(29 days)
Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils are indicated for endovascular embolization of:
- Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- Arterial and venous embolizations in the peripheral vasculature
Stryker Neurovascular Target Detachable Coils are comprised of the following coil types: Target 360 Nano, Target Helical Nano, Target 360 Ultra, Target Helical Ultra, Target 360 Soft, Target 3D, Target 360 Standard, Target XXL 360, Target XL 360 Soft, Target XL 360 Standard, Target XL Helical, Target Tetra. All Target Coils are stretch resistant coils. Target Coils incorporate a length of monofilament stretch resistant fiber or in the case of the Target Tetra, multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with the Stryker Neurovascular InZone® Detachment System (sold separately). Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless-steel delivery wire.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sampling sizes, ground truth establishment, or clinical study results for the Target Detachable Coils.
The document appears to be a 510(k) premarket notification for the consolidation of instructions for use and patient information leaflets, along with other minor changes, for existing Target Detachable Coils. It asserts that the modifications do not alter the intended use, indications for use, or fundamental scientific technology of the predicate devices. Therefore, a comparative clinical study is not detailed here.
The document states:
- "This 510(k) requests clearance for the consolidation of three separate Target Instructions for Use (IFUs) into a single shared IFU and consolidates two separate Target Patient Information Leaflet (PIL) with Patient Information Card (PIC), making it a single PIL with PIC for all Target Detachable Coils, in addition to other changes made since the last 510(k) clearance resulting in a cumulative assessment that a new 510(k) is required."
- "The subject devices utilize the same design and materials of existing Target Coils, and the same manufacturing, packaging and sterilization processes."
- "The modified Stryker Neurovascular Target Detachable Coils have the same intended use/indications for use as the predicate Target Detachable Coils. The modifications do not alter the intended use, indications for use, or the fundamental scientific technology of the Predicate Devices."
- "Because the subject modifications do not alter the intended use or indications for use of the predicate devices, or the fundamental scientific technology of the predicate devices; and because the risk assessment of the modifications raise no new questions of safety and effectiveness, Stryker Neurovascular has determined the modified Target Detachable Coils to be substantially equivalent to the predicate device."
Therefore, the requested information regarding acceptance criteria and a study proving device performance is not present in the provided text.
§ 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).