(349 days)
No
The summary describes a standard infrared thermometer and does not mention any AI or ML components or capabilities.
No.
This device is an infrared thermometer used to measure body temperature, which is a diagnostic tool, not a therapeutic one designed to treat or prevent a disease.
No
The device is an infrared body thermometer that measures body temperature. While temperature can be a symptom used in diagnosis, the device itself only provides a measurement and does not interpret the data to diagnose a condition.
No
The device description explicitly states it is a "hand-held, battery powered, infrared thermometer" and describes physical components and actions like positioning a probe and sliding the thermometer, indicating it is a hardware device with embedded software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
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 Infrared Body Thermometer, Model: HTD8823US, measures body temperature from the forehead using infrared radiation. It does not analyze any specimens taken from the body.
- Intended Use: The intended use is to detect body temperature from the forehead for home setting use. This is a direct measurement of a physiological parameter, not an analysis of a biological sample.
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 Body Thermometer, Model: HTD8823US, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead in people of all ages for home setting use.
Product codes
FLL
Device Description
Infrared (IR) Body Thermometer, model: HTD8823US, is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral.
The device can measure temperature with two modes, forehead mode and forehead scan mode, and both modes measure forehead temperature.
The forehead mode measures temperature from center of the forehead.
Forehead scan mode measures temperature by gently positioning the probe flush (flat) on the center of the forehead, midway between the eyebrow and the hairline, press and hold the On/Scan button. Lightly slide the thermometer across the forehead keeping the sensor flat and in contact with the skin until reaching the right hairline, release the On/Scan button and remove the thermometer from the forehead, then the temperature will display on the screen, the whole process takes 3~10 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
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
The clinical accuracy test report and data analysis followed the requirements of the ASTM E 1965-98 (2016).
The clinical accuracy testing evaluated 140 of subjects.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The clinical accuracy test report and data analysis followed the requirements of the ASTM E 1965-98 (2016).
The clinical accuracy testing evaluated 140 of subjects. Each model was evaluated in 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 age groups. The test data showed the clinical accuracy of the subject device complied with the requirements of ASTM E1965-98 (2016).
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.
0
Image /page/0/Picture/0 description: The image shows 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 is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
January 5, 2021
HeTaiDa Technology Co., Ltd. % You Yijie Manager Oimmig Medical Consulting Service Co., Ltd RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone Guangzhou, 510663 China
Re: K200159
Trade/Device Name: Infrared Body Thermometer, Model: HTD8823US Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 7, 2020 Received: December 7, 2020
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (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 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,
CAPT Alan Stevens Acting 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
2
Indications for Use
510(k) Number (if known) K200159
Device Name Infrared Body Thermometer, Model: HTD8823US
Indications for Use (Describe)
The Infrared Body Thermometer, Model: HTD8823US, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead 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 K200159
1. Submitter's Information
Establishment Reqistration 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 prepared: Dec. 16, 2020
2. Device Information
| Device Common Name: | Clinical electronic thermometer |
|---|---|
| Trade Name: | Infrared Body Thermometer |
| Model: | HTD8823US |
| Regulation name: | Clinical electronic thermometer |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Class: | II |
| Regulation Number: | 880.2910 |
3. Predicate Device Information
Primary predicate device:
510(k) submitter/holder: KAZ USA, Inc., A Helen of Troy Company 510(K) Number: K163516 Model: Braun No Touch + Forehead NTF3000 Thermometer Trade name: Infrared Thermometer Review Panel: General Hospital Product Code: FLL
4
Requlation Class: . Requlation Number: 880.2910
Secondary predicate device:
510(k) submitter/holder: Exergen Corporation 510(K) Number: K011291 Trade name: TemporalScanner Thermometer, SensorTouch Review Panel: General Hospital Product Code: FLL Regulation Class: -Regulation Number: 880.2910
4. Device description
Infrared (IR) Body Thermometer, model: HTD8823US, is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral.
The device can measure temperature with two modes, forehead mode and forehead scan mode, and both modes measure forehead temperature.
The forehead mode measures temperature from center of the forehead.
Forehead scan mode measures temperature by gently positioning the probe flush (flat) on the center of the forehead, midway between the eyebrow and the hairline, press and hold the On/Scan button. Lightly slide the thermometer across the forehead keeping the sensor flat and in contact with the skin until reaching the right hairline, release the On/Scan button and remove the thermometer from the forehead, then the temperature will display on the screen, the whole process takes 3~10 seconds.
Principle of operation:
Infrared Body Thermometer, model: HTD8823US, is an electronic thermometer uses IR sensor (thermopile) to detect infrared radiation emitting from forehead. The IR sensor outputs electrical signal which is fed to circuit for amplification and then inputted to the microcontroller unit (MCU). For forehead mode, the MCU captures the temperature measured from center of forehead. The measured temperature will finally appear on LCD display. For forehead scan mode, the MCU captures the highest temperature during scanning sampling process and calculation, finally the measured temperature will appear on LCD display.
5. Indications for Use
The Infrared Body Thermometer, Model: HTD8823US, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead in people of all ages for home setting use.
