(221 days)
The Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
The Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) catheter with a distal inflatable balloon. The Powerflex™ Pro PTA Catheter is designed for use with a 0.035" guide wire and a catheter sheath introducer and is available in a variety of diameters and lengths. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.
The provided text describes the Cordis Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter. It outlines the device description, indications for use, and a summary of performance testing to establish substantial equivalence to predicate devices.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list "acceptance criteria" with specific quantitative thresholds. Instead, it states that the conducted in-vitro performance tests provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." The performance is demonstrated by the completion of these tests aligning with engineering standards and existing predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device Design and Functionality: | The Powerflex™ Pro PTA Catheter is designed for use with a 0.035" guide wire and a catheter sheath introducer. It features two radiopaque marker bands for balloon placement and a tapered tip for ease of entry and crossing stenoses. |
| Material Biocompatibility: | All materials used in the proposed device are similar to the predicate devices and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process. |
| Mechanical/Physical Performance (In-vitro tests): | All listed in-vitro performance tests (Marker Band Spacing, Balloon Diameter (Nominal, RBP), System Burst (Inflation Lumen & Guidewire Lumen), Hub to Shaft Pull Strength, CSI Insertion Kink Diameter, Catheter Shaft, Inflation/Deflation Time, Multiple Inflation (System Fatigue), Torque Testing, Particle Free, Hemolysis, Balloon Working Length, Balloon Burst, Marker Band Placement, Proximal Pull Strength, Tip to Balloon/Inner Body Pull Strength, CSI Withdrawal Force, Guide Wire Compatibility, Useable Catheter Length, Rated Burst Pressure, PreConditioning, Tensile Testing, Cytotoxicity, Physicochemical Aqueous Extraction) were completed. The submission states, "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing." This implies acceptable performance across all these metrics relative to the predicate devices and industry standards. |
| Substantial Equivalence to Predicate Devices: | Comparison with Cordis Opta Pro/Powerflex™ P3 PTA Catheter and ClearStream Technologies, Savvy Long PTA Catheter (for dimensions) showed "technological characteristics such as materials, components, biocompatibility, performance properties, dimensions (size range), method of delivery, fundamental technology (operating principle), packaging configuration and packaging materials, labeling, manufacturing and sterilization processes featured with the Powerflex Pro PTA Catheter are substantially equivalent." The intended use is also identical, with the exception of the additional post-dilatation indication, for which the Cordis Corp., Aviator Plus PTA Catheter serves as a predicate. |
| Safety and Effectiveness: | Demonstrated via non-clinical design verification and validation tests, analyses, and post-market surveillance data analyses of the predicate devices. The document concludes that the device "has been shown to be appropriate for its intended use and is considered to be substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each of the in-vitro performance tests. It merely lists the tests that were completed.
- Data Provenance: The studies were "non-clinical design verification and validation tests and analyses," meaning they were laboratory/bench tests. The origin of the data is therefore laboratory-based, and not patient-specific (i.e., not a clinical study involving human subjects). It also mentions "post-market surveillance data analyses of the predicate devices," which would be retrospective data from existing devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device's safety and effectiveness were demonstrated through non-clinical, bench testing and comparison to predicate devices, not through a diagnostic accuracy study requiring expert consensus on a test set to establish "ground truth."
4. Adjudication Method for the Test Set
Not applicable, as there was no test set requiring human adjudication in the context of diagnostic accuracy. The testing was laboratory-based.
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 medical device (catheter), not an AI diagnostic software.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (catheter), not an AI algorithm. The performance described is "standalone" in the sense that the device itself was tested in a lab setting, but not in the context of an AI algorithm's performance.
7. The Type of Ground Truth Used
For the in-vitro performance tests, the "ground truth" would be established by:
- Engineering specifications and design requirements.
- Industry standards (e.g., ISO for biocompatibility).
- Performance characteristics of the legally marketed predicate devices.
- Accepted scientific and engineering principles for material properties and mechanical function.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (catheter), not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is a medical device (catheter), not an AI algorithm requiring a training set.
§ 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).