(228 days)
Not Found
No
The description details a standard infrared thermometer using a sensor, microprocessor, and display to convert infrared energy to a temperature reading. There is no mention of AI, ML, or any complex algorithms beyond basic signal processing and conversion.
No
The device is an infrared thermometer intended for temperature measurement, not for treatment or therapy.
No
Explanation: A diagnostic device identifies or characterizes a disease or condition. This device is an infrared thermometer, which measures body temperature, a physiological parameter, but does not diagnose a condition directly.
No
The device description explicitly lists multiple hardware components including an infrared sensor, integrated circuit, microprocessor, OLED display, buzzer, buttons, batteries, and a lens.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Infrared Thermometer described measures human body temperature externally by detecting infrared energy from the forehead. It does not analyze any biological specimens taken from the body.
Therefore, based on the provided information, the Infrared Thermometer is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Infrared Thermometer is a reusable thermometer intended for the intermittent determination of human body temperature in a non-contact mode using the center of the forehead as the measurement site on people of all ages. It can be used by consumers in the household environment and by healthcare provider.
Product codes
FLL
Device Description
The infrared thermometer uses infrared temperature sensor to detect infrared energy radiated from the forehead. The intensity of the emitted energy depends on the temperature of the object. The infrared probe can recognize the emitted energy and transfer it to an electronic signal. The electronic signal can be processed in the Infrared Thermometer to convert to a temperature reading, which is displayed on the screen.
This is a continuous non-invasive method of measuring body temperature. After measuring the forehead temperature with an infrared temperature sensor, the calculated temperature value is obtained.
The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization.
The device is for over-the-counter use.
The Infrared Thermometer, Model CFT-308, consists of the following parts:
- a) Infrared sensor
- b) Integrated circuit
- c) Microprocessor (with Bluetooth function) (Bluetooth transmission is optional)
- d) OLED display
- e) Buzzer
- f) 2 Buttons ("Start" button, "Measuring" button)
- g) Alkaline batteries; size AAA, 2 x 1.5 V
- h) Lens
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
all ages
Intended User / Care Setting
Used by consumers in the household environment and by healthcare provider.
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 Test: Clinical testing was conducted according to ASTM E1965-98(2016) and ISO 80601-2-56:2017. The Clinical Study of CFT-308 was conducted May 29th, 2020 to March 19th, 2021 in the second hospital of Tianjin medical university. The subject device was compared to a reference thermometer (Model Number: CRW-23) for this study. 152 subjects were screened. 2 subjects were eliminated, and 150 subjects completed the clinical trial (15 subjects aged 0 to 3 months, 35 subjects aged 3 months to 1-year-old, 50 subjects aged from 1 to 5 years old, 50 subjects aged 5 years and above).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
±0.2°C: 35.0 ~ 42.0°C
±0.3°C: 32.034.9°C,107.6°F
±0.3°C: 42.1 ~ 43.0°C
0.4°F for 95°F
Outside that range ±0.5°F
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
January 21, 2022
Beijing Choice Electronic Technology Co., Ltd. Haiying Zhao Official Correspondent 2nd Floor 3rd Floor and Room 410-412 4th Floor No. 2 Building No. 9 Shuangyuan Road Shijingshan District, 100041 Beijing, China
Re: K211752
Trade/Device Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 14, 2021 Received: December 22, 2021
Dear Haiying Zhao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
Gang Peng for Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211752
Device Name Infrared Thermometer
Indications for Use (Describe)
Infrared Thermometer is a reusable thermometer intentittent determination of human body temperature in a non-contact mode using the center of the forehead as the measurement site on people of all ages. It can be used by consumers in the household environment and by healthcare provider.
| 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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Section II 510(k) Summary
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
There is no prior submission for the device.
2.1 Submitter Information
Manufacturer Name: ●
Establishment Registration Number: 3005569927
Beijing Choice Electronic Technology Co., Ltd.
