(434 days)
No
The description details standard infrared thermometry components and processes, with no mention of AI or ML algorithms for temperature calculation or interpretation.
No.
The device is intended for the measurement of human body temperature, which is a diagnostic function, not a therapeutic one.
No
Explanation: The device is described as an infrared thermometer intended for "intermittent measurement of human body temperature." It measures temperature but is not described as diagnosing a disease or condition. While temperature is a diagnostic indicator, the device itself simply provides a measurement, not a diagnosis.
No
The device description explicitly details hardware components such as a thermopile sensor, thermistor, parabolic mirror, and infrared distance sensor, 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:
- Intended Use: The intended use is the "intermittent measurement of human body temperature". This is a direct measurement of a physiological parameter within the body, not an examination of specimens derived from the human body.
- Device Description: The device measures infrared energy emitted from the forehead to determine body temperature. This is a non-invasive, external measurement.
- Lack of Specimen Analysis: IVD devices are designed to examine specimens such as blood, urine, tissue, etc., to provide information about a person's health. This device does not involve the collection or analysis of any such specimens.
Therefore, the Non-contact Forehead Thermometer described is a medical device, but it falls under the category of a clinical thermometer rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Non-contact Forehead Thermometer is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
Product codes
FLL
Device Description
The Non-contact Forehead Thermometers are hand-held, battery powered devices designed to measure human body temperature. The subject devices are Infrared thermometers that convert a user's forehead temperature using the infrared energy emitted in the area around the user's forehead to an oral equivalent temperature when placed in the distance from subject's forehead up to 5-8cm(HW-2,HW-2S,HW-3,HW-302 and HW-303) or 1-2cm(HW-4 and HW-4S).
The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared distance sensor for detection with the distance from forehead up to 5~8cm(HW-2,HW-2S,HW-3,HW-302 and HW-303) or 1-2cm(HW-4 and HW-4S) and compensation of the temperature reading.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
all ages
Intended User / Care Setting
Not Found
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
Clinical tests were conducted on HW-2,HW-2S,HW-3,HW-4,HW-4S,HW-302 and HW-303. The clinical tests evaluated 96 subjects which were divided into three group age ranges-infant (new born to 1 year), children (greater than 1 to 5 years old) and adult(greater than5 years old). Each group has 32 patients and 30% of them got temperature equaling or exceeding 38.0℃.
Based on the result, the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).
Key Metrics
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
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December 6, 2018
Dongguan SIMZO Electronic Technology Co. Ltd. Mei Tan OA Manager No.81, Tianxin Street, Chongkong, Shijie Town Dongguan, Guangdong, China
Re: K173048
Trade/Device Name: Non-contact Forehead Thermometer, Model: HW-2/HW-2S/HW-3/HW-4 /HW-4S/HW-302/HW-303 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: October 22, 2018 Received: October 25, 2018
Dear Mei Tan:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173048
Device Name
Non-contact Forehead Thermometer, Model: HW-2/HW-2S/HW-3/HW-4/HW-4S/HW-302/HW-303
Indications for Use (Describe)
The Non-contact Forehead Thermometer is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
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
K173048
Prepared Date: 2018/12/4 Submitter Information
Name : Dongquan SIMZO Electronic Technology Co.Ltd. Address: No.81,Tianxin Street,Chongkong,Shijie Town,Dongguan,Guangdong,China Tel.+0086-769-86339010 Fax.+0086-769-86387762 Contact person: Mei Tan E-mail: Mei_FDA@foxmail.com
Subject Device Information
Trade name: Non-contact Forehead Thermometer Model: HW-2/HW-2S/HW-3/HW-4 /HW-4S/HW-302/HW-303 Common name: Non-contact Clinical Thermometer Classification name: Clinical electronic thermometer Production requlation: 21 CFR 880.2910 Product code: FLL
Predicate Device
Non-contact Clinical Thermometer, Model THB0F. (Radiant Innovation Inc,K121428)
Description
The Non-contact Forehead Thermometers are hand-held, battery powered devices designed to measure human body temperature. The subject devices are Infrared thermometers that convert a user's forehead temperature using the infrared energy emitted in the area around the user's forehead to an oral equivalent temperature when placed in the distance from subject's forehead up to 5-8cm(HW-2,HW-2S,HW-3,HW-302 and HW-303) or 1-2cm(HW-4 and HW-4S).
The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared distance sensor for detection with the distance from forehead up to 5~8cm(HW-2,HW-2S,HW-3,HW-302 and HW-303) or 1-2cm(HW-4 and HW-4S) and compensation of the temperature reading.
4
Indications for Use
The Non-contact Forehead Thermometer is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
Summary of technological characteristics of device compared to the predicate devices (K121428), see the table1
A comparison of key technological characteristics between the subject devices and predicate device was listed as below:
| Subject device(SD) | Predicate device(PD) | Note | |
|---|---|---|---|
| SIMZO HW series | Rdiant THB0F | ||
| 510K number | K173048 | K121428 | -- |
| Intended Use& | |||
| Indication for | |||
| use | The Non-contact Forehead | ||
| Thermometer is an infrared | |||
| thermometer intended for the | |||
| intermittent measurement of | |||
| human body temperature in | |||
| people of all ages. | The Non-contact Clinical | ||
| Thermometer, Model | |||
| THBOF is an infrared | |||
| thermometer intended for | |||
| the intermittent | |||
| measurement of human | |||
| body temperature in | |||
| people of all ages. | Same | ||
| Measurement | |||
| Method | Infrared radiation detection | Infrared radiation | |
| detection | Same | ||
| Measurement | |||
| Range | Forehead mode: | ||
| 35.5°C ~42.9°C | |||
| (95.9°F~109.2°F) | Forehead mode: | ||
| 34.0°C ~42.2°C | |||
| (93.2°F ~108.0°F) | Similar | ||
| Accuracy | Forehead mode: | ||
| ±0.2°C (0.4°F) within | |||
| 35.5°C~42.9°C | |||
| (95.9°F ~109.2°F), | |||
| ±0.3°C(0.5°F) other range | Forehead mode: | ||
| ±0.2°C (0.4°F) within | |||
| 36 | |||
| ±0.3°C(0.5°F) other | |||
| range | Similar | ||
| Display | 0.1°C(0.1°F) | 0.1°C(0.1°F) | Same |
| Measurement | |||
| distance | HW-2/HW-2S/HW-3/HW-302/ | ||
| HW-303:5-8cm | |||
| HW-4/HW-4S:1-2cm | 2-3cm | Similar | |
| Measurement | |||
| place | Forehead | Forehead | same |
| Response time | 1S | 1S | same |
Table 1
5
DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO.,LTD.
| Sensor type | Thermopile | Thermopile | Same |
|---|---|---|---|
| Fever alarm | Yes | Yes | Same |
| Scale selection | °C / °F | °C/°F | same |
| Display screen | LCD | LCD | same |
| Memory | HW-2/2S:32 sets | ||
| HW-3/4/4S: 1 set | |||
| HW-302/303:64 Sets | 60sets | Similar | |
| Fever alarm | Yes | Yes | same |
| Buzzer | Yes | Yes | same |
| Auto power-off | |||
| while no | |||
| operation | Yes | Yes | Same |
| Power supply | 2 x AAA | 2 x AAA | Same |
| Operation | 10~40°C(50°F ~104 °F) | 10~40°C(50°F ~104 °F) | Same |
| Environment | RH |