6. Summary of technological characteristics of device compared to the predicate devices (K163516 and K011291)
| SE
Comparisons | Subject device | Primary predicate device | Secondary predicate
device | Discussion
of difference |
|-------------------|---------------------------|-------------------------------------------------|-------------------------------|-----------------------------|
| | K200159
(Infrared Body | (K163516, Infrared
Thermometer, Model: Braun | (K011291, | |
5
| | Thermometer,
model: HTD8823US) | No Touch + Forehead
NTF3000 Thermometer)
(compared with Forehead
mode of HTD8823US) | TemporalScanner
Thermometer,
SensorTouch)
(compared with Forehead
scan mode of
HTD8823US) | |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Classification | 21CFR 880.2910 | 21CFR 880.2910 | 21CFR 880.2910 | Same |
| Product Code | FLL | FLL | FLL | Same |
| FDA Class | II | II | II | Same |
| Intended Use | The Infrared Body
Thermometer, Model:
HTD8823US, is an
electronic clinical
thermometer using an
infrared sensor to detect
body temperature from the
forehead in people of all
ages for home setting use. | The Braun No Touch +
Forehead NTF3000
Thermometer is a non-sterile,
reusable clinical thermometer
intended for the intermittent
determination of human body
temperature in a touch and no
touch mode on the center of
the forehead as the
measurement site on people
of all ages. | The TemporalScanner
Thermometer is an
infrared thermometer
intended for the
intermittent
measurement of human
body temperature of
people of all ages | Similar
(Discussion is
indicated in
D1) |
| Principle of
operation | Forehead mode: Measure
temperature by reading
infrared radiation emitting
from the forehead when
the thermometer is placed
within few centimeters of
forehead. | Measure temperature by
reading infrared radiation
emitting from the forehead
when the thermometer is
placed within few centimeters
of forehead. | NA | Same |
| | Forehead scan mode:
Measure temperature by
reading infrared radiation
emitting from the forehead
when the thermometer is
placed on the forehead. | NA | Measure temperature by
reading infrared radiation
emitting from the
forehead when the
thermometer is placed
on the forehead. | Same |
| target
population | people of all ages | people of all ages | people of all ages | Same |
| Measurement
site | forehead | forehead | forehead | Same |
| Material of
Patient
contact
components | ABS (device housing/ handle
and power button);
PMMA(LCD screen) | ABS (device housing/ handle and
power button); TPR (temperature
button and nose / forehead touch
bumper). | ABS | Similar
(Discussion is
indicated in
D2) |
| Biocompability
testing | Meets ISO 10993- 5
ISO 10993-10 | Meets ISO 10993 and
FDA Bluebook memo
G95-1 | Not public | Similar
(Discussion is
indicated in
D3) |
| Environment | home | home | home | Same |
| Design | Handheld | Handheld | Handheld | Same |
| Measurement
method | Infrared radiation
detection | Infrared radiation detection | Infrared radiation
detection | Same |
| Display Type | LCD | LCD | LCD | Same |
| Measurement | Forehead mode | Forehead mode | NA | Same |
| Mode | Forehead scan mode | NA | Forehead scan mode | Same |
| Key | One button(ON/Scan | Two button(Power button, | One button(SCAN | Similar
(Discussion is
indicated in
D4) |
| | button) | Temperature button) | Button) | indicated in
D4) |
| Scale
selection | °C/°F | °C/°F | °C/°F | Same |
| Display unit | °C/°F | °C/°F | °C/°F | Same |
| High
temperature
warning | Yes | Yes | Yes | Same |
| Low battery
indicator | Yes | Yes | Yes | Same |
| Case Material | ABS | ABS | ABS | Same |
| Sensor Type | Thermopile | Thermopile | Thermopile | Same |
| Performance
Testing | Meets ASTM E1965-98
and ISO 80601-2-56 | Meets ASTM E1965-98 and
ISO 80601-2-56 | Meets ASTM E1965-98 | Similar
(Discussion is
indicated in D5) |
| Electrical
Safety | ANSI AAMI ES60601-1 | ANSI AAMI ES60601-1 | ANSI AAMI ES60601-1 | Same |
| EMC Meets | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Measuring
Range for
Forehead
mode | 34.0°C ~ 43.0°C
(93.2°F ~109.4°F) | 34.4°C ~42.2°C
(93.9°F to 108.0°F) | NA | Similar
(Discussion is
indicated in D6) |
| Measuring
Range for
Forehead
scan mode | 34.0°C ~ 43.0°C
(93.2°F 109.4°F) | NA | Forehead scan:107.6°F);
15.5°C to 42°C
(60°F to 107.6°F) | Similar
(Discussion is
indicated in
D7) |
| Display
resolution | 0.1°F (0.1°C) | 0.1°F (0.1°C) | 0.1°F (0.1°C) | Same |
| Measuring
accuracy | ±0.2°C (0.4°F) within
35°C ~ 42°C
(95°F
±0.3°C (0.5°F) for other
range | ±0.2°C (0.4°F) within 35°C
~42°C (95°F 107.6°F);42°C (95°F
±0.3°C (0.5°F) for other
range | ±0.2°C (0.4°F) within
35107.6°F);10s for Forehead scan
±0.3°C (0.5°F) for other
range | Same |
| Measure time | ≤2S for Forehead mode;
3
mode; | ≤2S | Seconds | Similar
(Discussion is
indicated in D8) |
| Color
