(151 days)
Not Found
No
The description mentions "intelligent analyze and treat the analog signals" but does not provide any details or keywords typically associated with AI/ML, such as neural networks, deep learning, training data, or specific algorithms. The device description focuses on standard electronic components and infrared sensor technology.
No
The device is described as a non-contact thermometer used to measure forehead temperature, not to treat any condition.
No
The device is a non-contact thermometer used to measure forehead temperature. While temperature can be a diagnostic indicator, the device itself only measures a physiological parameter and does not interpret the measurement to provide a diagnosis of a disease or condition. It is a measurement tool, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including a thermopile sensor, integrated circuits, LCD, buttons, and batteries.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Infrared Forehead Thermometer measures the infrared energy radiated from the forehead to determine body temperature. This is a direct measurement of a physical parameter of the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to measure forehead temperature, which is a vital sign and not a diagnostic test performed on a sample.
Therefore, based on the provided information, the Infrared Forehead Thermometer is a medical device, but it falls under the category of a non-invasive thermometer rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Infrared Forehead Thermometer (Model: T80、T81、T82、T83、T84、T85) is a non-contact thermometer used to measurement forehead temperature at home or hospital. The device is indicated for use on people of all ages except for neonates/newborns.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Infrared Forehead Thermometer (Model: T80、T81、T84、T84、T85) is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value.
The Infrared Forehead Thermometer (Model: T80、T81、T84、T84、T85),consists of the following parts:
a) Thermopile Sensor
b) Application-Specific Integrated Circuitry
c) Erasable Programmable Read-Only Memory Integrated Circuit
d) Capacitance-touch Integrated Circuit
e) LCD and Backlight
f) 4 buttons (Setting button, Memory button, ON/OFF button, Measurement Trigger)
g) 2×1.5V AA dry batteries
The operation principle is based on Infrared Sensor technology. The sensor can turn body's temperature to analog signals, and a MCU with an AD can get the result by intelligent analyze and treat the analog signals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared Sensor
Anatomical Site
Forehead
Indicated Patient Age Range
all ages except for neonates/newborns.
Intended User / Care Setting
Home or hospital
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
Clinical tests were conducted on Model: T80、T81、T82、T85、The study excluded subjects with medical conditions such as inflammation at the measuring sites and subjects using medications known to affect body temperature. The clinical tests evaluated 150 subjects which were divided into three group age ranges-Infants (less than 1 year), children (1 to 5 years old)and adult (greater than 5 years old). No less than 50 subjects in each group and 30% of them got temperature equaling or exceeding 37.5℃.
The clinical accuracy of the proposed device was evaluated by ISO 80601-2-56 - clinical bias with stated uncertainty and clinical repeatability.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The clinical test results showed that the accuracy of the proposed device is within acceptable scope specified in ISO 81061-2-56.
Based on the result, the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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June 4, 2021
Guandong Genial Technology CO., LIMITED % Jet Li Regulation Manager Guangzhou KINDA Biology Technology Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, Guangdong China
Re: K210014
Trade/Device Name: Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: April 19, 2021 Received: May 4, 2021
Dear Jet Li:
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.
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
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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 (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 (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 Acting 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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Indications for Use
510(k) Number (if known) K210014
Device Name
Infrared Forehead Thermometer (Model: T80、T81、T82、T83、T84、T85)
Indications for Use (Describe)
The Infrared Forehead Thermometer (Model: T80、T81、T82、T83、T84、T85) is a non-contact thermometer used to measurement forehead temperature at home or hospital. The device is indicated for use on people of all ages except for neonates/newborns.
| 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 K210014
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter Information 1.
Sponsor Company Name: GUANGDONG GENIAL TECHNOLOGY CO., LIMITED.
Establishment Registration Number: Applying
- � Address: 1-6-05-02, 11th Road, Area B, Guangfozhao Economic Cooperation Zone, Zhagang Town, Huaiji County, Zhaoging City, Guangdong, 526437, China
- Phone: +86-020-37236838 �
Fax: +86-020-37236838
- Contact Person (including title): Jun Yu (General Manager) �
- E-mail: admin@genial.cn �
Application Correspondent: Guangzhou KINDA Biology Technology Co., Ltd.
