The intended use of the TTS100 Portable Hyperthermic Perfusion Device is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating, warmed, physiologically compatible sterile solution, according to a protocol to be selected by the physician.

Device Description

The TTS100 Portable Hyperthermic Perfusion Device is a prescription device comprised of two components - one durable and one disposable. The TTS L00 Console is the durable component - a portable, unit containing heater, pump, user touchscreen, microprocessor, and interface electronics. The primary user interface of the TTS100 is a large, color touchscreen display that receives operational commands from the clinical user, and presents normal operating conditions, flow rate, output fluid temperature, patient temperature, target temperature, line pressure, alarm and status messages, various timers and auxiliary temperatures. The TTS100 software monitors various sensors in the fluid path to ensure safe operation, automatically reacts to unsafe conditions, and alerts the clinical user to those conditions for resolution. Independent protection circuits prevent unsafe operation in the event of system software fault.

The disposable, single-use component is the Hyperthermic Lavage Tubing Set, which has two subcomponents - a Circulation Loop and an Accessory Kit. The Circulation Loop contains the filtered soft-shell fluid reservoir, inlet ports, vent lines, integrated distributed sensors, patient inlet circulation loop tubing, patient outlet circulation loop tubing, and drain line. The Accessory Kit - an integral component of the Hyperthermic Lavage Tubing Set - contains patient inlet and patient outlet tubing, tubing connectors, and auxiliary temperature sensors. Portions of the Accessory Kit can be implanted into the patient for use during the lavage procedure. The Circulation Loop does not have direct patient contact - only the circulating fluid within the loop contacts the patient. The Hyperthermic Lavage Tubing set is designed such that fluid travels through the Disposable Set without wetting the heater, pump or other TTS system components (e.g., only the internal surfaces of the Disposable Set are wetted), enabling rapid and straightforward post-processing of the TTS100 Console between patients. The Hyperthermic Lavage Tubing Set is supplied sterile, packaged in a proprietary-design container, and is only intended to be used in conjunction with the TTS100 Portable Hyperthermic Perfusion Device.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the TTS100 Portable Hyperthermic Perfusion Device:

The document is a 510(k) Summary for the TTS100 Portable Hyperthermic Perfusion Device. It outlines the regulatory submission for this device.

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with corresponding performance values for the TTS100 Portable Hyperthermic Perfusion Device. Instead, it describes various tests performed and states that the device "performed within specification in all of the above tests."

Based on the "Software Verification/Validation Testing" section (7.1.2), the implied acceptance criteria are related to the successful operation and safety features of the device, which it reportedly met.

Acceptance Criteria (Implied)	Reported Device Performance
Ability to heat fluids over the full range of fluid flowrates.	Performed within specification.
Ability to maintain fluid temperature over the full range of fluid flowrates.	Performed within specification.
Ability to detect and automatically respond to unsafe or ineffective operating conditions (e.g., sensor failure, excessive temperature/pressure, component failures).	Performed within specification.
Ability to inform the clinical user of unsafe or ineffective operating conditions (via notifications, alerts, alarms, system faults).	Performed within specification.
Ability to mitigate against known or predictable operator errors.	Performed within specification.
Ability to store treatment parameters and data in non-volatile memory.	Performed within specification.
Measured temperature accuracy over the full range of fluid flowrates within the operating pressure range.	Performed within specification.
Measured pressure accuracy over the full range of fluid flowrates within the operating temperature range.	Performed within specification.
Fluid flowrate accuracy over the full range of fluid flowrates within the operating temperature and pressure range.	Performed within specification.

Additionally, the device was tested for:

Biocompatibility: Complied with AAMI/ANSI/ISO 10993 series for biological evaluation, in vitro cytotoxicity, ethylene oxide sterilization residuals, irritation, delayed-type hypersensitization, and systematic toxicity.
Electrical Safety, EMC: Complied with IEC 60601-1 and IEC 60601-1-2.
Sterility: Complied with AAMI/ANSI/ISO 11135-1 for ethylene oxide sterilization.
Packaging: Complied with ASTM D4169-05 for performance testing of shipping containers.
Human Factors: A non-clinical study demonstrated that user- and patient-safety risks were identified, addressed, and mitigated.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical tests (Section 7.1) for verification and validation. It does not provide specific sample sizes for these tests (e.g., number of devices tested, number of test runs). The tests are described generally, for instance, "the TTS100 was tested to assess..." implies the device itself was the subject of these tests, rather than patient data.

The data provenance is internal testing performed by ThermalTherapeutic Systems, Inc. The document does not specify a country of origin for the data beyond that. There is no mention of retrospective or prospective patient data testing, as all tests discussed are non-clinical.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests performed are engineering and technical verification/validation activities against recognized standards and product specifications. There is no mention of experts being used to establish a "ground truth" in the context of clinical accuracy, as the tests were non-clinical.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the tests described are technical verification and validation against pre-defined specifications and recognized standards, not human assessment requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. A Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a medical apparatus (a hyperthermic perfusion device), not an imaging or diagnostic AI-powered tool that would involve human readers or AI assistance in interpretation. The document explicitly states "8.1 Performance Data Discussion of Clinical Tests: N/A".

