(332 days)
Not Found
No
The description details a standard infrared thermometer operation based on direct measurement and calculation, with no mention of AI/ML terms or processes.
No
The device is used to measure body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No
The device measures body temperature, which is a physiological parameter, but it does not diagnose a disease or condition. Its intended use is for detecting body temperature, not for identifying a specific medical condition.
No
The device description explicitly details hardware components like an infrared sensor (thermopile), circuitry for amplification and calculation, and an LCD display, 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 tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to monitor a person's overall health, to help diagnose a medical condition, or to monitor a medical condition.
- Device Function: The Infrared Ear Thermometer, Model: HTD8208C, measures body temperature directly from the auditory canal using infrared radiation. It does not analyze a sample taken from the body.
Therefore, based on the provided information, this device falls under the category of a clinical thermometer, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Infrared Ear Thermometer, Model: HTD8208C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in people of all ages for home setting use.
Product codes
FLL
Device Description
Infrared Ear Thermometer, model: HTD8208C, is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. The principle of operation is based on measuring the natural thermal radiation emanating from the tympanic membrane when the thermometer is inserted in the ear canal.
The Infrared Ear Thermometer measures temperature by reading infrared radiation emitting from the eardrum tissue when the thermometer is inserted into the ear canal. Pressing the measuring button to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will display on the device's LCD. The total operation takes less than 5 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared
Anatomical Site
auditory canal, eardrum tissue
Indicated Patient Age Range
people of all ages
Intended User / Care Setting
home setting 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The clinical investigation report and data analysis followed the requirements of the ASTM E 1965-98 and ISO 80601-2-56.
The clinical tests evaluated 140 of subjects. Each model was evaluated in each of the following age groups: 0 up to 3 months, 3 months up to one year, older than 1 year and younger than 5 years, and older than 5 years. The clinical performance test protocol and data analysis was conducted as the requirement of ASTM E1965-98 (2009). The test report demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2009).
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 10, 2019
HeTaiDa Technology Co., Ltd. % Yijie You Manager Qimmiq Medical Consulting Service Co., Ltd. RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone Guangzhou. 510663 China
Re: K180387
Trade/Device Name: Infrared Ear Thermometer, Model HTD8208C Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 19, 2018 Received: November 23, 2018
Dear Yijie You:
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 (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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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,
Sapana Patel -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
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Indications for Use
510(k) Number (if known) K180387
Device Name
Infrared Ear Thermometer, Model: HTD8208C
Indications for Use (Describe)
The Infrared Ear Thermometer, Model: HTD8208C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in people of all ages for home setting use.
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
K180387
1. Submitter's Information
Establishment Registration Information
Name: HeTaiDa Technology Co., Ltd Address: 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, DaLingShan Town, DongGuan City, Guangdong, China. 523820
Contact Person of applicant
Name: Tom Chen Address: 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, DaLingShan Town, DongGuan City, Guangdong, China TEL: +86 769-82658050 FAX: +86 769-82658050 Email: tomchen@hetaida.com.cn
Contact Person of the Submission:
Name: Yijie You Address: RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: +86 020-8224 5821 FAX: +86 020-8224 5821 Email: Jet.you@qimmiq-med.com
Date to prepare: January 9, 2019
2. Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Device Common Name: | Clinical electronic thermometer |
| Trade Name: | Infrared Ear Thermometer |
| Model: | HTD8208C |
| Regulation name: | Clinical electronic thermometer |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Class: | II |
| Regulation Number: | 880.2910 |
3. Predicate Device Information
| 510(k) submitter/holder: | Radiant Innovation Inc. |
|---|---|
| 510(K) Number: | K011059 |
| Device: | INFARED EAR THERMOMETER, Model: TH839 |
| Trade name: | TH839 Ear-Type Thermometer |
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4. Device description
Infrared Ear Thermometer, model: HTD8208C, is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. The principle of operation is based on measuring the natural thermal radiation emanating from the tympanic membrane when the thermometer is inserted in the ear canal.
The Infrared Ear Thermometer measures temperature by reading infrared radiation emitting from the eardrum tissue when the thermometer is inserted into the ear canal. Pressing the measuring button to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will display on the device's LCD. The total operation takes less than 5 seconds.
5. Indications for Use
The Infrared Ear Thermometer, Model: HTD8208C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in people of all ages for home setting use.
