DT007 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.

DT008 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.

Device Description

The basic principle of Digital Thermometer is that a change in thermistor resistance is caused by a change in temperature. The device measure body temperature by using a direct mode. The resistance is measured by a microcontroller unit, so that changes in temperature will correspond to changes in resistance. And the temperature value is displayed on the LCD screen. The device can be used for axillary, oral in the home, and used for axillary, oral and rectal temperature measurement in the hospital. The device is reusable and provided non-sterile. The device is intended for use on people of all ages. The probe cover is required when measuring the oral or rectal temperature, but not when measuring the axillary temperature.

The Digital Thermometer includes two models: DT007 and DT008. The differences of these two models are in appearance, PCB layout, external dimension and weight. All of them have the same function and they have the following basic functions:

Data displayed on LCD
Automatic stop (energy saver)
Small, convenient, easy to use

AI/ML Overview

The provided text describes the acceptance criteria and a study for a Digital Thermometer (Models DT007, DT008). Here's a breakdown of the requested information:

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

The acceptance criteria are generally implied by conformity to specific standards and the stated "Measuring Accuracy". The reported device performance is presented in the comparison table with the predicate device and the non-clinical test summary.

Acceptance Criteria (Implied by Standards)	Reported Device Performance (Subject Device)
Measuring Accuracy: To meet requirements of ASTM E1112 and ISO 80601-2-56.	* $32.0^\circ C \sim 35.9^\circ C \pm 0.2^\circ C$
	* $36.0^\circ C \sim 39.0^\circ C \pm 0.1^\circ C$
	* $39.1^\circ C \sim 42.9^\circ C \pm 0.2^\circ C$
Electromagnetic Compatibility & Electrical Safety: Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11.	Tested in compliance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014, and IEC 60601-1-11:2015.
Biocompatibility: Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 for human body contacting material.	Same human body contacting material as cleared device K163603; safety demonstrated in K163603 submission, complying with ISO 10993-1, ISO 10993-5 and ISO 10993-10.
General Performance: Compliance with ISO 80601-2-56 and ASTM E1112 for body temperature measurement.	Tested in compliance with ISO 80601-2-56:2017+A1:2018 and ASTM E1112-00 (Reapproved 2011).
Software Verification: Compliance with FDA guidance "Guidance for the Content of Premarket Submissions for Software in Medical Devices" (May 11, 2005).	Software documentation provided in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software in Medical Devices" issued May 11, 2005.
Operating Environment Condition: Ambient temperature, relative humidity, pressure altitude.	Ambient temperature: $5^\circ C \sim 40^\circ C$ ($41^\circ F \sim 104^\circ F$); Relative humidity: $\le 85%$; Pressure altitude: 700hPa to 1060hPa. (Passed performance tests; no adverse impact on safety/effectiveness)
Storage Condition: Storage temperature, storage humidity, pressure altitude.	Storage temperature: $-20^\circ C \sim 55^\circ C$ ($-4^\circ F \sim 131^\circ F$); Storage humidity: $\le 95%$; Pressure altitude: 700hPa $\sim$ 1060hPa. (Passed performance tests; no adverse impact on safety/effectiveness)
Response Time: Sufficient response time for temperature measurement.	30s. (Passed performance tests; no adverse impact on safety/effectiveness)
Auto-off Time: Sufficient for intended use.	10 mins. (Sufficient for intended user to obtain temperature data; no adverse impact on safety/effectiveness)

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

The document mentions "performance test" against standards like ASTM E1112 and ISO 80601-2-56. These typically involve rigorous testing of multiple units under controlled conditions. However, the specific sample size of devices tested and the number of measurements taken for these performance tests are not explicitly stated in the provided text. The document also does not provide details on data provenance (country of origin, retrospective/prospective).

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 applicable as the device is a digital thermometer, and the "ground truth" for temperature measurements is established against traceable reference standards and methods as defined by the performance standards (e.g., ASTM E1112, ISO 80601-2-56), not by human expert consensus or interpretation.

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

This information is not applicable for a digital thermometer as its performance is objectively measured against physical standards, not through expert adjudication of subjective interpretations.

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 information is not applicable as the device is a digital thermometer and does not involve AI assistance or human reader interpretation for its primary function.

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

This concept is not applicable to a digital thermometer in the context of diagnostic AI algorithms. The device itself is solely responsible for measuring temperature, and its performance is evaluated in a "standalone" manner (i.e., the device itself without human intervention affecting the measurement accuracy).

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

The "ground truth" for the performance evaluation of the digital thermometer is based on established metrological standards and reference temperatures as outlined in the technical standards ASTM E1112 and ISO 80601-2-56. These standards define the acceptable deviation from a true reference temperature.

