(373 days)
No
The document describes a standard infrared thermometer using a thermopile sensor and thermistor, with no mention of AI or ML algorithms for temperature determination or other functions.
No
The device is described as a clinical thermometer for determining human body temperature, not for treating any condition or disease.
No.
This device is a thermometer used to determine human body temperature, which is a measurement device, not a diagnostic device. A diagnostic device typically identifies or characterizes a disease or condition.
No
The device description explicitly lists hardware components such as a measuring sensor, buttons, battery compartment, buzzer, LCD, and ABS plastic enclosure, indicating it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: This device is an infrared thermometer that measures body temperature by sensing infrared energy emitted from the forehead. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is for the determination of human body temperature, which is a direct measurement of a physiological parameter, not an analysis of a sample.
Therefore, based on the provided information, the Infrared Forehead Thermometer is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Infrared Forehead Thermometer (Models: HA-610, HA-620, HA-630, HA-640, HA-650) is a non-sterile, reusable, clinical thermometer intent determination of human body temperature in a touch and no touch mode using the center of the forehead as the measurement site on people of all ages. The devices are reusable for home use only.
Product codes
FLL
Device Description
The Infrared Forehead Thermometer (Models: HA-610, HA-630, HA-640, HA-640, HA-650) is a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted from the area around the user's forehead, to an oral equivalent temperature when placed within 1-5 cm to the subject's forehead with no contact. It uses a thermopile sensor with integrated thermistor for ambient temperature readings.
It composed by a measuring sensor, set button, a start button, battery compartment, Buzzer, a LCD and a ABS plastic enclosure, and measuring without probe cover.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
center of the forehead
Indicated Patient Age Range
all ages
Intended User / Care Setting
home use only.
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 tests were conducted on the Model HA-610. The clinical tests evaluated 240 of subjects. and the thermometer was evaluated in four groups A1 - 0 up to three months to one year; B1 older than one years and younger than five years; and C - older than five years old. The clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO80601-2-56. The test report showed the clinical performance of the subject devices complied with the requirement of ISO 80601-2-56.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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.
April 22, 2020
Xiamen Ants Bro Technology Co., Ltd. % Cassie Lee Official Correspondent Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, Guangdong 510000 China
Re: K190984
Trade/Device Name: Infrared Forehead Thermometer (Models: HA-610, HA-620, HA-640, HA-650) Regulation Number: 21 CFR 880.2910
Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: March 17, 2020 Received: March 24, 2020
Dear Cassie Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Tina Kiang, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors OHT3: Office of Gastrorenal, OB/GYN, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190984
Device Name
Infrared Forehead Thermometer (Models: HA-610, HA-620, HA-630, HA-640, HA-650)
Indications for Use (Describe)
Infrared Forehead Thermometer (Models: HA-610, HA-620, HA-630, HA-640, HA-650)
is a non-sterile, reusable, clinical thermometer intent determination of human body temperature in a touch and no touch mode using the center of the forehead as the measurement site on people of all ages. The devices are reusable for home use only.
| 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
K190984
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: Xiamen Ants Bro Technology Co., Ltd. Establishment Registration Number: Applying Address: 4th and 5th floor, No. 5 Building, Tech.&Innovation center, No. 289 Wengjiao Road, Haicang District, Xiamen China Tel: +86-134-5902-0349 Fax: +86-0592-6537633 Contact Person: Jane Xu Email: Sales1@asxd.com.cn
Date: April 22, 2020
Application Correspondent:
Contact Person: Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
2. Subject Device Information
Trade Name: Infrared Forehead Thermometer (Models: HA-610, HA-620, HA-630, HA-640, Common Name: Clinical electronic thermometeHA-650) Classification name: Thermometer, electronic, clinical Review Panel: General Hospital Product Code: FLL Regulation Class: II Regulation Number: 21 CFR 880.2910
3. Predicate Device Information
Sponsor: Kaz USA, Inc., a Helen of Troy Company Trade Name: Braun BNT400 No Touch + Forehead Thermometer Common Name: Clinical electronic thermometer Classification Name: Thermometer, Electronic, Clinical 510(K) Number: K181242 Review Panel: General Hospital Product Code: FLL Regulation Number: 880.2910 Regulation Class: II
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4. Device Description
The Infrared Forehead Thermometer (Models: HA-610, HA-630, HA-640, HA-640, HA-650) is a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted from the area around the user's forehead, to an oral equivalent temperature when placed within 1-5 cm to the subject's forehead with no contact. It uses a thermopile sensor with integrated thermistor for ambient temperature readings.
It composed by a measuring sensor, set button, a start button, battery compartment, Buzzer, a LCD and a ABS plastic enclosure, and measuring without probe cover.
5. Intended Use / Indications for Use
Infrared Forehead Thermometer (Models: HA-610, HA-620, HA-630, HA-640, HA-650) is non-sterile, reusable, clinical thermometer intended for the intermination of human body temperature in a no touch mode using the center of the forehead as the measurement site on people of all ages. The devices are reusable for home use only.
6. Test Summary
6.1 Infrared Forehead Thermometer has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and ISO 80601-2-56 standards �
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- � 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
- ◆ Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement according to ASTM E1965-98 (2016): Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
6.2 Discussion of Clinical Tests Performed
Clinical tests were conducted on the Model HA-610. The clinical tests evaluated 240 of subjects. and the thermometer was evaluated in four groups A1 - 0 up to three months to one year; B1 older than one years and younger than five years; and C - older than five years old. The clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO80601-2-56. The test report showed the clinical performance of the subject devices complied with the requirement of ISO 80601-2-56.
