The Infrared thermometer is intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.

Device Description

The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the central forehead for clinical or home use. The thermometers are powered by AAA 1.5 V×2 alkaline batteries. The results can be displayed on LCD. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or ºF. The Infrared thermometer included DT-8806S, DT-8807S. These two models are identical on hardware and software except the physical dimensions and appearance.

AI/ML Overview

The provided text describes the acceptance criteria and a clinical study for the Infrared Thermometer (Models: DT-8806S, DT-8807S). However, it lacks specific numerical data for the acceptance criteria and detailed device performance metrics from the study.

Here's an attempt to extract and organize the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the device "meets the requirements," but does not provide the specific numerical acceptance criteria or the exact measured performance values from the clinical study. It only refers to compliance with standards.

Acceptance Criteria (Standard Reference)	Reported Device Performance (Compliance)
Accuracy: ±0.2°C (0.4°F) within 36.0°C ~ 39.0°C (96.8°F ~ 102.2°F) ±0.3°C (0.6°F) within 32°C ~ 35.9°C (89.6°F ~ 96.6°F) and 39.1°C ~ 42.5°C (102.3°F ~ 108.5°F) (Per ISO 80601-2-56:2017, ASTM E1965-98)	"The test result demonstrated the clinical performance of the subject device complied with the requirement of standard ASTM E 1965-98 (Reapproved 2016)."
Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating (Per ISO 10993-1)	"the device is non-cytotoxic, non-sensitizing and non-irritating."
Safety: Basic Safety and essential performance (Per IEC 60601-1)	Tested according to the standard.
EMC: Electromagnetic compatibility (Per IEC 60601-1-2)	Tested according to the standard.
Home Healthcare Environment: Requirements for medical electrical equipment and systems used in the home healthcare environment (Per IEC 60601-1-11)	Tested according to the standard.

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

Sample Size: A minimum of 150 subjects.
- 1/3 children (greater than one to five years).
- The rest (approximately 2/3) are adults (greater than five years old).
- (NOTE: Infants—newborn to one year) - The study appears to categorize infants separately from children and adults, but then specifies children as "greater than one to five years" and adults as "greater than five years old," implying that infants might not have been included in the 1/3 children or 2/3 adults categories, or that the term "people of all ages" in the intended use is somewhat broader than the specific age groups mentioned for the 150-subject split. However, the exact breakdown of the 150 subjects for these age groups is not explicitly given, only the minimum of 150 and the proportion for children and adults.
Data Provenance: Not explicitly stated (e.g., country of origin). Since the submission sponsor and correspondent are based in Shenzhen, China, it is highly probable the data originated from China, but this is an inference. The study is described as a "clinical study," implying prospective data collection for the purpose of the device's clearance.

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

The document does not mention the use of experts to establish ground truth for temperature measurements. Clinical accuracy studies for thermometers typically compare the device's reading against a "gold standard" reference thermometer (e.g., a rectal or oral thermometer), rather than expert consensus on temperature. It's implied that a reference thermometer provided the ground truth for body temperature.

4. Adjudication Method for the Test Set

Not applicable. Temperature measurement accuracy is typically determined by comparing the device reading to a reference thermometer, not by expert adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study (MRMC) is generally relevant for imaging diagnostics where human readers interpret medical images. This device is an infrared thermometer for direct measurement.

6. Standalone Performance Study

Yes, a standalone clinical performance study was conducted. The document states: "Clinical testing is conducted per ASTM E 1965-98 (Reapproved 2016)... The test result demonstrated the clinical performance of the subject device complied with the requirement of standard ASTM E 1965-98 (Reapproved 2016)." This indicates the algorithm's (or device's) direct performance was evaluated against a standard.

7. Type of Ground Truth Used

The ground truth for the clinical accuracy study would have been established using a reference thermometer (e.g., mercury-in-glass thermometer, electronic probe thermometer) as per ASTM E1965-98, which sets standards for clinical investigations of infrared thermometers. The document does not specify the exact type of reference thermometer used.

