(36 days)
The MicroPlex Coil System (MCS) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS 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 Bare Platinum Framing Coils, BPFC, consist of implant coil made of platinum alloy. The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to a V-Trake™ MCS 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-Grip™ Detachment Controller. The implant segment detaches upon activation of the Detachment Controller.
The provided text is a 510(k) summary for a medical device (Bare Platinum Framing Coils) and a clearance letter from the FDA. It does not contain information about acceptance criteria, device performance, or any studies using AI or human readers for diagnostic purposes. This document pertains to the regulatory clearance of a physical medical device, not a diagnostic algorithm or software. Therefore, I cannot fulfill the request to describe acceptance criteria and studies related to AI or diagnostic performance based on the provided text.
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510(k) Summary
| Trade Name: | Bare Platinum Framing Coils, BPFC | |
|---|---|---|
| Generic Name: | Neurovascular Embolization Device | OCT - 2 2008 |
| Classification: | Class II, 21 CFR 882.5950 | |
| Submitted By: | MicroVention, Inc75 ColumbiaAliso Viejo, California U.S.A. | |
| Contact: | Florin Truuvert |
Predicate Device:
| Number | Description | Predicate For | Clearance Date |
|---|---|---|---|
| K050954 | MicroVention Inc.,MicroPlex CoilSystem (MCS) | Bare Platinum FramingCoils | June 28, 2005 |
Device Description
The Bare Platinum Framing Coils, BPFC, consist of implant coil made of platinum alloy. The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to a V-Trake™ MCS 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-Grip™ Detachment Controller. The implant segment detaches upon activation of the Detachment Controller.
Indication For Use
The BPFC as a member of the MicroPlex Coil System (MCS) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS 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.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three curved lines representing wings or ribbons.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2008
Ms. Florin Truuvert Director, Regulatory Affairs Microvention, Incorporated 75 Columbia, Suite A Aliso Vicjo, California 92656-1408
Re: K082461
Trade/Device Name: Bare Platinum Framing Coils (BPFC) Regulation Number: 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: II Product Code: HCG Dated: August 25, 2008 Received: September 4, 2008
Dear Ms. Truuvert:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Ms. Truuvert
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K082461
Device Name: Bare Platinum Framing Coils (BPFC)
Indications For Use:
The MicroPlex Coil System (MCS) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS is also intended for wascular 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.
Prescription Use
AND/OR
Over-The-Counter Use
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(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
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(Division Sign-Off)
Reception Control, Dental Devices
Yhil Ko Ogden for axn
510 (k) Number: (Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 14 of 113
510(k) Number K082461
§ 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).