(282 days)
Infrared thermometer (Models: YRK-002A, T8, T9, T10, T11) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead at a distance of 2-5cm for people of all ages. The device is reusable for home use and clinical use.
Infrared thermometer (Models: YRK-002A, T8, T9, T10, T11) is a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead temperature when measure from 2-5 cm of the subject's forehead with no contact. It uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings. lt composed by a measuring sensor, PCB, 4 buttons, an LCD and an enclosure. The functions of the five models are same. Press the measurement key to turn on the device. The screen of the device lights up. The LCD screen has the power status, measurement mode, temperature unit and measurement temperature. Press the "Setting" key to open the F1: The function of "Temperature Unit" can be set. When measuring body temperature, users need to measure in body mode from 2-5 cm from their forehead. Press the trigger, after 1 second with the sound of "beep", the measurement is completed and the temperature is displayed on the LCD screen. Without any operation, it will close automatically in 17 sec. The difference between these models is only the model's name.
The provided text describes the regulatory clearance for an infrared thermometer and includes sections on non-clinical and clinical testing. However, it does not contain the specific level of detail requested for a comprehensive breakdown of acceptance criteria and study particulars, especially regarding AI/ML device performance.
Therefore, for aspects directly related to the performance of the infrared thermometer and its compliance with standards, I can extract information. For aspects like "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "Sample size for the training set," the document does not provide this level of detail as it pertains to a medical device clearance, not an AI/ML algorithm study.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the standards the device claims to meet, particularly ISO 80601-2-56 and ASTM E1965-98. The reported performance is that the device "complied" with these standards. Specific numerical values for criteria and performance are given for "Measuring accuracy."
| Acceptance Criteria (from ASTM E1965-98 / ISO 80601-2-56 compliance) | Reported Device Performance (as stated in comparison table) | Additional Detail from Comparison Table |
|---|---|---|
| Measuring Accuracy: | ||
| (Implicitly meets standard requirements) | $32°C ~ 39°C: ±0.2°C (89.6°F ~ 102.2°F: ±0.4°F)$ | Predicate Device Accuracy:$32°C ~ 34.9°C: ±0.3°C (±0.5°F)$$35°C ~ 42°C: ±0.2°C (±0.4°F)$$42.1°C ~ 42.9°C: ±0.3°C (±0.5°F)$ |
| $39°C ~ 42.9°C: ±0.3°C (102.2°F ~ 109.2°F: ±0.5°F)$ | Note: The subject device's accuracy specifications are slightly different from the predicate but both comply with the reference standards. | |
| Measuring Range: | $32.0°C ~ 42.9°C (89.6°F to 109.2°F)$ | Same as predicate |
| Display Resolution: | $0.1°C/0.1°F$ | Same as predicate |
| Measurement Distance: | 2-5cm (meets standard requirements, within predicate's range) | Predicate: 1-5cm |
| Operational Environmental Conditions: | Temperature: 10°C ~ 40°C (50 ~ 104°F) Humidity: ≤85% | Predicate: Temperature: 10 ~ 40°C (50 ~ 104°F)Humidity: ≤95% (Subject device has stricter humidity range) |
| Storage Environmental Conditions: | Temperature: -25°C ~ 70°C (-13 ~ 219.2°F) Humidity: ≤95% | Predicate: Temperature: -20°C ~ 60°C (-4 ~ 140°F)Humidity: ≤95% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 240 subjects.
- Data Provenance: The document does not explicitly state the country of origin but implies a clinical setting ("clinical tests were conducted"). It is a prospective clinical performance test ("clinical performance test protocol and data analysis is conducted as a requirement of ASTM E1965-98 (2016)").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The context is a clinical thermometer, where ground truth is typically established by direct measurement of body temperature using a reference standard thermometer (e.g., a rectal thermometer or other highly accurate clinical thermometer) at the same time and under controlled conditions, not by expert consensus on image interpretation.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided and is not typically relevant for a clinical thermometer performance study.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML-driven diagnostic tools where human readers interpret medical images or data. The device in question is a standalone infrared thermometer.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done. The clinical performance test evaluated the device (models YRK-002A, T8, T9, T10, T11) directly by measuring human body temperature. The report states that "the clinical performance of the subject device complied with ASTM E1965-98 (2016)." This indicates the device's performance was assessed as a standalone unit.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The ground truth in clinical thermometer studies is typically a simultaneous measurement from a highly accurate reference thermometer (e.g., a rectal or oral thermometer, traceable to national standards) in a controlled clinical setting. The document only states "The clinical performance test protocol and data analysis were conducted in accordance with the ASTM E1965-98 (2016)," which would implicitly define the ground truth methodology.
