(251 days)
The CEREGLIDE™ 71 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral -M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter of the Nouvag Vacuson 60 Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow. The Cerenovus Aspiration Tubing Set is also intended to connect the CEREGLIDE™ 71 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
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 euro 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 which can be used to attach accessories for flushing and aspiration. 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, insertion of catheters, and connection to an external aspiration system. 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 can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set.
The provided text describes the regulatory clearance of a medical device (CEREGLIDE™ 71 Intermediate Catheter and Cerenovus Aspiration Tubing Set) and outlines the non-clinical performance data used to demonstrate its substantial equivalence to a predicate device. It does not contain information about an AI/ML-driven device or study parameters related to AI/ML performance evaluation. Therefore, I cannot extract the requested information based on the input.
However, I can provide a summary of the non-clinical performance data presented in the document, which are described as meeting acceptance criteria, albeit not for an AI/ML device.
Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML)
| Test | Acceptance Criteria Summary | 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 |
| 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 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, relative to other devices of similar design, is acceptable. | 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 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 requirements. | PASS: Samples met the established acceptance criteria |
| Particulate Count | Coating integrity of the Catheter's outer surface meets 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 a specified 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 acceptable. | PASS: Samples met the established acceptance criteria |
| Torque Test | Number of revolutions to failure of the Catheter in simulated anatomy. | PASS: Samples exceeded comparator devices in revolutions to failure |
| In Vitro Usability Studies | Thrombus retrieval patency/durability, (ancillary) device compatibility, and accessory durability demonstrated. Simulated use evaluation of user requirements related to trackability and tip stability during thrombus removal. | PASS: Samples met the established acceptance criteria |
| Biocompatibility (Chemical Characterization) | Determination of extractable species from the test article was performed in purified water, isopropyl alcohol, and hexane. | PASS |
| Biocompatibility (Cytotoxicity) | Evaluation of potential cytotoxic effects using monolayers of L-929 mouse fibroblast cells with 1X MEM extract. | PASS |
| Biocompatibility (Sensitization) | Evaluation of the allergenic potential or sensitizing capacity in guinea pigs. | PASS |
| Biocompatibility (Irritation) | Determination of local irritation in the dermal tissues of rabbits. | PASS |
| Biocompatibility (Acute Systemic Toxicity) | Screening of test article extracts for potential toxic effects from a single-dose systemic injection in mice. | PASS |
| Biocompatibility (Pyrogenicity) | Determination if a saline extract causes a febrile response in rabbits. | PASS |
| Biocompatibility (ASTM Hemolysis Study) | Evaluation of the hemolytic potential of the test articles. | PASS |
| Biocompatibility (SC5b-9 Complement Activation Assay) | Measure of complement activation in Normal Human Serum (NHS). | PASS |
| Biocompatibility (ASTM Heparinized Platelet and Leukocyte Count) | Determination if medical materials exposed to human whole blood would adversely affect platelet and leukocyte ratios. | PASS |
| Biocompatibility (ASTM Partial Thromboplastin Time (PTT)) | Screening for detection of coagulation abnormalities in the intrinsic coagulation pathway. | PASS |
| Biocompatibility (In Vivo Thromboresistance) | Evaluation of the thrombogenic potential of a blood contacting medical device in comparison to a predicate device. | PASS |
Since the provided document is a 510(k) clearance letter for a physical medical device (catheter and aspiration tubing set) and does not describe any AI/ML components or studies, I cannot answer the questions related to AI/ML specific evaluations:
- Sample size used for the test set and the data provenance: Not applicable, as there's no machine learning test set described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical tests would be the established engineering and biocompatibility standards and specific design requirements.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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).