(177 days)
Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by health care providers.
Infrared Thermometer is mainly composed of infrared probe components, main circuit board components, LCD display components and housing components. The Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. Infants and children cannot operate the thermometer; it is recommended that adults take the measurement. The Infrared Thermometer can be used by consumers in the household environment and by healthcare providers. The operator should be an adult with relevant experience. The operator can replace the battery, transmit data, and measure temperature.
Here's an analysis of the acceptance criteria and study details for the Infrared Thermometer Model YJ600, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Infrared Thermometer Model YJ600 are primarily defined by the standards ISO 80601-2-56 and ASTM E1965-98. The 510(k) summary directly states that the device "meets the requirement of the standard" for these and other tests. The most critical performance criterion for a thermometer is its accuracy.
| Acceptance Criteria (from ISO 80601-2-56 and ASTM E1965-98) | Reported Device Performance (Model YJ600) |
|---|---|
| Maximum allowable error in temperature measurement | $\pm 0.3°C$ within the temperature display range of $22.0°C$ to $42.0°C$ (Pass) |
| Clinical repeatability for each age group | In the range of plus or minus 0.3°C (meets the clinical repeatability requirement ±0.3°C) |
| Resolution of the indication unit | $0.1°C$ ($0.1°F$) (Pass) |
| Temperature display range | $22.0°C~42.9°C$ (Pass) |
| Appearance and structure | Correct shape, smooth/clean surface, no scratches, sharp edges, burrs, or deformation (Pass) |
| Text and symbols clarity | Clear, accurate, and firm (Pass) |
| Control devices flexibility and reliability | Flexible and reliable, fasteners not loose (Pass) |
| Thermometer probe smoothness | Smooth with no burrs on edges (Pass) |
| Function key marking | Clearly marked and indicated (Pass) |
| Anti-drop test (1m to hard surface, 3 postures) | Requirements met (Pass) |
| Display reading value height | >4mm (Pass) |
| Prompt function for out-of-range temperatures | "LO" below 22.0°C, "HI" above 42.9°C with "Di di" sound twice (Pass) |
| Low voltage prompt | Icon flashes when battery < 2.5±0.2V (Pass) |
| Temperature measurement mode available | Yes (Pass) |
| Unit switching function ("℃" and "F") | Yes (Pass) |
| Sound prompt function for different temperature ranges | Green backlight/short sound (22°C-37.4°C), Orange backlight/1 long + 3 short sounds (37.5°C-38.4°C), Red backlight/1 long + 5 short sounds (38.5°C-42.9°C) (Pass) |
| Measurement time | Within 2s (Pass) |
| Memory query | 32 groups of local data (Pass) |
| Cleaning and disinfection | Requirements met after cleaning/disinfection per instructions (Pass) |
| Self-inspection function (LCD full display on power-on) | Yes (Pass) |
| Automatic self-off within 20 seconds (standby) | Yes (Pass) |
| Instruction Manual Inspection | Includes required information (Pass) |
| Electrical safety (Case/Patient Leakage Current, Dielectric Strength) | Meets specified limits and requirements (Pass) |
| Packaging Inspection | Consistent with packing list, correct nameplate content (Pass) |
| Electromagnetic Compatibility and Electrical Safety | Meets IEC 60601 series requirements (Pass) |
| Usability Test | Meets IEC 60601-1-6 requirements (Pass) |
| Biocompatibility (cytotoxicity, skin sensitization, irritation) | Non-cytotoxic, Non-sensitizer, Non-Irritation (ISO 10993 series) (Pass) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Test): 200 subjects.
- Age Group A (0 up to 3 months): 50 subjects
- Age Group B (3 months to one year): 50 subjects
- Age Group C (older than one year to five years): 50 subjects
- Age Group D (older than five years): 50 subjects
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, clinical accuracy testing is typically prospective, as it involves taking real-time measurements in a controlled study. Given the manufacturer's location (China), the study likely took place in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number or qualifications of experts used to establish ground truth for temperature measurements in the clinical study. For infrared thermometers, the "ground truth" (reference temperature) is typically established using a highly accurate, calibrated clinical thermometer (e.g., a rectal thermometer for core body temperature) as per standards like ISO 80601-2-56 and ASTM E1965-98. The experts involved would typically be clinical staff (nurses, physicians) following a strict protocol for reference temperature measurement.
