(14 days)
No
The description focuses on basic infrared temperature measurement and does not mention any AI or ML components or capabilities.
No
The device is an infrared thermometer for measuring skin temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No.
The device measures skin surface temperature, which is a physiological parameter, but it does not diagnose a disease or condition. Its intended use is for "intermittent measurement of skin surface temperature," not for diagnosing any medical condition.
No
The device description explicitly states it is a "handheld, 9V battery-operated device" that measures temperature using infrared radiation, indicating it is a hardware device, not software-only.
No, 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.
- TempTouch® Function: The TempTouch® Dermal Thermometer measures the surface temperature of the skin using infrared radiation. This is a non-invasive measurement taken directly from the body's surface, not from a sample taken from the body.
The intended use and device description clearly indicate it's a thermometer for measuring skin temperature, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The TempTouch® is an infrared thermometer intended for the intermittent measurement and monitoring of human skin surface temperature in the home or clinic for use with people of all ages.
Product codes
FLL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin surface
Indicated Patient Age Range
all ages
Intended User / Care Setting
home or clinic
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Omega Surface Temperature Scanner (K873010), Temp Touch Dermal Thermometer (K050137)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary
| Submitter: | Diabetica Solutions Inc.
12665 Silicon Drive
San 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 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. | |
| Intended Use: | The TempTouch® is an infrared thermometer intended for
the intermittent measurement and monitoring of human
skin surface temperature in the home or clinic for use with
people of all ages. | |
| Classification: | Clinical Electronic Thermometer
Product Code: FLL
Regulation No. 880.2910
Class: II
Panel: 80 (General Hospital) | |
| Predicate Device(s): | Omega Surface Temperature Scanner
(K873010)
Temp Touch Dermal Thermometer
(K050137) | |
| Technical Characteristics: | The TempTouch® Thermometer and the predicate devices
are used to measure the temperature of a human by means
of a thermopile infrared sensor transducer coupled with
electronic signal amplification, conditioning, and a display
unit | |
·
1
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.
2
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The background is white.
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.
3
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)
Page 1 of 1
Cinta air
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
TempTouch® FDA Submission
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