(28 days)
Matrix2 Detachable Coils are intended for embolizing certain intracranial aneurysms that because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be:
a) very high risk for management by traditional operative techniques, or,
b) inoperable,
and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.
Matrix2 Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.
Boston Scientific's detachable coil system consists of
- · a detachable coil power supply (GDC Power Supply)
- · an occlusion coil attached to a delivery wire (Matrix or GDC coil)
- · a set of connecting cables for connecting the coil / delivery wire assembly to the power supply (GDC connecting cables)
- · a patient return electrode
- two 9-volt batteries
each of which is sold separately.
The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.
Electrolytically detachable occlusion coils are manufactured from platinum wire which is first wound into a primary coil and then formed into a secondary helical shape.
Coils are attached to a delivery wire, which consists of a ground stainless-steel core with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is similar to that employed for the predicate Matrix SR devices cleared under K031168 and K012985.
The Detachable Coil Power Supply is a battery-operated, self-contained unit designed to initiate and control the electrolytic detachment of a coil inside an aneurysm.
Each time the power supply is turned on, the unit defaults to the 1.0 mA current setting. Pressing the "Current" switch one time changes the setting to the .05 mA current setting; pressing a second time changes the setting to 0.75 mA; pressing a third time returns the unit to the default 1.0 mA setting. Each time the switch is pressed, the current display flashes the new current setting.
The power supply is designed to apply a constant current through the GDC System and to detect when coil detachment has occurred. It maintains a constant current by:
-
- sensing the amount of resistance to current flow through the detachable coil system, and
-
- adjusting the voltage needed to maintain the desired current setting. It is also designed to identify subtle changes in the way current is flowing through the system and to recognize those changes which indicate detachment.
Once those patterns are identified, the power supply signals detachment and stops the flow of current through the system.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification for Boston Scientific Neurovascular's Matrix2 Detachable Coils, focusing on demonstrating substantial equivalence to predicate devices. It covers:
- Summary of Safety and Effectiveness: Contact person, trade name, common name, classification name.
- Predicate Devices: A table comparing the Matrix2 coils to previously cleared devices (K031168, K012985, K042539).
- Intended Use / Indications for Use: Specific medical conditions and locations for which the device is intended.
- Device Description: Details on the components (power supply, occlusion coil, delivery wire, cables, batteries) and how the electrolytic detachment works.
- Accessories Description: Lists connecting cables and batteries.
- Technological Characteristics Comparison (to predicate devices): Tables detailing coil dimensional attributes and materials, showing how they relate to the predicate devices.
- FDA Clearance Letter: Official communication from the FDA acknowledging the 510(k) and stating substantial equivalence.
- Indications for Use Statement: A formal statement of the device's intended use.
This document serves to demonstrate that the new device is as safe and effective as legally marketed predicate devices, rather than presenting a performance study against specific acceptance criteria. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, or adjudication methods from this 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).