(44 days)
Not Found
No
The device description explicitly states the operation principle is based on thermistor and ASIC technology, with the sensor signal calculated and displayed by an ASIC. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as a "Digital Clinical Thermometer" intended for "measurement and monitoring of human body temperature," which is a diagnostic function, not a therapeutic one. It does not mention treating or preventing any condition.
No
A diagnostic device identifies or characterizes a disease or condition. This device measures body temperature, which is a vital sign, but it does not diagnose a disease on its own.
No
The device description explicitly states it is a hand-held, reusable, battery-operated device that uses a thermistor and ASIC technology, including hardware components like a sensor, resistor, buzzer, ASIC, and LCD. This indicates it is a physical hardware device, not software-only.
Based on the provided information, the Famidoc Digital Clinical Thermometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Famidoc Thermometer Function: The Famidoc Digital Clinical Thermometer directly measures human body temperature. It does not analyze any biological specimens.
- Intended Use: The intended use is for "measurement and monitoring of human body temperature," which is a direct physiological measurement, not an analysis of a specimen.
Therefore, the Famidoc Digital Clinical Thermometer falls under the category of a general medical device for physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
Famidoc Digital Clinical Thermometer Model FDTH-V0-1、FDTH-V0-2、 FDTH-V0-3、 FDTH-V0-4 are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home. It is used alone for human beings at all ages.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Famidoc Digital Clinical Thermometer (model FDTH-V0-1, FDTH-V0-2, FDTH-V0-3, FDTH-V0-4) are hand-held, reusable, battery operated, maximum device that can measures human body temperature.
Models FDTH-V0-1, FDTH-V0-2, FDTH-V0-3, FDTH-V0-4 have the same indication for use. the difference points are their shapes、waterproof function and measurement speed.
The operation principle is based on thermistor and ASIC technology, a thermistor using as temperature sensor, the sensor's signal is then calculated and displayed by an ASIC. The digital thermometer comprises a thermistor for temperature sensing, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC and a LCD for calculating and displaying the target temperature digitally which the thermistor is immersed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human body
Indicated Patient Age Range
all ages
Intended User / Care Setting
Doctor or consumers in the hospital or home.
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)
The devices meet the ASTM Standard Specification for Electronic Thermometer for intermittent Determination of Patient Temperature ( ASTM Ell12-00 ), as well as IEC 60601-1 and IEC 60601-1-2 requirements, Bench testing confirmed accuracy, precision and repeatability measurements specified in the labeling. For all body contacting materials, analysis is made that the identical materials have been used in other legally marketed devices under the same use conditions (see Chapter 8 Safety and Effectiveness Evaluation and Risk Analysis, Chapter 10 Biological Compatibility Report). And we had made clinical tests to prove its repeatability and standard deviation are accord with the demand of EN 12470-3:2000 when applied human.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Chapter 13 510(K) Summary
510(K) SUMMARY
NOV - 1 2007
Famidoc Digital Clinical Thermometer FDTH-V0-1, FDTH-V0-2, FDTH-V0-3, FDTH-V0-4
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR § 807.92
| 1.0 Submitter's Name: | FAMIDOC TECHNOLOGY CO., LTD. |
|---|---|
| Address: | 6/F,G Building ,No.14, Liuxian 1st RD.71 Block |
| Baoan District, Shenzhen,Guangdong,P.R. China. | |
| Phone: | 86-755-27864337 Ext.807 |
| Fax: | 86-755-27864151 |
| Contact: | Mr. Steeljin, |
| E-mail: | steeljin@famidoc.com |
| leon@famidoc.com | |
| Date | October 11, 2007 |
| 2.0 Device Name: | Famidoc digital clinical thermometer |
|---|---|
| Model: | FDTH-V0-1, FDTH-V0-2, FDTH-V0-3, FDTH-V0-4 |
| Classification Name: | Clinical Electronic Thermometer |
3.0 Classification: Class II
4.0 Predicate Device Information:
Actherm digital clinical thermometer Model: ACT 2000. It's 510(K) number is K010238
5.0 Device Description:
Famidoc Digital Clinical Thermometer (model FDTH-V0-1, FDTH-V0-2, FDTH-V0-3, FDTH-V0-4) are hand-held, reusable, battery operated, maximum device that can measures human body temperature.
1
Models FDTH-V0-1, FDTH-V0-2, FDTH-V0-3, FDTH-V0-4 have the same indication for use. the difference points are their shapes、waterproof function and measurement speed.
The operation principle is based on thermistor and ASIC technology, a thermistor using as temperature sensor, the sensor's signal is then calculated and displayed by an ASIC. The digital thermometer comprises a thermistor for temperature sensing, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC and a LCD for calculating and displaying the target temperature digitally which the thermistor is immersed.
6.0 Intended Use:
Famidoc Digital Clinical Thermometer Model FDTH-V0-1、FDTH-V0-2、 FDTH-V0-3、 FDTH-V0-4 are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home. It is used alone for human beings at all ages.
7.0 Measurement Type:
There are three measurement types to use our thermometer. Axillary measurement, Oral measurement and rectal measurement, when used under the Axillary, it directly contacts body skin. For oral or rectum use, it directly contacts membrane tissue.
8.0 Performance Data:
The devices meet the ASTM Standard Specification for Electronic Thermometer for intermittent Determination of Patient Temperature ( ASTM Ell12-00 ), as well as IEC 60601-1 and IEC 60601-1-2 requirements, Bench testing confirmed accuracy, precision and repeatability measurements specified in the labeling. For all body contacting materials, analysis is made that the identical materials have been used in other legally marketed devices under the same use conditions (see Chapter 8 Safety and Effectiveness Evaluation and Risk Analysis, Chapter 10 Biological Compatibility Report). And we had made clinical tests to prove its repeatability and standard deviation are accord with the demand of EN 12470-3:2000 when applied human.
2
K072641 (P.3043)
9.0 Comparison to Predicate Devices and conclusions
Our Digital Clinical Thermometer Model FDTH-V0-1、FDTH-V0-2、 FDTH-V0-3、 FDTH-V0-4 are substantially equivalent to Actherm digital clinical thermometer Model: ACT 2000, It's 510(k) number is K010238.
They are very similar in design principle, intended use, functions, material and the adopting applicable standards.
Only their outlook and some parameter such as measurement speed, battery life is different. Moreover, tests in this submission provide demonstrate these small difference do not raise and new questions of safety or effectiveness.
Conclusions: the Famidoc Digital Clinical Thermometer Model FDTH-V0-1、FDTH-V0-2、FDTH-V0-3、 FDTH-V0-4 are substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 1 2007
Famidoc Technology Company, Limited C/O Mr. Tomas Huang Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747
Re: K072641
Trade/Device Name: Famidoc Digital Clinical Thermometer FDTH-VO-1, FDTH-VO-2, FDTH-VO-3, FDTH-VO-4 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 17, 2007 Received: October 18, 2007
Dear Mr. Huang:
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.
4
Page 2 - Mr. Hang
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 (OS) 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.
Chis Lins 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
5
Indications for Use
510(k) Number (if known):
Device Name: Famidoc Digital Clinical Thermometer
Indications for Use:
Famidoc Digital Clinical Thermometers are intended for the measurement and monitoring of human body temperature, by doctor or consumers in the hospital or home. It is used alone for human beings at all ages.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use イ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Am
on of Anesthesiology, General Horolhal, Incollion Control, Dental Devices
umber: K912641