(176 days)
Not Found
No
The device description and features are typical of a standard infrared thermometer and do not mention any AI or ML capabilities. The performance studies focus on clinical accuracy against a standard, not on evaluating an AI/ML algorithm.
No.
Explanation: The device is described as an "Infrared Thermometer" intended for "intermittent measurement and monitoring of human body temperature," which is a diagnostic function, not a therapeutic one. It measures temperature but does not treat any condition.
Yes
The device is described as an "Infrared Thermometer" intended for the "measurement and monitoring of human body temperature," which is a diagnostic function. While it doesn't diagnose a specific disease, it provides data (temperature) used to assess a health condition (fever or hypothermia), which falls under the broad definition of a diagnostic device.
No
The device description explicitly states it is a "hand-held, battery powered, infrared Thermometer" and lists hardware components such as a "thermopile sensor," "PCB," "buttons," "LCD," and an "enclosure." This indicates it is a physical hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "intermittent measurement and monitoring of human body temperature from forehead." This is a direct measurement of a physiological parameter (temperature) from the body surface.
- Device Description: The device description confirms it measures infrared energy emitted from the forehead to determine temperature.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples taken from the body (like blood, urine, tissue, etc.) in a laboratory setting. IVD devices are designed to perform tests on these types of samples outside of the body.
Therefore, this infrared thermometer falls under the category of a medical device used for direct physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Infrared Thermometer (Model: Y2001, Y20002) is intended for the intermittent measurement and monitoring of human body temperature from forehead. The device is indicated for use for people of two months and above at homecare and in hospital.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Infrared thermometer (Model: Y20001 , Y20002) are 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 when measure from 1-3cm of the subject's forehead with no contact. The temperature will displayed on the screen, and the reference body site is axilla. Infrared thermometer (Model: Y20001, Y20002) use a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the thermometer for ambient temperature readings. The device consists of measuring sensor, PCB, buttons, a LCD and an enclosure.
The difference between two models are size, weight and button settings. Y20001 has four buttons(Test button, °C/°F button, "B/S"button, "M" key) and Y20002 has two buttons(Function button, Measurement button). The functions of the two models are same. Infrared thermometer (Model: Y20001,Y20002) have the following features:
-
The device is intended to be reusable for home use and clinical use.
-
Switching of temperature unit between °C and °F.
-
The latest 32 sets of memory for measuring human body and object; the user can view or delete the previous measurement results.
-
Buzzer on or off to set the prompt tone on or off.
-
Prompt tone function.
-
Low battery indication, and auto power-off
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
two months and above
Intended User / Care Setting
homecare and in hospital.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Each clinical study evaluated 150 subjects, and the infrared thermometer was evaluated for the patient populations for two months and above. All subjects were divided into three age groups with 50 subjects in each group, including (1)Infants –two months to one year, (2)Children - greater than one to five years; (3)Adults - greater than five years old. The proportion of fever patient is more than 30% in each age groups.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Summary
7.1. Electromagnetic Compatibility and Electrical Safety Test
The subject device has been tested in compliance with the following standards:
- AAMI/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 requirementsfor 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 is considered for surface contacting, limited exposure (Less than 24 hours), it has been tested in compliance with the 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
- ISO 10993-23:2021 Biological evaluation of medical devices - Part 23:Tests for irritation
7.3. Performance Test-Bench
The subject device has been tested in compliance with the following standards:
- ISO 80601-2-56:2017+AMD2018 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 InfraredThermometers for Intermittent Determination of Patient Temperature
7.4. Software Verification
The softw are documentation of the subject device 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.
Clinical Accuracy Test Summary
Both models(Y20001, Y20002) have undergone clinical accuracy testing, both clinical studies are based on the requirement of ISO 80601-2-56:2017. The test reports showed the clinical performance of the subject device complied with the requirement of ISO 80601-2-56:2017+AMD2018 . The clinical accuracy test results demonstrated that the subject device meets the requirements for measurement distance. The performance testing shows that the subject device complies with the performance standard ISO 80601-2-56 and ASTM E1965-98. The measurement accuracy of the subject device has been demonstrated to comply with the requirements of standards IEC 60601-1 and ISO 80601-2-56 in operation and storage environment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".
