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510(k) Data Aggregation
(27 days)
ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing
The ZOOM Reperfusion Catheters, with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump), are 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 symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The ZOOM Aspiration Tubing is intended to connect the ZOOM Reperfusion Catheter of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.
The ZOOMTM 71 Reperfusion 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.
The ZOOM 71 Reperfusion 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 71 Reperfusion 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 71 Reperfusion Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.
The ZOOM Aspiration Tubing is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the ZOOM 71 Reperfusion 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.
The acceptance criteria and study proving the device meets them are summarized below.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Attribute | Specification (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Dimensional (Distal OD, Distal ID) | All defined catheter dimensions are within the specified tolerances. | Test results demonstrated that defined catheter dimensions were within specified tolerances. |
| Catheter Bond Strength | The catheter shall have sufficient bond strengths to remain intact throughout a procedure. | Test results demonstrated sufficient bond strengths to remain intact throughout a procedure. |
| Kink Resistance | There shall be no kinking of the catheter shaft (permanent deformation) at anatomically relevant bend radii. | Test results demonstrated no kinking of the catheter shaft (permanent deformation) at anatomically relevant bend radii. |
| Tip Flexibility | The flexibility of the catheter tip shall be comparable to competitive products and allow for easily tracking the device to the desired target anatomy. | Test results demonstrated comparable tip flexibility to competitive products, allowing for easy tracking to the desired target anatomy. |
| Freedom from Leakage - Positive Pressure | No liquid leakage from the hub or catheter shaft at 46psi for 30 seconds. | Test results demonstrated no liquid leakage from the hub or catheter shaft at 46psi for 30 seconds. |
| Freedom from Leakage - Negative Pressure | No air leakage into a 20cc syringe when vacuum pulled for 15 seconds. | Test results demonstrated no air leakage into a 20cc syringe when vacuum pulled for 15 seconds. |
2. Sample Size and Data Provenance:
The document does not specify the exact sample sizes used for each bench test. The data provenance is laboratory bench testing conducted by Imperative Care, Inc.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. The study involved bench testing against engineering specifications, not clinical evaluation requiring expert ground truth.
4. Adjudication Method for Test Set:
Not applicable, as this was bench testing against engineering specifications.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The data presented is from bench testing to demonstrate substantial equivalence to a predicate device.
6. Standalone Algorithm Performance:
Not applicable. This device is a reperfusion catheter and aspiration tubing, not an AI algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this study was engineering specifications and performance standards (e.g., ISO 10555-1) used for bench testing.
8. Sample Size for Training Set:
Not applicable. This device is a physical medical device, not an AI algorithm that requires a training set.
9. How Ground Truth for Training Set was Established:
Not applicable, as there is no training set for a physical medical device.
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