(37 days)
Not Found
Not Found
No
The summary describes a simple temperature sensor and does not mention any AI or ML capabilities.
No.
Explanation: The device is described as a "sensing device" and "temperature detector" used to "measure and display the temperature of the treatment area." Its purpose is to provide information to the laser operator, not to directly treat a condition or provide therapy.
No
The device measures and displays temperature, which is a physiological parameter, but its stated purpose is for monitoring during a laser procedure, not for diagnosing a condition or disease. The product name of the predicate device, "New Star Temperature Diagnostic Accessory," could be misleading, as this device's function as described is solely for measurement and display, not a diagnostic one.
No
The device description explicitly states it is a "temperature detector" and a "sensing device," implying a physical component that measures temperature, which is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The device described is a temperature sensor that measures the temperature of the treatment area during a laser procedure. It does not analyze biological samples from the patient.
- Intended Use: The intended use is to provide temperature feedback to the laser operator during a procedure, not to diagnose a condition based on analysis of a biological sample.
Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
"For use as a sensing device to measure and display the temperature of the treatment area during procedures with the NS130 laser"
"The CoolTouch Thermal Sensing Handpiece Accessory is intended for use as a sensing device to measure and display the temperature of the treatment area during procedures with the NS-130 Laser."
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
"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"
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
"None"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
New Star Temperature Diagnostic Accessory
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 Boulevard | |
| Roseville, 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 Predicate | ||
| Device: | New Star Temperature Diagnostic Accessory | |
| Description of the CoolTouch | ||
| Thermal Sensing Handpiece | ||
| Accessory: | 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 | ||
| Intended use of the CoolTouch | ||
| Thermal Sensing Handpiece | ||
| Accessory: | For use as a sensing device to measure and display the | |
| temperature of the treatment area during procedures with the | ||
| NS130 laser | ||
| Performance Data: | None | |
| Conclusion: | Based on the evaluation of the risks and hazards and | |
| including various testing of the modifications, the | ||
| CoolTouch Thermal Sensing Handpiece Accessory is | ||
| substantially equivalent to the predicate device, the New | ||
| Star Temperature Diagnostic Accessory |
1
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
2
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
3
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
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510(k) Number Logo410
Confidential