Microlife QT1JC1 Instant Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm.

The Microlife QT1JC1 Instant Thermometer is a hand- held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive ( Instant ) mode ( 5-seconds in oral and rectal mode, 8-seconds in under the arm mode-predicative temperature ) , or standard mode ( actual determination of temperature).

The device is for the adult and pediatric population.

Device Description

This Instant thermometer enables very fast and reliable measurements and with its predicative technology the thermometer offers a very high clinical accuracy and has been designed to provide a maximum of user- friendliness

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 give time period (to), by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number

AI/ML Overview

The provided text describes a 510(k) summary for the Microlife Instant Digital Electronic Thermometer, Model QT1JC1. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study results, sample sizes, expert qualifications, and ground truth methodologies is not explicitly available in the provided document.

However, I can extract the information that is present and highlight what is missing.

Acceptance Criteria and Device Performance (Based on available information)

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Clinical Accuracy (Predictive Mode)	High clinical accuracy	"the thermometer offers a very high clinical accuracy" (General statement)
Measurement Time (Predictive Mode)	5-seconds (oral, rectal) 8-seconds (under the arm)	Achieves 5-seconds in oral and rectal mode Achieves 8-seconds in under the arm mode
Intended Use	Intermittent measurement and monitoring of human body temperature (oral, rectal, under the arm) for adult and pediatric population.	Meets the stated intended use.
Substantial Equivalence	Functionality and performance identical to predicate device (Microlife Instant Thermometer, Model QT1JA1, K#031958), with differences only in external shape and PCB layout. No new questions of safety or effectiveness.	Stated to be "identical in functionality and performance" to the predicate, with only external and PCB layout differences. Bench testing demonstrated no new safety/effectiveness questions.
Applicable Standards Compliance	ASTM E1112, IEC60601-1, IEC60601-1-2	Complies with these voluntary standards.
Clinical Bias	(Not specified, but evaluated)	Evaluated per "Microlife Clinical Test Protocol outline."
Clinical Uncertainty	(Not specified, but evaluated)	Evaluated per "Microlife Clinical Test Protocol outline."
Clinical Repeatability	(Not specified, but evaluated)	Evaluated per "Microlife Clinical Test Protocol outline."

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Controlled human clinical studies were conducted," but does not provide the number of subjects or measurements.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document mentions "clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Microlife Clinical Test Protocol outline," but does not detail how ground truth references were established or who established them. For thermometers, ground truth is typically a high-precision reference thermometer, not expert consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for qualitative or subjective assessments where human interpretation is involved. For thermometer measurements, the ground truth is usually an objective measurement from a reference device, not subject to expert adjudication in this manner.
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 a digital electronic thermometer, not an AI-assisted diagnostic imaging device or a system involving human readers interpreting data.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Thermometers are inherently standalone devices in their measurement function. The "algorithm" here refers to the internal processing of the thermistor resistance changes. The clinical studies would have evaluated the performance of this device in a standalone manner. The document states "Controlled human clinical studies were conducted using the Microlife Instant Digital Electronic Thermometer, Model QT1JC1." This implies evaluating the device's output directly.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Implied objective measurement/reference standard. For clinical thermometers, the ground truth for temperature measurements is typically established using a highly accurate reference thermometer (e.g., a mercury-in-glass thermometer or a precision electronic thermometer) in a controlled environment, often in comparison to core body temperature. The document refers to "clinical bias, clinical uncertainty and clinical repeatability," which are metrics assessed against a known reference.
The sample size for the training set:
- Not applicable/Not specified. This device uses a "predictive technology" based on an R-C oscillator circuit and thermistor resistance changes. The "temperature measurements algorithm" mentioned is likely a deterministic algorithm or a calibration curve, not a machine learning model that requires a distinct "training set" in the modern sense. The document states the algorithm and fundamental scientific technology are identical to the predicate device, suggesting a proven, established method.
How the ground truth for the training set was established:
- Not applicable/Not specified. As there's no mention of a traditional "training set" for a machine learning model, the establishment of ground truth for such a set is not discussed. The device's underlying principle is described as converting thermistor resistance changes to frequency changes to determine temperature, which is a physics-based, calibrated approach.

Summary

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DEC - 6 2006

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: 06 x 86 7

1. Submitter's Identification:

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

Date Summary Prepared: Aug 15, 2006

2. Name of the Device:

Microlife Instant Digital Electronic Thermometer, Model QT1JC1

3. Predicate Device Information:

Microlife Instant Digital Electronic Thermometer, Model QT1JA1, K#031958,

4. Device Description:

For a give time period (to), by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number

5. Intended Use:

Microlife QT1JC1 Instant Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm.

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in under the arm mode-predicative temperature ) , or standard mode ( actual determination of temperature).

The device is for the adult and pediatric population.

6. Comparison to Predicate Devices:

The Microlife Instant Thermometer, Model QT1JC1 is substantially equivalent to Microlife instant Thermometer, Model QT1JA1, K#031958 which have the same intended use and are similar in design to the predicate device.

The Microlife Instant Thermometer QT1JC1 and the predicate device are identical in functionality and performance with the difference being the external shape of the devices, and PCB layout of the devices, include performance specifications, ergonomics of the user interface, dimensional specifications. The temperature measurements algorithm and its fundamental scientific technology are identical to the predicate device.

7. Discussion of Non-Clinical Tests Performed for 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 using the Microlife Instant Digital Electronic Thermometer, Model QT1JC1. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Microlife Clinical Test Protocol outline.

9. Conclusions:

The Microlife Instant Digital Electronic Thermometer, Model QT1JC1 has the same intended use and similar technological characteristics as the Microlife Instant Thermometer, Model QT1JA1. 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 Instant Digital Electronic Thermometer, Model QT1JC1 is substantially equivalent to the predicate device.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

DEC - 6 2006

Re: K062867

Trade/Device Name: Microlife Instant Digital Electronic Thermometer, Model QT1JC1 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: November 16, 2006 Received: November 17, 2006

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 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. 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); 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,

Sincerely yours,

Snette Y. Michael Duda

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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Indications for Use

510(k) Number (if known): K062867

Device Name: Microlife Instant Digital Thermometer, Model QT1JC1

Indications For Use:

Microlife QT1JC1 Instant Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm.

The Microlife QT1JC1 Instant Thermometer is a hand- held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive

( Instant ) mode ( 5-seconds in oral and rectal mode, 8-seconds in under the arm

mode-predicative temperature } , or standard mode ( actual determination of temperature).

The device is for the adult and pediatric population.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

X Over-The-Counter Use (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)

s. 202

Page 1 of 1

... . . . . Off) i of Anesthesiology, General Hospilal, on Control, Dental Devices

umber. K062847

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.