8. The Sample Size for the Training Set
- Not applicable / not provided. This device is a traditional infrared thermometer, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / not provided. As mentioned above, this is not an AI/ML device.
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Yibin Junxin Electronics Technology Co., Ltd. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Guangzhou, Guangdong 510000 China
Re: K203662
Trade/Device Name: Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 23, 2021 Received: August 27, 2021
Dear Cassie Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203662
Device Name Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11
Indications for Use (Describe)
Infrared thermometer (Models: YRK-002A, T8, T9, T10, T11) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead at a distance of 2-5cm for people of all ages. The device is reusable for home use and clinical use.
| 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 for K203662
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: Yibin Junxin Electronics Technology Co., Ltd. Establishment Registration Number: 3017015806 Address: Building B2, No. 136, West Section Of Xinggang Road, Lingang Economic And Technological Development Zone, Yibin Sichuan, China Tel: +86-831-3602202 Phone: +86-13530731921 Contact Person: Chaoze Guan Email: peter@tablet-china.com
Application Correspondent:
Contact Person: Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: regulatory@share-info.com
Date of the summary prepared: September 23, 2021
2. Subject Device Information
Trade Name: Infrared thermometer Models: YRK-002A, T8, T9, T10, T11 Common Name: Clinical Electronic Thermometer Regulation Name: Clinical electronic thermometer Review Panel: General Hospital Product Code: FLL Regulation Number: 21 CFR 880.2910 Regulatory Class: II
3. Predicate Device Information
Trade/Device Name: Infrared Forehead Thermometer Model: JZK-601, JZK-602, JZK-603 510(K) Number: K203707
4. Device Description
Infrared thermometer (Models: YRK-002A, T8, T9, T10, T11) is a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead temperature when measure from 2-5 cm of the subject's forehead with no contact.
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It uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings.
lt composed by a measuring sensor, PCB, 4 buttons, an LCD and an enclosure. The functions of the five models are same. Press the measurement key to turn on the device. The screen of the device lights up. The LCD screen has the power status, measurement mode, temperature unit and measurement temperature. Press the "Setting" key to open the F1: The function of "Temperature Unit" can be set. When measuring body temperature, users need to measure in body mode from 2-5 cm from their forehead. Press the trigger, after 1 second with the sound of "beep", the measurement is completed and the temperature is displayed on the LCD screen. Without any operation, it will close automatically in 17 sec. The difference between these models is only the model's name.
5. Intended Use / Indications for Use
Infrared thermometer (Models: YRK-002A, T8, T9, T10, T11) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead at a distance of 2-5cm for people of all ages. The device is reusable for home use and clinical use.
6. Comparison of indications for use and technological characteristics
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Thermometer is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Company | Yibin Junxin Electronics Technology Co., Ltd. | ShenZhen ZhengKang Technology Co., Ltd. | -- |
| Trade Name | Infrared thermometer | Infrared Forehead Thermometer | -- |
| Classification Name | Thermometer, Electronic, Clinical | Thermometer, Electronic, Clinical | Same |
| 510(k) Number | K203662 | K203707 | -- |
| Product Code | FLL | FLL | Same |
| Thermometer Type | Infrared Forehead | Infrared Forehead | Same |
| Indications for Use | Infrared thermometer (Models: YRK-002A, T8, T9, T10, T11) is a non-contact infrared | The Infrared forehead thermometer is a non-contact infrared thermometer (Models JZK-601, JZK-602, JZK-603) intended for | Similar Note 1 |
| Elements of Comparison | Subject Device | Predicate Device | Verdict |
| thermometer intendedfor the intermittentmeasurement of humanbody temperature fromforehead at a distanceof 2-5cm for people ofall ages. The device isreusable for home useand clinical use. | the intermittentmeasurement of humanbody temperature fromforehead at a distanceof 1-5cm for people ofall ages. The device isreusable for home useand clinical use. | ||
| Prescription/over-the-counteruse | OTC | OTC | Same |
| Intended use environment | Home, Clinical | Home, Clinical | Same |
| Measurementmethod | Infrared radiationdetection | Infrared radiationdetection | Same |
| Measurement place | Forehead | Forehead | Same |
| Measurementmode | Adjusted | Not public | DifferentNote 2 |
| Reference Body Site | Oral | Not public | DifferentNote 2 |
| Measuring range | $32.0°C ~ 42.9°C(89.6°F to 109.2°F)$ | $32.0°C ~ 42.9°C (89.6°Fto 109.2°F)$ | Same |
| Displayresolution | 0.1°C/0.1°F | 0.1°C/0.1°F | Same |
