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

Models MT-1027, MT-4127, MT-4132, MT-4132, MT-4335, MT-4335, MT-4326, MT-09, MT-30, MT-31, and MT-36 are non-predictive digital thermometers. Models MT-4726 and MT-4735 are predictive digital thermometers. Both predictive and non-predictive models include a sensor, buzz films, housing, a stainless steel cap, a LCD display, and a measurement control module. The thermometers include a dustproof case as an accessory. Additionally, both models do not need to be used in conjunction with a disposable probe cover when taking temperature.

AI/ML Overview

The provided document describes the Sejoy Electronics & Instruments Co., Ltd. Digital Thermometer MT series (Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36) and its substantial equivalence to predicate devices (MT-4119 and MT-4320).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards. The key performance acceptance criteria can be inferred from the "Accuracy" row in the comparison table and the clinical accuracy evaluation for predictive models.

Acceptance Criteria (Inferred from Predicate and Standards)	Reported Device Performance (Subject Device)
Accuracy (General)	±0.1°C between 35.5°C to 42.0°C (±0.2°F, 95.9°F-107.6°F)
	±0.2°C under 35.5°C or over 42.0°C (±0.4°F under 95.9°F or over 107.6°F)
Accuracy (Predictive Models MT-4726, MT-4735)	Performance met requirements of ISO 80601-2-56:2009 for clinical accuracy evaluation (specifically, clause 201.102). The displayed temperature is equivalent to the balanced temperature after 5 minutes according to the proprietary algorithm. Users only need about 5 seconds to take temperature readings.
Measurement Range	32°C~~42.9°C (90°F~~109.9°F)
Humidity Range	15%~95%, non-condensing
Storage Temperature	-20℃~~55℃ (-4°F~~131°F)
Precision and Repeatability	3 numerical digits, display in 0.1 degree increments
Electrical Safety	Complies with AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and, A2:2010/(R)2012, ISO 80601-2-56:2009, ASTM E1112-00(Reapproved 2011), IEC 60601-1-11:2010.
EMC	Complies with IEC 60601-1-2:2007, IEC 60601-1-2:2014.
Biocompatibility	Complies with ISO 10993-5:2009, ISO 10993-10:2010.
Cleaning/Disinfection	Complies with ASTM E2314-03(2014) and FDA Guidance: Reprocessing Medical Devices in Health Care Settings.
Software Validation (for predictive models)	Complies with EN 60601-1-4:2000 and General Principles of Software Validation – Final Guidance for Industry and FDA Staff.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not explicitly state the sample size (number of subjects or measurements) for the "clinical accuracy evaluation" mentioned for predictive models MT-4726 and MT-4735. It only states that the evaluation was conducted "according to clause 201.102 of ISO 80601-2-56:2009". This standard would typically define the required sample size and testing methodology.
Data Provenance: Not specified in the document. It does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document only references compliance with ISO 80601-2-56:2009 for the clinical accuracy evaluation. This standard would define the requirements for reference temperature measurements, which would implicitly involve qualified personnel, but their role as "experts to establish ground truth" in the context of an AI device is not directly applicable here as it's a device measuring a physical quantity.

4. Adjudication Method for the Test Set

Not applicable as this is a medical device for measuring a physical parameter (temperature), not an AI device making a diagnostic or interpretive output that would typically require expert adjudication for ground truth. The "ground truth" for temperature measurement would be established by a primary reference thermometer meeting metrological standards as outlined in ISO 80601-2-56.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI systems that assist human readers in interpreting medical images or data. The device in question is a standalone digital thermometer, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was done. The entire submission describes the standalone performance of the digital thermometers. Specifically for the "predictive models MT-4726 and MT-4735," a "clinical accuracy evaluation has been conducted according to clause 201.102 of ISO 80601-2-56:2009." This evaluation assesses the device's accuracy in measuring temperature without human interpretation of its output beyond reading the displayed value. The predictive algorithm itself is a "standalone" component of the device's operation.

