(44 days)
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.
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.
The document provided describes the Famidoc Digital Clinical Thermometer and its FDA 510(k) summary. Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Standards Met: | |
| ASTM Standard Specification for Electronic Thermometer for intermittent Determination of Patient Temperature (ASTM Ell12-00) | Bench testing confirmed accuracy, precision, and repeatability measurements specified in the labeling. |
| IEC 60601-1 | Met |
| IEC 60601-1-2 | Met |
| EN 12470-3:2000 (repeatability and standard deviation) | Clinical tests proved repeatability and standard deviation are in accord with the demand of EN 12470-3:2000 when applied to humans. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "clinical tests" for repeatability and standard deviation based on EN 12470-3:2000. However, it does not specify the sample size used for these tests. The country of origin and whether the data was retrospective or prospective are not mentioned.
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)
This information is not provided in the document. The nature of the device (a thermometer) suggests that ground truth would likely be established by a reference temperature standard rather than expert consensus on interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Given the type of device, an adjudication method as typically described for image analysis or diagnostic interpretation by experts would not be applicable.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. This type of study is typically relevant for AI-powered diagnostic tools that assist human readers, which is not the function of a digital clinical thermometer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone electronic thermometer. The "bench testing" mentioned for accuracy, precision, and repeatability, as well as the "clinical tests" for repeatability and standard deviation, effectively constitute standalone performance assessments. The performance reported in the table (meeting ASTM and IEC standards) is the standalone performance of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing and clinical tests, the ground truth would inherently be a highly accurate reference temperature (e.g., from a calibrated standard thermometer or controlled thermal environment). The document doesn't explicitly state "reference temperature" as the ground truth but refers to meeting standards like ASTM Ell12-00, which govern the accuracy of thermometers against such reference standards.
8. The sample size for the training set
The device described is a digital clinical thermometer, which is a physical measurement device based on thermistor and ASIC technology. It does not involve a "training set" in the context of machine learning or AI algorithms. Therefore, this question is not applicable to the described device.
9. How the ground truth for the training set was established
As there is no "training set" for this type of device, this question is not applicable.
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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 BlockBaoan District, Shenzhen,Guangdong,P.R. China. |
| Phone: | 86-755-27864337 Ext.807 |
| Fax: | 86-755-27864151 |
| Contact: | Mr. Steeljin, |
| E-mail: | steeljin@famidoc.comleon@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.
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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.
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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.
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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.
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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
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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
§ 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.