2nd Floor 3rd Floor and Room 410-412 4th Floor No. 2 Building, No. 9 Shuangyuan Road Shijingshan District 100041 Beijing PEOPLE'S REPUBLIC OF CHINA
● Contact Person:
Haiying Zhao
Beijing Choice Electronic Technology Co., Ltd.
2nd Floor 3rd Floor and Room 410-412 4th Floor No. 2 Building, No. 9 Shuangyuan Road Shijingshan District 100041 Beijing PEOPLE'S REPUBLIC OF CHINA
Phone: +86-10-88204631
Fax: +86-10-88204632
Email: cc@choicemmed.com
- Date prepared: May 25, 2021
2.2 Subject Device Information
Regulation Name: Clinical Electronic Thermometer
Device Trade/Proprietary Name: Infrared Thermometer
Model: CFT-308
Purpose of submission: 510 (k)
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Premarket Notification 510(k) Submission—Section II 510(k) Summary Regulation Number: 21 CFR 880.2910
Product Code: FLL
Class: II
Panel: General Hospital
2.3 Predicate Device
510(k) Number: K191829
Regulation Name: Clinical Electronic Thermometer
Device Trade/Proprietary Name: Microlife Non-Contact Infrared Forehead Thermometer
Model: FR1DG1 (NC200)
Product Code: FLL
Regulation Number: 21 CFR 880.2910
Device Class: II
Panel: General Hospital
Manufacturer: Microlife Intellectual Property GmbH, Switzerland
2.4 Device Description
The infrared thermometer uses infrared temperature sensor to detect infrared energy radiated from the forehead. The intensity of the emitted energy depends on the temperature of the object. The infrared probe can recognize the emitted energy and transfer it to an electronic signal. The electronic signal can be processed in the Infrared Thermometer to convert to a temperature reading, which is displayed on the screen.
This is a continuous non-invasive method of measuring body temperature. After measuring the forehead temperature with an infrared temperature sensor, the calculated temperature value is obtained.
The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization.
The device is for over-the-counter use.
5
Premarket Notification 510(k) Submission—Section II 510(k) Summary
The Infrared Thermometer, Model CFT-308, consists of the following parts:
- a) Infrared sensor
- b) Integrated circuit
- c) Microprocessor (with Bluetooth function) (Bluetooth transmission is optional)
- d) OLED display
- e) Buzzer
- f) 2 Buttons ("Start" button, "Measuring" button)
- g) Alkaline batteries; size AAA, 2 x 1.5 V
- h) Lens
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2.5 Comparison list of the technological characteristics
Table II-1 Performance Specification Comparison Table between the Subject Device and Predicate Device
| Comparison Elements | Subject Device | Predicate Device | Similar or
Different | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------|
| Item | Infrared Thermometer | Microlife Non-Contact Infrared Forehead
Thermometer | - | |
| Model | CFT-308 | FR1DG1 (NC200) | - | |
| Regulation No. | 21 CFR 880.2910 | 21 CFR 880.2910 | √ | |
| Classification | II | II | √ | |
| Regulation Name | Clinical Electronic Thermometer | Clinical Electronic Thermometer | √ | |
| Product Code | FLL | FLL | √ | |
| Indications for use | Infrared Thermometer is a reusable
thermometer intended for the intermittent
determination of human body temperature in
a non-contact mode using the center of the
forehead as the measurement site on people of
all ages. It can be used by consumers in the
household environment and by healthcare
provider. | The Microlife Non-Contact Infrared
Forehead Thermometer, Model FR1DG1
(NC200) 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. | Difference
1 | |
| Comparison Elements | Subject Device | Predicate Device | Similar or
Different | |
| Components | a) Infrared sensor
b) Integrated circuit
c) Microprocessor (with Bluetooth function)
(Bluetooth transmission is optional)
d) OLED display
e) Buzzer
f) 2 Buttons (“Start” button, “Measuring”
button)
g) Alkaline batteries; size AAA, 2 x 1.5 V