| C/F switchable | YES | YES | Same |
| Measuringaccuracy | $32°C ~ 39°C: ±0.2°C(89.6°F ~ 102.2°F:±0.4°F)39°C ~ 42.9°C: ±0.3°C(102.2°F ~ 109.2°F:±0.5°F)$ | $32°C ~ 34.9°C: ±0.3°C(±0.5°F)35°C ~ 42°C: ±0.2°C(±0.4°F)42.1°C ~ 42.9°C: ±0.3°C(±0.5°F)$ | SimilarNote 2 |
| Measurementdistance | 2-5cm | 1-5cm | SimilarNote 2 |
| Power Supply | DC3V (2 pieces 1.5VAAA) | JZK-601 and JZK-603:DC 3V (2x AA 1.5VAlkaline batteries)JZK-602: DC 3V (2xAAA 1.5V Alkalinebatteries) | Same |
| Dimensions | 136mm(L) x 87mm(W)x 40mm(H) | JZK-601 and JZK-603:154 x 96 x 42mmJZK-602: 143 x 81 x36mm | SimilarNote 3 |
| Weight | 88g | JZK-601 and JZK-603: | Similar |
| Elements of Comparison | Subject Device | Predicate Device | Verdict |
| 93gJZK-602: 86g | Note 3 | ||
| Auto Power off | Yes | Yes | Same |
| Memory | 30 sets | 32 sets | SimilarNote 3 |
| Display screen | LCD | LCD | Same |
| Operational environmentalconditions | Temperature: 10°C ~40°C (50 ~ 104°F)Humidity: ≤85% | Temperature: 10 ~ 40°C(50 ~ 104°F)Humidity: ≤95% | SimilarNote 2 |
| Storage environmentalconditions | Temperature: -25°C ~70°C (-13 ~ 219.2°F)Humidity: ≤95% | Temperature: -20°C ~60°C (-4 ~ 140°F)Humidity: ≤95% | SimilarNote 2 |
| Electric Safetyand EMC | IEC 60601-1IEC 60601-1-2IEC 60601-1-11ISO 80601-2-56ASTM E1965-98 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11ISO 80601-2-56ASTM E1965-98 | Same |
| Materials of construction | ABS plastic | ABS | Same |
| Biocompatibility | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | Same |
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Discussion:
Note 1:
Although there are a few differences in the Indications for Use, the intended user population is the same as the predicate device (K203707), and the measurement distance is within the measurement distance range of the predicate device (K203707), and the measurement positions of the subject device and the predicate device is the same, and they meet the requirement of safety and essential performance standards. The difference between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
Note 2:
The "Reference Body Site", "Reference Body Site", "Measuring accuracy", "Measurement distance", "Operational environmental conditions" and "Storage environmental conditions" of subject device is similar to the predicate device, all of them meet the requirement of safety and essential performance standard ISO 80601-2-56 and ASTM E1965-98. The differences between the predicate devices and subject device will not affect the safety and effectiveness of the subject device.
Note 3:
The "Dimensions", "Weight" and "Memory" of subject device is similar with predicate devices, both of them meet the requirement of safety and essential performance standard IEC 60601-1,
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IEC 60601-1-2 and IEC 60601-1-11. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
7. Summary of Non-Clinical Testing
7.1 Non-clinical testing was conducted to verify that the subject devices meet all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed:
A. Electromagnetic Compatibility, Electrical Safety, and Battery Safety:
The subject devices were tested for compliance with the following:
- � ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- � IEC 60601-1-2 Edition 4.0 2014-02 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 Edition 2.0 2015-01, 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 Second edition 2017-03 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
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
B. Software Verification: Software documentation was provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
C. Performance Testing:
- � ISO 80601-2-56 Second edition 2017-03 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
7.2 Discussion of Clinical Tests Performed
The clinical performance test protocol and data analysis is conducted as a requirement of ASTM E1965-98 (2016). The test report showed the clinical performance of the subject device complied with ASTM E1965-98 (2016).
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Clinical tests were conducted on the subject device Model YRK-002A, T8, T9, T10, T11. The clinical tests evaluated 240 of subjects. The proposed thermometer was evaluated in four groups: A1 - 0 up to 3 months to 1 year; B1 -older than 1 year and younger than 5 years; and C - older than 5 years old. Test subjects included patients from the neonatal subgroup patient population (0 – 28 days). The clinical performance test protocol and data analysis were conducted in accordance with the ASTM E1965-98 (2016). The test report showed the clinical performance of the subject device complied with ASTM E1965-98 (2016).
8. Final Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness.The subject device Infrared thermometer (Models: YRK-002A, T8, T9, T10, T11) is substantially equivalent to the Infrared Forehead Thermometer, Model: JZK-601, JZK-602, JZK-603 cleared under K203707 with respect to the indications for use, target populations, and technological characteristics.
§ 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.