(245 days)
Infrared Forehead Thermometers (model2: JA-11S; model3: JA-11C) are non-sterile, reusable, noncontact and handheld devices. They can be used by consumers in homecare environment and doctors in clinic as reference. They are intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
Infrared Forehead Thermometers (model1: JA-11A; model2: JA-11S; model3: JA-11C) are hand-held, battery powered, Infrared Forehead Thermometers that covert a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead to an equivalent temperature when measuring from 1-3 cm of the subject's forehead with no contact.
It is composed of a probe, a display, two buttons (start button and power button), an enclosure and a battery cover.
It is used to measure human body temperature based on the relationship between temperature and measurable infrared radiation. Simply aim the unit's probe toward the surface to be measured to obtain a quick and accurate temperature.
When measuring body temperature, users need to measure in body mode from 1-3 cm from their forehead. Press the measuring key and then release it. The instrument will start measuring the target temperature. After about 1 second, the buzzer emits the corresponding alert sound, the measurement result is displayed on the LCD, and the backlight of the corresponding color is turned on. After about 3 seconds, the backlight is turned off, the unit symbol flashes, and the buzzer beeps shortly. Wait until the key is pressed to measure the temperature again. Start the thermometer without any operation, or no operation after temperature measurement, the thermometer will shut off and LCD go out with one short beep in 60 s ± 20 s.
It can store 32 sets of measurements. Press the 【M】button to cycle through them.
User contact components are the enclosure and keys. The materials of the components are ABS plastic.
The thermometer is for intermittent use.
The provided text describes information about an Infrared Forehead Thermometer (models: JA-11A, JA-11S, JA-11C) and its substantial equivalence submission to the FDA. The information focuses on the device's technical specifications, comparison to a predicate device, and the standards it conforms to for safety and effectiveness.
However, the document does not provide details about a study that proves the device meets specific acceptance criteria in the context of AI/machine learning performance, which is implied by several of your questions (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)"). This is a medical device clearance, not an AI/ML software clearance.
The "Clinical Accuracy Validation" section mentions that the device was tested per ASTM 1965-98, which is a standard for infrared thermometers. This standard typically defines the accuracy requirements for temperature measurement.
Therefore, I will extract the relevant performance criteria and reported performance for this non-AI medical device from the provided text. Many of your specific questions related to AI/ML studies cannot be answered from this document.
Acceptance Criteria and Device Performance for Infrared Forehead Thermometer
Based on the provided FDA 510(k) summary, the device's performance is demonstrated through adherence to relevant medical device standards, particularly related to temperature measurement accuracy and safety. The "acceptance criteria" here are the specifications outlined in the standards, and the "reported device performance" is the claim that the device conforms to these standards and their specified accuracy limits.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Parameter | Acceptance Criteria (from predicate/standards) | Reported Device Performance (Claimed by manufacturer) |
|---|---|---|
| Temperature Measurement Accuracy | Predicate (K193253): | Subject Device (JA-11A, JA-11S, JA-11C): |
| (Per ASTM 1965-98 & ISO 80601-2-56) | 32 °C-34.9 °C: ± 0.3 °C (89.6 °F - 94.8 °F: ±0.5 °F) | 34.0 °C - 35.4 °C (93.2 °F - 95.7 °F): ±0.3 °C/±0.5 °F |
| 35 °C-42 °C: ±0.2 °C/95.0°F-107.6 °F: ±0.4 °F | 35.5 °C - 42.0 °C (95.0 °F - 107.6 °F): ±0.2 °C/±0.4 °F | |
| 42.1 °C-42.5 °C: ±0.3 °C/107.8 °F-108.5 °F: ±0.5 °F | 42.1 °C - 43.0 °C (107.8 °F - 109.4 °F): ±0.3 °C/±0.5 °F | |
| Operating Environment | 10 °C - 40 °C, 15 % - 90% RH (Predicate) | 10 °C - 40 °C, 15 % - 90% RH (Claimed conformance) |
| Storage Environment | -25°C - 55°C (-13°F - 131°F) with a relative humidity of up to 85% (non-condensing) (Predicate) | -25 °C - 55 °C (-13 °F - 131 °F) with a relative humidity of up to 85% (non-condensing) (Claimed conformance) |
| Measurement Range | 32 °C - 42.5 °C (Predicate) | 34 °C - 43 °C (Claimed range, deemed "Similar" and "sufficient to measure the human body temperature") |
| Measurement Distance | 3-5 cm (Predicate) | 1-3 cm (Claimed distance, deemed "Different" but "does not affect performance") |
| Biocompatibility | Conformance to ISO 10993-1, -5, -10 (Predicate) | Conformance to ISO 10993-1, -5, -10 (Reported compliance through testing) |
| Electrical Safety | Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 (Predicate) | Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 (Reported compliance through testing) |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "ASTM 1965-98: Sample size, Patient population age, compared to reference thermometer, reference thermometer, designed per ASTM 1965-98: Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature."
