(28 days)
Axium™ Detachable Coil:
Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Axium™ Prime Detachable Coil:
(Models: APB-X-Y-3D-ES, APB-X-Y-3D-SS, APB-X-Y-HX-ES, APB-X-Y-HX-SS)
The Axium™ Prime Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The Axium™ Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Axium™ Prime Detachable Coil:
(Models: FC-X-Y-3D)
The Axium™ Prime Detachable Col is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Prime Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.
The Axium™ Detachable Coil and Axium™ Prime Detachable Coil consist of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Instant Detacher (I.D.) which when activated detaches the coil from the delivery pusher tip. The I.D. is sold separately.
The document provided focuses on the substantial equivalence of the "Axium™ Detachable Coil" and "Axium™ Prime Detachable Coil" with the addition of fluorosafe markers. The primary purpose of the submission is to demonstrate that these changes do not raise new questions of safety and effectiveness compared to the predicate devices. Therefore, the "device" in question is not an AI/ML powered diagnostic device, but rather a neurovascular embolization device with a minor design change.
As such, many of the typical acceptance criteria and study details relevant to AI/ML powered devices, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable or provided in this document. The provided text describes bench testing and biocompatibility testing for the physical device itself.
However, I can extract the relevant "acceptance criteria" and "reported device performance" as presented for the specific tests conducted for this submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit from "Results" column) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Not induce cytotoxicity | Did not induce cytotoxicity. |
| Sensitization | Not be considered a sensitizer | Were not considered a sensitizer. |
| Irritation | Be considered non-irritant | Are considered non-irritant. |
| Acute Systemic Toxicity | Show no mortality or evidence of acute systemic toxicity | Showed no mortality or evidence of acute systemic toxicity. |
| Indirect (extract) Hemolysis | Be considered non-hemolytic | Are considered non-hemolytic. |
| Material-Mediated Pyrogenicity | Meet USP 151 requirements and be non-pyrogenic | Met the requirements and were found to be non-pyrogenic. |
| Bench Testing | ||
| Visual Inspection | Darkness of fluorosafe etch mark and 360° etch mark around delivery pusher meet specifications | Met the acceptance criteria for visual inspection. |
| Marker Dimensional (Marker Position and Total Marker Length) Inspection | Total length of fluorosafe markers and their position on the delivery pusher meet specifications | Met the acceptance criteria for marker dimensional inspection. |
| Corrosion Resistance | No corrosion on the delivery pusher after soaking in saline and immersion in boiling water per ISO 10555-1, Annex A | Met the acceptance criteria for corrosion resistance. |
| Fluorosafe Marker Visibility | Meet user needs for visibility under simulated use conditions | Met the user needs for which it was designed and tested. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each test, but standard for device verification and validation. For biocompatibility, animal models were used (guinea pig, rabbit, mice). For bench tests, "devices" (plural) were evaluated, implying a sample size greater than one but not specified numerically.
- Data Provenance: Not applicable in the context of AI/ML data sets. These are laboratory tests on physical 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)
- Not applicable. The "ground truth" for this device modification is established through physical and objective measures against predefined specifications and recognized international standards (e.g., ISO 10993, USP 151) and user needs (for marker visibility). The "clinical users" who evaluated fluorosafe marker visibility are mentioned, but their number and specific qualifications are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation). These tests involve objective measurements and evaluations against specified criteria and standards.
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 submission is for a physical medical device (embolization coil) with a minor design change (adding fluorosafe markers), not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" here is based on objective measurements against established engineering specifications, chemical/biological compatibility standards (ISO 10993, USP 151), and documented user needs. For example, meeting the criteria for "non-cytotoxic" or demonstrating "no corrosion."
8. The sample size for the training set
- 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
- Not applicable. There is no "training set."
§ 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).