Digital Thermometer is intended to measure the body temperature either oral or axillaries (under arms) and to be used by consumers in a household environment. The device is intended for repeatable use by one patient. It is intended for use on people of all ages.

Device Description

The Digital Thermometer utilizes measured thermistor resistance and a microcontroller unit to determine and display human body temperature. Changes in the probe temperature due to oral or auxiliary contact correspond to changes in resistance. The probe Temperature values are digitally displayed on an LCD screen in 0.2 degrees Fahrenheit increments. The measurements do not account for a probe cover. The user contacting materials are Stainless steel and Acrylonitrile Butadiene Styrene (ABS).

The Digital Thermometer includes 3 models: DT001, DT007 and DT008. The differences of these models are in appearance and specifications. All of them have the same basic functions:

Precision of 0.1℃ for measurements between 35℃ and 39℃ for measurement
Data displayed in Celsius -
Automatic stop (energy saver) -

AI/ML Overview

The provided document is a 510(k) premarket notification for a Digital Thermometer. It describes the device, its intended use, and a comparison to a predicate device. It also mentions non-clinical tests performed to demonstrate substantial equivalence.

However, the document does not contain the specific acceptance criteria for performance metrics of the digital thermometer (e.g., specific accuracy limits for different temperature ranges as defined by the manufacturer for acceptance) and does not explicitly detail a study report showing the device meets predefined acceptance criteria for these specific metrics. It lists the regulated accuracy standard, but not the manufacturer's internal acceptance criteria.

Therefore, many of the requested items cannot be fully answered from this document. I will extract what is available and indicate when information is not present.

1. A table of acceptance criteria and the reported device performance

The document lists performance standards and typical accuracy ranges for clinical electronic thermometers. It does not provide a table of acceptance criteria set by the manufacturer for the specific device and then report the device performance against those criteria in a tabular format. Instead, it states that the device complies with the standards.

Metric (Criterion Type)	Acceptance Criteria (from Standard)	Reported Device Performance (Compliance Statement)
Measuring Accuracy	±0.1°C between 36.0°C to 39.0°C; The rest: ±0.2°C (from ASTM E1112, ISO 80601-2-56)	Complies with ASTM E1112 and ISO 80601-2-56
Response Time	Shorter than predicate device (60s)	30s
Biocompatibility	Comply with ISO 10993-5:2009, ISO 10993-10:2010	Complies with ISO 10993-5:2009, ISO 10993-10:2010
Electrical Safety & EMC	IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11:2010	Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11:2010

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "nonclinical testing performed in accordance with applicable standards and FDA guidance documents," but does not detail the specific sample size of devices tested or the data provenance for these tests.

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 is a physical medical device (digital thermometer) and the "ground truth" for its accuracy would typically be established by comparison to a traceable temperature standard or reference thermometer in laboratory conditions, not by expert interpretation. Therefore, this question is not applicable in the context of this device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

As per the answer to point 3, this is not applicable for a physical device like a digital thermometer. Adjudication methods are typically relevant for studies involving human interpretation (e.g., image analysis by radiologists).

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

This is a physical medical device (digital thermometer) and its performance is evaluated in terms of accuracy and technical specifications, not human interpretive tasks. Therefore, an MRMC study is not applicable to this device.

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

The device is a digital thermometer. Its "standalone" performance refers to its ability to accurately measure temperature on its own. The document states "Performance tests protocols were performed in accordance with applicable standards... The results of the tests demonstrate the compliance to applicable thermometer standards." This implicitly indicates that the device's standalone performance was evaluated against these standards. The response time of 30s is also a standalone performance characteristic.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a digital thermometer, the "ground truth" would be the actual temperature measured by a highly accurate, calibrated reference thermometer or established through a traceable temperature standard in a controlled laboratory environment. The document implies this type of ground truth was used by stating compliance with standards like ASTM E1112 and ISO 80601-2-56, which outline methods for calibrating and testing thermometer accuracy.

8. The sample size for the training set

This information is not provided in the document. Digital thermometers typically do not involve "training sets" in the sense of machine learning algorithms. The development involves engineering and calibration, not algorithm training on data.

9. How the ground truth for the training set was established

As per the answer to point 8, the concept of a "training set" with ground truth as typically understood in AI/ML contexts is not applicable to a digital thermometer. Ground truth for calibration and testing would be established by reference to traceable temperature standards.

Summary

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

June 6, 2017

Guangzhou Jinxinbao Electronic Co., Ltd Ms. Elly Xu Consultant Manager Shenzhen Joyantech Consulting Co., Ltd. Room 1122, International Mayors Communication Centre NO.55 Shizhou middle road Nanshan District, Shenzhen, 518101 TAIWAN

Re: K163603

Trade/Device Name: Digital Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: April 25, 2017 Received: May 08, 2017

Dear Elly Xu:

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.

