(143 days)
The CEREGLIDE 92 Catheter System 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 CEREGLIDE™ 92 Catheter System consists of the CEREGLIDE™ 92 Intermediate Catheter and associated accessories, including the INNERGLIDE™ 9 Delivery Aid, Rotating Hemostasis Valve (RHV), and Slit Introducers.
Intermediate Catheter: The CEREGLIDE™ 92 Intermediate Catheter is a single lumen, variable stiffness catheter designed to be introduced over a steerable guidewire along with a microcatheter and/or compatible support device into the neuro vasculature. The catheter consists of a lubricious PTFE lined inner lumen to facilitate movement of the guidewires and other devices, variable pitch stainless steel and tungsten braid, and various durometer polymer jackets. These jackets provide distal flexibility and gradually transition to a stiffer proximal shaft to facilitate the advancement of the catheter in the anatomy. The outer surface of the catheter is hydrophilic coated in order to reduce friction during manipulation in the vessel. A radiopaque marker at the distal end of the catheter provides fluoroscopic visualization of the catheter tip. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories, a hub, and an ID band.
The CEREGLIDE™ 92 Catheter System is packaged with an INNERGLIDE™ 9 Delivery Aid, an RHV with a side port, and two Slit Introducer accessories. The INNERGLIDE™ 9 Delivery Aid is a compatible support device comprising of a single lumen catheter with a tapered tip, hydrophilic coating for increased lubricity, radiopaque tip for fluoroscopic visualization, and a proximal luer hub that is designed to be used as part of the CEREGLIDE™ 92 Catheter System to facilitate delivery of the CEREGLIDE™ 92 Intermediate Catheter to select blood vessels in the neurovasculature. The RHV with side port is used for flushing and insertion of catheters. The Slit Introducers are designed to introduce the CEREGLIDE™ 92 Intermediate Catheter into the base catheter and protect the distal tip of the CEREGLIDE™ 92 Intermediate Catheter during insertion into the hemostasis valve of the base catheter.
The provided text describes information about the CEREGLIDE 92 Catheter System (K233982). However, it does not include details about acceptance criteria or a study proving the device meets those criteria, as typically found in submissions for Artificial Intelligence/Machine Learning (AI/ML) based medical devices. The document focuses on demonstrating substantial equivalence to a predicate device (CEREGLIDE™ 92 Intermediate Catheter K230726) through non-clinical performance testing (bench, animal, and clinical were not required).
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Multi Reader Multi Case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only without human-in-the-loop performance) study results.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The "acceptance criteria" mentioned in the document refer to the success metrics for the bench testing conducted on the CEREGLIDE 92 Catheter System, primarily for individual physical and functional properties, not for an AI/ML-based diagnostic or prognostic task. The reported performance for these tests is simply "PASS: Samples met the established acceptance criteria."
Summary of what the document does provide regarding performance testing:
The device underwent non-clinical performance testing, primarily bench testing, to demonstrate substantial equivalence to the predicate device.
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection | Meet visual requirements described in ISO 10555-1 Section 4.4 | PASS: Samples met the established acceptance criteria |
| Catheter ID | Meet design requirements (internal diameters) | PASS: Samples met the established acceptance criteria |
| Catheter OD | Meet design requirements (outer diameters) | PASS: Samples met the established acceptance criteria |
| Catheter Working Length | Meet working length definition in ISO 10555-1 Section 3.6 | PASS: Samples met the established acceptance criteria |
| Catheter Tip Length | Meet design requirements (tip length and navigation length) | PASS: Samples met the established acceptance criteria |
| Hub Luer | Meet dimensional, interconnectability, and performance requirements defined in ISO 80369-7 | PASS: Samples met the established acceptance criteria |
| System Air Leak Resistance | No air leak | PASS: Samples met the established acceptance criteria |
| System Liquid Leak Resistance | Meet freedom from leakage (liquid during pressurization) requirements of ISO 10555-1:2013, section 4.7 | PASS: Samples met the established acceptance criteria |
| Hub Pull Testing | Meet acceptance criteria (hub to joint strength) | PASS: Samples met the established acceptance criteria |
| Shaft Tensile Strength | Meet acceptance criteria (joint strength) | PASS: Samples met the established acceptance criteria |
| Particulate Count | Comparison to predicate devices | PASS: Samples met the established acceptance criteria |
| Coating Durability and Friction | Meet design requirements (friction force and durability of hydrophilic coating) | PASS: Samples met the established acceptance criteria |
| Coating Length | Meet design requirements (hydrophilic coating length) | PASS: Samples met the established acceptance criteria |
| Coating Thickness | Meet design requirements (hydrophilic coating thickness) | PASS: Samples met the established acceptance criteria |
| Coating Integrity | Free of uncoated individual voids (Congo Red Dye Coverage Test) | PASS: Samples met the established acceptance criteria |
| Kink Resistance | Remain stable and not kink during use | PASS: Samples met the established acceptance criteria |
| Tip Flexibility | Relative to cleared devices of similar design | PASS: Samples met the established acceptance criteria |
| Torque Performance | Meet torque strength requirement | PASS: Samples met the established acceptance criteria |
| Trackability (Delivery and Withdrawal Force) | Meet design requirements | PASS: Samples met the established acceptance criteria |
| Burst Pressure | Meet minimum static burst pressure requirements | PASS: Samples met the established acceptance criteria |
| In Vitro Usability Studies | Evaluate compatibility, trackability, and durability in a neurovascular model | PASS: Samples met the established acceptance criteria |
Biocompatibility Testing:
| Test Method | Acceptance Criteria | Result |
|---|---|---|
| Cytotoxicity - MEM Elution | Grade ≤ 2 | PASS |
| Sensitization - Guinea Pig Maximization | 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).