4. Adjudication Method (for the test set)
The document does not detail an adjudication method. For clinical thermometer accuracy studies, adjudication is generally not a separate process as the reference standard measurement (ground truth) is considered definitive. The "test" is how closely the device's reading matches this established reference, not a subjective interpretation.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an infrared thermometer, not an AI-powered diagnostic imaging tool. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the primary clinical accuracy and performance testing of the Infrared Thermometer Model YJ600, as described, is a standalone (algorithm only) performance assessment. The device measures and displays temperature without human interpretation of the measurement itself. While a human operates the device, the core performance being evaluated is the device's ability to accurately measure temperature independently of human judgment.
7. The Type of Ground Truth Used
The ground truth used for the clinical accuracy test is the reference body temperature measurement obtained through methods specified in ISO 80601-2-56 and ASTM E1965-98. These standards typically require comparative measurements against a highly accurate reference thermometer (e.g., an electronic thermometer measuring core body temperature, often rectal, or a precise oral measurement) to assess the deviation and repeatability of the infrared thermometer. The document specifically states "clinical repeatability" and that it "meets the clinical repeatability requirement," implying comparison against a gold standard in a clinical setting.
8. The Sample Size for the Training Set
The document does not mention or specify a "training set" because this device is a physical medical device (thermometer) and not an AI/Machine Learning algorithm that requires a separate training dataset. Its performance is based on its hardware and firmware, which are designed and then validated through testing.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" in the context of an AI/ML algorithm for this device, the question of how its ground truth was established is not applicable. The device's design implicitly relies on established physics principles of infrared radiation and measurement, and its accuracy is validated against clinical ground truth during performance testing.
{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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
February 9, 2024
Zhuhai Yueja Medical Device Technology Co.,Ltd. Feng Yan Department manager Room 201, Building 2, No.2 Liushi Road Tangjiawan Town, High-tech Zone Zhuhai, Guangdong 519000 China
Re: K232473
Trade/Device Name: Infrared Thermometer: Model YJ600 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 11, 2024 Received: January 11, 2024
Dear Feng Yan:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
{1}------------------------------------------------
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Porsche Bennett
Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn,
{2}------------------------------------------------
General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K232473
Device Name Infrared Thermometer: Model YJ600
Indications for Use (Describe)
Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by health care providers.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
K232473- 510(k) Summary
- Device Submitter: Zhuhai Yueja Medical Device Technology Co.,Ltd. Room 201, Building 2, No.2 Liushi Road, Tangjiawan Town, High-tech Zone, Zhuhai, 519000, China
- Contact Person: Feng Yan Department Manager Phone: +86-18826906029 E-mail: fengy@myzr.com.cn Date Prepared February 9, 2024
l Subject Device
| Trade Name of Device: | Infrared Thermometer: |
|---|---|
| Model YJ600 | |
| Regulation Number: | 21 CFR 880.2910 |
| Product Code: | FLL |
| Regulation Name: | Clinical Electronic Thermometer |
| Common name | Electronic Thermometer |
| Regulatory Class | II |
| Review Panel | General Hospital |
II Predicate Device
| 510k Number | K200471 |
|---|---|
| Trade Name of Device: | Infrared |
| Thermometer, Model: | |
| RN-60A, RN-60B | |
| Regulation Number: | 21CFR 880.2910 |
| Regulation Name: | Clinical electronic thermometer |
| Regulatory Class | II |
| Product Code: | FLL |
III Device Descriptions
Infrared Thermometer is mainly composed of infrared probe components, main circuit board components, LCD display components and housing components. The Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. Infants and children cannot operate the thermometer; it is recommended that adults take the measurement. The Infrared Thermometer can be used by consumers in the household environment and by healthcare providers. The operator
{5}------------------------------------------------
should be an adult with relevant experience. The operator can replace the battery, transmit data, and measure temperature.
IV Indications for use
Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by health care providers.
