(211 days)
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.
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.
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.
§ 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).