(21 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.
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 Aspiration 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 document describes the acceptance criteria and a study conducted for the ZOOM Reperfusion Catheters and ZOOM Aspiration Tubing (K210996).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Attribute | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Visual | Free of kinks, breaks, separation or particulate (greater than $0.25mm^2$). No exposed metal. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. (Implies performance met this and other specifications by not negatively impacting safety/effectiveness). |
| Dimensional (Effective Length) | All defined catheter dimensions are within the specified tolerances. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
| Catheter Bond Strength | The catheter shall have sufficient bond strengths to remain intact throughout a procedure. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
| Flowrate - Positive (Forward) Pressure | The catheter lumen shall allow for a minimum flowrate comparable to competitive products. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
| Flowrate – Vacuum Pressure | The flowrate under a vacuum shall be similar to or greater than competitive devices. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
| Freedom from Leakage – Positive Pressure | No liquid leakage from the hub or catheter shaft at 46psi for 30 seconds. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
| Freedom from Leakage – Negative Pressure | No air leakage into a 20cc syringe when vacuum pulled for 15 seconds. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
| Dynamic Burst Pressure | Catheter does not burst under pressures that could be seen when performing contrast injections with a standard 10cc syringe. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
| 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. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
| Corrosion Resistance | No visible corrosion present on devices after saline immersion followed by 30 minutes in boiling water followed by 48 hours in 37°C water bath. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing to evaluate differences between the subject and predicate devices. No information about sample sizes for a clinical test set is provided in this submission summary, nor details about data provenance (country of origin, retrospective/prospective). This type of submission (510(k) Special) largely relies on demonstrating substantial equivalence through engineering and performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The study described is bench testing, not a clinical study involving experts to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was bench testing, not a clinical study requiring adjudication.
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
Not applicable. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for medical devices (catheters and tubing), not an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" was the predefined performance specifications and test methods based primarily on catheter performance standard ISO 10555-1. The devices were tested against these engineering and functional standards.
8. The sample size for the training set
Not applicable. This is a medical device submission based on bench testing of physical products, not an AI or machine learning model that would require a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML submission.
§ 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).