(108 days)
The ThermopeutiX TAPAS™ Catheter is intended for general intravascular use in the peripheral vasculature in arteries 1.8 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.
The TAPAS™ Catheter is contraindicated for use in the coronary and intracranial arteries.
The TAPAS™ Catheter is not intended for embolic protection or as an aspiration catheter.
Other than deletion of an optional extracorporeal circuit connection and the addition of a second balloon, the TAPAS™ catheter that is the subject of this submission is a substantially equivalent to the predicate ThermopeutiX DuoFlo catheter. The TAPAS™ catheter, as does the DuoFlo™ catheter, consists of two coaxial tubular shafts (inflow and outflow lumens) that can infuse diagnostic and/or therapeutic agents to selected regions, as well as direct arterial blood or other solutions to a specific region or organ. The lumens may be accessed using external devices connected to these lumens. There are three additional smaller lumen is used for inflation of the distal balloon on the inflow lumen. one is for optional pressure monitoring and the third lumen permits inflation of the balloon on the outflow lumen.
This document is a 510(k) summary for the ThermopeutiX TAPAS™ Catheter. It describes the device, its intended use, and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | In accordance with ISO 10993-1 standards for patient contact materials. | Demonstrated through biocompatibility studies. |
| Tip and Shaft Dimensions | In compliance with relevant standards and product specifications. | Results were acceptable. |
| Balloon Compliance & Inflation Volume | In compliance with relevant standards and product specifications. | Results were acceptable. |
| Balloon Inflation & Deflation Times | In compliance with relevant standards and product specifications. | Results were acceptable. |
| Balloon Fatigue | In compliance with relevant standards and product specifications. | Results were acceptable. |
| Balloon Burst | In compliance with relevant standards and product specifications. | Results were acceptable. |
| Balloon Bond Strength | In compliance with relevant standards and product specifications. | Results were acceptable. |
| Shaft/Lumen Joint Bond Strength | In compliance with relevant standards and product specifications. | Results were acceptable. |
| Sheath Compatibility | In compliance with relevant standards and product specifications. | Results were acceptable. |
| Shaft Kink | In compliance with relevant standards and product specifications. | Results were acceptable. |
| Shaft Torque | In compliance with relevant standards and product specifications. | Results were acceptable. |
| Shaft Burst Pressure | In compliance with relevant standards and product specifications. | Results were acceptable. |
| Tip Bond Strength | In compliance with relevant standards and product specifications. | Results were acceptable. |
| Concentric Shaft Movement | In compliance with relevant standards and product specifications. | Results were acceptable. |
| Manifold Lumen Joint Strength | In compliance with relevant standards and product specifications. | Results were acceptable. |
| Stopcock Lumen Joint Strength | In compliance with relevant standards and product specifications. | Results were acceptable. |
| Sterility | Sterility Assurance Level (SAL) of 10⁻⁶. | Conforms to SAL of 10⁻⁶ (adopted into existing validated ethylene oxide sterilization cycle). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify numerical sample sizes for the mechanical and biocompatibility tests performed. It states "Physical testing was performed and results were in compliance with relevant standards and the product specification." and "The biological safety of the device has been demonstrated through biocompatibility studies of patient contact materials in accordance with the standards outlined in ISO 10993-1."
There is no information regarding data provenance (e.g., country of origin, retrospective or prospective) as these are non-clinical, in-vitro/bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The tests performed are mechanical and biological (biocompatibility) in nature, not involving expert interpretation of data like medical image analysis. The "ground truth" for these tests would be established by the physical and chemical properties of the materials and device components, measured against established standards.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or subjective assessments that would require an adjudication method. The outcomes of the tests are objective measurements against predefined specifications or standards.
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
Not applicable. This device is a medical catheter, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance and safety tests described (biocompatibility, dimensions, balloon characteristics, bond strengths, etc.) is based on established industry standards (e.g., ISO 10993-1) and ThermopeutiX's internal product specifications. These serve as objective benchmarks.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device submission, which does not involve machine learning models or training sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).