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Infrared Forehead Thermometer is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device 1 | Remark |
|---|---|---|---|
| Company | Xiamen Ants Bro | Kaz USA, Inc., a Helen of | -- |
| Elements of | |||
| Comparison | Subject Device | Predicate Device 1 | Remark |
| Technology Co., Ltd. | Troy Company | ||
| Device Name and | |||
| Model | Infrared Forehead | ||
| Thermometer (Models: HA- | |||
| 610, HA-620, HA-630, HA- | |||
| 640, HA-650) | Braun BNT400 No Touch + | ||
| Forehead Thermometer | -- | ||
| 510(k) Number | Applying | K181242 | -- |
| Product Code | FLL | FLL | SE |
| Thermometer Type | Infrared Forehead | ||
| Thermometer | Infrared Forehead | ||
| Thermometer | SE | ||
| Intended Use & | |||
| Indications for Use | Infrared Forehead | ||
| Thermometer (Models: HA- | |||
| 610, HA-620, HA-630, HA- | |||
| 640, HA-650) | |||
| is non-sterile, reusable, | |||
| clinical thermometer | |||
| intended for the intermittent | |||
| determination of human | |||
| body temperature in a no | |||
| touch mode using the | |||
| center of the forehead as | |||
| the measurement site on | |||
| people of all ages. The | |||
| devices are reusable for | |||
| home use only. | The Braun BNT400 No | ||
| Touch + Forehead | |||
| Thermometer is non-sterile, | |||
| reusable, clinical | |||
| thermometer intended for | |||
| the intermittent | |||
| determination of human | |||
| body temperature in a touch | |||
| and no touch mode using | |||
| the center of the forehead | |||
| as the measurement site on | |||
| people of all ages. | SE | ||
| Difference | |||
| in name | |||
| and | |||
| included | |||
| home | |||
| use. | |||
| Measurement | |||
| method | Infrared radiation detection | Infrared radiation detection | SE |
| Measurement | |||
| mode | Forehead measure mode | Forehead measure mode | SE |
| Features | High Temperature Alarm | ||
| feature and memory | |||
| feature | Fever Insight temperature | ||
| guidance feature and | |||
| memory feature | SE | ||
| Note 2 | |||
| Measuring | |||
| range | 34.0 - 43.0°C (93.2 – | ||
| 109.4°F) | 34.0 - 43.0°C (93.2 – | ||
| 109.4°F) | SE | ||
| Measurement | |||
| Accuracy (Body) | $\pm$ 0.2°C (35.0~42.0°C) / $\pm$ | ||
| 0.4°F (95.0~107.6°F) | |||
| $\pm$ 0.3°C (34.0~34.9°C) | |||
| (42.1~43.0°C) | $\pm$ 0.2°C (35.0~42.0°C) / $\pm$ | ||
| 0.4°F (95.0~107.6°F) | |||
| $\pm$ 0.3°C (34.0~34.9°C) | |||
| (42.1~43.0°C) | SE | ||
| Display Resolution | 0.1 °C/°F | 0.1 °C/°F | SE |
| C/F switchable | Yes | Yes | SE |
| Display | LCD display | LCD display | SE |
| Elements of | |||
| Comparison | Subject Device | Predicate Device 1 | Remark |
| Battery type | 1.5V AAA x 2 | 1.5V AAA x 2 | SE |
| Low battery | |||
| indication | Yes | Yes | SE |
| Materials | ABS | User contacting materials | |
| include ABS (device | |||
| housing / handle, power | |||
| button), TPR (temperature | |||
| button & forehead touch | |||
| bumper), & PMMA (LCD | |||
| lens & protective scanner | |||
| cap). | SE | ||
| Note 3 | |||
| Measurement | |||
| distance | 1-5 cm | 0-2.5cm | Note 4 |
| Operating condition | Temperature: 10 - 40°C | ||
| (50.0 - 104.0°F) | |||
| Humidity: ≤ 85%RH | Temperature: 15 - 40°C (59 |
- 104.0°F)
Humidity: 15 ~ 95%RH | SE
Note 1 |
| Biocompatibility | ISO 10993 | ISO 10993 | SE |
| Electric Safety and
EMC | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-1-11 | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-1-11 | SE |
| Performance | ISO 80601-2-56 | ISO 80601-2-56 | SE |
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Comparison in Detail(s):
Note 1:
The "Operating condition" of subject device is a little different from the predicate devices, but all of them are meet the safety standards IEC 60601-1 and IEC 60601-1-11, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
Note 2:
Although the "High Temperature Alarm feature" of subject device is a little different from the predicate devices, but both measuring temperature of subject device and predicate device are for indicate only diagnosis should be made by a professional physician, so this difference will not cause safety and effectiveness issues.
Note 3:
The subject medical device in its final finished form is identical to Digital Thermometer (K190990) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g. plasticizers, fillers, additives, cleaning agents, mold release agents).
Note 4:
Although the "Measurement distance" of subject device is a little different from the predicate devices, but both of subject device and predicate device are meet the clinical accuracy requirements of the standards ISO 80601-2-56, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
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Finial Conclusion:
The subject device Infrared Forehead Thermometer (Models: HA-610, HA-630, HA-640, HA-650) have all features of the predicate devices K181242. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate devices.