- Sample Size: The exact sample size for the clinical accuracy validation is not explicitly stated in this summary, other than referring to compliance with ASTM 1965-98 criteria for sample size.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It implies a clinical study was conducted as part of the ASTM 1965-98 validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts, qualifications) is not applicable to the performance testing described for this device. The ground truth for temperature measurement, as per ASTM 1965-98, typically involves comparison to a highly accurate reference thermometer (e.g., a blackbody radiator or a calibrated clinical standard thermometer) and direct patient measurements. It does not involve expert consensus in the way AI/ML diagnostic studies do.
4. Adjudication Method for the Test Set
This is not applicable as the test involves direct measurement against a reference standard, not subjective interpretation requiring adjudication.
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 conducted and is not applicable to this device. This is a non-AI device for direct temperature measurement, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to AI algorithm performance. Not applicable as this is a non-AI device. The device's "standalone" performance is its direct measurement accuracy.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
For temperature measurement validation according to ASTM 1965-98, the ground truth is typically established by:
- Highly accurate reference thermometers: Used in controlled laboratory settings (e.g., blackbody radiator) to test the device's accuracy at different temperature points.
- Simultaneous measurements with a clinically accepted reference thermometer: On human subjects to compare the device's reading to a trusted standard.
The specific details are not provided in this summary but are inherent in the referenced standard.
8. The Sample Size for the Training Set
This question relates to AI/machine learning model training. Not applicable, as this is a non-AI device.
9. How the Ground Truth for the Training Set was Established
This question relates to AI/machine learning model training. Not applicable, as this is a non-AI device.
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September 12, 2022
Qingdao Yasee Medical Device Co., Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K220084
Trade/Device Name: Infrared Forehead Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: April 17, 2022 Received: May 23, 2022
Dear Prithul Bom:
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.
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) K220084
Device Name Infrared Forehead Thermometer
Indications for Use (Describe)
Infrared Forehead Thermometers (model2: JA-11S; model3: JA-11C) are non-sterile, reusable, noncontact and handheld devices. They can be used by consumers in homecare environment and doctors in clinic as reference. They are intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
| 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 summary of 510k safety and effectiveness information is being submitted in accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification
Qingdao Yasee Medical Device Co., Ltd. No.9 Xiuyuan Road, High-tech Industrial Development Zone, Qingdao City, 266112 Shandong Province, P.R. China Tel: +86 532 68012805 Submitter's FDA Registration Number: N/A
Contact Person
Name: Xiangqun Ye Company : JL Management and Consulting LLC Address: 755 Watershed Ct., Ann Arbor, MI 48105 USA Tel: +1.650.265.8159 Email: jlmcllc.info@gmail.com
Date of Summary: April 14, 2022
Device Name
| Trade name | Infrared Forehead Thermometers |
|---|---|
| Regulation Name | clinical electrical thermometer |
| Common Name | clinical electrical thermometer |
| Classification Name | Thermometer, Electronic, Clinical |
| Device Classification | II |
| Regulation Number | 21 CFR 880.2910 |
| Panel | General Hospital |
| General Product Code | FLL |
Predicate Device Information:
K193253, "Infrared Thermometer", manufactured by "Shenzhen Changkun (1) Technology Co., Ltd."
