(14 days)
The TempTouch® Dermal Thermometer is an infrared thermometer intended for the intermittent measurement of skin surface temperature of people of all ages.
The TempTouch® is a handheld, 9V battery-operated device that measures the surface temperature of the skin. Operation is based on measuring the natural thermal infrared radiation emitted from the surface of the skin.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy Test | Conformance to standard | Pass |
| Repeatability Tests | Conformance to standard | Pass |
| °F vs. °C tests | Conformance to standard | Pass |
| Variable Voltage Tests | Conformance to standard | Pass |
| Error Message Tests | Conformance to standard | Pass |
| Display Limits Tests | Conformance to standard | Pass |
Note: The document states "Since performance testing confirms conformance to the same standard as the predicate device," which implies the acceptance criteria for each test was to meet the standards set by the predicate device (Omega Surface Temperature Scanner K873010 and Temp Touch Dermal Thermometer K050137) for each specific test. The exact numerical or descriptive acceptance criteria for each test are not explicitly detailed in the provided text.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The document describes "Summary-Non-Clinical Performance Testing," suggesting laboratory-based assessments rather than clinical studies on human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to the provided document. The tests performed are "Non-Clinical Performance Testing" (e.g., Accuracy, Repeatability), which typically rely on calibrated instruments and objective measurements rather than expert human interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. Since the tests are non-clinical performance evaluations, there wouldn't be an adjudication method in the context of human expert review.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or reported in the provided document. The study focuses solely on the performance of the device itself, not on how human readers improve with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone study (algorithm/device only performance without human-in-the-loop) was done. The "Summary-Non-Clinical Performance Testing" directly assesses the device's accuracy, repeatability, and other functional aspects without human intervention in the measurement process.
7. Type of Ground Truth Used
The ground truth for the non-clinical performance tests would be based on calibrated reference standards and objective physical measurements. For example:
- Accuracy: Comparison to a highly accurate reference thermometer.
- Repeatability: Statistical analysis of multiple measurements under controlled conditions.
- °F vs. °C tests: Verification against standard temperature conversion calculations.
- Variable Voltage Tests: Operating the device at different voltage levels and checking for correct function.
8. Sample Size for the Training Set
This information is not applicable. The TempTouch® Dermal Thermometer is described as a device that measures infrared radiation to determine skin surface temperature. There is no mention of a "training set" in the context of machine learning or AI. The device likely relies on pre-programmed algorithms and physical principles rather than being "trained" on data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated in point 8. The device's functionality is based on established physical principles of infrared thermometry, not on machine learning from a training set.
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510(k) Summary
| Submitter: | Diabetica Solutions Inc.12665 Silicon DriveSan Antonio, TX 78249(210) 692-1114 Telephone(210) 692-1144 Fax | K081162 (P.1 of 2)MAY - 8 2008 |
|---|---|---|
| Contact Person: | J. B. Allinson Jr. | |
| Date of Summary: | February 28, 2008 | |
| Trade Name: | TempTouch® Dermal Thermometer | |
| Common Name: | Skin Surface Thermometer | |
| Device Description: | The TempTouch® is a handheld, 9V battery-operated devicethat measures the surface temperature of the skin. Operationis based on measuring the natural thermal infrared radiationemitted from the surface of the skin. | |
| Intended Use: | The TempTouch® is an infrared thermometer intended forthe intermittent measurement and monitoring of humanskin surface temperature in the home or clinic for use withpeople of all ages. | |
| Classification: | Clinical Electronic ThermometerProduct Code: FLLRegulation No. 880.2910Class: IIPanel: 80 (General Hospital) | |
| Predicate Device(s): | Omega Surface Temperature Scanner(K873010)Temp Touch Dermal Thermometer(K050137) | |
| Technical Characteristics: | The TempTouch® Thermometer and the predicate devicesare used to measure the temperature of a human by meansof a thermopile infrared sensor transducer coupled withelectronic signal amplification, conditioning, and a displayunit |
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KABI162 (0,2002)
The Omega predicate employs solid- state electronic signal amplification, which is technology similar to the electronic surface mount technology used by the TempTouch® thermometer. Both display units employ solid-state displays, with the predicate using an LED display while the TempTouch thermometer uses an LCD display.
Summary-Non-Clinical Performance Testing:
| Performance Test | Results |
|---|---|
| Accuracy Test | Pass |
| Repeatability Tests | Pass |
| °F vs. °C tests | Pass |
| Variable Voltage Tests | Pass |
| Error Message Tests | Pass |
| Display Limits Tests | Pass |
Conclusion:
Since performance testing confirms conformance to the same standard as the predicate device, we conclude the device is substantially equivalent to that device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 8 2008
Diabetica Solutions Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
Re: K081162
Trade/Device Name: TempTouch® Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 23, 2008 Received: April 24, 2008
Dear Mr. Devine:
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.
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Page 2 - Mr. Devine
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 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clive
Shieh-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number if known: __ Ko 8/163
Device Name: TempTouch®
Indications for use:
"The TempTouch® Dermal Thermometer is an infrared thermometer intended for the intermittent measurement of skin surface temperature of people of all ages."
Prescription use: XX Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter use: __ XX ___________________________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Cinta air
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
TempTouch® FDA Submission
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§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.