(83 days)
Not Found
Not Found
No
The summary describes standard digital thermometers and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details related to training/test sets and performance studies typically associated with AI/ML devices.
No.
The devices are described as electronic clinical thermometers intended to measure human body temperature, which is a diagnostic function, not a therapeutic one. They do not treat or alleviate a medical condition.
No
Explanation: The devices are described as electronic clinical thermometers intended to measure human body temperature. While temperature measurement can be part of a diagnostic process, the device itself is for measurement, not for making a diagnosis.
No
The device description explicitly lists "Digital Flexible Thermometer Model DT-101", "Basal Digital Thermometer Model DT-02", and "Digital Pacifier Thermometer Model NT-01", which are physical hardware devices designed to measure temperature.
No, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens obtained from the human body. This includes things like blood, urine, tissue, etc., to provide information about a physiological state, health, or disease.
- These devices measure the human body temperature directly. They are in contact with the body (orally, rectally, under the arm) and do not analyze a sample taken from the body.
Therefore, based on the provided information, these electronic clinical thermometers are medical devices, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The devices models DT-02 and DT-101 are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.
The device model NT-01 is an electronic clinical thermometer with pacifier probe head intended to measure oral temperature. The device is reusable for clinical or home use for children under the age of four.
Product codes
FLL
Device Description
Digital Flexible Thermometer Model DT-101
Basal Digital Thermometer Model DT-02
Digital Pacifier Thermometer Model NT-01
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orally, rectally or under the arm (for DT-02 and DT-101); oral (for NT-01)
Indicated Patient Age Range
people of all ages (for DT-02 and DT-101); children under the age of four (for NT-01)
Intended User / Care Setting
clinical or home use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 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 a stylized image of an eagle with three horizontal lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 3 2004
Mr. JI Bo General Manager Hangzhou Hua'an Medical & Health Instrument Company Limited Building 2, Baimiao Industrial Park, Economic Development Zone Wuchang Hangzhou Zhejiang 310023 P.R. CHINA
Re: K041694
Trade/Device Name: Digital Flexible Thermometer Model DT-101 Basal Digital Thermometer Model DT-02 Digital Pacifier Thermometer Model NT-01 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 7, 2004 Received: September 7, 2004
Dear Mr. Bo:
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 approvisions of the Act. The general controls provisions of the Act include controls provision 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 (1 will), it hay of base of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Bo
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 Incall that I Dri nab made a aves and regulations administered by other Federal agencies. of the Act of ally I outlar statutes including, but not limited to: registration You must comply with an all all the brog (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 007), absitisg (QS) regulation (21 CFR Part 820); and if requirences as set form in are qualify ion 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) This iction will anow your be FDA finding of substantial equivalence of your device to a premarket notification. - 11 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), If you desire specific at .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 may obtain other generational and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
2
Indications for Use Statement
510(k) Number (if known): K041694
Device Name:
Digital Flexible Thermometer Model DT-101
Basal Digital Thermometer Model DT-02
Digital Pacifier Thermometer Model NT-01
Indication For Use:
The devices models DT-02 and DT-101 are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.
The device model NT-01 is an electronic clinical thermometer with pacifier probe head intended to measure oral temperature. The device is reusable for clinical or home use for children under the age of four.
Prescription Use (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)
Cerothan vrm
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: Κώμβ 44
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