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 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Their 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 the five parts:

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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Microlife Digital Infrared Ear Thermometer, Model IR1DE1:

Key Finding: This 510(k) submission does not contain any clinical study data for the IR1DE1 model. It relies on the substantial equivalence to a previously cleared device (IR1DA1) and states that clinical studies were already conducted for the original, unmodified device. Therefore, a complete table of acceptance criteria and reported device performance directly from this document, as well as several other requested details, cannot be provided.

Acceptance Criteria and Study Details for Microlife Digital Infrared Ear Thermometer, Model IR1DE1

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, specific numerical acceptance criteria and reported device performance from a new study for the specific model IR1DE1 are not available. The submission states that compliance to various standards was performed, but it does not detail specific performance thresholds or results.

However, the document indicates compliance with the following:

Acceptance Criteria Category	Reported Device Performance (as implied by submission)
Standards Compliance	Compliant with ASTM E1112, ASTM E1104, ASTM E-1965-98, IEC 60601-1, and IEC 60601-1-2 requirements.
Functional Equivalence	Identical in functionality and performance to the predicate device (Model IR1DA1).
Algorithm and Software	Temperature measurement algorithm and software codes remain unchanged from the predicate device.
Safety and Effectiveness	Verification and validation tests demonstrate that modified portions maintained original safety and effectiveness.

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

Test Set Sample Size: Not applicable. No new clinical human testing was conducted for this specific modified device (IR1DE1).
Data Provenance: Not applicable for new clinical data. The submission refers to "clinical studies/low power testing were conducted for the original unmodified device," but details of those prior studies are not provided in this document.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. No new clinical studies requiring expert ground truth establishment for a test set were conducted for this device according to the document.

4. Adjudication Method for the Test Set:

Not applicable. No new clinical studies were conducted for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC comparative effectiveness study was not done for the modified device (IR1DE1). Clinical studies were explicitly not conducted for this modified device.

6. Standalone Performance Study:

No, a standalone (algorithm only without human-in-the-loop) performance study was not done specifically for the modified device (IR1DE1) as a new clinical study. The submission states that "Accuracy performance, reliability and EMC testing is only applicable," suggesting engineering and bench testing, but no specific in-depth performance study results are detailed in this document.

7. Type of Ground Truth Used:

Not applicable for new clinical data. The ground truth for the original device's clinical studies (referenced but not detailed here) would likely have been reference thermometer readings or medical consensus, but this is speculative given the lack of detail.

8. Sample Size for the Training Set:

Not applicable. The device's temperature measurement algorithm and software codes "remain unchanged" from the predicate device. Therefore, no new training set was used for the IR1DE1 model. The document does not provide details on the training set (if any, as an infrared thermometer might not 'train' in the AI sense) used for the original algorithm development.

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

Not applicable, as no new training set was described for the IR1DE1 model. Details on the ground truth establishment for the original algorithm are not provided in this document.

Summary of the Submission's Approach:

The submission for the Microlife Digital Infrared Ear Thermometer, Model IR1DE1, is a 510(k) for a modified device. The core argument for substantial equivalence relies on:

The device having the same intended use as the predicate device (Model IR1DA1).
The temperature measurement algorithm and software codes remaining unchanged.
The fundamental scientific technology remaining the same.
Modifications being limited to "ergonomics of the user interface, dimensional specifications and environmental specifications," and PCB layout, which are considered to not affect the intended use or alter the fundamental scientific technology.
Compliance with applicable voluntary standards and guidance documents.

Therefore, the submission explicitly states: "Controlled human clinical studies were not conducted for the Microlife Digital Infrared Ear Thermometer modified devices, as well as no low power test as clinical studies/low power testing were conducted for the original unmodified device and remain unchanged." This means no new primary clinical data for the IR1DE1 model is presented in this document.

Summary

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EXHIBIT #1

K020725

510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is: _______________________________________________________________________________________________________________________________________________

1. Submitter's Identification:

Microlife Corporation 9F, 431 Rui Guang Road Nei Hu. Taipei 114 Taiwan, Republic of China

Date Summary Prepared:

March 4, 2002

2. Name of the Device:

Microlife Digital Infrared Ear Thermometer, Model IR1DE1.

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

Microlife Digital Infrared Ear Thermometer, Model IR1DA1, K#000969, K#003308.

4. Device Description:

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

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

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LCD and Blacklight d)
Kev "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.

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

The Microlife Digital Infrared Ear Thermometer, Model IR1DE1 is substantially equivalent to the original Microlife Digital Ear Thermometer, Model IR1DA1.

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

The IR1DE1 and the IR1DA1 are identical in functionality and performance with the only difference being the external shape of the devices, and PCB layout of the devices. The modifications to our original 510(k) cleared device, model IR1DA1, include ergonomics of the user interface, dimensional specifications and environmental specifications. The 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 device (IR1DE1) works with only a 1second called a "normal" mode.

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

Compliance to applicable voluntary standards includes ASTM E1112, ASTM E1104 and ASTM E-1965-98, as well as IEC 60601-1 and IEC 60601-1-2 requirements.

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".

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8. Discussion of Clinical Tests Performed:

Controlled human clinical studies were not conducted for the Microlife Digital Infrared Ear Thermometer modified devices, as well as no low power test as clinical studies/low power testing were conducted for the original unmodified device and remain unchanged. Accuracy performance, reliability and EMC testing is only applicable.

9. Conclusions:

The Microlife Digital Infrared Ear Thermometer, Model IR1DE1 has the same intended use and technological characteristics as the unmodified model IR1DA1. 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2002

MicroLife Corporation C/O Ms. Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K020725

Trade/Device Name: Microlife Digital Infrared Ear Thermometer, Model IR1DE1 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 4, 2002 Received: March 6, 2002

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.

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.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit B

Page of 1 r

510(k) Number (if known): K020725

Device Name: Microlife Digital Infrared Ear Thermometer, Model IR1DE1

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)

Patricio Cussenite

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices F10(k) Number _ K- 020225

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.