(148 days)
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.
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:
- Forehead and ear temperature measurement.
- Fahrenheit and Celsius temperature unit setting.
- Display resolution is 0.1°C (0.1°F);
- Memorize the latest 10 measurement data;
- Three color backlight display (red, orange, green)
- Low battery indication.
- Prompt for Measurement completion.
- Buzzer feature setting (mute or unmute)
- Turn off automatically after 75 seconds of inactivity.
The provided text describes the clinical accuracy validation for the Berrcom Ear Thermometer, Model ET001. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the clinical accuracy validation was conducted according to ISO 80601-2-56:2017+AMD2018. This standard defines the performance requirements for clinical thermometers, including accuracy. While the specific numerical acceptance criteria (e.g., maximum allowable bias, standard deviation of clinical repeatability) are not explicitly listed in the table provided in the input, the text clearly states:
"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."
Therefore, the reported device performance is that it meets the acceptance criteria for clinical bias and clinical repeatability as defined by ISO 80601-2-56:2017+AMD2018.
| Metric | Acceptance Criteria (from ISO 80601-2-56:2017+AMD2018) | Reported Device Performance |
|---|---|---|
| Clinical Bias | (Not explicitly listed in the document) | Met the acceptance criteria |
| Clinical Repeatability | (Not explicitly listed in the document) | Met the acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 150 subjects
- 50 infants (newborn to one year)
- 50 children (greater than one to five years)
- 50 adults (greater than five years old)
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical study" and "clinical investigation," implying prospective data collection specifically for this validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The text only mentions "clinical accuracy validation was conducted in according to ISO 80601-2-56:2017+AMD2018" and doesn't detail the role or number of experts for ground truth establishment. Clinical thermometers typically use a reference thermometry method (e.g., rectal or oral core temperature measurement) as ground truth, rather than expert consensus on images.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically relevant for studies involving human interpretation (e.g., imaging studies) where disagreements among readers need to be resolved. For clinical thermometer accuracy, the ground truth is established by a reference thermometer, not by interpretation requiring adjudication.
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
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers (e.g., radiologists) use AI to improve their performance. The device here is a standalone thermometer, not an AI diagnostic assistant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The "Clinical Accuracy Validation" described for the Ear Thermometer, Model ET001, demonstrates the device's accuracy in measuring body temperature directly, without human interpretation for the measurement itself. The device is a direct measurement tool, not an algorithm assisting human interpretation.
7. The Type of Ground Truth Used
The ground truth used for clinical accuracy validation of a clinical thermometer is typically a reference temperature measurement obtained through a highly accurate and validated method (e.g., rectal, oral, or arterial core temperature) according to the standards like ISO 80601-2-56. The document mentions "represented by clinical bias and clinical repeatability," which are calculated by comparing the device's readings to such a reference.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The Ear Thermometer is a hardware device based on infrared radiation detection and signal processing, not a machine learning or AI model 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. As stated above, the device does not use a "training set" in the context of machine learning. Its performance relies on the design, calibration, and physical principles of thermometry.
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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.
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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.
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) 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)
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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 |
|---|---|
| Manufacturerinformation | Guangzhou Berrcom Medical Device Co., Ltd.Address:No.38 Huanzhen Xi Road, Dagang Town, Nansha, 511470,Guangzhou, Guangdong, PEOPLE'S REPUBLIC OF CHINAContact person: Zhigang DuTEL: +86(20)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: Ms.Yoyo ChenE-Mail: yoyo@cefda.com; field@cefda.comImage: Logo |
| Establishmentregistration 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 |
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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:
-
- Forehead and ear temperature measurement.
-
- Fahrenheit and Celsius temperature unit setting.
- Display resolution is 0.1°C (0.1°F); 3)
-
- Memorize the latest 10 measurement data;
- Three color backlight display (red, orange, green) 5)
-
- Low battery indication.
- Prompt for Measurement completion. 7)
-
- Buzzer feature setting (mute or unmute)
-
- 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.
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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(K213079) | Predicate Device(K191570) | Comments |
|---|---|---|---|
| Product Code | FLL | FLL | Same |
| Regulation number | 880.2910 | 880.2910 | Same |
| Manufacturer | Guangzhou Berrcom MedicalDevice Co., Ltd. | Guangzhou Berrcom MedicalDevice Co., Ltd. | Same |
| Indications for use | The Ear Thermometer is intended forthe intermittent measurement of bodytemperature from the auditory canal orcentral forehead skin surface onpeople of all ages. It is a non-contactmeasurement method for foreheadmeasurement, the recommendedmeasurement distance is 0cm to 3cm.The Ear Thermometer can be used byconsumers in the householdenvironment and by healthcareproviders. | 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. | 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 referencebody site | Axilla | Axilla | Same |
| Measurement method | Non-contact Type | Non-contact Type | Same |
| Measurement distanceof foreheadmeasurement | 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:32.0°C ~ 43.0°C(89.6°F ~ 109.4°F) | Ear & Forehead: 32.0°C | Same |
| Measurement accuracy | 32.0°C~ 34.9°C(89.6°F | $±0.4°F (0.2°C)$ within95 | Same |
| Items | Subject Devices(K213079) | Predicate Device(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 datamemories | 10sets | 20 sets | SE(Note 1) |
| Beeper setting | Yes | Yes | Same |
| Backlight | Yes | Yes | Same |
| Auto-off time | 75s | 30s | SE(Note 2) |
| Audible alert | Yes | Yes | Same |
| Use of probe covers | No | No | Same |
| Operation Condition | Temperature: 10°C | Temperature: 10°C | Same |
| Storage andtransportation condition | Temperature: -20°C | Temperature: -20°C | Same |
| IP Class | IP22 | IP22 | Same |
| Materials of skin-contacting components | ABS, PC | ABS | SE(Note 3) |
| Physical Dimensions | 126×35×45mm (L x W x H) | 156mm46mm48mm(L x W x H) | SE(Note 3) |
| Weight | 66g | 77g | SE(Note 3) |
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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
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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
-
- 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 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
-
- 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
-
- 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
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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 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.
§ 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.