The THERMOCLICK is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home. The device can be used in connection with a smart phone running the THERMOCLICK Mobile Application. The memory data can be transferred to the smart phone via Bluetooth.

Device Description

THERMOCLICK is a battery powered non-contact infrared thermometer that is intended to be used for the monitoring of body temperature of people of all ages. The reference body site of the output temperature is the axilla. With a sensor built into the product, it measures the infrared energy emitted from the skin surface of the forehead within 2cm so there is no need for contact with the skin. It can be used in the home or by a doctor in a clinic. It is indicated for use by people of all ages. After measurement, the temperature is directly displayed on the LED screen. The functions of the THERMOCLICK are controlled by software (firmware), and the user can also receive temperature data from a smartphone application via Bluetooth.

AI/ML Overview

Based on the provided text, the device in question is the THERMOCLICK, Model MT-3000, a non-contact infrared thermometer. The key study proving it meets acceptance criteria is a clinical accuracy validation study.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the device's accuracy performance "complies with the established standards of ASTM E1965-98" and that "The clinical validation results demonstrated that the clinical bias and clinical repeatability met the acceptance criteria of the clinical validation protocol."

While specific numerical acceptance criteria for clinical bias and repeatability are not provided in this document, the Measurement Accuracy section from the comparison table acts as a key performance metric.

Metric	Acceptance Criteria (from ASTM E1965-98 via stated compliance) / Reported Performance
Measurement Accuracy	*For THERMOCLICK:*
22.0°C ~ 36.0°C	± 0.3°C (± 0.6°F)
36.0°C ~ 39.0°C	± 0.2°C (± 0.4°F)
39.0°C ~ 42.2°C	± 0.3°C (± 0.6°F)
Clinical Bias	Met the acceptance criteria of the clinical validation protocol
Clinical Repeatability	Met the acceptance criteria of the clinical validation protocol
Operation Condition (Temperature)	15°C ~ 40°C
Operation Condition (Humidity)	15% ~ 90% (Passed humidity testing exceeding 95% per ASTM E1965-98 standards)
Storage & Transport Condition (Temperature)	-20°C ~ 50°C (Aligns with ASTM E1965-98)
EMC/Electrical Safety	IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 (Passed)
Biocompatibility	ISO 10993-5, ISO 10993-10, ISO 10993-23 (Passed)
Bluetooth RF Test	EN 300 328 V.2.2.2 (2019-07) (Met requirement of data transfer)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: 140 subjects. This population was broken down as:
- 50 Infants
- 45 Children
- 45 subjects 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 it was specifically conducted for this purpose, making it prospective data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The document refers to the ground truth as "clinical bias" and "clinical repeatability" derived from a "clinical accuracy validation" study, which would typically involve comparison to a gold standard temperature measurement method, often supervised by qualified medical professionals. However, the number and specific qualifications of experts for establishing this ground truth are not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document. The study is described as a "randomization, simple blind homologous control, pairing design of clinical investigation," but details on ground truth adjudication are absent.

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, an MRMC comparative effectiveness study was not done. This device is a standalone thermometer, not a diagnostic AI tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the device itself performs the measurement and displays the temperature. The "clinical accuracy validation was conducted in according to ISO 80601-2-56:2017+A1:2018, EN ISO 80601-2-56:2017+A1:2020." This standard focuses on the accuracy and performance of the thermometer itself. While there is a mobile app, its use is described as "an option for the additional function to provide the users" and for managing "recorded patient temperature history," not as part of a human-in-the-loop diagnostic process for core thermometry.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the clinical accuracy validation was established through comparison with a reference method for body temperature measurement, as implied by compliance with ISO 80601-2-56. This standard typically requires comparing the device's readings to a precisely calibrated reference thermometer, often in an oral or rectal site, depending on the standard's specific requirements, to establish "clinical bias" and "clinical repeatability." The document specifies "The reference body site of the output temperature is the axilla," indicating the device's forehead measurements are calibrated to infer axillary temperature, which would then be compared to a gold standard measurement at the axilla or a conversion from another core body site.

