(26 days)
The Smart Coil is indicated for the embolization of:
- Intracranial aneurysms
- · Other neurovascular abnormalities such as arteriovenous malformations and arterioyenous fistulae
- · Arterial and venous embolizations in the peripheral vasculature
The Smart Coil is an endovascular embolization coil for the treatment of aneurysms or other vascular abnormalities. The Smart Coil functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of platinum coils to achieve occlusion. The Smart Coil consists of three components: a Coil, a Detachment Pusher (attached to Coil), and a Detachment Handle (packaged separately).
The provided text describes the Penumbra Smart Coil, a neurovascular embolization device. The 510(k) premarket notification (K160832) is primarily for a change in the detachment pusher pull wire tensile strength specification to improve manufacturability.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Internal/Specification) | Reported Device Performance (Results) |
|---|---|---|
| Tensile (Minimum break force value) | Measured per specification (Implied) | Pass |
| Simulated Use (Delivery & Detachment) | Ability to deliver and detach embolic coils in a tortuous anatomical model of the neurovasculature | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the tensile and simulated use tests. It only mentions that "Design Verification testing was repeated for all attributes affected by change to device specifications."
The data provenance is not explicitly stated in terms of country of origin. The study appears to be prospective as it involves repeated design verification testing for a specific product modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish ground truth for the tensile or simulated use tests. These tests appear to be engineering-based performance assessments.
4. Adjudication Method for the Test Set:
Not applicable, as the tests are objective engineering assessments rather than subjective evaluations requiring adjudication.
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 device is a physical medical device (embolization coil), not an AI diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance for human readers is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done:
The concept of "standalone performance" typically applies to AI algorithms. For this physical device, the "standalone" performance is represented by the direct engineering tests (Tensile and Simulated Use) without human intervention in the device's function during the test.
7. The Type of Ground Truth Used:
For the Tensile test, the "ground truth" is the engineering specification for the minimum break force.
For the Simulated Use test, the "ground truth" is the successful delivery and detachment of the embolic coils within a representative anatomical model. These are inherently tied to mechanical performance requirements.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of medical device.
In summary:
The study conducted for the Penumbra Smart Coil (K160832) was a set of design verification tests focused on the mechanical performance of the device, particularly in light of a change to the detachment pusher pull wire tensile strength specification. The acceptance criteria were met by successfully passing these engineering tests. The study did not involve human readers, AI, or traditional clinical endpoints for establishing ground truth, but rather engineering specifications and simulated performance.
§ 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).