7. The Type of Ground Truth Used

Reference standard/metrological ground truth: For temperature measurement, the ground truth would be established using reference thermometers or calibrated temperature baths as per the requirements of ISO 80601-2-56 and ASTM E1112. The specific details, like the type of reference standard and its traceability, are not provided but would be implied by adherence to these standards. For the predictive models, the proprietary algorithm aims to predict the "balanced temperature after 5 minutes," which would be the "ground truth" target for the prediction.

8. The Sample Size for the Training Set

Not applicable / Not explicitly mentioned. The document describes a traditional medical device (digital thermometer), even with a predictive algorithm for some models. The term "training set" is typically used for machine learning models. While the predictive algorithm must have been developed and validated, the document does not present it as a machine learning model that would require a distinct "training set" in the sense of AI. The development of the proprietary algorithm would involve calibration and empirical data, but it's not described as a "training set" for an AI model.

9. How the Ground Truth for the Training Set Was Established

Not applicable / Not explicitly mentioned. As mentioned above, the concept of a "training set" with established "ground truth" for an AI model is not directly applied in the document's description of a digital thermometer, even for models with a predictive algorithm. The accuracy of the predictive algorithm would be validated against empirically measured "balanced temperatures" in a clinical setting as outlined by the ISO standard.

Summary

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

May 27, 2016

Sejoy Electronics & Instruments Co., Ltd. Mr. Ren Yunhua General Manager Building 2, No. 202, Zhenzhong Road West Lake Economy & Technology Zone Hangzhou, 310030 CHINA

Re: K153149

Trade/Device Name: Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 15, 2016 Received: May 13, 2016

Dear Mr. Yunhua:

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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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 devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours,

Tina Kiang -

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. 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) K153149

Device Name

Digital Thermometer, Models MT-1027, MT-4127, MT-4333, MT-4326, MT-4726, MT-4726, MT-4735, MT-09, MT-30, MT-31, MT-36

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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世佳电子有限公司 Sejoy Electronics & Instruments Co.,Ltd.

510(k) Summary

The assigned 510(k) number is: K153149

1. Date Prepared:

May 25, 2016

2. Submitter's Identification:

Name: Sejoy Electronics & Instruments Co., Ltd. Address: Building 2, No.202, Zhenzhong Road, West Lake Economy & Technology Zone, Hangzhou, China 310030 Contact Person: Yunhua Ren Phone: +86-571-81957767 Fax: +86-571-81957750 Email: RENYH@SEJOY.COM

3. Name of the Device:

Trade Name: Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-રેસ

Common Name: Digital Thermometer

Classification name: Clinical Electronic Thermometer

4. Classification Information:

Product Code: FLL- Clinical Electronic Thermometer Device Class: II Panel: 80 Regulation number: 21 CFR 880.2910

5. Predicate Device Information:

Digital Thermometers Models MT-4119 and MT-4320 manufactured by SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.

510(k) number: K110776

6. Intended use / Indication for Use:

The intended uses/ indication for use of the Digital Thermometers, models: MT series are Identical to the predicate devices, Digital Thermometers, models: MT-4119, MT-4320.

7. Device Description:

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Both predictive and non-predictive models include a sensor, buzz films, housing, a stainless steel cap, a LCD display, and a measurement control module. The thermometers include a dustproof case as an accessory.

Additionally, both models do not need to be used in conjunction with a disposable probe cover when taking temperature.

8. Principles of Operation:

The basic principle of the MT series digital thermometers is that a change in thermistor resistance is caused by a change in temperature. The resistance is measured by a microcontroller unit, so that changes in temperature will correspond to changes in resistance.

Compared to the non-predictive thermometers, the following is a description of the predictive thermometer models MT-4726 and MT-4735:

The predictive thermometer models display the temperature results in a short period of time. The displayed temperature is equivalent to the balanced temperature after 5 minutes according to the proprietary algorithm. Therefore, users only need about 5 seconds to take temperature readings. The measurement time may vary depending on the anatomical site of the temperature reading; however the measurement time should remain between 5-10 seconds. If the predictive temperature cannot be measured, the device will take the actual temperature (regular mode) automatically.

