(168 days)
The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, are 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE™ 71, 57 or 42 Intermediate Catheter of a compatible aspiration pump and to allow the user to control the fluid flow.
Both the CEREGLIDE ™ 42 Intermediate Catheter and CEREGLIDE ™ 57 Intermediate Catheter are variable stiffness, single lumen catheters 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 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 ™ 42 Intermediate Catheter and the CEREGLIDE ™ 57 Intermediate Catheter are designed for use in the removal of thrombus from the neurovasculature using continuous aspiration from an external vacuum source. The CEREGLIDE ™ 42 Intermediate Catheter and CEREGLIDE ™ 57 Intermediate Catheter are intended to be used with a compatible aspiration pump as a vacuum source that provides a minimum vacuum pressure of -68 kPa [-20 inHg] and a maximum vacuum pressure of -95 kPa [-28 inHg], and minimum 17 L/min flow rate, with a collection canister of at least 1000 mL volume.
The CEREGLIDE ™ 42 Intermediate Catheter and the CEREGLIDE ™ 57 Intermediate Catheter are intended to be connected to the vacuum source using the Cerenovus Aspiration Tubing Set which is an externally manufactured tubing set with an internal diameter (ID) of 0.110" and overall length of 112", containing an integrated flow control switch.
This document is a 510(k) premarket notification for CEREGLIDE™ 42 Intermediate Catheter, CEREGLIDE™ 57 Intermediate Catheter, and Cerenovus Aspiration Tubing Set. It aims to demonstrate substantial equivalence to a legally marketed predicate device.
The entire submission focuses on non-clinical performance data (bench testing), sterilization, shelf-life, and biocompatibility testing. Crucially, there is no mention of a study involving human readers, AI assistance, ground truth establishment by experts, or any clinical performance data derived from patient studies.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them in the context of AI/human reader performance or clinical outcomes, because this information is not present in the provided text. The document explicitly states:
- "No animal studies were required as appropriate verification of the device design were achieved based on the similarities of the proposed device and the predicate device, and from results of bench testing."
- "Clinical studies were not required as appropriate verification of the device design were achieved based on the similarities of the proposed device and the predicate device, and from results of bench testing."
The "acceptance criteria" and "device performance" described in the document are limited to bench testing results for physical and mechanical properties, sterilization, shelf life, and biocompatibility.
Here's the information that can be extracted or inferred from the provided text regarding the closest equivalent to "acceptance criteria and device performance" for this specific device, which is based on bench testing:
Acceptance Criteria and Reported Device Performance (Bench Testing)
The "acceptance criteria" for this device, based on the provided document, are that the samples for each test "met the established acceptance criteria." The document does not provide the specific quantitative thresholds for these criteria. The "device performance" is simply reported as "PASS" for all tests.
| Test | Test Summary | Acceptance Criteria (Not Explicitly Quantified) | Reported Device Performance |
|---|---|---|---|
| Design Verification | |||
| Visual Inspection | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters meet the visual requirement described in ISO 10555-1 Section 4.4. | Samples must meet ISO 10555-1 Section 4.4 visual requirements. | PASS |
| Catheter ID | Verify that the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters' internal diameters meet the requirements. | Samples must meet specified internal diameter requirements. | PASS |
| Catheter OD | Verify that the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters' outer diameters meet the requirements. | Samples must meet specified outer diameter requirements. | PASS |
| Catheter Working Length | Confirm the working lengths of the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters as defined in ISO 10555-1 Section 3.6. | Samples must meet ISO 10555-1 Section 3.6 working length definition. | PASS |
| Catheter Tip Length | Verify the catheter tip length of the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters. | Samples must meet specified tip length requirements. | PASS |
| System Air Leakage | Verify that there is no air leak into the hub subassembly. | No air leak into hub subassembly. | PASS |
| System Liquid Leakage | Verify that the catheter joint strength meets the freedom from leakage (liquid during pressurization) requirements of ISO 10555-1:2013, section 4.7. | Samples must meet ISO 10555-1:2013, section 4.7 for liquid leakage. | PASS |
| Delamination of PTFE Liner | Verify that the PTFE has appropriately adhered to the inner lumen of the catheter with braid reinforcement. | PTFE must appropriately adhere to the inner lumen. | PASS |
| Kink | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters meet the requirement for the catheter to remain stable and not kink during use. | Catheter must remain stable and not kink during use. | PASS |
| Tip Movement | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters meet the tip column stiffness requirement. | Catheter must meet tip column stiffness requirements. | PASS |
| Distal Tip Stiffness | Test the tip flexibility of the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters, relative to other devices of similar design. | Tip flexibility must be acceptable relative to similar devices. | PASS |
| Peak Tensile Strength | Verify that the catheter joint strength meets the acceptance criteria of Section 4.5 of ISO 10555-1. | Joint strength must meet ISO 10555-1 Section 4.5. | PASS |
| Particulate Count & Coating Integrity | Verify the particulate size and counts of the CEREGLIDE™ 42 Intermediate Catheter under simulated use conditions with comparison to the predicate device. Coating integrity was visually inspected and verified to be free of coating defects after simulated use. | Particulate size/counts acceptable; coating free of defects after simulated use. | PASS |
| Burst Pressure | Verify the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters meet minimum static burst pressure specifications. | Must meet minimum static burst pressure specifications. | PASS |
| Torque Strength | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters meet the torque strength requirement. | Catheter must meet torque strength requirements. | PASS |
| Trackability | Confirm that the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters meet the trackability requirement. | Catheter must meet trackability requirements. | PASS |
| Design Validation | |||
| In Vitro Usability Studies | The in-vitro studies were conducted to demonstrate thrombus retrieval patency/durability, ancillary and accessory device compatibility, and to evaluate user requirements related to trackability and tip stability during thrombus removal. | Device must demonstrate acceptable thrombus retrieval patency/durability, accessory compatibility, trackability, and tip stability. | PASS |
Since the device is a catheter and tubing set for mechanical thrombectomy, and the submission is a 510(k) for substantial equivalence based primarily on bench testing, the requested information that typically applies to diagnostic AI algorithms or clinical trials with human outcomes is not applicable here.
Here's a breakdown of why the specific points of your request cannot be answered from the provided document:
- A table of acceptance criteria and the reported device performance: Provided above for bench testing. No clinical or human-reader performance criteria are given.
- Sample sized used for the test set and the data provenance: For bench testing, it states "All testing was conducted using sampling methods as required by internal procedure," but does not provide specific sample sizes. Data provenance is "bench testing," not from patient data or clinical studies.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for image interpretation or clinical outcomes was established by experts in this submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human interpretation or adjudication described.
- 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. This is not an AI-enabled device and no MRMC study was performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the typical sense for image analysis. The "ground truth" for this device's performance is engineering specifications and compliance with ISO standards confirmed by bench testing.
- The sample size for the training set: Not applicable. No training set for an algorithm is described.
- How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment for an algorithm is described.
In summary, the provided FDA 510(k) clearance letter and summary for the CEREGLIDE™ catheters and tubing set demonstrate substantial equivalence through non-clinical bench performance testing, focusing on the physical and mechanical characteristics of the device. It does not involve AI, human readers, clinical trials, or the establishment of ground truth by medical experts in the context of diagnostic or interventional efficacy.
§ 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).