(132 days)
This product is intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the neurovasculature. This product is also intended to be used for injection of contrast media. This product is intended for use only in the neurovasculature.
The FUBUKI XF Neurovascular Long Sheath consists of a long sheath and a dilator. The long sheath is a single lumen neurovascular catheter designed for introduction of interventional devices, such as guidewires and other therapeutic devices. The long sheath consists of three sections: (1) a shaft, (2) a protector and (3) a connector. The distal portion of the shaft consists of a soft tip and a soft tube. The proximal part of the shaft is covered by the protector (strain relief) and the connector is bonded to the proximal end of the shaft.
The FUBUKI XF Neurovascular Long Sheath is provided sterile, by ethylene oxide, and is intended for single use only by physicians who have been adequately trained in neurointerventional procedures.
The outer surface of the long sheath is coated with a hydrophilic polymer to provide high lubricity when the surface is wet. The inner lumen of the shaft (excluding the connector portion) is lined with a fluoropolymer layer to facilitate movement of the quide wire and other devices.
The dilator consists of two parts: (1) a shaft and (2) a connector.
The FUBUKI XF Neurovascular Long Sheath is composed of a long sheath and a dilator packed in a sterile package. This sterile package is packed in an outer box with the Instructions for Use.
The provided document describes the non-clinical testing and biocompatibility assessments for the FUBUKI XF Neurovascular Long Sheath, but it does not describe a study involving an AI device or algorithm to establish acceptance criteria or performance.
The document is a 510(k) summary for a medical device (a long sheath and dilator) and focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility.
Therefore, most of the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document.
However, I can provide the acceptance criteria and performance data for the device itself (the FUBUKI XF Neurovascular Long Sheath) based on the non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
A. Non-Clinical Bench Testing for Long Sheath and Dilator
The document states: "The acceptance criteria were based on ISO standards identified, as applicable, and were identical to the acceptance criteria used for the predicate ASAHI FUBUKI Guide Catheters (K141981)." The results below are reported as "Pass" against these unnamed ISO standard criteria.
| Test (Long Sheath) | Reported Device Performance |
|---|---|
| Visual Inspection | Pass |
| Air Leakage | Pass |
| Burst Pressure Under Static Condition | Pass |
| Corrosion Resistance | Pass |
| Dimensional Verification | Pass |
| Kink Resistance | Pass |
| Liquid Leakage | Pass |
| Radio-Detectability | Pass |
| Slidability | Pass |
| Tensile Strength | Pass |
| Tensile Strength (Distal Tip) | Pass |
| Coating Integrity / Particulate Evaluation | Characterization Only |
| Simulated Use Test | Pass |
| Flowrate | Pass |
| Power Injection Test | Pass |
| Tip Flexibility | Pass |
| Torque Strength | Pass |
| Test (Dilator) | Reported Device Performance |
|---|---|
| Visual Inspection | Pass |
| Corrosion Resistance | Pass |
| Dimensional Verification | Pass |
| Radio-Detectability | Pass |
| Tensile Strength | Pass |
B. Biocompatibility Testing for Long Sheath and Dilator
(Note: The acceptance criteria and results are identical for both long sheath and dilator in the document.)
| Test | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Cytotoxicity (MEM Elution Test) | ISO 10993-5 | No signs of cellular reactivity (Grade 0) for both the negative control article and the medium control. | Non-Toxic |
| Sensitization (Kligman Maximization Test) | ISO 10993-10 | Extracts should show no evidence of causing delayed dermal contact sensitization in the guinea pig. | Non-Sensitizing |
| Irritation (Intracutaneous Injection Test) | ISO 10993-10 | Test article sites should not show a significantly greater biological reaction than the sites injected with the control article. | Non-Irritant |
| Systemic Toxicity (Acute Systemic Toxicity Test) | ISO 10993-11 | Test article must not show significantly greater biological activity than the control. | No Systemic Toxicity |
| Hemocompatibility (Rabbit Blood Hemolysis Test) | ISO 10993-4 | Test article in direct contact with blood and test article extract must be non-hemolytic. | Non-Hemolytic |
| Material Mediated Pyrogenicity (Rabbit Pyrogen Test) | ISO 10993-11 | Test article should not increase the temperature of any of the animals by more than 0.5 degrees Celsius. | Non-Pyrogenic |
| Hemocompatibility (Unactivated Partial Thromboplastin Time) | ISO 10993-4 | UPTT of the plasma exposed to test article extract should not be significantly decreased when compared to the UPTT of the plasma exposed to the negative control or the untreated control. | Not an Activator |
| Hemocompatibility (Complement Activation Assay (SC5b-9)) | ISO 10993-4 | Plasma exposed to test article must exhibit no significant increase in SC5b-9 when compared to activated NHS and negative control after 60 minutes exposure. | Not an Activator |
| Thrombogenicity (Thrombogenicity Study in Dogs) | ISO 10993-4 | Compare results of test article to predicate control for Thrombogenic response. Determine acceptability of results as part of risk management. | Comparable thromboresistance with control |
Information Not Present in the Document:
The provided document does not contain any information related to an AI device or algorithm. Therefore, the following points cannot be answered:
- 2. Sample size used for the test set and the data provenance (Not applicable, no AI test set)
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not applicable, no AI test set)
- 4. Adjudication method for the test set (Not applicable, no AI test set)
- 5. 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, no AI component)
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not applicable, no AI component)
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc) (Not applicable, no AI component)
- 8. The sample size for the training set (Not applicable, no AI component)
- 9. How the ground truth for the training set was established (Not applicable, no AI component)
The document focuses on the safety and effectiveness of a physical medical device (FUBUKI XF Neurovascular Long Sheath) through engineering bench tests and biological compatibility tests, rather than the performance of an AI algorithm.
§ 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).