(249 days)
The AXS Offset Delivery Assist Catheter is intended to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.
The AXS Offset Delivery Assist Catheter ("AXS Offset") is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and delivery of appropriately sized interventional devices, such as distal access catheters (DAC), into a selected blood vessel in the neurovascular system.
The AXS Offset catheter, when used in conjunction with an appropriately sized steerable guidewire and DAC, provides a smooth interventional device system profile. The distal outer diameter (OD) of the AXS Offset catheter gradually increases from 0.036in at the RO Marker to 0.050in, 2 cm proximal to the RO marker. The bulb section with a 0.050in OD is maintained for 28 cm. then gradually decreases towards the proximal section. The overall distal profile of the AXS Offset catheter acts as a smooth transition and reduces the gap between the outer diameter of a steerable guidewire and inner diameter of a DAC while allowing for continuous saline flush through the DAC.
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.
The provided document describes the acceptance criteria and study results for the AXS Offset Delivery Assist Catheter.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Testing | ||
| Dimensional Verification (Effective Length, Uncoated Length, Distal Tip OD, ID) | Meets acceptance criteria for specified dimensions. Compatible with standard neurovascular guidewires (for ID). | Meets acceptance criteria for catheter effective length, uncoated length, distal tip outer diameter, and inner diameter. Inner lumens compatible with standard neurovascular guidewires. XT-27 and AXS Offset meet same dimensional acceptance criteria. |
| Dimensional: Maximum Outer Diameter | Meets acceptance criteria. | Meets acceptance criteria for maximum outer diameter. |
| Friction Force | Meets acceptance criteria. | Meets acceptance criteria. XT-27 and AXS Offset meet the same friction force acceptance criteria. |
| Catheter Distal Tip Buckling | Meets acceptance criteria. | Meets acceptance criteria. XT-27 and AXS Offset meet the same distal tip buckling acceptance criteria. |
| Catheter Tensile Strength | Meets acceptance criteria. | Meets acceptance criteria. XT-27 and AXS Offset meet the same catheter tensile strength acceptance criteria. |
| Catheter Hub Tensile Strength | Meets acceptance criteria. | Meets acceptance criteria. XT-27, Transform, and AXS Offset meet the same catheter hub tensile strength acceptance criteria. |
| Liquid-Leakage | Meets acceptance criteria. | Meets acceptance criteria. XT-27, Transform, and AXS Offset meet the same liquid-leakage acceptance criteria. |
| Air Aspiration Leakage | Meets acceptance criteria. | Meets acceptance criteria. XT-27, Transform, and AXS Offset meet the same air aspiration leakage acceptance criteria. |
| Coating Integrity | Neither delamination at coating edges, nor coating defects (voids, scratches) baseline. No anomalies post-tracking. Coating functions as intended and exhibits appropriate integrity post-simulated use (considering lubricity, durability, and particulate generation results). | Neither Baseline nor Post-tracking test articles exhibited any delamination at coating edges or defects. Post tracking devices exhibited no anomalies. Coating functions as intended and exhibited appropriate integrity post-simulated use. |
| Track and Advance Force | Advance and retraction force in simulated use testing is equivalent to or lower than the predicate XT-27. | AXS Offset catheter advance and retraction force in simulated use testing has been demonstrated to be equivalent or lower than the predicate XT-27. |
| Flow Rate | Continuous positive displacement of saline fluid through the lumen of the DAC with the AXS Offset catheter positioned in the DAC lumen in a simulated neurovascular tortuosity model. | Testing has demonstrated a continuous positive displacement of saline fluid through the lumen of the DAC with the AXS Offset catheter positioned in the DAC lumen. Testing was conducted in a simulated neurovascular tortuosity model. |
| Catheter Kink Radius | Meets acceptance criteria. | Meets acceptance criteria. XT-27 and AXS Offset meet the same kink radius acceptance criteria. |
| Catheter Torsional Resistance | Meets acceptance criteria. | Meets acceptance criteria. XT-27 and AXS Offset meet the same torsional resistance acceptance criteria. |
| Visual Standards | Catheter length free from extraneous matter and process defects. Distal tip smooth and rounded. | Visual standards meet acceptance criteria for catheter length being free from extraneous matter and process defects and for catheter distal tip being smooth and rounded. XT-27 and AXS Offset meet the same visual standards acceptance criteria. |
| Visual and Dimensional Integrity – Chemical Compatibility | Visual, dimensional, and mandrel passage examinations show integrity of hub, inner lumen, and outer distal region after exposure to saline, non-ionic contrast, and ionic contrast. | Visual and Dimensional Integrity - Chemical Compatibility meets acceptance criteria. XT-27 and AXS Offset meet the same visual and dimensional integrity - chemical compatibility acceptance criteria. |
| Device Trackability | Evaluating physician(s) state that test articles can advance to the M1 in conjunction with the intermediate catheter in the bench model. | Device Trackability meets acceptance criteria. Evaluating physicians confirmed all test articles were able to advance to the M1 using standard access methods similar to XT-27. XT-27 and AXS Offset meet the same device trackability acceptance criteria. |
