(218 days)
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.
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;
The provided document describes the acceptance criteria and the study that proves the performance of the "Non-contact Electronic Forehead Infrared Thermometer. Model: FT3010."
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document references conformity with several standards, which implicitly define the acceptance criteria. The performance is reported as meeting these standards.
| Standard / Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Measurement Accuracy | As per ISO 80601-2-56:2017 and ASTM E1965-98. Specifically: - $\pm 0.2$ °C for $35.0 \sim 42.0$ °C - $\pm 0.3$ °C for $34$°C $\sim 34.9$°C and $42.1$°C $\sim 43$°C (based on predicate criteria, assumed similar for subject device based on "does not affect performance and accuracy") | Body temperature: $22.0$ °C ~ $43.0$ °C: $\pm 0.2$ °C $71.6$°F ~ $109.4$°F: $\pm 0.4$°F (The document states "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.") |
| Measurement Range | As per ISO 80601-2-56:2017 and ASTM E1965-98. Specifically: Body mode: $34.0$ °C -$43.0$ °C ($93.2-109.4$ °F) (Based on predicate criteria) | Body temperature: $22.0 \sim 43.0$ °C ($71.6 \sim 109.4$ °F) (The document states "Wider body temperature measurement range... 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.") |
| Electrical Safety | IEC 60601-1:2005+AMD 1: 2012 | Passed safety testing in accordance to IEC 60601-1:2005+AMD 1: 2012 |
| Electromagnetic Compatibility | IEC 60601-1-2:2014 | Passed safety testing in accordance to IEC 60601-1-2:2014 |
| Home Healthcare Environment | IEC 60601-1-11:2015 | Passed safety testing in accordance to IEC 60601-1-11:2015 |
| Biocompatibility - Cytotoxicity | ISO 10993-5:2009 | Passed biocompatibility tests in accordance to ISO 10993-5:2009 |
| Biocompatibility - Irritation & Sensitization | ISO 10993-10:2010 | Passed biocompatibility tests in accordance to ISO 10993-10:2010 |
| Clinical Performance (Bias & Repeatability) | Met the acceptance criteria of the clinical study protocol (as per ASTM E1965-98) | Clinical data, represented by clinical bias and clinical repeatability, met the acceptance criteria of the clinical study protocol. |
| Software Validation | Consistent with moderate level of concern as per FDA guidance | Software documentation consistent with moderate level of concern was submitted. |
2. Sample size used for the test set and the data provenance
- Sample size: 150 subjects
- 50 infants (newborn to 1 year)
- 50 children (1 - 5 years old)
- 50 subjects (> 5 years old)
- Data provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical investigation." It does not specify if it was retrospective or prospective, but clinical investigations are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. It mentions a "clinical study" conducted in accordance with ASTM E1965-98 and ISO 80601-2-56, which are standards for clinical thermometers and imply the use of reference thermometers for ground truth.
4. Adjudication method for the test set
The document does not mention an adjudication method. It describes the clinical study as a "randomization, simple blind homologous control, pairing design of clinical investigation."
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a standalone infrared thermometer, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was done. The entire document describes the performance of the device itself (Non-contact Electronic Forehead Infrared Thermometer), which operates as an algorithm-only device without human intervention beyond taking the measurement and reading the display. The clinical study and non-clinical bench tests evaluated the device's performance directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical study would have been established using reference temperature measurement devices as per the requirements of ASTM E1965-98 and ISO 80601-2-56. These standards typically require comparison against highly accurate clinical reference thermometers to determine bias and repeatability.
8. The sample size for the training set
Not applicable. This device is a traditional electronic thermometer, not an AI/ML-based device that requires a training set in the conventional sense. The "software validation" mentioned refers to traditional software engineering verification and validation steps, not machine learning model training.
9. How the ground truth for the training set was established
Not applicable, as there is no traditional "training set" for this type of device.
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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.
