(89 days)
The AXIOS Stent is 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.
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 medical device, the AXIOS Stent and Electrocautery Enhanced Delivery System, and its acceptance criteria as evaluated through bench testing, animal testing, and a clinical literature review.
Here's the information extracted and organized:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Reported Device Performance (Result) |
|---|---|
| Deployed Stent Saddle Length | Pass |
| Deployed Stent Saddle Outer Diameter | Pass |
| Deployed Stent Flange Width | Pass |
| Stent Pull-out Force (tensile) | Pass |
| Stent (Saddle) Radial Strength - in expansion | Pass |
| Stent (Saddle) Radial Strength - in compression | Pass |
| Tracking Force | Pass |
| Stent Fatigue | Pass |
| Stent Deployment Force | Pass |
| Implant Anchor Function - Retention (tensile) | Pass |
| MR Testing | Pass |
| Safety and performance in animal models | Performed as intended, no new safety/performance issues |
| Clinical success of larger diameter stents (literature review) | Similar to existing predicate devices; no increased risk for stent migration despite increased flange diameter |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Testing: The sample sizes for each specific bench test are not provided in the document.
- Animal Testing: The sample size for animal testing is not specified. The provenance (country/retrospective/prospective) is also not specified, though it implies a prospective study as it states "The proposed device performed as intended."
- Clinical Literature Review: The sample size is not explicitly stated as it's a review of existing literature, not a new clinical study. The provenance and details of the studies reviewed (e.g., country of origin, retrospective/prospective nature of those individual studies) are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The bench tests rely on objective physical measurements, and the animal testing and clinical literature review do not mention expert involvement for establishing ground truth in the way a diagnostic imaging study might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided in the document. The tests described (bench, animal, literature review) do not typically involve adjudication of results in the expert consensus sense.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any AI component described for this device. The device is a physical stent and delivery system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical implant and delivery system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Bench Testing: Ground truth is established by engineering specifications and physical measurement standards.
- Animal Testing: Ground truth is established by direct observation of device performance, and potentially histological examination or other animal physiology assessments to verify safety and function.
- Clinical Literature Review: Ground truth is derived from the reported outcomes and findings of the clinical studies included in the review, presumably based on clinical endpoints like stent migration, drainage efficacy, etc.
8. The sample size for the training set
Not applicable. This document describes the performance data for a medical device (stent), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a medical stent device.
§ 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.