(156 days)
Not Found
No
The summary describes a standard infrared thermometer and does not mention any AI or ML components or capabilities.
No
The device is used for measuring body temperature, which is a diagnostic function, not a therapeutic one. It does not actively treat or alleviate a condition.
No
Explanation: The device is an infrared thermometer that measures body temperature and is intended for general temperature measurement, not for diagnosing specific diseases or conditions. While temperature can be an indicator, the device itself does not provide a diagnosis.
No
The device description explicitly states it is an "electronic thermometer" utilizing an "infrared sensor" to measure temperature, indicating it is a hardware device.
Based on the provided information, the Belter Infra-red Ear Thermometer is not an In Vitro Diagnostic (IVD) device.
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 for diagnosis, monitoring, or screening.
- Device Function: The Belter Infra-red Ear Thermometer measures body temperature directly from the ear canal using infrared technology. It does not analyze a specimen taken from the body.
- Intended Use: The intended use is to detect human body temperature, which is a direct physiological measurement, not an analysis of a biological sample.
Therefore, this device falls under the category of a medical device but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Belter Infra-red Ear thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Belter Infra-red Ear Thermometer is characterized by measuring human body temperature from the ear canal. It utilizes infrared technology to measure infrared energy emitted from eardrum tissue when making a temperature measurement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear canal
Indicated Patient Age Range
all ages
Intended User / Care Setting
home and professional use
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The bench test report of this submission shows the laboratory accuracy is 0.01~0.19℃, which is not greater than 0.2 ℃, and the clinical repeatability is 0.07 ~ 0.11℃,which is less than 0.3℃,so the accuracy of the device ,both bench and clinical, meets the requirements of ISO80601-2-56. About the structural integrity of device item, the device has be done shock tests and broad-band random vibration test ,the result in bench test of this submission showed the device meets the requirement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Laboratory accuracy: 0.010.19°C; Clinical repeatability: 0.070.11°C
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an image of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2014
Shenzhen Belter Health Measurement and Analysis Technology Company, Limited Pang Ming RA Manager 702, 704, Block C, Tsinghua Unis Science Park, Langshan Rd, Hi-Tech Industrial Park (north), Nanshan District, Shenzhen, Gangdong CHINA 518057
Re: K140681 Trade/Device Name: Belter Infra-red Ear Thermometer, Models TE-66, TE-68, TE-79, TE-90, and TE-91 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Product Code: FLL Regulatory Class: II Dated: July 15, 2014 Received: July 21, 2014
Dear Mr. Ming:
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. 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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Page 2 - Mr. Ming
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K140681
Device Name Belter Infra-red Ear Thermometer Model: TE-66,TE-68, TE-79, TE-90, TE-91
Indications for Use (Describe)
The Belter Infra-red Ear thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5
510 (K) Summary
Date: 2014,1,15 Submitter Information
Name : Shenzhen Belter Health Measurement and Analysis Technology Co.,Itd Address: 702、704,block C ,Tsinghua Unis science park,No.13 Langshan Rd,Hi-Tech Industrial park(north),Nanshan District,518057 shenzhen. People's Republic of China Tel: +86-755-61869839 Fax: +86-755-61869122 Contact person: pang minq E-mail: panqm@ebelter.com
Name of device
Trade name: Belter Infra-red Ear Thermometer Model: TE-66,TE-68, TE-79, TE-90, TE-91 Common name: Belter Infra-red Ear Thermometer Classification name: Thermometer, Electronic, Clinical Production regulation: 21 CFR 880.2910 Product code: FLL
Predicate Device
Infrared Ear Thermometer THP Series (Radiant Innovation Inc,FLL,K111637)
Description
The Belter Infra-red Ear Thermometer is characterized by measuring human body temperature from the ear canal. It utilizes infrared technology to measure infrared energy emitted from eardrum tissue when making a temperature measurement.
Intended use
The Belter Infra-red Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use.
Summary of technological characteristics of device compared to the predicate devices (K111637), see the table1
| Table 1 | |||
|---|---|---|---|
| SE | Subject device | Predicate device | comment |
| Comparisons | Present application | K111637 | nt |
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| Intended Use&
Indication for use | The Belter Infra-red Ear
Thermometer is an
electronic thermometer
using an infrared sensor
to detect human body
temperature from the
ear canal on people of
all ages for home and
professional use. | The device is an electronic clinical
thermometer using an infrared
sensor to detect body
temperature from the auditory
canal in the neonatal, pediatric
and adult population used in the
home setting. | Similar |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Measurement
Range | 32.0 °C -42.2℃ (89.6 °F
-108.0°F) | 34.0°C ~42.2°C
(93.2°F ~108.0°F) | Similar |
| Accuracy | ±0.2℃ (36℃≤t