(381 days)
Not Found
No
The description focuses on standard infrared sensing and signal processing via an ASIC, with no mention of AI/ML terms or functionalities.
No
The device is a non-contact infrared thermometer intended for measuring body temperature, which is a diagnostic function rather than a therapeutic one. It does not treat or alleviate any condition.
No
While a thermometer can be used as part of a diagnostic process (e.g., to detect fever), its primary function is measurement, not diagnosis. It provides data that a clinician might use to make a diagnosis, but it does not independently diagnose a condition.
No
The device description explicitly states it uses infrared sensors, an ASIC, and an LCD for display, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the DT-100 non-contact infrared thermometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- DT-100 Function: The DT-100 measures body temperature directly from the surface of the skin (the face) using infrared technology. It does not analyze any biological specimens.
Therefore, the DT-100 falls under the category of a medical device used for physiological measurement, but not an IVD.
N/A
Intended Use / Indications for Use
The DT-100 non-contact infrared thermometer is intended to be used to measure the body temperature using infrared sensors. It can detect the body temperature of all ages from human's face. The DT-100 infrared thermometer can be used by consumers in household environment.
Product codes
FLL
Device Description
The DT-100 non-contact infrared thermometer is intended to be used to measure the body temperature using infrared sensors. It can detect the body temperature of all ages from human's face. The operation principle is based on infrared sensor technology. IR sensor can put out different signal when measuring the different object temperature or body temperature. An ASIC can turn the signal from IR sensor to a digital value and display it by LCD. The DT-100 non-contact infrared thermometer can measure body temperature at maximum 40cm between patient and product. The thermometer stores temperature measurement value up to 30, a user can compare prior measurement value and uses an alkaline battery AAA type for operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human's face
Indicated Patient Age Range
all ages
Intended User / Care Setting
consumers in household environment
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)
The clinical investigation was conducted at Yonsei University Severance Hospital (Accredited by IRB) to evaluate the clinical accuracy and clinical repeatability of DT-100 non-contact infrared thermometer. The clinical bias was calculated as 0.02℃, which are acceptable because data did not exceed accuracy requirement specified in the ASTM E1965-98 standard as follow.
- Temperature range from 36 to 39 °C (96.8 to 102.2 °F), 0.2 °C (0.4 °F)
- Temperatures less than 36 °C (96.8°F) or greater than 39 °C (102.2 °F), 0.3 °C (0.5 ° F)
The standard deviation( dt)) was calculated from the temperature differences as +0.60℃. The clinical repeatability(S), of all participants is 0.12, that may be considered reasonably small and not to pose a problem for diagnostic purposes. As a result of the test, the DT-100 non-contact infrared thermometer is considered a clinically useful thermometer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical bias: 0.02℃
Clinical repeatability: 0.12
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.
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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2017
Mediana Co., Ltd. % Charlie Mack Principal Engineer International Regulatory Consultants 2550 Duportail Street M275 Richland, Washington 99352
Re: K160358
Trade/Device Name: DT-100 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 18, 2017 Received: January 24, 2017
Dear Charlie Mack:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160358
Device Name DT-100
Indications for Use (Describe)
The DT-100 non-contact infrared thermometer is intended to be used to measure the body temperature using infrared sensors. It can detect the body temperature of all ages from human's face. The DT-100 infrared thermometer can be used by consumers in household environment.
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 K160358
Submitter's Identification
Mediana Co., Ltd 132, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Republic of Korea Tel) (82) 33 742 5400 Fax) (82) 33 742 5483
Contact: Min-hye, Kim January 15th, 2016 Date Summary Prepared:
Name of Device
| Trade Name: | DT-100 |
|---|---|
| Common Name: | Clinical electronic thermometer |
| Regulation: | 21 CFR 880.2910 |
| Classification: | Class II |
| Product Code: | FLL |
Predicate Device Information
The predicate device for the DT-100 Infrared Thermometer is:
- SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD Infrared Thermometer . Model DT-8806H/DT-8806 cleared by FDA through 510(k) No. K101736
Device Description
The DT-100 non-contact infrared thermometer is intended to be used to measure the body temperature using infrared sensors. It can detect the body temperature of all ages from human's face. The operation principle is based on infrared sensor technology. IR sensor can put out different signal when measuring the different object temperature or body temperature. An ASIC can turn the signal from IR sensor to a digital value and display it by LCD. The DT-100 noncontact infrared thermometer can measure body temperature at maximum 40cm between patient and product. The thermometer stores temperature measurement value up to 30, a user can compare prior measurement value and uses an alkaline battery AAA type for operation.
Indications for Use
The DT-100 non-contact infrared thermometer is intended to be used to measure the body temperature using infrared sensors. It can detect the body temperature of all ages from human's face. The DT-100 infrared thermometer can be used by consumers in household environment.
