(218 days)
Not Found
No
The description details standard infrared sensing and basic electronic processing (MCU, compensation circuit) for temperature measurement and display. There is no mention of AI/ML algorithms for data analysis, interpretation, or decision-making beyond simple threshold alerts.
No
A therapeutic device is used for treating or curing a disease. This device is a thermometer, used for measurement and monitoring, not for treatment.
Yes
The device measures body temperature, which is a physiological parameter used to identify potential illness or health conditions. While it doesn't provide a diagnosis itself, it provides data that can be used by individuals or healthcare professionals to infer a state of health or disease, thus serving a diagnostic purpose.
No
The device description explicitly states it is a "hand-held, battery powered IR thermometer" and details hardware components like an infrared sensor, MCU circuit, and LCD display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The Non-contact Electronic Forehead Infrared Thermometer, Model FT3010, measures body temperature by detecting infrared radiation emitted from the forehead. This is a direct measurement of a physiological parameter on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is "intermittent measurement and monitoring of human body temperature," which is a direct physiological measurement.
Therefore, the device falls under the category of a general medical device used for monitoring a vital sign, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Non-contact Electronic Forehead Infrared Thermometer, Model FT3010 is intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Non-contact Electronic Forehead Infrared Thermometer, Model FT3010 is a hand-held, battery powered IR thermometer. It is intended to measure the temperature of human body from forehead without contact to human body. It is indicated for use by people of all ages in the home.
The work principle of Non-contact Electronic Forehead Infrared Thermometer, Model FT3010, is by using the infrared sensor converts the radiated power into an electrical signal, electrical signal is processed by the ambient temperature compensation circuit and an internal MCU circuit. The electrical signal is displayed in degrees Celsius (or Fahrenheit) on LCD.
The Non-contact Electronic Forehead Infrared Thermometer has the following features:
- Measure the forehead temperature;
- . Provide the prompt tone for high or low body temperature alert;
- . Equip with 32 sets of measurement memories;
- LCD digital displayer with backlight;
- . Display unit of Fahrenheit or Celsius;
- Automatic shutdown feature to save energy;
- . Low battery detection;
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared radiation detection
Anatomical Site
Forehead
Indicated Patient Age Range
all ages
Intended User / Care Setting
people of all ages in the 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 study was conducted in according to ASTM E1965-98(Reapproved 2016). This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consisting of 150 subjects, of which 50 subjects are infants (newborn to 1 year), 50 subjects are children (1 - 5 years old) and 50 subjects are > 5 years old. The clinical test report demonstrated that the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical study 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.
0
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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 15, 2021
Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. % Ms. Yoyo Chen Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town Shenzhen, Guangdong 518000 China
Re: K201582
Trade/Device Name: Non-contact Electronic Forehead Infrared Thermometer. Model: FT3010 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 10, 2020 Received: December 18, 2020
Dear Ms. 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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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.
CAPT Alan Stevens Acting Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201582
Device Name
Non-contact Electronic Forehead Infrared Thermometer, Model: FT3010
Indications for Use (Describe)
The Non-contact Electronic Forehead Infrared Thermometer, Model FT3010 is intermittent measurement and monitoring of human body 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
510(k) Summary
K201582
This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.
1. Administrative Information
| Submission Date | May 27, 2020 |
|---|---|
| Manufacturer | |
| information | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. |
| Address: | |
| 283rd South Min'an Road, Xiaolan Town, Zhongshan City, | |
| Guangdong Province, 528416, P.R.China | |
| Contact person: Mr. Jerry Liang | |
| TEL: +86(0760) 28133793; +86 13928121219 | |
| FAX: +86(0760) 28133793 | |
| E-Mail: jerry@kinleehealth.com; | |
| 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 | |
| E-Mail: yoyo@cefda.com; field@cefda.com |
2. Device Information
| Device Name: | Non-contact Electronic Forehead Infrared Thermometer |
|---|---|
| Model: | FT3010 |
| Classification Name: | Clinical Electronic Thermometer |
| Review Panel: | General Hospital |
| Device Class: | 2 |
| Regulation Number: | 880.2910 |
| Product Code: | FLL |
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3. Predicate Device
| Manufacturer | Microlife Intellectual Property GmbH |
|---|---|
| Device name | Microlife Non-Contact Infrared Forehead Thermometer |
| Model | FR1DG1 (NC200) |
| 510(K) Number: | K191829 |
| Product Code | FLL |
4. Device Description
Non-contact Electronic Forehead Infrared Thermometer, Model FT3010 is a hand-held, battery powered IR thermometer. It is intended to measure the temperature of human body from forehead without contact to human body. It is indicated for use by people of all ages in the home.
