MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
Device Facts
| Record ID | K103758 |
|---|---|
| Device Name | MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 |
| Applicant | MicroVention, Inc. |
| Product Code | HCG · Neurology |
| Decision Date | Apr 28, 2011 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.5950 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS and 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.
Device Story
MicroPlex Coil System (MCS) Cosmos 10 and HydroCoil Embolic System (HES) HydroFrame 10 are implantable neurovascular embolic coils. MCS consists of bare platinum alloy coils; HES includes platinum alloy coils with a biologically inert hydrogel core for expansion. Both feature 3D spherical shapes, PET stretch-resistant members, and V-Trak delivery pushers. Operated by physicians in clinical settings, the device is connected to a handheld, battery-powered V-Grip Detachment Controller. Activation of the controller detaches the coil from the pusher. Coils are placed within aneurysms or vessels to obstruct blood flow, providing permanent occlusion. The hydrogel core in HES improves filling properties. Benefits include aneurysm stabilization and vascular malformation treatment.
Clinical Evidence
Bench testing only. No clinical data provided. Testing included visual inspection, dimensional measurement, simulated use (tracking, deployment, frame tumbling, microcatheter manipulation, basket formation, shape retention), spring constant, gel expansion, and weld tensile strength. All results met criteria established by predicate devices.
Technological Characteristics
Implantable coils made of platinum/tungsten alloy; HES includes hydrophilic acrylic copolymer hydrogel core. PET stretch-resistant member. V-Trak delivery pusher with polyolefin elastomer. 3D spherical shape. MRI compatible. Sterile, single-use. Handheld battery-powered detachment controller (external).
Indications for Use
Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae; vascular occlusion within the neurovascular system; and arterial/venous embolization in the peripheral vasculature.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
Submission Summary (Full Text)
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## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Trade Name: | MicroPlex Coil System – Cosmos 10<br>HydroCoil Embolic System - HydroFrame 10 | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Generic Name: | Neurovascular Embolization Device, accessory | |
| Classification: | Class II, 21 CFR 882.5950 | |
| Submitted By: | MicroVention, Inc<br>1311 Valencia Avenue<br>Tustin, California 92780 U.S.A.<br>714-247-8000 | |
| Contact: | Laraine Pangelina | |
| Date Prepared: | April 20, 2011 | |
| Predicate Device: | MicroPlex Coil System, Cosmos 10 (K093919)<br>HydroCoil Embolic System, HydroFrame 10 (K090357) | |
| Indications for Use: | Intended for the endovascular embolization of intracranial<br>aneurysms and other neurovascular abnormalities such as<br>arteriovenous malformations and artiovenous fistula. The MCS and<br>HES are also intended for vascular occlusion of blood vessels<br>within the neurovascular system to permanently obstruct blood flow<br>to an aneurysm or other vascular malformation and for arterial and<br>venous embolization in the peripheral vasculature. | |
| Device Description: | The MCS Cosmos 10 consists of an implantable coil made of bare<br>platinum alloy. The HES HydroFrame 10 consists of implantable coil<br>made of platinum alloy with a biologically inert and stable inner hydrogel<br>core. Both the Cosmos 10 and the HydroFrame 10 coils are available in<br>various loop sizes and lengths. The coil is attached to a V-Trak delivery<br>pusher. The proximal end of the delivery pusher is inserted into a hand<br>held battery powered V-Grip Detachment Controller (sold separately). The<br>implantable coil detaches upon activation of the Detachment Controller.<br><br>Both the Cosmos 10 and the HydroFrame 10 coil implants have a PET<br>member within the primary coil to provide stretch resistance properties.<br>Both feature a 3-dimensional shape that creates a frame when placed<br>within an aneurysm.<br><br>The HydroFrame 10 also has a hydrogel core member that runs parallel<br>with the stretch resistant member within the coil. The expansion<br>properties of the hydrogel allow for improved filling properties of the<br>implanted coil.<br><br>The table below provides information about the physical properties of the<br>Cosmos 10 and HydroFrame 10, with a comparison to their respective<br>predicate devices. | |
| MCS Cosmos 10 | | |
| Feature | Predicate Device | Subject Device |
| Coil shape | 3D - spherical | Same |
| Coil implant diameter | 3-12mm | 2.0-2.5mm |
| Coil restrained length | 6-45cm | 2-4cm |
| Deliver pusher length | 185cm | Same |
| Main coil wire material | Platinum/Tungsten alloy | Same |
| Coupler material | Platinum/Iridium | Same |
| Adhesive material | Utraviolet cure | Same |
| Implant to pusher material | Polyolefin elastomer | Same |
| Stretch resistant filar material | Polyolefin elastomer | PET |
| MRI compatibility | Yes | Same |
| Method of supply | Sterile, single use | Same |
| Packaging configuration | Dispenser coil, pouch, carton | Same |
| HES HydroFrame 10 | | |
| Feature | Predicate Device | Subject Device |
| Coil shape | 3D - spherical | Same |
| Coil implant diameter | 3-12mm | 2.0-2.5mm |
| Coil restrained length | 6-43cm | 2.4cm |
| Deliver pusher length | 185cm | Same |
| Main coil wire material | Platinum/Tungsten alloy | Same |
| Coupler material | Platinum/Iridium | Same |
| Adhesive material | Utraviolet cure | Same |
| Implant to pusher material | Polyolefin elastomer | Same |
| Stretch resistant filar material | Polyolefin elastomer | PET |
| Gel | Hydrophilic acrylic copolymer | Same |
| MRI compatibility | Yes | Same |
| Method of supply | Sterile, single use | Same |
| Packaging configuration | Dispenser coil, pouch, carton | Same |
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## MicroVention, Inc. Special 510(k) – MCS & HES Line Extension
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| Bench Test Summary: | Test | Result |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| | Visual Inspection | Met same criteria as predicate |
| | Dimensional Measurement | Met same criteria as predicate |
| | Simulated Use:<br>Introduction, Tracking, Deployment, Frame tumbling,<br>Microcatheter movement, Microcatheter manipulation,<br>Compartmentalization, Periphery fill, Basket formation,<br>Shape retention, Overall performance | Met same criteria as predicate |
| | Spring Constant | Met same criteria as predicate |
| | Gel Expansion (HES only) | Met same criteria as predicate |
| | Weld Tensile | Met same criteria as predicate |
Summary of Substantial Equivalence:
The Cosmos 10 and HydroFrame 10 coils that are the subject of this submission are substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Microention, Inc. Laraine Pangelina Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780
APR 2 8 2011
Re: K103758
Trade/Device Name: Microplex Coil System-Cosmos 10 and, Hydrocoil System-Hydroframe 10 Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: Class II Product Code: HCG Dated: March 25, 2011 Received: March 29, 2011
Dear Ms. Pangelina
We have reviewed your Section 510(k) premarket notification of intent to market the device m & re review 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 I ou may, mereleve, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Vie remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 100-1050,
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 inte (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Rick Remmers
Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known): K103758
Device Name: MicroPlex Coil System (MCS) - Cosmos 10 HydroCoil Embolic System (HES) - HydroFrame 10 ·
Indications For Use:
Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS and 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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
JEFFREY Toy
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K103758
