The infrared thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It can be used by consumers in the household environment and by healthcare providers.

Device Description

The Infrared Thermometer, Model MD-H30 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal or central forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or central forehead. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display.

AI/ML Overview

The provided text is related to the FDA 510(k) premarket notification for an Infrared Thermometer (Model MD-H30). This document focuses on demonstrating that the device is "substantially equivalent" to a legally marketed predicate device, rather than providing a detailed clinical study report with the typical elements of acceptance criteria and performance data for an AI/ML medical device.

Key takeaway: This document describes a medical thermometer, not an AI/ML device. Therefore, many of the questions regarding AI/ML specific criteria (e.g., training set, expert adjudication, MRMC study, standalone performance) are not applicable to the information contained here.

However, I can extract the relevant information concerning the device's accuracy and the validation study performed:

Acceptance Criteria and Reported Device Performance

Given that this is a non-AI/ML device (an infrared thermometer), the "acceptance criteria" primarily revolve around its stated accuracy specifications and compliance with relevant performance standards for thermometers.

Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria (Standard Specification)	Reported Device Performance (as demonstrated by compliance)
Measurement Accuracy	$\pm$ 0.4°F (0.2°C) within 95~~107.6°F (35~~42°C)	Demonstrated to meet this accuracy specification. (Stated as "Same" as predicate, which has this spec)
	$\pm$ 0.5°F (0.3°C) for other range	Demonstrated to meet this accuracy specification. (Stated as "Same" as predicate, which has this spec)
Measurement Range	Meets requirements of ISO80601-2-56 and ASTM E1965-98 (Predicate range: 34~~42.2°C (93.2~~108°F))	Proposed Device Range: 32.0-43°C (89.6-109.4°F). This wider range is noted as "Similar" and stated to meet the requirements of ISO80601-2-56 and ASTM E1965-98, not raising different safety and effectiveness issues.
Compliance with Standards	ASTM E 1965-98, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-56	Confirmed compliance with all listed standards through non-clinical tests.
Biocompatibility	Compliance with ISO 10993-5 and ISO 10993-10 for skin-contacting components (ABS material)	Biocompatibility tested and found compliant with ISO 10993-5 and ISO 10993-10.
Electrical Safety	Compliance with requirements for electrical safety (implied by IEC standards and battery difference note)	Demonstrated to comply with electrical safety requirements.
Cleaning and Disinfection	Validation of reprocessing according to Instructions for Use for a non-sterile device	Cleaning validation performed according to IFU.
Clinical Accuracy Validation	Clinical investigation report and data analysis to meet the requirements of ASTM E 1965-98 for acceptable temperature readings compared to a digital thermometer.	The test report shows the three group's temperature readings difference between digital thermometer and the subject device, MD-H30 are within acceptable range. "It can conclude that the Infrared Thermometer, Model MD-H30 is acceptable to measure human body's temperature."

Study Details (Focusing on a non-AI/ML device)

Sample size used for the test set and the data provenance:
- The document states, "The clinical investigation report and data analysis met the requirements of the ASTM E 1965-98."
- It mentions "the three group's temperature readings." However, the exact sample size (number of subjects or measurements) for this clinical accuracy validation is not provided in the submitted text.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This information would typically be in the full clinical study report, which is not provided here. The manufacturer is based in China, so it's plausible the study was conducted there.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of an infrared thermometer. Ground truth for temperature measurement would be established by a reference thermometer or standard. The document mentions comparison to a "digital thermometer."
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is a device for direct physical measurement, not an interpretative AI/ML system.
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:
- Not applicable. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a standalone physical device. Its performance is its direct measurement output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for the clinical accuracy validation was established by comparison to a "digital thermometer." For thermometer validation, this typically refers to a highly accurate reference thermometer, often using a controlled environment or comparing against an established method (e.g., rectal temperature for core body temperature, depending on the standard).
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable.

In summary, the provided document is a 510(k) summary for an infrared thermometer, focusing on its substantial equivalence to a predicate device based on its design, intended use, and performance against established non-clinical and clinical (accuracy) standards for medical thermometers. It does not contain the detailed information typically found in a clinical study report for an AI/ML-driven medical device.

Summary

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November 13, 2019

Guangzhou Berrcom Medical Device Co., Ltd. % Christy Young Consultant Shenzhen Joyantech Consulting Co., Ltd. NO. 55 Shizhou middle road, Nanshan District Shenzhen. 518000 China

Re: K191570

Trade/Device Name: Infrared Thermometer Model MD-H30 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: May 31, 2019 Received: June 13, 2019

Dear Christy Young:

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 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 Geeta Pamidimukkala 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) K191570

Device Name Infrared Thermometer Model MD-H30

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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Proposed product: Infrared Thermometer Model MD-H30

K191570 510(k) Summary

1. Contact Details

1.1 Applicant information

Applicant Name	Guangzhou Berrcom Medical Device Co., Ltd.
Address	No.38 Huanzhen Xi Road, Dagang Town, Nansha, Guangzhou,Guangdong 511470, China
Phone No.	+86(20)34938449
Fax No.	+86(20)34936960
Contact person	Zhigang Du
Date Prepared	November 12 2019

1.2 Submission Correspondent

	Shenzhen Joyantech Consulting Co., Ltd
	Room 1122, International Mayors Communication Centre, NO. 55
	Shizhou middle road, Nanshan District, Shenzhen
卓远天成
Phone No.	+86-755-86069197
Contact person	Christy Young; Field Fu;
Contact person's e-mail	christy@cefda.com; cefda@foxmail.com
Website	http://www.cefda.com

Device information 2.

