(243 days)
The Zoom 7X Catheter, with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing, and the Zoom Aspiration Pump (or equivalent vacuum pump), is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of last known well.
Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.
The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (7X, 71, 55, 45, 35) Catheter and the TracStar LDP Large Distal Platform, the Zoom 88 Large Distal Platform, or the Zoom 88 Large Distal Platform Support to the Zoom Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.
The Zoom™ 7X Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source, such as the Zoom Aspiration Pump, using the Zoom Aspiration Tubing or the Zoom POD Aspiration Tubing.
The Zoom 7X Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.
The distal section of the Zoom 7X Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.
The Zoom 7X Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is intended to be attached to the proximal hub of the catheter and used to control hemostasis during use with other devices. The Zoom 7X Catheter is also packaged with two (2) introducer sheath accessories. The introducer is intended to assist with insertion of the Zoom 7X Catheter into the RHV or the guide catheter.
The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Zoom 7X Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Zoom Aspiration Tubing is made of common medical grade polymers.
Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) clearance letter:
1. Acceptance Criteria and Reported Device Performance:
| Test Attribute | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Zoom 7X Catheter | ||
| Delivery, Compatibility, and Retraction (Trackability) | The catheter shall be able to be delivered, deployed, and retracted per the IFU within a simulated neurological model without incurring any damage to the catheter. | Pass |
| Compatibility with Other Devices (External) | The catheter shall be able to be delivered through the minimum introducer sheath or guide catheter size indicated in the product labeling. | Pass |
| Guidewire Compatibility | The catheter shall be able to be delivered over the maximum size guidewire indicated in the product labeling. | Pass |
| Microcatheter / Intermediate Catheter Compatibility | The catheter shall be able to accommodate a microcatheter/intermediate catheter up to the maximum size indicated in the product labeling. | Pass |
| Tip Flexibility | The catheter distal tip flexibility shall be comparable to the predicate. | Pass |
| Visual Inspection | The catheter shall meet visual inspection criteria. The printing on the strain relief must be legible. | Pass |
| Dimensional (ID, Distal OD, Tip Length) | All defined catheter dimensions are within the specified tolerances. | Pass |
| Catheter Bond Strength | The catheter shall have sufficient bond strength to remain intact throughout a procedure. | Pass |
| Dynamic Burst | The catheter must withstand pressure testing under dynamic flow conditions. | Pass |
| Static Burst | The catheter shall meet criteria for static burst pressure testing. | Pass |
| Catheter Torque Strength | The catheter shall not be damaged when rotated at least two (2) full rotations (720 degrees) with the tip constrained. | Pass |
| Kink Resistance | There shall be no kinking of the catheter shaft around respective clinically relevant minimum bend radii in distal tip, medial and proximal locations. | Pass |
| Flexibility | The catheter needs to have acceptable flexure values for tracking in the vasculature. | Pass |
| Luer Compatibility | Device and accessories shall be compatible with standard syringe luer fittings per ISO 80369-7. | Pass |
| Accessory Compatibility | Device shall be compatible with an RHV. | Pass |
| Coating - Particulate | The amount of particulate matter generated during simulated use testing shall be determined and comparable to competitive products. | Pass |
| Coating – Lubricity, Durability, and Integrity | Coating must be lubricious with a specified average pull force. There were no coating anomalies or significant wear observed post simulated use. | Pass |
| Clot Retrieval | The device shall be able to aspirate a variety of clot types in a range of vessel diameters. | Pass |
| Zoom POD Aspiration Tubing (new component) | ||
| Visual Inspection | The Zoom POD Aspiration Tubing shall meet visual inspection criteria. | Pass |
| Dimensional (Working Length) | The working length is within the specified tolerances. | Pass |
| Vacuum Force at Catheter Tip | The vacuum force delivered by the aspiration tubing to the tip of the catheter should be comparable to the vacuum force delivered by the predicate aspiration tubing. | Pass |
| Connector Compatibility | The aspiration tubing connectors shall securely connect to the pump canister lid and standard luer fittings. | Pass |
| Lumen Collapse Test | The tubing lumen shall not collapse under vacuum. | Pass |
| Flow Control Functionality | The flow control mechanism shall allow users to start and stop flow multiple times when the connected pump is running at maximum vacuum. | Pass |
| Freedom From Leakage | The vacuum pressure delivered at the tip of the aspiration tubing shall be consistent with the pressure generated by the pump. | Pass |
| Tensile Strength | The bonds between the tubing and connectors shall be sufficiently strong to ensure the tubing remains intact during use. | Pass |
| Clot Filter Functionality (Zoom POD only) | The clot filter should be able to be opened and closed without causing leak. | Pass |
| Introducer Sheath Accessory (new component biocompatibility tests) | ||
| Cytotoxicity | Test article extracts must yield grade 2 or lower. | Pass, Non-cytotoxic |
| Sensitization | Test article extracts must yield grade 0. | Pass, Non-sensitizing |
| Intracutaneous Reactivity | Test article extracts must yield a difference between the test extract overall mean score and corresponding control overall mean score of 1.0 or less. | Pass, Non-irritating |
| Acute Systemic Toxicity | None of the animals treated with the test article extracts must show a significantly greater reactivity than animals treated with the control article. | Pass, Non-toxic (acute systemic) |
| Material-Mediated Pyrogenicity | Test article extract must yield |
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).