| Device - Durability and Integrity | Evaluating physician(s) state that all test articles maintain their integrity throughout the procedure using the bench model. | Device Durability and Integrity meets acceptance criteria. Evaluating physicians confirmed all test articles maintained their integrity throughout the procedure. XT-27 and AXS Offset meet the device durability and integrity acceptance criteria. |
| Guidewire Compatibility | Evaluating physician(s) state that all test articles allow smooth advancement and withdrawal of standard guidewires up to 0.018in OD. | Guidewire Compatibility meets acceptance criteria. Evaluating physicians confirmed all test articles allowed smooth advancement and withdrawal of standard guidewires up to 0.018in OD. XT-27 and AXS Offset meet the same guidewire compatibility acceptance criteria. |
| Labelling requirements | Evaluating physician(s) state that DFU and labeling of all test articles clearly identify the product and provide information adequate to ensure the safe use of the device. | Labelling Requirements meet acceptance criteria. Evaluating physicians confirmed DFU and labeling clearly identify the product and provide information adequate for safe use. XT-27 and AXS Offset meet the labeling requirements acceptance criteria. |
| Intended Use Environment | Evaluating physician(s) state that all test articles can withstand conditions typically seen during use environment of the product. | Intended Use Environment meets acceptance criteria. Evaluating physicians confirmed all test articles withstand typical use environment conditions. XT-27 and AXS Offset meet the same intended use environment acceptance criteria. |
| Visibility | Evaluating physician(s) state that all test articles are visible under fluoroscopy during delivery to and withdrawal from the intended location. | Visibility meets acceptance criteria. Evaluating physicians confirmed all test articles are visible under fluoroscopy. XT-27 and AXS Offset meet the same visibility acceptance criteria. |
| Packaging | Visual, dimensional, and performance testing meets acceptance criteria for all packaging components (carton, labels, DFU, and pouch). | Packaging visual, dimensional, and performance testing meets the acceptance criteria for all packaging components. XT-27 and AXS Offset meet the same packaging visual, dimensional, and performance acceptance criteria. |
| Biocompatibility Testing | ||
| MEM Elution Cytotoxicity | No evidence of causing cell lysis or toxicity (grade 0). Considered non-cytotoxic. | Pass. No cytotoxicity or cell lysis. Test article is considered non-cytotoxic (grade 0). Met requirements as grade was less than grade 2. |
| Hemolysis Extract/Direct Contact Method | Hemolytic index | Non-volatile residue: 7 mg; Residue on ignition: 0.1ug/dm2. |
| In-vitro Blood Loop Assay with Comparison Article | Worst case score of '0', '1', or '2' (thromboresistant). | Pass. Test article (AXS DAC) received a worst case score of '1' and comparison article (Transform) received a worst case score of '1', both considered thromboresistant. |
| Guinea Pig Maximization Sensitization | No evidence of causing delayed dermal contact sensitization. Not considered a sensitizer. | Pass. No evidence of causing delayed dermal contact sensitization. Not considered a sensitizer. |
| Intracutaneous Reactivity | Difference between test extract mean score and control mean score is 0.0. Met requirements of the test. | Pass. Difference between test extract mean score and control mean score was 0.0. Met requirements of the test. |
| Acute Systemic Injection | No mortality or evidence of systemic toxicity. Met requirements of the test. | Pass. No mortality or evidence of systemic toxicity. Met requirements of the test. |
| Materials Mediated Rabbit Pyrogen | Total rise of rabbit temperatures during three-hour observation within acceptable USP limits. Nonpyrogenic. | Pass. Total rise of rabbit temperatures during the three-hour observation was within acceptable USP limits. Judged as nonpyrogenic. |
| Ames Mutagenicity | Extracts considered nonmutagenic to Salmonella typhimurium and Escherichia coli test strains. | Pass. Extracts considered nonmutagenic. |
| Genotoxicity - Mouse Lymphoma Assay | Extracts did not cause a twofold or greater increase in mean mutant frequency of the L5178Y/TK+/- cell line in either absence or presence of metabolic activation. Considered nonmutagenic. | Pass. Extracts did not cause a twofold or greater increase in mean mutant frequency. Considered nonmutagenic. |
| Partial Thromboplastin Time | Clotting time >= 50% of negative control. | Pass. Clotting time of the test article was 67% of the negative control. Met acceptance criteria of ≥50%. |
| In Vitro Hemocompatibility Assay | All counts for the test article not significantly different from the reference material. Comparable to reference material. | Pass. All counts for the test article were not significantly different from the reference material. Results comparable to reference material. |
| Complement Activation (SC5b-9) | Concentration of SC5b-9 not statistically higher than negative control. Not considered a potential activator of the complement system. | Pass. Concentration of SC5b-9 not statistically higher than negative control. Not considered a potential activator. |