Trade name	Infrared Thermometer Model MD-H30
Common name	Infrared Thermometer
Model	MD-H30
Classification	II
Classification name	Clinical Electronic Thermometer
Product code	FLL
Regulation No.	880.2910

Legally Marketed Predicate Device 3.

Trade Name	RII Multi-function Infrared Thermometer, Model TH52Z
510(k) Number	K162083
Product Code	FLL
Manufacturer	Radiant Innovation Inc

Device Description 4.

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Proposed product: Infrared Thermometer Model MD-H30

To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display.

Intended Use/Indication for Use 5.

Item	Proposed Device:Infrared Thermometer	Predicate Device:RII Multi-function InfraredThermometer	Comments
Product Code	FLL	FLL	Same
Regulationnumber	21 CFR 880.2910	21 CFR 880.2910	Same
Manufacturer	Guangzhou Berrcom MedicalDevice Co., Ltd.	Radiant Innovation Inc.	/
Indications forUse	The infrared thermometer isintended for the intermittentmeasurement of bodytemperature from the auditorycanal or central forehead skinsurface on people of all ages. Itcan be used by consumers inthe household environment andby healthcare providers.	The RII Multi-function InfraredThermometer, Model TH52Z isintended for the intermittentmeasurement of human bodytemperatures. The device isintended for the use at home bypeople of all ages and it can beselected Ear mode or Foreheadmode.	Same
	Thermometertype	Digital thermometer	Digital thermometer	Same
	Sensor	Thermopile	Thermopile	Same
	MeasurementMethod	Infrared radiation detection	Infrared radiation detection	Same
	Display Type	LCD	LCD	Same
Measuringrange	32.0-43°C (89.6-109.4°F)	34~~42.2°C (93.2~~108°F)	Similar (note1)
Accuracy	$\pm$ 0.4°F (0.2°C) within95~~107.6°F (35~~42°C),$\pm$ 0.5°F (0.3°C) for other range.	$\pm$ 0.4°F (0.2°C) within95~~107.6°F (35~~42°C),$\pm$ 0.5°F (0.3°C) for other range.	Same

6. Substantial Equivalence Comparison

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Proposed product: Infrared Thermometer Model MD-H30

Temperatureunit	°C or °F	°C or °F	Same
Powerrequirements	2X1.5V AAA battery	1.5V button battery	Different(note 2)
Operationenvironment	10℃~40℃; ≤95% RH	Not available	/
Storageenvironment	-20~55°C; ≤95%RH	Not available	/
Materials ofskin-contactingcomponents	ABS	ABS	Same

lssue:

Note 1: The measurement range of subject devices meet the requirements of ISO80601-2-56 and ASTM E1965-98. The difference does not raise different safety and effectiveness issues Note 2: The batteries of proposed device are different from that of predicate device. However, the proposed device has been demonstrated to comply with the requirements of electrical safety identified in the standards. The difference does not raise different safety and effectiveness issues.

7. Non-clinical studies and tests performed

Non-clinical tests were conducted to verify that the targeted device meet all design specifications in order to demonstrate that it is Substantially Equivalent to the predicate device.

The test results demonstrate that the targeted device complies with the following standards:

ASTM E 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

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 requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility

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

ISO 80601-2-56: 2009 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.

Software verification and validation:

Software documentation consistent with moderate level of concern is submitted in this 510(k). System validation testing presented in this 510(k) demonstrates that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.

Biocompatibility test:

The biocompatibility of the device was tested according to:

ISO 10993-5 Biological Evaluation of Medical Devices-Tests For In Vitro Cytotoxicity

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ISO 10993-10 Biological Evaluation of Medical Devices- Tests for Irritation and Skin Sensitization

Reprocessing: Cleaning and Disinfection

The subject device is a non-sterile device. The cleaning validation was performed according to the Instructions for Use.

8. Clinical accuracy validation

The clinical investigation report and data analysis met the requirements of the ASTM E 1965-98. The test report shows the three group's temperature readings difference between digital thermometer and the subject device, MD-H30 are within acceptable range. It can conclude that the Infrared Thermometer, Model MD-H30 is acceptable to measure human body's temperature.

9. Conclusion

Basing on the comparison and analysis above, the proposed device, Infrared Thermometer Model MD-H30 is determined to be Substantially Equivalent (SE) to the 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.