8. The sample size for the training set

This information is not applicable and therefore not provided. This device is a hardware medical device (a thermometer), not an AI/ML algorithm that requires a "training set" in the computational sense. The "software" mentioned refers to firmware controlling the device's functions and a companion mobile application, which would undergo traditional software verification and validation, not machine learning model training.

9. How the ground truth for the training set was established

This information is not applicable as there is no "training set" for an AI/ML algorithm. The device's performance is based on its physical design, sensors, and firmware, validated against established metrological standards for temperature measurement.

Summary

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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.

December 5, 2023

T&R BIOFAB CO., LTD. % Edward Park CEO LightenBridge LLC 4408 Tortuga Ln McKinney, Texas 75070

Re: K222057

Trade/Device Name: Thermoclick, Model MT-3000 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 4, 2023 Received: November 6, 2023

Dear Edward Park:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

David Walloschek

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices.

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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) K222057

Device Name THERMOCLICK, Model MT-3000

Indications for Use (Describe)

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/4/Picture/0 description: The image shows the logo for T&R Biofab. The letters "T&R" are in bold black font. To the right of the letters is the word "Biofab", with the "Bio" portion in black and the "fab" portion in a blue gradient.

510(k) Summary - Traditional 510(k)

K222057

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

Submitter Information

Submitter Name:	T&R BIOFAB CO., LTD.
Address:	96, Mayu-ro, Siheung-si, Gyeonggi-do 15111 Republic of Korea
Phone/Fax	+82-31-431-3344 / +82-31-8041-1783
Contact Person:	Edward Park, official correspondent of T&R BIOFAB CO., LTD.
Preparation Date:	Nov 28, 2023

Device Information

Proprietary Name(s):	THERMOCLICK
Model Name:	MT-3000
Common Name:	Non-contact Infrared Thermometer
Regulation Name:	Clinical Electronic Thermometer
Product Code:	FLL
Regulation Number:	21 CFR 880.2910
Classification Panel:	General Hospital
Device Class:	II

Device Description

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These thermometers have the following features:

1. Body temperature mode
1. Fahrenheit and Celsius temperature unit setting
1. LED display screen with automatic range selection, resolution is 0.1℃ (0.1ºF)
1. Body temperature measurement results can be checked through Bluetooth communication.
1. Memorize the latest 1000 measurement results
1. Low battery indication
1. Over range prompt (High temperature indication & Low temperature indication is available by being displayed in color on the screen)
- : Below 36℃ = Orange

36°C ~ 37.6°C (96.8°F ~ 99.7°F) = Green

37.6℃~~38.5℃(99.7°F~~101.3°F)=Orange

Over 38.5°C (101.3°F) = Red
1. Auto shutdown when the device is idle for 15 seconds when Bluetooth operation is turned off. In the case of Bluetooth operation, the power is automatically turned off after 1 minute and 15 seconds.

The THERMOCLICK hardware device can work with THERMOCLICK, a mobile application via Bluetooth connection. The application receives and manages the measured temperature data from the thermometer. This app is not a mandatory component to use THERMOCLICK, but an option for the additional function to provide the users. The mobile app is operated on Android and iOS systems and can be downloaded/installed from each app store.

Predicate Device

. Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)
- 510(k) Number: K211776
- Regulation Name: Clinical Electronic Thermometer
- Device Class: II
- Product Code: FLL
- Regulation Number: 21 CFR 880.2910
- Classification Panel: General Hospital

Indications for Use

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Technological Characteristics

The THERMOCLICK retains the same basic design components and operating features as the predicate Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150, The functionality of the user interface is also the same as the predicate device including mobile application. The power is supplied by AA type battery. The subject device is also similar to the predicate device.

Substantial Equivalence Discussion

THERMOCLICK has been compared to the Microlife Non-Contact Infrared Forehead Thermometer Model FR1MF1-B (NC150 BT) (K211776) for demonstrating substantial equivalence. A table comparing these devices is provided as follows.

