The Omron electronic thermometer Models MC-245, MC-341, MC-341, MC-343, and MC-344 are intended to measure the body temperature either oral, axillaries (under arm) and rectal and Model - MC-247 measure the body temperature oral (basal) and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.

Device Description

These are simple electronic thermometer which is a thermistor to measure temperature. All the functions, except posture symbol, are the same as the predicate device, MC-3B, K881446. Power source battery operated. Calculation method (system) is the same and identical to the predicate, K881449. The differences between the various models are: Some models have a flexible or rigid or rigid / flexible tip. Offered with a probe cover. Temperature scale offered in C° & F° or F° only. Readout time is different.

AI/ML Overview

The Omron Thermometers (Models MC-245, MC-246, MC-247, MC-341, MC-343, MC-344) are clinical electronic thermometers.

Here's an analysis of the provided information regarding their acceptance criteria and supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for this device is primarily its accuracy, as compared to a predicate device (MC-3B K881446).

Acceptance Criteria (from Predicate Device)	Reported Device Performance (New Device)
Accuracy: ±0.2 °F (for Celsius, not explicitly stated for predicate but implied by equivalence)	Accuracy: ±0.2 °F, ±0.1 °C
Measurement Range: 89.6 °F to 107.6 °F	Measurement Range: 89.6 °F to 107.6 °F, 32.0 °C to 42.0 °C
Display Resolution: 4 Digits (0.1 °F increments)	Display Resolution: 4 Digits (0.1 °F / 0.1 °C increments)

Note: The document states that the new devices are "substantially equivalent" to the predicate device K881446 due to "identical algorithms and means of measuring temperature," and "Operating specifications - Identical to predicate K881446." This implies that the performance characteristics of the new devices meet or are identical to those of the predicate device.

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

The provided 510(k) summary does not explicitly state the sample size used for a test set for performance evaluation. It primarily relies on demonstrating substantial equivalence to a predicate device.

For the materials testing (ISO 10993), the document states: "The materials have been tested in accordance to ISO 10993." However, specific sample sizes or data provenance for these material tests are not detailed in this summary.

Given the nature of a 510(k) summary for simple thermometers, detailed performance studies with dedicated test sets (as might be expected for complex AI/imaging devices) are often not presented if substantial equivalence can be demonstrated through other means (e.g., identical technology, components, and operating principles).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For simple electronic thermometers, the "ground truth" for temperature measurement is typically established using calibrated reference thermometers, not human experts.

4. Adjudication Method for the Test Set

An adjudication method is not applicable or mentioned because the performance assessment described primarily relies on direct measurement and comparison to a predicate device's specifications, rather than subjective interpretation requiring multiple expert opinions.

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

This information is not applicable to this device. The Omron Thermometers are simple electronic thermometers and do not incorporate AI or involve human readers in interpreting results in a way that would necessitate such a study.

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

A standalone performance evaluation of the "algorithm only" in the context of AI is not applicable here, as the device is a simple electronic thermometer. Its performance is inherent to its physical components (thermistor) and calculation method, which is stated to be "identical" to the predicate device. The accuracy specification of ±0.2 °F (±0.1 °C) can be considered a standalone performance metric for the device.

7. The Type of Ground Truth Used

The ground truth for a clinical electronic thermometer's accuracy is typically established using traceable, calibrated temperature standards or reference thermometers. This involves comparing the device's readings against these known, precise temperature values. The document doesn't explicitly detail the methodology for establishing ground truth but implies it through the stated accuracy specifications.

8. The Sample Size for the Training Set

This information is not applicable to this device. As a simple electronic thermometer, there is no "training set" in the context of machine learning or AI. The device's functionality is based on established physical principles and calibrated components, not learned data.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the reasons stated in point 8.

Summary

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Premarket Notification 510(k) Section 5 - 510(k) Summary

Omron Thermometers

KC916676

Omron Healthcare, Inc.1200 Lakeside Dr.Bannockburn, IL 60015	Tel - 847-247-5678Fax - 847-680-6269	SEP - 1 2009
Official Contact:	Ronald Dudek - Director of Quality
Proprietary or Trade Name:	Models – MC-245, MC-246, MC-247, MC-341, MC-343,MC-344
Common/Usual Name:	Clinical electronic thermometer
Classification Name/Code:	FLL – clinical electronic thermometer21 CFR 880.2910
Device:	Models – MC-245, MC-246, MC-247, MC-341, MC-343,MC-344

Device Description:

These are simple electronic thermometer which is a thermistor to measure temperature.

