(88 days)
Not Found
No
The description details a standard infrared thermometer operation based on measuring thermal radiation and converting it to a temperature reading. There is no mention of AI or ML algorithms for data processing, interpretation, or prediction.
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
This device measures body temperature, which is a physiological parameter, but it does not diagnose a medical condition. It provides data that a healthcare professional might use as part of a diagnostic process, but the device itself does not make a diagnosis.
No
The device description explicitly details hardware components like an infrared sensor (thermopile), probe, activation button, and LCD display, 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Infrared Body Thermometer, Model: HTD8216C, measures body temperature by detecting infrared radiation emitted from the forehead or auditory canal. This is a direct measurement of a physical property of the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use is to detect body temperature, which is a vital sign, not to diagnose a disease or condition based on a biological sample.
Therefore, this device falls under the category of a clinical thermometer, which is a medical device but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Infrared Body Thermometer, Model: HTD8216C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead or auditory canal in people of all ages for home setting use.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Infrared Body Thermometer, model: HTD8216C, is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the central forehead or auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the central forehead or tympanic membrane.
The forehead mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the central forehead skin. The central forehead skin is thin & flat, and the temperature is uniform to cover the Whole FOV (Field of View) of the sensor.
The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue. The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue when the thermometer is inserted into the ear canal.
To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) 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 be appeared on a LCD display. The total operation takes a few seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared
Anatomical Site
forehead or auditory canal (central forehead, auditory canal, eardrum tissue, outer ear canal)
Indicated Patient Age Range
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
The clinical investigation report and data analysis followed the requirements of the ASTM E 1965-98 and ISO 80601-2-56.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The test report shows the three group's temperature readings difference between digital thermometer and the subject device. HTD8216C is within acceptable range. It is concluded that the Infrared Body Thermometer, model HTD8216C is acceptable to measure human body's temperature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and includes the letters "FDA" and the words "U.S. Food & Drug Administration."
May 11, 2018
HeTaiDa Technology Co., Ltd. % You Yijie Qimmiq Medical Consulting Service Co., Ltd. RM.1711, Building K, NO.101 Science Ave International Creative Valley, Guangzhou, 510663 CHINA
Re: K180385
Trade/Device Name: Infrared Body Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 10, 2017 Received: February 15, 2018
Dear You Yijie:
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.
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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. Tina Kiang -S
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) K180385
Device Name Infrared Body Thermometer
Indications for Use (Describe)
The Infrared Body Thermometer, Model: HTD8216C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead or 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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3
510(K) Summary
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: You Yijie 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@qimmig-med.com
Contact Person to prepare summary:
Name: You Yijie 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@gimmig-med.com Date to prepare: May. 9, 2018
2. Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Device Common Name: | Clinical electronic thermometer |
| Trade Name: | Infrared Body Thermometer |
| Model: | HTD8216C |
| Classification name: | thermometer, electronic, clinical |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Class: | II |
| Regulation Number: | 880.2910 |
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3. Predicate Device Information
| 510(k) submitter/holder: | Radiant Innovation Inc. |
|---|---|
| 510(K) Number: | K162083 |
| Device: | RII Multi-Function Infrared Thermometer, Model TH52Z |
| Trade name: | TH52Z Multi-function Infrared Thermometer |
4. Device description
Infrared Body Thermometer, model: HTD8216C, is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the central forehead or auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the central forehead or tympanic membrane.
The forehead mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the central forehead skin. The central forehead skin is thin & flat, and the temperature is uniform to cover the Whole FOV (Field of View) of the sensor.
The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue. The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue when the thermometer is inserted into the ear canal.
To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) 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 be appeared on a LCD display. The total operation takes a few seconds.
5. Intended Use
The Infrared Body Thermometer, Model: HTD8216C, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead or auditory canal in people of all ages for home setting use.
6. Summary of technological characteristics of device compared to the predicate devices (K162083)
| SE
Comparisons | Subject device
Present application
(Infrared Body
Thermometer,
model: HTD8216C) | Predicate device
(K162083, RII
Multi-Function
Infrared
Thermometer, Model:
TH52Z) | Discussion of difference |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21CFR 880.2910 | 21CFR 880.2910 | Same |
| Product Code | FLL | FLL | Same |
| FDA Class | II | II | Same |
| Intended Use | The Infrared Body
Thermometer,
Model: HTD8216C,
is an electronic
clinical thermometer
using an infrared
sensor to detect
body temperature
from the forehead or
auditory canal in
people of all ages
for home setting
use. | The RII Multi-function
Infrared
Thermometer, Model
TH52Z is intended for
the intermittent
measurement of
human body
temperatures. The
device is intended for
the use at home by
people of all ages
including neonates
and it can be selected
Ear mode or
Forehead mode. | Same |
| target
population | people of all ages
who need to detect
body temperature | people of all ages
who need to detect
body temperature | Same |
| anatomical
site | central forehead
auditory canal | central forehead
auditory canal | Same |
| where used | 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/
Forehead mode | Ear measure mode/
Forehead mode | Same |
| Key | 2 button(ON / scan
button,
measurement unit
switch button is
behind the battery
cover) | 3 button("ear button",
"forehead button"
ON/Memory button) | Acceptable
The Key number will not
affect the safety and
effectiveness of the
proposed device |
| Scale
selection | °C/°F | °C/°F | Same |
| Fever 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 and ISO
80601-2-56 | Same |
| 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 raise |
| | | | |
| | | | the issue of product's
safety and effectiveness. |
| 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 | 1 set | 9 set | Acceptable
The memory capacity will
not affect the safety and
effectiveness of the
proposed device |
| Measure time | ≤5S (ear mode) | Ear: 1sec. | Acceptable
The Measure time will not
affect the safety and |
| | ≤2S (Forehead mode) | Forehead Mode:
530sec. | effectiveness of the35°C
proposed
device |
| Power source | 1.5V (AAA) Alkaline
batteryX2 | DC 3V, One lithium
cell (CR2032 x 1). | Acceptable
The proposed device was
demonstrated
electromagnetic compatibility
and electrical safety by the
testing. The difference
does not raise the issue of
product's safety and
effectiveness. |
| Operating
condition | 15°C
(5995°F),40°C (50~104°F),
Relative
Humidity≤85% | 10
15%~85% RH | Similar
The operating condition of
subject device has passed
the performance 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
safety and effectiveness of
subject device. |
5
6
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The recognized consensus standards for safety of medical electrical equipment: IEC 60601-1, IEC 60601-1-11 for safety, IEC 60601-1-2 for electromagnetic compatibility, ASTM E 1965-98 and ISO 80601-2-56 for performance, ISO 10993-5 and ISO
7
10993-10 for Biocompability are complied.
Guidance Documents included the "FDA Guidance on the Content of Premarket Notification 510(k) Submissions for Clinical Electronic Thermometers".
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 test report shows the three group's temperature readings difference between digital thermometer and the subject device. HTD8216C is within acceptable range. It is concluded that the Infrared Body Thermometer, model HTD8216C is acceptable to measure human body's temperature.
9. Conclusions
Infrared Body Thermometer, models HTD8216C, has the same intended use and similar characteristics as the predicate device. Moreover, the subject device demonstrates compliance with the IEC 60601 -1, IEC 60601-1-11standards and electromagnetic standard IEC 60601-1-2. The performance test demonstrates the HTD8216C meets the ASTM E 1965-98 and ISO 80601-2-56 standard and concludes that any differences in their characteristics do not raise different questions of safety and effectiveness. Thus, Infrared Body Thermometer, model new HTD8216C is substantially equivalent to the predicate device.