8. The sample size for the training set

This information is not applicable as the digital thermometer is a hardware device with embedded firmware for measurement, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.

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

This information is not applicable for the same reason as #8.

Summary

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January 20, 2023

Guangzhou Berrcom Medical Device Co., Ltd. % Liz Li Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town Shenzhen, Guangdong 518000 China

Re: K214077

Trade/Device Name: Digital Thermometer, Model: DT007, DT008 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 14, 2022 Received: December 21, 2022

Dear Liz Li:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

David Walloschek

David Wolloscheck, Ph.D. Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal. ObGyn. General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K214077

Device Name Digital Thermometer, Model: DT007, DT008

Indications for Use (Describe)

DT007 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the rectal body temperature measurement cannot be used for multipatient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.

DT008 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the rectal body temperature measurement cannot be used for multipatient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.

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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K214077 - 510(k) Summary

This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.

1. Administrative Information

Preparation Date	Dec.20, 2021
Manufacturer	Guangzhou Berrcom Medical Device Co., Ltd.Address:No. 38 Huanzhen Xi Road, Dagang Town, Nansha,Guangzhou, China.Contact person: Zhigang DuTEL: +86-020-34938449E-Mail: dube888@berrcom.com
SubmissionCorrespondent	Shenzhen Joyantech Consulting Co., Ltd.1713A, 17th Floor, Block A, Zhongguan Times Square, LiuxianAvenue, Xili Town, Nanshan District, Shenzhen, GuangdongProvince, China.Contact person: Liz LiE-Mail: liz@cefda.com; grace@cefda.com
Image: Logo
Establishmentregistration number	3008395508

2. Device Information

Type of 510(K):	Traditional
Submission:	K214077
Device Name:	Digital Thermometer
Model:	DT007, DT008
Classification Name:	Clinical Electronic Thermometer
Review Panel:	General Hospital
Device Class:	II
Regulation Number:	880.2910
Product Code:	FLL

3. Predicate Device

Manufacturer:	Smart Technology Co., Ltd.
Device Name:	Digital Thermometer
Model:	DT100
510(k) Number:	K203731
Product Code:	FLL

4. Device Description

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Product: Digital Thermometer

changes in resistance. And the temperature value is displayed on the LCD screen. The device can be used for axillary, oral in the home, and used for axillary, oral and rectal temperature measurement in the hospital. The device is reusable and provided non-sterile. The device is intended for use on people of all ages. The probe cover is required when measuring the oral or rectal temperature, but not when measuring the axillary temperature.

Data displayed on LCD ।
Automatic stop (energy saver)
Small, convenient, easy to use -

5. Intended Use/ Indications for Use

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6. Comparison with Predicate Device

Items	Subject Device(K214077)	Predicate Device(K203731)	Comparison
Device name andmodel	Digital thermometer,(Model: DT007, DT008)	DT100 Digital Thermometer	/
Product code	FLL	FLL	Identical
Intended Use/ Indications forUse	Digital Thermometer is intended forthe measurement of human bodytemperature by doctors orcustomers in the hospital or athome. It can be used for axillary,oral temperature measurement athome, and used for axillary, oraland rectal temperaturemeasurement in the hospital. Therectal body temperaturemeasurement cannot be used formulti-patient use at home. Theproduct is reusable and providednonsterile. The device is intendedfor use on people of all ages.	DT100 Digital thermometeris intended for themeasurement of humanbody temperature by doctoror consumers in the hospitalor home. It can be used foraxillary, oral and rectalmeasurement. The productis reusable and providednonsterile.The device is for people ofall ages.	Similar#1
Principle ofoperation	Thermistor resistance technology.	Thermistor resistancetechnology.	Identical
Measurement site	axillary, oral and rectal	axillary, oral and rectal	Identical
Where used	Hospital or home	Hospital or home	Identical
Operationenvironmentcondition	Ambient temperature: $5℃~~40℃$(41°F~~104°F)Relative humidity: ≤85%Pressure altitude:700hPa to 1060hPa	16 to $40℃$ (60.8 to 104°F)and 15 to 95% humiditynoncondensing;	Different#2
Storage condition	Storage temperature: $-20℃~~55℃$(-4°F~~131°F)Storage humidity: ≤95%Pressure altitude:700hPa ~ 1060hPa	-20 to $50℃$ (-4 to 120°F)and 15 to 95% humiditynoncondensing
Components	Main part, display screen, control button, probe tip	Main part, display screen, control button, probe tip	Identical
Sensor name	Thermistor	Thermistor	Identical
PowerRequirements	1.5V d.c	1.55V	Similar
Material used	Housing (including button): ABSProbe: Stainless steel	Enclosure: Acrylonitrile Butadiene Styreneprobe: stainless steelbutton: silicone	Different#3
Measuretemperature range	$32°C ~ 42.9°C$(89.6°F~109.2°F)	$32°C ~ 42.9°C$(89.6°F ~109.2°F)	Identical
Operating mode	Direct mode	Direct mode	Identical
Measuringaccuracy	$32.0°C ~35.9°C ±0.2°C$$36.0°C ~39.0°C ±0.1°C$$39.1°C ~42.9°C ±0.2°C$	$32°C$ - $42.9°C$ : +/- $0.1°C$	Different#4
Display resolution	$0.1°C$ ( $0.1°F$ )	$0.1°C/0.1°F$	Identical
Response time	30s	60s	Different#5
Auto-off Time	10 mins	unknown	Different#6
Probe cover	Measure oral or rectal position:Use probe coverMeasure axillary position: norequire of probe cover	Measure oral or rectalposition: Use probe coverMeasure axillary position: norequire of probe cover	Identical
Types of Tips	SUS304 stainless steel	unknown	Different#7
Biocompatibility	Comply withISO 10993-5,ISO 10993-10,	Comply withISO 10993-5,ISO 10993-10,	Identical
Electric Safety andEMC	IEC 60601-1,IEC 60601-1-2,IEC 60601-1-11	IEC 60601-1,IEC 60601-1-2,IEC 60601-1-11	Identical
Performance	ASTM E1112,ISO 80601-2-56	ASTM E1112,ISO 80601-2-56	Identical
Device size	DT007: 1281810mmDT008: 1251911mm	unknown	Different#8
LCD size	2311.39.15mm (LWH)	unknown

