(90 days)
Not Found
No
The summary describes a simple temperature sensor and display, with no mention of AI/ML terms or functionalities.
No
The device is described as a "sensing device" and a "temperature detector" that measures and displays temperature. Its function is to provide information for the laser operator, not to directly treat or cure a condition.
No
Explanation: The device is described as a "sensing device to measure and display the temperature" and a "temperature detector." While it provides information, it doesn't appear to analyze or interpret that information to diagnose a condition, which is a characteristic of a diagnostic device. Its function is to provide a measurement during a procedure, rather than to diagnose a medical state.
No
The device description explicitly states it is a "temperature detector" and a "sensing device," implying a physical component is required to measure temperature, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure and display the temperature of a treatment area during a procedure with a laser. This is a measurement taken on the patient's body (or the area being treated), not on a sample of biological material taken from the body.
- Device Description: The device is described as a "temperature detector" providing a "control panel read out of the temperature of the treatment area." This reinforces its function as a real-time measurement device during a procedure.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health status, diagnose diseases, or monitor treatment. This device does not perform any of these functions.
The device is an accessory for a laser system used in a medical procedure, providing real-time feedback to the operator. It does not analyze biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
treatment area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laser operator
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)
Nonclinical Performance Data: None
Clinical Performance Data: 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.
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.
0
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 Road | |
| Auburn, 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, laser | |
| 79-GEX | ||
| 21 CFR 878-4810 | ||
| Legally Marketed Predicate Device: | Fiber Tipped Protection System accessory cleared for market | |
| as part of the Optica 60 Nd: YAG Laser System, Mfg. by | ||
| Xintec Corp., Oakland, CA Cleared under 510(K) # | ||
| K912703 | ||
| Description of the Temperature Diagnostic | ||
| Accessory | 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. | ||
| Intended use of the Temperature | ||
| Diagnostic Accessory | 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. | ||
| Nonclinical Performance Data: | None | |
| Clinical Performance Data: | None | |
| Conclusion: | The Temperature Diagnostic Accessory is substantially | |
| equivalent to other existing automatic temperature | ||
| measuring accessories. | ||
| Additional Information: | None requested at this time |
1
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
Image /page/1/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wing shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle emblem.
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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.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tocoeep o
Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use ------