The work principle of Non-contact Electronic Forehead Infrared Thermometer, Model FT3010, is by using the infrared sensor converts the radiated power into an electrical signal, electrical signal is processed by the ambient temperature compensation circuit and an internal MCU circuit. The electrical signal is displayed in degrees Celsius (or Fahrenheit) on LCD.
The Non-contact Electronic Forehead Infrared Thermometer has the following features:
- Measure the forehead temperature;
- . Provide the prompt tone for high or low body temperature alert;
- . Equip with 32 sets of measurement memories;
- LCD digital displayer with backlight;
- . Display unit of Fahrenheit or Celsius;
- Automatic shutdown feature to save energy;
- . Low battery detection;
5. Indications for Use
The Non-contact Electronic Forehead Infrared Thermometer, Model FT3010 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.
6. Comparison with predicate device
The subject device Non-contact Electronic Forehead Infrared Thermometer, Model FT3010 is substantially equivalent to the predicate device (K191829). The comparison of technological characteristics between the subject device and predicate device is listed as follows:
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| Items | Subject Device
(K201582) | Predicate Device
(K191829) | Comparison |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Intended use | The Non-contact Electronic
Forehead Infrared
Thermometer, Model
FT3010 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 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 | Body temperature:
$22.0\sim43.0$ °C
(71.6109.4°F); | Body mode:104°F);
$34.0$ °C -43.0 °C
(93.2-109.4 °F); | Different
Note (1) |
| Measurement
accuracy | Body temperature:
$22.0$ °C 43.0 °C: ±0.2 °C104°F)
71.6°F 109.4°F: ±0.4°F | ±0.2 °C: 35.0 ~ 42.0 °C40°C (60.8°F
±0.3 °C: 34°C ~ 34.9°C,
42.1°C 43°C,50mm | 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 | 30mm
| Display Type | LCD Display | LCD Display | Same |
| Display
resolution | 0.1°C (0.1°F) | 0.1°C (0.1°F) | Same |
| Power supply | DC 3V (2 x AA LR6
batteries) | DC 3V (2x 1.5V AAA
batteries) | Different
Note (2) |
| Measurement
time | ≤ 1second | ≤ 3 second | Different
Note (3) |
| Measurement
data memories | 32 sets memories | 30 sets memories | Different
Note (4) |
| Items | Subject Device
(K201582) | Predicate Device
(K191829) | Comparison |
| Beeper setting | Yes | Yes | Same |
| Date and time
setting | No | Yes | Different
Note (5) |
| Backlight | White backlight | Green and red backlight
according to the measured
temperature; | Different
Note (6) |
| Auto-off time | Approx. 10 second after last
measurement has been
taken | Approx. 1 minute after last
measurement has been
taken | Different
Note (7) |
| Operation
Condition | Ambient Temperature:
16°C
Relative humidity:
15%95%RH (non-40°C (59°F
condense)
Atmospheric pressure: 860-
1060hPa | Ambient Temperature:
15°C
Relative humidity:
15%95%RH | Different50°C (-4°F
Note (8) |
| Storage and
transportation
condition | Ambient Temperature:
-20°C122°F)131°F);
Relative humidity:
15%95%RH (non-55°C(-13°F
condense)
Atmospheric pressure: 860-
1060hPa | Ambient Temperature:
-25°C
Relative humidity:
15%~95%RH | Different
Note (8) |
| IP Class | IP22 | IP22 | Same |
| Error | Display Err when system
has malfunction | Display Er0 or Er6 when
system has malfunction | Different
Note (9) |
| High
temperature
alarm | 3 short beeps and LCD
display " H " while equal to
or higher than 37.5°C | 10 short beeps and a red
LCD backlight alerts that the
temperature equal to or
higher than 37.5°C | Different
Note (10) |
| Auto
measurement | No | The device can take a
measurement automatically
when the device detects the
distance is appropriate within
5 cm. | Different
Note (11) |
| Sensor type | STP583F55 | TPS336 | Different
Note (12) |
| Housing
material | ABS/PA-757 | ABS/PA 707 | Different
Note (13) |
| Button material | ABS/PA-757 | PMMA | Different |
| Items | Subject Device
(K201582) | Predicate Device
(K191829) | Comparison |
| IC (Integrated
Circuitry) | HY11P13 | HY11P14 | Different
Note (13) |
| Physical
Dimensions | 9043148mm | 156.74347 mm | Different
Note (12) |
| Safety &
Performance | IEC 60601-1:2005+AMD 1:
2012;
IEC 60601-1-2:2014;
IEC 60601-1-11:2015;
ISO 80601-2-56: 2017;
ASTM E1965-98. | IEC 60601-1:2005+AMD 1:
2012;
IEC 60601-1-2:2014;
IEC 60601-1-11:2015;
ISO 80601-2-56: 2017;
ASTM E1965-98. | Same
Note (15) |
| 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 Study
Support | Yes | Yes | Same |
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7
Note 1: Measurement Range and Accuracy
Compare with the predicate device, the subject device has a wider body temperature measurement range, and the accuracy in the temperature range is different. 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 difference does not raise new safety and effectiveness questions.
