(64 days)
The HydroCoil Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula. 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 embolization in the peripheral vasculature.
The HydroFrame coils consist of implant coil made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to a V-TrakTM delivery pusher via a polymer filament. The delivery pusher contains radiopaque positioning markers at the distal end. The proximal end is inserted into a hand held battery powered V-GripTM Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller.
The provided text describes the HydroCoil Embolic System, HydroFrame, a neurovascular embolization device. The submission is a Special 510(k) for this device, comparing it to an existing predicate device (K090357). The acceptance criteria and supporting study are focused on demonstrating that the updated device maintains the same performance characteristics as the predicate through bench testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test was "Met same specifications as predicate". The reported device performance for all tests listed below was that this criterion was met.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection | Met same specifications as predicate device (K090357) | Met same specifications as predicate |
| Dimensional Measurement | Met same specifications as predicate device (K090357) | Met same specifications as predicate |
| Simulated Use: Introduction, Tracking, Deployment, Frame tumbling, Microcatheter movement, Microcatheter manipulation, Compartmentalization, Periphery fill, Basket formation, Shape retention, Overall performance | Met same specifications as predicate device (K090357) | Met same specifications as predicate |
| Advancement/Retraction | Met same specifications as predicate device (K090357) | Met same specifications as predicate |
| Spring Constant | Met same specifications as predicate device (K090357) | Met same specifications as predicate |
| Gel Expansion | Met same specifications as predicate device (K090357) | Met same specifications as predicate |
| Weld Tensile | Met same specifications as predicate device (K090357) | Met same specifications as predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set (number of devices tested for each bench test). It also does not provide information on data provenance (country of origin or whether it was retrospective or prospective), as these were bench tests of a physical device, not an AI algorithm utilizing clinical data.
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 purely bench testing of a physical medical device, not an AI algorithm requiring expert ground truth for interpretation. The ground truth for bench tests would be directly measurable physical properties and performance characteristics.
4. Adjudication Method for the Test Set
This information is not applicable as the study described is purely bench testing of a physical medical device. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI algorithms or imaging interpretation, not for the bench testing of a physical embolization device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests was based on engineering specifications and measurable physical properties of the predicate device. The goal was to ensure the new device met the same objective specifications as the existing one.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is a physical medical device, not an AI algorithm that requires a training set and associated ground truth.
§ 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).