(511 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard infrared temperature measurement and Bluetooth data transfer.
No
The device is described as an infrared thermometer intended for "measurement and monitoring of human body temperature," which is a diagnostic function, not a therapeutic one. It does not claim to treat or alleviate any condition.
No
Explanation: The device is described as a thermometer for "measurement and monitoring of human body temperature," which falls under general health monitoring rather than diagnosis. It does not claim to identify, screen, or aid in the detection of any specific disease or condition.
No
The device description explicitly states it is a "battery powered non-contact infrared thermometer" with a "sensor built into the product" and an "LED screen" for displaying temperature. While it uses software (firmware) and connects to a smartphone app, it is fundamentally a hardware device that measures temperature using infrared technology.
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.
- THERMOCLICK Function: The THERMOCLICK measures body temperature by detecting infrared radiation emitted from the skin surface (forehead). It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is for the intermittent measurement and monitoring of human body temperature, which is a direct measurement of a physiological parameter, not an analysis of a specimen.
Therefore, based on the provided information, the THERMOCLICK falls under the category of a medical device but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead (measurement location), axilla (reference body site)
Indicated Patient Age Range
all ages
Intended User / Care Setting
Home, doctor in a clinic / Lay user and professional
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+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 demonstrated that the 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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"
1
(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.
2
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
3
Indications for Use
510(k) Number (if known) K222057
Device Name THERMOCLICK, Model MT-3000
Indications for Use (Describe)
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.
| 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
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.
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Image /page/5/Picture/0 description: The image shows the logo for T&R Biofab. The logo consists of the letters "T&R" in black, followed by the word "Biofab", with the "Bio" portion in black and the "fab" portion in blue. The blue portion of the logo also includes a stylized image of a molecule.
These thermometers have the following features:
-
- Body temperature mode
-
- Fahrenheit and Celsius temperature unit setting
-
- LED display screen with automatic range selection, resolution is 0.1℃ (0.1ºF)
-
- Body temperature measurement results can be checked through Bluetooth communication.
-
- Memorize the latest 1000 measurement results
-
- Low battery indication
-
- 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°F101.3°F)=Orange
- Over 38.5°C (101.3°F) = Red
-
- 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
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.
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Image /page/6/Picture/0 description: The image shows the logo for T&R Biofab. The logo is black except for a blue graphic between the words Bio and fab. The graphic is a series of circles connected by lines.
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 Forehead | |
| Thermometer 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 |
| Regulation | |||
| Number | 880.2910 | 880.2910 | Identical |
| Indications | |||
| for Use | 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. | The Microlife Non-Contact Infrared Forehead | ||
| Thermometer, Model FR1MF1-B (NC150 BT) 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 «Microlife Connected Health +» APP. The | |||
| memory data can be transferred to the smart phone via | |||
| Bluetooth. | Similar | ||
| Device Name | Proposed Device | Predicate | Remark |
| THERMOCLICK | Microlife Non-Contact Infrared Forehead | ||
| Thermometer 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 Patient | |||
| Population | All ages | All ages | Identical |
| Sensor Type | Thermopile (Name: JEDS74) | Thermopile & Thermistor | Similar |
| Operational | |||
| Principle | Infrared radiation detection | Infrared radiation detection | Identical |
| Contact type | Non-contact use | Non-contact use | Identical |
| Display type | LED display | LCD display | Different |
| Measuring | |||
| location (human) | Forehead | Forehead | Identical |
| Reference | |||
| body Site | Axilla | Axilla | Identical |
| User Interface | Display panel, exposure buttons, application on | ||
| the mobile device | Display panel, exposure buttons, application on | ||
| the 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 | |
| Measurement | |||
| Range | 22.0°C (71.6°F) ~ 42.2°C (107.9°F) | 34°C (93.2°F) ~ 43°C (109.4°F) | Similar |
| Measurement | |||
| Accuracy | 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 | ||
| Measurement | |||
| Distance | 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 |
| Measurement | |||
| Time | Within 1 second | Unknown | |
| Memory Capacity | 1000 sets | 30 sets | Different |
| Auto-Shutdown | |||
| time | When Bluetooth operation is turned off: 15 | ||
| seconds | |||
| In 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°C | ||
| Humidity: 15% ~ 90% | |||
| Atmospheric Pressure | |||
| : 80kPa~106kPa | |||
| Altitude: Less than 2000 m | Temperature | ||
| : 15°C | |||
| Relative Humidity: 15%~95% | |||
| Atmospheric Pressure: Unknown | Similar | ||
| Storage and Transportation Condition | Temperature: -20°C ~ 50°C | ||
| Humidity: 0% ~ 95% | |||
| Atmospheric Pressure: 50kPa~106kPa | Temperature | ||
| :-25°C | |||
| Relative Humidity: 15%~95% | |||
| Atmospheric Pressure: Unknown | Similar | ||
| Materials of Skin- | |||
| Contacting | |||
| Components | 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 |
| Compatible | |||
| Mobile | |||
| Application | Yes, (name: THERMOCLICK) | Yes (Name: Microlife Connected Health +) | Identical |
| Device Name | Proposed Device | Predicate | Remark |
| THERMOCLICK | Microlife Non-Contact Infrared Forehead | ||
| Thermometer Model FR1MF1-B (NC150 BT) | |||
| 510k number | K222057 | K211776 | |
| Manufacturer | T&R BIOFAB CO., LTD. | Microlife Intellectual Property GmbH | |
| Purpose of | |||
| Mobile | |||
| Application | The memory data can be transferred to the smart | ||
| phone via Bluetooth to record patient temperature | |||
| history | The memory data can be transferred to the smart | ||
| phone via Bluetooth to record patient temperature | |||
| history | 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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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.