(296 days)
Not Found
No
The device description and performance studies focus on standard infrared temperature measurement technology and validation against a recognized standard (ASTM E1965-98). There is no mention of AI, ML, or related concepts like training sets, algorithms, or complex data processing beyond basic signal processing and display.
No.
The device is an infrared thermometer intended for temperature measurement, not for treating any condition.
No
The device is an infrared thermometer intended for temperature measurement, not for diagnosing a specific disease or condition. While temperature measurements can be relevant to diagnosis, the device itself doesn't provide a diagnosis.
No
The device description explicitly lists hardware components such as an infrared sensor, signal receiving processor, buttons, buzzer, LCD display, and batteries. It also describes the use of a Fresnel lens. This indicates it is a physical device with integrated software, not a software-only medical device.
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: This infrared thermometer measures body temperature by receiving infrared energy radiation from the ear or forehead. It does not analyze samples taken from the body.
- Intended Use: The intended use is for the intermittent measurement of body temperature, which is a direct measurement of a physical parameter of the body, not an analysis of a biological sample.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The infrared thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It can be used by consumers in the household environment and by healthcare providers.
Product codes
FLL
Device Description
HT series infrared thermometers (includes model HT-101, HT-102, HT-103 and HT-104) measure the body temperature through receiving infrared energy radiation via the ear or forehead. These thermometers have the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display. These thermometers have the following features:
- The device is intended to be used by consumers in the household environments and by healthcare providers;
- The device is mainly composed of infrared sensor, signal receiving processor, buttons, buzzer, LCD display. It is powered by 2*1.5 AAA batteries;
- It focuses the infrared energy received from the human's forehead or ear by using the Fresnel lens of the thermometer;
- Switching between Celsius and Fahrenheit;
- Multi-functional, can measure ear and forehead temperature;
- Automatic range selection; resolution is 0.1°C (0.1°F);
- The latest 35 measurement data can be memorized and stored; the user can view the previous measurement results;
- High temperature alarm function, displayed in green, orange and red backlight;
- Switching between mute and un-mute mode;
- Low battery indication, and auto shut-down.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auditory canal or central forehead skin surface
Indicated Patient Age Range
all ages
Intended User / Care Setting
consumers in the household environment and by healthcare providers
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)
Clinical accuracy validation testing was conducted according to ASTM E1965-98(Reapproved 2016). The clinical accuracy validation test report included temperature readings of 150 subjects, of which 50 subjects were infants, 50 subjects were children and the rest of the 50 subjects were adults (NOTE: Infants---newborn to one year; Children--greater than one to five years; Adults---greater than five years old.). The clinical accuracy validation test report demonstrates that the subject devices met the requirements for clinical bias and clinical repeatability per ASTM E1965-98(Reapproved 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 & 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".
June 17, 2021
Shenzhen Sonida Digital Technology Co., Ltd % Yoyo Chen Consultant Shenzhen Joyantech Consulting Co.,Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town Shenzhen, Guangdong 518000 China
Re: K202440
Trade/Device Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 8, 2020 Received: December 8, 2020
Dear Yoyo Chen:
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
1
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/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 medical devices and radiation-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 M. 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
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Indications for Use
510(k) Number (if known) K202440
Device Name Infrared Thermometer, Models HT-101, HT-102, HT-103, HT-104
Indications for Use (Describe)
The infrared thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It can be used by consumers in the household environment and by healthcare providers.
