The digital thermometers MT series are 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.

Device Description

Digital Thermometer MT series enable fast and reliable measurements. These thermometers provide very high clinical accuracy, and have been designed to provide maximum user-friendliness. Digital Thermometer MT series can be used in conjunction with or without a disposable probe cover, when preferred. The basic principle of these thermometers is that a change of thermistor resistance, caused by changes of temperature, is converted to changes of frequency of R-C oscillator circuit. Therefore, temperature can be given by measuring the frequency of the oscillator. For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SEJOY Digital Thermometer MT series. The document asserts the device's substantial equivalence to previously cleared predicate devices. While it mentions compliance with standards and the performance of clinical studies, it does not provide detailed acceptance criteria or the specific results of those studies in a format that allows for the extraction of the requested information.

Specifically, the document states:

"Controlled human clinical studies were conducted using the digital thermometer MT series. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Sejoy Clinical Test Protocol outline."

However, it does not provide the acceptance criteria for these metrics (e.g., maximum allowable bias, uncertainty, or repeatability), nor does it report the observed performance of the device against any such criteria.

Therefore, I cannot populate the table of acceptance criteria and reported device performance.

Furthermore, without the detailed study report, the following information cannot be extracted:

Sample size used for the test set and the data provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. For a thermometer, "ground truth" would typically refer to a highly accurate reference thermometer, not expert consensus.
Adjudication method: Not applicable for a thermometer accuracy study.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for a thermometer.
Standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a thermometer, and its primary performance is standalone measurement. While clinical studies were done, the details of how "standalone performance" (e.g., in a laboratory setting with a reference standard) compared to human-in-the-loop (e.g., actual clinical use) are not discussed in this summary. The summary focuses on "clinical bias, clinical uncertainty and clinical repeatability."
The type of ground truth used: Not explicitly stated, but for thermometer accuracy, it would be a reference thermometer and/or a controlled thermal environment.
The sample size for the training set: Not applicable; this device is a hardware product, not an AI/algorithm-based device requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary of available information:

Information Requested	Details from the Document
Acceptance Criteria & Reported Performance	Not provided in the document. The document mentions "clinical bias, clinical uncertainty, and clinical repeatability" were evaluated, but the specific numerical acceptance criteria and the device's achieved performance against these criteria are not disclosed.
Sample size (test set)	Not specified.
Data provenance (country, retrospective/prospective)	Not specified. "Controlled human clinical studies were conducted," implying prospective, but location is not mentioned.
Number of experts / qualifications (ground truth)	Not applicable in the context of thermometer accuracy. Ground truth would be established by a reference standard.
Adjudication method	Not applicable.
MRMC comparative effectiveness study	No, not applicable for this device type.
Standalone performance study	Yes, the clinical studies evaluate the device's performance, which is inherently standalone for a thermometer. Specific separate "standalone" studies vs. "human-in-the-loop" are not detailed.
Type of ground truth	Not explicitly stated, but for a thermometer, this would typically involve highly accurate reference thermometers in controlled environments or during clinical measurements.
Sample size (training set)	Not applicable; this is a hardware device, not an AI/algorithm.
Ground truth for training set	Not applicable.

In conclusion, while clinical studies were performed to evaluate the SEJOY Digital Thermometer MT series, the provided 510(k) summary does not contain the detailed quantitative acceptance criteria or the specific results required to populate the requested table and answer the study-specific questions. The summary focuses on declaring substantial equivalence based on overall design, intended use, and compliance with general standards (ASTM E 1112, IEC60601-1, IEC60601-1-2 and ISO10993-1).

Summary

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SEJOY

AUG 2 4 2011

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K110776

l. Submitter's Identification:

Name: SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. Address: Building 2, No.202, Zhenzhong Road, West Lake Economy &. Technology Zone, 310030 Hangzhou, China

2. Information of the Device:

Name of the Device:	Digital thermometer MT Series
Including:	Digital Thermometer Model
	MT-101D, MT-101M, MT-101P, MT-101R, MT-111,
	MT-111R, MT-1019;
	MT-201R, MT-2019, MT-2121;
	MT-402S, MT-4218, MT-4220, MT-4223;
	MT-401, MT-401A, MT-401P, MT-401R, MT-4119,
	MT-4121, MT-403S, MT-4318, MT-4320,MT-4323,
	MT-4625
Classification name:	Clinical Electronic Thermometer (per CFR 880.2910)
Class:	II
Panel:	80
Product code:	FLL- Clinical Electronic Thermometer

3. Information of Predicate Device:

DIGITAL THERMOMETER MODEL MT-101 510(k) number: K051699 Applicant: SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. Owner: SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.

