Temple Touch Pro (TTP) Non-invasive temperature monitoring system

K150160 · Medisim, Ltd. · FLL · Oct 20, 2015 · General Hospital

Device Facts

• Record ID: K150160
• Device Name: Temple Touch Pro (TTP) Non-invasive temperature monitoring system
• Applicant: Medisim, Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Oct 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TTP™ is a non-sterile temperature monitoring system intended to measure and monitor core body temperature of patients of all ages, by applying a sensor unit on the forehead.

Device Story

TTP™ is a non-invasive, continuous core body temperature monitoring system. It consists of a disposable sensor unit applied to the patient's temple, a monitor connecting unit (MCU), and a power supply. The system uses heat flux technology; a double-layer sensor measures heat flux from the temporal artery area to derive core temperature. The MCU processes this data and can display the temperature on its own screen or transmit it to a YSI-400 compatible vital signs monitor. Used in clinical settings, it provides continuous temperature data to healthcare providers, facilitating clinical decision-making regarding patient thermal status. The device benefits patients by providing a non-invasive alternative to invasive thermometry methods.

Clinical Evidence

Clinical study conducted per ISO 80601-2-56 and GCP standards. Study included 181 subjects (95 males, 86 females; ages 0-73, median age 4) with 4,591 total samples. The study compared TTP™ measurements against invasive thermometers to demonstrate no statistically significant difference. Results indicated the device is as reliable as other clinical thermometers. No adverse effects were reported.

Technological Characteristics

Non-sterile, disposable thermistor-based sensor unit. Uses heat flux sensing principle. Dimensions/form factor: forehead-applied sensor with MCU. Connectivity: YSI-400 compatible output. Standards: ASTM E-1112-00, ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 10993-5/10, EN 12470-4.

Indications for Use

Indicated for measuring and monitoring core body temperature in patients of all ages (pediatric to adult) via forehead sensor application.

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

• 3M SpotOn Temperature monitoring system (K120412)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.

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

October 20, 2015

Medisim, Ltd. Mr. Avi Ben Yaish QA Manager G.G. Communication Center Neve Ilan ISRAEL 90850

Re: K150160

Trade/Device Name: Temple Touch Pro™ (TTP™) – Temperature monitoring system Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: II Product Code: FLL Dated: September 6, 2015 Received: September 9, 2015

Dear Mr. Ben Yaish:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, 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.

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

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known) K150160

Device Name

Temple Touch Pro™ (TTPTM) - Temperature monitoring system

Indications for Use (Describe)

The TTP™ is a non-sterile temperature monitoring system intended to measure and monitor core body temperature of patients of all ages, by applying a sensor unit on the forehead.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Image /page/3/Picture/0 description: The image shows the logo for Medisim. The logo features a stylized "M" with a green line that resembles a heartbeat. The text "Medisim" is written in blue, and below it, the words "Non Invasive Thermometry" are written in a smaller font size.

# SECTION 5 - 510(k) Number K150160 Summary

# Medisim Ltd.

Temple Touch Pro™ (TTP™) - Temperature Monitoring System

# Applicants Name:

Medisim Ltd. G.G. Communication Center Neve Ilan 90850, Israel Tel: [phone] Fax: [phone]

# Contact Person:

Avi Ben Yaish [e-mail]

Date Prepared: 20 OCT 2015

## Trade Name of the device subject to this submission:

Temple Touch Pro™ (TTP™) - Temperature Monitoring System

Common name: Clinical, Electronic thermometer

Classification Name: Clinical Electronic Thermometer

Classification: Clinical Electronic Thermometers are class II devices, 20 CFR 880.2910.

Classification Panel: General Hospital (Part 880 in the 21 CFR)

## Indication for Use:

The TTP™ is a non-sterile temperature monitoring system intended to measure and monitor core body temperature of patients of all ages, by applying a sensor unit on the forehead.

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

Image /page/4/Picture/0 description: The image contains the logo for Medisim, a company that specializes in non-invasive thermometry. The logo features a stylized "M" with a plus sign at the bottom left. The text "Medisim" is written in a blue sans-serif font to the right of the "M" symbol. Below the company name, the words "Non Invasive Thermometry" are written in a smaller font size.

# Description of the device

The TTP™ system monitors the body core temperature through continuous measurements of the patient. The system is non-sterile and comprised of a disposable Sensor Unit, attached to the patient temple, and connected to a Monitor Connecting Unit which is connected to a power supply and to any YSI-400 input vital signs monitor, through which, the patient temperature is presented. The MCU is able to present the patient temperature as a standalone unit.

## Statement of substantial equivalence:

The TTP™ is substantially equivalent to 3M SpotOn Temperature monitoring system (Arizant healthcare Inc.) cleared under K120412.