V Technological Characteristics Comparison
VI-1: Comparison of Subject and Predicate Devices
| DeviceCharacteristic | Subject Device | Predicate Device(K200471) | Discussion |
|---|---|---|---|
| Type ofThermometer | Infrared Thermometer:Model YJ600 | InfraredThermometer,Model:RN-60A, RN-60B | - |
| Product Code | FLL | FLL | Same |
| Regulation No. | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Class | II | II | Same |
| Indications for Use | Infrared Thermometer isintended for the intermittentmeasurement of bodytemperature fromforehead on people of allages. It can be used byConsumers inhousehold environment andby health care providers. | The Infraredthermometer is anon-contact infraredthermometerintended forintermittentthe measurement ofall human bodytemperature fromthe forehead forpeople of one monthold and above. Thedevice is reusable forhome use andclinical use. | Different 1 |
| Patient population | All ages | One month oldand above | Different 2 |
| Operation Principle | According to thecharacteristics of naturalobjects, all objects withtemperatures higher | The InfraredThermometersRN-60A and RN-60Bmeasure the | Different 3 |
| zero (-273.15 °C ) are constantly emitting infrared capabilities to surrounding space. Its radiation characteristics, radiation energy and wavelength distribution are closely related to the surface temperature of the object. The human body, like other organisms, radiates infrared energy around itself, and its wavelength is generally 9-14µm, which is in the infrared band of 0.76-100 μ m. Because the light in this wavelength range is not absorbed by air, the infrared radiation from human body has nothing to do with the environmental impact, but only with the energy released by human body. | temperature by using the principle of receiving infrared. An object with a temperature higher than absolute zero and will radiate a certain amount of infrared energy. According to the infrared energy and wavelength, the surface temperature of the object can be determined. The temperature of human forehead is relatively constant, so the temperature of human forehead can be measured according to this principle. The thermometer adopts a new CMOS thermopile sensor with good sensitivity. The pressure difference generated by the sensor after receiving the infrared signal is amplified and analyzed then display on the LCD screen in digital form. | ||
| Prescription/over-the-counter use | over-the-counter use | over-the-counter use | Same |
| Measurement technology | Infrared radiation detection that converts a user's forehead temperature using | Infrared radiation detection that converts a user's | Same |
| the infrared energy emittedin the area around the user'sforehead to a reference siteequivalent temperature. | foreheadtemperatureusingthe infrared energyemitted in the areaaround the user'sforehead to areference siteequivalenttemperature. | ||
| Measurement site | Forehead | Forehead | Same |
| Measurement Range | $22.0 °C~42.9 °C$ | Forehead mode:$32.0°C ~42.9°C$(89.6 to 109.2 ° F) | Different 4 |
| Accuracy | $±0.3°C$ | Forehead mode:$±0.2°C (0.4°F)$ within(96.8°F ~102.2°F), $±0.3°C(0.5°$F) when $<36.0°C$(96.8°F) and >$39.0°C$ (102.2°F) | Different 5 |
| Display resolution | $0.1°C$ | $0.1°C(0.1°F)$ | Same |
| C/F switchable | Yes | Yes | Same |
| Measurement distance | 1-3 cm | 3~5 cm | Different 6 |
| Measurement time | 2s | 1s | Different 7 |
| Sensor type | high precision infraredsensor | Thermopile | Different 8 |
| Memory | 32 sets | 60 sets | Different 9 |
| Buzzer | Yes | Yes | Same |
| Auto power-off while nooperation | Yes | Yes | Same |
| Power supply | 2 AAA size batteries | 2*AAA battery | Same |
| Display screen | LCD | LCD | Same |
| Operation Environment | +15°C~+40C RH<95%non-condensing,70kPa~106kPa | $5.0°C | Different10 |
| Storage Environment | -20°C~+55°Chumidity<93%,70kPa~106kPa | -25.0℃ | Different11 |
| Conformancestandard | ISO80601-2-56(performance),IEC60601-1(Safety),IEC60601-1-2(EMC)IEC 60601-1-11(Home use)ASTM E1965-98IEC60601-1-6(Usability) | ISO80601-2-56(performance),IEC60601-1(Safety),IEC60601-1-2(EMC)IEC60601-1-11(Homeuse)ASTM E1965-98 | Same |
| Patient contactmaterials | ABS | ABS | Same |
| Biocompatibility | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | Same |
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
Different 1
There are minor differences in the wording of the indications for use. In addition, the subject device is indicated for people of all ages, while the predicate device is indicated for people one month old and above. Clinical accuracy testing was conducted to ISO80601-2-56. Therefore, the difference does not raise different questions of safety and effectiveness.
Different 2
The subject device is indicated for people of all ages, while the predicate device is indicated for people one month old and above. Clinical accuracy testing was conducted to ISO80601-2-56. Therefore, the difference does not raise different questions of safety and effectiveness.
Different 3
The description of operation principle is different. However, its working principle is the same, both use the principle of receiving infrared rays to measure the temperature of the human body. Therefore, the difference does not raise different questions of safety and effectiveness.
