The Microlife Digital Electronic Thermometer MT16K1 is used for the intermittent measurement and monitoring of human body temperature, oral, rectal and under the arm. The device is for the adult and pediatric population.

Device Description

This Digital Electronic Thermometer enables easy and highly accurate readings over the body temperature range and has been designed to provide maximum user-friendliness. The body temperature is measured by the thermistor and displayed as numbers on the LCD (liquid crystal display) through microprocessor of IC.

The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-C oscillator circuit, Therefore, temperature can be given by measuring the frequency of oscillator.

For a given time period, by applying the R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.

AI/ML Overview

The provided document is a 510(k) summary for the Microlife Digital Electronic Thermometer, Model MT16K1. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a robust study report as might be seen for novel AI/software devices. Therefore, some of the requested information, particularly regarding AI-specific criteria like multi-reader multi-case studies, ground truth establishment for training data, and expert qualifications, is not applicable or not present in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria is compliance with recognized voluntary standards for clinical electronic thermometers and a demonstration of substantial equivalence to a predicate device.

Acceptance Criteria	Reported Device Performance
Compliance with ASTM E1112 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature)	The device demonstrates compliance with ASTM E1112.
Compliance with IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)	The device demonstrates compliance with IEC 60601-1.
Compliance with IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests)	The device demonstrates compliance with IEC 60601-1-2.
Clinical bias, clinical uncertainty, and clinical repeatability evaluated	Clinical studies were conducted in accordance with ASTM E1965-03, evaluating clinical bias, clinical uncertainty, and clinical repeatability per the Microlife Clinical Test Protocol outline. (Specific numerical performance metrics are not provided in this summary).
Substantial Equivalence to Predicate Device (Microlife Digital Electronic Thermometer, Model MT3001, K#851146)	The device has the same intended use and similar technological characteristics, including identical temperature measurement algorithm and fundamental scientific technology. Bench testing showed that differences (probe tip, case material) do not raise new safety or effectiveness concerns.

Note: The document does not provide specific numerical thresholds for "acceptance" for clinical bias, uncertainty, or repeatability, only that they were evaluated according to a standard.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided summary. The document mentions "Controlled human clinical studies were conducted in accordance with ASTM E1965-03," but does not give the number of subjects or measurements.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective clinical studies as they are described as "controlled human clinical studies" using the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. For a digital electronic thermometer, the ground truth for temperature is typically established using a reference standard thermometer, not expert consensus as would be the case for image interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. Adjudication methods are typically used when subjective interpretations are involved, such as in image reading. For a medical device measuring a physical parameter, the "truth" is typically determined by a reference measurement instrument.
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 applicable. This device is a digital electronic thermometer, not an AI-powered diagnostic imaging tool that would involve human readers and AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The study evaluates the device's performance (temperature measurement algorithm) directly against a reference standard. The "algorithm only" performance is the core of the evaluation for this type of device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for temperature measurement would be established by a highly accurate and calibrated reference thermometer or established methods for taking body temperature, in accordance with standards like ASTM E1965-03. This is an objective measurement rather than expert consensus or pathology.
The sample size for the training set:
- Not applicable/Not mentioned. For a simple electronic thermometer, there isn't typically a "training set" in the machine learning sense. The device's algorithm for converting thermistor resistance to temperature is based on physical principles and calibration, not learned from a dataset.
How the ground truth for the training set was established:
- Not applicable. As there's no training set in the AI sense, there's no ground truth established for one. The device is calibrated and its algorithm is fixed.

Summary

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

EXHIBIT #1

K491589

510 (K) SUMMARY

JUN 1 0 2009

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: May 27, 2009

2. Name of the Device:

Microlife Digital Electronic Thermometer, Model MT16K1

3. Predicate Device Information:

Microlife Digital Electronic Thermometer, Model MT3001, K#851146 .

4. Device Description:

For a given time period, by applying the R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.

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

5. Intended Use:

5091589

6. Comparison to Predicate Devices:

The Microlife Digital Electronic Thermometer, Model MT16K1 is substantially equivalent to Microlife Digital Electronic Thermometer, Model MT3001, K#851146, which has the same intended use and is similar in design to the predicate device.

The Microlife Digital Electronic Thermometer MT16K1 and the predicate device are identical in the temperature measurements algorithm and fundamental scientific technology, differing mostly in probe tip and case material.

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

Compliance to applicable voluntary standards includes ASTM E1112, 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 in accordance with ASTM E1965-03 using the Microlife Digital Electronic Thermometer, Model MT16K1. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Microlife Clinical Test Protocol outline.

9. Conclusions :

The Microlife Digital Electronic Thermometer, Model MT16K1 has the same intended use and similar technological characteristics as the Microlife Digital Electronic Thermometer, Model MT3001. Moreover, bench testing

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

contained in this submission demonstrates that differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the Microlife Digital Electronic Thermometer, Model MT16K1 is substantially equivalent to the predicate device.

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

Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and wings at the top.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUN 1.0 2009

Re: K091589

Trade/Device Name: Microlife Digital Electronic Thermometer, Model MT16K1 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: May 29, 2009 Received: June 2, 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 either 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.

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

Page 2- Ms. Goldstein-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. 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 medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Centers Offices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Anthony, D. m
Susan Runner, D.D.S., M.A.

Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

EXHIBIT B

Indications for Use

510(k) Number (if known): Komissy

Device Name: Microlife Digital Electronic Thermometer, Model MT16K1

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 で of -

Nade

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

510(k) Number: JC 091589

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.