(74 days)
The Axium ™ Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature.
The Axium™ Detachable Coil System consists of a platinum coil secured to a composite delivery wire and is compatible with a 2-marker band micro catheter and a mechanical detachment system. The Axium™ Detachable Coil System consists of three (3) components: 1 -- Implantable Coil, 2 - Implant Delivery Pusher, 3 - Instant Detacher. The Instant Detacher is packaged and sold separately. Axium™ coil configurations include bare platinum, PGLA enlaced platinum and Nylon enlaced platinum coils. Bare configuration coils are non-fiber-enlaced, whereas PGLA and Nylon are enlaced with PGLA and Nylon fibers respectively. This submission expands the size offerings of the Axium™ Detachable Coil System by adding one (1) new model number to the Axium bare product portfolio with a new diameter and coil length combination (SKU QC-1.5-1-Helix). Currently cleared sizes for Axium™ bare under K081465 already include a coil diameter of 1.5mm and a coil length of 1cm; however, not in combination.
This document describes a 510(k) submission for the Axium™ Detachable Coil System, which is a neurovascular embolization device. The submission is for expanding the size offerings of an already cleared device.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document describes the performance data in textual form, stating that "The following test(s) was performed to support the addition of the new size offering" and then lists several categories of bench testing. It does not explicitly present a table of acceptance criteria with corresponding reported device performance values. Instead, it states that these tests were "adopted from existing test data for currently cleared Axium™ coil sizes" and that the conclusion is based on "successful completion of non-clinical testing; a thorough assessment of existing test data; as well as identical principles of operation, materials of construction, dimensions, packaging, and indications for use."
Therefore, the acceptance criteria are implicitly that the new size offering (SKU QC-1.5-1-Helix) performs comparably to the previously cleared Axium™ coils in the listed bench tests. The reported device performance is that it did successfully meet these implied criteria.
Implied Acceptance Criteria and Reported Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensions - 1st Loop Outer Diameter | Successfully met (implied by "successful completion of non-clinical testing") |
| Dimensions - Length | Successfully met (implied by "successful completion of non-clinical testing") |
| Coil Deformation | Successfully met (implied by "successful completion of non-clinical testing") |
| Friction | Successfully met (implied by "successful completion of non-clinical testing") |
| Fatigue After Knotting and Reliability Detachment | Successfully met (implied by "successful completion of non-clinical testing") |
| Torque Response | Successfully met (implied by "successful completion of non-clinical testing") |
| Force Transfer - Implant | Successfully met (implied by "successful completion of non-clinical testing") |
| Coil Tensile - Polypropylene | Successfully met (implied by "successful completion of non-clinical testing") |
| Coil Tensile - Implant/Weld (Implant Coil to Coil Shell Weld) | Successfully met (implied by "successful completion of non-clinical testing") |
| Coil Tensile - Assembly | Successfully met (implied by "successful completion of non-clinical testing") |
| Particulate | Successfully met (implied by "successful completion of non-clinical testing") |
| Pusher Dimensions | Successfully met (implied by "successful completion of non-clinical testing") |
| Marker Radiopacity | Successfully met (implied by "successful completion of non-clinical testing") |
| Tip Buckling | Successfully met (implied by "successful completion of non-clinical testing") |
| Detachment Zone Stiffness | Successfully met (implied by "successful completion of non-clinical testing") |
| Kink Resistance | Successfully met (implied by "successful completion of non-clinical testing") |
| Hypotube and Weld Tensile Strength | Successfully met (implied by "successful completion of non-clinical testing") |
| Force Transfer - Pusher | Successfully met (implied by "successful completion of non-clinical testing") |
| Pusher Elongation | Successfully met (implied by "successful completion of non-clinical testing") |
| MRI Compatibility | Successfully met (implied by "successful completion of non-clinical testing") |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to "bench testing" and "existing test data" for currently cleared devices. It does not specify the sample size for the new SKU (QC-1.5-1-Helix) or the provenance (country of origin, retrospective/prospective) of the data. Given it's a 510(k) for an additional size, it's highly likely this is internal R&D data from the company, likely prospective for the new SKU but leveraging retrospective data for comparison to the predicate devices.
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)
This submission does not involve clinical studies with human expert evaluation for establishing ground truth in the traditional sense of a diagnostic or AI device. The testing is bench-based and focuses on physical and mechanical properties. Therefore, these questions are not applicable to this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is bench testing, not a clinical study requiring adjudication of expert opinions.
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. This submission is for a physical medical device (detachable coil system) and does not involve AI or a multi-reader, multi-case study. This question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This submission is for a physical medical device and does not involve an algorithm or standalone performance testing in this context. This question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" would be the established engineering and materials specifications and performance characteristics derived from recognized standards and internal quality control protocols for the predicate devices. These are quantitative and measurable physical properties.
8. The sample size for the training set
This is not an AI/machine learning device; therefore, there is no training set in the conventional sense. The "training data" equivalent in this context would be the extensive manufacturing specifications, material properties, and performance data accumulated from the predicate devices' development and testing.
9. How the ground truth for the training set was established
As there is no training set for an AI algorithm, this question is not applicable. The "ground truth" for the overall device's performance is established through rigorous engineering design, material science characterization, and comprehensive bench testing against established industry standards and internal acceptance criteria for medical devices.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).