(184 days)
The CERENOVUS Large Bore Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CERENOVUS Large Bore Catheter is also indicated for use as a conduit for retrieval devices.
The CERENOVUS Large Bore Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopague marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a luer fitting located on the end of the catheter hub. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing and insertion of catheters. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve.
Here's the information about the acceptance criteria and the study proving the device meets them, based on the provided text:
Note: The provided document is a 510(k) summary for a medical device (CERENOVUS Large Bore Catheter). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy in the same way a new drug or high-risk device might. Therefore, the "study" described is primarily a series of bench tests and biocompatibility assessments, not clinical trials comparing device performance with and without AI, or studies involving human experts for ground truth establishment. Many of the specific points requested (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study effect size, standalone performance, training set details) are generally not applicable or not reported in this type of document for a Class II percutaneous catheter.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection | Catheter meets visual requirements described in ISO 10555-1 Section 4.4 | PASS: Samples met the established acceptance criteria |
| Catheter ID | Catheter internal diameters meet requirements | PASS: Samples met the established acceptance criteria |
| Introducer ID | Introducer internal diameters meet requirements | PASS: Samples met the established acceptance criteria |
| Catheter OD | Catheter outer diameters meet requirements | PASS: Samples met the established acceptance criteria |
| Introducer OD | Introducer outer diameters meet requirements | PASS: Samples met the established acceptance criteria |
| Catheter Working Length | Catheter working length confirms to ISO10555-1 Section 3.6 | PASS: Samples met the established acceptance criteria |
| Introducer Working Length | Introducer working length confirms to requirements | PASS: Samples met the established acceptance criteria |
| Distal Tip Length | Distal tip length of catheter meets requirements | PASS: Samples met the established acceptance criteria |
| Hub Luer Taper | Catheter hub luer taper fits standard luer fittings using a taper device | PASS: Samples met the established acceptance criteria |
| Air Leak testing | No air leak into the hub subassembly | PASS: Samples met the established acceptance criteria |
| System Liquid Leakage | Catheter joint strength meets freedom from leakage (liquid during pressurization) requirements of ISO 10555-1:2013, section 4.7 | PASS: Samples met the established acceptance criteria |
| Delamination of PTFE Liner | PTFE has appropriately adhered to the inner lumen of the catheter with braid reinforcement | PASS: Samples met the established acceptance criteria |
| Kink (Distal & Proximal) | Catheter remains stable and does not kink during use | PASS: Samples met the established acceptance criteria |
| Tip Movement | Catheter meets tip column stiffness requirement | PASS: Samples met the established acceptance criteria |
| Tip Linear Stiffness | Demonstrates tip flexibility relative to other devices of similar design | PASS: Samples met the established acceptance criteria |
| Coating Lubricity & Durability | Lubriciousness and durability of the catheter hydrophilic coating | PASS: Samples met the established acceptance criteria |
| Coating Length | Catheter hydrophilic coating length meets design requirements | PASS: Samples met the established acceptance criteria |
| Catheter Tensile Strength | Catheter joint strength meets requirements of Section 4.5 of ISO 10555-1 | PASS: Samples met the established acceptance criteria |
| Introducer Separation Force | Force required to separate the peel-away introducer accessory | PASS: Samples met the established acceptance criteria |
| Particle Count | Coating integrity of the catheter's outer surface meets requirements for content of particulates | PASS: Samples met the established acceptance criteria |
| Burst Pressure (static) | Maximum hydrostatic pressure a catheter can withstand | PASS: Samples met the established acceptance criteria |
| In-vitro Usability Studies | Evaluate catheter usability parameters such as trackability, tip stability and visibility under fluoroscopy, durability, etc. | PASS: Samples met the established acceptance criteria |
| Packaging Visual Inspection | Proposed packaging system has no visible defects that would result in exposure of the primary package or IFU | PASS: Samples met the established acceptance criteria |
| Packaging Dye Leak | Sterile package integrity by detecting and locating defects in package seals and pinholes in the packaging materials | PASS: Samples met the established acceptance criteria |
| Biocompatibility (Catheter) | ||
| Cytotoxicity (MEM Elution) | Test article extract shows no evidence of causing cell lysis or toxicity (grade |
§ 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).