(239 days)
INFRARED BODY THERMOMETER (Model: YK-001) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature using the center of the forehead as the measurement site. The device is indicated for use by people over one month old. It can be used by consumers in household environment and doctors in clinic as reference.
The proposed device, INFRARED BODY THERMOMETER, which includes model YK-001 hand-held, reusable, battery powered device, which is intended to detect body temperature from forehead. The proposed device measure temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The distance of the measurement is 3cm~5cm. The proposed device uses a temperature sensor, which can detect the human forehead temperature, object temperature and environment temperature; these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module in MCU of the proposed device. MCU will calculate the body temperature, and then transfer to screen for display. The device has the following features: About two-second measuring time, measuring Body or Ambient temperature, 99-memory recalls, degree C/degree F unit switchable, over range message (Hi/Lo), low battery indication, auto shut-off when the device is idle for 15 seconds. When completes, the results will be displayed on the LCD display screen. The device will display 3 different background colors according to the result.
The power supply of INFRARED BODY THERMOMETER (YK-001) is 3.0V DC, it is powered by two AAA batteries.
The reference body site of INFRARED BODY THERMOMETER (Model: YK-001) is armpit.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device is an Infrared Body Thermometer. The primary acceptance criteria for such a device are related to its accuracy in measuring body temperature. The text explicitly mentions compliance with ISO 80601-2-56:2017 and ASTM E 1965-98 (2016) for performance.
| Acceptance Criteria (from ISO 80601-2-56:2017 and ASTM E 1965-98) | Reported Device Performance (Subject Device) |
|---|---|
| Accuracy (Forehead mode for core body temp range) | ±0.2°C (±0.4°F) for range 35.0°C ~ 42.0°C (95°F ~ 107.6°F) |
| Accuracy (Forehead mode outside core body temp range) | ±0.3°C (±0.5°F) for temperatures outside 35.0°C ~ 42.0°C (95°F ~ 107.6°F) |
| Measurement Range | 32°C ~ 42.9°C (89.6°F ~ 109.2°F) (Meets requirements of ASTM E 1965-98) |
| Compliance with ISO 80601-2-56:2017 | Complied |
| Compliance with ASTM E 1965-98 (2016) | Complied |
| Biocompatibility (patient contact materials) | Compliance with ISO 10993-5 (in vitro cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) |
| Electrical Safety | Complied with IEC 60601-1:2012 |
| Electromagnetic Compatibility (EMC) | Complied with IEC 60601-1-2:2014 |
| Software Life Cycle Processes | Complied with IEC 62304:2006+AMD1:2015 |
| Home Healthcare Environment Requirements | Complied with IEC 60601-1-11:2015 |
| Operating Conditions | Temperature: +15°C~+40°C (59°F |
| Storage Conditions | Temperature: -20℃ |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 137 subjects were used for the clinical accuracy study.
- Data Provenance: The document does not explicitly state the country of origin. The study is described as a "clinical accuracy study" indicating it was a prospective study where measurements were taken on human subjects. The fact that the manufacturer is in China and the application correspondent is SGS-CSTC in Guangzhou, China, suggests the study was likely conducted in China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide this information. For a clinical thermometer, the "ground truth" would typically be established by simultaneous measurement with a highly accurate reference thermometer (e.g., a rectal thermometer or a hospital-grade electronic thermometer with known calibration) under medical supervision, rather than by human "experts" evaluating the device's output.
4. Adjudication Method for the Test Set
The document does not provide this information. As mentioned above, for a thermometer's accuracy study, the ground truth is typically a direct reference measurement, not a subjective interpretation requiring adjudication of multiple readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human interpretation plays a significant role. This device is a direct measurement tool (a thermometer).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in essence, the "clinical accuracy study" describes the standalone performance of the device. The study evaluated the thermometer's ability to accurately measure body temperature on its own, comparable to a reference standard, without human interpretation of the device's output being the variable under test. The output displayed on the LCD is the device's determination.
7. The Type of Ground Truth Used
The ground truth for the clinical accuracy study would have been established by comparing the device's measurements to a reference standard body temperature measurement (e.g., a calibrated reference thermometer, likely a rectal thermometer or other highly accurate clinical thermometer). The text states "The clinical test results showed that the accuracy of the proposed device is within acceptable scope specified in ISO 81061-2-56," and specifies accuracy ranges. This implies a comparison to a known accurate measurement.
8. The Sample Size for the Training Set
The document does not mention a training set. This is a medical device that performs a direct measurement, not an AI/Machine Learning diagnostic algorithm that requires a training set. Therefore, this information is not applicable.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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September 15, 2021
Longnan RenZhong Medical Equipment Co., Ltd. % Iris Fung Regulation Manager SGS-CSTC Standards Technical Services Co., Ltd. 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology Development District Guangzhou, Guangdong, 510000 China
Re: K210118
Trade/Device Name: Infrared Body Thermometer (Model: YK-001) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 6, 2021 Received: August 16, 2021
Dear Iris Fung:
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.
