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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the DT-100 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (ASTM E1965-98 Standard)	Reported Device Performance (DT-100)
Temperature range: 36 to 39 °C (96.8 to 102.2 °F), accuracy ± 0.2 °C (0.4 °F)	Clinical bias: 0.02 °C (within ±0.2°C)
Temperatures < 36 °C (96.8°F) or > 39 °C (102.2 °F), accuracy ± 0.3 °C (0.5 ° F)	Clinical bias: 0.02 °C (within ±0.3°C)
Repeatability (standard deviation)	Clinical repeatability (S): 0.12 (considered reasonably small)

2. Sample Size Used for the Test Set and Data Provenance

The exact sample size for the clinical test set is not explicitly stated. The text mentions "all participants" in reference to repeatability, suggesting a cohort of individuals.

Provenance: The clinical investigation was conducted at Yonsei University Severance Hospital, Republic of Korea. The study was prospective as it involved a clinical investigation to evaluate the device's accuracy and repeatability.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth. It states that the clinical investigation was conducted at an "Accredited by IRB" hospital, implying ethical oversight and likely involvement of medical professionals in the data collection process. However, the exact method for determining "ground truth" temperature (e.g., comparison to rectal thermometer, other validated method) is not detailed.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The "clinical bias" and "clinical repeatability" were calculated based on the measurements obtained during the clinical investigation, implying a direct comparison to a reference standard rather than an adjudicated interpretation of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. This device is a thermometer, and the evaluation focuses on its accuracy and repeatability against a reference, not on how it assists human readers in interpreting images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was done for the device. The clinical accuracy and repeatability validation test reports, which are part of the listed performance testing, would reflect the device's intrinsic performance. The clinical investigation directly assessed the device's ability to measure temperature.

7. Type of Ground Truth Used

The type of ground truth used was likely a clinical reference standard for temperature measurement, against which the DT-100's readings were compared. While not explicitly stated, in a clinical thermometer validation, this typically involves a highly accurate and validated method (e.g., rectal thermometer, or another established core body temperature measurement technique) as the "truth." The document mentions that the clinical bias and repeatability were evaluated against requirements of the ASTM E1965-98 standard, which specifies reference thermometry.

8. Sample Size for the Training Set

The document does not provide information about a training set since this is a medical device (thermometer) and not a machine learning/AI algorithm that requires a separate training phase. The discussion focuses on the validation of the device's performance through clinical and bench testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable as there is no mention of a training set for this device.

Summary

{0}------------------------------------------------

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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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

