(28 days)
The Bashir™ S-B Endovascular Catheter is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The Bashir™ S-B Endovascular Catheter (Model 7101) is a continuous flush catheter designed to enable delivery of physician-specified fluids, including thrombolytics, into the peripheral circulation. The design of the Bashir™ S-B 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 delivered via multiple laser-drilled holes through the infusion limbs of the Bashir™ S-B Endovascular Catheter after placement. After the completion of solution delivery, the infusion limbs are collapsed to a straight position and then the Bashir™ S-B Endovascular Catheter is retracted into the sheath and removed.
The Bashir™ S-B Endovascular Catheter is comprised of common materials used in vascular catheters. The catheter is mechanical and contains no electrical components.
This document describes the Bashir™ S-B Endovascular Catheter (Model 7101) and its substantial equivalence to a predicate device. The information provided primarily focuses on technical specifications and bench testing, rather than clinical study data involving human readers or AI.
Here's an analysis based on the provided text, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Metric | Acceptance Criteria | Reported Performance (or Conclusion) |
|---|---|---|---|
| Mechanical Performance | Trackability | Not specified (implied to be acceptable) | Pass (demonstrated substantial equivalence) |
| Advancement Force | Not specified (implied to be acceptable) | Pass (demonstrated substantial equivalence) | |
| Slider Actuator Force | Not specified (implied to be acceptable) | Pass (demonstrated substantial equivalence) | |
| Catheter Retraction | Not specified (implied to be acceptable) | Pass (demonstrated substantial equivalence) | |
| Radial Force | Not specified (implied to be acceptable) | Pass (demonstrated substantial equivalence) | |
| Delivery Flow Rate | Not specified (implied to be acceptable) | Pass (demonstrated substantial equivalence) | |
| Infusion Pressure (various flow rates) | Not specified (implied to be acceptable) | Pass (demonstrated substantial equivalence) | |
| Infusion Pressure (with pulse spray) | Not specified (implied to be acceptable) | Pass (demonstrated substantial equivalence) | |
| Dimensional Verification | Not specified (implied to be acceptable) | Pass (demonstrated substantial equivalence) | |
| Joint Tensile Strengths | Not specified (implied to be acceptable) | Pass (demonstrated substantial equivalence) | |
| Labeling/Usability | Label Legibility | Not specified (implied to be acceptable) | Pass (demonstrated substantial equivalence) |
| Usability Testing (device handle) | "pre-defined acceptance criteria" | Met pre-defined acceptance criteria | |
| Sterility & Shelf Life | Sterilization Validation | Sterility Assurance Level of 10^-6 (ISO 11135:2014) | Complied with ISO 11135:2014, validated to SAL of 10^-6 |
| Shelf Life | 2 years | Established through accelerated aging studies, supports 2 years |
2. Sample Size Used for the Test Set and Data Provenance
Since the performance testing primarily involved bench testing of the physical device, the concept of a "test set" in the context of clinical data or image-based AI is not directly applicable. The text mentions "performance data repeated for the modified device," implying a certain number of devices were produced and tested, but the exact sample sizes for each bench test are not specified.
The Usability Testing involved "ten (10) intended users." The provenance of this user data (e.g., country of origin, retrospective/prospective) is not specified, but it was likely prospective testing conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an endovascular catheter, and the evaluation did not involve establishing ground truth from images or clinical data by experts in the context of an AI study. Usability testing involved "intended users," whose specific qualifications (beyond being "intended users") are not detailed.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication method is mentioned, as the evaluation type was primarily physical device performance and usability.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
No. This submission does not describe an AI medical device, nor does it present any MRMC comparative effectiveness study involving human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a medical instrument, not an AI algorithm.
7. The Type of Ground Truth Used
- For Mechanical Performance: The "ground truth" would be established by engineering specifications, physical measurements, and industry standards for catheter performance (e.g., force required for advancement, flow rates).
- For Sterilization: The "ground truth" is adherence to ISO 11135:2014 and achieving a Sterility Assurance Level (SAL) of 10^-6.
- For Shelf Life: The "ground truth" is the stability of the device over time, established through accelerated aging studies predicting a 2-year shelf life.
- For Usability Testing: The "ground truth" is the "pre-defined acceptance criteria" for the usability of the device handle by intended users.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI device.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).