Infrared Ear Thermometer ET-101A is indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment. It's intended for use on people of all ages.

Device Description

Infrared Ear Thermometer ET-101A is electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.
To measure ear temperature, put a new clean probe cover on the infrared ear thermometer, then insert it into a patient's outer ear canal. A test button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a LCD display. The total operation takes a few seconds.

AI/ML Overview

The provided text describes a 510(k) summary for the Infrared Ear Thermometer ET-101A, comparing it to a predicate device and outlining non-clinical and clinical tests. However, it does not explicitly state detailed acceptance criteria with numerical targets or specific performance metrics that were compared against those criteria.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states compliance with ASTM E1965-98 for non-clinical standards and implies that clinical studies evaluated clinical bias, clinical uncertainty, and clinical repeatability. However, specific numerical acceptance criteria (e.g., maximum allowable bias, precision limits) for these parameters and the reported performance values are not explicitly detailed in the provided text. The document concludes that the device is "substantially equivalent" to the predicate, implying it meets comparable performance levels.

Acceptance Criterion	Reported Device Performance
Non-Clinical:
Compliance with ASTM E1965-98	Compliant
Compliance with IEC60601-1	Compliant
Compliance with IEC60601-1-2	Compliant
Clinical:
Clinical Bias	Evaluated (Specific values not provided)
Clinical Uncertainty	Evaluated (Specific values not provided)
Clinical Repeatability	Evaluated (Specific values not provided)

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

Sample Size for Test Set: Not explicitly stated. The document mentions "Controlled human clinical studies were conducted using the Infrared Ear Thermometer ET-101A" but does not give a number for participants.
Data Provenance: Not explicitly stated. The document indicates "human clinical studies were conducted," but details like country of origin or whether the data was retrospective or prospective are not provided. Given it's a clinical study, it's typically prospective.

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

This information is not provided in the document. For a thermometer, "ground truth" would typically refer to a reference temperature measurement method, not expert consensus on an image or diagnosis.

4. Adjudication Method for the Test Set:

This information is not provided. As "ground truth" for a thermometer is usually a reference device, a human adjudication method like 2+1 or 3+1 for diagnostic interpretation is not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, and an AI provides assistance. For a thermometer, the output is a numerical temperature reading, not an interpretation by a human reader.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the clinical evaluation of the thermometer's performance (clinical bias, uncertainty, repeatability) would inherently be a standalone performance evaluation of the device itself, as it directly measures a physical parameter. There is no "human-in-the-loop" influencing the temperature reading provided by the device.

7. The Type of Ground Truth Used:

The type of ground truth used for clinical studies of a thermometer would typically be comparison to a precisely calibrated reference thermometer or a "gold standard" clinical thermometry method (e.g., rectal thermometer, central venous temperature) under controlled conditions. The document states "Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Sejoy Clinical Test Protocol outline," implying such a comparison was performed, but the specific "gold standard" used is not mentioned.

8. The Sample Size for the Training Set:

This information is not applicable/provided. Thermometers like the ET-101A typically do not employ machine learning or AI algorithms that require a "training set" in the conventional sense. Their operation is based on established physical principles (infrared detection) and calibration procedures. If any internal calibration or adjustment uses data, it's not described as a "training set" in this context.

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

This information is not applicable/provided for the reasons stated in point 8.

Summary

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SEP 1 7 2008

K$\phi$82192 (l. l$\alpha$2)

510(K) SUMMARY

The 510(k) summary is selected by my Sejoy Electronics & Instruments Co., Ltd for this submission.

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.

The assigned 510(k) number is:

1. Submitter's Identification:

Name: SEJOY ELECTRONICS &. INSTRUMENTS CO., LTD Add .: 4th Floor, B2 Building, Feng-Tan-Lu Industrial Zone, West Lake District, Hangzhou, P. R. China Tel.: 0086-571-81957767 Fax: 0086-571-81957750 Name of contact person: Mr. Ren Yunhua Prepared date: November 17, 2007

2. Name of the Device:

Trade name: Infrared Ear Thermometer ET-101A Common name: Clinical Electronic Thermometer Classification Name: Thermometer, Electronic, Clinical Class: II Panel: 80 Procode: FLL- Clinical Electronic Thermometer Regulation Number: 21 CFR 880.2910

Predicate Device Information: 3.

BRAUN THERMOSCAN IRT 4520 510(k) number: K031928 Applicant: BRAUN GMBH Owner: THE GILLETTE COMPANY

4. Device Description:

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(482192 (0.2022)

To measure ear temperature, put a new clean probe cover on the infrared ear thermometer, then insert it into a patient's outer ear canal. A test button is pressed to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a LCD display. The total operation takes a few seconds.

ട്. Intended Use:

The devices Model ET-101A is intended to measure the human body temperature from the auditory canal. The devices are reusable for home use on people of all ages.

6. Comparison to Predicate Devices:

The device Infrared Ear Thermometer ET-101A is similar in design and intended use to BRAUN THERMOSCAN IRT 4520, differing mostly in physical dimensions, display resolution, battery replacement method.

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

Compliance to applicable voluntary standards includes ASTM E1965-98, as well as IEC60601-1 and IEC60601-1-2 requirements.

Guidance documents included the "FDA Guidance on the Content of Premarket Notification 510(K) Submissions for Clinical Electronic Thermometers.

8. Discussion of Clinical Tests Performed:

Controlled human clinical studies were conducted using the Infrared Ear Thermometer ET-101A. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Sejoy Clinical Test Protocol outline.

9. Conclusions:

Infrared Ear Thermometer ET-101A has the same intended use and similar technological characteristics as the BRAUN THERMOSCAN IRT 4520. Moreover, information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the Ear Thermometer ET-101A is substantially equivalent to the predicate devices.

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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 an abstract eagle design with three talons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 2008

Sejoy Electronics & Instruments Company, Limited C/O Mr. Tzu-Wei Li Responsible Third Party Officer Center for Measurement Standards/Industrial Technology Research Institute Building 16, 321 Kuang Fu Road, Section 2 Hsinchu, Taiwan 30042 REPUBLIC OF CHINA

Re: K082192

Trade/Device Name: Infrared Ear Thermometer ET-101A Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 9, 2008 Received: September 10, 2008

Dear Mr. Li:

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 - Mr. Li

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly yours.

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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Image /page/4/Picture/0 description: The image shows the text "Kø82192" in a handwritten style, followed by the words "Indications for Use" in a bold, sans-serif font. The handwritten text appears to be a code or identifier, while the phrase below suggests the image is related to instructions or guidelines for a product or procedure. The contrast between the handwritten and printed text creates a visual hierarchy, emphasizing the "Indications for Use" as the main subject.

510(k) Number (if known): Device Name: Infrared Ear Thermometer ET-101A Indications For Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K 482192

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.