(10 days)
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.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).