9. Modifications to Predicate Device:

The subject device models have each been altered in at least one of the following ways as noted in the table below:

-Addition of predictive algorithm for Models MT-4735 and MT-4726

-New battery type to support added backlight feature

-Modification of labeling including cleaning/disinfection instructions
-Temperature associated color light indication with updated labeling
-Thermometer response time
-Battery life

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TechnologicalCharacteristicsof Comparison	Subject Device:	Predicate DeviceModel MT-4119(K110776):	Predicate DeviceModel MT-4320(K110776)	ComparisononResult	Remark
Digitalthermometers	Models:MT-1027,MT-4127,MT-1032,MT-4132,MT-4333,MT-4326,MT-4726,MT-4335, MT-4735,MT-09,MT-30,MT-31,MT-36	Model: MT-4119(Rigid tip thermometer)	Model: MT-4320(Flexible tipthermometer)	/	/
Intended use/Indication for Use	Measuring the human body temperature in regular mode orally, rectally or under the arm, and thedevices are reusable for clinical or home use on people of all ages.			Identical	/
Components	Sensor, buzz film, housing, stainless steel cap, LCD display, measurement control module.			Identical	/
Accessory	Dustproof case			Identical	/
Sensor	Thermistor			Identical	/
PowerRequirements	MT-1027,MT-4127MT-1032,MT-4132MT-4333,MT-4326, MT-4335,MT-09, MT-30,MT-31,MT-4726,MT-4735	1.5V d.c (LR41 orSR41,UCC392)3.0V d.c(CR2032)	1.5V d.c (LR41 or SR41,UCC392)	Similar	Change inbattery typefrom 1.5Vd.c. (LR41 orSR41,UCC392)to 3.0V d.c.(CR2032)
Backlight function	MT-1027,MT-4127MT-1032,MT-4132MT-4333,MT-4326,MT-4335,MT-09,MT-30,MT-31,MT-36	No backlight function	No backlight function		Identical	/
	MT-4726,MT-4735	Yes	No backlight function		Different	/
Material used	MT-1027,MT-4127MT-1032,MT-4132MT-09,MT-30,MT-31MT-4333,MT-4326,MT-4726,MT-4335,MT-4735,MT-36	Housing: ABSProbe: Stainlesssteel	Housing: ABSProbe: Stainless steel	Housing: ABSFlexible tip: TPEProbe: Stainless steel	Identical	Flexible tipthermometersare identical toMT-4320 andrigid tipthermometersare identical toMT-4119
Measure range	MT-1027,MT-4127MT-1032,MT-4132MT-4326,MT-4335,MT-4333,MT-09,MT-30,MT-31,MT-36MT-4726,MT-4735	32°C~~42.9°C(90°F~~109.9°F)	32°C~~42.9°C(90°F~~109.9°F)		Similar	Meet therequirement ofASTM E1112
	MT-1027,MT-4127MT-1032,MT-4132MT-4333,MT-4326,		Direct Mode
Operating mode	MT-4335,MT-09,MT-30,MT-31,MT-36	Direct Mode		Similar	/
	MT-4726,MT-4735	Adjusted mode :Oral mode/Rectal mode/Underarm modeDirect Mode:Bath mode			/
Accuracy	$±0.1°C$ between $35.5°C$ to $42.0°C$ ( $±0.2°F,95.9°F-107.6°F$ ),$±0.2°C$ under $35.5°C$ or over $42.0°C$ ( $±0.4°F$ under $95.9°F$ or over $107.6°F)$			Identical	/
Humidity range	15%~95%,non-condensing			Identical	/
Storage	Temperature: $-20℃~~55℃$ ( $-4°F~~131°F$ )			Identical	/
Environment	Humidity:15% ~95% RH; Atmospheric Pressure:800hPa ~ 1060hPa			Identical	/
Color-temperaturelight indicators	MT-4132,MT-4333	Different colored lights		Different	/
	MT-4335,MT-4735MT-4726,MT-4326	corresponding todifferent temperatures.	No this function		/
	MT-1027,MT-4127MT-1032, MT-09,MT-30,MT-31,MT-36		No this function	Identical	/
Response time	MT-4326,MT-4127MT-4132,MT-4333MT-4335,MT-30	<45s	<45s	Identical	/
	MT-1027 MT-1032	<60s	<45s	Similar	/
	MT-09,MT-31
	MT-4726,MT-4735MT-36	<10s	<45s	Similar	/
	MT-1027,MT-4127
Software	MT-1032,MT-4132
	MT-4333,MT-4335	No software	No software	Identical	/
	MT-4326,MT-09, MT-
	30,MT-31, MT-36
	MT-4726,MT-4735	Have software	No software	Different	/
Battery life	MT-1027,MT-4127				Battery life
	MT-1032,MT-4132				changes from
	MT-4333,MT-4335			Similar	approx 200 hours
	MT-4326,MT-09, MT-	Approx 200 hours	Approx 200 hours		to approx
	30,MT-31, MT-36				40 hours
	MT-4726,MT-4735	Approx 40 hours
Biocompatibility	Complied with the biocompatible requirements of FDA			Identical	/
Labeling	Updated cleaning/disinfection instructions,Updated MR Safety labeling		Outdated cleaning/disinfection instructions and MRSafety labeling	Different	/
Where used	Clinical or home			Identical	/
Number of				Identical	/
readings stored in	Display of temperature last measured
Memory
Precision and	3 numerical digits, display in 0.1 degree increments			Identical	/
repeatability
ReferenceStandards	AAMI / ANSI ES60601-1,IEC 60601-1-2, IEC 60601-1-11,ISO 80601-2-56, ASTM E1112, ISO10993-5, ISO 10993-10			Identical	/

