Infrared Ear Thermometer (IRT-21 and IRT-22), designed with infrared technology, is used to measure body temperature from ear canal. Press the ON/OFF button to turn on the power, insert the probe into the ear canal then press the SCAN button to measure the temperature, when you hear a beep sound, the measurement is complete. Infrared Ear Thermometer (IRT-21 and IRT-22) is intended for household and hospital use on people of all ages.

Device Description

Infrared Ear Thermometer (IRT-21 and IRT-22) is used to measure body temperature from ear canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces. Probe cover is used for measuring to ensure accurate temperature measurement. For hygienic purpose, it is advised to discard the probe cover after each use. Press the ON/OFF button to turn on the power, the symbol 1888 appears immediately. Insert the probe into the ear canal then press the SCAN button to measure the temperature, when you hear a beep sound, the measurement is complete. The temperature is graduated on 0.1 Tor 0.1 ℃, reading a range of 89.6°F -- 109.2°F (32°C -- 42.9°C ). The ambient temperature environment is intended for used is 50°F -- 104°F (10°C-40°C).

AI/ML Overview

The provided text describes a 510(k) submission for an Infrared Ear Thermometer (IRT-21 and IRT-22). Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
Accuracy (ASTM E1965-1998, Re-approved 2003)	No individual reading was in error by more than the acceptable maximum error.
Electrical Safety (IEC 60601-1, IEC 60601-1-2)	Conforms to applicable voluntary standards.
Biocompatibility (ISO 10993-1:2003 on skin irritation, in vitro cytotoxicity, sensitivity)	Conforms to applicable voluntary standards.
Repeatability (Clinical Study based on ASTM E1965-98)	Reasonably small and will not pose a problem for diagnostic purposes.
Clinical Bias and Uncertainty (Clinical Study based on ASTM E1965-98)	Indicate that this IR thermometer can be used reliably.

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

Sample Size for Test Set: 100 patients were enrolled for the clinical trial.
Data Provenance: Not explicitly stated, but based on the overall submission from "Choice Smart Health Care Company Limited" in Hong Kong, and the study being a "clinical trial" it is likely prospective, though the exact country of origin for the patient data is not specified.

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

The document does not mention the use of experts to establish a "ground truth" in the traditional sense of medical image or diagnostic interpretation. Instead, the ground truth was established by a "reference thermometer" for comparative purposes in the clinical study. The number or qualifications of individuals using the reference thermometer are not provided.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned. The clinical study involved comparing the infrared thermometer to a reference thermometer, implying a direct comparison rather than an adjudication process by multiple expert reviewers.

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

No MRMC comparative effectiveness study was done. This device is an infrared ear thermometer, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable.

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

Yes, the device performance, particularly the accuracy, electrical safety, and biocompatibility, was evaluated in a standalone manner against established standards (ASTM, IEC, ISO). The clinical study also assesses the device's performance directly against a reference thermometer, which is a standalone evaluation of the device itself.

7. The Type of Ground Truth Used

Clinical Study: The ground truth for the clinical study was established using a reference thermometer. The study involved a "comparison study" and "clinical repeatability testing" against this reference.
Non-Clinical Tests: For accuracy testing, a controlled environment likely provided standardized temperature points (35°C/95°F, 37°C/98.6°F, 41°C/105.8°F) as a form of ground truth for calibration and verification.

8. The Sample Size for the Training Set

This device is a hardware device (infrared ear thermometer) and does not inherently have a "training set" in the context of machine learning or AI models. The concept of a training set is not applicable here. The manufacturing and calibration processes would involve internal quality control and testing, but these are distinct from a "training set" for an algorithm.

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

As stated above, the concept of a "training set" does not apply to this device.

Summary

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510(K) Summary

NOV 2 1 2006

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 guidance.