	Proposed Device	Predicate
Device Name	THERMOCLICK, Model MT-3000	Microlife Non-Contact Infrared ForeheadThermometer Model FR1MF1-B (NC150 BT)	Remark
510k number	K222057	K211776
Manufacturer	T&R BIOFAB CO., LTD.	Microlife Intellectual Property GmbH
Product Code	FLL	FLL	Identical
RegulationNumber	880.2910	880.2910	Identical
Indicationsfor Use	The THERMOCLICK is intended for the intermittentmeasurement and monitoring of human bodytemperature. The device is indicated for use by people ofall ages in the home. The device can be used inconnection with a smart phone running theTHERMOCLICK Mobile Application. The memory datacan be transferred to the smart phone via Bluetooth.	The Microlife Non-Contact Infrared ForeheadThermometer, Model FR1MF1-B (NC150 BT) isintended for the intermittent measurement and monitoringof human body temperature. The device is indicated foruse by people of all ages in the home.The device can be used in connection with a smart phonerunning the «Microlife Connected Health +» APP. Thememory data can be transferred to the smart phone viaBluetooth.	Similar
Device Name	Proposed Device	Predicate	Remark
	THERMOCLICK	Microlife Non-Contact Infrared ForeheadThermometer Model FR1MF1-B (NC150 BT)
510k number	K222057	K211776
Manufacturer	T&R BIOFAB CO., LTD.	Microlife Intellectual Property GmbH
Prescription/OTC	Over-the-Counter use	Over-the-Counter use	Identical
Intended User	Lay user and professional	Lay user and professional	Identical
Intended PatientPopulation	All ages	All ages	Identical
Sensor Type	Thermopile (Name: JEDS74)	Thermopile & Thermistor	Similar
OperationalPrinciple	Infrared radiation detection	Infrared radiation detection	Identical
Contact type	Non-contact use	Non-contact use	Identical
Display type	LED display	LCD display	Different
Measuringlocation (human)	Forehead	Forehead	Identical
Referencebody Site	Axilla	Axilla	Identical
User Interface	Display panel, exposure buttons, application onthe mobile device	Display panel, exposure buttons, application onthe mobile device	Identical
Dimension	$148.5 \times 38.5 \times 46.0$ mm	$141.1 \times 43.3 \times 36.9$ mm	Similar
Weight(w/o batteries)	85 g	67 g	Similar
Device Name	Proposed Device	Predicate	Remark
510k number	K222057	K211776
Manufacturer	T&R BIOFAB CO., LTD.	Microlife Intellectual Property GmbH
MeasurementRange	22.0°C (71.6°F) ~ 42.2°C (107.9°F)	34°C (93.2°F) ~ 43°C (109.4°F)	Similar
MeasurementAccuracy	36 °C ~ 39 °C (96.8 °F ~102.2 °F)→ ± 0.2 °C (± 0.4 °F)Other range → ± 0.3 °C (± 0.6 °F)	34.0°C~ 34.9°C (93.2°F~~94.8°F)→ ±0.3°C (±0.6°F)35.0°C~~ 42.0°C (95°F~~107.6°F)→ ±0.2°C (±0.4°F)42.1°C~~ 43.0°C (107.8°F~109.4°F )→ ±0.3°C (±0.6°F)	Similar
MeasurementDistance	Within 2 cm	Within 5 cm	Different
Power Supply	3V DC (2 ea of AA type batteries)	3V DC (2 ea of AAA type batteries)	Different
MeasurementTime	Within 1 second	Unknown
Memory Capacity	1000 sets	30 sets	Different
Auto-Shutdowntime	When Bluetooth operation is turned off: 15secondsIn case of Bluetooth operation: 1 minute and 15 seconds	60 seconds	Different
Device Name	Proposed Device	Predicate	Remark
510k number	K222057	K211776
Manufacturer	T&R BIOFAB CO., LTD.	Microlife Intellectual Property GmbH
Operation Condition	Temperature: 15°C ~ 40°CHumidity: 15% ~ 90%Atmospheric Pressure: 80kPa~106kPaAltitude: Less than 2000 m	Temperature: 15°C~~40°C(59°F~~104°F)Relative Humidity: 15%~95%Atmospheric Pressure: Unknown	Similar
Storage and Transportation Condition	Temperature: -20°C ~ 50°CHumidity: 0% ~ 95%Atmospheric Pressure: 50kPa~106kPa	Temperature:-25°C~~55°C(-13°F~~131°F)Relative Humidity: 15%~95%Atmospheric Pressure: Unknown	Similar
Materials of Skin-ContactingComponents	ABS	ABS	Identical
Electrical Safety	IEC 60601-1	IEC 60601-1	Identical
EMC	IEC 60601-1-2	IEC 60601-1-2	Identical
Performance	ASTM E1965-98 & ISO80601-2-56	ASTM E1965-98 & ISO80601-2-56	Identical
Bluetooth version	4.2 LE	4.0	Different
CompatibleMobileApplication	Yes, (name: THERMOCLICK)	Yes (Name: Microlife Connected Health +)	Identical
Device Name	Proposed Device	Predicate	Remark
	THERMOCLICK	Microlife Non-Contact Infrared ForeheadThermometer Model FR1MF1-B (NC150 BT)
510k number	K222057	K211776
Manufacturer	T&R BIOFAB CO., LTD.	Microlife Intellectual Property GmbH
Purpose ofMobileApplication	The memory data can be transferred to the smartphone via Bluetooth to record patient temperaturehistory	The memory data can be transferred to the smartphone via Bluetooth to record patient temperaturehistory	Identical