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The term "standalone" performance typically refers to the algorithmic performance of AI models. This device is a physical medical device, not an AI algorithm. Its performance was evaluated through non-clinical engineering and validation tests as described in Section 7.1. These tests assess the device's ability to operate according to its specifications (e.g., heating, maintaining temperature, detecting faults), which is analogous to a standalone performance assessment for its intended function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests was established by:

Engineering Specifications: The design and performance specifications set for the device (e.g., target temperature ranges, flow rates, pressure limits, safety response times).
Recognized Consensus Standards: International and national standards for biocompatibility (ISO 10993), electrical safety and EMC (IEC 60601), sterility (ISO 11135), and packaging (ASTM D4169).
Human Factors Analysis: Identification and mitigation of user- and patient-safety risks.

8. The sample size for the training set

This information is not applicable/provided. The TTS100 Portable Hyperthermic Perfusion Device is a hardware medical device with embedded software, not a machine learning or AI system that requires a "training set" in the conventional sense. The software verification/validation tests confirm its adherence to hard-coded specifications and logic, not learned patterns from a dataset.

9. How the ground truth for the training set was established

This information is not applicable/provided for the same reason as point 8. The "ground truth" for the device's development (not a training set) would have been its design specifications, regulatory requirements, and the functional requirements derived from its intended use and comparison to predicate devices.

Summary

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MAR - 4 2010

ThermalTherapeuticSystems, Inc.

POB 82670 Pittsburgh, PA 15218 Phone: 412.571.2622 www.thermaltherapeutics.com

510(k) Summary

Model TTS100 Portable Hyperthermic Perfusion Device

510(k) Number: K092366

Submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.

1.0 21CFR 807.92(A)(1)

1.1 Applicant's Information

J. Michael Fausset BS CP Chief Technical Officer ThermalTherapeutic Systems, Inc. Mobile: 765 427.3308 Fax: 412 291.1951 E: imf@thermaltheraneutics.com I: http://www.thermaltherapeutics.com Medical Establishment Registration No .: pending

1.2 Submitter's Information

James Jochen Rogers General Manager Coastal Consulting Group, Ltd. P.O. Box 961 Moon Township, PA 15108 Mobile: 724 713.2298 Fax: 412 291.1951 E: ir@coastalco.com I: http://www.coastakcg.com

1.3 Date
March 1, 2010

2.0 21CFR 807.92(A)(2)

2.1 Device Information

Trade/Proprietary Name: TTS100 Portable Hyperthermic Perfusion Device Common Name: TTS100 Portable Hyperthermic Perfusion Device Model Number: TTS100 ·Regulation Number: None Regulation Name: None Regulatory Class: Unclassified, pre-amendment device; non-exempt from 510(k) Device Classification Name: Warmer, thermal, Infusion fluid Classification Panel: General Hospital Classification Product Code(s): LGZ

2.2 Device Classification

Infusion fluid thermal warmers and their accessories are unclassified, Pre-Amendment devices. 510(k) premarket notification submissions for these devices are reviewed by the General Hospital Devices Branch, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices,

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ThermalTherapeuticSystems, Inc.

3.0 21CFR 807.92(A)(3)

3.1 Predicate Device Information

PREDICATE DEVICES
510(k) #	DEVICE	510(k) SPONSOR	510(k)CLEARANCE DATE
K993330	ThermoChem-HT System	Hemocleanse, Inc.	12/30/1999
K070654	Belmont Hyperthermia Pump	Belmont Instrument, Inc.	6/8/2007

4.0 21CFR 807.92(A)(4)

4.1 Device Description

5.0 21CFR 807.92(A)(5)

5.1 Indications for Use
The intended use of the TTS100 Portable Hyperthermic Perfusion Device is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating, warmed, physiologically compatible sterile solution, according to a protocol to be selected by the physician.

6.0 21CFR 807.92(A)(6)

6.1 Technological Characteristics Comparison to Predicate Device(s)

As compared to the predicate devices, the TTS100 Portable Hyperthermic Perfusion Device has the same operating principle, energy type, environmental specifications, and performance specifications. All devices use a roller-type fluid pump, touchscreen-based clinical user Interface for machine set-up and control, sensor monitoring of various fluid temperatures, and a proprietary-design disposable set including large fluid reservoir to circulate sterile fluid into and out of the body cavity. For the TTS100, fluid in the reservoir is heated via direct heat to the desired temperature, and the heater drain tubing passes through a roller pump and out to the patient inlet. Fluid returns from the patient outlet wia gravity drain back to the fluid reservoir. The TTS100 monitors circulating fluid temperature and pressure, and automatically responds to ineffective or unsafe operating conditions.