The assigned 510(K) number is:

Submitter's Identifications: Mr. Mok Chi Wing Choice Smart Health Care Company Limited. RM 1901, CC WU BUILDING, 302 HENNESSY ROAD, WANCHAI Hong Kong

Date Summary Prepared: April 25, 2006

2. Name of the device:

Trade name: Infrared Ear Thermometer (IRT-21 and IRT-22) Common Name: Clinical Electronic Thermometer Classification Name: Thermometer, Electronic, Clinical

1. Information of the 510(K) Cleared Device(Predicate Device): Infrared Ear Thermometer (GT-302) (K010383).

4. Device Description:

Press the ON/OFF button to turn on the power, the symbol 1888 appears immediately. Insert the probe into the ear canal then press the SCAN button to measure the temperature, when you hear a beep sound, the measurement is The temperature is graduated on 0.1 Tor 0.1 ℃, reading a range of complete. 89.6°F -- 109.2°F (32°C -- 42.9°C ). The ambient temperature environment is intended for used is 50°F -- 104°F (10°C-40°C).

1. Intended Use:
  Infrared Ear Thermometer (IRT-21 and IRT-22), designed with infrared technology, is used to measure body temperature from ear canal. Press the ON/OFF button to turn on the power, the symbol #88 appears immediately.

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Insert the probe into the ear canal then press the SCAN button to measure the temperature, when you hear a beep sound, the measurement is complete. Infrared Ear Thermometer (IRT-21 and IRT-22) is intended for household and hospital use on people of all ages.

6. Comparison to the 510(K) Cleared Device(Predicate Device):

Infrared Ear Thermometer (IRT-21 and IRT-22) has the same intended use and technological characteristics as the cleared device of Infrared Ear Thermometer (GT-302) (K010383). Although Infrared Ear Thermometer (IRT-21 and IRT-22) has slightly broader ambient operating temperature, slightly broader display temperature range and more memorization capacity compared with legally marketed one, these differences do not affect the safety, performance of the subject device. So the new device is substantial equivalence to the selected predicate device.

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

Various testing was performed as per ASTM E1965-1998 (Re-approved 2003) and ASTM E1104-1998 (Re-approved 2003). Accuracy testing was done at 35°C/95°F, 37°C/98.6°F, 41°C/105.8°F according to the requirements of ASTM E1965-98 (Re-approved 2003) and results show that no individual reading was in error by more than the acceptable maximum error. Declaration of conformity letter of conformed standards sees Appendix VIII.

Electrical safety conforms to applicable voluntary standards IEC 60601-1, IEC 60601-1-2. And Biocompatibility conforms to applicable voluntary standards ISO 10993-1:2003 biocompatibility testing on skin irritation, in vitro cytotoxicity and sensitivity.

For predicate device (K010383), it is complied with voluntary standards includes ASTM 1965-98, ASTM 1104, IEC 60601-1 and IEC 60601-1-2 based on its 510K summary.

So the new device is substantial equivalence to the selected predicate device.

8. Discussion of Clinical Study:

A comparison study and clinical repeatability testing was performed between Infrarcd thermometer and reference thermometer. 100 patients were enrofled for this trial. The repeatability result can be considered reasonably small and will not pose a problem for diagnostic purposes. The results of clinical bias and

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uncertainty indicate that this IR thermometer can be used reliably. Clinical result conform ASTM E1965-98 (Re approved 2003).

1. Conclusions:
  Infrared Ear Thermometer (IRT-21 and IRT-22) has the same intended use and technological characteristics as the cleared device of Infrared Ear Thermometer Various performance testing data which conducted (GT-302) (K010383). according to ASTM E1965 and ASTM E1104 standards, such as accuracy test, storage test, shock test demonstrate the same safety and effectiveness as that of cleared device. In the other words, the Infrared Ear Thermometer (IRT-21 and IRT-22) is substantial equivalence to predicted device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Choice Smart Health Care Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 Northwest Lake Road Camas, Washington 98607-9526

NOV 2 1 2006

Re: K063291

Trade/Device Name: Infrared Ear Thermometer (IRT-21 and IRT-22) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 11, 2006 Received: November 1, 2006

Dear Mr. Mouser:

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. Mouser

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Cuy Duleom for
Shin-Hwa Phat

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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K063299
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Indication for Use

510(k) Number (if known):

Device name: Infrared Ear Thermometer (IRT-21 and IRT-22)

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Md C. A. f. Amw 11/21/06

I of Anesthesiology. General Hospital ontrol. Dent

K063291

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.