(238 days)
The Excelsior 1018 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature.
The Excelsior 1018 Microcatheter is a single lumen device designed to aid the physician in accessing the distal vasculature when used with a guiding catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires without displacement of the wire. A luer fitting located on the catheter hub is used for the attachment of accessories. A radiopaque tip facilitates fluoroscopic visualization. The outer diameter is coated with a hydrophilic surface that reduces friction during manipulation in the vessel. The catheter is packaged with a steam shaping mandrel accessory.
The provided text describes a 510(k) submission for the Excelsior™ 1018 Microcatheter, focusing on its substantial equivalence to a predicate device, the TurboTracker-18 Infusion Catheter. The submission primarily details performance testing and biocompatibility to support this claim, rather than a clinical study with traditional acceptance criteria for a new AI/software device.
Therefore, many of the requested categories for AI/ML device studies (such as MRMC studies, ground truth establishment for training sets, number of experts for ground truth, sample sizes for test/training sets, data provenance, and adjudication methods) are not applicable to this 510(k) summary, as it pertains to a physical medical device.
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a physical microcatheter, the "acceptance criteria" are related to established engineering and biocompatibility standards rather than clinical performance metrics typical of an AI device. The document states that "performance testing (tensile strength, coefficient of friction, static rupture, tip buckling, dimensional inspection, critical bend radius, particulate analysis, and coil compatibility) and biocompatibility testing support this claim of substantial equivalence."
While specific numerical acceptance criteria and reported performance values for each of these tests are not provided in the given text, the submission states that the results "demonstrate that the Excelsior 1018 Microcatheter is substantially equivalent to the predicate TurboTracker-18 Infusion Catheter device." This implies that the Excelsior 1018 Microcatheter met the necessary performance and safety standards to be considered equivalent to the predicate device.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Tensile Strength | Met established engineering standards for medical catheters and was comparable to predicate. | Met. |
| Coefficient of Friction | Met established engineering standards for medical catheters and was comparable to predicate. | Met. |
| Static Rupture | Met established engineering standards for medical catheters and was comparable to predicate. | Met. |
| Tip Buckling | Met established engineering standards for medical catheters and was comparable to predicate. | Met. |
| Dimensional Inspection | Conformed to specified dimensions and was comparable to predicate. | Met. |
| Critical Bend Radius | Met established engineering standards for medical catheters and was comparable to predicate. | Met. |
| Particulate Analysis | Met established safety standards for particulate matter in medical devices. | Met. |
| Coil Compatibility | Compatible with target coils (GDC-10 & GDC-18). | Met. |
| Biocompatibility | Met ISO 10993 standards for biological evaluation of medical devices. | Met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable to this type of device submission. Performance testing usually involves a defined number of units per test, but these are engineering tests, not clinical studies with "test sets" in the AI/ML sense. Data provenance would be from internal lab testing at Boston Scientific.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth in this context refers to established engineering specifications and biocompatibility standards, not expert assessments of clinical data for AI performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies, particularly for AI, to resolve discrepancies in ground truth labeling. This submission relies on objective engineering measurements and standard biocompatibility assessments.
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. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance testing is based on established engineering specifications, industry standards (e.g., for biocompatibility), and comparison to the predicate device's characteristics. For coil compatibility, the "ground truth" is whether the microcatheter can successfully deliver the specified GDC coils.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).