(89 days)
The AXS Catalyst Distal Access Catheter as part of the AXS Universal Aspiration System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in 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 failed IV t-PA are candidates for treatment.
The AXS Catalyst 7 Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in the removal of thrombus from the neuro vasculature using continuous aspiration. The catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing and aspiration. It is packaged with a Rotating Hemostasis Valve (RHV), Tuohy Borst Valve with Sideport, and two peel-away introducer sheaths. The RHV and Tuohy Borst valve with sideport are used for flushing, insertion of catheters, and aspiration. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the RHV or Tuohy Borst.
When used as part of the aspiration system, the AXS Catalyst Distal Access Catheter requires a minimum vacuum pressure of -68 kPa [-20.08 in Hg] from an external device (Medela Dominant Flex Pump). Bench and Animal testing utilizing the Medela Dominant Flex Pump and Suction Jar, AXS Universal Aspiration Tubing, and AXS Universal Liner Set were conducted to successfully demonstrate aspiration.
The provided document is a 510(k) summary for the AXS Universal Aspiration System (AXS Catalyst 7 Distal Access Catheter). It details the device's characteristics, comparison to predicate devices, and a summary of performance data (bench, animal, and clinical) to demonstrate substantial equivalence.
Based on the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document presents its "acceptance criteria" implicitly through the "Conclusions" column in Table 2 (Performance Data - Bench Testing), Table 3 (Performance Data - Animal Testing), and Table 4 (Biocompatibility Studies). The acceptance criteria are "meets acceptance criteria," "acceptable," "equivalent," or "PASS."
| Test Type | Acceptance Criteria (Implicit from "Conclusions") | Reported Device Performance ("Conclusions" column) |
|---|---|---|
| Design Verification Bench Testing | ||
| Dimensional Verification | Meets acceptance criteria | Dimensional verification meets acceptance criteria. |
| Tip Configuration | Meets acceptance criteria | Tip configuration meets acceptance criteria. |
| Surface Integrity | Meets acceptance criteria | Surface integrity meets acceptance criteria. |
| Tip Buckling | Meets acceptance criteria | Tip buckling meets acceptance criteria. |
| Catheter lubricity and durability | Meets acceptance criteria | Coating lubricity and durability meets acceptance criteria. |
| Particulate characterization | Acceptable | Particulate generation was acceptable. |
| Coating integrity | Acceptable | Coating integrity was acceptable. |
| Trackability | Meets acceptance criteria | Track advance force meets acceptance criteria. |
| Tensile Strength | Meets acceptance criteria | Tensile strength meets acceptance criteria. |
| Liquid Leak Resistance | Meets acceptance criteria | Liquid leak resistance of catheter meets acceptance criteria. |
| Air Leak Resistance | Meets acceptance criteria | Air leak resistance of catheter meets acceptance criteria. |
| Catheter Torsional Bond Strength | Meets acceptance criteria | Catheter torsional bond strength meets acceptance criteria. |
| Flexural Fatigue | Meets acceptance criteria | Flexural fatigue meets acceptance criteria. |
| Catheter Kink Radius | Meets acceptance criteria | Catheter kink radius meets acceptance criteria. |
| Catheter Tip and Lumen Integrity (Direct Aspiration) | Meets acceptance criteria | Catheter tip and lumen integrity during direct aspiration meets acceptance criteria. |
| Chemical Compatibility | Meets acceptance criteria | Chemical compatibility meets acceptance criteria. |
| Hub Gauging | Meets acceptance criteria | Hub gauging meets acceptance criteria. |
| Aspiration Flow Rate Bench Testing | ||
| Aspiration Flow Rate | Meets acceptance criteria | All test samples meet acceptance criteria. |
| Design Validation Bench Testing | ||
| In-vitro Usability Study | Meets acceptance criteria | All test samples meet acceptance criteria. |
| Animal Study | Equivalent to predicate in safety | Subject Device is equivalent to the Additional Predicate Device in safety. |
| Biocompatibility Studies | PASS | MEM Elution Cytotoxicity: PASS (No cytotoxicity or cell lysis) |
| Hemolysis Extract/Direct Contact Method: PASS (Non-hemolytic) | ||
| USP Physiochemical : PASS | ||
| Chemistry (Heptane) Analysis: PASS (Below level of detection) | ||
| FTIR (ISO 10993-18): PASS | ||
| Natural Rubber Latex ELISA Inhibition Assay for Antigenic Protein ASTM D6499-12: PASS (Below level of detection) |
2. Sample sizes used for the test set and the data provenance
The document does not explicitly state the numerical sample sizes (e.g., number of catheters tested) for each bench test. It mentions qualitative assessments like "Visually inspect" or "Prepare sample for test." For the animal study, it mentions "porcine test subjects" but does not give the exact number.
- Provenance: The studies were conducted by Stryker Neurovascular ("Submitter Name, Address, and Content" section) and likely took place at their facilities or certified labs. The animal study was conducted "in compliance with applicable requirements in the GLP regulation (21 CFR Part 58)," which specifies good laboratory practices, but not geographic provenance. The clinical data was not from a study conducted by the submitter but rather a "review was conducted considering published clinical study articles that featured the Predicate devices." This implies that the clinical data is retrospective from existing literature, and its origin would vary based on those publications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies described are primarily bench and animal tests, along with a review of published clinical articles. There's no mention of expert consensus or human readers being used to establish ground truth for a test set in the context of device performance, as one might find for an AI/imaging device. The "In-vitro Usability Study" mentions "multiple physician users" but doesn't specify their number or qualifications, nor is it described as establishing "ground truth" for the device's technical performance, but rather "evaluat[ing] aspiration integrity, ability to restore flow and the durability and kink resistance."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are typically used in studies involving human readers or expert panels evaluating diagnostic outputs (like images), especially in the context of establishing ground truth where there might be disagreement. The studies described here are primarily engineering (bench) and animal model tests, where outcomes are determined by physical measurements or biological responses, not human interpretation 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
This is not applicable. The device is a "Percutaneous Catheter" (specifically, a distal access catheter for stroke treatment), not an AI-based diagnostic or assistive software. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance would not be relevant to this device's submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench and animal tests, the "ground truth" is established through physical measurements, established engineering test methods (e.g., EN ISO 10555-1, EN 1707, EN ISO 14971), and biological evaluations (histopathology in the animal study). For the biocompatibility tests, it's based on established ISO standards (EN ISO 10993-1 and sub-parts) and analytical chemistry results. There is no mention of expert consensus or pathology reports serving as "ground truth" in the way it might for a diagnostic imaging AI. The "clinical performance" relies on a review of published clinical outcomes of predicate devices, leveraging their established safety and efficacy rather than generating new outcomes data for the subject device.
8. The sample size for the training set
This is not applicable/not provided. The device is a physical medical device, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This is not applicable. As there is no training set for a physical device, there's no ground truth established for one.
§ 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).