- Address: 6F, No.1 TianTairoad, Science City, LuoGangDistrict, GuangZhouCity, China �
- Contact Person: Mr. JetLi �
- � Tile: Regulation Manager
- � Tel: +86-18588874857
- Email: med-jl@foxmail.com �
3 Subject Device Information:
- � Type of 510(k) submission: Traditional
- � Common Name: Infrared Forehead Thermometer
- � Trade Name: Infrared Forehead Thermometer(Model: T80、T81、T82、T83、T84、T85)
- � Classification Name: Clinical Electronic Thermometer
- � Review Panel: General Hospital
- � Product Code: FLL
- � Regulation Number: 21 CFR880.2910
- � Regulation Class: 2
4 Predicate Device Information:
- Sponsor: Dongguan SIMZO Electronic TechnologyCo.Ltd. �
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- � Trade Name: Non-contact Forehead Thermometer
- � 510(k) number: K173048
- � Review Panel: General Hospital
- � Product Code: FLL
- � Regulation Number: 21 CFR880.2910
- � RequlationClass: 2
2. Device Description
The Infrared Forehead Thermometer (Model: T80、T81、T84、T84、T85) is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value.
The Infrared Forehead Thermometer (Model: T80、T81、T84、T85),consists of the following parts:
- a) Thermopile Sensor
- b) Application-Specific Integrated Circuitry
- c) Erasable Programmable Read-Only Memory Integrated Circuit
- d) Capacitance-touch Integrated Circuit
- e) LCD and Backlight
- f) 4 buttons (Setting button, Memory button, ON/OFF button, Measurement Trigger)
- g) 2×1.5V AA dry batteries
The operation principle is based on Infrared Sensor technology. The sensor can turn body's temperature to analog signals, and a MCU with an AD can get the result by intelligent analyze and treat the analog signals.
3. Intended Use
The Infrared Forehead Thermometer (Model: T80、T81、T82、T83、T84、T85) is a non-contact thermometer used to measurement forehead temperature at home or hospital. The device is indicated for use on people of all ages except for neonates/newborns.
4. Test Summary
Infrared Forehead Thermometer conforms to applicable standards that include:
- � ASTM E 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
- � IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements 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
- � IEC 62304:2006+AMD1:2015 Medical Device Software -Software Life Cycle Processes
- � IEC60601-1-11:2015 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
- � ISO 80601-2-56:2017/AMD 1:2018 Medical electrical equipment - part 2-56: particular requirements f or basic safety and essential performance of clinical thermometers for body temperature measurement
- � ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity,
- � ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
5. Comparison to Predicate Device
Compare with predicate device, the subject device is very similar in design principle, intended use, sensor, measurement mode, measuring range, accuracy and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Manufacturer | GUANGDONG GENIAL | ||
| TECHNOLOGY CO., LIMITED. | Dongguan SIMZO Electronic | ||
| Technology Co.Ltd. | -- | ||
| 510 (k) Number | K210014 | K173048 | -- |
| Product Name | Infrared Forehead Thermometer | Non-contact Forehead | |
| Thermometer | -- | ||
| Models | Model: T80、T81、T82、T83、 | ||
| T84、T85 | HW-2/HW-2S/HW-3/HW-4 /HW- | ||
| 4S/HW-302/HW-303 | -- | ||
| Intended Use | The Infrared Forehead | ||
| Thermometer (Model: T80、T81、 | |||
| T82、T83、T84、T85) is a non- | |||
| contact thermometer used to | |||
| measurement forehead temperature | |||
| at home or hospital. The device is | |||
| indicated for use on people of all | |||
| ages except for neonates/newborns | The Non-contact Forehead | ||
| Thermometer is an infrared | |||
| thermometer intended for the | |||
| intermittent measurement of human | |||
| body temperature in people of all | |||
| ages. | Note 1 | ||
| Sensor | Infrared Sensor | Infrared Sensor | SE |
| Measurement | |||
| Mode | Forehead measurement Mode | Forehead measurement Mode | SE |
| Measurement | |||
| type | Non-contact type | Non-contact type | SE |
| Measurement | |||
| method | Infrared radiation detection | Infrared radiation detection | SE |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| Measurement | |||
| time |