(37 days)
For use as a sensing device to measure and display the temperature of the treatment area during procedures with the NS-130 laser.
The Thermal Sensing Handpiece Accessory is a temperature detector which will provide the laser operator with a readout of the temperature of the treatment area
The provided text does not contain detailed information about specific acceptance criteria or an analytical study proving the device meets those criteria. The "Performance Data" section explicitly states "None."
Instead, the document is a 510(k) Premarket Notification summary that:
- Identifies the device, its intended use, and a legally marketed predicate device.
- Concludes that the CoolTouch Thermal Sensing Handpiece Accessory is "substantially equivalent" to the predicate device based on an evaluation of risks and hazards and "various testing of the modifications." However, it does not elaborate on what this "various testing" entailed or present specific data.
- Includes the FDA's letter confirming the substantial equivalence determination, allowing the device to be marketed.
Therefore, for your request, I must report that the requested information is largely unavailable in the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | No specific performance data is reported as "Performance Data: None." The conclusion states "various testing of the modifications" was done, leading to the substantial equivalence finding, but no numerical or descriptive performance metrics are provided. |
2. Sample size used for the test set and the data provenance:
- Sample Size (test set): Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no specific test set or ground truth establishment by experts is described for a performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no specific test set or adjudication process is described for a performance study.
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:
- No MRMC study was mentioned. The device is a "thermal sensing handpiece accessory," not an AI-driven diagnostic system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an accessory that provides information to a human operator, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no specific performance study requiring ground truth is detailed.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document is a regulatory filing for substantial equivalence, focusing on the device's description and comparison to a predicate, rather than a detailed report of a performance study with specific acceptance criteria and results.
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Premarket Notification 510(k) Summary CoolTouch Thermal Sensing Handpiece Accessory
This 510(K) Summary of safety and effectiveness for the CoolTouch Thermal Sensing Handpiece Accessory is submitted in accordance with the requirements of 21CFR 807.92.
| Applicant: | New Star Lasers, Inc. dba CoolTouch, Inc. | |
|---|---|---|
| Address: | 9085 Foothills BoulevardRoseville, CA 95747 | MAR 2 7 2009 |
| Contact Person: | Natalie R. Vollrath | |
| Telephone: | (916) 677-1900 | |
| Fax: | (916) 677-1901 | |
| Preparation Date: | February 17, 2009 | |
| Device Trade Name: | CoolTouch Thermal Sensing Handpiece Accessory | |
| Common Name: | Handpiece Accessory | |
| Classification Name: | Instrument, Surgical Powered, Laser 79-GEX | |
| Legally Marketed PredicateDevice: | New Star Temperature Diagnostic Accessory | |
| Description of the CoolTouchThermal Sensing HandpieceAccessory: | The Thermal Sensing Handpiece Accessory is a temperaturedetector which will provide the laser operator with a readoutof the temperature of the treatment area | |
| Intended use of the CoolTouchThermal Sensing HandpieceAccessory: | For use as a sensing device to measure and display thetemperature of the treatment area during procedures with theNS130 laser | |
| Performance Data: | None | |
| Conclusion: | Based on the evaluation of the risks and hazards andincluding various testing of the modifications, theCoolTouch Thermal Sensing Handpiece Accessory issubstantially equivalent to the predicate device, the NewStar Temperature Diagnostic Accessory |
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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 an abstract image of an eagle with its wings spread.
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
New Star Lasers, Inc. % Ms. Natalie Vollrath OA/RA Manager 9085 Foothills Boulevard Roseville, California 95747
MAR 2 7 2009
Re: K090410
Trade/Device Name: CoolTouch Thermal Sensing Handpiece Accessory Regulation Number: 21 CFR 878.4810 . Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 19, 2009
Dear Ms. Vollrath:
Received: March 23, 2009
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
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Page 2 - Ms. Natalie Vollrath
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
R.A. m.D. for
Melkerson 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
Device Name CoolTouch Thermal Sensing Handpiece Accessory Indications for The CoolTouch Thermal Sensing Handpiece Accessory is intended Usc for use as a sensing device to measure and display the temperature
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
of the treatment area during procedures with the NS-130 Laser.
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krone for mkm 3/27/2009
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number Logo410
Confidential
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.