The NIR is non-sterile non-invasive infrared thermometer intended for the intermittent calculation of human body temperature of people of all ages for home and professional use.

Device Description

The device is built of one or more infrared thermopile sensors that is/are designed to measure a temperature above the artery on the skin. Each of the sensor/s is mounted on a reflector which is used to reduce the sensor field of view. In order to minimize distance effects on the readouts the device is equipped with a distance measurement sensor. Each of the thermopile/s has its own thermistor which is used for calculating the self temperature of each sensor. In addition there is another external thermistor which is used for measuring the ambient temperature and to asses the thermal condition of the thermal equilibrium of the device and to correct the result according to its value and the difference between the external sensor and the internal termistors readout.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Medisim Ltd. NIR Electrical Thermometer, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy	Below 0.3°C

Study Details

Due to the nature of this submission (510(k) for a non-invasive infrared thermometer), the study design is focused on demonstrating substantial equivalence to a predicate device and adherence to industry standards, rather than proving efficacy through a typical clinical trial comparing intervention vs. control.

Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated in the provided text. The submission mentions "comparative testing with market-cleared devices," and "clinical and bench tests." However, the exact number of participants or measurements in these tests is not quantified.
- Data Provenance: Not explicitly stated. The manufacturer is Medisim Ltd. in Israel, and the Israeli Institute of Standards was involved in safety validation. It's reasonable to infer that testing occurred in Israel, but this is not definitively stated for the clinical performance. The submission refers to "clinical and bench tests," which implies prospective data collection for the purpose of this submission.
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):
- This information is not provided in the text. For a thermometer, "ground truth" would typically refer to a highly accurate reference thermometer (e.g., a rectal thermometer or a laboratory-grade temperature measurement device), not expert consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This concept of "adjudication" is not applicable to the type of device and study described. Adjudication methods like 2+1 or 3+1 are typically used in studies where subjective interpretation (e.g., of medical images) requires multiple experts to reach a consensus for ground truth. For a thermometer, objective measurements against a reference are performed.
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. The NIR Electrical Thermometer is a direct measurement device; it does not involve "human readers" or "AI assistance" in the interpretation of complex data in the way an MRMC study would apply (e.g., for diagnostic imaging). The device provides a direct temperature reading.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device itself is a standalone system that measures and displays temperature. The "clinical and bench tests" would have evaluated the device's accuracy in isolation, independent of human interpretation beyond recording the displayed temperature.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth would have been established using reference temperature measurements from highly accurate and calibrated thermometers, either in a controlled laboratory ("bench tests") or clinical setting. This is implied by the nature of temperature measurement device testing and the reference to ASTM E1965-98, which outlines standards for infrared thermometers, including accuracy testing against known temperatures.
The sample size for the training set:
- Not applicable/Not provided. The NIR thermometer is not described as a device that uses machine learning or AI that requires a "training set" in the conventional sense. Its function is based on established physical principles of infrared thermometry. Any internal calibration or algorithm development would fall under engineering validation rather than an AI training set.
How the ground truth for the training set was established:
- Not applicable. As stated above, there is no "training set" for an AI or machine learning algorithm described for this device.

Summary

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MAY 2 8 2010

510(k) Summary

Medisim Ltd.

NIR Electrical Thermometer

510(k) Number K090386

Applicant's Name:

Medisim Ltd. G.G. Communication Center Neve Ilan 90850, Israel Tel: 972-2-579-1921 Fax: 972-2-579-1926

Contact Person:

Yevgenia Libster G.G. Communication Center Neve Ilan 90850, Israel Tel: 972-2-579-1921 ext. 826 Fax: 972-2-579-1926

Date Prepared: January, 2009

Trade Name of the device subject to this submission: NIR thermometer

Classification Name:

Electronic Clinical Thermometer

Classification:

Clinical Electronic Thermometers are class II devices (product code 80 FLL) and are reviewed by the General Hospital Division and Personal Use Panel.

