IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)

K152402 · Securus,Inc · FLL · Mar 4, 2016 · General Hospital

Device Facts

• Record ID: K152402
• Device Name: IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)
• Applicant: Securus,Inc
• Product Code: FLL · General Hospital
• Decision Date: Mar 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Indications for Use

The IRTS Probe is intended for continuous esophageal temperature monitoring. The IRTS Patient Monitoring Unit Patient Interface Unit (PIU) is intended to display continuous temperature measurements (C°) from the IRTS Thermal Imaging Probe.

Device Story

IRTS is an esophageal temperature monitoring system consisting of a Thermal Imaging Probe (TIP), Patient Interface Unit (PIU), and Patient Monitoring Unit (PMU). The probe, a 9 French catheter, contains a Type-T thermocouple for standard temperature sensing and a thermographic sensor with fiber optic assembly to passively collect infrared radiation from esophageal tissue. The system transforms these inputs into a two-dimensional color map of the esophageal surface temperature and a peak temperature value, displayed on the PMU. Used in clinical settings, the device is operated by healthcare professionals to provide continuous temperature data. The additional thermal imaging feature assists clinicians in monitoring esophageal temperature, potentially aiding in clinical decision-making during procedures requiring temperature management. The device is provided non-sterile.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993-1), electrical safety/EMC (AAMI/ANSI ES60601-1, IEC 60601-1-2), and performance testing per ISO 80601-2-56 (accuracy ± 0.3°C, response time < 2.5 seconds). Mechanical testing confirmed strength and service life under simulated worst-case conditions.

Technological Characteristics

9 French catheter probe; materials: polyethylene and platinum iridium. Sensing: Type-T thermocouple and infrared thermographic sensor with fiber optic assembly. Energy: 24 VDC power supply. Connectivity: System components (Probe, PIU, PMU). Standards: ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2, ISO 10993-1. Software: System-level verification and validation performed.

Indications for Use

Indicated for continuous esophageal temperature monitoring in patients requiring such monitoring.

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

• ESOTEST Esophageal Temperature Probe and Temperature Monitoring System (K123361)

Reference Devices

• S-Cath Esophageal Temperature Probe and Temperature Monitoring System (K112376)

Submission Summary (Full Text)

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

March 4, 2016

Securus, Inc. Mr. William Gorman Director of Quality and Regulatory Affairs 100 Cummings Center, Suite 215f Beverly, Massachusetts 01915

Re: K152402

Trade/Device Name: InfraRed Thermographic System (IRTS) IRTS Thermal Imaging Probe (TIP), IRTS Patient Monitoring Unit (PMU), IRTS Patient Interface Unit (PIU) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometers Regulatory Class: II Product Code: FLL Dated: January 27, 2016 Received: February 2, 2016

Dear Mr. Gorman:

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.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -5

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

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## Indications for Use

510(k) Number (if known) K152402

#### Device Name

Infrared Thermographic System (IRTS) IRTS Thermal Imaging Probe (TIP), IRTS Patient Monitoring Unit (PMU), IRTS Patient Interface Unit (PIU)

Indications for Use (Describe)

The IRTS Probe is intended for continuous esophageal temperature monitoring.

The IRTS Patient Monitoring Unit Patient Interface Unit (PIU) is intended to display continuous temperature measurements (C°) from the IRTS Thermal Imaging Probe.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|----------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <span>☑</span> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span>☐</span> |

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# 510(K) SUMMARY K152402, INFRARED THERMOGRAPHIC SYSTEM (IRTS)

## PREPARED: MARCH 3, 2016

## 1) Submitter

Securus Medical Group, Inc. 100 Cummings Center Suite 215F Beverly, MA 01915

Phone: [phone] Contact: William J. Gorman

## 2) Device

| <b>Trade name:</b> | InfraRed Thermographic System (IRTS) |
|--------------------|--------------------------------------|
| | IRTS Thermal Imaging Probe (TIP) |
| | IRTS Patient Monitoring Unit (PMU) |
| | IRTS Patient Interface Unit (PIU) |

Clinical Electronic Thermometer Common name:

## Classification Number/ Classification name/Product code:

Clinical Electronic Thermometers are Class II devices under 21 CFR § 880.2910 and are classified by the General Hospital Panel. Product code - FLL.

## Special Controls:

Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers, March 1993

## 3) Predicate Device

ESOTEST Esophageal Temperature Probe and Temperature Monitoring System, FIAB, (K123361)

## 4) Reference Device

S-Cath Esophageal Temperature Probe and Temperature Monitoring System, Circa Scientific, (K112376)

## 5) Device Description

The Securus InfraRed Thermographic System (IRTS) is an esophageal temperature probe and monitoring system intended for continuous temperature monitoring of the patient's esophagus. The Probe includes a thermocouple sensor for temperature monitoring and a thermographic sensor for thermal imaging. Data from both sensors are displayed on a monitor for the user.

