(30 days)
The FUBUKI XF-R Neurovascular Long Sheath 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. The FUBUKI XF-R Neurovascular Long Sheath is also intended to be used for injection of contrast media.
The FUBUKI XF-R Neurovascular Long Sheath is intended for use only in the neurovasculature.
The FUBUKI XF-R Neurovascular Long Sheath (FUBUKI XF-R) 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 subject device 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 and the inner lumen of the shaft (excluding the connector portion) is lined with a fluoropolymer layer to facilitate movement of the guidewire and other devices.
The dilator consists of two parts: (1) a shaft and (2) a connector.
The FUBUKI XF-R is supplied with a dilator and rotating hemostasis valve (RHV) packed in a sterile package.
The provided FDA 510(k) Clearance Letter for the FUBUKI XF-R Neurovascular Long Sheath describes the device and its demonstrated substantial equivalence to a predicate device. However, it does not contain information about a study involving an AI/algorithm or a multi-reader multi-case (MRMC) comparative effectiveness study.
Therefore, many of the requested details regarding acceptance criteria, ground truth, expert opinions, and sample sizes for AI/algorithm performance studies cannot be extracted from this document because such a study was not conducted or reported for this submission. This is a medical device, specifically a catheter, not an AI/software device.
I will provide the information that is available in the document, framed as if it were a typical medical device clearance, rather than an AI/ML clearance.
Here's the breakdown based on the provided document:
Acceptance Criteria and Study for FUBUKI XF-R Neurovascular Long Sheath
This clearance pertains to a physical medical device (a neurovascular long sheath), not an AI/software device. Therefore, the "acceptance criteria" and "study" refer to non-clinical bench testing and biocompatibility testing to demonstrate the device's physical performance, safety, and substantial equivalence to a predicate device. There is no AI component involved in this device or its clearance documentation.
1. A table of acceptance criteria and the reported device performance:
The document states that the device met all acceptance criteria, but it does not specify the numerical acceptance criteria for each test. Instead, it lists the types of tests performed and the conclusions.
| Acceptance Criteria Category (Test Type) | Reported Device Performance / Conclusion |
|---|---|
| Non-Clinical Bench Testing | |
| Dimensional Verification | Met all acceptance criteria and performed similarly to the predicate. |
| Simulated Use | Met all acceptance criteria and performed similarly to the predicate. |
| Lubricity | Met all acceptance criteria and performed similarly to the predicate. |
| Coating Integrity / Particulate Evaluation | Met all acceptance criteria and performed similarly to the predicate. |
| Appearance | Met all acceptance criteria and performed similarly to the predicate. |
| Biocompatibility Testing | |
| Cytotoxicity (MEM Elution Test) | Non-Cytotoxic |
| Sensitization (Kligman Maximization Test) | Non-Sensitizing |
| Intracutaneous Reactivity (Intracutaneous Injection Test) | Non-Irritant |
| Acute Systemic Toxicity (System Injection Test) | Non-Toxic |
| Material Mediated Pyrogenicity (Rabbit Pyrogen Test) | Non-Pyrogenic |
| Hemocompatibility (Rabbit Blood Hemolysis Test) | Non-Hemolytic |
| Hemocompatibility (Complement Activation Test SC5b-9) | Non-Activator |
| Hemocompatibility (Partial Thromboplastin Time Test PTT) | Non-Activator |
| Thrombogenicity (In Vivo Thrombogenicity Study) | Comparable thromboresistance to the predicate device. |
| Sterilization and Shelf Life | |
| Sterilization Method | Ethylene Oxide Gas (SAL 10⁻⁶) - Unchanged from predicate, no new issues. |
| Shelf Life | 3 years (supported by accelerated aging performance testing). |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of devices tested for each non-clinical bench or biocompatibility test. It only states that testing was "performed." For biocompatibility, it refers to standard ISO test methods (e.g., "Rabbit Pyrogen Test" implies a certain number of rabbits, but the exact count isn't given).
- Data Provenance: Not explicitly stated, but typically, non-clinical lab testing data would originate from the manufacturer's own testing facilities or contract research organizations. No geographic origin is mentioned for the data, nor is it specified if the tests were retrospective or prospective; however, given that these are physical device tests for a 510(k) submission, they would inherently be prospective (i.e., new tests conducted specifically for this submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device clearance. "Ground truth" in the context of expert consensus, pathology, or outcomes data is typically reserved for diagnostic devices, particularly those involving image interpretation or clinical decision support, or AI/ML-driven devices. For a physical medical device like a catheter, "ground truth" is established through standardized engineering and biological tests (e.g., tensile strength, fluid flow, material composition, biological response), rather than expert clinical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable. Adjudication methods are relevant for clinical trials or multi-reader studies where there might be disagreement in expert assessment (e.g., image interpretation). For bench and biocompatibility testing, results are quantitative or qualitative based on predefined scientific standards and validated test methods.
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:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specific to diagnostic devices, especially those that involve human interpretation assisted by algorithms (AI). This submission is for a physical percutaneous catheter, not a diagnostic or AI-assisted device. Therefore, a discussion of human reader improvement with AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this medical device is based on:
- Predefined engineering specifications and performance standards (e.g., dimensions, strength, lubricity).
- Validated test methods outlined in ISO standards (e.g., ISO 10555-1 for catheters, ISO 10993 series for biocompatibility).
- Chemical and material analysis.
- Biological responses observed in animal models (for biocompatibility).
This is fundamentally different from a ground truth established by expert clinical consensus, pathology, or outcomes data for diagnostic devices.
8. The sample size for the training set:
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
This is not applicable. There is no "training set" or "ground truth for a training set" as this is not an AI/ML device.
§ 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).