured by Olympic Medical, cleared under510(K) number K932881. |
| Description of the Dermatherm 100: | See Attachment II |
| Intended use of the Dermatherm 100: | The Dermatherm 100 is indicated for use to emit energy in theInfrared Spectrum to provide topical heating for the purpose ofelevating and/or maintaining tissue temperature. |
| Non-clinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Dermatherm 100 is substantially equivalent to other existingHeat Lamps in commercial distribution. |
| Additional Information: | None requested at this time |
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 1998
Mr. Dave Fullmer ·New Star Lasers, Inc. 11802 Kemper Road Auburn, California 95603
Re: K980607 Trade Name: Dermatherm 100 Regulatory Class: II Product Code: ILY Dated: January 4, 1998 Received: January 17, 1998
Dear Mr. Fullmer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement; as set .................................................................................................................. forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Dave Fullmer
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
510(k) Number: New submission
Device Name Dermatherm 100
Indications for Use:
The Dermatherm 100 is indicated for use to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH Office of Device Evaluation (ODE)
Acceul
11 : 11 : 11 510(k) Num
.
Over-the Counter Use $\not$
Prescription Use (per 21 CFR 801.109)
OR
N/A