(53 days)
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Not Found
No
The summary describes a simple infrared thermometer and lacks any mention of AI/ML, image processing, or performance studies typically associated with AI/ML devices.
No
The device is described as a thermometer for measuring skin surface temperature, which is a diagnostic function, not a therapeutic one. It does not exert any direct treatment or intervention.
No
Explanation: The device measures skin surface temperature, which is a physiological parameter, but the provided information does not state it is used to diagnose a disease, condition, or state of health.
No
The device is described as an "infrared thermometer," which is inherently a hardware device that uses infrared technology to measure temperature. The summary does not mention any software-only components or functions.
Based on the provided information, the TempTouch® Dermal Thermometer 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 skin surface temperature using infrared technology. This is a direct measurement of a physical property of the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states it measures "skin surface temperature of people of all ages." This aligns with a general medical device for monitoring a physiological parameter, not an IVD for analyzing a biological sample.
Therefore, the TempTouch® Dermal Thermometer falls under the category of a general medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"The TempTouch® Dermal Thermometer is an infrared thermometer intended for the non-contact measurement of skin surface temperature of people of all ages."
Product codes
FLL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
skin surface
Indicated Patient Age Range
all ages
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
Image /page/0/Picture/11 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest the shape of a bird's head and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 2005
Xilas Medical, Incorporated C/O Ms. Silvia Ankova Responsible Third Party Official Responsions Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062-2096
Re: K050137
Trade/Device Name: TempTouch® Prade Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 1, 2005 Received: March 2, 2005
Dear Ms. Ankova:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Scellon 310(t) promazine is substantially equivalent (for the referenced above and have decimined the arrest as and interest predicate devices marketed in
indications for use stated in the enclosure) to legally marketed of the Medical indications for use stated in the chelosator to regalized of the Medical Device interstate commerce prior to way 20, 1770, ce ssified in accordance with the provisions of
Amendments, or to devices that have been receive enroyel of a premarket Amendments, of to devices mat nave been rocksoned and require approval of a premarket.
The Federal Food, Drug, and Cosmetic Act (Act) that do not requires to the geperal the Federal Food, Drug, and Cosmetic Act (recy therefore, subject to the general
approval application (PMA). You may, therefore, market the device, subject to the general approval application (11MT). Four rely controls provisions of the Act include controls provisions of the Fet. "The genting of devices, good manufacturing practice, requiremond for aibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (See above) in the existing major regulations affecting (PMA), It may of subject to such adamer coal Regulations, Title 21, Parts 800 to 898. In the Archively your device can be found in the Gode of Preceives
addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Ms. Ankova
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. or me 1 co or any 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 vour 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.
Sincerelv vours.
Gustave M. Michel O.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
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STATEMENT OF INDICATIONS FOR USE
510(k) Number if known: ______________________________________________________________________________________________________________________________________________________
Device Name: TempTouch®_______________________________________________________________________________________________________________________________________________________
Indications for use:
"The TempTouch® Dermal Thermometer is an infrared thermometer "The "The "Ciffication" Delina" "Desurement of skin surface temperature of people of all ages."
Prescription use:___ XX Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter use: (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
Signature
. Ession Sign-Off) . . Mon Ogn sthesiology, General Hospital, in Section Control Dental Devices
Number K456132