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510(k) Data Aggregation
(56 days)
Advanix Biliary Stent with NaviFlex RX Delivery System
Advanix™ Biliary Stent with NaviFlex™ RX Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
The Advanix™ Biliary Stent with NaviFlex™ RX Delivery System consists of biliary plastic stents and delivery system catheters. They are sold separately or in a pre-loaded configuration, in which a stent comes attached to the catheter via a suture. The system is comprised of two (2) primary components: stent and delivery catheter with a locking mechanism. The Advanix Biliary Stent allows for drainage of the biliary duct by preventing closure and maintaining the patency of the biliary duct. These biliary stents are provided in center bend and duodenal bend shapes and have leading and trailing bars, a tapered leading end tip to facilitate access through the papilla, and a rounded tailing end to match the profile of the push catheter portion of the delivery system.
This document is a 510(k) Summary for a medical device (Advanix Biliary Stent with NaviFlex RX Delivery System) and does not describe a study involving an AI/Machine Learning device or comparative effectiveness with human readers. Therefore, many of the requested categories are not applicable.
Here's an analysis of the provided text based on the specific questions, focusing on what can be extracted:
The document is a 510(k) premarket notification for a medical device (Advanix Biliary Stent with NaviFlex RX Delivery System). It discusses the device's characteristics, indications for use, and performance data to demonstrate substantial equivalence to a predicate device (K101314).
Crucially, this is NOT a document about an AI device or a study involving AI/Machine Learning performance. Therefore, many of the questions regarding AI-specific elements (like human reader improvement with AI, standalone AI performance, ground truth for test/training sets in an ML context, sample sizes for ML sets, multi-reader multi-case studies) are not relevant to this content.
However, I can extract information related to the device's non-clinical performance and acceptance criteria.
Acceptance Criteria and Device Performance Study (Non-AI Device)
1. Table of acceptance criteria and reported device performance:
The document broadly states that "All tests met required acceptance criteria, therefore supporting a finding of substantial equivalence." However, it does not provide a specific table with numerical acceptance criteria and corresponding reported performance metrics. It lists the types of tests performed.
| Test Category | Specific Test Performed | Acceptance Criteria (General Statement) | Reported Device Performance (General Statement) |
|---|---|---|---|
| Biocompatibility | MEM Elution Cytotoxicity | Aligned with ISO 10993, ISO 11135-1, ISO 10993-7, and FDA Guidance document. | Results meet requirements. |
| Guinea Pig Maximization | Aligned with ISO 10993, ISO 11135-1, ISO 10993-7, and FDA Guidance document. | Results meet requirements. | |
| Intracutaneous Reactivity | Aligned with ISO 10993, ISO 11135-1, ISO 10993-7, and FDA Guidance document. | Results meet requirements. | |
| Acute Systemic Injection | Aligned with ISO 10993, ISO 11135-1, ISO 10993-7, and FDA Guidance document. | Results meet requirements. | |
| Implantation | Aligned with ISO 10993, ISO 11135-1, ISO 10993-7, and FDA Guidance document. | Results meet requirements. | |
| Chemical Extractables | Studies on chemical extractables | Aligned with FDA's Guidance document, "Use of International Standard ISO 10993-1". | Results meet requirements. |
| Bench Testing | Drainage Lumen ID | Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions". | All tests met required acceptance criteria. |
| Stent Length | Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions". | All tests met required acceptance criteria. | |
| Stent OD | Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions". | All tests met required acceptance criteria. | |
| Stent Shape | Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions". | All tests met required acceptance criteria. | |
| Repositionability (pre-loaded system only) | Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions". | All tests met required acceptance criteria. | |
| Deployment Force | Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions". | All tests met required acceptance criteria. | |
| Device Trackability Force | Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions". | All tests met required acceptance criteria. | |
| Guidewire Compatibility | Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions". | All tests met required acceptance criteria. | |
| Duodenoscopy Compatibility | Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions". | All tests met required acceptance criteria. | |
| Barb Flap Cover Compatibility | Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions". | All tests met required acceptance criteria. | |
| Tensile: Aged in Bile | Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions". | All tests met required acceptance criteria. | |
| Lumen Patency | Aligned with FDA guidance document, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions". | All tests met required acceptance criteria. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions that bench tests were performed but does not quantify the number of devices or components tested.
- Data Provenance: Not specified. The tests are bench tests performed on the device itself (parts of the device).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests would be the physical properties and performance characteristics of the device measured against predetermined specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is for clinical or radiological studies with expert review.
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 a traditional medical device (biliary stent), not an AI diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This refers to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Ground truth is established by adherence to international standards (ISO 10993, ISO 11135-1, ISO 10993-7) and FDA guidance for biological evaluation and sterilization residuals.
- For bench testing: Ground truth is implicitly defined by the specified engineering and performance requirements for the device, and adherence to FDA guidance for non-clinical bench performance testing.
8. The sample size for the training set:
- Not applicable. This is not an AI/Machine Learning device, so there is no training set in that context.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI model.
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(73 days)
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
Advanix™ Biliary Stent with NaviFlex™ RX Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
The proposed Advanix™ Biliary Stent with NaviFlex™ RX Delivery System consists of biliary plastic stents and delivery system catheters. They are sold separately or in a pre-loaded configuration, in which a stent comes attached to the catheter via a suture. The system is comprised of two (2) primary components: stent and delivery catheter with a locking mechanism. The Advanix Biliary Stent allows for drainage of the biliary duct and gall bladder by preventing closure and maintaining the patency of the biliary duct. These biliary stents are provided in center bend and duodenal bend shapes and have leading and trailing bars, a tapered leading end tip to facilitate access through the papilla, and a rounded tailing end to match the profile of the push catheter portion of the delivery system.