Indication | Green: ≥ 35.8°C -
37.4 °C (96.4°F -99.3°F)
Yellow: ≥ 37.5°C- 38.5°C
(99.5°F -101.3°F)
Orange: ≥ 38.6°C - 43.0°C
(≥101.5°F -109.4°F) | Green: > 35.7 °C -37.4 °C
(> 96.3°F - 99.3 °F)
Yellow: > 37.4 °C - 38.5 °C
(> 99.4°F - 101.3 °F)
Red: > 38.5 °C - 42.2 °C
(> 101.3°F - 108.0 °F) | NA | Similar
(Discussion is
indicated in D9) |
| Measuring
Distance for
forehead
mode | 1 CM -5CM | 1 CM -5CM | NA | Same |
| Measuring
Distance for
forehead scan
mode | 0 cm | NA | 0 cm | Same |
6
7
| Power source | 3 V d.c. (2X AAA batteries) | Two (2) AA batteries | 9 volt Alkaline | Similar
(Discussion is
indicated in
D10) |
|---------------------|------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------|
| Operating condition | Temperature: 5°C ~40°C
(41°F ~104°F)
Humidity: ≤ 95%(no
condensing) | Temperature: 15°C ~40°C
(59°F ~104°F)
Humidity: Not public | Temperature:15.5°C
~40°C (60°F ~104°F)
Humidity: ≤ 95%(no
condensing) | Different
(Discussion is
indicated in
D11) |
The discussion of differences exist between the subject and predicate devices is listed in followina:
- D1: There is only difference in description, all three devices are infrared electronic clinical thermometer used to measure body temperature of all ages from forehead.
- D2: The proposed device has been validated for cytotoxicity per ISO 10993- 5 and Irritation as well as Sensitization per ISO 10993-10. The difference will not affect the safety and effectiveness.
- D3: The proposed device has been validated for the lasted version of ISO 10993-5: 2009 and ISO 10993-10:2010. the difference will not affect the safety and effectiveness.
- D4: The different button number will not affect the safety and effectiveness.
- D5: The proposed device conducted performance testing in accordance with ASTM E1965-98. ISO 80601-2-56 to demonstrate the difference does not affect the safety and effectiveness.
- D6: The proposed device conducted performance testing in accordance with ASTM E1965-98, ISO 80601-2-56 to demonstrate the difference does not affect the safety and effectiveness.
- D7: The proposed device conducted performance testing in accordance with ASTM E1965-98, ISO 80601-2-56 to demonstrate the difference does not affect the safety and effectiveness.
- D8: The Measure time of proposed device was validated through performance testing in accordance with ASTM E1965-98, ISO 80601-2-56 to demonstrate the difference does not affect the safety and effectiveness.
- D9: The Color Indication of proposed device in upper temperature range ≥ 38.6℃ 43.0℃ is orange and the predicate is red in upper temperature range > 38.6℃ - 42.2℃, it's only different in visual effect of color, this difference does not affect the safety and effectiveness.
- D10: The proposed device was electromagnetic compatility and electrical safety in accordance with IEC 60601-1-2 and ANSI AAMI ES60601-1. The difference does not affect the safety and effectiveness.
- D11: The operating condition of subject device has passed the safety test, and the subject device complies the standard IEC 60601-1-11, so the difference between the operating conditions of subject device and predicate device will not affect the safety and effectiveness.
7. Discussion of Non-Clinical Tests Performed for Safety and effectiveness are as follows:
The recognized consensus standards for safety of medical equipment: ANSI AAMI ES60601-1, IEC 60601-1-11 for safety, IEC 60601-1-2 for electromagnetic compatibility, ASTM E 1965-98 and ISO 80601-2-56 for performance and IEC 62304 are complied, and see below table for details.
| Standards | Standards Name |
|---|---|
| ANSI AAMI | |
| ES60601-1:2005/(R)2012 and | |
| 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 |
8
| 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: 2017 | Medical Electrical Equipment - Part 2-56: Particular Requirements
For Basic Safety And Essential Performance Of Clinical
Thermometers For Body Temperature Measurement. |
| ASTM E1965-98:2016 | Standard Specification For Infrared Thermometers For Intermittent
Determination Of Patient Temperature |
| IEC 62304:2006+A1:2015 | Medical device software - Software life cycle processes |
Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005.
8. Discussion of Clinical Accuracy Testing Performed:
The clinical accuracy test report and data analysis followed the requirements of the ASTM E 1965-98 (2016).
The clinical accuracy testing evaluated 140 of subjects. Each model was evaluated in 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 age groups. The test data showed the clinical accuracy of the subject device complied with the requirements of ASTM E1965-98 (2016).
9. Conclusions
Based on performance testing, comparison and analysis, the subject device Infrared Body Thermometer, model HTD8823US is substantially equivalent to the predicate devices.