(30 days)
The Flash PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.
The Flash PTA Balloon Dilatation Catheter is designed for the dilation of stenotic ostial lesions in the peripheral vasculature. The Flash PTA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash PTA Balloon Dilatation Catheter uses a dual balloon design, which prevents distal migration of the balloon during angioplasty. The distal semi-compliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.
The Flash PTA Balloon Dilatation Catheter underwent in vitro performance bench testing to confirm its characteristics compared to a predicate device.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO MEM Elution Assay | Met established specifications; materials are non-toxic and non-sensitizing. |
| ASTM Hemolysis Assay | Met established specifications; materials are non-toxic and non-sensitizing. | |
| Materials Mediated Rabbit Pyrogen | Met established specifications; materials are non-toxic and non-sensitizing. | |
| ISO Guinea Pig Maximization Sensitization | Met established specifications; materials are non-toxic and non-sensitizing. | |
| Complement Activation C3a and SC5b-9 Assay | Met established specifications; materials are non-toxic and non-sensitizing. | |
| Thromboresistance Evaluation | Met established specifications; materials are non-toxic and non-sensitizing. | |
| Pyrogen (LAL) Chromogenic | Met established specifications; materials are non-toxic and non-sensitizing. | |
| ISO Acute Systemic Injection Test | Met established specifications; materials are non-toxic and non-sensitizing. | |
| ISO Intracutaneous Reactivity Test | Met established specifications; materials are non-toxic and non-sensitizing. | |
| In-vitro Performance | Balloon Crossing Profile | All test results demonstrate that the device materials, manufacturing process, and design met the established specifications necessary for consistent performance according to its intended use. |
| Catheter Shaft Diameter | (Same as above) | |
| Angioplasty Balloon Rated Burst Pressure | (Same as above) | |
| Anchoring Balloon Burst Volume | (Same as above) | |
| Angioplasty Balloon Compliance | (Same as above) | |
| Balloon Inflation Time | (Same as above) | |
| Balloon Deflation Time | (Same as above) | |
| Angioplasty Balloon Rated Burst Pressure (in Stent) | (Same as above) | |
| Anchoring Balloon Fatigue (in Stent) | (Same as above) | |
| Anchoring Balloon Burst Volume (in Stent) | (Same as above) | |
| Angioplasty Balloon Fatigue | (Same as above) | |
| Anchoring Balloon Fatigue | (Same as above) | |
| Catheter Bond Strength | (Same as above) | |
| Catheter Tip Pull Strength | (Same as above) | |
| Catheter Torque Strength | (Same as above) | |
| Simulated Use | (Same as above) | |
| Flexibility and Kink Resistance | (Same as above) | |
| Radiopacity | (Same as above) | |
| Angioplasty Balloon Fatigue (in Stent) | (Same as above) |
2. Sample Size and Data Provenance for Test Set:
The document does not specify the exact sample size for each performance test. It broadly states that "The Flash PTA Balloon Dilatation Catheter was evaluated using the following in-vitro performance bench testing." The data provenance is in-vitro bench testing, implying laboratory-controlled conditions. No information on country of origin or retrospective/prospective nature is provided for this specific testing, as it's not clinical data.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
Not applicable. The study involved in-vitro bench testing and biocompatibility assessments, not a diagnostic task requiring expert interpretation for ground truth establishment.
4. Adjudication Method for Test Set:
Not applicable. This was bench testing against established engineering specifications, not a subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The testing focused on device performance against a predicate and established specifications, not human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance:
Not applicable. The Flash PTA Balloon Dilatation Catheter is a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used:
The ground truth for the in-vitro performance bench testing was based on established specifications and comparison to the predicate device. For biocompatibility testing, the ground truth was based on the requirements of ISO 10993 and other relevant biological evaluation standards.
8. Sample Size for Training Set:
Not applicable, as this refers to a physical medical device and its manufacturing/performance characteristics, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as above.
§ 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).