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10. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:

The Sponsor performed a risk assessment based on the changes made to their predicate device and determined that the following non-clinical testing was necessary to demonstrate that the changes did not introduce any new risks to the subject device.

Laboratory testing was conducted to validate and verify that the thermometers continued to meet all requirements of related international standards, including electrical safety, EMC, software, biocompatibility, and cleaning/disinfection. Results of these tests demonstrated compliance to the requirements of the below consensus standards and FDA Guidance documents. Software validation testing was only performed for predictive Models MT-4726 and MT-4735.

Electrical Safety and Performance:

AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and, A2:2010/(R)2012:

AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, and C1:2009/(R)2012 and A2:2010/(R)2012;

ISO 80601-2-56:2009;

ASTM E1112-00(Reapproved 2011)

Medical Electrical Equipment and medical Electrical Systems Used in the Home Healthcare Environment:

IEC 60601-1-11:2010

Electromaqnetic Compatibility:

IEC 60601-1-2:2007

IEC 60601-1-2:2014

Biocompatibility:

ISO 10993-5:2009

ISO 10993-10:2010

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Cleaning/Disinfection/Reprocessing:

ASTM E2314 -03(2014)

FDA Guidance: Reprocessing Medical Devices in Health Care Settings -Validation Methods and Labeling

Software:

EN 60601-1-4:2000 General Requirements for safety - Collateral Standard: Programmable electrical medical system

General Principles of Software Validation – Final Guidance for Industry and FDA Staff

Clinical Electronic Thermometers Guidance:

Guidance on the content of Premarket Notification[510(k)] Submission for clinical electronic thermometers

11. Discussion of Clinical Tests Performed:

In order to demonstrate that the subject device did not introduce any new risks in comparison to the subject device a clinical accuracy evaluation has been conducted according to clause 201.102 of ISO 80601-2-56:2009 for predictive models MT-4726 and MT-4735.

12. Conclusions:

Based on the information provided in this submission, the subject digital thermometer MT series is substantially equivalent to the predicate models MT-4119 and MT-4320. The devices are as safe and as effective as the predicate device models.

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.