8. Sample Size for the Training Set

The document does not mention a "training set" or "training data." This device is a hardware product with embedded software; therefore, the concept of a "training set" as understood in machine learning (where algorithms are trained on large datasets) typically doesn't apply in the same way. The device's calibration and internal algorithms would be developed and validated internally during manufacturing and engineering processes, rather than through a distinct "training set" in the context of regulatory submission for clinical accuracy.

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

As noted above, the concept of a training set as typically described for AI/ML validation is not discussed for this device. The device's internal calibration and algorithmic accuracy would be established through engineering and manufacturing processes, likely against highly accurate temperature references in a controlled environment.

Summary

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April 16, 2021

Shenzhen Everbest Machinery Industry Co., LTD % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, 518067 Cn

Re: K203170

Trade/Device Name: Infrared Thermometer, Models: DT-8806S, DT-8807S Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: March 15, 2021 Received: March 15, 2021

Dear Kevin Wang:

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.

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

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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 medical devices and radiation-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,

for Payal Patel 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) K203170

Device Name

Infrared Thermometer, Models: DT-8806S, DT-8807S

Indications for Use (Describe)

The Infrared thermometer is intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.

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

Registration Under Part 4 of STP 92-1 Select Sites
Coverage Under Part 4 of STP 92-1 Select Sites

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

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Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: March 11, 2021

1. Submission sponsor

Name: SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD.

Address: 19th Building, 5th Region, Baiwangxin Industrial Park, Songbai Rd., Baimang, Xili, Nanshan, Shenzhen, Guangdong, China 518108 Contact person: Deng Aiguo Title: Quality Manager E-mail: dengaiguo(acem-meter.com.cn

2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd.

Address: Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067

Contact person: Kevin Wang E-mail: kevin(@chonconn.com

Tel: +86-755 33941160

3. Subject Device Information
Trade/Device Name	Infrared Thermometer
Model	DT-8806S, DT-8807S
Common Name	Infrared Thermometer
Regulatory Class	Class II
Classification	21CFR 880.2910 / Clinical electronic thermometer / FLL
Submission type	Traditional 510(K)

2 Subiect Device Information

Predicate Device 4.

SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD. Infrared thermometer Models: DT-8806, DT-8806H, Regulation 21 CFR 880.2910, Product Code FLL, under K 101736.

5. Device Description

The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the central forehead for clinical or home use.

The thermometers are powered by AAA 1.5 V×2 alkaline batteries. The results can be displayed on LCD. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or ºF

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The Infrared thermometer included DT-8806S, DT-8807S. These two models are identical on hardware and software except the physical dimensions and appearance.

Intended use & Indication for use 6.

The Infrared thermometer is intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.