h) Lens | a) Thermopile Sensor
b) Application-Specific Integrated
Circuitry
c) Erasable Programmable Read-Only
Memory Integrated Circuit
d) Capacitance-touch Integrated Circuit
e) LCD and Backlight
f) 3 buttons (“START/POWER” button,
“M” button, “MODE” button)
g) Alkaline batteries; size AAA, 2 x 1.5 V
h) Lens | Difference
2 | |
| Performance Specification | Thermometer
type | Infrared thermometer | Infrared thermometer | √ |
| | Device
Measurement
Technology | Non-Contact | Non-Contact | √ |
| | Infrared | Infrared | √ | |
| | Temperature
Measurement
distance | Appropriate within 1 cm | Appropriate within 5 cm | Difference
3 |
| Comparison Elements | Subject Device | Predicate Device | Similar or
Different | |
| Measuring
location(human) | Forehead | Forehead | √ | |
| Physical
dimension | 1513850.2 mm | 156.7 * 43 * 47 mm | - | |
| Power supply | Alkaline batteries; size AAA, 2 x 1.5 V | Alkaline batteries; size AAA, 2 x 1.5 V | √ | |
| Display resolution | 0.1°C or 0.1°F | 0.1°C or 0.1°F | √ | |
| Measuring range | 32.0°C ~ 43.0°C (89.6°F109.4°F) | 32.0 ~ 43.0°C (89.6-109.4 °F) | √ | |34.9°C,
| Accuracy | ±0.2°C: 35.0 ~ 42.0°C
±0.3°C: 32.0
±0.3°C: 42.1 ~ 43.0°C
0.4°F for 95°F107.6°F104°F (15°C
Outside that range ±0.5°F | ±0.2°C: 35.0 ~ 42.0°C
±0.3°C: 34.0 ~ 34.9°C
±0.3°C: 42.1 ~ 43.0°C
±0.4 °F: 95.0 ~ 107.6 °F
±0.5 °F: 93.2 94.8 °F,109.4 °F | √ | |
107.8
| Comparison Elements | Subject Device | Predicate Device | Similar or
Different | |
| Response Time | 1 second | 3 second | Difference
4 | |
| Shelf life | 5 years | 5 years | √ | |
| Operating
conditions | Body mode:
59°F40°C),104°F),
Relative humidity: 15%93%40°C (59°F
(non-condensing) | Body mode:
15
15-95% relative maximum humidity | Difference
5 | |
| Storage
conditions | 13°F158°F (-25℃131°F)70℃)55°C(-13°F
Relative humidity ≤93% (non-condensing) in
storage/transport | -25
15-95% relative maximum
humidity | Difference
5 | |
| Reference
site | Armpit | Oral | Difference
6 | |
| Display | OLED display | LCD display | Difference
7 | |
| Date, time, and
beeper setting | Yes | Yes | √ | |
| Memory | 10 sets memories | 30 sets memories | Difference
8 | |
7
8
9
10
| Comparison Elements | Subject Device | Predicate Device | Similar or
Different | | | | | | | | |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-------------------------|--|--|--|--|--|--|---------------------------------------------------------------------------------------------------------|------------------|
| Automatic
Switch-off | The thermometer shall automatically shut off
without manipulating in 30 seconds. | Approx. 1 minute after last measurement
has been taken | Difference
9 | | | | | | | | |
| Beeper indication | Yes | Yes | √ | | | | | | | | |
| Age setting | Selectable between three age ranges:
0 ~ 3 months (Screen display 0-3 Months)
3 ~ 36 months (Screen display 3-36 Months)
36 months (Screen display 36+ Months) | None | | | | | | | | | |
| Fever remind | If the individual temperature being measured
is in the fever range, four “beeps” will be
heard and upset face icon will appear on
the screen
Different fever ranges at different ages as
below:
Age range Above Normal 0 ~ 1 months >37.4°C(>99.4°F) 1 ~ 3 months >37.4°C(>99.4°F) 3 ~ 36 months >37.6°C(>99.6°F) | | | | | | | | | 10 short beeps and a red LCD backlight
alerts that the temperature equal to or
higher than 37.5°C | Difference
10 |
11
| Comparison Elements | Subject Device | Predicate Device | Similar or
Different | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------------------------|
| | >36 months
37.7°C(>99.9°F) | | | |
| Clinical Study
Support | Yes. Clinical test report | Yes. Clinical test report | √ | |
| Contacting
Material | Battery Cover
Enclosure | ABS | ABS | √ |
| | Performan
ce Testing | Laboratory
Testing | ISO80601-2-56:2017
ASTM E1965-98:2016 | ISO80601-2-56:2017
ASTM E1965-98:2016 |
| Electrical Safety | | IEC60601-1:2020