December 14, 2022
Zhangzhou Easepal Medical Science And Technology Co.,Ltd. % Jet Li Regulation Manager Guangdong Jianda Medical Technology Co., Ltd. 906 Room, Longxiang Garden, Tianhe District Guangzhou, Guangdong 510630 China
Re: K221800
Trade/Device Name: Infrared Thermometer (Model: Y20001, Y20002) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 14, 2022 Received: November 14, 2022
Dear Jet Li:
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
1
(24. SER. B. — 967) 1. hdl., (24. SER. B.
Page 2
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,
Danil Walloschek
David Wolloscheck, Ph.D. For Joyce M. Whang, Ph.D. 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221800
Device Name Infrared Thermometer (Model: Y20001, Y20002)
Indications for Use (Describe)
The Infrared Thermometer (Model: Y2001, Y20002) is intended for the intermittent measurement and monitoring of human body temperature from forehead. The device is indicated for use for people of two months and above at homecare and in hospital.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K221800
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 870.1130. Summary Prepared Date:14 December 2022
1. Submitter Information
- Sponsor Company Name: Zhangzhou Easepal Medical Science And Technology Co.,Ltd. �
- � Address: West of the 4th Floor, No. 7 Building, Easepal Factory, No. 228 Jiaosong Road, Jiaomei Town, Zhangzhou Taiwanese Investment Zone, Fujian, China
- � Phone: +86-18905963518
- Contact Person (including title): Flower Huang/ Engineer �
- E-mail: flower@easepal.com.cn �
Application Correspondent:
- Guangdong Jianda Medical Technology Co.,Ltd. �
- Address: 906 Room, Longxiang Garden, Tianhe district, Guangzhou, China �
- Contact Person: Mr. Jet Li �
- Tile: Regulation Manager �
- � Tel: +86- 13512755282
- Email: jianda-lee@foxmail.com �
2. Subject Device Information
| Common Name: | Infrared Thermometer |
|---|---|
| Trade Name: | Infrared Thermometer |
| Model names: | Y20001,Y20002 |
| Classification Name: | Thermometer, electronic, clinical |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Number: | 21 CFR 880.2910 |
| Regulation Class: | II |
4
3. Predicate Device Information
| Sponsor: | SHENZHEN EVERBEST MACHINERY INDUSTRY CO.,
LTD. |
|----------------------|---------------------------------------------------|
| Common Name: | Infrared Thermometer |
| Trade Name: | Infrared Thermometer |
| Classification Name: | Clinical Electronic Thermometer |
| Model names: | DT-8806S, DT-8807S |
| 510(k) number: | K203170 |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Number: | 21 CFR 880.2910 |
| Regulation Class: | II |
4. Device Description
Infrared thermometer (Model: Y20001 , Y20002) are 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 when measure from 1-3cm of the subject's forehead with no contact. The temperature will displayed on the screen, and the reference body site is axilla. Infrared thermometer (Model: Y20001, Y20002) use a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the thermometer for ambient temperature readings. The device consists of measuring sensor, PCB, buttons, a LCD and an enclosure.
The difference between two models are size, weight and button settings. Y20001 has four buttons(Test button, °C/°F button, "B/S"button, "M" key) and Y20002 has two buttons(Function button, Measurement button). The functions of the two models are same. Infrared thermometer (Model: Y20001,Y20002) have the following features:
-
The device is intended to be reusable for home use and clinical use.
-
Switching of temperature unit between °C and °F.
-
The latest 32 sets of memory for measuring human body and object; the user can view or delete the previous measurement results.
-
Buzzer on or off to set the prompt tone on or off.
5
- Prompt tone function.
-
- Low battery indication, and auto power-off
5. Indication for use
The Infrared Thermometer (Model: Y20001, Y20002) is intended for the intermittent measurement and monitoring of human body temperature from forehead. The device is indicated for use for people of two months and above at homecare and in hospital.