Different 4
The minimum measurement temperature of the subject device is lower than that of the predicate device. Performance testing was conducted to ISO 80601-2-56. Therefore, the difference does not raise different questions of safety and effectiveness.
Different 5
The accuracy is different, however compliant with ISO 80601-2-56. Therefore, the difference does not raise different questions of safety and effectiveness.
{9}------------------------------------------------
Different 6
The measurement distance is different; however, performance testing was conducted to demonstrate the difference does not raise different questions of safety and effectiveness.
Different 7
The measurement time is different; however, performance testing was conducted to demonstrate the difference does not raise different questions of safety and effectiveness.
Different 8
The sensor type is different; however, performance testing was conducted to demonstrate the difference does not raise different questions of safety and effectiveness.
Different 9
The memory is different; however, the difference does not raise different questions of safety and effectiveness.
Different 10
The operation environment is different, however compliant with ISO 80601-2-56. Therefore, the difference does not raise different questions of safety and effectiveness.
Different 11
The storage environment is different, however compliant with ISO 80601-2-56. Therefore, the difference does not raise different questions of safety and effectiveness.
VI Summary of Non-clinical Testing (Bench)
The non-clinical testing for Infrared Thermometer: Model YJ600 was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below.
| Inspecting item | Inspection content and acceptance standard | Result | ||
|---|---|---|---|---|
| 1. Appearanceand structuretest | 1.1 | The shape of the thermometer shouldbe correct, the surface should besmooth and clean, and there shouldbe no obvious scratches, sharpedges, burrs and deformation. | Pass | |
| 1.2 | The text and symbols on thethermometer control panel andfunction keys should be clear,accurate and firm. | Pass | ||
| 1.3 | The control devices of thethermometer should be flexible andreliable, and the fasteners should not | Pass | ||
| he loose. | ||||
| 1.4 | The top of the thermometer probe should be smooth and the edges should be free of burrs. | Pass | ||
| 1.5 | The function keys of the thermometer should be clearly marked, indicating that the function keys of the thermometer should be clearly marked and indicated. | Pass | ||
| 2. Temperature range test | display | In body temperature mode, the temperature display range of the thermometer $22.0°C~42.9°C$ | Pass | |
| 3. Maximum allowable error test | The maximum allowable error of the thermometer is $\pm 0.3° C$ within the temperature display range of $22.0° C$ to $42.0°C$ . | Pass | ||
| 4. Anti-drop test | The thermometer shall meet the requirements of 6.3.1 after falling freely from a height of 1m in vertical distance to a hard surface with three different initial postures during normal use. | Pass | ||
| 5. Indicative unit test | 5.1 Resolution | The resolution of the indication unit of the thermometer is $0.1°C$ ( $0.1° F$ ). | Pass | |
| 5.2 Display | The height of the reading value on the thermometer display is >4mm. | Pass | ||
| 5.3 Prompt function | In the body temperature mode, when the measured value of the thermometer is lower than $22.0°C$ , there should be a prompt sound "Di di" twice and "LO" should be displayed; when the measured value is higher than $42.9°C$ , a prompt sound " Beep" twice and display "HI" | Pass | ||
| 5.4Low | Thebatteryof thevoltage | Pass | ||
| voltage | thermometer is lower than 2.5±0.2V. | |||
| prompt | " icon flashes onWhen the " | |||
| function | ||||
| the screen, it means that the battery | ||||
| is low and needs to be replaced. | ||||
| 5.5 Mode | a) The thermometer should have a | Pass | ||
| temperature measurement mode. | ||||
| Thecalibrationmodeb)for | ||||
| calibration purposesshallbe | ||||
| obtained by a conversion technique | ||||
| directly sets the infraredthat | ||||
| thermometer to this mode. | ||||
| 6 Function and | 6.1Unit | The thermometer has a temperature | Pass | |
| performance | switching | unit switching function, which can | ||
| test | function | switch between "℃" and "F". | ||
| 6.2 Sound | a) In body temperature mode, when | Pass |
Table VII-1: Performance testing was conducted on the subject device
{10}------------------------------------------------
{11}------------------------------------------------
