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510(k) Data Aggregation
(28 days)
The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angroplasty and for capture and containment of embolic material during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.
The Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture is not intended for use in the renal, cerebral, coronary or carotid vasculature.
The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is an over the wire dual lumen catheter with a foldable balloon (5) located near the distal atraumatic soft tip (9).
One lumen is used for inflation of the balloon and is accessed via the inflation port (2). The other lumen, starting at the guidewire port (10), allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopaque markers (8) for positioning the balloon relative to stenosis. The radiopaque markers indicate the dilating section of the balloon and help in balloon placement. The balloon is designed to provide an inflatable segment of known diameter and length at specified pressure.
Acceptance Criteria and Device Performance for PROTEUS™ PTA Catheter with Embolic Capture Feature
This submission describes the non-clinical testing performed to demonstrate the substantial equivalence of the modified PROTEUS™ PTA Catheter with Embolic Capture Feature. The testing followed Angioslide's Risk Analysis, applicable FDA Guidance documents, and ISO standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual inspection - external surface | External surface of catheter effective length, including the distal end, is free from extraneous matter and surface defects (<0.2mm² TAPPI). 90% Confidence, 90% Reliability | PASS |
| Visual inspection - distal tip | Distal tip is smooth, rounded, tapered, or similarly finished. 90% Confidence, 90% Reliability | PASS |
| Distal Bond Outer Diameter | In Tolerance. 90% Confidence, 90% Reliability | PASS |
| Distal Balloon Cone to Distal Tip | In Tolerance. 90% Confidence, 90% Reliability | PASS |
| Distal Tip to Proximal Outer Tube Tip Length | In Tolerance. 90% Confidence, 90% Reliability | PASS |
| Soft Tip Length | In Tolerance. 90% Confidence, 90% Reliability | PASS |
| Wrapped Balloon Outer Diameter | In Tolerance. 90% Confidence, 90% Reliability | PASS |
| Guide Wire Lumen Inner Diameter | In Tolerance. 90% Confidence, 90% Reliability | PASS |
| Proximal Bond Outer Diameter | In Tolerance. 90% Confidence, 90% Reliability | PASS |
| Marker Band Spacing | In Tolerance. 90% Confidence, 90% Reliability | PASS |
| Balloon Working Length | In Tolerance. 90% Confidence, 90% Reliability | PASS |
| Balloon Outer Diameter | In Tolerance. 90% Confidence, 90% Reliability | PASS |
| Catheter Overall Effective Length | In Tolerance. 90% Confidence, 90% Reliability | PASS |
| Catheter Overall Length | In Tolerance. 90% Confidence, 90% Reliability | PASS |
| Minimum Balloon Burst Pressure (RBP) | RBP ≥ 14atm. 95% Confidence, 99.9% Reliability | PASS |
| Balloon Fatigue (Repeated Inflation/Deflations) | Inflation/Deflation Cycles ≥ 10 at 14atm (for 3x100). No leakage, rupture, and/or herniation up to max 40 cycles. 95% Confidence, 90% Reliability | PASS |
| Tensile Strength- Distal Balloon to Inner Tube (Peel) | ≥ 5N. 90% Confidence, 95% Reliability | PASS |
| Tensile Strength- Distal Balloon to Inner Tube (Shear) | ≥ 5N. 90% Confidence, 95% Reliability | PASS |
| Tensile Strength- Proximal Balloon to Outer Tube | ≥ 10N. 90% Confidence, 95% Reliability | PASS |
| Tensile Strength- Cylinder to T-Connector | ≥ 15N. 90% Confidence, 90% Reliability | PASS |
| Tensile Strength- Inflation Tube to T-Connector | ≥ 15N. 90% Confidence, 90% Reliability | PASS |
| Tensile Strength- Outer Tube to T-Connector | ≥ 15N. 90% Confidence, 90% Reliability | PASS |
| Tensile Strength- Inner Shaft to Pulling Rod | ≥ 10N. 90% Confidence, 95% Reliability | PASS |
| Tensile Strength- Pulling Rod to Proximal Luer | ≥ 15N. 90% Confidence, 90% Reliability | PASS |
| Tensile Strength- Pulling Rod to Knob Base | ≥ 15N. 90% Confidence, 90% Reliability | PASS |
| Tensile Strength- Cylinder to O-ring Cap | ≥ 15N. 90% Confidence, 90% Reliability | PASS |