Indication for Use:

The NIR is non-sterile non-invasive infrared thermometer intended for the intermittent calculation of human body temperature of people of all ages for home and professional use.

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Statement of substancial equivalence:

The NIR thermometer, which is the subject of this submission, is substantially equivalent to Exergen's TemporalScanner (K011291) which is the predicate device. Medisim's NIR and the aforementioned predicate device share the technology as well as the intended use. NIR as well as Exergen's TemporalScanner are intended for the intermittent measurement of human body temperature of people of all ages. NIR device as well as the predicate device measure the temperature of a human by means of a thermopile infrared sensor/s transducer coupled with electronic signal amplification, conditioning, and display unit.

Both NIR and meet ASTM E1965-98 Standard for Infrared Thermometers for Intermittent Determination of Patient Temperature, to the extent that this standard applies to them.

For convenience, the various similarities and differences are summarized in the substantial equivalence comparison table.

	NIR	The Predicate
Device Name	NIR	TemporalScanner
Manufacturer	Medisim, Ltd.	Exergen corporation
510(k) number	K090386	K011291
Thermometer type	Infrared	Infrared
Intended use(s)	Measuring human body temperature	Measuring human body temperature
MeasurementLocation	Temple	Temple
Clinical Setting	Home Use	Home Use
Labeling	Instructions For Use are attached	User Manual is attached
Sensor Type	Thermopile	Thermopile
Powerrequirements	3.0V battery	9.0V battery
Product Material	Medical grade ABS	Medical grade ABS

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	NIR	The Predicate
MeasuredTemperaturerange	22.0 °C to 40.0°C (71.6 °F to 104.0 °F)	15.5°C to 42.0°C (60.0°F to 107.6°F)
Storageenvironment	-20° C to 50° C (-4°F to 122°F)	Ambient temperature: -20.0°C to+50.0°C (-4.0 °F to 122.0 °F)
Accuracy	Below 0.3°C	±0.2°C/0.4°F between 37.0°C-39.0°C(98°F to 102 °F)

NIR thermometer description:

In addition there is another external thermistor which is used for measuring the ambient temperature and to asses the thermal condition of the thermal equilibrium of the device and to correct the result according to its value and the difference between the external sensor and the internal termistors readout.

Non-Clinical and Clinical Tests Performed for Determination of Substantial Equivalence:

The safe and effective performance of the device has been non-clinically and clinically established through comparative testing with market-cleared devices. NIR's safety has been checked and validated by Medisim's internal checks and Israeli Institute of standards. The clinical and bench tests demonstrated its accuracy and effectiveness.

NIR thermometer complies with additional voluntary standards:

IEC60601-1 (1995) General safety requirements for medical devices

IEC 60825-9 (1999) Safety of laser products

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ISO 14971 (2007) Risk analysis for medical device

Conclusion:

Based on the safety and performance testing and compliance with acceptable voluntary standards, we believe that the NIR Electrical Thermometer is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.

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Image /page/4/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines forming its body and wings.

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

Ms. Yevgenia Libster Regulatory Manager Medisim, Limited G.G. Communications Center Neve Ilan Israel 90850

MAY 2 8 2010

Re: K090386

Trade/Device Name: Non-Invasive Infrared (NIR) Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electric Thermometer Regulatory Class: II Product Code: FLL Dated: April 26, 2010 Received: May 6, 2010

Dear Ms. Libster:

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 thp?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. Please note: CDRF, not evaluate information related to contract liability warranties. We remind you, Nowever, that device labeling must be truthful and not misleading.

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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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,

Susan Bunsen

Anthony D. Watson, B.S., M.S., M.B.A. 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:

Device Name: NIR

Indications for Use:

The NIR is non-sterile non-invasive infrared thermometer

intended for the intermittent calculation of human body

temperature of people of all ages for home and professional use.

Contra Indications: NA

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

Charles Sims, III

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

510(k) Number: K090386

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.