(119 days)
The digital thermometer is intended to measure body temperature either orally or axillary (under the arm).
Digital Thermometer, HMCDT-002/Kinetik Branded DT1 Series
This FDA 510(k) clearance letter for a Digital Thermometer (K092557) does not contain the specific information required to complete your request.
The provided document is primarily an administrative letter granting clearance based on substantial equivalence to a predicate device. It confirms that the device can be legally marketed but does not detail the technical study results, acceptance criteria, or performance data you are asking for.
To answer your questions thoroughly, you would typically need access to the actual 510(k) summary or the full submission, which would include sections on performance testing, clinical performance (if applicable), and statistical analyses.
Therefore, under the constraints of the provided text:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The letter does not describe any specific acceptance criteria or performance metrics for the thermometer.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not available in the provided text. As this is a digital thermometer, the ground truth would likely be a reference thermometer, not expert-derived interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the provided text. (Not applicable for a thermometer performance study).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable in the provided text. This is a digital thermometer, not an AI-assisted diagnostic tool for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the provided text. The device itself is standalone in its function as a thermometer, but no "algorithm-only" performance as typically understood in AI/imaging is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available in the provided text. For a thermometer, the ground truth would typically be established using a calibrated reference thermometer, but this is not stated in the document.
8. The sample size for the training set
- Not available in the provided text. (Not typically relevant for a simple electronic thermometer, which is not usually 'trained' in the machine learning sense).
9. How the ground truth for the training set was established
- Not available in the provided text. (Not typically relevant for a simple electronic thermometer).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mr. Martin Ma Harvard Medical Devices Limited Unit 1301-2, 13th Floor, Railway Plaza 39 Chatham Road South Tsimshatsui, Kowloon HONG KONG
DEC 1 7 2009
Re: K092557
Trade/Device Name: Digital Thermometer, HMCDT-002/Kinetik Branded DT1 Series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: November 9, 2009 Received: November 12, 2009
Dear Mr. Ma:
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 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.Ma
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH /CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Susan Purrer
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use
510(k) Number (if known):
Device Name:
Digital Thermometer, HMCDT-002/Kinetik Branded DT1 Series
Indications For Use:
The digital thermometer is intended to measure body temperature either orally or axillary (under the arm).
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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.