(245 days)
Not Found
No
The description details a standard infrared thermometer that measures temperature based on infrared radiation. There is no mention of AI, ML, or any complex algorithms beyond basic signal processing and temperature conversion. The device stores measurements but doesn't appear to use this data for learning or prediction.
No
The device is described as an Infrared Forehead Thermometer used for measuring human body temperature, not for treating any condition.
No
Explanation: The device is described as an "Infrared Forehead Thermometer" used for "measuring human body temperature." While temperature can be an indicator of health, the text explicitly states it's for "reference" and does not indicate it diagnoses any disease or condition. Diagnostic devices are typically used to identify the presence or nature of a disease or medical condition.
No
The device description explicitly lists hardware components such as a probe, display, buttons, enclosure, and battery cover, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device measures human body temperature by detecting infrared heat emitted from the forehead. It does not analyze any biological specimens.
The intended use and device description clearly indicate that it is a non-contact thermometer for measuring body temperature, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
people over one month old
Intended User / Care Setting
consumers in homecare environment and doctors in clinic
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Accuracy Validation:
- ASTM 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature was used.
- Sample size, Patient population age, compared to reference thermometer, reference thermometer, designed per ASTM 1965-98.
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 contains the logo of the U.S. Food & 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.
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.
1
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
2
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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3
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 |
4
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:
5
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 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. | Infrared Thermometer (model: | ||
| CK-T1501, CK-T1502, CK- | |||
| T1503) is a non-sterile, | |||
| reusable, non-contact and | |||
| handheld device. It can be used | |||
| by consumers in homecare | |||
| environment and doctors in | |||
| clinic as reference. It is | |||
| intended for measuring human | |||
| body temperature of people | |||
| over one month old by detecting | |||
| infrared heat from the forehead. | Same | ||
| Product Code | FLL | FLL | Same |
| Classification | |||
| Name | Clinical Electronic | ||
| Thermometer | Clinical Electronic | ||
| Thermometer | Same | ||
| Use | |||
| Environment | at home and hospital | at home and hospital | Same |
| Table 1: Comparison of Intended Use. Mechanism, and Design | ||||
|---|---|---|---|---|
| Patient | ||||
| population | people over one month old | people over one month old | Same | |
| Contact/Non- | ||||
| Contact | Non-Contact | Non-Contact | Same | |
| Biocompatibility | ISO 10993-1 | |||
| ISO 10993-5 | ||||
| ISO 10993-10 | ISO 10993-1 | |||
| ISO 10993-5 | ||||
| ISO 10993-10 | Same | |||
| Standards | ||||
| conformance | IEC60601-1 IEC60601-1-2 | |||
| IEC60601-1-11 | ||||
| ISO80601-2-56 | IEC60601-1 IEC60601-1-2 | |||
| IEC60601-1-11 | ||||
| ISO80601-2-56 | Same | |||
| Weight | 50 g | unknown | Different. The weight | |
| does not affect the | ||||
| performance. | ||||
| Dimensions | 149X38.5X38.5 mm | unknown | Different. The | |
| dimensions do not | ||||
| affect the performance. | ||||
| Storage | ||||
| environment | -13 °F - 131 °F (-25 °C - 55 °C) | |||
| with a relative humidity of up to | ||||
| 85% (non-condensing) | -13 °F - 131 °F (-25°C - 55°C) | |||
| with a relative humidity of up to | ||||
| 85% (non-condensing) | Same | |||
| Operational | ||||
| Environment | 10 °C - 40 °C | |||
| 15 % - 90% RH | 10°C - 40 °C | |||
| 15 % - 90% RH | Same | |||
| Display | LCD | LCD | Same | |
| Measurement | ||||
| Range | 34 °C - 43 °C | 32 °C - 42.5 °C | Similar. Both ranges | |
| are sufficient to | ||||
| measure the human | ||||
| body temperature. | ||||
| C/F switchable | °C/°F Switchable | °C/°F Switchable | Same | |
| Measurement | ||||
| Accuracy | 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 °F | ||||
| 42.1 °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 °F | ||||
| 42.1 °C-42.5 °C: ±0.3 °C/107.8 | ||||
| °F-108.5 °F: ±0.5 °F | Different. In the range | |||
| of 34.0 °C - 42.0 °C, | ||||
| the measurement | ||||
| accuracy is the same | ||||
| (±0.2°C). | ||||
| Measurement | ||||
| distance | 1-3 cm | 3-5 cm | Different. | |
| Measurement distance | ||||
| does not affect | ||||
| performance. | ||||
| Thermometer | ||||
| Type | 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 alkaline | |||
| batteries) | DC 3V (2 of AAA alkaline | |||
| batteries) | Same | |||
| Material | ABS | ABS | Different due to | |
| unknown | ||||
| polymerization | ||||
| specifications. It does | ||||
| not affect performance. | ||||
| Display | LCD | LCD | Same | |
| OTC/Prescription | OTC | OTC | Same |
6
7
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
8
| • | 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 reference
thermometer, reference thermometer, designed per ASTM 1965-98:
Standard Specification for Infrared Thermometers for Intermittent
Determination 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.