Note 2: Power supply
The electrical safety of the subject device complies with standard IEC 60601-1. The difference does not raise new issues on the device safety and effectiveness
Note 3: Measurement time
The measurement time of subject device is much quicker than predicate device, the accuracy of measurement has been validated during performance testing. The difference does not raise new issues on the device safety and effectiveness.
Note 4: Measurement data memories
This function has been verified during software verification. The difference does not raise new issues on the device safety and effectiveness.
Note 5: Date and time setting
Although there is no date and time setting functions for subject device, but both subject device and predicate device are meet the basic safety requirement of IEC 60601-1, ASTM E1965-98, and ISO 80601-2-56. The difference does not raise new issues on the device
8
safety and effectiveness.
Note 6: Backlight
The subject device and predicate device are all tested in according to ISO 80601-2-56 and ASTM E1965-98. The difference does not raise new issues on the device safety and effectiveness.
Note 7: Auto-off time
Both subject device and predicate device are met the basic safety requirement of ISO 80601-2-56 and ASTM E1965-98. The difference does not raise new issues on the device safety and effectiveness.
Note 8: 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 9: Error
Although the icons are different, but the purpose means are the same. It does not affect device's performance, safety and effectiveness.
Note 10: High temperature alarm
Even though the beeping time is different, but the purpose of the alarm is the same. It does not affect device's performance, safety and effectiveness.
Note 11: Auto measurement
The purpose of body temperature measurement can be achieved for subject device and predicate device. The subject device performance complies with ISO 80601-2-56 and ASTM E1965-98. The difference does not raise new issues on the device safety and effectiveness.
Note 12: Sensor type, IC
The subject device was tested to conform with same safety and performance standard IEC 60601-1, ASTM E1965-98, and ISO 80601-2-56. A clinical study was carried out on the subject device in accordance with ASTM E1965-98. The different will not arise new safety and effectiveness issues.
Note 13: Housing material, button material
Although the housing material and button material of the 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.
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Note 15: Physical Dimensions
The appearance of the subject device and predicate device is different. The subject device has been tested and confirmed according to IEC 60601-1-2, IEC 60601-1, and ISO 80601-2-56 standards. 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 device has passed safety testing in according to following standards.
-
- IEC 60601-1:2005+AMD 1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
-
- IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
7.2. Biocompatibility Test
The subject device has passed biocompatibility tests in according to following standards.
-
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
-
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
7.3. Performance Test-Bench
The subject device has passed performance testing in according to following standard.
-
- ISO 80601-2-56:2017 Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
-
- ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
7.4. Software 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.
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8. Clinical Study
Clinical study was conducted in according to ASTM E1965-98(Reapproved 2016). This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consisting of 150 subjects, of which 50 subjects are infants (newborn to 1 year), 50 subjects are children (1 - 5 years old) and 50 subjects are > 5 years old. The clinical test report demonstrated that the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical study protocol.
9. Conclusion
Based on the performance testing, technological characteristics and analysis, the subject device is substantially equivalent to the predicate device.