IEC60601-1-11:2020 | IEC60601-1:2012,
IEC60601-1-11:2015 | Difference
11 |
| EMC and
Electrical
Safe | Electromagnetic
Compatibility | IEC60601-1-2:2014
FCC certification
ANSI C63.27-2017 | IEC60601-1-2:2014 | Difference
12 |
| Biocompa
tibility | Biocompatibility
Testing | ISO 10993-1:2018
ISO 10993-5:2009
ISO 10993-10:2010 | ISO 10993-1:2018
ISO 10993-5:2009
ISO 10993-10:2010 | √ |
| Comparison Elements | Subject Device | Predicate Device | Similar or
Different | |
| Software Validation | FDA November 2005 document “Guidance
for the Content of Premarket Submissions for
Software Contained in Medical Devices”. | FDA November 2005 document
“Guidance for the Content of Premarket
Submissions for Software Contained in
Medical Devices”. | √ | |
| Risk Management | Risk Management in Compliance with
ISO14971:2019 | Risk Management in Compliance with
ISO14971:2007 | Difference
13 | |
12
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Premarket Notification 510(k) Submission—Section II 510(k) Summary
- Difference 1: The intended uses of subject device and predicate device are similar. They are both used for intermittent measurement on the forehead in a no touch mode, and are intended to be used by all ages. The use environment of subject device and predicate device are home and medical setting. While there are some minor differences, these do not raise different questions of safety and effectiveness. The device has been tested in accordance with the appropriate standards.
- . Difference 2: The subject device and the predicate device have the similar components. The subject device has the function of Bluetooth transmission (Bluetooth transmission is optional). The safety and effectiveness of the Bluetooth function was tested per FCC Part 15B and Part 15C and ANSI C63.27-2017 American National standard for evaluation of wireless coexistence.
- Difference 3: Subject device and predicate device have similar measuring requirements. Both require that the probe be aimed at the center of the forehead during the test and keep a certain distance. Subject device 's distance is ≤ 1cm, predicate device 's distance is ≤ 5cm. It does not affect performance and accuracy which was evaluated in the performance testing. The accuracy of the subject device under this algorithm is demonstrated through the Clinical study. The Clinical Study Report was present in Performance Testing - Clinical. The difference in measurement distance has no impact on the safety of the device and is compliant to IEC60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- . Difference 4: Subject device response time is 1s. Tested to be compliant to the Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers.
- . Difference 5: Subject device and predicate device have similar operating conditions and storage conditions. The storage and operating environment conditions of subject device meet the IEC60601-1: 2005, AMD1:2012, AMD2:2020 and IEC60601-1-11: 2015, AMD1:2020 standards. The test report is presented in the Electromagnetic Compatibility and Electrical Safety.
- . Difference 6: Subject device and predicate device have different reference sites. The subject device is developed with reference to armpit test temperature. Through clinical trials, the measured temperature of subject device and armpit thermometers are compared to demonstrate the measurement accuracy of subject device meets its declared accuracy range. The test report is presented in the Performance Testing-Clinical.
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Premarket Notification 510(k) Submission-Section II 510(k) Summary
- Difference 7: Subject device and predicate device have different display type. The subject device display meets the requirement of IEC60601-1: 2005, AMD1:2012, AMD2:2020 and IEC60601-1-2:2014. The test report is presented in the Electromagnetic Compatibility and Electrical Safety.
