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510(k) Data Aggregation
(261 days)
Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter
The Conquest™ 40 PTA Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of stents in the peripheral vasculature. This catheter is not for use in coronary arteries.
The Atlas™ Gold PTA Dilation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the illac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.
The Vida™ PTV Dilatation Cather is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in the following:
· A patient with isolated pulmonary valve stenosis.
· A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
The Vida™ BAV Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.
The Conquest™ 40 PTA Dilatation Catheter is a high-performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary ultra non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes a tapered atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the quidewire lumen. The over-the-wire catheter is compatible with 0.035" guidewires and is available in 50cm and 75cm working lengths. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. A stylet is placed into the tip of the catheter to aid in re-wrap/refolding of the balloon. This product is not manufactured with any latex.
The Atlas™ Gold PTA Dilatation Catheter is a high-performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes a tapered atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. The over-the-wire catheter is compatible with .035" guidewire and is available in 80 cm and 120 cm working lengths.
Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft to aid in re-wrap/refolding of the balloon. This product is not manufactured with any natural rubber latex.
The Vida™ PTV Dilatation Catheter is a high-performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary, noncompliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over-the-wire catheter is compatible with .035" guidewire and is available in 100 cm working length. The proximal portion of the catheter includes a female luer-lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen.
Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.
The Vida™ BAV Balloon Valvuloplasty Catheter is a high-performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary, non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over-the-wire catheter is compatible with .035" guidewire and is available in 100 cm working length. The proximal portion of the catheter includes a female luer-lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen.
Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.
The provided document describes the substantial equivalence determination for several medical devices, specifically balloon dilatation and valvuloplasty catheters. It does not present acceptance criteria or performance data for an AI/ML-driven medical device. Instead, it focuses on the engineering and material characteristics of physical medical devices and their comparison to previously cleared predicate devices.
Therefore, I cannot provide a response based on the requirements of your prompt, as the document does not contain information related to:
- AI/ML performance testing: The document details physical device performance tests (e.g., trackability, burst strength, fatigue, biocompatibility), not AI model performance metrics like sensitivity, specificity, or AUC.
- Test/training sets for AI/ML: There is no mention of data sets, sample sizes for AI training or testing, data provenance, or ground truth establishment relevant to an AI algorithm.
- Expert adjudication or MRMC studies: These are concepts specific to the evaluation of AI systems, typically involving human readers or experts, which are not applicable to the physical devices described in this submission.
The document states: "The subject devices...met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not specify what those "predetermined acceptance criteria" are for each test, nor does it present the reported device performance in detail (e.g., actual burst pressures achieved vs. minimum required). It lists the types of tests performed.
To fulfill your request, the input document would need to describe the development and validation of an AI/ML component, including its specific acceptance criteria and the results of studies demonstrating its performance.
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(10 days)
CONQUEST 40 PTA DILATATION CATHETER
The Conquest® 40 PTA Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.
The Conquest® 40 PTA Dilatation Catheter is a high pressure percutaneous transluminal angioplasty (PTA) balloon catheter consisting of a 0.035" compatible over the wire catheter with a low profile balloon fixed at the distal tip. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the quidewire lumen.
Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. This product is not manufactured with any latex.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Conquest® 40 PTA Dilatation Catheter:
Based on the provided 510(k) summary, the device is a PTA Dilatation Catheter (a physical medical device), not an AI/ML powered device. Therefore, many of the requested categories (such as sample size for test set, provenance, number of experts, adjudication, MRMC study, training set details) are not applicable to this submission. The "acceptance criteria" here refer to the performance standards and safety criteria for the physical device, not an algorithm's performance.
The submission focuses on demonstrating substantial equivalence to predicate devices through in vitro testing and biocompatibility assessments, rather than clinical efficacy studies in the way an AI/ML device would.