The InfraRed Thermographic System (IRTS) consists of three components:

- A. Thermal Imaging Probe (TIP or Probe)

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- B. Patient Interface Unit (PIU)
- C. Patient Monitoring Unit (PMU)

The Probe provides esophageal temperature monitoring through the use of a standard thermocouple mounted in a flexible 9 French catheter. This design is standard for esophageal temperature probes commonly used in the industry. The Probe has been tested in compliance with ISO 80601-2-56:2009, Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. In addition, the IRTS incorporates a thermographic sensor and fiber optic assembly to passively collect the infrared radiation that is self-emanating from the surrounding esophageal tissue surface. The thermal data is presented on the Patient Monitoring Unit as a twodimensional color map with peak temperature over the mapped area. The thermal image and peak temperature are offered as additional temperature monitoring features. The thermal data of the IRTS is not classified under the Clinical Thermometer designation of ISO 80601-2-56.

#### 6) Indications for Use

The IRTS Probe is intended for continuous esophageal temperature monitoring.

The IRTS Patient Monitoring Unit (PMU) with Patient Interface Unit (PIU) is intended to display continuous temperature measurements (C') from the IRTS Thermal Imaging Probe.

#### 7) Comparison to Predicate Device

The IRTS is substantially equivalent to the primary predicate device FIAB ESOTEST System (K123361). Both the subject device and the primary predicate device have the same intended use and indications for use as a continuous esophageal temperature monitor. Both use thermocouple sensors for temperature monitoring of the patients esophagus. The subject device also includes a thermographic sensor for displaying thermal images as an additional temperature monitoring feature. This feature does not raise different questions of safety or effectiveness as it provides additional information about the temperature in the patient's esophagus. Similar to reference device Circa Scientific, Esophageal Temperature Probe and Temperature Monitoring System (K112376), the subject device is provided non-sterile. Thus, the subject device has the same intended use and similar technological characteristics as the primary predicate device K123361. Any differences in technological characteristics do not raise different questions of safety or effectiveness. A summary comparison between the subject, primary predicate and reference devices is provided in the following table:

| | Securus Medical Group,<br>Inc.,<br>IRTS System<br>Subject Device | FIAB, ESOTEST<br>Esophageal Temperature<br>Probe and Temperature<br>Monitoring System<br>K123361<br>Primary Predicate<br>Device | Circa Scientific,<br>Esophageal Rectal<br>Temperature Probe and<br>Temperature Monitoring<br>System<br>K 112376<br>Reference Device | SE Discussion |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Intended Use | Continuous temperature<br>monitoring of the<br>patients esophagus | Continuous temperature<br>monitoring of the<br>patients esophagus. | Continuous esophageal<br>temperature monitoring | Same intended use |
| | Securus Medical Group,<br>Inc.,<br>IRTS System<br>Subject Device | FIAB, ESOTEST<br>Esophageal Temperature<br>Probe and Temperature<br>Monitoring System<br>K123361<br>Primary Predicate<br>Device | Circa Scientific,<br>Esophageal Rectal<br>Temperature Probe and<br>Temperature Monitoring<br>System<br>K 112376<br>Reference Device | SE Discussion |
| Indications for<br>Use | The IRTS Probe is<br>intended for continuous<br>esophageal temperature<br>monitoring.<br>The IRTS Monitor is<br>intended to display<br>continuous esophageal<br>temperature<br>measurements (°C) from<br>the IRTS Probe. | The ESOTEST Probe is<br>intended for continuous<br>esophageal temperature<br>monitoring.<br>ESOTEST Monitor is<br>intended to display<br>continuous temperature<br>measurement (°C) from<br>3 sensors temperature<br>probe. | The Esophageal<br>Temperature Probe is<br>intended for continuous<br>patient temperature<br>monitoring. The<br>radiopaque probe is<br>designed for placement<br>in the esophagus.<br>Temperature Monitor:<br>Display continuous<br>temperature<br>measurement (°C) from<br>12-sensor temperature<br>probe. | Same indications<br>as primary<br>predicate |
| System<br>Components | Temperature probe<br>Patient Interface Unit<br>Patient Monitoring Unit | Temperature probe<br>Interconnect cable<br>Patient Monitor | Temperature probe<br>Interconnect cable<br>Monitor | Similar<br>components |
| Probe Sterility | Provided Non-sterile | Provided Sterile | Provided Non-sterile | Same as reference<br>device |
| Probe Material<br>(patient contact) | Polyethylene and<br>platinum iridium | Polyurethane and<br>stainless steel | Flexible Polyester and<br>Rigid Pebax | Similar materials,<br>tested for<br>biocompatibility |
| Probe size | 9 Fr catheter with 9 Fr<br>sensor<br>150 cm length | 7 Fr catheter with 11 Fr<br>sensors<br>95 cm length | 10 Fr OD, 30.5" total<br>length.<br>Interconnect Cable 10'<br>long | Similar sizes |
| System<br>Temperature<br>Precision and<br>Resolution | 0.1° C | 0.1° C | 0.2° C | Similar precision<br>and resolution. |
| Temperature<br>Sensor | Type-T thermocouple | Type-T thermocouple | Thermistor | Similar sensor |
| Temperature<br>Sensor Range | 25° - 45° C | 15°-75° C | 25° - 45° C | Same range as<br>reference device |