| 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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K202440 510(k) Summary
1. Administrative Information
| Prepared Date | June 14, 2021 |
|---|---|
| Manufacturer | |
| information | Shenzhen Sonida Digital Technology Co., Ltd |
| Address: | |
| 6F./3F-B., Building B, Zhengchangda Technopark, Tangwei | |
| Jianan Road, Fuhai Street, Baoan, Shenzhen, Guangdong, | |
| China, 518103 | |
| Contact person: Vivi Wey | |
| TEL Number: +(86) 0755-29607298 | |
| FAX Number: +(86) 0755-85259480 | |
| E-Mail: 2609815717@qq.com | |
| Submission | |
| Correspondent | Shenzhen Joyantech Consulting Co., Ltd. |
| 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian | |
| Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong | |
| Province, China. | |
| Contact person: Ms. Yoyo Chen | |
| E-Mail: yoyo@cefda.com; field@cefda.com | |
| Image: Green logo with text "卓远天成" below it |
2. Device Information
| Type of 510(k) Submission: | Traditional |
|---|---|
| Device Name: | Infrared Thermometer |
| Model: | HT-101, HT-102, HT-103, HT-104 |
| Classification Name: | Thermometer, Electronic, Clinical |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 880.2910 |
| Product Code: | FLL |
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3. Predicate Device
| Manufacturer | Guangzhou Berrcom Medical Device Co., Ltd. |
|---|---|
| Device name | Infrared Thermometer |
| Model | MD-H30 |
| 510(K) Number: | K191570 |
| Product Code | FLL |
4. Device Description
HT series infrared thermometers (includes model HT-101, HT-102, HT-103 and HT-104) measure the body temperature through receiving infrared energy radiation via the ear or forehead. These thermometers have the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display. These thermometers have the following features:
- The device is intended to be used by consumers in the household environments and 1) by healthcare providers;
-
- The device is mainly composed of infrared sensor, signal receiving processor, buttons, buzzer, LCD display. It is powered by 2*1.5 AAA batteries;
-
- It focuses the infrared energy received from the human's forehead or ear by using the Fresnel lens of the thermometer;
- Switching between ℃ and ºF; 4)
-
- Multi-functional, can measure ear and forehead temperature;
- Automatic range selection; resolution is 0.1℃ (0.1℃F); 6)
-
- The latest 35 measurement data can be memorized and stored; the user can view the previous measurement results;
-
- High temperature alarm function, displayed in green, orange and red backlight;
- Switching between mute and un-mute mode; 9)
-
- Low battery indication, and auto shut-down.
5. Intended Use/Indication for Use
The infrared thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It can be used by consumers in the household environment and by healthcare providers.
6. Substantial Equivalence Comparison
| Items | Subject Devices | Predicate Device
(K191570) | Comments |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Code | FLL | FLL | Same |
| Items | Subject Devices | Predicate Device
(K191570) | Comments |
| Regulation number | 880.2910 | 880.2910 | Same |
| Manufacturer | Shenzhen Sonida Digital
Technology Co., Ltd | Guangzhou Berrcom Medical
Device Co., Ltd. | Same |
| Indications for use | The infrared thermometer is
intended for the intermittent
measurement of body
temperature from the auditory
canal or central forehead skin
surface on people of all ages. It
can be used by consumers in the
household environment and by
healthcare providers. | The infrared thermometer is
intended for the intermittent
measurement of body
temperature from the auditory
canal or central forehead skin
surface on people of all ages.
It can be used by consumers
in the household environment
and by healthcare providers. | Same |
| Thermometer type | Digital thermometer | Digital thermometer | Same |
| Sensor | Thermopile | Thermopile | Same |
| Operational
principle | Infrared radiation detection | Infrared radiation detection | Same |
| Display type | LCD | LCD | Same |
| Measurement site | Forehead and ear | Forehead and ear | Same |
| Measurement
Range | Ear & Forehead: 32.0°C43.0°C109.4°F) | Ear & Forehead:
(89.6°F
32.0°C43.0°C109.4°F) | Same |
(89.6°F
| Measurement
accuracy | 34.0°C43.0°C109.4°F): ±0.2°C(0.4°F)
(89.6°F
32.0 °C34.0°C(89.6°F93.2°F):
±0.3°C(0.5°F) | ±0.4°F (0.2°C) within
95107.6°F (35.042.0°C),
±0.5°F (0.3°C) for other
range. | Comparable
(Note 1) |
| Display resolution | 0.1°C (0.1°F) | 0.1°C (0.1°F) | Same |
| Power supply | d.c.3.0V (2pcs AAA batteries) | 2pcs AAA batteries | Same |
| Measurement time | 1 second | 1 second | Same |
| Measurement data
memories | 35 sets | 20 sets | Comparable
(Note 2) |
| Beeper setting | Yes | Yes | Same |
| Date and time
setting | No | No | Same |
| Backlight | Yes | Yes | Same |
| Auto-off time | 15s±1s | 30s | Similar