The Advanix Biliary Stent will be offered in 7Fr. 8.5Fr, and 10Fr diameters. The stent leneths for each diameter vary from 5cm-18cm stent lengths. The Advanix biliary stents are constructed of a Polyethylene material.
The NaviFlex RX Delivery System will be offered in 202.5cm working length. The delivery system consists of a guide catheter and outer push catheter. The guide catheter is constructed of Polyvinylidene fluoride material. The guide catheter also includes a radiopaque marker. The push catheter is composed of polyether block amide material and also has a Nylon repositioning suture.
The provided text describes the regulatory clearance for a medical device, specifically the Advanix™ Biliary Stent with NaviFlex™ RX Delivery System. It functions as a 510(k) Summary, outlining the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.
However, the information provided does not contain the details typically found in a study report designed to "prove the device meets acceptance criteria" in terms of clinical performance or a detailed analytical study with statistical analysis. Instead, it focuses on bench testing and biocompatibility to demonstrate safety and performance similar to an already cleared device.
Therefore, for many of the requested categories, the answer will be "Not Applicable" or "Not specified in this document" because the document is a 510(k) summary, not a clinical study report.
Here's the breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes a series of tests performed, implying that for each test, there were "required specifications" that were met. However, the specific numerical acceptance criteria and the quantitative reported performance for each criterion are not detailed in this summary.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance (General Statement) |
|---|---|---|
| Biocompatibility | Cytotoxicity (EN ISO 10993-1:2009) | Passed |
| Sensitization (EN ISO 10993-1:2009) | Passed | |
| Intracutaneous Reactivity (EN ISO 10993-1:2009) | Passed | |
| Systemic Toxicity - Acute (EN ISO 10993-1:2009) | Passed | |
| Subacute Toxicity (Intravenous/Intraperitoneal) | Passed | |
| Genotoxicity (Ames Assay & Mouse Lymphoma) | Passed | |
| Implantation (EN ISO 10993-1:2009) | Passed | |
| USP Physicochemical (Stent) | Passed | |
| USP Physicochemical (Delivery System) | Passed | |
| Device Bench Testing | Drainage Lumen ID (Required Specifications) | Acceptable (Met design specifications) |
| Stent Length (Required Specifications) | Acceptable (Met design specifications) | |
| Stent OD (Required Specifications) | Acceptable (Met design specifications) | |
| Stent Shape (Required Specifications) | Acceptable (Met design specifications) | |
| Repositionability (Required Specifications) | Acceptable (Met design specifications) | |
| Deployment Force (Required Specifications) | Acceptable (Met design specifications) | |
| Trackability Force (Required Specifications) | Acceptable (Met design specifications) | |
| Guidewire Compatibility (Required Specifications) | Acceptable (Met design specifications) | |
| Duodenoscope Compatibility (Required Specifications) | Acceptable (Met design specifications) | |
| Barb Flap Cover Compatibility (Required Specifications) | Acceptable (Met design specifications) | |
| Biopsy Cap Compatibility (Required Specifications) | Acceptable (Met design specifications) | |
| Delivery System Working Length (Required Specifications) | Acceptable (Met design specifications) | |
| Delivery System OD (Required Specifications) | Acceptable (Met design specifications) | |
| Guide Catheter Pushability (Required Specifications) | Acceptable (Met design specifications) | |
| RX Port Buckling Resistance (Required Specifications) | Acceptable (Met design specifications) | |
| Locking Mechanism Retention Ability (Required Specifications) | Acceptable (Met design specifications) | |
| Locking Mechanism to Dual Lumen Catheter Tensile Strength | Acceptable (Met design specifications) | |
| Dual Lumen Catheter to Single Lumen Catheter Tensile Strength | Acceptable (Met design specifications) | |
| Pullwire Assembly to Guide Catheter Tensile Strength | Acceptable (Met design specifications) | |
| Pullwire Tensile Strength (Required Specifications) | Acceptable (Met design specifications) | |
| Guide Catheter RO Marker Band Strength (Required Specifications) | Acceptable (Met design specifications) | |
| Push Catheter RO Marker Band Strength (Required Specifications) | Acceptable (Met design specifications) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in this 510(k) summary. The document mentions "in-vitro testing" and "all components, subassemblies, and/or full devices" but does not give a specific number of units tested for each criterion.
- Data Provenance: The tests are described as "in-vitro testing" and "bench tests," implying laboratory-based testing, not human patient data. There is no mention of country of origin for data or whether it was retrospective or prospective, as these are typically clinical study terms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document describes engineering and biocompatibility testing, not a study where human experts would establish a "ground truth" for a test set (e.g., image interpretation). The "ground truth" for these tests would be the established engineering specifications and recognized biocompatibility standards.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical or image-based studies where expert consensus is needed to resolve discrepancies. This document describes laboratory testing against predetermined specifications.
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 document does not describe a multi-reader multi-case study, clinical trial, or any assessment of AI assistance. The device is a physical medical implant (stent) and a delivery system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical stent and delivery system, not an algorithm or AI.
7. The type of ground truth used
- The "ground truth" for the tests described would be based on engineering specifications (for device bench testing) and established international standards (EN ISO 10993-1:2009 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" explicitly mentioned as ground truth for the evaluations detailed in this summary.
8. The sample size for the training set
- Not Applicable. This document does not describe a machine learning algorithm or AI model that would require a "training set." The performance assessments are for a physical medical device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, this question does not apply.
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