(281 days)
PG-IRT1612 & PG-IRT1618
Infrared Forehead Thermometer is intended to measure human body temperature by measuring forehead. The device can be used on people of all ages at home or in hospital environment.
PG-IRT1613 & PG-IRT1615
Infrared Ear/Forehead Thermometer is intended to measure human body temperature by measuring ear canal or forehead. The device can be used on people of all ages at home or in hospital environment.
The proposed device includes 4 models, which are PG-IRT1613, PG-IRT1613, PG-IRT1615 and PG-IRT1618. All models of infrared thermometers are intended for people of all age.
The proposed devices, Infrared Forehead Thermometers, Model PG-IRT1612 and PG-IRT1618, are hand-held, reusable, battery powered device, which are intended to measure human body temperature by measuring forehead. They are non-contact infrared thermometers. The distance of the measurement is 3~5cm.
The proposed devices, Infrared Ear/Forehead Thermometers, Model PG-IRT1613 and PG-IRT1615, are hand-held, reusable, battery powered device, which are intended to measure human body temperature by measuring ear canal or forehead. The ear cavity mode is contact measurement. The forehead mode is non-contact measurement and the measurement distance is 1~5mm.
The proposed devices are operated in adjusted mode. The body site used to reference the adjusted temperature value displayed on the proposed device of each model is oral.
Principle of operation
The proposed device uses a temperature sensor, which can detect the object temperature (OBJ) [human body temperature], environment temperature (NTC) and temperature of sensor itself (AMB); these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module (signal conversion module) in MCU (Microcontroller Unit) of the proposed device. MCU will calculate the body temperature based on OBJ, NTC and AMB, and then transfer to screen for display.
The provided text describes the acceptance criteria and a clinical study conducted for the Shenzhen Pango Medical Electronics Co., Ltd. Infrared Thermometers (Models: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the infrared thermometers are primarily based on the standards ISO 80601-2-56 and ASTM E1965-98. The reported device performance indicates compliance with these standards.
| Feature / Criteria | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Accuracy | ±0.2°C (0.4°F) at 35.0°C ~ 42.0°C (95.0°F ~ 107.6°F); Others ±0.3°C (0.5°F) (per ISO 80601-2-56 and ASTM E1965-98) | Achieved; clinical accuracy not inferior to predicate device and complies with ASTM E1965-98. |
| Measurement Range | 34.0°C ~ 43.0°C (93.2 ~ 109.4°F) | Achieved |
| Display Resolution | 0.1°C (0.1°F) | Achieved |
| Response Time | 1s | Achieved |
| Biocompatibility | Compliant with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) | Complied; no adverse effect observed. |
| Electrical Safety | Compliant with IEC 60601-1 | Complied; no performance degradation or safety issue. |
| EMC | Compliant with IEC 60601-1-2 | Complied; no performance degradation or safety issue. |
| Clinical Bias | Evaluated per clinical validation for infrared thermometer (implied within ASTM E1965-98) | Not inferior to the predicate device. |
| Clinical Uncertainty | Evaluated per clinical validation for infrared thermometer (implied within ASTM E1965-98) | Not inferior to the predicate device. |
| Clinical Repeatability | Evaluated per clinical validation for infrared thermometer (implied within ASTM E1965-98) | Not inferior to the predicate device. |
| Software Validation | Compliant with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Met requirements. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study): A total of 120 subjects were used for each clinical study, split into three age groups:
- Age 0-1: 40 subjects
- Age 1-5: 40 subjects
- Age above 5: 40 subjects
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It does state that "Controlled human clinical studies were conducted in accordance with ASTM E1965-98 (Reapproved 2016)," but the location of these studies is not specified. It is likely a prospective study as it involved actively recruiting subjects to test the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical study.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No information about a Multi Reader Multi Case (MRMC) comparative effectiveness study is provided in the document. The study was a comparison to a predicate device's performance, not specifically focusing on human reader improvement with or without AI assistance.
6. Standalone Performance Study
Yes, the clinical study performed can be considered a standalone performance study for the algorithm embedded within the device, as it evaluates the device's accuracy, bias, and repeatability against established clinical standards (ASTM E1965-98). The device itself is an "algorithm only" in the sense that it automatically calculates and displays temperature based on sensor readings without human interpretation of raw data.