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| | Securus Medical Group,<br>Inc.,<br>IRTS System<br>Subject Device | FIAB, ESOTEST<br>Esophageal Temperature<br>Probe and Temperature<br>Monitoring System<br>K123361<br>Primary Predicate<br>Device | Circa Scientific,<br>Esophageal Rectal<br>Temperature Probe and<br>Temperature Monitoring<br>System<br>K 112376<br>Reference Device | SE Discussion |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Temperature<br>Sensor Accuracy | $\pm$ 0.3° C<br>tested in accordance with<br>ISO 80601-2-56 | $\pm$ 0.5° C<br>tested in accordance with<br>ISO 80601-2-56 | $\pm$ 0.3° C<br>tested in accordance with<br>ISO 80601-2-56 | Better accuracy<br>than primary<br>predicate device |
| Transient<br>Response Time<br>of Temperature<br>Sensor | Both heating transient<br>response time and<br>cooling transient<br>response time are less<br>than 2.5 seconds: time<br>for probe plunged from<br>reference bath to a water<br>bath with a 2° C<br>differential. | Both heating transient<br>response time and<br>cooling transient<br>response time are<br>approximately 1 second:<br>time for probe plunged<br>from reference bath to a<br>water bath with a 2° C<br>differential. | Heating transient 7<br>seconds, cooling<br>transient 4.5 seconds | Insignificant time<br>differential. |
| Power Supply | 100-240 Vac AC adaptor<br>power supply 24 VDC | 100-120/230 Vac | 100-240 Vac | Compliant to US<br>power supply |
| Electrical Safety<br>and<br>Electromagnetic<br>Compatibility | Fully complies with IEC<br>60601-1:2005 +A1:2012<br>IEC 60601-1-2:2007 | Fully complies with IEC<br>UL 60601-1: 2006<br>IEC 60601-1-2:2007 | Fully complies with IEC<br>60601-1:1998<br>(applicable sections) | Same standards |

## 8) Performance Data

The following performance data were provided in support of the substantial equivalence determination:

## Biocompatibility:

Probes were tested in accordance with ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. Testing included:

- . Cytotoxicity
- . Sensitization
- . Irritation/Intracutaneous Reactivity

Test results show that the device meets the requirements of ISO 10993 for its intended use.

## Electrical Safety and EMC:

The InfraRed Thermographic System (IRTS) was tested in accordance with:

- AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012,, c1:2009/(r)2012 and .

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a2:2010/(r)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

- IEC 60601-1-2 Edition 3:2007-03 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
This testing demonstrates that the InfraRed Thermographic System (IRTS) meets the recognized standards for electrical safety and compatibility.

#### Software Verification and Validation:

Per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", Securus has provided appropriate software documentation based on Level of Concern. A system level software verification and validation protocol was developed to test each requirement. This protocol includes a cross-reference matrix to map each requirement with a test activity and a pass/fail criteria. Results of each test are recorded and compared to the pass/fail criteria. All software verification and validation activities show that the software meets product requirements documentation.

#### Performance Testing:

The InfraRed Thermographic System (IRTS) was tested in accordance with the requirements of ISO 80601-2-56 first Edition 2009-10-01: Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. Testing included accuracy and response time. All performance testing data shows that the IRTS system meets the requirements of ISO 80601-2-56.

#### Mechanical Testing:

Finished devices were tested in accordance with pre-approved protocols based on design input requirements for mechanical strength and service life (simulated use). This testing shows that the IRTS system meets pre-established design input requirements for mechanical strength and service life when tested in simulated worst case conditions.

## Conclusions

The IRTS has the same intended use, indications for use and similar technological characteristics as the primary predicate device K123361. Any difference in technological characteristics does not raise different questions of safety or effectiveness. The thermal imaging feature of the IRTS provides additional temperature monitoring of the patient's esophagus. The performance testing supports substantial equivalence of the IRTS to the predicate.