. All the functions, except posture symbol, are the same as the predicate device, MC-3B, K881446.
Power source battery operated .
Calculation method (system) is the same and identical to the predicate, K881449 �

The differences between the various models are:

Some models have a flexible or rigid or rigid / flexible tip .
Offered with a probe cover .
Temperature scale offered in C° & F° or F° only .
Readout time is different .

Indications for Use:

Environment of Use: Clinics, hospital and home environments

Contraindications: None

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510(k) Summary Page 2 of 3 5-Jun-09

Summary of substantial equivalence .

	MC-3BK881446	MC-245/246/247MC-341/343/344
MeasurementMethod	Human temperature is detected bythermistor and calculated	Human temperature is detected bythermistor and calculated
Display	Reading value is displayed on LCDwith 4 digits.(0.1 increments)	Reading value is displayed on LCDwith 4 digits.(0.1 increments)
Buzzer	Beeper sound at peak temperature	Beeper sound at peak temperature
Power Source	Battery(LR41 type)	Battery(LR41 type)

SPECIFICATION	MC-3BK881446	MC-245, MC-246, MC-247MC-341, MC-343, MC-344
Display	LCD Digital Display	LCD Digital Display
MeasurementRange	89.6 °F to 107.6 °F	89.6 °F to 107.6 °F, 32.0 °C to 42.0 °CThese models switch the display unit (°F, °C) alternately.
Measurement area	Oral, rectum, under arm	Oral, rectum, under arm, except Model MC-247 is for oral (basal) only
Accuracy	±0.2 °F	±0.2 °F, ±0.1 °C
Display Resolution	4 Digits(0.1 °F increments)	4 Digits(0.1 °F / 0.1 °C increments)
Weight	Approx. 1/3 oz /(11g)	Approx. 1/3 oz / (11g)
Length	Approx. 130mm	Approx. 130mm
Battery	1 each LR41 Alkali1.5V D.C	1 each LR41 Alkali 1.5V D.C
Battery Life	Approx. 300 hours.(Continuous use)	Approx. 2 years (3 times measurements / day )
AmbientTemperature foruse	50 °F to 104 °F(10 °C to 40 °C)	50 °F to 104 °F(10 °C to 40 °C)
AmbientTemperature foruse	(10 ° C to 40 ° C)	(10 ° C to 40 ° C)
AmbientTemperature forstorage	4 °F to 140 °F(-20 °C to 60 °C)	4 °F to 140 °F(-20 °C to 60 °C)
AmbientTemperature forstorage	(-20 ° C to 60 ° C)	(-20 ° C to 60 ° C)
Ambient Humidityfor use	30 to 85%RH	30 to 85%RH
Ambient Humidityfor storage	30 to 95%RH	10 to 95%RH

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510(k) Summary Page 3 of 3

5-Jun-09

Differences Between Other Legally Marketed Predicate Devices

The Omron thermometer models MC-245, MC-247, MC-341, MC-341, MC-343, and MC-344 are viewed as substantially equivalent to the predicate device because:

Indications -

. Identical to predicate - K881446

Technology -

. Identical algorithms and means of measuring temperature to predicate - K881446

Operating specifications -

Identical to predicate K881446 .

Materials -

The materials have been tested in accordance to ISO 10993.

Environment of Use -

Identical to predicate K881446 �

Patient Population -

Identical to predicate K881446 .

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Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four abstract shapes that resemble a stylized human figure or a flame-like design. The logo is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Omron Healthcare, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134

Re: K091676

Trade/Device Name: Omron Thermometer Models MC-245, MC-246, MC-247,

MC-341, MD-343, MC-344 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 25, 2009 Received: July 29, 2009

Dear Mr. Dryden:

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.

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Page 2- Mr. Dryden

Enclosure

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/CentersOffices/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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony L., Amato Jr.

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

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Indications for Use Statement

Page 1 of 1

510(k) Number:

0 91676 (To be assigned)

Device Name:

Omron Thermometers Models MC-245, MC-246, MC-247, MC-341, MC-343, MC-344

Indications for Use:

Prescription Use	or	Over-the-counter use XX
(Part 21 CFR 801 Subpart D)		(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Y. Schacter

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

510(k) Number: K091676

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.