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Similar#1

The intended use of the subject device is described in more detail. The rectal measurement should be used in hospital because the high-level disinfection may only be done in hospital by health professionals. This is also specified in 【Warnings and precautions】in the user manual. This difference does not raise safety and effectiveness issues.

Similar#2

Although the "Operating environment condition" and "Storage condition" of subject device is different to the predicate device, the subject device has passed the performance test according to ASTM E1112 and ISO 80601-2-56. Additionally, the subject device was conformed to IEC 60601-1 and IEC 60601-1-11. Therefore, this difference would not raise adversely impact on safety and effectiveness.

Different#3

The materials used in the subject device is the same as the cleared device (K163603) from the same manufacturer. And the safety of the material has been demonstrated in the submission of K163603. Therefore, this difference would not raise adversely impact on safety and effectiveness.

Different#4

The measuring accuracy of subject device can meet the requirements of ASTM E1112 and ISO 80601-2-56. Therefore, this difference would not raise adversely impact on safety and effectiveness.

Different#5

The subject device has passed the performance test according to ASTM E1112 and ISO 80601-2-56. Therefore, this difference in the response time would not raise adversely impact on safety and effectiveness.

Different#6

Although the auto-off time of the predicate device is unknown, the 10-minute auto-off time of the subject device is sufficient for the intended user to obtain temperature data. Therefore, this difference would not raise adversely impact on safety and effectiveness.

Different#7

Although the information about the tips of the predicate device is unknown, the material of subject device is the same as that of the cleared device (K163603) from the same manufacturer. Additionally, the subject device has passed the performance test according to ASTM E1112 and ISO 80601-2-56. Therefore, this difference would not raise adversely impact on safety and effectiveness.

Different#8

Although the information about the size of the predicate device is unknown, the subject device has passed the performance test according to ASTM E1112 and ISO 80601-2-56. Therefore, this difference would not raise adversely impact on safety and effectiveness.

7. Non-Clinical Test Summary

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7.1.Electromagnetic Compatibility and Electrical Safety Test

The subject device has been tested in compliance with the following standards:

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2) IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic

disturbances - Requirements and tests

IEC 60601-1-11:2015 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

7.2.Biocompatibility Test

The subject device and the cleared device (K163603) of the same manufacturer use the same human body contacting material, and has the same nature of body contact and contact duration. The safety of the material has been demonstrated in the submission of K163603, complying with the requirements of ISO 10993-1, ISO 10993-5 and ISO 10993-10.

7.3.Performance Test-Bench

The subject device has been tested in compliance with the following standards:

ISO 80601-2-56: 2017+ A1:2018 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
ASTM E1112-00 (Reapproved 2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

7.4.Software Verification

The software documentation of the subject device was provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software in Medical Devices" issued May 11, 2005.

7.5.Clinical Test Summary

No clinical testing was performed.

8. Conclusion

The subject device digital thermometer (Model: DT007, DT008) is substantially equivalent to the predicate device (K203731). This conclusion is based upon comparison on intended use, technological characteristics and performance testing.

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.