Predicate Devices

Reference Devices

None

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system that collects and displays temperature and thermal image data. There is no mention of algorithms that learn from data or perform complex analysis beyond basic display and measurement. The "Relative display of color graphical image representing infrared radiation emitted from the body" suggests a direct mapping of thermal data to a visual representation, not an AI/ML interpretation.

Therapeutic

No
The device is described as a monitoring system for continuous temperature measurements and thermal imaging, not for treating or preventing a disease or condition.

Diagnostic

No

The device is intended for continuous temperature monitoring, not for diagnosing a disease or condition. While it collects data, the data is used for monitoring rather than diagnosing.

SaMD (Software as a Medical Device)

No

The device description clearly outlines two hardware components: the ATS Thermal Imaging Probe (a physical catheter with sensors) and the ATS Patient Interface Unit (a display unit). While software is involved in processing and displaying data, the core functionality relies on these physical components.

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, not an analysis of a sample taken from the body (like blood, urine, or tissue).
Device Description: The device measures temperature and thermal imaging directly from the esophagus. It does not process or analyze biological samples.
Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, sample preparation, or analysis of biological markers.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device measures a physical parameter (temperature and thermal radiation) directly from the patient's tissue.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ATS Thermal Imaging Probe is intended for continuous esophageal temperature monitoring.

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

Product codes

FLL

Device Description

The Securus Aurora Thermographic System (ATS) 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 the Patient Interface Unit.

Aurora Thermographic System (ATS) consists of two components:

A. ATS Thermal Imaging Probe
B. ATS Patient Interface Unit

The ATS Thermal Imaging 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. In addition, the ATS Thermal Imaging Probe 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 ATS Patient Interface Unit displays temperature measurements (°C) from the ATS Thermal Imaging Probe. The ATS Patient Interface Unit has a Digital Video (DVI) port for streaming thermal image data to an auxiliary monitor (not offered with the system).

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Thermal imaging (infrared radiation)

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

A risk analysis was performed to identify risks associated with the device modifications. Verification and validation testing has been performed to demonstrate that identified risks have been mitigated. This testing demonstrates that the modified ATS Thermal Imaging Probe and the ATS Patient Interface Unit is substantially equivalent to the predicate.

Key Results from Non-Clinical Testing & Performance Data:

ATS Thermal Imaging Probe Modifications:
- Electrical connections adequate for Accuracy: All samples tested met the accuracy acceptance criteria ± 0.3° C.
- Electrical connections adequate for Response time: Test results met the acceptance criteria

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

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

March 21, 2018

Securus Medical Group, Inc. William J. Gorman Director of Quality and Regulatory Affairs 100 Cummings Center, Suite 215F Beverly, Massachusetts 01915

Re: K180148

Trade/Device Name: ATS Thermal Imaging Probe, ATS Patient Interface Unit Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: February 20, 2018 Received: February 21, 2018

Dear Mr. William J. 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 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tina Kiang
s

Tina Kiang, Ph.D. Acting 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) K180148

Device Name

ATS Thermal Imaging Probe, ATS Patient Interface Unit

Indications for Use (Describe)

The ATS Thermal Imaging Probe is intended for continuous esophageal temperature monitoring.

The ATS Patient Interface Unit is intended to display continuous temperature measurements (C°) from the ATS 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)

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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary for the Aurora Thermographic System (ATS) made up of the ATS Thermal Imaging Probe and the ATS Patient Interface Unit is provided below.

1) Submitter

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

978-317-0836 Phone: Contact: William J. Gorman Date Prepared: March 15, 2018

2) Device

| Trade name: | ATS Thermal Imaging Probe
ATS Patient Interface Unit |

-------------	---------------------------------------------------------

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.

3) Predicate Device

InfraRed Thermographic System (IRTS), (K152402).

Reference Device: None

4) Device Description

The Securus Aurora Thermographic System (ATS) 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 the Patient Interface Unit.

Aurora Thermographic System (ATS) consists of two components:

A. ATS Thermal Imaging Probe
B. ATS Patient Interface Unit

The ATS Thermal Imaging 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. In addition, the ATS Thermal Imaging Probe 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 ATS Patient Interface Unit displays temperature measurements (°C) from the ATS Thermal

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Imaging Probe. The ATS Patient Interface Unit has a Digital Video (DVI) port for streaming thermal image data to an auxiliary monitor (not offered with the system).