6. Comparison to Predicate Device
| Elements of
| Comparison | Subject Device | Predicate Device 1# | Verdict |
|---|---|---|---|
| Manufacturer | Zhangzhou Easepal Medical | ||
| Science And Technology Co.,Ltd. | SHENZHEN EVERBEST | ||
| MACHINERY INDUSTRY CO., | |||
| LTD. | -- | ||
| 510 (k) Number | K221800 | K203170 | -- |
| Product Name | Infrared Thermometer | Infrared Thermometer | -- |
| Models | Y20001, Y20002 | DT-8806S, DT-8807S | -- |
| Intended Use | The Infrared Thermometer | ||
| (Model: Y20001, Y20002) is | |||
| intended for the intermittent | |||
| measurement and monitoring of | |||
| human body temperature from | |||
| forehead. The device is indicated | |||
| for use for people of two months | |||
| and above at homecare and in | |||
| hospital. | The Infrared thermometer is intended | ||
| for the intermittent measurement of | |||
| human body temperature from | |||
| forehead for people of all ages. The | |||
| device is reusable for home use and | |||
| clinical use. | Different, | ||
| See Note 1 | |||
| Measurement | |||
| Method | Infrared radiation detection, | ||
| adjusted mode | Infrared radiation detection, adjusted | ||
| mode | Same | ||
| Principle of | |||
| operation | It detects the radiant energy of | ||
| infrared radiation emitted by | |||
| objects or human body and | |||
| converts it into electrical signals, | |||
| and eventually into a temperature | |||
| value | It detects the radiant energy of | ||
| infrared radiation emitted by objects | |||
| and converts it into electrical signals, | |||
| and eventually into a temperature | |||
| value | Same | ||
| Measurement | |||
| Place | Forehead | ||
| Surface | Forehead | ||
| Surface | Same | ||
| Sensor type | Thermopile | Thermopile | Same |
| Measurement | |||
| Distance | 1-3cm | 8806S: 1 cm - 10 cm | |
| 8807S: 1 cm-4 cm | Different, | ||
| See Note 2 | |||
| Measuring | |||
| Range | 34.0°C to 42.9°C (93.2 to 109.2 ° | ||
| F) | 32.0°C -42.5°C (89.6 to 108.5 ° F) | Different, | |
| See Note 3 | |||
| Accuracy | $\pm$ 0.3°C/0.5°F | ±0.2°C(0.4°F) within 36.0°C - | |
| 39.0°C, (96.8°F - 102.2°F) | Different, | ||
| See Note 4 | |||
| Elements of | |||
| Comparison | Subject Device | Predicate Device 1# | Verdict |
| ±0.3°C(0.6°F) within 32°C -35.9°C | |||
| (89.6°F -96.6°F) and 39.1 °C-42.5°C | |||
| (102.3°F -108.5°F) | |||
| Display | |||
| Resolution | 0.1°C/0.1°F | 0.1°C/0.1°F | Same |
| Display Screen | LCD | LCD | Same |
| Buzzer | Yes | Yes | Same |
| °C/°F | |||
| switchable | Yes | Yes | Same |
| Memory | 32 sets | 32 sets | Same |
| Auto power-off | |||
| Same while no | |||
| operation | Yes | Yes | Same |
| Power Supply | 2 * 1.5V AAA | 2 * 1.5V AAA | Same |
| Contact | |||
| materials | ABS | ABS | Same |
| Operating | |||
| Conditions | Temperature:10°C-40°C; | ||
| Relative humidity: ≤95% | Temperature: 10.0°C~40°C (50.0°F | ||
| ~104.0°F); | |||
| Relative humidity: ≤85% | Different, | ||
| See Note 5 | |||
| Storage | |||
| Conditions | Temperature:-20°C-55°C; | ||
| Relative humidity: ≤95%RH | 0 to 50°C (32 to 122°F) ;RH≤85% | ||
| Dimension | Y20001:145 mm * 93 mm * 38 | ||
| mm | |||
| Y20002:155 mm *40 mm *40 | |||
| mm | 128 * 74 * 36 mm | Different, | |
| See Note 6 | |||
| Weight | Y20001: 110 g(excluding | ||
| batteries ) | |||
| Y20002: 59g (excluding batteries) | 104.5 g | ||
| Performance | Compliance with ASTME 1965; | ||
| ISO80601-2-56 | Compliance with ASTME 1965; | ||
| ISO80601-2-56 | Same | ||
| Clinical | |||
| accuracy | Meet the requirements of ISO | ||
| 80601-2-56:2017, ASTM 1965- | |||
| 98(2016) | Meet the requirements of ISO 80601- | ||
| 2-56:2017, ASTM 1965-98(2016) | Same | ||
| Biocompatibility | All the patient contacting | ||
| materials are compliance with | |||
| ISO 10993-1,ISO 10993-5, | |||
| ISO 10993-10,ISO 10993-23. | |||
| Under the condition of this study | All the patient contacting materials | ||
| are compliance with ISO 10993. | |||
| Under the condition of this study the | Same | ||
| the device is non-cytotoxic , non- | |||
| sensitizing and non-irritating. | device is non-cytotoxic, non- | ||
| sensitizing and non-irritating. | |||
| Elements of | |||
| Comparison | Subject Device | Predicate Device 1# | Verdict |
| Electrical Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | Same |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Same |
6
7
Note 1
The population of the predicate device is wider than the subject device. The user population of the subject device is subset of the predicate. Therefore, this difference does not raise new safety and effectiveness questions.
