The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

Device Description

The Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1 is an electronic thermometer using an infrared sensor (thermopile) 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.

The Microlife Digital Infrared Ear Thermometer, consists mainly of five parts:

IR Thermopile Sensor a)
b) ASIC
E2 PROM IC C)
LCD and Blacklight d)
Key "2, Buzzer" 1 e)

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1, based on the provided text:

Important Note: The provided text is a 510(k) summary for a device seeking substantial equivalence to a predicate device. It primarily discusses non-clinical tests for compliance with standards and a clinical study to validate a specific change (probe cover-free use). It does not provide detailed acceptance criteria and performance data in the way a clinical study report for a novel device would. Many of the requested details are therefore not available from this document.

Acceptance Criteria and Reported Device Performance

The document refers to compliance with ASTM E-1965-98 as an applicable voluntary standard. This standard likely outlines the performance requirements for infrared thermometers, including accuracy specifications. However, the exact numerical acceptance criteria and the device's reported performance against these criteria are not explicitly stated in this 510(k) summary. The summary only generally states that "verification and validation tests contained in this submission demonstrate that the modified portions maintained its original safety and effectiveness."

Acceptance Criteria (Based on ASTM E-1965-98 - details not provided in text)	Reported Device Performance (not explicitly stated in text)
e.g., Accuracy within +/- 0.2°C for specified temperature ranges	Stated to maintain original safety and effectiveness after modification
e.g., Repeatability within specified limits	Stated to maintain original safety and effectiveness after modification
e.g., Readout resolution	Stated to maintain original safety and effectiveness after modification

Study Details where Information is Available:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The document states "Controlled human clinical studies were conducted," but does not give the number of subjects.
Data Provenance: Not specified (e.g., country of origin). The studies were "controlled human clinical studies," implying prospective data collection in a clinical setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided. This type of information is typically relevant for studies involving image interpretation or complex diagnostic assessments. For a thermometer, "ground truth" would typically come from a highly accurate reference thermometer, not expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided. Adjudication methods are used when multiple experts are interpreting data and their opinions need to be reconciled. This is not relevant to a thermometer's performance testing where accuracy is measured against a reference standard.

5. 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. This is not relevant. The device is a thermometer, not an AI-assisted diagnostic tool for human readers.

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

Yes, implied. The "clinical studies" mentioned are to "validate the effectiveness of use without a probe cover." This implies testing the device's performance (i.e., its algorithm and sensor) in a standalone manner, measuring its output directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Implied Reference Standard. For a thermometer, the "ground truth" would be established using a highly accurate reference thermometer (e.g., a laboratory-grade precision thermometer or a rectal thermometer) with known calibration. This is not explicitly stated in the document but is the standard practice for thermometer validation.

8. The sample size for the training set

Not applicable. This device is a traditional electronic thermometer, not an AI/ML-based device that requires a distinct "training set." The phrase "temperature measurements algorithm and its software codes of the modified devices remains unchanged" suggests the core algorithm was already established.

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

Not applicable. As above, no training set for an AI/ML model for this device.

Summary

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JAN 1 5 2004

EXHIBIT #1

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.

The assigned 510(k) number is:_KO34073

1. Submitter's Identification:

Microlife Intellectual Property GmbH, Switzerland Max Schmidheiny-Strasse 201 9435 Heerbrugg / Switzerland

Date Summary Prepared: December 23, 2003

Contact: Mr. Gerhard Frick

2. Name of the Device:

Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1

3. Information for the 510(k) Cleared Device (Predicate Device):

Microlife Digital Infrared Ear Thermometer, Model IR1DE1, K#020725

4. Device Description:

The Microlife Digital Infrared Ear Thermometer, consists mainly of five parts:

IR Thermopile Sensor a)
b) ASIC
E2 PROM IC C)

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LCD and Blacklight d)
Key "2, Buzzer" 1 e)

5. Intended Use:

The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

This device is used probe cover free.

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

The Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1 is substantially equivalent to the original Microlife Digital Infrared Ear Thermometer, Model IR1DE1.

The new model, IR1DE1-1, has the same intended use and is similar in design to the 510(k) cleared device.

The IR1DE1-1 is identical in functionality and performance, with the only difference being that the device is to be used probe cover free, and, the PCB layout of the device. The working environmental specification of 5-40 degree C, temperature measurements algorithm and its software codes of the modified devices remains unchanged.

The fundamental scientific technology of the modified device remains the same as that of the 510(k) cleared device. The Microlife IR1DE1-1 device works with a only a 1-second called a "normal mode".

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

Compliance to applicable voluntary standards includes ASTM E-1965-98, as well as IEC 60601-1 and IEC 60601-1-2 requirements.

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Guidance documents included the "FDA Guidance On The Content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers", "Deciding When to Submit a 510(k) for a Change to An Existing Devices", and, "The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications".

Discussion of Clinical Tests Performed: 8.

Controlled human clinical studies were conducted for the Microlife Digital Infrared Ear Thermometer modified devices to validate the effectiveness of use without a probe cover.

9. Conclusions:

The Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1 has the same intended use and technological characteristics as the unmodified model IR1DE1. Moreover, verification and validation tests contained in this submission demonstrate that the modified portions maintained its original safety and effectiveness. These engineering changes do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2004

Microlife Intellectual Property GmbH C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K034023

Trade/Device Name: Digital Infrared Ear Thermometer, Model IR1DE1-1 Regulation Number: CFR 21 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 23, 2003 Received: December 29, 2003

Dear Ms. Falk:

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 - Ms. Falk

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. or the rice or ally i vith all the Act's requirements, including, but not limited to: registration 1 od intilet comply would and (21 CFR Part 801); good manufacturing practice and instills (21 OF real 807), equality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in are quadion 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) rms retet 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), 11 you don't the Office of Compliance at (301) 594-4618. 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 maj con 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/dsma/dsmamain.html

Sincerely yours,

Chas. L. Dees

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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Exhibit B

Page 1 of 1

510(k) Number (if known): _ 034023

Device Name: Digital Infrared Ear Thermometer, Model IR1DE1-1

Indications For Use:

The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Qur

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

510(k) Number _ KO3 4023

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.