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The AXS Infinity LS Plus Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The AXS Infinity LS Plus Long Sheath is a variable stiffness catheter that has a catheter shaft reinforced with a stainless-steel mixed coil design (single wind and cross coil wind). It has a radiopaque Platinum/Iridium marker band on the distal end. The distal 10 cm of the AXS Infinity LS Plus Long Sheath has a hydrophilic coating which reduces the insertion force and allows the catheter to traverse the vasculature more easily. The catheter has a maximum average outer diameter of 0.109", where no point is > 0.112" and a nominal inner diameter of 0.091". It is available in three working lengths: 70 cm, 80 cm, and 90 cm. The AXS Infinity LS Plus Long Sheath has a PTFElined lumen. The AXS Infinity LS Plus Long Sheath is inserted at a vascular access point to provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and a Vessel Dilator. The accessories are identical to those in the previous clearance (K172468). The AXS Infinity LS Plus Long Sheath is supplied sterile, non-pyrogenic, and intended for single use only.

This document is a 510(k) summary for the AXS Infinity LS Plus Long Sheath, a medical device. It describes the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are presented across several tables in the document, categorized by the type of testing.

Biocompatibility Testing (Table 5-3, page 9):

Design Verification - Bench Testing (Table 5-4, page 11):

| Design Requirement/Test Name | Acceptance Criteria | Results |
|---|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tensile Strength | Peak tensile force shall be ≥ 15N at all joints | Pass. Two deviations were identified. The deviations did not impact the outcome of Tensile Strength testing. Refer to the summary of the deviations provided below. In all cases, the 90/95 confidence/reliability was higher than the specification of 15N. |
| PTFE Delamination | PTFE liner shall not delaminate. Any observed delamination within 1 mm of the cut is not considered a failure. | Pass. All samples did not exhibit any PTFE delamination. |
| Torque Strength | Catheter shall withstand at least one 360 degree turn of the hub | Pass. A reliability analysis was completed at 85% reliability and 95% confidence (8.50 turns minimum torque strength). |
| Catheter Burst | Product shall not burst below 44 psi | Pass. The minimum catheter burst pressure recorded was 119.7 psi. In addition, the 85%/95% lower bound value at 117.28 psi is greater than the lower specification limit of 44 psi. |
| Leak (Liquid) | No liquid leaking from hub and catheter shaft at 44 psi for 30 second duration | Pass. All units passed the liquid leak test. |
| Leak (Air) | No air shall leak into the catheter assembly during manual aspiration | Pass. All units passed air leakage testing. |
| Catheter Dimensional Testing (ID, OD, and Working Lengths) | The ID of the catheters shall be ≥ 0.090" | Pass. 95% confidence lower bound is 0.0914", which is greater than the lower specification limit of 0.090". |
| | The average OD of the catheter shall be ≤ 0.110" over the length of the catheter where no point measured shall be > 0.112" maximum | Pass. The average OD, the 95% confidence, 90% reliability upper bound is 0.109886" which is less than 0.110". For max OD, the 95% confidence, 90% reliability upper bound is 0.0110" which is less than 0.112", max OD. |
| | The catheter working length shall be within 2 cm of nominal | Pass. For catheter working length, the 95% confidence, 90% reliability lower bound is 89.72 cm and the upper bound is 90.23 cm, which is within 2 cm of nominal (90 cm). |
| Chemical Compatibility | Product shall withstand exposure to the following chemicals without degradation: Saline, Dextrose, Heparin, Contrast | Pass. All units passed chemical compatibility. |
| Kink Resistance | The kink resistance shall be: ≤ 0.215" at the distal most material ≤ 2" at the proximal most material | Pass. All units passed kink resistance. |
| Visual Inspection (Transitions and Tip) | The catheter shall have progressively lower durometer moving from proximal end to distal tip with smooth transition points to facilitate navigation through tortuous vascular anatomy. The catheter's distal tip shall be visibly tapered. | Pass. Units were inspected for smooth transitions and rounded tip. All units met the acceptance criteria and passed the transitions and tip visual inspection. |

