(251 days)
The CEREGLIDE™ 71 Intermediate 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 CEREGLIDE™ 71 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.
The CEREGLIDE™ 71 Intermediate 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 radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity to reduce friction during navigation in the vasculature. 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 Tuohy Borst rotating hemostasis valve (RHV) with a side port and two slit introducers as accessories. The RHV with side port is used for flushing and insertion of catheters. The slit introducers are designed to introduce the catheter into the base catheter and protect the distal tip of the catheter during insertion into the RHV of the base catheter.
The CEREGLIDE™ 71 Intermediate Catheter is a medical device for facilitating neurovascular interventions. The document provided outlines the non-clinical performance data to demonstrate its substantial equivalence to a legally marketed predicate device, the CERENOVUS Large Bore Catheter (K191237).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CEREGLIDE™ 71 Intermediate Catheter are implicitly defined by a series of bench tests and biocompatibility tests, with the reported performance consistently being "PASS" or "Samples met the established acceptance criteria," sometimes exceeding comparator devices.
| Test Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Design Verification | 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 | |
| Catheter OD | Catheter outer diameters meet requirements. | PASS: Samples met the established acceptance criteria | |
| Catheter Working Length | Working length of the catheter as defined in ISO 10555-1 Section 3.6. | PASS: Samples met the established acceptance criteria | |
| Catheter Tip Length | Catheter tip length meets requirements. | PASS: Samples met the established acceptance criteria | |
| System Air Leakage | No air leak into the hub subassembly. | PASS: Samples met the established acceptance criteria | |
| System Liquid Leakage | Catheter joint strength meets the 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 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 the tip column stiffness requirement. | PASS: Samples met the established acceptance criteria | |
| Tip Linear Stiffness | Tip flexibility of the Catheter is acceptable, relative to other devices of similar design. | PASS: Samples met the established acceptance criteria | |
| Coating Lubricity and Durability | Lubriciousness and durability of the Catheter's hydrophilic coating are verified. | PASS: Samples met the established acceptance criteria | |
| Coating Length | Catheter hydrophilic coating length meets the design requirements. | PASS: Samples met the established acceptance criteria | |
| Peak Tensile Strength | Catheter joint strength meets the requirements of Section 4.5 of ISO 10555-1. | PASS: Samples met the established acceptance criteria | |
| Introducer ID | Introducer internal diameters meet the requirements. | PASS: Samples met the established acceptance criteria | |
| Particulate Count | Coating integrity of the Catheter's outer surface meets the requirements for content of Particle Matter in alignment with USP counting methods and compared to the reference predicate device. | PASS: Samples met the established acceptance criteria | |
| Burst Pressure | Catheter can withstand the maximum hydrostatic pressure. | PASS: Samples met the established acceptance criteria | |
| Introducer Working Length | Working length of the introducer is confirmed. | PASS: Samples met the established acceptance criteria | |
| Introducer Separation Force | Force required to separate the introducer is confirmed. | PASS: Samples met the established acceptance criteria | |
| Torque Test | Number of revolutions to failure of the Catheter in simulated anatomy meets or exceeds established criteria. | PASS: Samples exceeded comparator devices in revolutions to failure | |
| Design Validation | In Vitro Usability Studies | Usability parameters such as trackability, tip stability, durability, and (ancillary) device compatibility with tracking of the Catheter to target sites and delivery of a stent-retriever in the neurovascular model are acceptable. | PASS: Samples met the established acceptance criteria |
| Biocompatibility | Chemical Characterization | Determination of extractable species from the test article in purified water, isopropyl alcohol, and hexane is acceptable. | PASS |
| Cytotoxicity | Lack of potential cytotoxic effects using monolayers of L-929 mouse fibroblast cells when evaluated with 1X MEM extract. | PASS | |
| Sensitization – Guinea Pig Maximization | No allergenic potential or sensitizing capacity. | PASS | |
| Irritation - Rabbit Intracutaneous Reactivity | No chemicals that may leach or be extracted capable of causing local irritation in the dermal tissues of rabbits. | PASS | |
| Acute Systemic Toxicity in Mice | No potential toxic effects as a result of a single-dose systemic injection in mice. | PASS | |
| Pyrogenicity – Materials Mediated Rabbit Pyrogen | No febrile response in rabbits caused by a saline extract of the test article. | PASS | |
| ASTM Hemolysis Study: Direct and Extraction Methods | Acceptable hemolytic potential of the test articles and test article extract according to ASTM method (F756-17). | PASS | |
| SC5b-9 Complement Activation Assay | Test article is not capable of generating the activation fragment, SC5b-9, which contributes to inflammatory immune response in humans, as measured in Normal Human Serum (NHS). | PASS | |
| ASTM Heparinized Platelet and Leukocyte Count | Medical materials exposed to human whole blood do not adversely affect the platelet and leukocyte ratios in whole blood. | PASS | |
| ASTM Partial Thromboplastin Time (PTT) | No coagulation abnormalities in the intrinsic coagulation pathway that would indicate an adverse effect. | PASS | |
| In Vivo Thromboresistance | Acceptable thrombogenic potential of a blood contacting medical device in comparison to a predicate device. | PASS | |
| Shelf-Life | Stability Testing | Device maintains its performance and safety for 1 year when subjected to standard transportation conditioning and aging. | PASS: Results of testing on the subject device all met established acceptance criteria. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document states: "All testing was conducted using sampling methods as required by internal procedure." Specific sample sizes for each test are not explicitly provided.
The data provenance is non-clinical bench testing and in-vitro testing. There is no mention of human clinical data or patient data. Therefore, there is no country of origin or retrospective/prospective distinction for patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device's evaluation relies on objective engineering and material science tests (bench and in-vitro, and biocompatibility tests), not expert interpretation of diagnostic images or clinical outcomes. Therefore, there is no "ground truth" established by experts in this context.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical or image-based studies where expert consensus is required for ambiguous cases. As the studies described are bench and biocompatibility tests, human adjudication is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this is a device clearance based on substantial equivalence using non-clinical performance data, not an AI or diagnostic imaging device requiring human reader interaction.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This pertains to an intermediate catheter, which is a physical medical device, not a software algorithm or AI.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the non-clinical tests is established by pre-defined engineering specifications, material properties, and regulatory standards (e.g., ISO standards, ASTM methods, USP guidance). The device's performance is compared against these objective criteria. For the biocompatibility tests, the "ground truth" is typically the absence of adverse biological reactions as defined by the specific test (e.g., no cytotoxicity, no sensitization, no irritation).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established**
Not applicable. As there is no training set, there is no ground truth establishment for it.
§ 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).