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ThermalTherapeuticSystems, Inc.

7.0 21CFR 807.92(B)(1)

7.1 Performance Data - Discussion of Non-Clinical Tests

7.1.1 FDA Recognized Consensus Standards
The TTS100 is designed to, complies with, and has been tested as part of verification and validation activities to, the FDA Recognized Consensus Standards listed in the table below, as applicable to device features and components:

REQUIREMENT	REFERENCE #	TITLE
Biocompatibility	AAMI/ANSI/ISO 10993-1:2003(E)	Biological evaluation of medical devices - Part1: Evaluation and testing
	AAMI/ANSI/ISO 10993-5:1999	Biological evaluation of medical devices - Part5: Tests for in vitro cytotoxicity
	AAMI / ANSI / ISO 10993-7:1995(R)2001	Biological Evaluation of Medical Devices - Part7: Ethylene Oxide Sterilization Residuals.
	AAMI/ANSI/ISO 10993-10:2002	Biological evaluation of medical devices -Part 10: tests for irritation and delayed-typehypersensitization
	AAMI/ANSI/ISO 10993-11:2006	Biological evaluation of medical devices - Part11: Tests for systematic toxicity
ElectricalSafety, EMC	IEC60601-1:1988+A1:1991+A2:1995(IEC 60601-1+A1+A2)	Medical electrical equipment - Part 1: GeneralRequirements for Safety, 1988; Amendment 1,1991-11, Amendment 2, 1995
	IEC 60601-1-2:2001+A1:2004(IEC 60601-1-2+A1)	Medical Electrical Equipment - Part 1-2: GeneralRequirements for Safety - Collateral standard:Electromagnetic Compatibility - Requirementsand Tests (Ed. 2.1)
Sterility	AAMI / ANSI / ISO 11135-1:2007	Sterilization of health care products -Ethylene oxide - Part 1: Requirements for thedevelopment, validation, and routine control ofa sterilization process for medical devices.
Packaging	ASTM D4169-05:2005	Standard Practice for Performance Testing ofShipping Containers and Systems

7.1.2 Software Verification/Validation Testing

As part of software verification/validation activities, and in support of substantial equivalence, the following tests were carried out the TTS100 to evaluate its ability to meet product performance specifications. Specifically, the TTS100 was tested to assess ...

I The ability of the TTS100 to heat fluids over the full range of fluid flowrates.
The ability of the TTS100 to maintain fluid temperature over the full range of fluid flowrates. E
E The ability of the TTS100 to detect and automatically respond to unsafe or ineffective operating conditions, as caused by the failure of the system sensors, excessive fluid temperature, excessive fluid pressure, or system-internal component failures.
The ability of the TTS100 to inform the clinical user of those unsafe or ineffective operating conditions via notifications, alerts, alarms, and/or system faults.
D The ability of the TTS100 to mitigate against known or predictable operator errors.
The ability of the TTS100 to store treatment parameters and data in non-volatile memory. D
ם Measured temperature accuracy over the full range of fluid flowrates within the operating pressure range.
D Measured pressure accuracy over the full range of fluid flowrates within the operating temperature range.
Fluid flowrate accuracy over the full range of fluid flowrates within the operating temperature and pressure range.

The TTS100 performed within specification in all of the above tests.

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K092366

ThermalTherapeuticSystems, Inc.

7.1.3 Human Factors

A human factors non-cilnical study evaluated user- and patient-safety risks associated with the design of the TTS100, and demonstrated that the task-risks have been identified, addressed and mitigated.

8.0 21CFR 807.92(s)(2)

8.1 Performance Data Discussion of Clinical Tests
N/A
9.0 21CFR 807.92(B)(3)

9.1 Conclusions

Based upon safety and performance testing and compliance with voluntary standards, ThermalTherapeutic Systems, Inc. believes that the TTS100 Portable Hyperthermic Perfusion Device is substantially equivalent to the predicate devices, and does not raise any new questions of safety or effectiveness.

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Image /page/4/Picture/0 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Thermal Therapeutic Systems, Incorporated C/O Mr. James Jochen Rogers General Manager Coastal Consulting Group, Limited P.O. Box 961 Moon Township, Pennsylvania 15108

JAN 1 0 2017

Re: K092366

Trade/Device Name: TTS100 Portable Hyperthermic Perfusion Device Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: March 3, 2010 Received: March 4, 2010

Dear Mr. Rogers:

This letter corrects our substantially equivalent letter of March 4, 2010.

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.

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

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Page 2 - Mr. James Jochen Rogers

CFR Part 807); labeling (21 CFR Parts 801 and 809 ); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Erin I. Keith -S

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): K092366

Device Name: TTS100 Portable Hyperthermic Perfusion Device

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Charles Schwab

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K092366

Page 1 of 1

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).