7. Type of Ground Truth Used
The ground truth for the clinical study was established by comparison with a predicate device and compliance with standardized clinical validation methods (ASTM E1965-98). While not explicitly stated as "expert consensus" or "pathology," the ASTM E1965-98 standard defines methods for clinical accuracy assessment of intermittent thermometers, which usually involves comparing the device's readings to highly accurate reference thermometers or established clinical methods as the ground truth. The statement that "febrile persons" were included implies that actual body temperatures, including elevated ones, were measured.
8. Sample Size for the Training Set
The document does not provide any information about a "training set" or its sample size. This type of device (infrared thermometer) typically relies on engineering calibration and validation against physical standards and clinical studies rather than machine learning training sets in the AI sense.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned for this device, a method for establishing its ground truth is also not applicable or not provided. The development process likely involves engineering design, component selection, calibration, and then validation through the non-clinical and clinical tests described.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 5, 2022
Shenzhen Pango Medical Electronics Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China
Re: K212346
Trade/Device Name: Infrared Thermometer, Model: PG-IRT1613, PG-IRT1613, PG-IRT1615, PG-IRT1618 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: March 26, 2022 Received: April 5, 2022
Dear Diana Hong:
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 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.
David Wolloscheck 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212346
Device Name
Infrared thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618
Indications for Use (Describe)
PG-IRT1612 & PG-IRT1618
Infrared Forehead Thermometer is intended to measure human body temperature by measuring forehead. The device can be used on people of all ages at home or in hospital environment.
PG-IRT1613 & PG-IRT1615
Infrared Ear/Forehead Thermometer is intended to measure human body temperature by measuring ear canal or forehead. The device can be used on people of all ages at home or in hospital environment.
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
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K212346
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- Date of Preparation: 04/22/2022
-
- Sponsor Identification
Shenzhen Pango Medical Electronics Co., Ltd.
No. 25, 1st Industry Zone, Fenghuang Road, Xikeng Village, Henggang Town, Longgang District, Shenzhen, Guangdong, 518115, China
Establishment Registration Number: 3006792041
Contact Person: Youjian Xie Position: Technical Director Tel: +86-755-33825988-301 Fax: +86-755-33825989 Email: xie_you_jian@163.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: Infrared thermometer Common Name: Clinical electronic thermometer Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618
Regulatory Information
Classification Name: Clinical electronic thermometer; Classification: II; Product Code: FLL; Regulation Number: 21CFR 880.2910 Review Panel: General Hospital;
Indications for Use:
PG-IRT1612 & PG-IRT1618
Infrared Forehead Thermometer is intended to measure human body temperature by measuring forehead.
The device can be used on people of all ages at home or in hospital environment.
PG-IRT1613 & PG-IRT1615
Infrared Ear/Forehead Thermometer is intended to measure human body temperature by measuring ear canal or forehead.
The device can be used on people of all ages at home or in hospital environment.
Device Description
The proposed device includes 4 models, which are PG-IRT1613, PG-IRT1613, PG-IRT1615 and PG-IRT1618. All models of infrared thermometers are intended for people of all age.
The proposed devices, Infrared Forehead Thermometers, Model PG-IRT1612 and PG-IRT1618, are hand-held, reusable, battery powered device, which are intended to measure human body temperature by measuring forehead. They are non-contact infrared thermometers. The distance of the measurement is 3~5cm.
The proposed devices, Infrared Ear/Forehead Thermometers, Model PG-IRT1613 and PG-IRT1615, are hand-held, reusable, battery powered device, which are intended to measure human body temperature by measuring ear canal or forehead. The ear cavity mode is contact measurement. The forehead mode is non-contact measurement and the measurement distance is 1~5mm.
The proposed devices are operated in adjusted mode. The body site used to reference the adjusted
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temperature value displayed on the proposed device of each model is oral.
Principle of operation
The proposed device uses a temperature sensor, which can detect the object temperature (OBJ) [human body temperature], environment temperature (NTC) and temperature of sensor itself (AMB); these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module (signal conversion module) in MCU (Microcontroller Unit) of the proposed device. MCU will calculate the body temperature based on OBJ, NTC and AMB, and then transfer to screen for display.
