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510(k) Data Aggregation
(29 days)
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 ZOOM 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 Reperfusion Catheter is offered in various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1 below.
The ZOOM 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 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 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 offered in one model with the features indicated in Table 2.
The ZOOM Reperfusion Tubing is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the ZOOM 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 provided text describes the performance data for the ZOOM Reperfusion Catheters and ZOOM Aspiration Tubing (Gen 2), comparing it to a predicate device (Gen 1). However, it does not include information about AI/algorithm-specific acceptance criteria or studies. The documentation focuses on demonstrating substantial equivalence to a previous version of the same medical device through bench and lab testing, biocompatibility, sterilization, and shelf-life testing.
Therefore, many of the requested sections related to AI/algorithm performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this document.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally qualitative "Pass" or "Comparable to predicate/competitive products" based on the described tests. The reported performance is summarized as "Pass" for all validated attributes, indicating that the device meets its internal specifications and is comparable to the predicate.
ZOOM Reperfusion Catheter
| Test Attribute | Specification | Reported Device Performance |
|---|---|---|
| Delivery, Compatibility, & 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 |
| Flexibility and Kink Resistance | There shall be no kinking of shaft (permanent deformation) after simulated use. | Pass |
| Compatibility with other devices (external) | The catheters shall be able to be delivered through the minimum introducer sheath or guide catheter size indicated in the product labeling. | Pass |
| Guidewire compatibility | The catheters shall be able to be delivered over the guidewire size indicated in the product labeling. | Pass |
| Interventional device compatibility (internal) | The catheters shall be able to accommodate other interventional devices (e.g., support catheter, diagnostic catheter) up to the maximum size indicated in the product labeling. | Pass |
| Luer compatibility | Devices and accessories shall be compatible with standard syringe luer fittings per ISO 80369-7. | Pass |
| Accessory compatibility | Devices shall be compatible with the accessory RHV. | Pass |
| Visual | Free of kinks, breaks, separation or particulate (greater than 0.25mm^2). No exposed metal. | Pass |
| Dimensional | All defined catheter dimensions are within the specified tolerances. | Pass |
| Catheter Bond Strength | The catheter shall have sufficient bond strengths to remain intact throughout a procedure. | Pass |
| Flowrate - positive (forward) pressure | The catheter lumen shall allow for a minimum flowrate comparable to competitive products. | Pass (Comparable) |
| Flowrate – vacuum pressure | The flowrate under a vacuum shall be similar to or greater than competitive devices. | Pass (Similar/Greater) |
| Freedom from Leakage – positive pressure | No liquid leakage from the hub or catheter shaft at 46psi for 30 seconds | Pass |
| Freedom from Leakage – negative pressure | No air leakage into a 20cc syringe when vacuum pulled for 15 seconds. | Pass |
| Burst Pressure | Catheter does not burst under pressures that could be seen when performing contrast injections with a standard 10cc syringe. | Pass |
| Catheter Torque Strength | No separation of any portion of the catheter when rotated at least two (2) full rotations (720 degrees). | Pass |
| Lumen Integrity | The catheter lumen shall not collapse under vacuum after multiple passes. | Pass |
| Kink Resistance | There shall be no kinking of the catheter shaft (permanent deformation) at anatomically relevant bend radii. | Pass |
| 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. | Pass (Comparable) |
| Coating - Particulate | The amount of particulate matter that comes off the hydrophilic-coated shaft during simulated use testing shall be determined and compared to competitive products and techniques. | Pass (Comparable) |
ZOOM Aspiration Tubing
| Test Attribute | Specification | Reported Device Performance |
|---|---|---|
| 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 (Comparable) |
| 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 |
Biocompatibility Testing (ZOOM Reperfusion Catheter)
| Test | Test Method | Acceptance Criteria | Results |
|---|---|---|---|
| Cytotoxicity: ISO MEM Elution | ISO 10993-5 | Sample extracts must yield cell lysis grade 2 or lower. | Pass, Non-cytotoxic |
| Cytotoxicity: ISO MTT Assay | ISO 10993-5 | The percentage of cells exhibiting lysis should be similar for all test devices. No Significant Differences | Pass, No Significant Differences |
| Hemocompatibility: Hemolysis (Extract Method) | ASTM F 756 ISO 10993-4 | Sample extracts must be non-hemolytic (≤ 2% hemolytic index). | Pass, Non-hemolytic |
Sterilization Validation (ZOOM Reperfusion Catheter & ZOOM Aspiration Tubing)
| Requirement/Acceptance Criteria | Results | Summary |
|---|---|---|
| Positive BI controls must be positive in fractional, half and full cycles. | PASS | All positive controls in each cycle read positive. |
| Fractional cycle requirements: 1) IPCDs and EPCDs must be more difficult to sterilize than the natural product. | PASS | IPCDs and EPCDs showed more growth than natural product. |
| Fractional cycle requirements: 2) Product Sterility testing must show no growth in all samples. | PASS | The devices did not show any growth when tested per the methods in ISO 11737-2. |
| Fractional cycle requirements: 3) Bacteriostasis/Fungistasis testing must show that the product is not inhibitory for growth. | PASS | Bacteriostasis/Fungistasis Testing showed product is not inhibitory to growth when tested per the methods in ISO 11737-2. |
| Half cycle requirements: 1) IPCDs and EPCDs should show no growth for all samples. | PASS | IPCDs and EPCDs showed no growth. |
| Full cycle requirements: 1) IPCDs and EPCDs must show no growth for all samples. | PASS | IPCDs and EPCDs showed no growth. |
| Full cycle requirements: 2) The results for Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) shall meet the requirements of ISO 10993-7. | PASS | Samples passed EO residual testing. |
Packaging Validation (ZOOM Reperfusion Catheter & ZOOM Aspiration Tubing)
| Test | Test Method | T0 Results (Pass/Fail) | Shelf Life Results (Pass/Fail) |
|---|---|---|---|
| Packaging Visual Inspection | ASTM F1886 / Imperative Care Internal | Pass | Pass |
| Pouch Integrity Test - Gross Leak Detection | ASTM F2096 | Pass | Pass |
| Pouch Seal Strength – Peel Strength | ASTM F88 | Pass | Pass |
| Label Integrity | Imperative Care Internal | Pass | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document states that "The largest and smallest diameter catheters were tested for both the subject and predicate devices." Exact numerical sample sizes for each test are not specified, but the tests were performed on representative samples of the devices.
- Data Provenance: The studies were bench and lab testing. This means the tests were conducted in a laboratory setting on the physical devices themselves, not on patient data. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable in the clinical data sense. The testing was conducted by Imperative Care Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The reported studies are bench and lab testing of physical device performance, biocompatibility, sterilization, and packaging. There is no "ground truth" in the diagnostic sense or involvement of medical experts for interpreting diagnostic results. The acceptance criteria are based on engineering specifications and recognized consensus standards (e.g., ISO, ASTM).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is related to clinical interpretation or AI model output validation, which is not covered in this document.
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
No. This document describes the performance of a physical medical device (catheter and aspiration tubing), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This document does not describe an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for these engineering and biological tests are the established specifications, standards (e.g., ISO, ASTM), and comparison to the predicate device's performance.
8. The sample size for the training set
Not applicable. There is no AI model or training set described in this document.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set described in this document.
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