Note 2
The measurement distance is different. But we had conducted clinical accuracy testing on subject device according to ISO 80601-2-56:2017, and the clinical accuracy test result can demonstrate that the subject device can meet the requirement on this measurement distance. So, the different does not raise different questions of safety and effectiveness.
Note 3
The measurement range of subject device is different from the predicate device. The performance testing shows that the subject device complies with the performance standard ISO 80601-2-56 and ASTM E1965-98. Therefore, this difference does not affect the performance and accuracy.
Note 4
The subject device's accuracy are wider than the predicate device within 36.0℃ - 39.0℃, (96.8°F -102.2°F) ,these are based on device's performance standards. These differences do not affect the performance and accuracy according to our Test Report (ASTM E1965- 98), ISO 80601-2-56 Test Report, and our Clinical Test Report.
Note 5
The operation and storage environment of subject device is different from the predicate device, but the measurement accuracy of subject device has been demonstrated to comply with the requirements of standards IEC 60601-1 and ISO 80601-2-56 in operation and storage environment. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness.
Note 6
The "Dimensions", "Weight" of subject device is similar with predicate devices, both of them meet the requirement of safety and essential performance standard IEC 60601-1-2 and IEC 60601-1-2 and IEC 60601-1
8
- The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
7. Non-Clinical Test Summary
7.1. Electromagnetic Compatibility and Electrical Safety Test
The subject device has been tested in compliance with the following standards:
-
AAMI/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 3) IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirementsfor 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 is considered for surface contacting, limited exposure (Less than 24 hours), it has been tested in compliance with the 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
-
ISO 10993-23:2021 Biological evaluation of medical devices - Part 23:Tests for irritation
7.3. Performance Test-Bench
The subject device has been tested in compliance with the following standards:
- ISO 80601-2-56:2017+AMD2018 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement 2) ASTM E1965-98 (Reapproved 2016) Standard Specification for InfraredThermometers for Intermittent Determination of Patient Temperature
7.4. Software Verification
The softw are documentation of the subject device 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.
8. Clinical Accuracy Test Summary
9
Both models(Y20001, Y20002) have undergone clinical accuracy testing, both clinical studies are based on the requirement of ISO 80601-2-56:2017. The test reports showed the clinical performance of the subject device complied with the requirement of ISO 80601-2-56:2017+AMD2018 .
Each clinical study evaluated 150 subjects, and the infrared thermometer was evaluated for the patient populations for two months and above. All subjects were divided into three age groups with 50 subjects in each group, including (1)Infants –two months to one year, (2)Children - greater than one to five years; (3)Adults - greater than five years old. The proportion of fever patient is more than 30% in each age groups.
9. Conclusion
The subject device Infrared Thermometer (Model: Y20002) are substantially equivalent to the predicate device (K203170). This conclusion is based upon comparison of the intended use, technological characteristics and applicable safety standards. Any differences in the technological characteristics do not raise any new issues or different questions of safety or effectiveness.