(141 days)
The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty 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 Feature is not intended for use in the renal, cerebral, coronary or carotid vasculature.
The Angioslide PROTEUSTM 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. 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 (11) 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 ( 1 l ) and pulling the pulling knob away from the handle (1). The embolic capture feature involves a single-use suction mechanism that works through inward folding of the balloon, which creates negative pressure within the capture cavity for debris capture and removal. The reduced pressure in the capture cavity causes some of the particles that are released during the procedure to flow into the cavity for containment and removal. 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.
Here's a breakdown of the acceptance criteria and the study information for the PROTEUS™ PTA Catheter with Embolic Capture Feature, based on the provided text:
Acceptance Criteria and Device Performance
The device underwent extensive non-clinical bench testing, sterilization, packaging, and shelf-life testing to demonstrate conformance. The table below summarizes the acceptance criteria and reported device performance for these non-clinical tests.
Note: The provided document is a 510(k) summary for a submission that claims substantial equivalence to a predicate device (K111750), implying that the new device has identical technological characteristics for both PTA balloon function and embolic capture. Therefore, the "study" described here is a suite of design verification and validation tests rather than a comparative clinical trial.
| Test Description | 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 (90% Confidence, 90% Reliability) | PASS |
| Visual Inspection - Distal Tip | Distal tip is smooth, rounded, tapered, or similarly finished. (90% Confidence, 90% Reliability) | PASS |
| Dimensional Inspection - Distal Bond O.D. | In Tolerance (90% Confidence, 90% Reliability) | PASS |
| Dimensional Inspection - Soft Tip Length | In Tolerance (90% Confidence, 90% Reliability) | PASS |
| Dimensional Inspection - Guidewire Inner Lumen | In Tolerance (90% Confidence, 90% Reliability) | PASS |
| Dimensional Inspection - Wrapped Balloon O.D. | The balloon must pass aperture |
§ 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).