(292 days)
No
The summary describes a standard infrared thermometer and does not mention any AI or ML capabilities, training data, or complex algorithms beyond basic temperature measurement.
No
The device is described as an Infrared Forehead Thermometer intended for "intermittent measurement and monitoring of forehead temperature," indicating a diagnostic or monitoring function, not a therapeutic one.
No
This device is intended for the measurement and monitoring of forehead temperature, not for diagnosing a condition or disease.
No
The device description explicitly states it is a "hand-held forehead thermometer" and measures temperature based on "infrared energy emitted from the forehead," indicating it is a physical hardware device.
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 Forehead Thermometer measures temperature by detecting infrared energy emitted from the forehead. This is a non-invasive measurement taken directly from the body, not from a specimen taken from the body.
- Intended Use: The intended use is for the intermittent measurement and monitoring of forehead temperature, which is a physiological parameter, not an analysis of a biological sample.
Therefore, based on the provided information, the Infrared Forehead Thermometer is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Infrared Forehead Thermometer is intentermittent measurement and monitoring of forehead temperature. The device is indicated for use by people of all ages in the home.
Product codes
FLL
Device Description
The Infrared Forehead Thermometer, model FR200 is a hand-held forehead thermometer and it is intended for the non-contact intermittent measurement and monitoring of forehead temperature which is based on the infrared energy emitted from the forehead. It is indicated for use by people of all ages in the home.
After measurement, the temperature is directly shown on the LCD display so that the users can quickly get measurement results after properly scanning the forehead. The features of the thermometer are as follow:
-
- This device can be used for measuring the body temperature and object temperature
-
- Measurement in a matter of seconds;
- Switching between ℃ and ℃ F; 3)
- Automatic range selection; resolution is 0.1°C (0.1 °F); 4)
- Body mode and object mode switching 5)
-
- Low battery indication, and auto shut-down;
-
- With a high and low temperature alarm function (color and sound indication);
- Multiple reading recall (30 sets data could be stored and recalled); 8)
-
- Two color backlight display:
-
- Ambient detection
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
people of all ages
Intended User / Care Setting
Home
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 testing was conducted in according to ASTM E1965-98(Reapproved 2016) and ISO 80601-2-56:2017. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consisting of 180 subjects, of which 60 subjects are infants, 60 subjects are children and the rest 60 subjects are adults (NOTE: Infants--newborn to one year; Children-- greater than one to five years; Adults---greater than five years old.). The clinical test report demonstrated that the clinical data, represented by clinical repeatability met the acceptance criteria of the clinical study protocol.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the full name written in a smaller font next to it.
July 7, 2021
Shenzhen Combei Technology Co., Ltd. % Yoyo Chen Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town Shenzhen, Guangdong 518000 China
Re: K202741
Trade/Device Name: Infrared Forehead Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: May 24, 2021 Received: June 7, 2021
Dear Yoyo Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Payal Patel Acting 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) K202741
Device Name Infrared Forehead Thermometer, Model:FR200
Indications for Use (Describe)
Infrared Forehead Thermometer is intentermittent measurement and monitoring of forehead temperature. The device is indicated for use by people of all ages in the home.
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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3
510K Summary
This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.
1. Administrative Information
| The date the summary
| was prepared | May 24, 2021 |
|---|---|
| Manufacturer | |
| information | Shenzhen Combei Technology Co., Ltd. |
| Address: | |
| Floor 3, Bldg. B, Jinxiongda Technology Park, No.105, | |
| Huanguan South Road, Dahe Community, Guanlan, Long Hua | |
| District, Shenzhen, Guangdong, China, 518110 |
Contact person: Kevin Fong
TEL: 086-755-29588956
E-Mail: kevin.fong@combei.cn |
| Submission
Correspondent | Shenzhen Joyantech Consulting Co., Ltd.
1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian
Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong
Province, China.
Contact person: Ms. Yoyo Chen
Tel: +86(755)86069197
E-Mail: yoyo@cefda.com; field@cefda.com |
| Image: Logo | |
| Establishment
registration number | 3013561145 |
2. Device Information
| Device Name: | Infrared Forehead Thermometer |
|---|---|
| Model: | FR200 |
| Common name: | Clinical Electronic Thermometer (Infrared Thermometer) |
| Classification Name: | Thermometer, Electronic, Clinical |
| Review Panel: | General Hospital |
| Device Class: | Class II |
| Regulation Number: | 880.2910 |
| Product Code: | FLL |
4
3. Predicate Device
| Manufacturer | Microlife Intellectual Property GmbH |
|---|---|
| Device name | Microlife Non-Contact Infrared Forehead Thermometer |
| Model | FR1DG1 (NC200) |
| 510(K) Number: | K191829 |
| Regulation Number: | 880.2910 |
| Device Class: | Class II |
| Product Code | FLL |
4. Device Description
The Infrared Forehead Thermometer, model FR200 is a hand-held forehead thermometer and it is intended for the non-contact intermittent measurement and monitoring of forehead temperature which is based on the infrared energy emitted from the forehead. It is indicated for use by people of all ages in the home.
