(273 days)
Not Found
No
The device description details standard infrared temperature measurement technology and signal processing. There is no mention of AI, ML, or complex algorithms beyond basic calculation and amplification. The performance studies focus on clinical accuracy and repeatability according to a standard, not on the performance of an AI/ML model.
No.
The device is an infrared body thermometer used for measuring body temperature, not for therapeutic purposes.
Yes
Explanation: The device is an Infrared Body Thermometer whose "Intended Use / Indications for Use" states that it is for "intermittent determination of body temperature." Measuring body temperature for health assessment purposes is a diagnostic function.
No
The device description clearly states it is a hand-held, battery-powered infrared thermometer with physical components like a sensor, mirror, and LCD display, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Infrared Body Thermometer measures body temperature by detecting infrared radiation emitted from the forehead or auditory canal. This is a direct measurement of a physiological parameter from the body itself, not an analysis of a specimen taken from the body.
Therefore, based on the provided information, the Infrared Body Thermometer, Model: HTD822US, is a clinical thermometer and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Infrared Body Thermometer, Model: HTD822US, is an electronic clinical thermometer using an infrared sensor for the intermittent determination of body temperature from the forehead and auditory canal in people of all ages for home setting use.
Product codes
FLL
Device Description
Infrared Body Thermometer, model: HTD8222US, is a hand-held, battery powered, infrared thermometer that measures human body temperature through the opening of the auditory canal or on forehead, by measuring the infrared energy emitted in the area around the user's forehead or tympanic membrane and adjacent surfaces when placed within 1~5 centimeter of the subject's forehead or insert into auditory canal. The Infrared Body Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead or tympanic membrane and the adjacent surfaces for detection of non-contact use and contact use and compensation of the temperature reading.
The Infrared Body Thermometers measure temperature by pressing the On/Scan 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 be appeared on a LCD display. The total operation takes a few seconds.
The device can measure temperature with three modes, forehead scan mode and ear mode.
Both forehead mode and forehead scan mode modes are non-contact with human body and measure forehead temperature. The forehead mode measures temperature from middle of the forehead, forehead scan mode measures temperature by scan the forehead from left to right or from right to left with position light spot following within approximately 3~10 seconds, then the maximum temperature will display on the screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared
Anatomical Site
forehead and auditory canal
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 investigation report and data analysis followed the requirements of the ASTM E 1965-98 (2016). The clinical tests evaluated 140 of subjects.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The clinical tests evaluated 140 of subjects. Each mode was evaluated in 0 up to one year, older than 1 year and younger than 5 years, and older than 5 years age groups. The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2016). The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical bias:
0.14°C/0.15°C/0.15°C
with Uncertainty:
± 0.14/ ± 0.15/ ± 0.14 for group I/II/II
Clinical repeatability: 0.12 °C (Calculated per ASTM E:1965-98)
Clinical bias:
0.16°C/0.15°C/0.14°C
with Uncertainty:
±0.10/ ±0.09/ ±0.09 for group I/II/II
Clinical repeatability:
0.12 °C (Calculated per ASTM E:1965-98)
Clinical bias:
0.12 °C/0.10/0/10
with Uncertainty: ±
0.12 °C/ ± 0.14 °C/ ± 0.14 °C for group I/II/II
Clinical repeatability:
0.12 °C (Calculated per ASTM E:1965-98)
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
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
December 9, 2020
HeiTaiDa Technology Co., Ltd. % You Yijie Manager Qimmiq Medical Consulting Service Co., Ltd RM. 1711, Building K. NO. 101 Science Ave International Creative Vallev Guangzhou, 510663 Cn
Re: K200781
Trade/Device Name: Infrared Body Thermometer, Model: HTD8222US Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 9, 2020 Received: November 9, 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 Director (acting) 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) K200781
Device Name Infrared Body Thermometer, Model: HTD8222US
