The device measures the body temperature from the auditory canal of of a patient by means of an infrared sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for home use on people of all ages.

Device Description

The Mesure ear thermometer, models ST66, and ST67, are the handheld electronic thermometers that measures the temperature through the opening of the auditory canal by using a thermopile as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view, the ear thermometer comprises of a thermopile for the measuring sensor, a reference thermistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared. This system uses a 3.0 V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of ST66 and ST67, they were designed and verified according to the US standard ASTM E 1965-00.

AI/ML Overview

Here’s a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document indicates that the device (Ear Thermometers Models ST66 and ST67) was designed and verified according to the US standard ASTM E 1965-00. It also states compliance with EN 60601-1 and EN 60601-1-2. However, the document does not explicitly list specific numerical acceptance criteria or reported device performance metrics from these standards. Instead, it makes a general statement of compliance and states that the devices maintain the "same safety and effectiveness" as the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from ASTM E 1965-00, EN 60601-1, and EN 60601-1-2)	Reported Device Performance (Models ST66 & ST67)
Specific numerical criteria for accuracy, precision, stability, etc., as defined by ASTM E 1965-00, EN 60601-1, and EN 60601-1-2 are implied but not explicitly stated in this document.	"Designed and verified according to the US standard ASTM E 1965-00." "Compliance to applicable voluntary standards includes ASTM E1965: 2000, as well as EN 60601-1, and EN 60601-1-2 requirement." "Verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate could maintain the same safety and effectiveness as that of cleared device."
Specific criteria regarding functional safety, electromagnetic compatibility, electrical safety, etc., as defined by EN 60601-1 and EN 60601-1-2 are implied but not explicitly stated.	"Compliance to applicable voluntary standards includes ASTM E1965: 2000, as well as EN 60601-1, and EN 60601-1-2 requirement."

Study Information

Sample size used for the test set and the data provenance:
- The document does not specify the sample size used for the test set.
- The document does not specify the data provenance (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The study described is an engineering verification and validation against standards, not a clinical study involving human readers or expert-established ground truth in the traditional sense of AI/medical imaging applications.
Adjudication method for the test set:
- This information is not applicable as the document does not describe a clinical study requiring expert adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The device is a standalone ear thermometer, not an AI-assisted diagnostic tool that would typically involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the evaluation described is essentially a standalone performance assessment against engineering standards (ASTM E1965-00, EN 60601-1, EN 60601-1-2). The device itself operates as a standalone measurement tool.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth would be established by calibrated reference standards and controlled environmental conditions as specified by the engineering standards (e.g., blackbody radiators for temperature, controlled ambient temperatures, etc.). It's not clinical diagnosis-based ground truth.
The sample size for the training set:
- This information is not applicable. The device is an electronic thermometer with an ASIC (Application Specific IC) - controlled circuit, not a machine learning or AI-based device that requires a "training set" in the conventional sense. The ASIC is described as "hard-wire control instead of programmable control."
How the ground truth for the training set was established:
- This information is not applicable as there is no training set for this device.

Summary

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K080981 (P. 1 of 2)

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92, and the relevant 510(k) submission quidance.

The assigned 510(k) number is:

Submitter's Identifications:

Company: Mesure Technology Co., Ltd.

Address: 7F, No. 86, Sec. 1, KwangFu Road, Sanchung City, Taipei Hsien, Taiwan, R.O.C. Contact person: John Chen / Ph. D.

1. Name of the Device: Ear Thermometer / Models ST66 and ST67
Information of the 510(k) Cleared Device (Predicate Device): 2. Ear Thermometer Model ST64 & ST65.(K040627)

ဒေ Device Description:

From the construction point of view, the ear thermometer comprises of a thermopile for the measuring sensor, a reference thermistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared.

This system uses a 3.0 V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of ST66 and ST67, they were designed and verified according to the US standard ASTM E 1965-00.

4. Intended Use:

The device measures the body temperature from the auditory canal of of a patient by means of an infrared sensor coupled with an electronic signal amplification. conditioning and digital LCD (display) unit. The device is reusable and intended for home use on people of all ages.

Comparison to the 510(k) Cleared Device (Predicate Device): 5.

Since the new models ST66 and ST67 were developed from the cleared device ST64 and ST5 through the design control procedures of Measure Technology Co., Ltd. with only the small change in dimension, device housing, and some non-performance and safety related features, the new device is substantial equivalence to that of device being modified. ST64 and ST65

1. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
  Compliance to applicable voluntary standards includes ASTM E1965: 2000, as well as EN 60601-1, and EN 60601-1-2 requirement.

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7. Conclusions

Kobo 981 (P.2052)

The Mesure ear thermometer thermometer, models ST66, and ST67 have the same intended use and technological characteristics as the cleared device of Measure's model ST64 and ST65. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate could maintain the same safety and effectiveness as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2008

John Chen, Ph.D. General Manager Mesure Technology Company, Limited 7F, No. 86 Sec. 1, Kwang Fu Road Sanchung City, Taipei Hsien, TAIWAN, R.O.C.

Re: K080981

Trade/Device Name: Ear Thermometer, Models ST66 and ST67 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 13, 2008 Received: April 7, 2008

Dear Dr. 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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Dr. Chen

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clive
Shin-Liang, Ph.D.

Chiu Lin. Ph.D. 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): ЌФ§Ф98ј

Device Name: Ear Thermometer, Models ST66 and ST67.

Indications For Use:

Prescription Use
(Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use
(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (QL

Cathong to me

(Division Sign-Off) Division of Anesthesiology, General Hospital tion Control, Dental Devices

510(k) Number: K984978

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.