	Subject deviceInfrared thermometer: DT-8806S, DT-8807S	Predicate device K101736Infrared thermometer: DT-8806, DT-8806H	Note
Features
Regulation number	21 CFR 880.2910	21 CFR 880.2910	Same
Product code	FLL	FLL	Same
Intended Use &Indications for use	The Infrared thermometer isintended for the intermittentmeasurement of human bodytemperature from forehead forpeople of all ages. The device isreusable for home use and clinicaluse.	Infrared Thermometer Model:DT-8806H/DT-8806 Non-contact body infraredthermometer is designed for bodysurface and forehead temperaturemeasurement for infants andadults without contact to humanbody.	Different (1)
MeasurementMethod	Infrared radiation detection,adjusted mode	Infrared radiation detection,adjusted mode	Same
MeasurementRange	$32.0°C ~42.5°C$(89.6 to 108.5 ° F)	$32.0°C ~42.5°C$(89.6 to 108.5 ° F)	Same
Accuracy	$±0.2°C (0.4°F) within$$36.0°C ~ 39.0°C, (96.8°F ~$$102.2°F),$$±0.3°C(0.6°F) within$$32°C ~35.9°C (89.6°F ~~96.6°F)$and $39.1°C~~42.5°C (102.3°F$$~108.5°F)$	$±0.2°C (0.4°F) within$$36.0°C ~ 39.0°C, (96.8°F ~$$102.2°F),$$±0.3°C(0.6°F) within$$32°C ~35.9°C (89.6°F ~~96.6°F)$and $39.1°C~~42.5°C (102.3°F$$~108.5°F)$	Same
Display	$0.1°C(0.1°F)$	$0.1°C(0.1°F)$	Same
Measurementdistance	8806S: 1 cm - 10 cm8807S: 1 cm - 4 cm	5 cm - 15 cm	Different (2)
Measurementplace	ForeheadSurface	ForeheadSurface	Same
Sensor type	Thermopile	Thermopile	Same
Scale Selection	°C /°F	°C /°F	Same
Memory	32 sets	32 sets	Same
Features	Subject deviceInfrared thermometer: DT-8806S, DT-8807S	Predicate device K101736Infrared thermometer: DT-8806, DT-8806H	Note
Buzzer	Yes	Yes	Same
Autopower-offwhile no operation	Yes	Yes	Same
Power supply	2 * 1.5V AAA	2 * 1.5V AAA	Same
Display screen	LCD	LCD	Same
Contact materials	ABS	ABS	Same
Operation	10~40°C (50°F ~104 °F)	10~40°C (50°F ~104 °F)	Same
Environment	RH ≤85%	RH ≤85%	Same
Storage condition	0 to 50°C (32 to 122°F)RH ≤85%	0 to 50°C (32 to 122°F)RH ≤85%	Same
Dimension	128 * 74 * 36 mm	149 * 77 * 43mm	---
Weight	104.5 g	172 g	---
Conformancestandard	ISO80601-2-56(performance),IEC60601-1(Safety),IEC60601-1-2(EMC)ASTM E1965-98	ISO80601-2-56(performance),IEC60601-1(Safety),IEC60601-1-2(EMC)ASTM E1965-98	Same
Biocompatibility	Under the condition of this studythe device is non-cytotoxic, non-sensitizing and non-irritating.	Under the condition of this studythe device is non-cytotoxic, non-sensitizing and non-irritating.
Expected batterylife	40000 times measure	40000 times measure
Measuring time	1 second	1 second
Clinical accuracy	Meet the requirements of ISO80601-2-56:2017, ASTM 1965-98(2016)	Meet the requirements of ISO80601-2-56:2017, ASTM 1965-98(2016)	Same

7. Comparison to the Predicate Device

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Justification of difference:

Different (1): The description of the intended use is different. The population of the subject device is wider than the predicate device. The performance testing can demonstrate that the subject device can meet the requirement on this population. So, the different does not raise different questions of safety and effectiveness.

The subject device is only used to measure the body temperature from forehead. The clinical study report can demonstrate this measuring site. So, the different does not raise different questions of safety and effectiveness.

Different (2): The measurement distance is different. The performance testing can demonstrate that the subject device can meet the requirement on this measurement distance. So, the different does not raise different questions of safety and effectiveness.

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8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the Infrared thermometer was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:

. Cytotoxicity
. Sensitization
. Irritation

Non-clinical data

The Infrared thermometer has been tested according to the following standards:

IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and essential performance
IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
ISO 80601-2-56: Medical electrical equipment – Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
IEC 60601-1-11: 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

The test was selected to show substantial equivalence between the subject device and the predicate.

Clinical data

Clinical testing is conducted per ASTM E 1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.

This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consists of a minimum of 150 subjects, of which 1/3 are children and the rest 1/3 are adults (NOTE: Infants---newborn to one year; Children--- greater than one to five years; Adults--- greater than five years old.). The test result demonstrated the clinical performance of the subject device complied with the requirement of standard ASTM E 1965-98 (Reapproved 2016).

9. Conclusion

Based on the perf ormance testing, comparison and analysis provided it was concluded that the subject device, Infrared Thermometer, Models: DT-8806S, DT-8807S is substantially equivalent to the Infrared Thermometer, Models: DT-8806, DT-8806H cleared under K101736

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.