Indications for Use (Describe)
The Infrared Body Thermometer, Model: HTD822US, is an electronic clinical thermometer using an infrared sensor for the intermittent determination of body temperature from the forehead and 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 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@qimmig-med.com
Date prepared: December 8, 2020
2. Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Device Common Name: | Clinical electronic thermometer |
| Trade Name: | Infrared Body Thermometer |
| Model: | HTD8222US |
| Regulation name: | thermometer, electronic, clinical |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Class: | II |
| Regulation Number: | 880.2910 |
| 510(K) number: | K200781 |
3. Predicate Device Information
Predicate Device #1:
510(k) submitter/holder: KAZ USA, Inc., A Helen of Troy Company 510(K) Number: K163516 Model: Braun No Touch + Forehead NTF3000 Thermometer
4
Trade name: Infrared Thermometer Review Panel: General Hospital Product Code: FLL Requlation Class: II Requlation Number: 880.2910
Predicate Device #2:
510(k) submitter/holder: Exergen Corporation 510(K) Number: K011291 TemporalScannerThermometer Trade name: Review Panel: General Hospital Product Code: FLL Regulation Class: II Regulation Number: 880.2910
Predicate Device #3:
510(k) submitter/holder: KAZ USA, Inc (a Subsidiary of Helen of Troy, Inc) K152748 510(K) Number: Trade name: Braun Thermoscan® PRO 6000 Ear Thermometer Review Panel: General Hospital Product Code: FLL Regulation Class: II Regulation Number: 880.2910
4. Device description
Infrared Body Thermometer, model: HTD8222US, is a hand-held, battery powered, infrared thermometer that measures human body temperature through the opening of the auditory canal or on forehead, by measuring the infrared energy emitted in the area around the user's forehead or tympanic membrane and adjacent surfaces when placed within 1~5 centimeter of the subject's forehead or insert into auditory canal. The Infrared Body Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead or tympanic membrane and the adjacent surfaces for detection of non-contact use and contact use and compensation of the temperature reading.
The Infrared Body Thermometers measure temperature by pressing the On/Scan 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 be appeared on a LCD display. The total operation takes a few seconds.
The device can measure temperature with three modes, forehead scan mode and ear mode.
Both forehead mode and forehead scan mode modes are non-contact with human body and measure forehead temperature. The forehead mode measures temperature from middle of the forehead, forehead scan mode measures temperature by scan the forehead from left to right or from right to left with position light spot following within approximately 3~10 seconds, then the maximum temperature will display on the screen.
5
The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue. After removing the probe covering cap, the small cone-shape end of the thermometer is inserted into the ear canal, where the eardrum (tympanic membrane) and surrounding tissues emit IR radiation.
Principle of operation:
Infrared Body Thermometer, model: HTD8222US, is a hand-held, battery powered, infrared thermometer that measures human body temperature through the opening of the auditory canal or on forehead, by measuring the infrared energy emitted in the area around the user's forehead or tympanic membrane and adjacent surfaces when placed within 1~5 centimeter of the subject's forehead or insert into auditory canal. 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.
6
5. Indications for Use
The Infrared Body Thermometer, Model: HTD822US, is an electronic clinical thermometer using an infrared sensor for the intermittent determination of body temperature from the forehead and auditory canal in people of all ages for home setting use.
6. Comparison of technological characteristics with the predicate devices (K163516, K011291 and K152748)
| SE
Comparisons | Subject device
K200781
(Infrared Body
Thermometer,
model:
HTD8222US) | Predicate device #1
(K163516, Infrared
Thermometer, Model:
Braun No Touch +
Forehead NTF3000
Thermometer)
(compared with
Forehead mode of
HTD8222US) | Predicate device #2
(K011291,
TemporalScanner
Thermometer)
(compared with
Forehead scan mode
of HTD8222US) | Predicate device #3
(K152748, Braun
Thermoscan® PRO
6000 Ear
Thermometer)
(compared with ear
mode of
HTD8222US) | Discussion of
difference |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21CFR 880.2910 | 21CFR 880.2910 | 21CFR 880.2910 | 21CFR 880.2910 | Same |
| Product
Code | FLL | FLL | FLL | FLL | Same |
| FDA Class | II | II | II | II | Same |