| PromptFunction | the measurement result is in therange of 22° C to 37.4°C, a greenbacklight will be displayed and a shortsound will arise.b) In body temperature mode, whenthe measurement result is in therange of 37.5° C to 38.4° C, an orangebacklight will be displayed and 1 longsound + 3 short sounds will arise.c) In body temperature mode, whenthe measurement result is in therange of 38.5° C to 42.9° C, a redbacklight will be displayed and 1 longsound + 5 short sounds will arise. | |
|---|---|---|
| 6.3Measuringtime | The thermometer should completethe temperature measurement within2s. | Pass |
{12}------------------------------------------------
| 6.4Memoryquery | 32 groups of local data can be queried. | Pass | |
|---|---|---|---|
| 7. Cleaning and disinfection test | After the thermometer is cleaned/disinfected according to the instructions in the instruction manual, it shall meet the requirements of 6.3.1. | Pass | |
| 8. Self-inspection function test | All LCDs on the screen should be fully displayed every time the thermometer is turned on. | Pass | |
| 9. Automatic shutdown function test | In standby mode, when there is no button action, it will automatically shut down within 20 seconds. | Pass | |
| 10. Instruction Manual Inspection | The instructions for use of the thermometer shall at least include the following: | Pass |
| 11.Electricalsafety inspection | 11.1 | a) Temperature display range,temperature unit, maximum allowableerror, normal working and storageconditions.b) Conversion method betweencalibration mode and bodytemperature mode;c) The clinical accuracy or clinicalbias of the subject population, bodypart and thermometer. | Case Leakage Current and PatientLeakage Current: | Pass | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Test item Normalstatus Case leakagecurrent <100uA Patient d.c <10uA |
{13}------------------------------------------------
| leakage(BF) | a.c | <100uA | |||
|---|---|---|---|---|---|
| 11.2 | Dielectric Strength:Dielectric strength, apply 500Vd.c.,the device under test should not bebroken down | Pass | |||
| 12. Packaging inspection | The actual product is consistent withthe packing list, and the content onthe nameplate is correct. | Pass |
Others test:
| ID# | Test | Method | Acceptance Criteria | Conclusion |
|---|---|---|---|---|
| 1 | Performance test | ASTM E 1965-98 | Meet the requirement of the standard | Pass |
| ISO 80601-2-56 | Meet the requirement of the standard | Pass | ||
| 2 | ElectromagneticCompatibility and ElectricalSafety | IEC 60601-1 | Meet the requirement of the standard | Pass |
| IEC 60601-1-2 | Meet the requirement of the standard | Pass | ||
| IEC 60601-1-11 | Meet the requirement of the standard | Pass | ||
| IEC/TR 60601-4-2 | Meet the requirement of the standard | Pass | ||
| 3 | Usability Test | IEC 60601-1-6 | Meet the requirement of the standard | Pass |
| 4 | Biocompatibility Testing (skin contact < 24h) | |||
| 4.1 | In Vitro Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Pass |
| 4.2 | Skin Sensitization Test | ISO 10993-10:2010 | Non-sensitizer | Pass |
| 4.3 | Skin Irritation Test | ISO 10993-10:2010 | Non-Irritation | Pass |
{14}------------------------------------------------
VII Clinical Test Conclusion
YJ600 was tested to 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 — Amendment 1 and ASTM E1965-98(Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.
This study included 200 subjects (the age range include 0 up to 3 months to one year, older than one year to five years, older than five years, detail groups as below)
| Age group | Age Range | Number | Gender distribution | ||
|---|---|---|---|---|---|
| Gender | Number | Percentage | |||
| A | 0 up to 3 months | 50 | Female | 22 | 44% |
| Male | 28 | 56% | |||
| B | 3 months to one year | 50 | Female | 23 | 46% |
| Male | 27 | 54% | |||
| C | older than one year to five years | 50 | Female | 28 | 56% |
| Male | 22 | 44% | |||
| D | older than five years | 50 | Female | 28 | 56% |
| Male | 22 | 44% |
According to the results, Infrared thermometer: Model YJ600 clinical repeatability of each age group are in the range of plus or minus 0.3℃, meets the clinical repeatability requirement ±0.3℃ of ISO 80601-2-56:2017+A1:2018 and ASTM E1965-98(Reapproved 2016) standards.
VIII Conclusion
The testing conducted demonstrates that the differences in technological characteristics do not raise different questions of safety and effectiveness. The subject device, Infrared Thermometer: Model YJ600 is substantially equivalent to the predicate device, Infrared Thermometer, Model: RN-60A, RN-60B, cleared under K200471.
§ 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.