Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard infrared sensing and signal processing, with no mention of AI or ML terms or methodologies.

Therapeutic

No
The device is solely intended for the measurement of body temperature and does not directly provide therapy or treatment.

Diagnostic

No.
The device measures body temperature, which is a physiological parameter, but it does not diagnose any disease or condition based on this measurement. It is intended for intermittent measurement for monitoring purposes, not for diagnostic conclusions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "hand-held, battery powered infrared thermometer" and describes the physical components like an infrared sensor and a screen, indicating it is a hardware device with embedded software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: This device measures body temperature from the ear or forehead using infrared radiation. It does not analyze any biological specimens taken from the body.
Intended Use: The intended use is for the intermittent measurement of body temperature, which is a physiological measurement, not an in vitro diagnostic test.

Therefore, based on the provided information, the Ear Thermometer described is a medical device, but it falls under a different category than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Ear 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 is a non-contact method for forehead measurement, the recommended measurement distance is 0cm. The Ear Thermometer can be used by consumers in the household environment and by healthcare providers.

Product codes

FLL

Device Description

The Ear Thermometers are a hand-held, battery powered infrared thermometer. It is intended to measure the temperature of human body from ear or forehead. The infrared sensor contained in the device can monitor the energy radiated from the human ear tympanum and forehead. The device can analyze and processes the signal transmitted by the infrared sensor, and finally displays it on the screen in digital form to achieve the measurement of human body temperature. People of all ages in household environment and doctors in clinic as reference are suitable for using the device.

It has the following features:

Forehead and ear temperature measurement.
Fahrenheit and Celsius temperature unit setting.
Display resolution is 0.1°C (0.1°F).
White color LED digital display screen.
Automatically shut down if there is no operation within 30 seconds to conserve energy.
Mute or unmute setting.
High temperature indication.
Exceeds measurement range prompt.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

auditory canal, central forehead skin surface

Indicated Patient Age Range

people of all ages

Intended User / Care Setting

consumers in the household environment and by healthcare providers

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical accuracy validation was conducted in according to ISO 80601-2-56:2017+AMD2018. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consisting of 150 subjects, of which 50 subjects are infants, 50 subjects are children, and the rest 50 subjects are adults (NOTE: Infants---newborn to one year; Children-- greater than one to five years; Adults---greater than five years old.). The clinical validation results demonstrated that the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical validation protocol.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K191570

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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February 25, 2022

Guangzhou Berrcom Medical Device Co., Ltd. % Yoyo Chen Senior Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, Guangdong 518000 China

Re: K213084

Trade/Device Name: Ear Thermometer, Model ET005, ET008, ET009 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 15, 2021 Received: September 23, 2021

Dear Yoyo Chen:

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

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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,

Gang Peng for Payal Patel 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) K213084

Device Name

Ear Thermometer, Model: ET005, ET008, ET009

Indications for Use (Describe)

The Ear 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 is a non-contact method for forehead measurement, the recommended measurement distance is 0cm. The Ear Thermometer can be used by consumers in the household environment and by healthcare providers.

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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Image /page/3/Picture/0 description: The image shows the word "Berrcom" in blue font. The first letter "B" is stylized with a heart-shaped curve on the left side. The rest of the letters are in a simple, sans-serif font. The word appears to be a logo or brand name.

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

I. Administrative Information
Submission Date	December 3, 2021
Manufacturer
information	Guangzhou Berrcom Medical Device Co., Ltd.
	Address:
	No.38 Huanzhen Xi Road, Dagang Town, Nansha, 511470,
Guangzhou, Guangdong, PEOPLE'S REPUBLIC OF CHINA
	Contact person: Zhigang Du
	TEL: +86(20)34938449
	E-Mail: dube888@berrcom.com
Submission
Correspondent	Shenzhen Joyantech Consulting Co., Ltd.
	1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian
Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong
Province, China.
	Contact person: Ms.Yoyo Chen
	E-Mail: yoyo@cefda.com; field@cefda.com
	Image: logo
Establishment
registration number	3008395508

2. Device Information

Type of 510(k) Submission:	Traditional
Device Name:	Ear Thermometer
Model:	ET005,ET008,ET009
Classification Name:	Clinical Electronic Thermometer (Infrared Thermometer)
Review Panel:	General Hospital
Device Class:	2
Regulation Number:	880.2910
Product Code:	FLL

3. Predicate Device

Manufacturer:	Guangzhou Berrcom Medical Device Co., Ltd.
Device Name:	Infrared Thermometer Model MD-H30
Model:	MD-H30

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4. Device Description

The Ear Thermometers are a hand-held, battery powered infrared thermometer. It is intended to measure the temperature of human body from ear or forehead. The infrared sensor contained in the device can monitor the energy radiated from the human ear tympanum and forehead. The device can analyze and processes the signal transmitted by the infrared sensor, and finally displays it on the screen in digital form to achieve the measurement of human body temperature. People of all ages in household environment and doctors in clinic as reference are suitable for using the device.

It has the following features:

Forehead and ear temperature measurement. 1)
1. Fahrenheit and Celsius temperature unit setting.
Display resolution is 0.1°C (0.1°F). 3)
1. White color LED digital display screen.
1. Automatically shut down if there is no operation within 30 seconds to conserve energy.
1. Mute or unmute setting.
1. High temperature indication.
1. Exceeds measurement range prompt.