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
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Indications for Use
510(k) Number (if known) K210118
Device Name INFRARED BODY THERMOMETER (Model: YK-001)
Indications for Use (Describe)
INFRARED BODY THERMOMETER (Model: YK-001) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature using the center of the forehead as the measurement site. The device is indicated for use by people over one month old. It can be used by consumers in household environment and doctors in clinic as reference.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
1. Summary Prepared Date
15 September 2021
Submitter Information 2
Sponsor Company Name: Longnan Renzhong Medical Equipment Co., Ltd.
- Address: Information Industry Technology City, Longnan Economic � Development Zone, Longnan, Ganzhou, Jiangxi Province, 341000, China
- Phone: +86-13715212441 �
- Contact Person (including title): Liangping Liao (Manager) �
- � E-mail: In@akkord.com.cn
Application Correspondent: SGS-CSTC Standards Technical Services Co., Ltd.
- Address: 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology � Development District, Guangzhou, Guangdong, 510000, China
- � Contact Person: Ms. Iris Fung
- Tel: +86-20-32136908 �
- Email: Iris.Fung@sgs.com �
Subject Device Information ನ
Trade Name: INFRARED BODY THERMOMETER (Model: YK-001) Common Name: Clinical Electronic Thermometer Requlation Name: Clinical Electronic Thermometer Review Panel: General Hospital Product Code: FLL Regulation Number: 21 CFR 880.2910 Regulation Class: II
4. Predicate Device Information
Sponsor: Shenzhen Jumper Medical Equipment Co., Ltd. Trade Name: Non-contact Infrared Thermometer 510(k) number: K131243 Review Panel: General Hospital Product Code: FLL Regulation Number: 21 CFR 880.2910 Regulation Class: II
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5. Device Description
The proposeddevice, INFRARED BODY THERMOMETER, which includes model YK-001 hand-held, reusable, battery powered device, which is intended to detect body temperature from forehead. The proposed device measure temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The distance of the measurement is 3cm~5cm. The proposed device uses a temperature sensor, which can detect the human forehead temperature, object temperature and environment temperature; these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module in MCU of the proposed device. MCU will calculate the body temperature, and then transfer to screen for display. The device has the following features: About two-second measuring time, measuring Body or Ambient temperature, 99-memory recalls, ℃/ί unit switchable, over range message (Hi/Lo), low battery indication, auto shut-off when the device is idle for 15 seconds. When completes, the results will be displayed on the LCD display screen. The device will display 3 different background colors according to the result.
The powersupply of INFRARED BODY THERMOMETER (YK-001)is 3.0V DC, it is powered by two AAA batteries.
The reference body site of INFRARED BODY THERMOMETER (Model: YK-001) is armpit.
6. Indications for Use
INFRARED BODY THERMOMETER (Model: YK-001) is a non-contactinfrared thermometer intended f or the intermittentmeasurement of human body temperature using the center of the forehead as the measurement site. The device is indicated for use by people over one month old. It can be used by consumers in household environment and doctors in clinic as reference.
7. Comparison to Predicate Device
A comparison of key technological characteristics between the subject device and predicate device was listed as below:
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Manufacturer | Longnan Renzhong MedicalEquipment Co.,Ltd. | Shenzhen Jumper MedicalEquipment Co., Ltd | -- |
| 510 (k) Number | K210118 | K131243 | -- |
| Product Name | INFRARED BODYTHERMOMETER | Non-contactInfraredThermometer | -- |
| Models | YK-001 | JPD-FR100 | -- |
| Intended Use | INFRARED BODYTHERMOMETER (Model: YK-001) isa non-contact infrared thermometerintended for the intermittentmeasurement of human bodytemperature using the center of theforehead as the measurement site. | The Non-contactForehead Thermometeris an infraredthermometer intended forthe intermittentmeasurement of humanbody temperature inpeople of all ages. | Note 1 |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| The device is indicated for use bypeople over one month old. It canbe used by consumers inhousehold environment anddoctors in clinic as reference. | |||
| Sensor | Infrared Sensor | Infrared Sensor | Identical |
| Principleoperation | The proposed device measuretemperatures of people by detectingthe infrared energy radiated directlyfrom the forehead without physicalcontact.The proposed device uses atemperature sensor, which candetect the human foreheadtemperature, object temperatureand environment temperature; thesetemperatures are then transfer toelectronic signal and amplified; andthen it is transferred to digital signalby AD module in MCU of theproposed device. MCU will calculatethe body temperature,and then transfer to screen fordisplay. | The device uses infraredsensor(thermopile)to detectthe radiated infrared energyemitted by the object, solid,liquid orgas. The intensity ofthe emitted energy dependson the temperature of theobject and the infrared sensorcan recognize it to transfer tothe proper electronic signal.The signal can be processedin the subject device to convertto the temperature reading. | Identical |
| MeasurementMode | Forehead measurement Mode | Forehead measurementMode | Identical |
