(83 days)
To measure the human body temperature in regular mode orally, rectally or underarm. The devices are reusable for clinical or home use on people of all ages.
The GF-MT501 and GF-MT502 digital thermometer comprise of a thermistor for measuring sensor, a reference resistor for comparison of the temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. The thermometers use a DC 1.5V battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays ' in LCD display.
Here's an analysis of the provided information regarding the GF-MT501 and GF-MT502 digital thermometers:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM E1112-00 (2006) | Complied with requirements |
| IEC 60601-1 (2005) | Complied with requirements |
| IEC 60601-1-2 (2007) | Complied with requirements |
| ISO 10993-5 (2009) | Complied with requirements |
| ISO 10993-10 (2002) | Complied with requirements |
| Temperature Range | Confirmed |
| Accuracy | Confirmed |
| Operating Environment | Confirmed |
| Storage Environment | Confirmed |
| Resolution | Confirmed |
| Readability | Confirmed |
| Repeatability | Confirmed |
| Biocompatibility (Body contacting materials) | Identical materials used in other legally marketed devices under same use conditions (implies acceptable, but specific test results for these devices not provided) |
Note on "Complied with requirements": The provided text states the devices "complied with the requirements" of the listed standards and that bench testing "confirmed" various performance aspects. However, it does not provide specific numerical values for accuracy, temperature range, resolution, or repeatability from these tests. These specific performance metrics are typically defined within the cited standards.
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated. The document refers to "bench testing" but does not specify the number of units tested or the number of measurements taken.
- Data provenance: Not explicitly stated. However, since the manufacturer is Hangzhou Universal Electronic Co., Ltd. located in China, it is reasonable to infer the testing was likely conducted in China. The study appears to be prospective bench testing as it was performed to demonstrate compliance for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This study involves bench testing of a medical device (digital thermometer) against technical standards. It does not involve human expert interpretation of data or images to establish a "ground truth" in the way a diagnostic AI study would. The ground truth for temperature measurement would be established by calibrated reference thermometers in a controlled laboratory environment.
4. Adjudication method for the test set:
- Not applicable. As this is bench testing of a physical device against technical standards, there is no need for expert adjudication. The compliance is determined by measurements against specified thresholds and methodologies outlined in the standards (e.g., ASTM E1112).
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:
- No. This is a regulatory submission for a simple digital thermometer, not an AI-powered diagnostic device, so an MRMC study is not relevant or included.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The testing described is standalone performance testing of the digital thermometer itself. The device's measurement capabilities (accuracy, resolution, etc.) were assessed independently against established standards and reference measurements, without human interaction influencing the measurement process (beyond operating the device in a standard way). However, it's not "algorithm only" in the context of AI, but rather the device's inherent design and functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the bench testing would be calibrated reference measurements from highly accurate and traceable temperature sensors/probes in a controlled laboratory environment, as specified by the testing standards (e.g., ASTM E1112).
8. The sample size for the training set:
- Not applicable. This device is a digital thermometer, not an AI/machine learning model, so there is no concept of a "training set" in the context of the provided documentation.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, this question does not apply.
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Hangzhou Universal Electronic Co., Ltd.
No.38, Yangjiatang, Sandun, Westlake District, Hangzhou, Zhejiang Province, China, 310030 .Tel: +86 86-571-88308206 ------Fax:-+86--86-571-89905288 --------- -- . .
510(k) Summary
DEC 1 3 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date of summary was prepared: Aug. 30, 2010
Device
Trade name: GF-MT501 digital thermometer
GF-MT502 digital thermometer
Common/Usual name: Digital thermometer
Classification name: Clinical electronic thermometer
Medical specialty (Panel): General Hospital
Regulation number: 880.2910
Product Code: FLL
Classification: Class II
Predicate devices
ECT Digital Thermometer(K101043)/Changshan Estar Electronics Co., Ltd.
Indication for Use
GF-MT501 and GF-MT502 digital thermometer are electronic clinical thermometers which are intended to measure the human body temperature in regular mode orally, rectally or underarm. The devices are reusable for clinical or home use on people of all ages.
Device description:
The GF-MT501 and GF-MT502 digital thermometer comprise of a thermistor for measuring sensor, a reference resistor for comparison of the temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.
The thermometers use a DC 1.5V battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays ' in LCD display.
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Hangzhou Universal Electronic Co., Ltd. No.38, Yangjiatang, Sandun, Westlake District, Hangzhou, Zhejiang Province, China, 310030
.
Tel: +86 86-571-88308206 Fax: +86- 86-571-89905288 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Statement of substantial equivalence
The GF-MT501 and GF-MT502 digital thermometer are similar in design and intended use to the ECT(K101043) digital thermometer, differing only in physical dimensions. They use a thermistor to measure temperature and comprise of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.
While there are minor differences in performance specifications of the thermometers, these differences do not alter the intended use function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, Hangzhou Universal Electronic Co., LTD. believes that the GF-MT501 and GF-MT502 digital thermometer are substantially equivalent to legally marketed devices currently in commercial distribution.
Summary of Non-Clinical Testing
The GF-MT501 and GF-MT502 digital thermometer complied with the requirements of ASTM E1112-00 (2006) standard specifications, as well as IEC 60601-1(2005), IEC 60601-1-2(2007), ISO 10993-5(2009) and ISO 10993-10(2002) requirements. Bench testing confirmed the temperature range, accuracy, operating environment, storage environment, resolution, readability and repeatability. 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.
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Hangzhou Universal Electronic Co., Ltd. concludes that, GF-MT501 and GF-MT502 digital thermometer are substantially equivalent to predicate devices as described herein.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem is a blue-colored design that resembles a stylized caduceus or a symbol representing health and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
International Regulatory Consultants, LLC (IRC) C/O Mr. Jacob Chang Beitun District 16F-2(16A), Sec. 2. Chong De Road Taichung China 406
JAN 1 2 2011
Re: K102718
Trade/Device Name: GF-MT501 digital Thermometer and GF-MT502 Digital Thermometer Regulation Number: 21 CFR 880.2190 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 5. 2010 Received: November 5, 2010
Dear Mr. Chang:
This letter corrects our substantially equivalent letter of December 13, 2010.
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 (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. Chang
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 vours.
Jama D. Ksoces
for
Arthur D. Watson, P.S.M.
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
DEC 1 3 2010
510(k) Number (if known): Klog718
Device Name: GF-MT501 digital thermometer and GF-MT502 digital thermometer
Indications for Use:
. t
To measure the human body temperature in regular mode orally, rectally or underarm. The devices are reusable for clinical or home use on people of all ages.
Over-The-Counter Use __ X Prescription Use (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) AND/OR
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard Chavez 12/13/20
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K10271 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
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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.