| Trade name | Infrared Thermometer, models: CK-T1501, CK-T1502, CK-T1503 |
|---|---|
| Common Name | clinical electrical thermometer |
| Classification Name | Thermometer, Electronic, Clinical |
| Device Classification | II |
| Regulation Number | 21 CFR 880.2910 |
| Panel | General Hospital |
| Product Code | FLL |
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Device Description:
Infrared Forehead Thermometers (model1: JA-11A; model2: JA-11S; model3: JA-11C) are hand-held, battery powered, Infrared Forehead Thermometers that covert a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead to an equivalent temperature when measuring from 1-3 cm of the subject's forehead with no contact.
It is composed of a probe, a display, two buttons (start button and power button), an enclosure and a battery cover.
It is used to measure human body temperature based on the relationship between temperature and measurable infrared radiation. Simply aim the unit's probe toward the surface to be measured to obtain a quick and accurate temperature.
When measuring body temperature, users need to measure in body mode from 1-3 cm from their forehead. Press the measuring key and then release it. The instrument will start measuring the target temperature. After about 1 second, the buzzer emits the corresponding alert sound, the measurement result is displayed on the LCD, and the backlight of the corresponding color is turned on. After about 3 seconds, the backlight is turned off, the unit symbol flashes, and the buzzer beeps shortly. Wait until the key is pressed to measure the temperature again. Start the thermometer without any operation, or no operation after temperature measurement, the thermometer will shut off and LCD go out with one short beep in 60 s ± 20 s.
It can store 32 sets of measurements. Press the 【M】button to cycle through them.
User contact components are the enclosure and keys. The materials of the components are ABS plastic.
The thermometer is for intermittent use.
Indications for Use:
Infrared Forehead Thermometers (model1:JA-11A; model2: JA-11S; model3: JA- 11C) are non-sterile, reusable, non-contact and handheld devices. They can be used by consumers in homecare environment and doctors in clinic as reference. They are intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
Testing Summary:
To prove the safety and effectiveness of Infrared Forehead Thermometers, we tested the device according to corresponding standards.
Infrared Forehead Thermometer conforms to the following standards:
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ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
IEC60601-1, Electrical safety
IEC 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance
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
Technological Comparison with Predicate Device
The following table shows similarities and differences between our device and the predicate devices.
| Description | Subject Device | Predicate Device (K193253) | Comparison |
|---|---|---|---|
| Indication ForUse | Infrared ForeheadThermometers (model1: JA-11A: model2: JA-11S: model3:JA-11C) are non-sterile,reusable, non-contact andhandheld devices. They can beused by consumers in homecareenvironment and doctors inclinic as reference. They areintended for measuring humanbody temperature of peopleover one month old bydetecting infrared heat from theforehead. | Infrared Thermometer (model:CK-T1501, CK-T1502, CK-T1503) is a non-sterile,reusable, non-contact andhandheld device. It can be usedby consumers in homecareenvironment and doctors inclinic as reference. It isintended for measuring humanbody temperature of peopleover one month old by detectinginfrared heat from the forehead. | Same |
| Product Code | FLL | FLL | Same |
| ClassificationName | Clinical ElectronicThermometer | Clinical ElectronicThermometer | Same |
| UseEnvironment | at home and hospital | at home and hospital | Same |
| Table 1: Comparison of Intended Use. Mechanism, and Design | ||||
|---|---|---|---|---|
| Patientpopulation | people over one month old | people over one month old | Same | |
| Contact/Non-Contact | Non-Contact | Non-Contact | Same | |
| Biocompatibility | ISO 10993-1ISO 10993-5ISO 10993-10 | ISO 10993-1ISO 10993-5ISO 10993-10 | Same | |