4
Comparison to Predicated Devices
The infrared thermometer, model DT-100 is substantially equivalent to the SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD, infrared thermometer, model DT-8806H/DT-8806, K101736 which has the same intended use and is similar in design to the predicate device.
| Characteristics | Subject Device | Predicate Device |
|---|---|---|
| Device name | DT-100 | DT-8806H/DT-8806 |
| K number | K160358 | K101736 |
| Manufacturer | Mediana Co., Ltd. | Shenzhen Everbest Machinery Industry |
| Co., Ltd. | ||
| Measurement method | Infrared radiation detection | Same as DT-100 infrared thermometer |
| Indications for use | The DT-100 non-contact infrared | |
| thermometer is intended to be used | ||
| to measure the body temperature | ||
| using infrared sensors. It can detect | ||
| the body temperature of all ages | ||
| from human's face. The DT-100 | ||
| infrared thermometer can be used | ||
| by consumers in household | ||
| environment. | 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. | ||
| Physical | ||
| dimension/weight | Dimensions: 52.3 x 34.3x143.5 | |
| (mm) (WxHxL) | ||
| Weight : 111g (including batteries) | Dimensions: 82 x43x134 (mm) | |
| (WxHxL) | ||
| Weight : 205g | ||
| Display | LCD | Same as DT-100 infrared thermometer |
| Device Pictures | ||
| Button | Soft keys | Same as DT-100 infrared thermometer |
| Battery type | Alkaline battery AAA type | Alkaline battery AA type |
| Voltage | DC 3V (1.5V, 2EA) | Same as DT-100 infrared thermometer |
| Buzzer | - Set the sound on/off function |
- Inform the temperature
measurements and error
situations of the environmental
conditions | Same as DT-100 infrared thermometer |
| Operating condition | Temperature:
10 to 40°C (50 to 104°F) | Temperature:
10 to 40 °C (50 to 104°F): DT-8806H
0 to 50°C (32 to 122°F): DT-8806 |
| | Relative Humidity:
30 to 95% | Relative Humidity:
10 to 90% |
| | Altitude:
70 to 106kPa | N/A |
| Storage condition | Temperature: - 20 to 50°C (-68 to 122°F) | Temperature:
- 20 to 60°C (-4 to 140°F): DT-8806H
0 to 50°C (32 to 122°F): DT-8806 |
| Characteristics | Subject Device | Predicate Device |
| | Relative Humidity:
15 to 95% | Relative Humidity:
IEC 60068-2-27 Drop shock test report - A IEC 60068-2-64 Vibration test report
- IEC 60068-2-1, IEC 60068-2-2, IEC 60068-2-30, Temperature and humidity for A operation/storage test report
- ASTM E1965-98 test report (Standard specification for infrared thermometers for A intermittent determination of patient temperature)
- A Atmospheric test report
- A ISTA 2A test report
- A Cleaning validation test report
- A Battery discharge test report
- A Free fall test report
- A Verification and validation plan/test report
- A Verification report
- Clinical accuracy validation test report A
- ISO 10993-5, In Vitro Cytotoxicity test report A
- ISO 10993-10, Skin Irritation and Sensitization test report A
Compliance to applicable standards includes IEC 60601-1-2, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60068-2-27, IEC 60068-2-64, IEC 60068-2-1, IEC 60068-2-2, IEC 60068-2-30, ASTM E1965-98, ISTA 2A, ISO 10993-5, ISO 10993-10 requirements.
The bench test report of this submission showed that substantial equivalence has demonstrated to be suitable for the subject device.
8
Discussion of Clinical Tests Performed:
The clinical investigation was conducted at Yonsei University Severance Hospital (Accredited by IRB) to evaluate the clinical accuracy and clinical repeatability of DT-100 non-contact infrared thermometer. The clinical bias was calculated as 0.02℃, which are acceptable because data did not exceed accuracy requirement specified in the ASTM E1965-98 standard as follow.
- Temperature range from 36 to 39 °C (96.8 to 102.2 °F), 0.2 °C (0.4 °F) A
-
Temperatures less than 36 °C (96.8°F) or greater than 39 °C (102.2 °F), 0.3 °C (0.5 ° F)
The standard deviation( dt)) was calculated from the temperature differences as +0.60℃. The clinical repeatability(S), of all participants is 0.12, that may be considered reasonably small and not to pose a problem for diagnostic purposes. As a result of the test, the DT-100 non-contact infrared thermometer is considered a clinically useful thermometer.
Conclusions
The DT-100 non-contact infrared thermometer has the same intended use and similar technological characteristics as the predicated device, model DT-8806. Moreover, bench testing contained in this submission. Thus, the DT-100 non-contact infrared thermometer is substantially equivalent to predicated device.