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510(k) Data Aggregation
(91 days)
Bashir™ Endovascular Catheter: The Bashir™ Endovascular Catheter is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Bashir™ N-X Endovascular Catheter: The Bashir™ N-X Endovascular Catheter is intended for the controlled and selective infusion of physician-specified fluids into the peripheral and pulmonary artery vasculature.
Thrombolex developed the Bashir™ Endovascular Catheter (Model 7201) to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. The Bashir™ N-X Endovascular Catheter (Model 7200) is a second model developed for infusion of physician-specified fluids in the pulmonary artery. The Bashir™ N-X differs from the Bashir™ Endovascular Catheter in that the infusion limbs do not expand into an infusion basket but remain collapsed in a straight configuration. The two device models have a different appearance, namely in the handle design and color, which ensures appropriate use and identification.
The design of the Bashir™ Endovascular Catheter allows for delivery and positioning of the catheter at the target peripheral location via a sheath, over a guidewire using fluoroscopic guidance. Depending on the target location, the infusion can be initiated either in the non-expanded position (for vessels with smaller diameters), or by controlled expansion of the infusion basket to a desired dimension inside the vessel by the interventional specialist under fluoroscopic guidance. The physician-specified solution is then delivered via multiple laser-drilled holes through the infusion limbs of the Bashir™ Endovascular Catheter. After the completion of solution delivery, the infusion limbs are collapsed to a straight position in the case of peripheral vasculature, and then the Bashir™ Endovascular Catheter is retracted into the sheath and removed.
The handle of the Bashir™ N-X Endovascular Catheter has been modified to disable expansion of the basket. The Bashir™ N-X Endovascular Catheter, unexpanded, is thus similar to other straight infusion catheters including the predicate device.
Delivery of the Bashir N-X™ Endovascular Catheter into the pulmonary artery is accomplished using a long guide sheath using standard interventional techniques. The Bashir™ Endovascular Catheter is placed over a guidewire inside the sheath to the desired location under fluoroscopic guidance. The catheter does not come in direct contact with the right atrium, tricuspid valve, right ventricle or pulmonic valve at any time, as it is within a guide sheath.
The Bashir™ Endovascular Catheter and Bashir™ N-X Endovascular Catheter are comprised of common materials used in vascular catheters. The catheter is mechanical and contains no electrical components.
The provided text describes the Bashir Endovascular Catheter and Bashir N-X Endovascular Catheter and their substantial equivalence to a predicate device, the Ekosonic Endovascular System. However, it does not contain information about acceptance criteria or a study that uses a standalone AI algorithm, or a multi-reader, multi-case comparative effectiveness study with human readers.
Based on the provided text, the following information can be extracted regarding the device performance and acceptance:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Area | Acceptance Criteria (Implied by testing) | Reported Device Performance |
|---|---|---|
| Sterilization | Compliance with ISO 11135:2014 and a sterility assurance level (SAL) of 10-6. | The sterilization cycles have been validated following international standards (ISO 11135:2014) to a sterility assurance level of 10-6. |
| Shelf Life | Not explicitly stated, but implies the device must maintain its functionality and sterility for a defined period. | A shelf life of 1 year has been established through accelerated aging studies. |
| Biocompatibility | Compliance with ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" to be suitable for its intended use. | Biocompatibility evaluation has been performed, showing the finished, sterilized device is biocompatible and suitable for its intended use, taking into account ISO 10993 and FDA Draft Guidance. |
| Human Factors (Usability) | Predefined acceptance criteria for participants' ability to perform procedures with the devices. | Usability testing found the devices substantially equivalent for the intended users, uses, and use environments. Participants were able to perform procedures and meet predefined acceptance criteria. |
| Bench Performance | Performance characteristics (e.g., kink radius, trackability, radial force, flow rates, pressure measurements, compatibility, dimensional verification, leakage, etc.) should be comparable to or within acceptable limits relative to the predicate device and reference devices (where applicable for expandable features). For expandable features, radial force should be similar to balloon reference devices. Differences should not raise new questions of safety or effectiveness. | Performance testing characterized the devices, demonstrating substantial equivalence to the predicate device. This included evaluation of kink radius, trackability, advancement force, slider actuator force, catheter retraction, radial force (demonstrated similar to balloon reference devices for expandable features), delivery flow rate, infusion pressure at various flow rates, infusion pressure with pulse spray, pressure measurement through central lumen, guidewire compatibility, dimensional verification, compliance of injection hubs, air leakage, fluid leakage, stress cracking, resistance to separation, torque strength, corrosion resistance, joint tensile strengths, and particulate generation. |
| Animal Study (GLP Porcine) | No adverse systemic or pathological effects observed from the use of the catheter. | A GLP porcine study demonstrated the safety of the Bashir Endovascular Catheter, showing no adverse effects systemically or pathologically, supporting safe use. |
| Substantial Equivalence (Overall) | The device should not raise new questions of safety or effectiveness compared to the predicate device and have similar intended use, technology, and performance. | The information presented demonstrates that the Bashir Endovascular Catheter and Bashir N-X Endovascular Catheter are substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified for any of the performance tests. The text mentions "participants" for human factors testing and a "GLP porcine study" but does not quantify the number of subjects/samples.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. The animal study is described as a "GLP porcine study," implying a prospective, controlled study conducted under Good Laboratory Practice regulations.
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 studies described are primarily bench, animal, and usability tests, not diagnostic accuracy studies that would typically involve expert-established ground truth. Expert involvement is implied in assessing usability criteria and potentially in interpreting animal study results, but no specifics are given.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the tests (bench, animal, usability), formal adjudication methods like 2+1 or 3+1 (common in diagnostic accuracy studies) would not typically be applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done or described. The document focuses on demonstrating substantial equivalence of a medical device (catheter) through bench, animal, and usability testing, not on evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm study was not done. The device is a mechanical endovascular catheter, not an AI algorithm.
7. Type of Ground Truth Used
- Bench Testing: Ground truth is established by physical measurements, engineering specifications, and validated test methods (e.g., verifying flow rates against expected values, measuring device dimensions, checking for leaks).
- Animal Study: Ground truth is established by physiological and pathological assessments in the porcine model (e.g., absence of systemic or pathological adverse effects).
- Human Factors Testing: Ground truth is established by predefined acceptance criteria for task performance and user feedback, evaluated against the device's intended use.
8. Sample Size for the Training Set
This is not applicable as the device is a mechanical catheter and does not involve AI or machine learning algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is a mechanical catheter and does not involve AI or machine learning algorithms that require a training set.
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