Indications for Use

{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 IndustryCo., Ltd.
Measurement method	Infrared radiation detection	Same as DT-100 infrared thermometer
Indications for use	The DT-100 non-contact infraredthermometer is intended to be usedto measure the body temperatureusing infrared sensors. It can detectthe body temperature of all agesfrom human's face. The DT-100infrared thermometer can be usedby consumers in householdenvironment.	DT-8806H/DT-8806 Non-contact bodyinfrared thermometer is designed forbody surface and forehead temperaturemeasurement for infants and adultswithout contact to human body.
Physicaldimension/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 temperaturemeasurements and errorsituations of the environmentalconditions	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-8806H0 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-8806H0 to 50°C (32 to 122°F): DT-8806
Characteristics	Subject Device	Predicate Device
	Relative Humidity:15 to 95%	Relative Humidity:< 85%
	Altitude:70 to 106kPa	N/A
Automaticallyshutdown	Within 30 seconds	Within 7 seconds
Memory	saves total 30 temperaturemeasurement values	Same as DT-100 infrared thermometer
Method	Infrared sensor technology	Same as DT-100 infrared thermometer
Unit of measure	Celsius(°C) and Fahrenheit(°F)	Same as DT-100 infrared thermometer
Measurement mode	Body temperature mode	Same as DT-100 infrared thermometer
Measurement site	Face surface	Forehead
Temperaturemeasurement range	22.0 to 42.4°C (71.6 to 108.3°F)	32.0 to 42.5°C (90 to 108°F)
Temperaturemeasurementaccuracy	- 22.0 to 35.9°C (71.6 to 96.6°F) ± 0.3°C (32.5°F)- 36.0 to 39.0°C (96.8 to 102.2°F) ± 0.2°C (32.4°F)- 39.1 to 42.4°C (102.4 to 108.3°F) ± 0.3°C (32.5°F)	± 0.3°C (32.5°F)
Display resolution	0.1°C (0.1°F)	Same as DT-100 infrared thermometer
Measurement distance	30 ~ 40 cm	5 ~ 15 cm
Patient contactmaterials	Case: ABS 780, TPEMount Cradle: ABS 780, TPE	-
Cleaning/disinfection	cleans the device with a soft clothdampened with either acommercial, nonabrasive cleaner orone of the solutions listed below.Lightly wipe the surfaces of thethermometer.- 70% Isopropyl alcohol- 10% Chlorine bleach solution	cleans the device with a cotton budlightly moistened with 70% alcohol
Performance testing	The test results showed that subjectdevice is satisfied with the followingtest report and conformancestandard.- IEC 60601-1 test report(General requirements forsafety)- IEC 60601-1-2 test report(General requirements forsafety - Collateral standard:Electromagnetic compatibility- requirements and tests)- IEC 60601-1-6, IEC 62366Usability test report- IEC 60601-1-11 test report(General requirements forbasic safety and essentialperformance-CollateralStandard: Requirements formedical electrical equipmentand medical electrical systems	- IEC 60601-1- IEC 60601-1-2- ISO 14971- EN ISO 10993-5- EN ISO 10993-10
Characteristics	Subject Device	Predicate Device
	used in the home healthcareenvironment)
	- IEC 60068-2-27 Drop shocktest report
	- IEC 60068-2-64 Vibration testreport
	- IEC 60068-2-1, IEC 60068-2-2, IEC 60068-2-30,Temperature and humidity foroperation/storage test report
	- ASTM E1965-98 test report(Standard specification forinfrared thermometers forintermittent determination ofpatient temperature)
	- Atmospheric test report
	- ISTA 2A test report
	- Cleaning validation test report
	- Battery discharge test report
	- Free fall test report
	- Verification and validationplan/test report
	- Verification report
	- Clinical accuracy validationtest report
	- ISO 10993-5, In VitroCytotoxicity test report
	- ISO 10993-10, Skin Irritationand Sensitization test report

{5}------------------------------------------------

{6}------------------------------------------------

Discussion of Differences between the Subject Device and the Predicate Device:

The DT-100 non-contact infrared thermometer has substantially equivalent measurement method and technological characteristics as the predicate device. The differences between the subject device and the predicate device are as follows.

Indications for use

The subject device, Model DT-100 and predicate device, Model DT-8806/DT-8806H are intended to be used to measure the body temperature using infrared sensor. The DT-100 can detect the body temperature of all ages from human's face, while the predicated device, Model DT-8806H/DT-8806 can detect the body temperature for infants and adults from human's forehead.
-The clinical performance test and data analysis for difference between the subject device and the predicate device have performed.
-The repeatability and accuracy of the subject device has complied with the requirements the ASTM 1965 standard in accordance with clinical performance test protocol.
-Therefore the indications for use difference does not affect the safety and effectiveness of the device.

Temperature measurement range and operating/storage condition

The temperature measurement range and operating/storage condition are satisfied with the requirements the ASTM 1965 standard.

{7}------------------------------------------------

Measurement site and distance

The operating principle of DT-100 and the predicated device, Model DT-8806/DT-8806H are "the same". The two devices are designed under the same principle which an electronic thermometer using the infrared sensor to detect human body temperature. The DT-100 design has improved by applying multi-sensors, while the predicated device, Model DT-8806H/DT-8806 has a single sensor. The DT-100 can be measured with wide area (face) using multi-sensors, while the predicated device, Model DT-8806 can be measured with narrow area (forehead) using single sensor.
-The clinical performance test and data analysis for difference between the subject device and the predicate device have performed.
-The repeatability and accuracy of DT-100 has complied with the requirements the ASTM 1965 standard in accordance with clinical performance test protocol.

Patient contact materials

The biocompatibility testing of subject device, DT-100, was conducted in accordance with . . the ISO 10993-5 and ISO 10993-10.

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following test report:

IEC 60601-1 test report (General requirements for safety) A
A IEC 60601-1-2 test report (General requirements for safety - Collateral standard: Electromagnetic compatibility - requirements and tests)
A IEC 60601-1-6, IEC 62366 Usability test report
A IEC 60601-1-11 test report (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)
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.

Regulation Number and Section

§ 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.