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510(k) Data Aggregation
(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.
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(27 days)
The AXIOS Stent and Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, with ≥ 70% fluid content that are adherent to the bowel wall. Once placed, the AXIOS Stent functions as a 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 resolution.
The AXIOS Stent and Delivery System is designed to secure the apposition of tissue, minimize stent displacement and create a large access/drainage lumen. The AXIOS Stent and Delivery System is provided sterile, disposable and intended for single patient use. 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.
This document is a 510(k) premarket notification for the AXIOS Stent and Delivery System. It explains that the device's labeling (Directions For Use - DFU) is being modified to align with a previously cleared version, and therefore, no new studies or acceptance criteria are being presented for the device itself.
The document states: "No additional verification or validation activities were required to support the DFU changes proposed in this submission for the AXIOS Stent with Delivery System. The MR data and clinical data that supported the proposed labeling modifications were also used to support the same labeling changes that were cleared for the AXIOS with Electrocautery Enhanced Delivery System per K150692."
Therefore, based on the provided text, there is no new study described within this specific submission that proves the device meets new acceptance criteria. The submission relies on previously conducted studies for the predicate device (K150692) to support the DFU changes.
As such, I cannot provide the requested information regarding acceptance criteria and a study from this document, as it explicitly states no new studies were required for this submission. The "Conclusion" also reinforces this, stating: "The modified DFU of the AXIOS Stent and Delivery System is substantially equivalent to the predicate devices."
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(49 days)
The AXIOS™ Stent and Delivery System is indicated for use to facilitate transenteric endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 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 resolution.
The AXIOS™ Stent and Delivery System is an endoscopic device designed to deliver a fully-covered stent between a pancreatic pseudocyst and the gastrointestinal tract. The AXIOS™ Stent is a flexible, MR compatible, fully-covered self-expanding Nitinol stent preloaded within the AXIOS Delivery System. The AXIOS™ Delivery System is compatible with endoscopes equipped with a 3.7mm diameter or larger working channel. The AXIOS Stent and Delivery System is provided sterile, disposable and intended for use during a single patient procedure. The AXIOS Stent and Delivery System are sterilized by a validated method of sterilization via Ethylene Oxide (EO).
The provided document is limited to a 510(k) summary for the AXIOS™ Stent and Delivery System. This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than detailed clinical studies with acceptance criteria, performance metrics, and human reader evaluations typical for AI/ML-based diagnostic devices.
Therefore, the information required to populate most of the sections of your request (acceptance criteria, detailed study design with sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/ML models) is not present in this document.
However, I can extract information related to non-clinical testing and the overall conclusion about device performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Confirmed biocompatible, non-toxic, and safe for temporary implantation (in accordance with FDA guidance "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices," dated May 1, 1995 (G95-1)). |
| Device Function/Specifications | Verified that the device meets product specifications, performance characteristics, and requirements established by special controls for a pancreatic drainage stent and accessories. |
| Performance Levels | Test results established that the specified performance levels were achieved. |
| Risk Mitigation | Mitigations for anticipated risks were met through standard test methods, available guidances, and recognized technical requirements. |
| Comparison to Predicate | As safe, as effective, and performs as well as or better than the predicate AXIOS Stent and Delivery System (K123250). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes non-clinical bench testing and biocompatibility testing, not human clinical trials or AI/ML model performance evaluation with test sets derived from patient data.
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. Ground truth, in the context of expert consensus for AI/ML, is not relevant to this type of device submission. The "ground truth" here is implied by predefined engineering specifications and regulatory standards met through non-clinical laboratory testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically for clinical outcome or diagnostic agreement, which is not described for this non-clinical submission.
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
- No. An MRMC study is not mentioned as this is a medical device for drainage, not an AI-based diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a hardware medical device; the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical testing, the "ground truth" was established by predetermined product specifications, performance characteristics, regulatory standards, and recognized consensus standards (e.g., for biocompatibility and sterilization). The direct comparison was against the predicate device (AXIOS™ Stent and Delivery System K123250) for substantial equivalence.
8. The sample size for the training set
- Not Applicable. This document does not pertain to an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set for an AI/ML model is described.
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(302 days)
The AXIOS Stent and Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, with ≥ 70% fluid content that are adherent to the bowel wall. Once placed, the AXIOS Stent functions as a 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 resolution.
The AXIOS Stent and Delivery System consists of two major components, the catheter-based delivery system and the implantable stent. The stent is a flexible, fully-covered. self-expanding Nitinol stent, which is preloaded within the catheter-based delivery system. The system is intended to cannulate the transgastric or transduodenal wall into a pancreatic pseudocyst for endoscopic drainage. The stent serves as a conduit for passive drainage of pseudocyst contents directly into the GI tract. The large lumen diameter provides a short path and may allow secure access to the pseudocyst interior for additional diagnostic or therapeutic procedures. The AXIOS Stent is designed with a duplicate "anchor" or "flange" on each end to achieve tissue apposition and prevent migration. The stent is radiopaque and is fully covered with silicone to prevent leakage, minimize tissue in-growth, and facilitate removal. The AXIOS Stent will be provided in two lumen diameters (10mm and 15mm) and one length (10mm). The AXIOS Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS stent. The AXIOS Delivery System is sized to fit within commercially available echoendoscopes with a working channel of 3.7 mm diameter or larger. The Delivery System catheter is 138 cm in working length and attached directly to the endoscope handle. The AXIOS Delivery System requires an access site of at least 10 Fr. The AXIOS Stent and Delivery System is provided sterile, disposable and intended for use during a single patient procedure.
Acceptance Criteria and Device Performance for the AXIOS Stent and Delivery System
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the AXIOS Stent and Delivery System were primarily drawn from the "Safety Endpoints" and "Effectiveness Endpoints" sections of the pivotal clinical study.