-
న. Identification of Predicate Device
510(k) Number: K182597 Device Name: Infrared Thermometer Model: PG-IRT1601 Infrared Ear Thermometer PG-IRT1602 Infrared Forehead Thermometer (selected as predicate device) PG-IRT1603 Infrared Ear/Forehead Thermometer (selected as predicate device) -
- Comparison of Technological characteristics
| ITEM | Proposed Device K212346 | Predicate Device K182597 | Remark |
|---|---|---|---|
| Model | PG-IRT1612 and PG-IRT1618 | PG-IRT1602 | / |
| Product Code | FLL | FLL | Same |
| Regulation Number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Indications for Use | PG-IRT1612 & PG-IRT1618 InfraredForehead Thermometer is intended tomeasure human body temperature bymeasuring forehead.The device can be used on people of allages at home or in hospitalenvironment. | PG-IRT1602 Infrared ForeheadThermometer is intended to measurehuman body temperature by measuringforehead.The device can be used on people of allages. | Similar |
| Principle of Operation | The proposed device uses atemperature sensor, which can detectthe object temperature (OBJ) [humanbody temperature], environmenttemperature (NTC) and temperature ofsensor itself (AMB); thesetemperatures are then transfer toelectronic signal and amplified; and | The proposed device uses a temperaturesensor, which can detect the objecttemperature (OBJ) [human bodytemperature], environment temperature(NTC) and temperature of sensor itself(AMB); these temperatures are thentransfer to electronic signal andamplified; and then it is transferred to | Same |
| Table 1 Comparison of Technology Characteristics of Infrared Forehead Thermometers | ||||
|---|---|---|---|---|
| Features and characteristics | Non-contacting, Infrared Temperature Measurement | Non-contacting, Infrared Temperature Measurement | Same | |
| Measurement Site | Forehead | Forehead | Same | |
| Measurement Method | Infrared radiation detection | Infrared radiation detection | Same | |
| Measurement Range | $34.0°C ~43.0°C$$(93.2 ~ 109.4 °F)$ | $34.0°C ~43.0°C$$(93.2 ~ 109.4 °F)$ | Same | |
| Accuracy | $±0.2°C (0.4°F) at 35.0°C ~ 42.0°C$$(95.0°F ~ 107.6 °F)$$Others ±0.3°C (0.5 °F)$ | $±0.2°C (0.4°F) at 35.0°C ~ 42.0°C$$(95.0°F ~ 107.6 °F)$$Others ±0.3°C (0.5 °F)$ | Same | |
| Display | $0.1°C (0.1°F)$ | $0.1°C (0.1°F)$ | Same | |
| Memory | 32 sets | 9 sets | Different | |
| Display type | LCD | LCD | Same | |
| Activation | Scan button | Scan button | Same | |
| Measurement distance | 3~5cm | 3~5cm | Same | |
| Sensor name | Thermal Infrared Detectors 10TP583Tmanufactured by Semitec InshizukaElectronics Corporation | Thermal Infrared Detectors 10TP583Tmanufactured by Semitec InshizukaElectronics Corporation | Same | |
| Sensor type | Thermopile | Thermopile | Same | |
| Scale Selection | °C/°F | °C/°F | ||
| Auto power-off while no operation | Yes | Yes | Same | |
| Response time | 1s | 1s | Same | |
| Operation environment | $10.0°C ~ 40.0°C (50.0 ~ 104.0 °F)$$15%~93% RH$ | $10.0°C ~ 40.0°C (50.0 ~ 104.0 °F)$$15%~93% RH$ | Same | |
| Storage environment | $-25.0°C~+55.0°C (-13.0~+131.0°F)$$0%~93% RH$ | $-25.0°C~+55.0°C (-13.0~+131.0°F)$$0%~93% RH$ | Same | |
| Service life | 5 years | 5 years | Same | |
| Power requirements | Two pieces of 1.5V AAA batteries | Two pieces of 1.5V AAA batteries | Same | |
| Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Same | |
| Performance | Complied with ISO 80601-2-56 | Complied with ISO 80601-2-56 | Same | |
| Complied with ASTM E1965-98 | Complied with ASTM E1965 -98 | Same | ||
| Patient-contactMaterials | Shell Material: ABS;lens: PMMA;Button: High density polyethylene(HDPE);Color additives | Shell Material: ABS;lens: PMMA;Button: High density polyethylene(HDPE);Color additives | Same | |
| Biocompatibility | Complied with ISO 10993-5 | Complied with ISO 10993-5 | Same | |
| Complied with ISO 10993-10 | Complied with ISO 10993-10 | Same |
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| Table 2 Comparison of Technology Characteristics of Infrared Ear/Forehead Thermometers | ||||
|---|---|---|---|---|
| ITEM | Proposed Device K212346 | Predicate Device K182597 | Remark |
|---|---|---|---|
| Model | PG-IRT1613 and PG-IRT1615 | PG-IRT1603 | / |