Acceptance Criteria and Device Performance (for a physical medical device)
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Attribute | Acceptance Criteria (Implied by equivalence to predicates and industry standards) | Reported Device Performance Conclusion |
|---|---|---|
| In Vitro Tests (Newly Performed for Conquest® 40) | Meets design specifications, comparable to predicate devices, and adheres to relevant FDA Guidance Documents and internal Risk Assessment procedures. | "The results from these tests demonstrate that the technological characteristics and performance criteria of the Conquest® 40 PTA Dilatation Catheter are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the similar intended use." Specific numeric criteria/results are not detailed in this summary. |
| Specific In Vitro Tests: | ||
| - Tip Length | Meets design specifications for safe and effective use; comparable to predicates. | Demonstrated comparability. |
| - Balloon Outer Diameter | Meets design specifications for stated diameters (4, 5, 6, 7, 8, 9, 10, 12 mm); comparable to predicates. | Demonstrated comparability. |
| - Shaft Outer Diameter | Meets design specifications for device profile; comparable to predicates. | Demonstrated comparability. |
| - Balloon Distensibility | Meets design specifications for controlled expansion; comparable to predicates. | Demonstrated comparability. |
| - Fatigue | Withstands expected operational stresses and cycles without failure. | Demonstrated comparability. |
| - Fatigue in a Stent/Stent Graft/Graft | Maintains integrity when used within stents/grafts. | Demonstrated comparability. |
| - Balloon Burst Strength in a Stent/Stent Graft and Balloon Removal | Withstands specified pressures without catastrophic failure, and allows for safe removal. | Demonstrated comparability. |
| - Balloon Inflation and Deflation Time | Achieves inflation/deflation within clinically acceptable times. | Demonstrated comparability. |
| - Balloon Burst Strength and Burst Mode | Withstands specified pressures without catastrophic failure, and fails in a safe manner. | Demonstrated comparability. |
| - Balloon to Shaft Tensile Force | Maintains secure connection under stress. | Demonstrated comparability. |
| - Catheter Shaft Elongation | Remains within acceptable elongation limits during use. | Demonstrated comparability. |
| - Guidewire Extension to Bifurcate Tensile Force | Maintains secure connection under stress. | Demonstrated comparability. |
| - Bifurcate to Shaft Tensile Force | Maintains secure connection under stress. | Demonstrated comparability. |
| - Guidewire Hub to Guidewire Extension Tensile Force | Maintains secure connection under stress. | Demonstrated comparability. |
| - Introducer Sheath Compatibility | Compatible with specified introducer sheath sizes (6F, 7F, 8F). | Demonstrated comparability. |
| - Catheter Shaft Leaks | No leaks under operational pressure. | Demonstrated comparability. |
| - Trackability and Guidewire Compatibility | Navigates vascular anatomy effectively and is compatible with standard guidewires. | Demonstrated comparability. |
| - Syringe Inflation Pressure Capability | Compatible with standard inflation devices and pressures. | Demonstrated comparability. |
| Biocompatibility Tests (Newly Performed for Conquest® 40) | Meets biological safety requirements as per ISO 10993-1:2010 and Blue Book Memorandum G95-1. | "The results from these tests demonstrate that the subject device, the Conquest® 40 PTA Dilatation Catheter, is comparable to the predicate devices and that it is considered safe and biocompatible for its intended use." |
| - Cytotoxicity | No unacceptably high cytotoxic effects. | Demonstrated comparability. |
| - Chemical Characterization | Identification and quantification of leachable substances within acceptable limits. | Demonstrated comparability. |
| Leveraged Biocompatibility Tests (from Predicate Devices) | Meets biological safety requirements as per ISO 10993-1:2010 and Blue Book Memorandum G95-1. | "The results from these tests demonstrate that the subject device... is comparable to the predicate devices and that it is considered safe and biocompatible for its intended use." |
| - Irritation/Intracutaneous Reactivity | No unacceptable irritation or intracutaneous reactivity. | Demonstrated comparability. |
| - Sensitization | No unacceptable sensitization potential. | Demonstrated comparability. |
| - Acute Systemic Toxicity | No unacceptable acute systemic toxicity. | Demonstrated comparability. |
| - Material Mediated Pyrogenicity | No unacceptable pyrogenic response. | Demonstrated comparability. |
| - Hemocompatibility (Hemolysis and Thrombogenicity) | Acceptable levels of hemolysis and thrombogenicity. | Demonstrated comparability. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for individual in vitro tests. For physical device testing, sample sizes are typically determined by statistical rationale to ensure confidence in the results for each specific test (e.g., n=3, n=5, n=10 per batch, etc.). The summary states "in vitro tests were performed" but does not detail the sample sizes.
- Data Provenance: The data is from in vitro testing conducted by the manufacturer, Bard Peripheral Vascular, Inc. This is not clinical data, so concepts like country of origin or retrospective/prospective do not apply in the same way they would for a clinical study with patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. This is a physical device submission focused on engineering performance and biocompatibility rather than diagnostic accuracy or human interpretation tasks. Ground truth for in vitro tests is based on established engineering principles, metrology, and standardized test methods.
4. Adjudication Method for the Test Set
- Not Applicable. As above, this is not a diagnostic or interpretive task requiring expert adjudication. Test results are objectively measured against pre-defined engineering specifications and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is for evaluating the impact of a new diagnostic tool (often AI) on human reader performance. This submission is for a physical medical device (catheter) and does not involve human readers evaluating cases with or without AI assistance.
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. There is no "algorithm" in the context of AI/ML to test in a standalone manner.
7. The Type of Ground Truth Used
- For in vitro performance tests: Ground truth is established by engineering specifications, material science standards, and validated test methods (e.g., ISO standards). Measurements are taken directly from the manufactured devices.
- For biocompatibility tests: Ground truth is established by biological endpoints (e.g., cellular viability for cytotoxicity, specific immune responses for sensitization) as defined by international standards (ISO 10993).
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, there is no training set for a physical medical device. Manufacturing processes and design controls are validated through engineering studies and quality assurance practices.
Summary of Device Performance (Overall):
The submission concludes that the Conquest® 40 PTA Dilatation Catheter met all predetermined acceptance criteria for design verification and validation. This was based on:
- Direct in vitro testing of various physical and mechanical attributes.
- Direct in vitro biocompatibility testing (cytotoxicity, chemical characterization).
- Leveraging in vitro test data from its predicate devices where components and materials were identical (e.g., balloon operating pressure, marker band visibility, irritation, sensitization).
The study demonstrates that the new device is substantially equivalent to legally marketed predicate devices by showing comparable technological characteristics and performance criteria, and by being deemed safe and biocompatible for its intended use.
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