The Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

Device Description

The Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) is hand-held, non-sterile, reusable, battery operated device that can measure human body temperature via the human ear. Operation is based on the measuring of the natural thermal infrared radiation emitted from the ear tympanic.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Criteria	Acceptance Criteria (Predicate Device K103800)	Reported Device Performance (Thermo Pal ETH-101)
Measured Temperature Range	34°C~~42.2°C (93.2°F~~108°F)	32~~43°C (89.6~~109.5°F)
Operating Ambient Temperature	10°C~40°C	10°C~40°C
Storage Ambient Temperature	-20°C~50°C	-20°C~50°C
Accuracy	$\pm$0.2°C (0.4°F) for 36.0°C-39.0°C (96.8°F-102.2°F); $\pm$ 0.3°C (0.5°F) outside this range	$\pm$0.2°C, 36~~39°C ( $\pm$0.4°F, 96.8~~102.2°F); $\pm$0.3°C, the rest ( $\pm$0.5°F, the rest)
Resolution	0.1°C / 0.1°F	0.1°C / 0.1°F

2. Sample size used for the test set and data provenance:

The document mentions "A Clinical Test Report conducted according to ASTM E1965: 2003" but does not specify the sample size used for the test set.

The data provenance is described as "conducted by manufacturer," suggesting it was conducted by Digio2 International Co., LTD. The country of origin of the data is not explicitly stated, but the manufacturer is based in Taipei Hsien, Taiwan. The study appears to be prospective as it was "carried out in such a way that compared the accuracy performance between Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) and the predicate device."

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth in the clinical test.

4. Adjudication method for the test set:

The document does not specify any adjudication method used for the test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device described is an infrared ear thermometer, which is a standalone measurement device and does not involve human readers or AI assistance in the context of diagnostic interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, a standalone performance test was done, as the device is an infrared ear thermometer. The "Clinical Test Report" assessed the device's accuracy against a predicate device without human-in-the-loop performance.

7. The type of ground truth used:

The type of ground truth used for checking the accuracy of the Thermo Pal Infrared Ear Thermometer was comparison with a predicate device (BRAUN THERMOSCAN IRT 4000 series). Specifically, the report "compared the accuracy performance between Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) and the predicate device according to the method recommended in ASTM E1965 standard." This implies that the predicate device's readings served as the reference or "ground truth" for comparison.

8. The sample size for the training set:

The document does not mention a training set as this device is a hardware measurement instrument and not an AI/machine learning algorithm that requires training data.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

Summary

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510(K) SUMMARY

JAN 1 3 2012

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

Date of Preparation: Sept. 1, 2011

1. Submitter's Name:	Digio2 International Co., LTD.
Address:	4F-13, No. 79, Sec. 1, Hsin Tai Wu Rd., Hsi-Chih, Taipei Hsien 221, Taiwan
Phone:	+886-2-2698-5593
Fax:	+886-2-2698-1274
Contact:	Casper Chen, President

1. Device Name

Trade Name:	Thermo Pal Infrared Ear Thermometer,
	Model no.: ETH-101
Common Name:	IR Thermometer
Classification name	thermometer, electronic, clinical
3. Device Class:	The Thermo Pal Infrared Ear Thermometer, (Model no.: ETH-101)has been classified asRegulatory Class: IIPanel: 80Product Code: FLLRegulation Number: 21CFR 880.2910

4. Predicate Device: The predicate device is the

BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED . EAR THERMOMETERS (K103800) marketed by BRAUN AG.

The Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) is 5. Intended Use: infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
Product: Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) Page 1 of 4 Section 4 - 510(k) Summary REV. 【B】

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1. Device The Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) is hand-held, non-sterile, reusable, battery operated device that can Description: measure human body temperature via the human ear.
  Operation is based on the measuring of the natural thermal infrared radiation emitted from the ear tympanic.

The Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101)

technological characteristics as predicate devices. Please find

1. Comparison to 510(k) Predicate has the same intended use, principles of operation, and similar Devices & Substantial Equivalence Discussion
  ﺘﯿﻤ

Item	Thermo Pal Infrared EarThermometer(Model no.: ETH-101)	Predicate DeviceBraun THERMOSCANIRT4520/4020 ClinicalInfrared Ear Thermometer(K103800)
RegulationNumber:	21CFR 80.2910	21CFR 880.2910
DisplayedTemperatureRange	32~~43°C(89.6~~109.5°F)	34°C~~42.2°C(93.2°F~~108°F)
AmbientTemperatureEnvironment	1. Operating: 10°C~~40°C2. Storage: -20°C~~50°C	1. Operating: 10°C~~40°C2. Storage: -20°C~~50°C
Accuracy	±0.2°C, 36~~39°C±0.3°C, the rest(±0.4°F, 96.8~~102.2°F±0.5°F, the rest)	1. 36.0°C(96.8°F) to39.0°C(102.2°F):± 0.2°C (0.4°F)2. Outside this range:± 0.3°C (0.5°F)
Resolution	0.1°C / 0.1°F	0.1°C / 0.1°F
Display	Three different backing color4 digit LCD screen	Three different backing color4 digit LCD screen
Components	Main components:1. Chip IC (μP)2. IR Sensor3. LCD(Liquid CrystalDisplay)	Main components:1. Chip IC (μP)2. IR Sensor3. LCD(Liquid CrystalDisplay)
Powerrequirements	Two 1.5Vdc AlkalineManganese battery (AAA)	Two 1.5Vdc AlkalineManganese battery (AAA)

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SUBSTANTIAL EQUIVALENCE DISCUSSION:

Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) has the same general design with the predicate devices. It has the following similarities to the predicate devices in:

· having the same intended use
· using similar operating principle
· using similar technological characteristics

In summary, the Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) described in this submission are, in our opinion, substantially equivalent to the predicate devices.

Non-Clinical Discussion of Non-Clinical Tests Verification Activities Performed to Tests Verification Determine the Safety and Performance of Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) are as the followings:

1. Performance Compliance Test according to ASTM E1965: 2003 conducted by manufacturer
1. Electrical Safety Compliance Test according to IEC 60601-1 by accredited laboratory.
1. EMC Compliance Test according to IEC 60601-1-2 by accredited laboratory.
1. Clinical Test for Discussion of Clinical Test Validation Activities Performed to Determine the Measurement Effectiveness of Device are as the followings: Accuracy

A Clinical Test Report conducted according to ASTM E1965: 2003 performed by the manufacturer was included as Clinical Investigation report. This report was carried out in such a way that compared the accuracy performance between Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) and the predicate device according to the method recommended in ASTM E1965 standard.

The results of the Clinical Test Report could positively support the claim of Substantial Equivalence for Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) against the chosen 510K predicate device.

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10. Conclusions:

The Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) has the same intended use and similar technological characteristics as the BRAUN THERMOSCAN IRT4520/4020 CLINICAL INFRARED EAR THERMOMETERS (K103800) marketed by BRAUN AG.. Moreover, bench testing contained in this submission demonstrates that any differences in their technological characteristics DO NOT RAISE ANY NEW QUESTIONS OF SAFETY OR EFFECTIVENESS. Thus, the Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) is substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings outstretched, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The eagle is depicted in black and white, and the text is also in black.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN 1 3 2012

Digio2 International Company, Limited C/O Ms. Jennifer Reich Senior Consultant Harvest Consulting Corporation, USA 2904 N. Boldt Drive Flagstaff, Arizona 86001

Re: K112189

Trade/Device Name: Thermo Pal Infrared Ear Thermometer, Model no.: ETH-101 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: November 2, 2011 Received: November 14, 2011

Dear Ms. Reich:

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.

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Page 2 - Ms. Reich

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Meni

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):____K112189

Thermo Pal Infrared Ear Thermometer Device Name: Model no .: ETH-101 Digio2 International Co., LTD.

Indications for Use:

The Thermo Pal Infrared Ear Thermometer (Model no.: ETH-101) is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Star for Rze

(Division Sign-Üff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K112180 510(k) Number:

Page 1 of 1

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.