| Liquid Leakage | No leakage. 90% Confidence, 90% Reliability | PASS |
| Balloon Inflation/Deflation Testing | Inflation Time: ≤ 14.0s. Deflation Time: ≤ 30.6s. 90% Confidence, 90% Reliability | PASS |
| Balloon Compliance | Compliance: ≤ 13%. Nominal Pressure: 8atm. RBP: 14atm. 90% Confidence, 90% Reliability | PASS |
| Flow Characteristics- Straight Configuration | Distal flow observed in uninflated and deflated state, occlusion of distal flow in inflated state. 90% Confidence, 90% Reliability | PASS |
| Flow Characteristics- Extreme Angle Configuration | Distal flow observed in uninflated and deflated state, occlusion of distal flow in inflated state. 90% Confidence, 90% Reliability | PASS |
| Stroke Length | Minimum Stroke Length: ≥ 70% of the associated Balloon Working Length. Maximum Stroke Length: Balloon can be deflated after reaching stroke limit. | PASS |
| Simulated Use in Tortuous Anatomy Model - guide wire compatibility | 90% Confidence / 90% Reliability. Catheter can be mounted over a 0.014" guide wire. 90% Confidence, 90% Reliability | PASS |
| Simulated Use in Tortuous Anatomy Model - Introducer Sheath Compatibility | 90% Confidence, 90% Reliability. Completely folded balloon passes through identified Introducer Sheath at the end of procedure. 90% Confidence, 90% Reliability | PASS |
| Simulated Use in Tortuous Anatomy Model - Kink Resistance | 90% Confidence, 90% Reliability. No permanent deformations (kinks) are present once removed from the tortuous anatomy model. 90% Confidence, 90% Reliability | PASS |
| Simulated Use in Tortuous Anatomy Model - Max Advancement Force | N/A - Characterization only | N/A |
| Simulated Use in Tortuous Anatomy Model - Max Collapse Force | N/A - Characterization only | N/A |
| Simulated Use in Tortuous Anatomy Model - Max Anatomy Retraction Force | N/A - Characterization only | N/A |
| Simulated Use in Tortuous Anatomy Model - Max Removal Retraction Force | N/A - Characterization only | N/A |
| Capture Efficiency Comparison | N/A - Characterization only | N/A |
2. Sample Sizes Used for the Test Set and Data Provenance
The sample sizes for testing varied depending on whether the data collected was variable or attribute data, which was determined by the risk analysis (DFMEA) performed for the PROTEUS™ PTA catheter and required confidence/reliability levels as per FDA Guidance "Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems." The documentation does not specify the exact number of units tested for each individual test but states that the number met the required statistical confidence and reliability levels.
The data provenance is from in vitro bench testing conducted by Angioslide, Ltd. and is thus not from a specific country of origin in a clinical context (e.g., patient data). It is prospective in the sense that the tests were designed and conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The tests described are non-clinical (bench testing) of the physical and mechanical properties of the device, not an evaluation requiring expert interpretation of clinical ground truth.
4. Adjudication Method for the Test Set
Not applicable. This was bench testing, not an evaluation relying on expert consensus for clinical interpretations. The results are objective measurements against defined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a device performance evaluation (bench testing) and not an AI-based diagnostic device.
6. Standalone Performance Study
This document details standalone performance testing of the device itself (hardware), not an algorithm or AI without human interaction. The results demonstrate the device's ability to meet its specifications.
7. Type of Ground Truth Used
The "ground truth" for these tests was established by engineering specifications, regulatory standards (ISO), and defined acceptance criteria for the physical and mechanical properties of the device, such as dimensions, tensile strength, burst pressure, and flow characteristics.
8. Sample Size for the Training Set
Not applicable. This is a medical device (catheter) and not an AI/Machine Learning algorithm, therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
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