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

• K Number: K152402
• Device Name: IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)
• Manufacturer: SECURUS,INC
• Date Cleared: 2016-03-04 ( 192 days)
• Product Code: FLL CLI
• Regulation Number: 880.2910

Intended 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 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) - 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. 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 two-dimensional color map with peak temperature over the mapped area. The thermal image and peak temperature are offered as additional temperature monitoring features.

Predicate Devices

K123361

Reference Devices

K112376

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system that collects and displays temperature data and thermal images. There is no mention of AI/ML algorithms being used for analysis, interpretation, or decision-making based on this data. The performance studies focus on standard medical device testing (biocompatibility, electrical safety, software validation, performance accuracy) rather than AI/ML model performance metrics.

Therapeutic

No.
The device is intended for continuous esophageal temperature monitoring and does not provide therapy.

Diagnostic

No

The device is intended for continuous esophageal temperature monitoring, which is a measurement function rather than a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly lists three hardware components: a Thermal Imaging Probe, a Patient Interface Unit, and a Patient Monitoring Unit. The performance studies also include testing for hardware aspects like biocompatibility, electrical safety, EMC, and mechanical testing.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "continuous esophageal temperature monitoring." This is a physiological measurement taken directly from the patient's body.
• Device Description: The device measures temperature using a thermocouple and thermal imaging of the esophageal tissue. This is a direct measurement of a physical parameter within the body.
• Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a physiological state, health, or disease. This device does not analyze any such specimens.

The device is a medical device used for patient monitoring, specifically measuring temperature within the esophagus. It does not perform any diagnostic testing on samples taken from the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

FLL

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)
• 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 two-dimensional 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

esophagus

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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 .
  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.

Key Metrics

Temperature Sensor Accuracy: +/- 0.3 Celsius

Predicate Device(s)

K123361

Reference Device(s)

K112376

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing to the right, stacked one behind the other, with flowing lines beneath them.

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.

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 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

2

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)	☑
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

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

Trade name:	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)

4

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

5

6

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

7

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.