| Product Code | FLL | FLL | Same |
| Regulation Number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Indications for Use | PG-IRT1613 & PG-IRT1615 InfraredEar/Forehead Thermometer is intendedto measure human body temperatureby measuring ear canal or forehead.The device can be used on people ofall ages at home or in hospitalenvironment. | PG-IRT1603 Infrared Ear/ForeheadThermometer is intended to measurehuman body temperature by measuringear canal or forehead.The device can be used on people of allages. | Similar |
| PrincipleofOperation | The proposed device uses atemperature sensor, which can detectthe object temperature (OBJ) [humanbody temperature], environmenttemperature (NTC) and temperature ofsensor itself (AMB); thesetemperatures are then transfer toelectronic signal and amplified; andthen it is transferred to digital signal byAD module in MCU of the proposeddevice. MCU will calculate the bodytemperature based on OBJ, NTC andAMB, and then transfer to screen fordisplay. | The proposed device uses atemperature sensor, which can detectthe object temperature (OBJ) [humanbody temperature], environmenttemperature (NTC) and temperature ofsensor itself (AMB); thesetemperatures are then transfer toelectronic signal and amplified; andthen it is transferred to digital signal byAD module in MCU of the proposeddevice. MCU will calculate the bodytemperature based on OBJ, NTC andAMB, and then transfer to screen fordisplay. | Same |
| Featuresandcharacteristics | Non-contacting, Infrared TemperatureMeasurement | Non-contacting, Infrared TemperatureMeasurement | Same |
| Measurement Site | Forehead and eardrum | Forehead and eardrum | Same |
| Measurement | Infrared radiation detection | Infrared radiation detection | Same |
| Method | |||
| Measurement | 34.0°C | 34.0°C | Same |
| Range | ±0.2°C (0.4°F) at 35.0°C ~ 42.0°C(95.0°F~107.6 °F)Others ±0.3°C (0.5 °F) | ±0.2°C (0.4°F) at 35.0°C ~ 42.0°C(95.0°F~107.6 °F)Others ±0.3°C (0.5 °F) | Same |
| Accuracy | 0.1°C (0.1°F) | 0.1°C (0.1°F) | Same |
| Display | 32 sets | 9 sets | Different |
| Memory | LCD | LCD | Same |
| Display type | Scan button | Scan button | Same |
| Activation | Contact (Ear)1~5mm (Forehead) | 0~5mm | Different |
| Measurementdistance | Thermal Infrared Detectors 10TP583Tmanufactured by Semitec InshizukaElectronics Corporation | Thermal Infrared Detectors 10TP583Tmanufactured by Semitec InshizukaElectronics Corporation | Same |
| Sensor name | Thermopile | Thermopile | Same |
| Sensor type | °C/°F | °C/°F | Same |
| Scale Selection | Yes | Yes | Same |
| Auto power-offwhile no operation | 1s | 1s | Same |
| Response time | 10.0°C ~ 40.0°C (50.0 ~ 104.0 °F)15%~93% RH | 10.0°C ~ 40.0°C (50.0 ~ 104.0 °F)15%~93% RH | Same |
| Operationenvironment | -25.0°C ~ +55.0°C (-13.0 ~ +131.0°F)0%~93% RH | -25.0°C ~ +55.0°C (-13.0 ~ +131.0°F)0%~93% RH | Same |
| Storageenvironment | 5 years | 5 years | Same |
| Service life | Two pieces of 1.5V AAA batteries | Two pieces of 1.5V AAA batteries | Same |
| Power requirements | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Same |
| Safety | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 | Same |
| EMC | Complied with ISO 80601-2-56Complied with ASTM E1965-98 | Complied with ISO 80601-2-56Complied with ASTM E1965 -98 | Same |
| Performance | Shell Material: ABS;lens: PMMA;Button: High density polyethylene (HDPE);Color additives | Shell Material: ABS;lens: PMMA;Button: High density polyethylene (HDPE);Color additives | Same |
| Patient-contactMaterials | Complied with ISO 10993-5 | Complied with ISO 10993-5 | Same |
| Biocompatibility | Complied with ISO 10993-10 | Complied with ISO 10993-10 | Same |
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Similar - Indications for Use
The Indications for Use for the proposed device is not exactly the same as the predicate device. The
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Indication for Use for the proposed device includes the use environment, i.e. at home and hospital. The performance test environment condition complies with standards. It does not affect the measurement function of the proposed device. The different will not affect the safety and effectiveness of the proposed device.