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance (Pivotal Study, Per-Protocol population unless otherwise specified) |
|---|---|---|
| Effectiveness | Technical success (placement of AXIOS Stent using AXIOS Delivery System and removal with standard endoscopic snare) | Placement: 90.9% (30/33) in ITT population. Removal: 96.6% (28/29) using standard endoscopic tools; one was inadvertently dislodged. |
| Stent lumen patency at 30 days and/or 60 days (protocol defined drainage, including partial drainage, as patent) | 93.1% (27/29) had stent lumens that were patent at stent removal. (Note: 9 required debridement, 3 required supplemental stenting, 2 of which were non-patent at removal and considered failures for patency, though partial drainage considered success for the third). | |
| Stent removability at 30 days and/or 60 days | 96.6% (28/29) successfully removed using standard endoscopic tools. | |
| Clinical success (at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days) | 86.2% (25/29) achieved at least a 50% decrease in pseudocyst size at time of stent removal. (Note: This includes 75.9% at 30 days, and 77.8% for the 9 subjects remaining at 60 days. The failures included 2 with <50% decrease and 2 with supplemental stenting, despite resolution. Overall, 86.2% considered successful for clinic. success.) | |
| Safety | Overall Safety: 85% of subjects free of major complications through 1 week post-removal visit. Major complications defined as: | 86.2% (25/29) for PP subjects. |
| - Absence of access site-related bleeding requiring transfusion | 100% (29/29) | |
| - Absence of access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization | 96.6% (28/29) | |
| - Absence of surgery for access-site related perforation | 100% (29/29) | |
| - Absence of stent migration/dislodgement into the pseudocyst or enteral lumen | 96.6% (28/29) | |
| - Absence of tissue injury (ulceration to submucosa) at stent site persisting through 1-week post-stent removal | 100% (29/29) | |
| - Absence of serious adverse event classified as implant-associated or implant/surgical procedure associated | 86.2% (25/29) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Pivotal Study (effectiveness and safety): 33 subjects enrolled (Intent-to-Treat, ITT).
- Modified Intent-to-Treat (mITT): 30 subjects (received an AXIOS stent).
- Per-Protocol (PP): 29 subjects (received an AXIOS stent and had an evaluable clinical outcome). The effectiveness endpoints were evaluated on the ITT (technical success) and PP (patency, removability, clinical success, overall effectiveness) populations. Safety endpoints were evaluated on both ITT and PP populations.
- Data Provenance: The pivotal study was a prospective, multi-center, single-arm study conducted under an IDE (Investigational Device Exemption). The specific countries of origin are not mentioned, but "multi-center" implies multiple study sites. There was also a feasibility study that was a retrospective case series conducted at a single site, Tokyo Medical University.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not explicitly state the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience").
- Clinical Study Setting: The "Pivotal" study was a multi-center study, meaning several physicians (likely gastroenterologists or surgeons specializing in endoscopic procedures) at different sites were involved in patient selection, procedures, and outcome assessment.
- Radiographic Analysis: "Clinical success, defined as at least a 50% decrease in pseudocyst size, based on radiographic analysis," indicates that imaging experts (radiologists) were involved in evaluating pseudocyst resolution. However, the exact number, their role in establishing ground truth (e.g., independent adjudication), or their specific qualifications are not detailed.
4. Adjudication Method for the Test Set
The document does not explicitly detail a formal adjudication method (e.g., 2+1, 3+1) for the clinical outcomes.
- Pivotal Study Design: It was a prospective, single-arm study where outcomes were assessed as part of the standard clinical trial procedure at various time points (30-day, 60-day, 3 and 6 months post-removal).
- Radiographic Interpretation: Clinical success was based on "radiographic analysis." While this implies interpretation by experts, there's no mention of a blinded, independent central review or a consensus-based adjudication process for these radiographic assessments. The interpretation likely occurred at each study site.
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
- No MRMC Study: A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a medical implant (stent) and its delivery system, not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a physical medical device (stent and delivery system), not an algorithm or AI product. Therefore, standalone algorithm performance is not relevant or applicable.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical study was primarily based on:
- Clinical Outcomes Data: This includes direct measurements and observations from the intervention and follow-up, such as:
- Radiographic Analysis: Pseudocyst size reduction (e.g., ≥50% decrease) based on imaging (CT, ultrasound, MRI, EUS).
- Direct Observation during Endoscopy: Stent placement, patency, successful removal, and presence of tissue injury.
- Patient Symptoms and Adverse Events: Documented by clinical staff at study sites.
- Pathology: Histopathological evaluation was performed in the animal study, but it's not explicitly stated as the primary ground truth for human clinical outcomes.
8. The Sample Size for the Training Set
- No Training Set (for an algorithm): Since this is a physical medical device and not an AI algorithm, there was no separate "training set" in the context of machine learning. The "training" for the device's design and manufacture would involve engineering principles, bench testing data, and animal studies prior to human use.
- Feasibility Study as preliminary data: A non-randomized feasibility clinical study was conducted with 15 subjects prior to the pivotal study. This could be considered as preliminary human data informing the design and protocol for the larger pivotal study, but not a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable (no training set for an algorithm): As clarified above, there was no machine learning "training set" for an algorithm.
- Ground Truth for Pre-Clinical and Feasibility Data:
- Animal Study: Ground truth for the animal study was established through direct observation during procedures, subsequent endoscopic evaluations, and histopathological evaluation post-euthanasia.
- Feasibility Study: For the 15-subject feasibility study, ground truth was based on clinical assessment of technical success (deployment, implantation, removal) and clinical success (pseudocyst resolution) via follow-up visits and likely imaging. Methods were similar to those used in the pivotal study.
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