- Difference 8: Subject device and predicate device have same memory type, but the amount of storage is different. This does not affect the safety and effectiveness of the device.
- Difference 9: Subject device and predicate device have the same function of automatic switch-off, the difference is the time for automatic shutdown. This does not affect the safety and effectiveness of the device.
- . Difference 10: Subject device and predicate device have same function of above normal temperature reminder; the difference is subject device can set age range but predicate device not include this function. Because different ages have different definitions of above normal temperatures, this subject device has the function of selecting different age ranges (0-1months, 3-36months, and +36months). This does not affect the safety and effectiveness of the device.
- . Difference 11: Subject device and predicate device utilize the same standard, but the subject device uses the latest standards.
- Difference 12: The subject device has Bluetooth function (Bluetooth transmission is optional), so we have conducted testing for the subject device according Bluetooth Wireless Test according to FCC Part 15B and Part 15C and wireless coexistence testing. The test report is presented in the Electromagnetic Compatibility and Electrical Safety.
- . Difference 13: Subject device and predicate device have same standard, but the subject device uses the latest standards.
2.6 Indications for use
Infrared Thermometer is a reusable thermometer intended for the intermittent determination of human body temperature in a non-contact mode using the center of the forehead as the measurement site on people of all ages. It can be used by consumers in the household environment and by healthcare provider.
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2.7 Testing
The Infrared Thermometer CFT-308 was supported by both laboratory and clinical accuracy testing in order to ensure that they were appropriate performance and functional features to fully comply with recognized standards and is substantially equivalent to the predicate device.
Non-clinical Test
The Infrared Thermometer CFT-308 is designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
- IEC60601-1: 2005, AMD1:2012, AMD2:2020 Medical electrical equipment Part 1: ● General requirements for basic safety and essential performance
- . IEC60601-1-11: 2015, AMD1:2020 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.
- . IEC60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- . ISO80601-2-56:2017 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- . ASTM E1965-98:2016 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
- ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . ISO10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
We have performance tests per FDA guidance "Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers''.
The Software Validation is in compliance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
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Premarket Notification 510(k) Submission-Section II 510(k) Summary
Compliant to FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
| No. | Test Name |
|---|---|
| 1 | System Performance Test |
| 2 | Performance Test according to ISO 80601-2-56: 2017 |
| 3 | Electromagnetic Compatibility Test According to IEC60601-1-2:2014 |
| 4 | Electrical Safety Test According to IEC60601-1: 2005, AMD1:2012, |
| AMD2:2020 | |
| 5 | Used in the home healthcare environment test according to |
| IEC60601-1-11: 2015, AMD1:2020 | |
| 6 | Bluetooth Wireless Test according to FCC Part 15B and Part 15C |
| 7 | Wireless coexistence testing |
| 8 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a |
| risk management process ISO 10993-1:2018 | |
| 9 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| ISO10993-5:2009 | |
| 10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin |
| sensitization ISO10993-10:2010 |
Table II-2 The list of non-clinical test performed on the subject devices.
The test results indicate that the safety and effectiveness of the subject device is substantially equivalent to that of the predicate device.
Clinical Test
Clinical testing was conducted according to ASTM E1965-98(2016) and ISO 80601-2-56:2017. The Clinical Study of CFT-308 was conducted May 29th, 2020 to March 19th, 2021 in the second hospital of Tianjin medical university. The subject device was compared to a reference thermometer (Model Number: CRW-23) for this study.152 subjects were screened. 2 subjects were eliminated, and 150 subjects completed the clinical trial (15 subjects aged 0 to 3 months, 35 subjects aged 3 months to 1-year-old, 50 subjects aged from 1 to 5 years old, 50 subjects aged 5 years and above).
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2.8 Determination of substantial equivalence
The subject device of Infrared Thermometer CFT-308 has the same classification information, same intended use, similar components, similar performance effectiveness as the predicated device. The subject device is Substantially Equivalent (SE) to the predicate device which is US legally market device.