(175 days)
No
The description details a standard infrared thermometer using a thermopile sensor and basic temperature conversion, with no mention of AI, ML, or related concepts.
No
This device is an infrared thermometer, intended for measuring body temperature, which is a diagnostic function, not a therapeutic one. It does not provide any treatment or therapy.
Yes
The device is an infrared thermometer intended for the measurement of human body temperature from the forehead, which is used to obtain information about a physiological state (temperature). While it doesn't provide a diagnosis on its own, it provides data that can be used to aid in a diagnosis of conditions such as fever.
No
The device description explicitly states it is a hand-held, battery-powered device that employs a thermopile sensor to detect infrared thermal energy. This indicates the device includes significant hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The Infrared thermometer described measures human body temperature from the forehead. This is a measurement taken directly from the living body (in vivo), not from a sample taken from the body.
Therefore, based on the intended use and device description, this infrared thermometer falls under the category of a medical device used for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Infrared thermometer is intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.
Product codes
FLL
Device Description
The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the central forehead for clinical or home use.
The thermometers are powered by AAA 1.5 V×2 alkaline batteries. The results can be displayed on LCD. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or ºF.
The Infrared thermometer included DT-8806S, DT-8807S. These two models are identical on hardware and software except the physical dimensions and appearance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared radiation detection
Anatomical Site
Forehead
Indicated Patient Age Range
People of all ages (Infants---newborn to one year; Children--- greater than one to five years; Adults--- greater than five years old.)
Intended User / Care Setting
Home use and clinical use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing: The biocompatibility evaluation for the Infrared thermometer was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests: Cytotoxicity, Sensitization, Irritation.
Non-clinical data: The Infrared thermometer has been tested according to the following standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-56, IEC 60601-1-11. The test was selected to show substantial equivalence between the subject device and the predicate.
Clinical data: Clinical testing is conducted per ASTM E 1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consists of a minimum of 150 subjects, of which 1/3 are children and the rest 1/3 are adults. The test result demonstrated the clinical performance of the subject device complied with the requirement of standard ASTM E 1965-98 (Reapproved 2016).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/- 0.2°C (0.4°F) within 36.0°C ~ 39.0°C, (96.8°F ~ 102.2°F), +/- 0.3°C (0.6°F) within 32°C ~35.9°C (89.6°F 96.6°F) and 39.1°C42.5°C (102.3°F ~108.5°F)
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
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April 16, 2021
Shenzhen Everbest Machinery Industry Co., LTD % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, 518067 Cn
Re: K203170
Trade/Device Name: Infrared Thermometer, Models: DT-8806S, DT-8807S Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: March 15, 2021 Received: March 15, 2021
Dear Kevin Wang:
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 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,
for Payal Patel Acting Assistant 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) K203170
Device Name
Infrared Thermometer, Models: DT-8806S, DT-8807S
Indications for Use (Describe)
The Infrared thermometer is intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.
Type of Use (Select one or both, as applicable)
| Registration Under Part 4 of STP 92-1 Select Sites | |
|---|---|
| Coverage Under Part 4 of STP 92-1 Select Sites |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: March 11, 2021
1. Submission sponsor
Name: SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD.
Address: 19th Building, 5th Region, Baiwangxin Industrial Park, Songbai Rd., Baimang, Xili, Nanshan, Shenzhen, Guangdong, China 518108 Contact person: Deng Aiguo Title: Quality Manager E-mail: dengaiguo(acem-meter.com.cn
2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067
Contact person: Kevin Wang E-mail: kevin(@chonconn.com
Tel: +86-755 33941160
| 3. Subject Device Information | |
|---|---|
| Trade/Device Name | Infrared Thermometer |
| Model | DT-8806S, DT-8807S |
| Common Name | Infrared Thermometer |
| Regulatory Class | Class II |
| Classification | 21CFR 880.2910 / Clinical electronic thermometer / FLL |
| Submission type | Traditional 510(K) |
2 Subiect Device Information
Predicate Device 4.
SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD. Infrared thermometer Models: DT-8806, DT-8806H, Regulation 21 CFR 880.2910, Product Code FLL, under K 101736.
5. Device Description
The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the central forehead for clinical or home use.
The thermometers are powered by AAA 1.5 V×2 alkaline batteries. The results can be displayed on LCD. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or ºF
4
The Infrared thermometer included DT-8806S, DT-8807S. These two models are identical on hardware and software except the physical dimensions and appearance.
Intended use & Indication for use 6.