Different - Memory
The memory function for the proposed device is different from the predicate device. The memory of the proposed device is 32 sets, while the memory of the predicate device is only 9 sets. The proposed device has more memory than the predicate device, which allows users to access more records to get a better grasp of recent body temperature. Software validation and verification test demonstrate the subject devices performance as intended. The difference does not affect the indications for use. In addition, the working principle and measurement methods and parameters of the proposed device are the same as those of the predicate device. Therefore, the different will not affect the safety and effectiveness of the proposed device.
Different - Measurement distance
The measurement distance for the proposed device is different from the predicate device. The forehead mode of the proposed device is non-contact measurement distance is 1~5mm, which can be covered by the predicate device. While the ear cavity mode for the proposed device is contact measurement. However, the biocompatibility test of the human contact part of the proposed device was performed and the results showed no adverse effect. In addition, the performance test and clinical test were performed on the proposed device and the test results demonstrate that the proposed device meets the requirements of ASTM E1965-98 (Reapproved 2016). Therefore, the different will not affect the safety and effectiveness of the proposed device.
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test performed on the proposed device include
- Non-Clinical Test Conclusion
Biocompatibility testing
The biocompatibility test for the proposed device was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing items include cytotoxicity, Sensitization and Irritation test, the test result demonstrated that there was no adverse effect, thereby, it can be determined that the device can comply with the following standards:
- A ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- A ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
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Electrical safety and EMC
Electrical safety and EMC testing were conducted on the proposed device and the test result demonstrated that the device can operate normally and did not raise any performance degradation and safety issue, thereby, it can be determined that the device can comply with the following standards:
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IEC 60601-1: 2005+CORR.1(2006)+CORR.2(2007)+AMI(2012) Medical electrical equipment-Part 1: general requirement for basic safety and essential performance
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IEC 60601-1-2:2014 Medical Electrical Equipment- Part 1-2: General Requirements for Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests.
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ISO 80601-2-56: 2017+A1: 2018 Medical Electrical Equipment- Part 1-2: Particular Requirements for Basic Safety And Essential Performance of Clinical thermometers for body temperature measurement
- ▲ 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
The software verification and validation were conducted in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. The test results demonstrated the software function met the requirements.
-
- Clinical Test Conclusion
Controlled human clinical studies were conducted in accordance with ASTM E1965-98 (Reapproved 2016), clinical bias, clinical uncertainty and clinical repeatability have been evaluated per clinical validation for infrared thermometer. The clinical trial results verify that the clinical accuracy of the proposed device is not inferior to that of predicate device.
- Clinical Test Conclusion
Total 120 subjects and three age groups, including age 01 (40 subjects), age 15 (40 subjects) and age above 5 (40 subjects) are included in each clinical study, including febrile persons. Compared statistical result of clinical bias and clinical repeatability of two comparison groups, the results of proposed device are not being inferior to that of predicate device. The result of proposed device was not inferior to that of predicate device, and the proposed device complies with ASTM E1965-98 (Reapproved 2016).
-
- Conclusion
Based on the performance testing, comparison and analysis above, the proposed devices are substantially equivalent to the predicate device K182597.
- Conclusion
§ 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.