(90 days)
The Temperature Diagnostic Accessory is intended for use as a sensing device to measure and display the temperature of the treatment area during procedures with the ND-130 Laser.
The Temperature Diagnostic Accessory is a temperature detector which will provide the laser operator with a control panel read out of the temperature of the treatment area.
The provided documentation for the New Star Lasers Temperature Diagnostic Accessory (K973064) does not contain information regarding acceptance criteria or a study proving the device meets those criteria. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria.
Specifically, the "Nonclinical Performance Data" and "Clinical Performance Data" sections both state "None." This indicates that no studies, as typically understood for establishing performance against predefined criteria, were conducted or submitted.
The conclusion states: "The Temperature Diagnostic Accessory is substantially equivalent to other existing automatic temperature measuring accessories." This suggests that the substantial equivalence argument was based on design, intended use, and potentially basic functional comparisons without rigorous performance testing against specific acceptance criteria.
Therefore, I cannot provide the requested information in the table or address the details about sample size, ground truth, expert involvement, or comparative effectiveness studies because this information is not present in the provided text.
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Attachment I 510(K) Summary Temperature Diagnostic Accessory
This 510(K) Summary of safety and effectiveness for the Temperature Diagnostic Accessory is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | New Star Lasers | DEC 31 1997 |
|---|---|---|
| Address: | 11802 Kemper RoadAuburn, CA 95603 | |
| Contact Person: | Nina Davis | |
| Telephone: | (916) 823-1434(916) 823-1446 | |
| Preparation Date: | 10-1-97 | |
| Device Trade Name: | Temperature Diagnostic Accessory | |
| Common Name: | Temperature Diagnostic Accessory | |
| Classification Name: | Instrument, Surgical, Powered, laser79-GEX21 CFR 878-4810 | |
| Legally Marketed Predicate Device: | Fiber Tipped Protection System accessory cleared for marketas part of the Optica 60 Nd: YAG Laser System, Mfg. byXintec Corp., Oakland, CA Cleared under 510(K) #K912703 | |
| Description of the Temperature DiagnosticAccessory | The Temperature Diagnostic Accessory is a temperaturedetector which will provide the laser operator with a controlpanel read out of the temperature of the treatment area. | |
| Intended use of the TemperatureDiagnostic Accessory | The Temperature Diagnostic Accessory is intended for useas a sensing device to measure and display the temperatureof the treatment area during procedures with the ND-130Laser. | |
| Nonclinical Performance Data: | None | |
| Clinical Performance Data: | None | |
| Conclusion: | The Temperature Diagnostic Accessory is substantiallyequivalent to other existing automatic temperaturemeasuring accessories. | |
| Additional Information: | None requested at this time |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dave Hennings, M.S. President New Star Lasers, Incorporated 11802 Kemper Road Auburn, California 95603
Re: K973764
Trade Name: Temperature Diagnostic Accessory Regulatory Class: II Product Code: GEX Dated: October 1, 1997 Received: October 2, 1997
DEC 3 1 1997
Dear Mr. Hennings:
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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections. the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements 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
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Page 2 - Mr. Hennings
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4595. 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,
toole
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
K973764 510(k) Number:
Device Name: New Star Temperature Diagnostic Accessory Indications for Use:
The Temperature Diagnostic Accessory is intended for use as a sensing device to measure and display the temperature of the treatment area during procedures with the ND-130 Laser.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
tocoeep o
Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use ------
§ 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.