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510(k) Data Aggregation
The AXIOS Stent and Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transquodenal endoscopic drainage of the gallbladder in patients with acute cholecystitis who are at high risk for surgery.
The AXIOS Stent and Electrocautery-Enhanced Delivery system is designed to help facilitate the transgastric or transduodenal endoscopic drainage of the gallbladder. The AXIOS Stent remains identical to the stents cleared previously per K220112. The AXIOS Stent is a flexible, magnetic resonance conditional, fully covered, self-expanding, braided nitinol stent, which comes preloaded into the delivery system. The AXIOS stent is designed with two flanges, one on each end, to prevent migration and to enable tissue plane apposition and a "saddle" in between the flanges to span the tissue implant distance. The stent is fully covered with silicone to prevent leakage, discourage tissue in-growth within the nitinol woven braid, and facilitate removal. The AXIOS Electrocautery-Enhanced Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS™ Stent. The AXIOS™ Electrocautery-Enhanced Delivery System is designed to be used in the gastrointestinal tract with commercially available echoendoscopes with a 3.7 mm diameter or larger working chamel and is compatible with commercially available 0.035-inch insulated endoscopic guidewires. The Electrocautery-Enhanced Delivery System connects with an off-the-shelf electrosurgical unit or generator that is compliant to IEC 60601-1-2 and IEC 60601-2-2.
The provided text describes the acceptance criteria and the study that proves the AXIOS Stent and Electrocautery-Enhanced Delivery System meets those criteria. The information is primarily from non-clinical/bench testing and a pivotal clinical study, supplemented by a meta-analysis of clinical literature.
Here's the breakdown of the requested information:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The document presents two main categories of performance data: non-clinical/bench testing and clinical study results.
Table 1: Non-Clinical/Bench Testing Performance for AXIOS Stent and Delivery System
| Test | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Deployed Stent Saddle Length | Verify dimensions of deployed stent | Deployed Stent Saddle Length (inside flange to inside flange) @37°C $\geq$ 8.5 mm $\leq$ 13 mm for both AXIOS 10 mm x 10 mm & AXIOS 15 mm x 10 mm | Pass |
| Deployed Stent Saddle Outer Diameter | Verify dimensions of deployed stent | AXIOS 10mm x 10 mm stent: $\geq$ 8 mm; AXIOS 15mm x 10mm stent: $\geq$ 13 mm | Pass |
| Deployed Stent Flange Width | Verify dimensions of deployed stent | AXIOS 10 mm x 10 mm: $\geq$ 3 mm; AXIOS 15 mm x 10 mm: $\geq$ 3 mm | Pass |
| Stent Pull-Out Force | Verify stent will remain in place when pull-out force is applied | AXIOS 10 mm x 10 mm: $\geq$ 2.54 N; AXIOS 15 mm x 10 mm stent: Not explicitly stated, implied same as 10mmx10mm via "Pass" result column. | Pass |
| Stent (Saddle) Radial Strength – Compression & Expansion | Verify expansion strength of the compressed stent meets product specification | In compression @ 37°C $\geq$ 0.06 N/mm of length @ 50% Ø; In expansion @ 37°C $\geq$ 0.02 N/mm of length @ 50% Ø (for both AXIOS 10mm x 10 mm and 15 mm x 10 mm) | Pass |
| Deployment (Unsheathing) Force | Verify force needed to deploy stent | AXIOS 10 mm x 10 mm: $\leq$ 40 N; AXIOS 15 mm x 10 mm stent: $\leq$ 40 N | Pass |
| Implant Anchor Function – Retention (Tensile) | Verify force needed to achieve apposition of distal flange to target structure | AXIOS 10 mm x 10 mm: $\geq$ 2 N; AXIOS 15 mm x 10 mm stent $\geq$ 2 N | Pass |
| Magnetic Resonance Testing | Verify stent will not prevent ability to use MRI | The stent should not prevent the ability of the physician to use Magnetic Resonance Imaging on the patient. | Pass |
| Fatigue Testing | Ensure stent remains intact throughout the period of use | The stent must remain intact after 940,000 translation (distal flange with respect to proximal flange) cycles. | Pass |
| Corrosion Testing | Evaluate corrosion resistance of stent | The metal stent and stent covering must show corrosion resistance when subjected to an in vitro corrosive environment equivalent to sixty days. | Pass |
| Delivery System Working Length | Verify working length of delivery device | Working Length (distal point of the handle to distal end of the catheter tip) $\leq$ 138 cm | Pass |
| Slider lock hold force testing | Evaluate performance of lock under compressional and torsional forces | Lock hold force $\geq$ 22 N | Pass |
| Nose lock hold force | Evaluate performance of lock under compressional and torsional forces | Lock hold force $\geq$ 22 N | Pass |
| Nose/slide lock cycling | Inspect function of nose/slide lock feature | Nose lock must function after 6 cycles; slide lock must function after 4 cycles. | Pass |
| Joint Strength Testing | Verify joint strength meets design requirements | Per EN ISO 10555-1, the device shall meet specific minimum force. | Pass |
| Luer to Nose Joint Strength | Verify peak tensile force of luer to nose joint | Luer to Nose Joint Strength $\geq$ 22 N | Pass |
| Outer Sheath to Handle Torque Strength | Verify ability of AXIOS catheter to withstand torque when the device is rotated 360° | The catheter system must withstand a minimum of 1 full turn. | Pass |
| Tracking Force | Verify tracking force of outer sheath through a 3.7 mm working channel | Track force $\leq$ 8.83 N | Pass |
Table 2: Clinical Study Performance (Pivotal Study and Meta-Analysis)
| Endpoint/Outcome | Acceptance Criteria (Performance Goal) | Reported Device Performance (Pivotal Study, N=30 ITT) | Reported Device Performance (Meta-Analysis, N=713 combined) |
|---|---|---|---|
| Primary Effectiveness: Days to resolution of Acute Cholecystitis (AC) | $ |
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