| | Subject device
K180387
(Infrared Ear
Thermometer,
model: HTD8208C) | Predicate device
(K011059, INFARED
EAR
THERMOMETER,
Model: TH839) | Discussion of difference |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Infrared Ear
Thermometer, Model:
HTD8208C, is an
electronic clinical
thermometer using an
infrared sensor to
detect body
temperature from the
auditory canal in people
of all ages for home
setting 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
The device name is
included in the subject
device. |
| Principle of
operation | Measure temperature
by reading infrared
radiation emitting from
the eardrum tissue
when the thermometer
is inserted into the ear
canal. | Measure temperature
by reading infrared
radiation emitting from
the eardrum tissue
when the thermometer
is inserted into the ear
canal. | Same |
| | | | |
| target
population | people of all ages | Neonatal, pediatric, and
adult | Same |
| Measurement
site | auditory canal | auditory canal | Same |
| Material of
Patient contact
components | ABS | ABS | Same |
| Biocompatibility | Comply with ISO
10993-5, ISO
10993-10 | Comply with ISO
10993-5, ISO
10993-10 | Same |
| Environment | home | home | Same |
| Design | Handheld | Handheld | Same |
| Measurement
method | Infrared radiation
detection | Infrared radiation
detection | Same |
| Display Type | LCD | LCD | Same |
| Measurement
mode | Ear measure mode | Ear measure mode | Same |
| Key | 2 button(scan,
ON/Memory button) | 2 button(scan,
ON/Memory button) | Same |
| Scale
selection | °C/°F | °C/°F | Same |
| Display unit | °C/°F | °C/°F | Same |
| High
temperature
warning | Yes | Yes | Same |
| Low battery
indicator | Yes | Yes | Same |
| Case Material | ABS | ABS | Same |
| Sensor Type | Thermopile | Thermopile | Same |
| Performance | Meet ASTM E1965-98
and ISO 80601-2-56 | Meet ASTM E1965-98 | Similar
The proposed device
complies with standards
ASTM E1965-98 and
ISO 80601-2-56. The
difference does not
affect the determination
of substantial
equivalence. |
| Measuring
range | 34.0°C42.9°C;109.22°F) | 34
(93.242.2°C108.0°F) | Similar
(93.2
The proposed device
meets ASTM E1965-98,
ISO 80601-2-56 and the
difference does not
affect the determination
of substantial
equivalence. |
| Display
resolution | 0.1°F (0.1°C) | 0.1°F (0.1°C) | Same |
| Measuring
accuracy | ±0.2°C (0.4°F) within
3542°C107.6°F),
(95
±0.3°C (0.5°F) for
other range | ±0.2°C (0.4°F) within
3542°C107.6°F),
(95
±0.3°C (0.5°F) for
other range | Same |
| Memory | 10 set | 9 set | Similar
The memory capacity
will not affect the
determination of
substantial
equivalence |
| Measure time | ≤5S | About 1 second | Similar
The Measure time will
not affect the
determination of
substantial equivalence |
| Power source | DC 3V (Alkaline AAA
size battery x 2) | DC 3V, One lithium
cell (CR2032 x 1). | Similar
The proposed device
was demonstrated
electromagnetic
compatibility and
electrical safety by the
testing. The difference
does not affect the
determination of
substantial equivalence. |
| Operating
condition | 15°C35°C (5995°F),
Relative
Humidity≤85% | 1040°C104°F),15%~85%
(50
RH | Similar
The operating
condition of subject
device has passed the
safety test, and the
Instructions for Use
provides the operating
condition, so the
difference between the
operating conditions of
subject device and
predicate device will
not affect the
determination of
substantial
equivalence. |
6. Summary of technological characteristics of device compared to the predicate devices (K011059)
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6
7
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
| Standards | Standards Name |
|---|---|
| IEC 60601-1: 2005+A1:2012 | Medical Electrical Equipment - Part 1: General |
| Requirements For Basic Safety And Essential | |
| Performance | |
| IEC 60601-1-2: 2014 | Medical Electrical Equipment -- Part 1-2: General |
| Requirements For Basic Safety And Essential | |
| Performance -- Collateral Standard: Electromagnetic | |
| Disturbances -- Requirements And Tests | |
| IEC 60601-1-11: 2015 | Medical Electrical Equipment - Part 1-2: General |
| Requirements For Basic Safety And Essential | |
| Performance - Collateral Standard: Electromagnetic | |
| Disturbances - Requirements And Tests | |
| ISO 80601-2-56: 2009 | Medical Electrical Equipment - Part 2-56: Particular |
| Requirements For Basic Safety And Essential | |
| Performance Of Clinical Thermometers For Body | |
| Temperature Measurement. | |
| ASTM E1965-98 | Standard Specification For Infrared Thermometers For |
| Intermittent Determination Of Patient Temperature | |
| 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 | |
| IEC 62304:2006+A1:2015 | Medical device software - Software life cycle processes |
The subject device is a non-sterile device. The validation testing result for cleaning and disinfection of the subject device is adequate.
Software validation and verification test:
The software contained in the subject device complies with the applicable requirements set forth in the referenced guidance document, "Guidance for the Content of Premarket Submissions for Software Contained, issued on May 11, 2005.
8. Discussion of Clinical Tests Performed:
The clinical investigation report and data analysis followed the requirements of the ASTM E 1965-98 and ISO 80601-2-56.
The clinical tests evaluated 140 of subjects. Each model was evaluated in each of the following age groups: 0 up to 3 months, 3 months up to one year, older than 1 year and younger than 5 years, and older than 5 years. The clinical performance test protocol and data analysis was conducted as the requirement of
8
ASTM E1965-98 (2009). The test report demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2009).
9. Conclusions
Infrared Ear Thermometer, model HTD8208C, has the same intended use and similar characteristics as the predicate device. Based on performance testing and compliance with standards demonstrate the subject device Infrared Ear Thermometer, model HTD8208C is substantially equivalent to the predicate device.