The Microlife Digital Infrared Ear Thermometer IR1DV1-1 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 1R1DV1-1 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: a) IR Thermopile Sensor b) ASIC c) E2PROM IC d) LCD and Backlight e) 2 Keys, 1 Buzzer This device is used probe cover free.

AI/ML Overview

The provided text is a 510(k) summary for the Microlife Digital Infrared Ear Thermometer, Model IR1DV1-1. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or the detailed results of a study that proves the device meets those criteria.

Here's a breakdown of what is and is not in the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance:

Not provided. The document states compliance with ASTM E1965 and IEC60601-1/-2, but does not list specific numeric acceptance criteria for temperature accuracy or other performance metrics, nor does it present the device's measured performance against such criteria.

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

Partially provided. The submission mentions "Controlled human clinical studies were conducted for the Microlife Digital Infrared Ear Thermometer Model IR1DV1-1 to validate the effectiveness of use without a probe cover."
Sample size: Not specified.
Data provenance: "human clinical studies" is mentioned, implying prospective, but no country of origin is stated.
Retrospective/Prospective: Implied prospective due to "conducted."

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 provided. This information is generally more relevant for diagnostic AI devices where expert interpretation is the gold standard. For a thermometer, "ground truth" would typically refer to a highly accurate reference thermometer measurement.

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

Not provided. This is not typically relevant for a thermometer's performance validation.

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:

Not provided. This is a question specifically for AI-assisted diagnostic devices and does not apply to a standalone medical device like a thermometer.

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

Implied, but not explicitly detailed as "standalone performance study." The device is a thermometer, which inherently operates in a "standalone" manner to measure temperature. The clinical studies mentioned aimed to validate its "effectiveness of use without a probe cover," which implies testing its accuracy in that usage mode. No human "in-the-loop" interaction with an algorithm is described beyond reading the temperature.

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

Not explicitly stated in the document. For a thermometer, the "ground truth" for temperature would typically be established by a highly accurate, calibrated reference thermometer measuring core body temperature (e.g., rectal or arterial measurement).

8. The sample size for the training set:

Not applicable/Not provided. This device is a traditional electronic thermometer, not an AI/machine learning device that requires a "training set" in the sense of supervised learning. Its "algorithm" refers to the signal processing for temperature measurement, not a learned model.

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

Not applicable/Not provided. (See point 8).

Summary of what is present:

The document states that the device complies with ASTM E1965, IEC60601-1, and IEC60601-1-2 requirements. ASTM E1965, "Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature," would contain the specific acceptance criteria for accuracy.

It also mentions that:

"Controlled human clinical studies were conducted for the Microlife Digital Infrared Ear Thermometer Model IR1DV1-1 to validate the effectiveness of use without a probe cover."

To fully answer your request, one would need to refer to the actual ASTM E1965 standard to find the acceptance criteria and then examine the full submission or a detailed clinical report that would show the results of the "controlled human clinical studies" against these criteria. The 510(k) summary only provides a high-level overview.

Summary

{0}------------------------------------------------

MAY 13 2009

EXHIBIT #1a

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:________________________________________________________________________________________________________________________________________________

1. Submitter's Identification:

Microlife Intellectual Property GmbH, Switzerland Espenstrasse 139 9443 Widnau / Switzerland

Date Summary Prepared: March 2, 2009

2. Name of the Device:

Microlife Digital Infrared Ear Thermometer, Model IR1DV1-1

3. Predicate Device Information:

Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1, K#034023

4. Device Description:

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

a) IR Thermopile Sensor
b) ASIC
c) E2PROM IC
d) LCD and Backlight
e) 2 Keys, 1 Buzzer

ട്. Intended Use:

EXHIBIT #1a-1

{1}------------------------------------------------

This device is used probe cover free.

દ. Comparison to Predicate Devices:

The Microlife Digital Infrared Ear Thermometer, Model IR1DV1-1 is substantially equivalent to Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1, K#034023, which has the same intended use and is similar in design to the predicate device.

The Microlife Digital Infrared Ear Thermometer IR1DV1-1 and the predicate device are identical in the temperature measurements algorithm and fundamental scientific technology, differing mostly in the construct of probe head, offset and blackbody mode.

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

Compliance to applicable voluntary standards includes ASTM E1965, 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 for the Microlife Digital Infrared Ear Thermometer Model IR1DV1-1 to validate the effectiveness of use without a probe cover. .

g. Conclusions:

The Microlife Digital Infrared Ear Thermometer, Model IR1DV1-1 has the same intended use and similar technological characteristics as the Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1. Moreover, bench testing contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the Microlife Digital Infrared Ear Thermometer. Model IR1DV1-1 is substantially equivalent to the predicate device IR1DE1-1.

EXHIBIT #1a-2

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an eagle emblem with three lines above it.

MAY 13 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susan D. Goldstein-Falk Microlife Intellectual Property GmbH Espenstrasse 139 9443 Widnau SWITZERLAND

Re: K091040

Trade/Device Name: Microlife Digital Infrared Ear Thermometer, Model IR IDV 1-1 Regulation Number: 21 CFR 880.2910 Regulation Name .- Clinical-Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 10, 2009 Received: April 13, 2009

Dear Ms. Goldstein-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 cither class II (Special Controls) or class III (PMA), it may be subject to 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.

{3}------------------------------------------------

Page 2- Ms. Goldestein-Falk

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); medical device reporting

(reporting of mcdical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Anthong Osmun for

Susan Runner, D.D.S., M Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

EXHIBIT B

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Bevice Name: Microlife Digital Infrared Ear Thermometer, Model IR1DV1-1

Indications For Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1_ of __ 1

Rial Morris for ABC LCDR. Colburn 05/13/09

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

510(k) Number: K091040

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.