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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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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 |
|---|---|
| Manufacturerinformation | Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.Address:283rd South Min'an Road, Xiaolan Town, Zhongshan City,Guangdong Province, 528416, P.R.ChinaContact person: Mr. Jerry LiangTEL: +86(0760) 28133793; +86 13928121219FAX: +86(0760) 28133793E-Mail: jerry@kinleehealth.com; |
| SubmissionCorrespondent | Shenzhen Joyantech Consulting Co., Ltd.1713A, 17th Floor, Block A, Zhongguan Times Square, LiuxianAvenue, Xili Town, Nanshan District, Shenzhen, GuangdongProvince, China.Contact person: Ms. Yoyo ChenE-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 ElectronicForehead InfraredThermometer, ModelFT3010 is intended for theintermittent measurementand monitoring of humanbody temperature. Thedevice is indicated for useby people of all ages in thehome. | The Microlife Non-ContactInfrared ForeheadThermometer, ModelFR1DG1 (NC200) isintended for the intermittentmeasurement andmonitoring of human bodytemperature.The device is indicated foruse by people of all ages inthe home. | Same |
| Thermometertype | Infrared thermometerNon-contact | Infrared thermometerNon-contact | Same |
| DeviceMeasurementTechnology | Infrared radiation detection | Infrared radiation detection | Same |
| Measurementlocation | Forehead | Forehead | Same |
| MeasurementRange | Body temperature:$22.0\sim43.0$ °C(71.6~109.4°F); | Body mode:$34.0$ °C -43.0 °C(93.2-109.4 °F); | DifferentNote (1) |
| Measurementaccuracy | Body temperature:$22.0$ °C ~43.0 °C: ±0.2 °C71.6°F ~109.4°F: ±0.4°F | ±0.2 °C: 35.0 ~ 42.0 °C±0.3 °C: 34°C ~ 34.9°C,42.1°C ~43°C,±0.4 °F: 95.0 ~ 107.6 °F,±0.5 °F: 93.2 | DifferentNote (1) |
| TemperatureMeasurementdistance | 30mm~50mm | Appropriate within 5 cm | Similar |
| Display Type | LCD Display | LCD Display | Same |
| Displayresolution | 0.1°C (0.1°F) | 0.1°C (0.1°F) | Same |
| Power supply | DC 3V (2 x AA LR6batteries) | DC 3V (2x 1.5V AAAbatteries) | DifferentNote (2) |
| Measurementtime | ≤ 1second | ≤ 3 second | DifferentNote (3) |
| Measurementdata memories | 32 sets memories | 30 sets memories | DifferentNote (4) |
| Items | Subject Device(K201582) | Predicate Device(K191829) | Comparison |
| Beeper setting | Yes | Yes | Same |
| Date and timesetting | No | Yes | DifferentNote (5) |
| Backlight | White backlight | Green and red backlightaccording to the measuredtemperature; | DifferentNote (6) |
| Auto-off time | Approx. 10 second after lastmeasurement has beentaken | Approx. 1 minute after lastmeasurement has beentaken | DifferentNote (7) |
| OperationCondition | Ambient Temperature:16°C | Ambient Temperature:15°C | DifferentNote (8) |
| Storage andtransportationcondition | Ambient Temperature:-20°C | Ambient Temperature:-25°C | DifferentNote (8) |
| IP Class | IP22 | IP22 | Same |
| Error | Display Err when systemhas malfunction | Display Er0 or Er6 whensystem has malfunction | DifferentNote (9) |
| Hightemperaturealarm | 3 short beeps and LCDdisplay " H " while equal toor higher than 37.5°C | 10 short beeps and a redLCD backlight alerts that thetemperature equal to orhigher than 37.5°C | DifferentNote (10) |
| Automeasurement | No | The device can take ameasurement automaticallywhen the device detects thedistance is appropriate within5 cm. | DifferentNote (11) |
| Sensor type | STP583F55 | TPS336 | DifferentNote (12) |
| Housingmaterial | ABS/PA-757 | ABS/PA 707 | DifferentNote (13) |
| Button material | ABS/PA-757 | PMMA | Different |
| Items | Subject Device(K201582) | Predicate Device(K191829) | Comparison |
| IC (IntegratedCircuitry) | HY11P13 | HY11P14 | DifferentNote (13) |
| PhysicalDimensions | 9043148mm | 156.74347 mm | DifferentNote (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. | SameNote (15) |
| Biocompatibility | Cytotoxicity, ISO 10993-5Skin Irritation, ISO 10993-10Skin Sensitization,ISO 10993-10 | Cytotoxicity, ISO 10993-5Skin Irritation, ISO 10993-10Skin Sensitization,ISO 10993-10 | Same |
| Clinical StudySupport | Yes | Yes | Same |
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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
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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.
§ 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.