For convenience, the various similarities and differences are presented in the substantial equivalence comparison table and summarized below:

| | TTPTM | 3M SpotOn (Arizant healthcare Inc.) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | | K120412 |
| Manufacturer | Medisim Ltd. | 3M (Arizant healthcare Inc.) |
| Device name | Temple Touch ProTM | SpotOn |
| Intended use | Measure and monitor core body<br>temperature of patients of all ages, by<br>applying a sensor unit on the<br>forehead. | Measure, monitor, and trend body<br>temperature of adult and pediatric<br>patients. |
| Components | Sensor Unit (SU) Sensor Unit Cable Monitor Connecting Unit (MCU) Power Supply | Temperature Sensor Sensor Cable Control Unit Power Supply |
| Measurement<br>Technology | TTP TM system uses heat flux<br>technology to measure the patient's<br>body core temperature.<br>The Sensor Unit is attached to the<br>skin above the temporal artery. The<br>system utilizes double layer sensor to<br>measures the heat flux and derive the<br>core temperature. Once the<br>temperature is calculated, the TTP | The 3M SpotOn system uses zero-<br>heat-flux thermometry to measure the<br>patient's core temperature.<br>The 3M SpotOn system warms the<br>sensor (attached to the skin), creating<br>an isothermal zone under the sensor.<br>Once equilibrated to the core<br>temperature, a zero-heat-flux<br>condition is established. When the |

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

Image /page/5/Picture/0 description: The image shows the Medisim logo. The logo features a stylized green "M" with a line extending from the bottom left corner. To the right of the "M" is the word "edisim" in blue. Below the word "edisim" is the phrase "Non Invasive Thermometry" in a smaller font.

| | displays a noninvasive measurement<br>of the patient's core temperature. | temperature sensor reaches<br>equilibrium with the patient's core<br>temperature, the 3M SpotOn displays<br>a noninvasive measurement of the<br>patient's core temperature. |
|-------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Output to<br>hospital<br>monitor | compatible with YSI400 | compatible with YSI400 |
| Sensor/s | Thermistor | Thermistor |
| Measurement<br>location | Patient's temple area of the forehead | Patient's forehead above the orbital<br>ridge |
| Temperature<br>measurement<br>range | 25°C - 45°C (77°F - 113°F) | 25°C - 43°C (77°F - 109°F) |
| Accuracy | $\pm$ 0.2°C | $\pm$ 0.2°C |
| Reusable/<br>Disposable | Disposable ,non-sterile | Disposable ,non-sterile |

#### The similarities and differences between TTP™ device and its predicate:

The devices are similar in:

- . Intended use (measure & monitor body temperature)
- System components (sensor, control/connecting unit, cables, power supply) .
- Technological characteristics (incorporating heat conduction & heat flux method ) .
- . Sensor type (thermistor)
- Place of measurement (both TTP's and 3M SpotOn's sensors are placed on the . forehead skin surface).
- . Both systems transmitting the output to any YSI400 compatible patient monitor and are also able to present the temperature on their' standalone display units.

#### The devices are different in:

| | TTP™ | 3M SpotOn (Arizant healthcare Inc.) |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Temperature<br>determination<br>principal | Heat flux from the tissue, to the<br>sensor is measured and used to,<br>calculate (determine) the body<br>temperature. | Applying zero-heat flux principal by<br>locally heating the tissue at the<br>measuring site, is used to determine<br>the body temperature. |

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the Medisim logo. The logo features a stylized green "M" with a plus sign on the left side. The text "edisim" is in blue, and below it, the words "Non Invasive Thermometry" are in a smaller font size.

Non-Clinical and Clinical Device Testing (Software Validation, Bench & Clinical test) The TTP was tested and evaluated in order to fully validate its performance:

- A. Software Validation Tests
- B. Performance testing :
- 1. Bench testing according to ASTM E-1112-00
- 2. Clinical testing through a clinical study according to ISO80601-2-56 .

#### A. Software Validation:

The software was validated to assure the full functionality of the TTP.

The device software was validated successfully as device is fully function.

#### B. Performance testing:

#### B. 1. Bench testing

Bench testing was performed in accordance to ASTM E-1112-0.0 The device passed all bench tests successfully as it withstands acceptance criteria for each and every bench test performed.

#### B.2 Clinical Study

This clinical trial was performed in compliance with ISO 80601-2-56 and GCP standards.

The purpose of the clinical study was to demonstrate there is no statistically significant difference between temperatures measured by Temple Touch Pro™ and by other invasive thermometers.

In order to achieve this goal the trial was conducted among various populations (different age groups, genders and operations) and compared to various reference measurements.

Subjects were 95 males and 86 females in the ages 0-73 years old (median age was 4), Total subjects were 181, and total samples of 4591.

There were no observations or reports of adverse effects. The TTP™ was found to be as reliable as other clinical thermometers.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image contains the Medisim logo. The logo features the word "Medisim" in a combination of teal and blue colors, with a stylized "M" that resembles a medical graph. Below the word "Medisim" is the phrase "Non Invasive Thermometry" in a smaller font size.

The compliance of the new device and the predicate device has been assessed and validated against the standards below:

- IEC60601-1(2005, 3 Ed) Medical electrical equipment Part 1: . General requirements for basic safety and essential performance. IEC60601-1-2 (2007, 3 Ed) Medical electrical equipment - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- ISO 14971(2007, 2 Ed) Medical devices- Application of risk management to . medical devices.
- ISO 10993-10, Biological evaluation of medical devices, Part 10: Tests for . irritation and skin sensitization.
- ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for ● in vitro cytotoxicity.
- . ASTM E 1112-00 (2006) 3 RD Electronic thermometer for intermittent determination of patient temperature.
- . ISO 80601-2-56:1ST 2009 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
- . EN 12470-4:2009-11 - Performance of electrical thermometers for continuous measurement.

## Conclusion:

The subject product was found substantially equivalent to the legal predicate device based on the results from the performance testing and the clinical investigation.