(178 days)
The AXIOS™ Stent and Electrocautery-Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris. The stent is intended for implantation up to 60 davs and should be removed upon confirmation of pseudocyst 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 deploving 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 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.
This FDA 510(k) summary describes a medical device, the AXIOS Stent and Electrocautery-Enhanced Delivery System, and its performance. However, it does not involve an AI/ML algorithm, and therefore the acceptance criteria and study information related to AI/ML performance metrics (such as effect size for human readers with AI assistance, type of ground truth, training set size, etc.) are not applicable here.
The document focuses on demonstrating substantial equivalence to a predicate device (K181905) through engineering performance data (bench testing) rather than clinical study data involving AI/ML.
Here's a breakdown of the available information based on your request, with an emphasis on what is not present due to the nature of this device submission:
1. A table of acceptance criteria and the reported device performance
The document provides a table summarizing the types of bench tests performed and their results. The "acceptance criteria" are implied by the "Pass" result for each test, indicating that the device met the pre-defined product specifications for these engineering parameters. Specific numerical acceptance criteria values are not provided, only the pass/fail outcome.
| Test Item | Reported Result (Pass/Fail) |
|---|---|
| AXIOS Stent | |
| Deployed Stent Saddle Length | Pass |
| Deployed Stent Saddle Outer Diameter | Pass |
| Deployed Stent Flange Width | Pass |
| Stent Pull-out Force | Pass |
| Stent (Saddle) Radial Strength - in compression & expansion | Pass |
| Deployment Force | Pass |
| Implant Anchor Function- Retention (tensile) | Pass |
| Magnetic Resonance Testing | Pass |
| Fatigue Testing | Pass |
| AXIOS 9 Fr. Electrocautery-Enhanced Delivery System | |
| Delivery System Working Length | Pass |
| Catheter Extension | Pass |
| Nose Lock Hold Force | Pass |
| Slider Lock Hold Force | Pass |
| Nose Lock Cycling | Pass |
| Slider Lock Cycling | Pass |
| Distal Pusher Catheter to Distal Nose Joint Strength | Pass |
| Pusher Catheter to Hypotube Joint Strength | Pass |
| Outer Sheath to Hypotube Joint Strength | Pass |
| Pusher Hypotube to Handle Joint Strength | Pass |
| Outer Sheath Hypotube to Handle Joint Strength | Pass |
| Distal Pusher to Proximal Pusher Catheter Joint Strength | Pass |
| Outer Sheath to Handle Torque Strength | Pass |
| Luer to Nose Joint Strength | Pass |
| Tracking Force | Pass |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the bench tests. For medical devices, bench testing typically involves a sufficient number of samples to ensure statistical confidence in the results, but the exact N is not disclosed in this summary.
- Data Provenance: Not applicable as this relates to engineering bench testing of physical device components, not clinical data sets.
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)
Not applicable. This device is not an AI/ML diagnostic tool requiring expert interpretation for ground truth establishment. The "ground truth" for the performance tests are engineering specifications verified through physical measurement and functional testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human interpretation or adjudication of cases.
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 is not an AI/ML powered device, and no MRMC study was conducted or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm to test in a standalone configuration.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these tests are the pre-defined product specifications and engineering requirements for the device's physical and functional characteristics. This is established through engineering design, material science, and manufacturing standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no AI/ML component, there is no training set or associated ground truth establishment process.
§ 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.