| Measurementtype | Non-contact type | Non-contact type | Identical |
| MeasurementDistance | 3-5cm | 1-6 cm | Note 2 |
| MeasuringRange | $32°C | $32.2°C | Note 3 |
| Accuracy | Forehead mode: $±0.2°C (±0.4°F)$ , for range $35.0°C ~42.0°C(95°F ~107.6°F)$ ;$±0.3°C(±0.5°F)$ , outside thistemperature range | Forehead mode:$±0.2°C (0.4°F)$ | Note 3 |
| Sensor type | Thermopile | Thermopile | Identical |
| Hightemperatureprompt | Yes | Yes | Identical |
| Buzzer | Yes | Yes | Identical |
| Display type | LCD | LCD | Identical |
| Auto power-offwhile nooperation | Yes | Yes | Identical |
| °C/°Fswitchable | Yes | Yes | Identical |
| Memory | 99 sets | 20 sets | Note 4 |
| Power Supply | DC 3V, 2×AAA Batteries | DC 3V, 2 x AAA Batteries | Identical |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| OperatingConditions | Temperature: +15°C~+40°C(59°F | 10~40°C(50°F ~104 °F) RH<85% | Note 5 |
| StorageConditions | Temperature: -20℃~50℃ (-4°F | -25°C ~ +55°C (-13° F-+131) RH≤ 90% | Note 5 |
| Dimension (LxW x H) | 138x95x40mm (L* W * H) | 145X60X50 mm | Note 6 |
| Weight | About 90g(without battery) | 180 g | Note 6 |
| Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Identical |
| EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 | Identical |
| Performance | Complied with ISO 80601-2- 56:2017 | Complied with ISO 80601-2-56 | Identical |
| Complied with ASTM E 1965 -98(2016) | Complied with ASTM E 1965 -98(2003) | Identical | |
| Components | It composed by a measuringsensor, set buttons, batterycompartment, Buzzer, a LCD anda ABS plastic enclosure, andmeasuring without probe cover. | It composed by a measuringsensor, set buttons, batterycompartment, Buzzer, aLCD and a ABS plasticenclosure, and measuringwithout probe cover. | Identical |
| Biocompatibility | All the patient contactingmaterialsare compliance with ISO 10993-5; ISO10993-10 | All the patient contactingmaterials are compliancewith ISO 10993-5;ISO10993-10 | Identical |
| Materials | ABS for enclosure | ABS for enclosure | Identical |
| Labeling | OTC | OTC | Identical |
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Note 1
The patient population between the subject device and predicate is different. The clinical accuracy test was conducted in accordance with ISO 80601-2-56:2017. The test result complies with the standard. The difference does not raise new safety and effectiveness questions.
Note 2
Measurement distance of the subject device is 3-5cm whereas the predicate device's is in the range of 1- 6cm. But the performance testresult of subject device shows the accuracy meets the requirements within the distance range. The difference does not raise new safety and effectiveness questions.
Note 3
The subject device and predicate device have different measurement range, but they have the same accuracy. The measurement range of subject device meet the requirements of ASTM E 1965-98. The difference does not raise new safety and effectiveness questions.
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K210118 Summary
Note 4
The memory capacity of predicate device and subject device is different, but the memory function does not affectaccuracy of measurement and does not impact the performance of subject device.
Note 5
The operating condition and storage condition are different between the subject device and predicate. The operating condition and storage condition met the requirements of ISO 80601-2-56 and performance test was conducted in accordance with the standard. The difference does not impact the performance of subject device.
Note 6
There is minor difference on the size and weight between predicate device and subject device. But they both are portable device; such minor difference would not cause issue of safety and effectiveness.
8. Test Summary
Non-clinical test:
INFRARED BODY THERMOMETER conforms to applicable standards that include:
- � ASTM E 1965-98 Standard Specification for Infrared Thermometers for Internittent Determination of Patient Temperature
- � IEC 60601-1:2012, 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 compatibility
- � ISO 10993-1:2009, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
- � 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
- � IEC 62304:2006+AMD1:2015 Medical Device Software - Software Life Cycle Processes
- � 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
- � ISO 80601-2-56:2017/AMD 1:2018 Medical electrical equipment-part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
Clinical Data:
The clinical accuracy study for the non-contact thermometer was performed to determine the clinical accuracy. The three groups of subjects being tested were: 1) over 1 month to under 1 year old, 2) children between 1 and 5 years old, and 3) patients over 5 years old.
The study includes 137 subjects. For each age group, theratio of febrile subjects was more than 30% and less than 50%. The study excluded subjects with medical conditions such as inflammation at the
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K210118 Summary
measuring sites and subjects using medications known to affect body temperature. The clinical test results showed that the accuracy of the proposed device is within acceptable scope specified in ISO 81061-2-56.
9. Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. Based on the performance testing, comparison and analysis, the subject device INFRARED BODY THERMOMETER (Model: YK-001) is substantially equivalent to the Non-contact Infrared Thermometer cleared under K131243.
§ 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.