| Complement Activation (C3a) | Concentration of C3a not statistically higher than negative control. Not considered a potential activator of the complement system. | Pass. Concentration of C3a not statistically higher than negative control. Not considered a potential activator. |
| In-Vivo Thromboresistance | For both test article and control, platelet counts and APTT time within normal ranges. Scored the same for thrombosis and vessel patency as control. Demonstrated comparable thromboresistance. | Pass. For both test article and control, platelet counts and APTT time were within normal ranges. Scored the same for thrombosis and vessel patency. Demonstrated comparable thromboresistance to the control article. |
| Other Testing | ||
| Endotoxin Limit | Within ANSI/AAMI ST72:2011 Endotoxin Limit of 20 Endotoxin Units per device (EU/device). | Test results are within the ANSI/AAMI ST72:2011 Endotoxin Limit of 20 EU/device. |
| Ethylene Oxide (EO) Residuals | Less than maximum allowed for EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. | EO residuals on a sample representative of the AXS Catalyst Distal Access Catheter are less than the maximum allowed per EN ISO 10993-7. |
| Shelf Life | Maintained over the duration of the labeled shelf-life (3 years). | Bench testing conducted on accelerated aged devices confirmed the shelf-life of 3 years is maintained. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state a specific numerical sample size for all tests. However, it mentions:
- Bench Testing: Performed on the "subject device" (AXS Offset Delivery Assist Catheter) to verify its performance against acceptance criteria and predicate devices. For some tests (e.g., trackability, durability, guidewire compatibility), "all test articles" were evaluated by physicians, implying a consistent test sample was used for these specific simulated use scenarios.
- Biocompatibility Testing: Conducted on "the AXS Offset Delivery Assist Catheter" (though specific counts are not given for all tests, e.g., "The test article extract showed no evidence..."). Some biocompatibility data was leveraged from the predicate device (Transform Occlusion Balloon Catheter).
- Data Provenance: The studies are described as "verification and validation testing" and "bench testing," and involve "simulated use conditions" and "bench models." This indicates the data is from prospective in-vitro (bench) studies and simulated clinical use rather than real-world human data. There is no mention of country of origin for the data; it's likely conducted by Stryker Neurovascular per regulatory guidelines.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Number of Experts: For tests like Device Trackability, Device Durability and Integrity, Guidewire Compatibility, Labelling Requirements, Intended Use Environment, and Visibility, the acceptance criteria explicitly state "the evaluating physician/s must state..." This implies one or more physicians were involved.
- Qualifications of Experts: The document explicitly refers to them as "evaluating physician/s," confirming they are medical doctors. No specific details about their years of experience or specialization (e.g., neuroradiologist, neurosurgeon) are provided beyond the general term "physician."
4. Adjudication Method for the Test Set:
For the tests involving physician evaluation (e.g., Trackability, Durability, etc.):
- The phrasing "the evaluating physician/s must state" suggests that a consensus or agreement among the participating physicians was required to meet the acceptance criteria.
- It does not specify a quantitative adjudication method like 2+1 or 3+1. It could imply either a single physician's assessment or an unstated consensus approach if multiple physicians were involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The studies described are primarily bench testing, simulated use, and biocompatibility evaluations to demonstrate substantial equivalence to predicate devices, not to measure human reader improvement with AI assistance. The device is a physical catheter, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The device is a physical medical instrument (catheter), not a software algorithm. Therefore, "standalone algorithm performance" is not relevant. The device's performance is intrinsically tied to its physical interaction and manipulation, often by a human operator (physician) in a clinical or simulated environment.
7. The Type of Ground Truth Used:
The "ground truth" for the various tests aligns with the nature of the test:
- Mechanical/Physical Tests: Ground truth is based on engineering specifications and measurements (e.g., dimensions, force, flow rates) and adherence to recognized standards (e.g., ISO, ASTM, EN).
- Simulated Use Tests (physician evaluated): Ground truth is based on expert consensus/opinion from the evaluating physician(s) regarding performance characteristics like trackability, durability, guidewire compatibility, and visibility in a bench model.
- Biocompatibility Tests: Ground truth is established through adherence to biological testing standards (e.g., EN ISO 10993 parts) and the resulting biological and chemical properties observed (e.g., cytotoxicity, hemolytic index, pyrogenicity, mutagenicity, thromboresistance).
8. The Sample Size for the Training Set:
Not applicable. The AXS Offset Delivery Assist Catheter is a physical medical device. It does not use machine learning or AI, and therefore does not have a "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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).