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T&R B

Discussion

Based on above comparison chart, differences between predicate and subject device are as follows,

A. Indications for Use

The proprietary name of the proposed device is THERMOCLICK, and the predicate device is Microlife Non-Contact Infrared Forehead Thermometer Model FR1MF1-B. This difference does not raise any new safety and effectiveness questions.

B. Sensor Type

The sensor type of the proposed device is only thermopile, whereas the predicate device has both thermopile and thermistor. It is not identical, but the safety and efficacy of the subject device is evaluated through performance testing. Therefore, the difference doesn't raise new or different safety and effectiveness questions.

C. Display type

The display type is also different. But the LED display of THERMOCLICK operates identically to the display of the predicate device. The color-coded light on the LED display of the proposed device simply helps users to recognize which temperature range their measured body temperature is currently within. Software verification and validation testing have been performed on the subject device, and the results complied with the requirements. This doesn't raise new or different safety and effectiveness questions.

D. Weight

Considering the weight of the two batteries, the THERMOCLICK weighs 133g, while the predicate device weighs 91g. Despite their weights, both devices are significantly lighter than a tall size cup of water, ensuring ease of handling. Therefore, the weight difference between the two devices is negligible and does not raise any safety or effectiveness concerns.

E. Measurement Range

The THERMOCLICK has a broader range compared to the predicate device, extending coverage to include the 22~34°C range. However, the total measurement range of THERMOCLICK is in compliance with the ASTM E 1965-98 standard and does not raise any new safety and effectiveness questions.

F. Measurement Accuracy

THERMOCLICK' measurement accuracy is ± 0.3 ℃ within 22.0 ~ 36.0 ℃ and 39.0 ~ 42.2°C ranges. But within 36.0 ~ 39.0 °C, the accuracy is ± 0.2 °C. Compared to the predicate device, THERMOCLICK performs with different accuracy in the 35 ~ 36 °C and 39 ~ 42 °C ranges. In these particular ranges, THERMOCLICK's accuracy varies by ± 0.3 ℃, while the reference device maintains an accuracy of ± 0.2 ℃.

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Image /page/12/Picture/0 description: The image shows the logo for T&R Biofab. The logo is composed of the text "T&R Biofab" in a bold, sans-serif font. The "T&R" is in black, while the "Bio" is in black and the "fab" is in black. There is a blue graphic above the "Bio" portion of the logo.

However, the accuracy performance of THERMOCLICK complies with the established standards of ASTM E1965-98. The difference does not raise new safety and effectiveness questions.

G. Measurement Distance

The difference in measurement distances between the THERMOCLICK (within 2 cm) and the predicate device (within 5 cm) is indeed notable. However, the clinical accuracy was conducted in accordance with ISO 80601-2-56 and the test results met the requirements. Therefore, this difference does not lead to any new safety or effectiveness concerns.

H. Power supply and Memory Capacity

The subject device incorporates bigger batteries, which means bigger power capacity. The electrical safety testing and software validation were conducted. The test results met the requirements. The differences do not raise any safety and effectiveness questions.