The medical grade plastics that mold the enclosures and the probe head are made of ABS and stainless steel.

DIGITAL THERMOMETER MODEL MT SERIES 510(k) number: K062784 Applicant: SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. Owner: SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.

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SEJOY

4. Device Description:

For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.

5. Intended Use:

Digital Thermometer MT series are intended to measure the human body temperature in regular mode orally, rectally or under the arm, and the devices are reusable for clinical or home use on people of all ages.

6. Comparison to Predicate Devices:

The device models MT-101D, MT-101M, MT-101P, MT-101R, MT-111, MT-111R. MT-1019 are similar in design and intended use to the DIGITAL THERMOMETER MODEL MT-101, differing only in physical dimensions.

The device models MT-201R, MT-2019, MT-2121 are similar in design and intended use to the MT-201 of DIGITAL THERMOMETER MODEL MT SERIES, differing only in physical dimensions.

The device models MT-402S, MT-4218, MT-4220, MT-4223 are similar in design and intended use to the MT-402 of DIGITAL THERMOMETER MODEL MT SERIES, differing only in physical dimensions.

The device models MT-401, MT-401A, MT-401P, MT-401R, MT-4119, MT-4121, MT-403S, MT-4318, MT-4320, MT-4323, MT-4625 are similar in design and intended use to the MT-403 of DIGITAL THERMOMETER MODEL MT SERIES, differing only in physical dimensions. And MT-401, MT-401A, MT-401P, MT-401R, MT-4119, MT-4121 are rigid tip, MT-403 flexible tip.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Compliance to applicable voluntary standards includes ASTM E 1112, as well as IEC60601-1, IEC60601-1-2 and ISO10993-1 requirements.

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SEJOY

Guidance documents included the "FDA Guidance on the Content of Premarket Notification 510(K) Submissions for Clinical Electronic Thermometers."

8. Discussion of Clinical Tests Performed:

Controlled human clinical studies were conducted using the digital thermometer MT series. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Sejoy Clinical Test Protocol outline.

9. Conclusions:

The digital thermometer MT series with all corresponding Models have the same intended use and similar technological characteristics as the cleared devices of DIGITAL THERMOMETER MODEL MT-101(K051699) and DIGITAL THERMOMETER MODEL MT SERIES (K062784).

Moreover, verification and validation tests contained in this submission clearly demonstrate that any differences in their characteristics do not raise any new questions of safety or effectiveness. Furthermore, those engineering differences do not affect the intended use or alter the fundamental scientific technology of the cleared devices of DIGITAL THERMOMETER MODEL MT-101(K051699) and DIGITAL THERMOMETER MODEL MT SERIES( K062784).

Thus, the digital thermometer MT series with all corresponding Models are substantially equivalent to the Predicate Devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 an abstract symbol resembling an eagle or bird in flight, with three stylized wing-like shapes.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Yunhua Ren General Manager Sejoy Electronics & Instruments Company, Limited Building 2, No. 202 Zhenzhong Road West Lake Economy & Technology Zone Hangzhou, Zhejiang China 310030

AUG 2 4 2011

Re: K110776

Trade/Device Name: Digital Thermometer MT series Regulation Number: 21 CFR 880.2910 -Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 15, 2011 Received: July 26, 2011

Dear Mr. Yen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Ren

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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Anthony O. Norton

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

Enclosure

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SEJOY.

K110776.

Indications for Use

510(k) Number (if known):

Digital Thermometer MT series Device Name:

Indications For Use:

Over-The-Counter Use V Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Neil C. Ahn

(Division Sign Off)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K110776

Regulation Number and Section

§ 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.