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510(k) Data Aggregation
(71 days)
The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and removal of embolic material (e.g. debris, thrombus) during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.
The Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature 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 (S) 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.
The shaft (4) comprises the outer shaft (6) and the inner shaft (7). The distal end of the balloon (A) is connected to the inner shaft and the proximal end of the balloon (B) is connected to the outer shaft. The inner shaft is connected to the proximal hub (10) which is connected to the pulling knob (1) and the outer shaft is connected to the handle grip (3). The pulling knob lock ( 1 ) locks the handle grip and the pulling knob together. The distal end of the balloon is folded inwards towards the proximal end of the balloon, by pressing on pulling knob lock (11) and pulling the pulling knob away from the handle (1). The inward-folding of the balloon forms a cavity and allows for collection and removal of embolic material.
The balloon size and diameter are printed on the strain relief (12). Refer also to the package label for information about catheter length, balloon nominal and rated burst pressure, balloon size, balloon compliance, guidewire compatibility and sheath compatibility.
The PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature underwent non-clinical bench testing to demonstrate its performance and safety, particularly regarding its use within a stent environment.
1. Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Post-Dilatation, Minimum Balloon Burst Pressure (RBP) | RBP ≥ 14atm (3x100 only), 12atm for all other sizes with 95% Confidence, 99.9% Reliability | PASS |
| Post-Dilatation, Balloon Fatigue (Repeated Inflation/Deflations) | Inflation/Deflation Cycles ≥ 10 at 14atm (for 3x100 only), 12atm for all other sizes. No leakage, rupture, and/or herniation. Up to max 40 cycles with 95% Confidence, 90% Reliability | PASS |
| Post Dilatation Balloon Inflation/Deflation Testing | Inflation time: ≤ 14.0 sec, Deflation time: ≤ 30.6 sec. No leakage upon inflation with 90% Confidence, 90% Reliability | PASS |
| Post Dilatation, Simulated Use in Tortuous Anatomy Model - Guide Wire Compatibility | Catheter can be mounted over a 0.014" guide wire (3x100 only), 0.035" guide wire for all other sizes with 90% Confidence, 90% Reliability | PASS |
| Post Dilatation Simulated Use in Tortuous Anatomy Model - Introducer Sheath Compatibility | Completely folded balloon passes through identified Introducer Sheath (5F, 6F, 7F) at the end of procedure with 90% Confidence, 90% Reliability | PASS |
| Post Dilatation Simulated Use in Tortuous Anatomy Model – Kink Resistance | No permanent deformations (kinks) are present once removed from the tortuous anatomy model with 90% Confidence, 90% Reliability | PASS |
| Post-Dilatation Capture Efficiency | N/A - Characterization only | PASS (Overall CE consistent with previously tested device sizes without multiple overlapping stents, despite slight increase in particulate generation with stents.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states that "Sample sizes used for Design Verification and Validation testing were based on required confidence / reliability levels as a result of risk analysis performed for the PROTEUS™ PTA Balloon Catheter, or per recommendations within the FDA Guidance "Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems." Specifically, the number of samples utilized for each test depended on whether the data to be collected was variable data or attribute data in nature." Specific numerical sample sizes for each test are not explicitly provided in the text.
- Data Provenance: The tests were non-clinical in vitro bench tests conducted by Angioslide, Ltd. No patient data (retrospective or prospective) from specific countries was used for these tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The study involved non-clinical bench testing, not human expert evaluation of clinical data to establish ground truth.
4. Adjudication Method for the Test Set:
Not applicable. The study involved non-clinical bench testing, not human expert review with adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This was a non-clinical bench test. No human readers or AI assistance were involved in evaluating efficacy.
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 (catheter), not an algorithm or AI system.
7. The Type of Ground Truth Used:
In a non-clinical bench study for a physical device, "ground truth" is established by the specifications and measurable outcomes of the device's physical performance against predefined engineering and regulatory standards (e.g., burst pressure, inflation/deflation times, absence of leakage, ability to pass through a tortuous model). The "ground truth" is essentially the expected physical behavior and integrity of the device under simulated conditions.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device undergoing performance testing, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As this is not an AI model, there is no training set or ground truth for a training set in this context.
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