I. Auto Shutdown Time

The proposed device differs from the predicate device in terms of the 'lead time for Auto-Shutdown', which varies based on the status of the Bluetooth operation. With Bluetooth operation turned off, the proposed device has a shorter lead time compared to the predicate device. Conversely, when the Bluetooth operation is turned on, the lead time extends beyond that of the predicate device. However, software verification and validation were conducted for the proposed device, demonstrating these differences do not raise any new or different safety and effectiveness concerns.

J. Operating Condition

The difference in operating condition is humidity factor. However, THERMOCLICK has passed humidity testing under conditions exceeding 95% humidity, in accordance with the ASTM E1965-98 standard requirements. The measurement accuracy results of THERMOCLICK fall within the acceptance criteria set in the Standard. Therefore, this discrepancy raises no concerns regarding safety and effectiveness.

K. Storage and Transport Condition

The storage and transportation conditions of both THERMOCLICK and the predicate device fall within safe and functional ranges for medical devices. The temperature range for THERMOCLICK is -20℃ to 50℃, which is slightly narrower than the predicate device's range of -25°C to 55°C. However, THERMOCLICK's intended temperature and humidity ranges align precisely with the ASTM E1965-98 standard requirements for storage & transport conditions. Moreover, THERMOCLICK has successfully undergone the accuracy test after storage and/or transport under these specific conditions and

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Image /page/13/Picture/0 description: The image shows the logo for "T&R Biofab". The logo consists of the letters "T&R" in bold black font, followed by the word "Biofab", with the "Bio" portion in black and the "o" replaced by a blue gradient graphic of three connected circles. The "fab" portion of the word is in black.

requirements. Therefore, this discrepancy does not raise any safety or effectiveness concerns.

L. Bluetooth version

THERMOCLICK uses a Bluetooth version of 4.2 LE, whereas the predicate device uses 4.0. THERMOCLICK has successfully undergone the Bluetooth RF Test in accordance with EN 300 328 V.2.2.2 (2019-07), and the result met the requirement of data transfer. The difference does not raise any new safety and effectiveness questions.

Non-Clincial Test Summary

Non-clinical test was performed in accordance with the following international standards,

A. Electromagnetic Compatibility and Electrical Safety Test

AAMI ANSI ES60601-1:2005+A1:2012, Medical Electrical Equipment Part 1; General -Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2:2015, 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

B. Biocompatibility Test

ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-23: 2021 Biological evaluation of medical devices Part 23: Tests for -Irritation

C. Performance Test-Bench

ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
Clinical accuracy validation was conducted in according to ISO 80601-2--56:2017+A1:2018, EN ISO 80601-2-56:2017+A1:2020. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consisting of 140 subjects, of which 50 subjects are Infants, 45 subjects are Children, and the rest 45 subjects are greater than five years old. The clinical validation results

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Image /page/14/Picture/0 description: The image shows the logo for T&R Biofab. The logo consists of the letters "T&R" in bold, black font, followed by the word "Biofab", also in bold, black font. The "Bio" portion of the word is connected to a blue graphic of connected circles.

demonstrated that the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical validation protocol.

D. Software Verification and Validation

ANSI AAMI IEC 62304:2006+A1:2015, Medical Device Software Software Life -Cycle Processes
ANSI AAMI IEC 62366-1:2015+A1:2020, Medical devices Part 1: Application of usability engineering to medical devices
-EN ISO 14971:2019 Medical devices - Applications of risk management to medical devices
IEC 60601-1-6:2010+A1:2013, Medical Electrical Equipment Part 1-6: General -Requirements for Basic Safety And Essential Performance - Collateral Standard: Usability
FDA Guidance for the Content of Premarket Submissions for Software Contained in -Medical Devices
FDA Guidance for the Content of Premarket Submissions for Management of -Cybersecurity in Medical Devices
The software of the subject device is consistent with moderate level of concern. 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.

Conclusion

The subject device is substantially equivalent in the areas of indications for use, general functions & features, principle of operation, technological characteristics, and applicable safety standards. The new device does not introduce fundamentally new scientific technology, and the successful results of bench testing and clinical accuracy validation should be sufficient evidence of substantial equivalence. Therefore, we conclude that the subject device described in this submission is substantially equivalent 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.