5) Indications for Use

The ATS Thermal Imaging Probe is intended for continuous esophageal temperature monitoring.

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

6) Comparison of Technological Characteristics

The proposed Aurora Thermographic System (ATS) is a modification of the Securus Infrared Thermographic System (IRTS). Both systems include a 9 French Clinical Thermometer designed to provide continuous direct mode esophageal temperature monitoring through the use of a standard T-type thermocouple. In addition, both systems incorporate the identical infrared thermographic technology for quantifying surface temperature changes in the esophagus. Infrared accuracy and resolution are unchanged. The indications for use, intended use, temperature measurement technology and route of administration remain identical for the two systems.

The modifications involve hardware integration, software and packaging of the ATS Patient Interface Unit and ATS Thermal Imaging Probe.

Technological Characteristics Comparison Table
	ATS Thermal Imaging Probe
ATS Patient Interface Unit	IRTS System (K152402)	Discussion
	Modified Device	Predicate Device
Intended Use	Continuous temperature monitoring of
the patient's esophagus.	Continuous temperature monitoring of
the patient's esophagus.	Identical
Indications for Use	The ATS Thermal Imaging Probe

is intended for continuous esophageal
temperature monitoring.

The ATS Patient Interface Unit

is intended to display continuous
temperature measurements (C°) from
the ATS Thermal Imaging Probe. | The IRTS Probe

is intended for continuous esophageal
temperature monitoring.

The IRTS Patient Monitoring Unit
(PMU) with Patient Interface Unit
(PIU)

5

6

The subject Aurora Thermographic System (ATS) is identical to the predicate device in the following areas:

Identical Indications for Use and Intended Use ●
Identical temperature monitoring technology
Identical catheter diameter and route of administration ●
Identical accuracy, resolution and response time ●

The primary differences between the proposed Aurora Thermographic System (ATS) and its predicate are the integration of two electronic devices into a single unit package and the related ATS Thermal Imaging Probe changes.

The predicate system includes 3 components.

IRTS Thermal Imaging Probe
IRTS Patient Monitoring Unit ●
IRTS Patient Interface Unit ●

The modified Aurora Thermographic System (ATS) includes 2 components.

ATS Thermal Imaging Probe ●
ATS Patient Interface Unit ●

The ATS Thermal Imaging Probe incorporates a modification of the connection to the ATS Patient Interface Unit. The predicate IRTS Thermal Imaging Probe has two separate connectors, one for the thermocouple and one for the infrared measurement. The modified ATS Thermal Imaging Probe integrates the same thermocouple connector with the infrared connector to form a single connection. The ATS Thermal Imaging Probe length has been shortened from 150 cm to 108 cm.

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The infrared temperature range reported to the user has been modified from 35° - 60°C to -20°C -70°C. The infrared detector is unchanged and collects the same infrared energy as the predicate. The modified ATS Patient Interface Unit software allows more infrared data to be displayed.

The impact of each modification has been evaluated using the Securus Risk Management and Design Control systems. Each modification was considered for its impact. All verification testing (non-clinical, performance, and software validation) has been repeated to provide assurance that the modifications did not affect system performance.

Both systems have been validated using FDA recognized consensus standard ISO 80601-2-56:2017, Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.

Thus, the differences between the systems do not raise new questions for the subject device.

7) Non Clinical Testing & Performance Data

A risk analysis was performed to identify risks associated with the device modifications. Verification and validation testing has been performed to demonstrate that identified risks have been mitigated. This testing demonstrates that the modified ATS Thermal Imaging Probe and the ATS Patient Interface Unit is substantially equivalent to the predicate.

| Device Modification | Associated Risk | Verification / Validation
Method | Acceptance
Criteria | Results |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| ATS Thermal Imaging Probe Modifications | | | | |
| Two connectors combined
into one handle. | Electrical connections not
adequate -
Accuracy thermocouple | Testing in accordance with ISO
80601-2-56 second Edition 2017-
03: Medical electrical equipment -
Part 2-56. | Accuracy $\pm$ 0.3° C
across the rated output
range. | All samples tested met
the accuracy
acceptance criteria $\pm$
0.3° C . |
| Two connectors combined
into one handle. | Electrical connections not
adequate -
Response time
thermocouple | Testing in accordance with ISO
80601-2-56 second Edition 2017-
03: Medical electrical equipment -
Part 2-56. | Response time same as
predicate,