5. Intended Use/Indications for Use

The Ear 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 is a noncontact measurement method for forehead measurement, the recommended measurement distance is 0cm to 3cm. The Ear Thermometer can be used by consumers in the household environment and by healthcare providers.

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Image /page/5/Picture/0 description: The image shows the word "Berrcom" in a stylized, sans-serif font. The word is rendered in a blue color. The "B" in "Berrcom" is stylized with a heart-shaped curve on the left side. The letters are connected to each other, giving the word a flowing appearance.

Comparison with predicate device 6.

| Items | Subject Devices
(K213084) | Predicate Device
(K191570) | Comments |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Product Code | FLL | FLL | Same |
| Regulation number | 880.2910 | 880.2910 | Same |
| Manufacturer | Guangzhou Berrcom Medical
Device Co., Ltd. | Guangzhou Berrcom Medical
Device Co., Ltd. | Same |
| Indications for use | The Ear 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 is a non-contact
measurement method for forehead
measurement, the recommended
measurement distance is 0cm to 3cm.
The Ear Thermometer can be used by
consumers in the household
environment and by healthcare
providers. | 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. | Same |
| Thermometer type | Digital thermometer | Digital thermometer | Same |
| Sensor | Thermopile | Thermopile | Same |
| Operational principle | Infrared radiation detection | Infrared radiation detection | Same |
| Measurement reference
body site | Axilla | Axilla | Same |
| Measurement mode | Adjusted mode | Adjusted mode | Same |
| Measurement method | Non-contact type | Non-contact type | Same |
| Measurement distance
of forehead
measurement | 0cm to 3cm | 0cm to 3cm | Same |
| Patient population | People of all ages | People of all ages | Same |
| RX/OTC Use | OTC | OTC | Same |
| Display type | LED screen | LCD screen | Different
(Note 1) |
| Measurement site | Forehead and ear | Forehead and ear | Same |
| Measurement Range | Ear & Forehead:
32.0°C ~ 43.0°C
(89.6°F ~ 109.4°F) | Ear & Forehead: 32.0°C43°C
(89.6°F109.4°F) | Same |
| Measurement accuracy | 32.0°C~ 34.9°C(89.6°F~94.8°F) :
$\pm$ 0.3°C( $\pm$ 0.5°F)

35.0°C~ 42.0°C(95°F~107.6°F):
$\pm$ 0.2°C( $\pm$ 0.4°F);

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Image /page/6/Picture/0 description: The image shows the word "Berrcom" in a stylized, sans-serif font. The word is rendered in a blue color. The "B" in "Berrcom" is designed with a unique, rounded shape, resembling a stylized heart or a curved shape. The letters are connected with rounded edges, giving the word a smooth and flowing appearance.

Note 1: Display type

The subject device meets the basic safety requirement of IEC 60601-1:2005+AMD 1: 2012, and IEC 60601-1-11. The difference does not raise any issues on the device safety and effectiveness.

Note 2: Materials of skin-contacting components, Physical Dimensions, and weight The biocompatibility tests have conducted on the subject device to demonstrate that the subject device did not have any potential toxicity, skin sensitization and skin irritation during normal use. Otherwise, the subject device has passed the electrical safety tests in according to IEC 60601-1-2, IEC 60601-1, and IEC 60601-1-11 to demonstration that the subject device could be as safe as the predicate device in the intended use environment, and the performance testing shows that the subject device complies with performance standard ISO 80601-2-56 and ASTM E1965-98. The difference does not raise any issues on the device safety and effectiveness.

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Image /page/7/Picture/0 description: The image shows the word "Berrcom" in a stylized, sans-serif font. The word is rendered in a dark blue color. The "B" in "Berrcom" is stylized with a heart-shaped curve on the left side of the letter. The rest of the letters are in lowercase.

nical Test Summary

7.1. Electromagnetic Compatibility and Electrical Safety Test

The subject device meets the following standards:

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and 1) A2:2010/(R)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
1. 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
1. 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 has passed biocompatibility tests in according to following standards.

ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro 1) cytotoxicity
1. ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

7.3. Performance Test-Bench

The subject device has passed performance tests in according to following standards.

1. ISO 80601-2-56:2017+AMD2018 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
1. ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

7.4. Software Verification and Validation

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

8. Clinical Accuracy Validation

Clinical accuracy validation was conducted in according to ISO 80601-2-56:2017+AMD2018. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consisting of 150 subjects, of which 50 subjects are infants, 50 subjects are children, and the rest 50 subjects are adults (NOTE: Infants---newborn to one year; Children-- greater than one to five years; Adults---greater than five years old.). The clinical validation results demonstrated that the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical validation protocol.

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Image /page/8/Picture/0 description: The image shows the word "Berrcom" in a stylized, sans-serif font. The word is rendered in a dark blue color. The "B" in "Berrcom" is stylized to resemble a heart shape, with the left side of the "B" forming the curve of the heart.

9. Conclusion

The Ear Thermometers (Model: ET005, ET008, ET009) are substantially equivalent to the infrared Thermometer Model MD-H30 cleared under K191570. This conclusion is based upon comparison on intended use, technological characteristics and applicable safety standards. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.