(252 days)
The AXIOS Stent and Delivery System & AXIOS Stent and Electrocautery Enhanced Delivery System are indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥6cm in size, and symptomatic Walled Off Necrosis ≥6cm in size, with ≥70% fluid content, that are adherent to the gastric or bowel wall. Once placed, the AXIOS stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or Walled Off Necrosis resolution.
The AXIOS Stent is a flexible, MR conditional, fully-covered self-expanding braided nitinol stent, which comes preloaded into the delivery system. The AXIOS stent is designed with two flanges 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.
Non-Cautery Enhanced Delivery System: The stent is preloaded within the AXIOS delivery catheter. The Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS stent. The Delivery System is designed to be used in the gastrointestinal tract in conjunction with commercially available echoendoscopes with a 3.7 mm diameter or larger working channel and is compatible with commercially-available 0.035-inch insulated endoscopic guidewires.
Electrocautery Enhanced Delivery System: The AXIOS Electrocautery Enhanced Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS Sten. 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 channel 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 AXIOS Stent and Electrocautery Enhanced Delivery System is provided sterile, disposable and intended for single use.
The provided text describes a 510(k) submission for the AXIOS Stent and Delivery System. The focus of this submission is to reinstate a passivation/etching manufacturing step that had previously been removed. Because the change involves reinstating a prior manufacturing step and the device is being claimed as substantially equivalent to previously cleared versions, the performance data presented is primarily bench testing to confirm that the reinstation of this step does not negatively impact the device's performance or safety.
Here's the breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" values in a quantitative format for each test. Instead, it states that the device "successfully passed all pre-defined product specifications and is equivalent to the predicate passivated AXIOS stent for the tests performed." This implies that the acceptance criteria for each test were met, resulting in a "Pass" outcome.
| Test | Reported Device Performance (Pass/Fail) | Acceptance Criteria (Implied) |
|---|---|---|
| Deployed Stent Saddle Length | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Deployed Stent Saddle Outer Diameter | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Deployed Stent Flange Width | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Corrosion Testing via ASTM Standard F2129 | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Stent Fatigue | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Stent Radial Strength – in expansion & in compression | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Stent Deployment Force | Pass | Met pre-defined product specifications; equivalent to predicate device |
| Biocompatibility Testing (Cytotoxicity test on finished stent) | Pass | Confirmed manufacturing change did not impact toxicity; equivalent to predicate device |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each bench test conducted (e.g., number of stents tested for fatigue, corrosion, etc.). It only lists the types of tests performed.
The data provenance is from bench testing performed to verify design and validation requirements after reinstating a manufacturing step. The document does not specify if these tests were conducted internally by Boston Scientific or by an external laboratory. It does not refer to patient data (retrospective or prospective), as this submission is focused on a manufacturing change for an already cleared device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission concerns bench testing of a physical device for manufacturing changes, not diagnostic or interpretive tasks requiring expert ground truth establishment.
4. Adjudication method for the test set
Not applicable. This submission concerns bench testing of a physical device, not a diagnostic 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. This submission is for a medical device (stent and delivery system), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This submission is for a medical device (stent and delivery system), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" would be the pre-defined product specifications and performance characteristics of the predicate device. The tests were designed to verify that the modified device met these engineering and material standards. For example, for "Deployed Stent Saddle Length," the ground truth would be the specified design length within allowable tolerances.
8. The sample size for the training set
Not applicable. This submission focuses on bench testing a physical device after a manufacturing change, not on training a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a machine learning algorithm in this submission.
§ 876.5015 Pancreatic drainage stent and delivery system.
(a)
Identification. A pancreatic drainage stent is a prescription device that consists of a self-expanding, covered, metallic stent, intended for placement to facilitate transmural endoscopic drainage of pancreatic pseudocysts. This stent is intended to be removed upon confirmation of pseudocyst resolution. This device may also include a delivery system.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device and elements of the delivery device that may contact the patient must be demonstrated to be biocompatible.
(2) Performance data must demonstrate the sterility of patient-contacting components of the device.
(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the requested shelf life.
(4) Non-clinical testing data must demonstrate that the stent and delivery system perform as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Deployment testing of the stent and delivery system must be conducted under simulated use conditions.
(ii) Removal force testing must be conducted. The removal force testing must demonstrate that the stent can be safely removed, and that the stent will remain in place when subjected to forces encountered during use.
(iii) Expansion force testing must be conducted. The expansion force must demonstrate that the forces exerted by the stent will not damage the tissue surrounding the stent.
(iv) Compression force testing must be conducted. The compression force must demonstrate that the stent will withstand the forces encountered during use.
(v) Dimensional verification testing must be conducted.
(vi) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(vii) Fatigue testing must be conducted. Material strength must demonstrate that the stent will withstand forces encountered during use.
(viii) Corrosion testing must be conducted. Corrosion resistance must demonstrate that the stent will withstand conditions encountered during use.
(5) Non-clinical testing must evaluate the compatibility of the stent in a magnetic resonance (MR) environment.
(6) Well-documented clinical experience must demonstrate safe and effective use, and capture any adverse events observed during clinical use.
(7) Labeling must include the following:
(i) Appropriate instructions, warnings, cautions, limitations, and information related to the safe use of the device, including deployment of the device, maintenance of the drainage lumen, and removal of the device.
(ii) A warning that the safety and patency of the stent has not been established beyond the duration of the documented clinical experience.
(iii) Specific instructions and the qualifications and clinical training needed for the safe use of the device, including deployment of the device, maintenance of the drainage lumen, and removal of the device.
(iv) Information on the patient population for which the device has been demonstrated to be effective.
(v) A detailed summary of the clinical experience pertinent to use of the device.
(vi) A detailed summary of the device technical parameters.
(vii) A detailed summary of the device- and procedure-related complications pertinent to use of the device.
(viii) An expiration date/shelf life.