Ear Thermometer, Model ET001

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 18, 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: K213079 Trade/Device Name: Ear Thermometer, Model ET001 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 12, 2022 Received: January 18, 2022 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. {1}------------------------------------------------ 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. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213079 Device Name Ear Thermometer, Model: ET001 #### 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) | | Own-Time Recreation Use (36 CFR 211 Subpart B) | |--|------------------------------------------------| | | Commercial Use (36 CFR 251 Subpart B) | | | Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "Berrcom" in blue font. The "B" in "Berrcom" is stylized to look like a heart. The rest of the letters are in a sans-serif font. The image is simple and clean, with a white background. # 510(k) Summary - K213079 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 | Submission Date | January 12, 2022 | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer<br>information | Guangzhou Berrcom Medical Device Co., Ltd.<br>Address:<br>No.38 Huanzhen Xi Road, Dagang Town, Nansha, 511470,<br>Guangzhou, Guangdong, PEOPLE'S REPUBLIC OF CHINA<br>Contact person: Zhigang Du<br>TEL: +86(20)34938449<br>E-Mail: dube888@berrcom.com | | Submission<br>Correspondent | Shenzhen Joyantech Consulting Co., Ltd.<br>1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian<br>Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong<br>Province, China.<br>Contact person: Ms.Yoyo Chen<br>E-Mail: yoyo@cefda.com; field@cefda.com<br>Image: Logo | | Establishment<br>registration number | 3008395508 | ### 2. Device Information | Type of 510(k) Submission: | Traditional | |----------------------------|--------------------------------------------------------| | Device Name: | Ear Thermometer | | Model: | ET001 | | 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 | {4}------------------------------------------------ #### 4. Device Description The Ear Thermometer, model of ET001 is 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: - 1) Forehead and ear temperature measurement. - 2) Fahrenheit and Celsius temperature unit setting. - Display resolution is 0.1°C (0.1°F); 3) - 4) Memorize the latest 10 measurement data; - Three color backlight display (red, orange, green) 5) - 6) Low battery indication. - Prompt for Measurement completion. 7) - 8) Buzzer feature setting (mute or unmute) - 9) Turn off automatically after 75 seconds of inactivity. #### 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. {5}------------------------------------------------ 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<br>(K213079) | Predicate Device<br>(K191570) | Comments | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | Product Code | FLL | FLL | Same | | Regulation number | 880.2910 | 880.2910 | Same | | Manufacturer | Guangzhou Berrcom Medical<br>Device Co., Ltd. | Guangzhou Berrcom Medical<br>Device Co., Ltd. | Same | | Indications for use | The Ear Thermometer is intended for<br>the intermittent measurement of body<br>temperature from the auditory canal or<br>central forehead skin surface on<br>people of all ages. It is a non-contact<br>measurement method for forehead<br>measurement, the recommended<br>measurement distance is 0cm to 3cm.<br>The Ear Thermometer can be used by<br>consumers in the household<br>environment and by healthcare<br>providers. | The infrared thermometer is<br>intended for the intermittent<br>measurement of body<br>temperature from the auditory<br>canal or central forehead skin<br>surface on people of all ages. It<br>can be used by consumers in<br>the household environment and<br>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 mode | Adjusted mode | Adjusted mode | Same | | Measurement reference<br>body site | Axilla | Axilla | Same | | Measurement method | Non-contact Type | Non-contact Type | Same | | Measurement distance<br>of forehead<br>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 | LCD | LCD | Same | | Measurement site | Forehead and ear | Forehead and ear | Same | | Measurement Range | Ear & Forehead:<br>32.0°C ~ 43.0°C<br>(89.6°F ~ 109.4°F) | Ear & Forehead: 32.0°C~43°C<br>(89.6°F~109.4°F) | Same | | Measurement accuracy | 32.0°C~ 34.9°C(89.6°F~94.8°F) :<br>$±0.3°C(±0.5°F)$<br><br>35.0°C~ 42.0°C(95°F~107.6°F):<br>$±0.2°C(±0.4°F)$ ;<br><br>42.1°C~ 43.0°C(107.8°F~109.4°F ):<br>$+0.3°C(+0.5°F)$ | $±0.4°F (0.2°C)$ within<br>95~107.6°F (35~42°C),<br>$±0.5°F (0.3°C)$ for other range. | Same | | Items | Subject Devices<br>(K213079) | Predicate Device<br>(K191570) | Comments | | Display resolution | 0.1°C (0.1°F) | 0.1°C (0.1°F) | Same | | Power supply | DC 3V (2pcs AAA batteries) | DC 3V (2pcs AAA batteries) | Same | | Measurement time | 1 second | 1 second | Same | | Measurement data<br>memories | 10sets | 20 sets | SE<br>(Note 1) | | Beeper setting | Yes | Yes | Same | | Backlight | Yes | Yes | Same | | Auto-off time | 75s | 30s | SE<br>(Note 2) | | Audible alert | Yes | Yes | Same | | Use of probe covers | No | No | Same | | Operation Condition | Temperature: 10°C~40°C<br>Relative Humidity: ≤85%,<br>Atmospheric Pressure: 70kPa~106kPa | Temperature: 10°C~40°C<br>Relative Humidity: ≤85%<br>Atmospheric Pressure: 70kPa~106kPa | Same | | Storage and<br>transportation condition | Temperature: -20°C~55°C<br>Relative Humidity: ≤95%RH,<br>noncondensing<br>Atmospheric Pressure: 70kpa~106kpa | Temperature: -20°C~55°C<br>Relative Humidity: ≤95%RH,<br>Atmospheric Pressure: 70kpa~106kpa | Same | | IP Class | IP22 | IP22 | Same | | Materials of skin-<br>contacting components | ABS, PC | ABS | SE<br>(Note 3) | | Physical Dimensions | 126×35×45mm (L x W x H) | 156mm*46mm*48mm(L x W x H) | SE<br>(Note 3) | | Weight | 66g | 77g | SE<br>(Note 3) | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Berrcom. The logo is in blue and features a stylized letter "B" that resembles a heart shape. The rest of the company name, "errcom", is written in lowercase letters with rounded edges, also in blue. The logo has a clean and modern design. #### Note 1: Measurement data memories The subject device meets the basic safety requirement of IEC 60601-1:2005+AMD 1: 2012, IEC 60601-1-11, IEC 80601-2-56 and ASTM E1965-98. The difference does not raise any issues on the device safety and effectiveness. #### Note 2: Auto-off time Although the time of auto-off time will longer than predicate device, but both of subject devices and predicate device are meet 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 3: 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 {7}------------------------------------------------ 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 ISO80601-2-56 and ASTM E1965-98. The difference does not raise any issues on the device safety and effectiveness. # 7. Non-Clinical 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 - 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 - 3) 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 - 2) 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. - ISO 80601-2-56:2017+AMD2018 Medical electrical equipment Part 2-56: Particular 1) requirements for basic safety and essential performance of clinical thermometers for body temperature measurement - 2) 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 {8}------------------------------------------------ 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 first letter, "B", is designed with a heart-shaped loop at the top, giving the logo a friendly and approachable feel. The rest of the letters are connected and have a rounded appearance. linical 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. # 9. Conclusion The Ear Thermometer (Model: ET001) is 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 do not raise any new issues or concerns of safety or effectiveness.