(46 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 and Delivery System and the AXIOS Stent and Electrocautery Enhanced Delivery System are discussed below and presented in Table 5 - 1 . There have been no changes to the AXIOS Stent or the delivery systems; it is identical to the stent and delivery systems cleared in 510(k) K152572 and K150692.
AXIOS Stent:
The AXIOS Stent and Delivery System is designed to secure the apposition of tissue, minimize stent displacement and create a large access/drainage lumen.
AXIOS Non-Cautery 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.
AXIOS Electro-Cautery Enhanced Delivery System:
The stent is preloaded onto the AXIOS delivery catheter. The Electro-cautery Enhanced Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS stent. The Electro-cautery Enhanced 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.
This document is a 510(k) submission for the AXIOS Stent and Delivery System, seeking to update its Indications for Use. The submission argues that no new performance data is required because the proposed changes align with existing clinical guidelines and previous IDE studies have already established safety and effectiveness for similar conditions.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. | Not applicable. |
Note: This 510(k) submission is for a revised indication for use based on aligning with existing clinical guidelines and previously established safety and effectiveness through IDE studies. It is not a submission presenting new performance data against specific acceptance criteria for a new device or a significant modification requiring new performance testing.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a new test set or sample size for this specific 510(k) submission. The revision is based on:
- Data Provenance: Clinical guidelines from "Classification of acute pancreatitis- 2012: revision of the Atlanta classification and definitions by international consensus".
- Previous Studies: IDEs G110068 and G130266, which established safety and effectiveness for similar conditions. The sample sizes and data provenance for these IDE studies are not detailed in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not detail experts used for a new test set. The basis for the revised indication relies on:
- Clinical Guidelines: "Classification of acute pancreatitis- 2012: revision of the Atlanta classification and definitions by international consensus". This consensus would have been established by a group of medical experts in the field of pancreatitis. Their specific number and qualifications are not detailed here, but such guidelines are typically developed by leading specialists (e.g., gastroenterologists, interventional endoscopists, surgeons).
4. Adjudication Method for the Test Set
Not applicable, as no new test set is described or analyzed in this 510(k) submission. The revision is based on existing clinical consensus and previous IDE study findings.
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 device is a medical stent and delivery system, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to human reader performance with AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical stent and delivery system, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the revised indication is based on:
- Expert Consensus/Clinical Guidelines: The "Classification of acute pancreatitis- 2012: revision of the Atlanta classification and definitions by international consensus". This is a form of expert consensus derived from clinical research and practice.
- Outcomes Data from Previous IDEs: The safety and effectiveness were established via IDEs G110068 and G130266, which would have involved collecting patient outcomes data.
8. The Sample Size for the Training Set
Not applicable. This document does not describe a training set as it's not an AI/machine learning device. The previous IDE studies (G110068 and G130266) would have had patient cohorts, but their sizes for "training" purposes (if considered in the broader sense of informing device development) are not detailed here.
9. How the Ground Truth for the Training Set was Established
Not applicable. As noted above, there is no "training set" in the context of an AI/machine learning device. The "ground truth" for the device's efficacy and safety was established through the clinical outcomes and data collected during the IDE studies (G110068 and G130266). These studies would have involved clinical assessments, imaging, and potentially pathology or other diagnostic measures to define the conditions being treated and the success of the treatment.
§ 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.