(Note 3) |
| Operation
Condition | Temperature: 10°C40°C106kPa | Temperature: 10°C
Relative Humidity: ≤95%
Atmospheric Pressure:
70kPa40°C106kPa | Comparable
Relative Humidity: ≤85%
AtmosphericPressure:
70kPa
(Note 4) |
| Storage and
| Temperature: -20°C50°C | Temperature: -20°C55°C | Comparable |
| Items | Subject Devices | Predicate Device (K191570) | Comments |
| transportation
condition | Relative Humidity: ≤95%
Atmospheric Pressure:
70kpa~106kpa | Relative Humidity: 15%93%106kpa | (Note 4) |
Atmospheric Pressure:
70kpa
| Protection against
electric shock | Externally power supply, Type BF | Externally power supply, Type BF | Same |
| IP Class | IP22 | IP22 | Same |
| Mode of operation | Continuous Operation | Continuous Operation | Same |
| Materials of skin-
contacting
components | ABS/ PA757(+);
PC/PC-110 | ABS | Comparable
(Note 5) |
| Physical
Dimensions | HT-101:1653850 mm;
HT-102:1563744mm;
HT-103:1555238 mm;
HT-104:1543950mm | Not available | Comparable
(Note 5) |
| Weight | HT-101: 62.5g (Battery excluded)
HT-102: 58g (Battery excluded)
HT-103: 64.5g (Battery excluded)
HT-104: 63g (Battery excluded) | Not available | Comparable
(Note 5) |
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Note 1: Measurement accuracy:
The measurement accuracy of the subject devices has been verified to meet the requirements of ISO80601-2-56 and ASTM E1965-98 standard. The difference does not raise different safety and effectiveness issues.
Note 2: Measurement data memories
The purpose of function of measurement data memories is intended to store and view the previous readings. This function has been verified during software verification. The difference does not raise any issues on the device safety and effectiveness.
Note 3: Auto-off time
Although the time of auto-off time is less than the predicate device, both the subject devices and predicate device meet the basic safety requirement of IEC 60601-1:2005+AMD 1: 2012. The difference itself does not raise any issues on the device safety and effectiveness.
Note 4: Operation, Storage and transportation condition
The differences in operating and storage does not raise any safety and effectiveness questions. The subject device has been tested according to IEC 60601-1-2 EMC, IEC 60601-1, and ISO 80601-2-56 and ASTM E1965-98 standards. Therefore, the difference does not raise any issues on the device safety and effectiveness.
Note 5: Materials of skin-contacting components, Physical Dimensions, and weight The subject devices and predicate device have different appearances, but the difference does not raise any new safety and effectiveness questions. This has been tested and confirmed according to IEC 60601-1-2 EMC, IEC 60601-1, and ISO 80601-2-56, ASTM E1965-98 and ISO 10993-1 standards.
7
7. Non-Clinical Test Summary
7.1. Electromagnetic Compatibility and Electrical Safety Test
The subject devices have passed safety testing in according to following standards.
-
- IEC 60601-1:2005+AMD 1: 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 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
7.2. Biocompatibility Test
The subject devices have passed biocompatibility tests in according to following standards.
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro 1) cytotoxicity
-
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
7.3. Performance Test-Bench
The subject devices have passed performance testing in according to following standards.
-
- ISO 80601-2-56:2017+AMD2018 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers 2) for Intermittent Determination of Patient Temperature
7.4. Software verification and validation
Software documentation consistent with moderate level of concern is submitted in this 510(k). System validation testing presented in this 510(k) demonstrates that all software requirement specifications are met and all software hazards have been mitiqated to acceptable risk levels
8. Clinical Accuracy Validation
Clinical accuracy validation testing was conducted according to ASTM E1965-98(Reapproved 2016). The clinical accuracy validation test report included temperature readings of 150 subjects, of which 50 subjects were infants, 50 subjects were children and the rest of the 50 subjects were adults (NOTE: Infants---newborn to one year; Children--greater than one to five years; Adults---greater than five years old.). The clinical accuracy validation test report demonstrates that the subject devices met the requirements for
8
clinical bias and clinical repeatability per ASTM E1965-98(Reapproved 2016).
9. Conclusion
The Infrared Thermometer (Model HT-101, HT-102, HT-103, HT-104) is substantially equivalent to the predicate device (K191570). This conclusion is based upon comparison of intended use, technological characteristics and applicable safety standards. Any differences in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.