(57 days)
The HES is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
The HES consists of implantable coil made of platinum alloy with inner hydrogel core. The helical-shaped implantable coil is available in various outer dimensions and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end of the pusher is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller. The RD11-006 HES is a line extension which is substantially the same as the predicate devices (K070656, K080666, K091641). The implantable coil portion of both the predicate and the subject device is constructed from platinum alloy wire. The RD11-006 implantable coil is constructed of an oval-shaped platinum alloy wire, whereas the predicate devices are constructed of a round platinum alloy wire. All other materials and design features are the same for both the predicate and subject devices.
This document describes an FDA 510(k) summary for the HydroCoil Embolic System (HES) and asserts its substantial equivalence to a predicate device. It specifically focuses on a line extension with an oval-shaped platinum alloy wire, while the predicate devices used a round wire. There is no information in the provided text about a study (clinical or otherwise) that uses human readers, ground truth, or statistical analysis in the context of device performance. The entire submission is a declaration of equivalence based on bench testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document indicates that the acceptance criteria for the subject device are the "same criteria as predicate" for all bench tests. The reported device performance is that it "Met same criteria as predicate."
| Acceptance Criteria (Bench Test) | Reported Device Performance |
|---|---|
| Visual Inspection | Met same criteria as predicate |
| Dimensional Measurement | Met same criteria as predicate |
| Simulated Use (Introduction, Tracking, Reposition/Deployment, Detachment, Overall Performance) | Met same criteria as predicate |
| Spring Constant | Met same criteria as predicate |
| Gel Expansion | Met same criteria as predicate |
| Weld Tensile | Met same criteria as predicate |
| Advancement / Retraction Force | Met same criteria as predicate |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The "Bench Test Summary" implies testing of device features, but the number of units tested is not provided.
- Data Provenance: The data is from bench testing, presumably conducted by the manufacturer, MicroVention, Inc., in the USA (Tustin, California). It is not retrospective or prospective in the clinical sense, but rather a series of laboratory experiments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the provided document details a 510(k) submission for a medical device (embolic coils) where the primary evidence presented is bench testing for substantial equivalence to a predicate device. There is no mention of a performance study involving human readers or experts to establish ground truth in the context of diagnostic interpretation.
4. Adjudication method for the test set:
This is not applicable for the reasons stated above. The evaluation is based on objective measurements from bench tests, not expert adjudication of diagnostic images or outcomes.
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:
This is not applicable. The device is an embolic coil, not an AI-powered diagnostic tool. No MRMC study was performed or is relevant for this type of device based on the information provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical implant, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this submission is related to the physical and mechanical properties of the device. The "acceptance criteria" for the bench tests effectively serve as the ground truth against which the subject device's performance is measured. This includes:
- Meeting dimensional specifications.
- Achieving established thresholds for mechanical properties (e.g., spring constant, weld tensile strength, advancement/retraction force).
- Performing as expected during simulated use (introduction, tracking, deployment, detachment).
- Exhibiting expected gel expansion characteristics.
These are objective, measurable characteristics that confirm functional equivalence to the predicate device.
8. The sample size for the training set:
This is not applicable. There is no "training set" in the context of an embolic coil device submission for bench testing. The device is not learning from data.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated above.
§ 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).