(97 days)
The Axium Prime Detachable Coil System is indicated for the endovascular embolization of intracranial anewrysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium Prime Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature.
The Axium™ Prime Detachable Coil System consists of a platinum/tungsten embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Axium™ I.D. (Instant Detacher) which, when activated, detaches the coil from the delivery pusher tip. The Axium™ I.D. (Instant Detacher) is sold separately. This submission expands Axium™ Detachable Coil (subject device) family by adding forty-four (44) new model numbers to the currently cleared Axium product portfolio (predicate device). These new model numbers come in the 3D configuration only and are a line extension of the currently sold predicate device, ranging in size from 3mm diameter x 6cm length to 25mm diameter x 50cm length. All forty-four (44) new SKUs fall within the currently cleared Axium size range of 1mm diameter x 1cm length to 25mm diameter x 50cm length. The subject device was modified to change the 3D loop configuration from a 4-loop configuration to a 6-loop configuration and to slightly increase the primary wire diameter size for the 7 - 10mm and the 12 - 25mm size coils. All other aspects of the subject device design (materials of construction of the implant coil, principles of operation, packaging, labeling and indications for use) are identical to the predicate device.
The provided document is a 510(k) summary for the Axium™ Prime Detachable Coil System. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual and Dimensional Inspection of Coil (Length, First Loop OD) | Key characteristics of the implant coil within specified dimensions. | All devices met acceptance criteria. |
| Coil Deformation Force | Peak force recorded when the first loop is compressed to 20% of its OD within specified limits. | All devices met acceptance criteria. |
| Ease of Deliverability: Friction Testing | Peak delivery force within specified limits when navigating a tortuous anatomical model. | All devices met acceptance criteria. |
| Ease of Deliverability: Force Transfer | Calculated force transfer when the device is advanced until distal force exceeds a specified value. | All devices met acceptance criteria. |
| Ease of Deliverability: Fatigue and Knotting | Device integrity maintained after deployment and retraction cycles; no damage observed upon inspection. | All devices met acceptance criteria. |
| Detachment Stretch Resistant Polypropylene Tensile test | Stretch resistant member breaks at a peak force above specified limit. | All devices met acceptance criteria. |
| Coil-Coil Shell Tensile Test | Coil-coil shell weld breaks at a peak force above specified limit. | All devices met acceptance criteria. |
| Labeling Verification | Text and format of drawings match labeling and packaging product specifications. | All devices met acceptance criteria. |
| Physician Usability Testing | Device demonstrates stability, neck coverage, conformability, softness, and smoothness of delivery. | All test results met the acceptance criteria. |
Note: Specific quantitative acceptance criteria values are not provided in the summary. The document generally states that "All devices met acceptance criteria" or "All test results met the acceptance criteria."
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing, meaning the tests were performed in a lab setting, not on patient data.
- Sample Size: The sample sizes for each specific bench test are not explicitly stated in the provided summary. The summary refers to "all devices" meeting criteria, implying that a sufficient number for each test was used and passed.
- Data Provenance: The data is from bench testing performed by the manufacturer, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It is retrospective, as it refers to testing conducted prior to this submission for substantial equivalence. The country of origin for the data is implied to be the USA where the company is located (Irvine, CA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the study described is a bench study for device performance, not a study evaluating diagnostic accuracy or a human-in-the-loop system requiring expert-established ground truth. Physician usability testing was performed by "physicians," but their number and specific qualifications (beyond being physicians) are not detailed, and this test assesses usability rather than ground truth for a diagnostic output.
4. Adjudication Method for the Test Set:
This information is not applicable as the described tests are objective bench tests (e.g., measuring forces, dimensions) or verification of physical characteristics, not involving subjective interpretations that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a MRMC comparative effectiveness study was not done. The submission relies on bench testing and comparison to a predicate device. The document explicitly states: "No clinical or animal testing was performed, as the subject device has a similar safety profile and a similar effectiveness profile when compared to the predicate device."
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a neurovascular embolization coil system, a physical medical device, not a software algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.
7. Type of Ground Truth Used:
The "ground truth" for the bench tests was established by engineering specifications and scientific principles that define acceptable ranges for physical properties and performance characteristics (e.g., specific force limits, dimensional tolerances, integrity after cycles). For biocompatibility, it was based on standardized test methods and passing criteria (e.g., "Non-cytotoxic," "Negligible irritant").
8. Sample Size for the Training Set:
Not applicable. This submission is for a physical medical device and does not involve an AI or machine learning model that would require a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As stated above, there is no training set for this type of device submission.
§ 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).