| Indications
for Use | The Infrared Body
Thermometer, Model:
HTD8222US, is an
electronic clinical
thermometer using an
infrared sensor for the
intermittent
determination of body
temperature from the
forehead and auditory
canal 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. | A non-sterile,
re-useable clinical
thermometer intended
for the intermittent
determination of the
human's body
temperature for
people of all ages | Same |
| Principle of
operation | Measure temperature
by reading infrared | Measure temperature by
reading infrared radiation | Measure temperature
by reading infrared | Measure temperature
by reading infrared | Same |
| | radiation emitting from the forehead tissue or tympanic membrane and adjacent surfaces when the thermometer is placed within few centimeters of forehead or inserted into auditory canal. | emitting from the forehead tissue when the thermometer is placed within few centimeters of forehead. | radiation emitting from the forehead tissue when the thermometer is placed within few centimeters of forehead. | radiation emitting from tympanic membrane and adjacent surfaces when the thermometer is inserted into auditory canal. | |
| target
population | people of all ages | people of all ages | people of all ages | people of all ages | Same |
| Measurement
site 1 | Forehead | forehead | forehead | NA | Same
Predicate 3 has no forehead mode, the subject device is compared with predicated devices 1 and 2 for this technical item, and shows same with predicated devices 1 and 2. Since modes work not at the same time, The difference will not affect the determination of substantial equivalence |
| Measurement
site 2 | ear | NA | NA | ear | Same
Predicate 1 and 2 has no ear mode, the proposed device is compared with predicated device 3 for this technical item, and shows same with predicated device 3. Since modes work not at the same time, the difference will not affect the determination of substantial equivalence |
| | | | | | |
| Type of thermometer | intermittent | intermittent | intermittent | intermittent | Same
All three predicate device
declare they are
intended for intermittent
measurement of human
body temperature which
is indicated in the
intended use/ Indications
for Use of 510(K)
summary. |
| Material of
Patient
contact
components | ABS | NA, not contact with
Patient body | ABS | Common Materials-
including an impact
resistant casing.
Biocompatible metals
and resins. | Similar
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
determination of substantial
equivalence |
| Biocompability | Nature of body contact
category: Surface
Contact class: A ( $35.7°-37.4 °C$
(> $96.3°$ - $99.4 °F$ )
Yellow: > $37.4°$ -
$38.5 °C$
(> $99.4°$ - $101.3 °F$ ) | NA | NA | Similar
The Color
Indication will not affect the
determination of substantial
equivalence |
| | | | | | |
| | Orange: ≥ 38.6 -
43.0°C (101.4 -
109.4°F) | Red: > 38.5° - 42.2 °C
(> 101.3° - 108.0 °F) | | | |
| Measuring
Distance | 1 CM -5CM | 1 CM -5CM | 0 CM | 0 CM | Similar |
| Power
source | DC3.0V X1
(CR2032) | Two (2) AA batteries | 9 volt Alkaline | Two AA Alkaline
Batteries | Similar |
| Expected
battery life | More than 1000
measurements | at least 1000
measurements | Approximately 7,500
readings | 1000 measurements | Similar |
| Clinical
accuracy
(forehead mode) | Clinical bias:
0.14°C/0.15°C/0.15°C
with Uncertainty:
$\pm$ 0.14/ $\pm$ 0.15/ $\pm$ 0.14
for group I/II/II
Clinical repeatability: | Not public | NA | NA | Different |
| | 0.12 °C
(Calculated per ASTM
E:1965-98) | | | | of proposed device are
sufficiently small and
acceptable which will not
affect the determination of
substantial equivalence
even though any difference
existed. |
| Clinical
accuracy
(forehead scan
mode) | Clinical bias:
0.16°C/0.15°C/0.14°C
with Uncertainty:
±0.10/ ±0.09/ ±0.09
for group I/II/II
Clinical repeatability:
0.12 °C
(Calculated per ASTM
E:1965-98) | NA | Meets ASTM E1965-98
and EN60601-1
standards for electronic
and radiation
thermometers to the
extent applicable to
thermometers which
measure the surface of
the skin over the
temporal artery. | NA | Similar
The clinical biases,
uncertainties and
Repeatability of ear mode
of proposed device are
sufficiently small and
acceptable and meet the
requirement of ASTM
E1965-98. Therefore, the
difference existed will not
affect the determination of
substantial equivalence. |
| Clinical
accuracy
(ear mode) | Clinical bias:
0.12 °C/0.10/0/10
with Uncertainty: ±
0.12 °C/ ± 0.14 °C/ ±
0.14 °C
for group I/II/II
Clinical repeatability:
0.12 °C
(Calculated per ASTM
E:1965-98) | NA | NA | Clinical bias: 0.09 °C
Limits of agreement:
0.58 °C
Clinical repeatability:
0.19 °C
(Calculated per ASTM
E:1965-98)
(less than the
standard