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

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Page 2 - Elly Xu

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 (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 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,

Tina Kiang
-s

Tina Kiang, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K163603

Device Name Digital Thermometer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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K163603 510(k) Summary

This 510(K) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

1. Administrative Information

Date of Summaryprepared	May 31, 2017
Manufacturerinformation	Company title:Guangzhou Jinxinbao Electronic Co., Ltd.Company address:No.38 Huanzhen Xi Road, Dagang Town,Nansha Distric, Guanzhou,Guangdong,China 511470Contact person: Mowu ZhuPhone: +86-020-34938449Fax: +86-020-34936960E-mail: jxb_qc_moo@jxb-htb.net
SubmissionCorrespondent	Shenzhen Joyantech Consulting Co., Ltd.Room 1122, International MayorsCommunication Centre, NO. 55 Shizhou middleroad , Nanshan District, ShenzhenContact person: Ms. Elly Xu; Mr. Field FuE-Mail: elly@cefda.com; cefda13485@163.comImage: logo

2. Device Information

Type of 510(k)submission:	Traditional
Trade Name:	Digital Thermometer
Model:	DT001, DT007, DT008
Classification name:	Clinical Electronic Thermometer
Review Panel:	General Hospital
Product Code:	FLL

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II Device Class: Regulation Number: | 880.2910

3. Predicate Device Information

Fudakang Industrial Co., Ltd Sponsor: Device: Digital Thermometer BT-A11CN, BT-A21CN, BT-A41CN Model: 510(K) Number: K101387

4. Device Description

The Digital Thermometer includes 3 models: DT001, DT007 and DT008. The differences of these models are in appearance and specifications. All of them have the samebasic functions:

Precision of 0.1℃ for measurements between 35℃ and 39℃ for measurement
Data displayed in Celsius -
Automatic stop (energy saver) -

5. Indications for Use

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6. Technological characteristics of the proposed device compared to the predicate device

	Predicate Device (K101387),
ltems	Fudakang Digital	Subject Device	Remarks
	Thermometer
Indication forUse	Intended for measurementand monitoring of human bodytemperature by doctor orconsumers in the hospital orhome.BT-A11CN, BT-A21CN andBT-A41CN can be used inaxillary measurement, oralmeasurements and rectalmeasurement.	DigitalThermometer isintended tomeasure the bodytemperature eitheroral or axillaries(under arms) and tobe used byconsumers ina householdenvironment. Thedevice is intendedfor repeatableuse by one patient.It is intended foruse on people of allages.	Seeexplanationbelow
Use environment	Clinical or home	Home use	Same
Components	Sensor, buzz film, housing,stainless steel cap, LCDdisplay, measurement controlmodule	Sensor, buzz film,housing, stainlesssteel probe, LCDdisplay,measurementcontrolmodule(MCU)	Same
Sensor	Thermistor	Thermistor	Same
Powerrequirements	Battery	1.5V d.c	Same
Material used	Housing: ABSProbe: Stainless steel	Housing: ABSProbe: Stainlesssteel	Same
Measure range	32°C ~42.9°C	32°C ~42.9°C	Same
Operating mode	Direct mode	Direct mode	Same
Measuringaccuracy	35.0°C±0.1°C betweento39.0°С;The rest: ±0.2ºC	±0.1°Cbetween36.0°C to 39.0°C;The rest: ±0.2℃	Seeexplanationbelow
Response time	60s	30s	Seeexplanationbelow
Items	Predicate Device (K101387),Fudakang DigitalThermometer	Subject Device	Remarks
Biocompatibility	Comply with ISO 10993-5:2009, ISO 10993-10:2010	Comply with ISO10993-5:2009, ISO10993-10:2010	Same
Electric safetyand EMC	IEC 60601-1, IEC 60601-1-2,IEC 60601-1-11:2010	IEC 60601-1, IEC60601-1-2, IEC60601-1-11:2010	Same
Performance	ASTM E1112	ASTM E1112,ISO 80601-2-56.	Same

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The predicate device and subject device indications for use are not identical in language. The predicate device provides a list of models and can be used for obtaining a rectal temperature reading and the subject device identifies the user populations. The differences in technology between the subject and the predicate device are the measuring range of subject device meet the maximum error of ±0.1℃, temperature range from 37℃ to 39℃, which is stated in standard ASTM E 1112. Also, the subject device has a shorter response time in obtaining and displaying the temperature measurement on the LCD display. These minor differences in indications for use, and differences in technology do not raise different questions of safety and effectiveness.

7. Brief discussion of the nonclinical tests

All nonclinical testing performed on new devices is to demonstrate the substantial equivalence to the predicate devices. Performance tests protocols were performed in accordance with applicable standards and FDA quidance documents. The results of the tests demonstrate the compliance to applicable thermometer standards and FDA quidance documents which are list below, and demonstrate the performance of new devices is equivalent to the predicate devices.

IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.

IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General

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Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.

IEC 60601-1-11 Edition 1.0 2010-04, Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.

ISO 80601-2-56 First Edition 2009-10-01, Medical Electrical Equipment - Part 2-56: Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement.

ISO 10993-1:2009, Biological Evaluation of Medical Devices -- Part 1: Evaluation and Testing Within a Risk Management Process.

ISO 10993-5:2009, Biological Evaluation of Medical Devices -- Part 5: Tests for In Vitro Cytotoxicity.

ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.

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

8. Clinical tests

Substantial equivalence does not depend on the clinical test data as the subject and predicate device both have thermistors utilized in direct mode and clinical testing is not required.

9. Conclusions

Based on device comparison analysis and non-clinical performance bench testing, the proposed device is substantially equivalent to legally marketed predicate device.

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.