After measurement, the temperature is directly shown on the LCD display so that the users can quickly get measurement results after properly scanning the forehead. The features of the thermometer are as follow:
-
- This device can be used for measuring the body temperature and object temperature
-
- Measurement in a matter of seconds;
- Switching between ℃ and ℃ F; 3)
- Automatic range selection; resolution is 0.1°C (0.1 °F); 4)
- Body mode and object mode switching 5)
-
- Low battery indication, and auto shut-down;
-
- With a high and low temperature alarm function (color and sound indication);
- Multiple reading recall (30 sets data could be stored and recalled); 8)
-
- Two color backlight display:
-
- Ambient detection
5. Indication for Use
Infrared Forehead Thermometer is intended for the intermittent measurement and monitoring of forehead temperature. The device is indicated for use by people of all ages in the home.
6. Comparison with Predicate Device
The subject devices are substantially equivalent to the predicate device (K191829). The comparison of technological characteristics between the subject device and predicate device is listed as follows:
| Items | Subject Device
(K202741) | Predicate Device
(K191829) | Comparison |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Product code | FLL | FLL | Same |
| Regulation number | 880.2910 | 880.2910 | Same |
| Items | Subject Device
(K202741) | Predicate Device
(K191829) | Comparison |
| Device class | 2 | 2 | Same |
| Intended use | Infrared Forehead Thermometer is
intended for the intermittent
measurement and monitoring of
forehead temperature. The device is
indicated for use by people of all ages
in the home. | 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. | Same |
| Thermometer type | Infrared thermometer
Non-contact | Infrared thermometer
Non-contact | Same |
| Device
Measurement
Technology | Infrared radiation detection | Infrared radiation detection | Same |
| Measurement
location | Forehead | Forehead | Same |
| Measurement
Range | $34.0°C43.0°C (93.2°F ~ 109.4° F);$ | $34.0°C -43.0 °C (93.2-109.4 °F);$ | Same |40°C (59°F
| Measurement
accuracy | $±0.2°C (±0.4°F): 34.0°C ~ 43.0°C(93.2°F ~ 109.4°F);$ | $±0.2 °C: 35.0 ~ 42.0 °C$
$±0.3 °C: 34°C ~ 34.9°C, 42.1°C$
$43°C,$5cm | Appropriate within 5 cm | Similar |
$±0.4 °F: 95.0 ~ 107.6 °F,$
$±0.5 °F: 93.2 94.8 °F,$109.4 °F$ | Different
$107.8
(Note 1) |
| Temperature
Measurement
distance | 3cm
| Display Type | LCD Display | LCD Display | Same |
| Display resolution | $0.1°C (0.1°F)$ | $0.1°C(0.1°F)$ | Same |
| Power supply | d.c.3.0V (2pcs AAA batteries) | d.c.3.0V (2pcs AAA batteries) | Same |
| Measurement data
memories | 30 sets memories | 30 sets memories | Same |
| Backlight | Green and red backlight according to
the measured temperature; | Green and red backlight according to
the measured temperature; | Same |
| Auto-off time | Approx. 1 minute after last
measurement has been taken | Approx. 1 minute after last
measurement has been taken | Same |
| Operation
Condition | Temperature:
$16-40.0 °C (60.8-104.0 °F)$
Humidity: 15-95%RH, non-condensing | Ambient Temperature:
$15°C104°F)$ ;55°C
Relative humidity: 15%-95%RH | Different
(Note 2) |
| Items | Subject Device
(K202741) | Predicate Device
(K191829) | Comparison |
| Storage and
transportation
condition | Temperature: -20 °C to +50 °C (-4 °F
to 122 °F)
Humidity:15-95 % relative maximum
humidity(non-condensing) | Ambient Temperature: -25°C
(-13°F~131°F) ;
Relative humidity: 15%~95%RH | Different
(Note 2) |
| Protection against
electric shock | Internally power supply, Type BF | Internally power supply, Type BF | Same |
| IP Class | IP22 | IP22 | Same |
| High temperature
alarm | Yes | Yes | Same |
| Auto measurement | No | The device can take a
measurement automatically
when the device detects the
distance is appropriate within
5 cm. | Different
(Note 3) |
| Sensor type | Thermopile | Thermopile | Same |
| Housing material | ABS/ PA-757 | ABS/PA 707 | Different
(Note 4) |
| Patient-contact
button material | ABS/ PA-757 | PMMA | Different
(Note 4) |
| Display case | PMMA/CM-203 | unknown | Different
(Note 4) |
| Physical
Dimensions | 145 x 36 x 33 mm | 156.74347 mm | Similar |
| Weight | 62g (without battery) | 68.5 g (Battery excluded) | Similar |
| Expected Service
Life | 5 year | 5 year | Same |
