NON-INVASIVE INFRARED (NIR)

K090386 · Medisim, Ltd. · FLL · May 28, 2010 · General Hospital

Device Facts

• Record ID: K090386
• Device Name: NON-INVASIVE INFRARED (NIR)
• Applicant: Medisim, Ltd.
• Product Code: FLL · General Hospital
• Decision Date: May 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Non-invasive infrared thermometer; measures temperature above artery on skin (temple). Input: infrared radiation detected by thermopile sensor; ambient temperature via external thermistor; self-temperature via internal thermistor. Operation: thermopile sensor mounted on reflector to reduce field of view; distance measurement sensor minimizes distance effects; internal/external thermistors provide thermal equilibrium correction. Output: calculated body temperature displayed to user. Used in home and professional settings; operated by patients or clinicians. Output used for clinical decision-making regarding patient health status; provides non-invasive, intermittent temperature monitoring.

Clinical Evidence

Safety and effectiveness established through comparative bench and clinical testing against market-cleared devices. Compliance with ASTM E1965-98, IEC 60601-1, IEC 60825-9, and ISO 14971 confirmed. Clinical and bench tests demonstrated accuracy and effectiveness.

Technological Characteristics

Infrared thermopile sensor; medical grade ABS housing; 3.0V battery powered. Features distance measurement sensor and internal/external thermistors for thermal equilibrium correction. Complies with ASTM E1965-98, IEC 60601-1, IEC 60825-9, and ISO 14971. Non-sterile.

Indications for Use

Indicated for intermittent human body temperature measurement in patients of all ages in home and professional settings. No contraindications reported.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• TemporalScanner (K011291)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

#### Contact Person:

Yevgenia Libster G.G. Communication Center Neve Ilan 90850, Israel Tel: [phone] ext. 826 Fax: [phone]

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 |
| Measurement<br>Location | Temple | Temple |
| Clinical Setting | Home Use | Home Use |
| Labeling | Instructions For Use are attached | User Manual is attached |
| Sensor Type | Thermopile | Thermopile |
| Power<br>requirements | 3.0V battery | 9.0V battery |
| Product Material | Medical grade ABS | Medical grade ABS |

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| | NIR | The Predicate |
|----------------------------------|-----------------------------------------|------------------------------------------------------------------|
| Measured<br>Temperature<br>range | 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) |
| Storage<br>environment | -20° C to 50° C (-4°F to 122°F) | Ambient temperature: -20.0°C to<br>+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<br>(98°F to 102 °F) |

## NIR thermometer 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.

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 [phone] or [phone] 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