The Infrared thermometer is intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.
| | Subject device
Infrared thermometer: DT-
8806S, DT-8807S | Predicate device K101736
Infrared thermometer: DT-
8806, DT-8806H | Note |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Features | | | |
| Regulation number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Product code | FLL | FLL | Same |
| Intended Use &
Indications for use | The Infrared thermometer is
intended for the intermittent
measurement of human body
temperature from forehead for
people of all ages. The device is
reusable for home use and clinical
use. | Infrared Thermometer Model:
DT-8806H/DT-8806 Non-
contact body infrared
thermometer is designed for body
surface and forehead temperature
measurement for infants and
adults without contact to human
body. | Different (1) |
| Measurement
Method | Infrared radiation detection,
adjusted mode | Infrared radiation detection,
adjusted mode | Same |
| Measurement
Range | $32.0°C ~42.5°C$
(89.6 to 108.5 ° F) | $32.0°C ~42.5°C$
(89.6 to 108.5 ° F) | Same |
| Accuracy | $±0.2°C (0.4°F) within$
$36.0°C ~ 39.0°C, (96.8°F ~$
$102.2°F),$
$±0.3°C(0.6°F) within$
$32°C ~35.9°C (89.6°F 96.6°F)$42.5°C (102.3°F$
and $39.1°C
$~108.5°F)$ | $±0.2°C (0.4°F) within$
$36.0°C ~ 39.0°C, (96.8°F ~$
$102.2°F),$
$±0.3°C(0.6°F) within$
$32°C ~35.9°C (89.6°F 96.6°F)$42.5°C (102.3°F$
and $39.1°C
$108.5°F)$ | Same |40°C (50°F
| Display | $0.1°C(0.1°F)$ | $0.1°C(0.1°F)$ | Same |
| Measurement
distance | 8806S: 1 cm - 10 cm
8807S: 1 cm - 4 cm | 5 cm - 15 cm | Different (2) |
| Measurement
place | Forehead
Surface | Forehead
Surface | Same |
| Sensor type | Thermopile | Thermopile | Same |
| Scale Selection | °C /°F | °C /°F | Same |
| Memory | 32 sets | 32 sets | Same |
| Features | Subject device
Infrared thermometer: DT-
8806S, DT-8807S | Predicate device K101736
Infrared thermometer: DT-
8806, DT-8806H | Note |
| Buzzer | Yes | Yes | Same |
| Auto
power-off
while no operation | Yes | Yes | Same |
| Power supply | 2 * 1.5V AAA | 2 * 1.5V AAA | Same |
| Display screen | LCD | LCD | Same |
| Contact materials | ABS | ABS | Same |
| Operation | 10104 °F) | 1040°C (50°F ~104 °F) | Same |
| Environment | RH ≤85% | RH ≤85% | Same |
| Storage condition | 0 to 50°C (32 to 122°F)
RH ≤85% | 0 to 50°C (32 to 122°F)
RH ≤85% | Same |
| Dimension | 128 * 74 * 36 mm | 149 * 77 * 43mm | --- |
| Weight | 104.5 g | 172 g | --- |
| Conformance
standard | ISO80601-2-56(performance),
IEC60601-1(Safety),
IEC60601-1-2(EMC)
ASTM E1965-98 | ISO80601-2-56(performance),
IEC60601-1(Safety),
IEC60601-1-2(EMC)
ASTM E1965-98 | Same |
| Biocompatibility | Under the condition of this study
the device is non-cytotoxic, non-
sensitizing and non-irritating. | Under the condition of this study
the device is non-cytotoxic, non-
sensitizing and non-irritating. | |
| Expected battery
life | 40000 times measure | 40000 times measure | |
| Measuring time | 1 second | 1 second | |
| Clinical accuracy | Meet the requirements of ISO
80601-2-56:2017, ASTM 1965-
98(2016) | Meet the requirements of ISO
80601-2-56:2017, ASTM 1965-
98(2016) | Same |
7. Comparison to the Predicate Device
5
Justification of difference:
Different (1): The description of the intended use is different. The population of the subject device is wider than the predicate device. The performance testing can demonstrate that the subject device can meet the requirement on this population. So, the different does not raise different questions of safety and effectiveness.
The subject device is only used to measure the body temperature from forehead. The clinical study report can demonstrate this measuring site. So, the different does not raise different questions of safety and effectiveness.
Different (2): The measurement distance is different. The performance testing can demonstrate that the subject device can meet the requirement on this measurement distance. So, the different does not raise different questions of safety and effectiveness.
6
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Infrared thermometer was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- . Cytotoxicity
- . Sensitization
- . Irritation
Non-clinical data
The Infrared thermometer has been tested according to the following standards:
- IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and essential performance
- IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- ISO 80601-2-56: Medical electrical equipment – Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
- IEC 60601-1-11: 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
The test was selected to show substantial equivalence between the subject device and the predicate.
Clinical data
Clinical testing is conducted per ASTM E 1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.
This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consists of a minimum of 150 subjects, of which 1/3 are children and the rest 1/3 are adults (NOTE: Infants---newborn to one year; Children--- greater than one to five years; Adults--- greater than five years old.). The test result demonstrated the clinical performance of the subject device complied with the requirement of standard ASTM E 1965-98 (Reapproved 2016).
9. Conclusion
Based on the perf ormance testing, comparison and analysis provided it was concluded that the subject device, Infrared Thermometer, Models: DT-8806S, DT-8807S is substantially equivalent to the Infrared Thermometer, Models: DT-8806, DT-8806H cleared under K101736