| Safety &
Performance | IEC 60601-1;
IEC 60601-1-2;
IEC 60601-1-11;
ISO 80601-2-56;
ASTM E1965-98. | IEC 60601-1;
IEC 60601-1-2;
IEC 60601-1-11;
ISO 80601-2-56;
ASTM E1965-98. | Same |
| Biocompatibility | Cytotoxicity, ISO 10993-5
Skin Irritation, ISO 10993-10
Skin Sensitization,
ISO 10993-10 | Cytotoxicity, ISO 10993-5
Skin Irritation, ISO 10993-10
Skin Sensitization,
ISO 10993-10 | Same |
| Clinical Accuracy
Support | Yes | Yes | Same |
5
6
7
Note 1 Measurement accuracy
The measurement accuracy for the subject device is different with the predicate device. But The difference does not affect the performance and accuracy which was evaluated in the performance testing of ISO 80601-2-56 and ASTM E1965-98. The different will not arise new safety and effectiveness issue.
Note 2 Operation Condition, Storage, and transportation condition
The subject device has been demonstrated to comply with the requirements of electrical safety IEC 60601-1, IEC60601-1-11, and ASTM E1965-98 standard. The difference does not raise new issues on the device safety and effectiveness.
Note 3 Auto measurement
The predicate device can take a measurement automatically when the device the distance is appropriate within 5 cm. The purpose of auto measurement is to obtain the body temperature. However, for the subject device, the user can read the body temperature by aim the probe at the center of the forehead and keep distance of no more than 3~5cm and press measurement button. The measurement function has been verified during software verification. Otherwise, a clinical study was carried out on 160 subjects for all ages of population, it is demonstrating the subject device clinically safe and effective with all age groups. The difference does not raise new issues on the device safety and effectiveness.
Note 4 Housing material. Patient-contact button material and Display case
Although the patient contact materials for subject device and predicate device are different, but they are all compliance with the biocompatibility standards ISO 10993-5 and ISO 10993-10. The difference does not raise new issues on the device safety and effectiveness.
7. Non-Clinical Test Summary
7.1. Electromagnetic Compatibility and Electrical Safety Test
The subject devices have passed safety testing in according to following standards.
- IEC 60601-1:2005+AMD 1: 2012 Medical electrical equipment Part 1: General requirements for basic 1) safety and essential performance
-
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: General requirements for basic safety 3) and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
7.2. Biocompatibility Test
The subject devices have passed biocompatibility tests in according to following standards.
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity 1)
-
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
7.3. Performance Test-Bench
The subject devices have passed performance testing in according to following standard.
8
- ISO 80601-2-56:2017 Medical electrical equipment Part 2-56: Particular requirements for basic safety 1) and essential performance of clinical thermometers for body temperature measurement
- ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent 2) Determination of Patient Temperature
7.4. Software verification and validation
Software documentation consistent with moderate level of concern was submitted in this 510(k) in according to FDA guidance - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.
8. Clinical Accuracy
Clinical accuracy testing was conducted in according to ASTM E1965-98(Reapproved 2016) and ISO 80601-2-56:2017. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consisting of 180 subjects, of which 60 subjects are infants, 60 subjects are children and the rest 60 subjects are adults (NOTE: Infants--newborn to one year; Children-- greater than one to five years; Adults---greater than five years old.). The clinical test report demonstrated that the clinical data, represented by clinical repeatability met the acceptance criteria of the clinical study protocol.
9. Conclusion
The Infrared Forehead Thermometer (Model FR200) is substantially equivalent to the predicate device (K191829). This conclusion is based upon comparison on intended use, technological characteristics and applicable safety standards. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.