| Standardsconformance | IEC60601-1 IEC60601-1-2IEC60601-1-11ISO80601-2-56 | IEC60601-1 IEC60601-1-2IEC60601-1-11ISO80601-2-56 | Same | |
| Weight | 50 g | unknown | Different. The weightdoes not affect theperformance. | |
| Dimensions | 149X38.5X38.5 mm | unknown | Different. Thedimensions do notaffect the performance. | |
| Storageenvironment | -13 °F - 131 °F (-25 °C - 55 °C)with a relative humidity of up to85% (non-condensing) | -13 °F - 131 °F (-25°C - 55°C)with a relative humidity of up to85% (non-condensing) | Same | |
| OperationalEnvironment | 10 °C - 40 °C15 % - 90% RH | 10°C - 40 °C15 % - 90% RH | Same | |
| Display | LCD | LCD | Same | |
| MeasurementRange | 34 °C - 43 °C | 32 °C - 42.5 °C | Similar. Both rangesare sufficient tomeasure the humanbody temperature. | |
| C/F switchable | °C/°F Switchable | °C/°F Switchable | Same | |
| MeasurementAccuracy | 34.0 °C - 35.4 °C (93.2 °F -95.7 °F: ±0.3 °C/±0.5 °F)35.5 °C - 42.0 °C (95.0 °F -107.6 °F): ±0.2 °C/±0.4 °F42.1 °C - 43.0 °C (107.8 °F -109.4 °F): ±0.3 °C/±0.5 °F | 32 °C-34.9 °C: ± 0.3 °C (89.6°F - 94.8 °F: ±0.5 °F)35 °C-42 °C: ±0.2 °C/95.0°F-107.6 °F: ±0.4 °F42.1 °C-42.5 °C: ±0.3 °C/107.8°F-108.5 °F: ±0.5 °F | Different. In the rangeof 34.0 °C - 42.0 °C,the measurementaccuracy is the same(±0.2°C). | |
| Measurementdistance | 1-3 cm | 3-5 cm | Different.Measurement distancedoes not affectperformance. | |
| ThermometerType | Infrared Forehead Thermometer | Infrared Forehead Thermometer | Same | |
| Mechanism | Infrared radiation detection | Infrared radiation detection | Same | |
| Anatomy Site | Forehead | Forehead | Same | |
| User Control | Manual On/Off Switch | Manual On/Off Switch | Same | |
| Memory | 32 sets | 32 sets | Same | |
| Power Source | DC 3V (2 of AAA alkalinebatteries) | DC 3V (2 of AAA alkalinebatteries) | Same | |
| Material | ABS | ABS | Different due tounknownpolymerizationspecifications. It doesnot affect performance. | |
| Display | LCD | LCD | Same | |
| OTC/Prescription | OTC | OTC | Same |
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Our device is essentially identical to the predicate device in terms of indications for use, design, mechanism between subject device and the predicate device. The several minor differences do not affect the safety and effectiveness of the device.
Performance Testing
| Software | Software verification and validation per the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) for a Moderate Level of Concern |
|---|---|
| Electrical Safety | Electrical Safety testing per IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance |
| EMC | Electromagnetic Compatibility and Wireless testing was evaluated per the following: IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance |
| Medical Electrical Equipment-home health care environment | 60601-1-11 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance |
| Device performance | ASTM 80601-2-56 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement ASTM 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature |
| Reprocessing/Cleaning | Validation per the FDA Guidance for Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (March 17, 2015) confirmed cleaning and disinfection instruction provided in instructions for use |
| Biocompatibility | Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity |
Table 2: Standards Used for Testing
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| • | ISO 10993-10 Biological evaluation of medical devices — Part 10:Tests for skin sensitization |
|---|---|
| --- | -------------------------------------------------------------------------------------------------- |
Clinical Accuracy Validation
| ASTM 1965-98 | • Sample size, Patient population age, compared to referencethermometer, reference thermometer, designed per ASTM 1965-98:Standard Specification for Infrared Thermometers for IntermittentDetermination of Patient Temperature |
|---|---|
| -------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Substantial Equivalence Conclusion
Based on the comparison of intended use, design, biocompatibility, and performance, "Infrared Forehead Thermometer (model1: JA-11A; model2: JA-11S; model3: JA-11C)" manufactured by "Qingdao Yasee Medical Device Co., Ltd." is substantially equivalent to its predicate devices.
§ 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.