Shelf Life (3-Year Accelerated Aging) (Table 5-5, page 14):

| Design Requirement/Test Name | Acceptance Criteria | Results |
|---|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tensile Strength | Peak tensile force shall be ≥ 15N at all joints | Pass. All samples had a peak tensile force of less than 15N. |
| PTFE Delamination | PTFE liner shall not delaminate. Any observed delamination within 1 mm of the cut is not considered a failure. | Pass. All samples did not exhibit any PTFE delamination. |
| Torque Strength | Catheter shall withstand at least one 360 degree turn of the hub | Pass. All samples withstood at least one 360 degree turn of the hub. |
| Catheter Burst | Product shall not burst below 44 psi | Pass. All samples had a burst rate greater than the lower specification limit of 44 psi. |
| Leak (Liquid) | No liquid leaking from hub and catheter shaft at 44 psi for 30 second duration | Pass. All units passed the liquid leak test. |
| Leak (Air) | No air shall leak into the catheter assembly during manual aspiration | Pass. All units passed air leakage testing. |
| Catheter Dimensional Testing (ID, OD, and Working Lengths) | The ID of the catheters shall be ≥ 0.090" | Pass. The ID of all catheters was greater than the lower specification limit of 0.090". |
| | The average OD of the catheter shall be ≤ 0.110" over the length of the catheter where no point measured shall be > 0.112" maximum | Pass. The average OD of all catheters was less than 0.110". The max OD of all catheters was less than 0.112". |
| | The catheter working length shall be within 2 cm of nominal | Pass. The working length of all catheters was within 2 cm of nominal. |
| Kink Resistance | The kink resistance shall be: ≤ 0.215" at the distal most material ≤ 2" at the proximal most material | Pass. All units passed kink resistance. |
| Visual Inspection (Transitions and Tip) | The catheter shall have progressively lower durometer moving from proximal end to distal tip with smooth transition points to facilitate navigation through tortuous vascular anatomy. The catheter's distal tip shall be visibly tapered. | Pass. Units were inspected for smooth transitions and rounded tip. All units met the acceptance criteria and passed the transitions and tip visual inspection. |

Sterilization Testing (Table 5-6, page 17):

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state a specific numerical sample size for each individual test. Instead, it generally refers to "all samples," "all units," or implies multiple replicates by stating "replicate results" or "triplicate." For Design Verification (Bench Testing) and Shelf Life (Accelerated Aging), a reliability analysis is mentioned for some tests (e.g., Tensile Strength, Torque Strength, Catheter Burst, Dimensional Testing), which typically involves a defined sample size to achieve the stated confidence and reliability levels (e.g., 90/95 confidence/reliability). However, the exact sample numbers are not provided in this summary.
• Data Provenance: The studies are described as "non-clinical data," "benchtop testing," "simulated-use testing," and "animal testing." No human clinical data was used for this submission. The testing was conducted by Stryker Neurovascular. The data is prospective in nature as it was generated specifically for this 510(k) submission to demonstrate equivalence. The provenance is internal to the manufacturer, Stryker Neurovascular, based in Fremont, CA, USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This submission pertains to a physical medical device (catheter) and relies on engineering and laboratory test results rather than expert interpretation of medical images or other diagnostic data. Therefore, the concept of "experts" establishing a "ground truth" in the clinical diagnostic sense is not directly applicable here. The "ground truth" for each non-clinical test is defined by the established and accepted engineering standards and validated test methodologies (e.g., ISO, ASTM standards, internal validated protocols). The "experts" would be the qualified engineers and technicians performing and verifying these tests. Their specific numbers and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of data requiring adjudication. The results are quantitative measurements against predefined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document explicitly states, "No clinical study was conducted as bench testing and previously performed animal testing was determined to be sufficient for verification and validation purposes" (page 17). Therefore, no MRMC study or AI-related comparative effectiveness study was performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No. This device is a physical medical catheter, not an algorithm or AI product.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is based on:

• Established Industry Standards and Regulations: Such as ISO 10993-1:2018 for Biocompatibility, EN ISO 14971:2012 for Risk Assessment, and ASTM methods for Hemolysis.
• Pre-determined Acceptance Criteria: Developed based on the device's intended use, safety, performance, and comparison to the predicate device.
• Physical Measurements and Chemical Analyses: Performed in a laboratory setting.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The tested devices are physical products.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, there is no training set for this type of device.

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