MICROPLEX COIL SYSTEM (MCS), VFC

K132317 · MicroVention, Inc. · HCG · Sep 20, 2013 · Neurology

Device Facts

• Record ID: K132317
• Device Name: MICROPLEX COIL SYSTEM (MCS), VFC
• Applicant: MicroVention, Inc.
• Product Code: HCG · Neurology
• Decision Date: Sep 20, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MicroPlex Coil System 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.

Device Story

MicroPlex Coil System (MCS) VFC is a neurovascular embolization device consisting of a 3D-shaped platinum alloy coil attached to a V-Trak delivery pusher. Used by physicians in clinical settings to treat intracranial aneurysms and vascular malformations. The device is deployed endovascularly; detachment is triggered by a hand-held, battery-powered V-Grip Detachment Controller (sold separately). The coil provides permanent mechanical obstruction of blood flow to the target site. Benefits include minimally invasive treatment of neurovascular abnormalities. The system is supplied sterile for single use.

Clinical Evidence

Bench testing only. Testing included visual/dimensional inspection, simulated use (introduction, tracking, deployment, detachment), coil-to-coupler weld tensile strength, and spring constant measurement. All tests met acceptance criteria.

Technological Characteristics

Implantable coil made of platinum/tungsten (92/8%) alloy; coupler made of platinum/iridium (10%); adhesive is DYMAX 1128-AM-VT UV; stretch resistance filar is polyolefin elastomer or PET. Delivery via V-Trak pusher. MRI compatible. Sterile, single-use. 3D coil shape.

Indications for Use

Indicated for patients requiring endovascular embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae, and vascular occlusion within the neurovascular system or peripheral vasculature to obstruct blood flow.

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

• MicroPlex Coil System (MCS) (K111451)

Submission Summary (Full Text)

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K132317

P 2 0 2013

### 510(K) SUMMARY

Trade Name:

Class II, 21 CFR 882.5950

August 22, 2013

MicroVention, Inc 1311 Valencia Avenue Tustin, California 92780

MicroPlex Coil System (MCS), VFC

Neurovascular Embolization Device

Generic Name:

Classification:

Date Submitted

Submitted By:

Contact: Laraine Pangelina

Predicate Device: MicroPlex Coil System (MCS) (K111451)

U.S.A.

Indications for Use:

Bench Test Summary:

The MicroPlex Coil System 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 MCS VFC consists of an implantable coil made of bare platinum alloy. Device Description: The MCS VFC implantable coils has a 3D shape in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller.

| Test | Results |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Visual/Dimensional Inspection<br>Perform visual inspection and measurments using<br>device drawing | PASS, acceptance criteria met |
| Simulate Use<br>Introduction, Tracking, Deployment,<br>Compartmentalizing, Frame Movement, Microcatheter<br>movement, Detachment, Overall Performance | PASS, acceptance criteria met |
| Detachment Test<br>Confirm successful detachment according using V-Grip<br>Detachment Controller during simulated use testing | PASS, acceptance criteria met |
| Coil-to-Coupler Weld Test<br>Test the tensile strength of the coil/coupler weld | PASS, acceptance criteria met |
| Spring Constant<br>Measure the spring constant force of the coil | PASS, acceptance criteria met |
| CONCLUSION: The results of the bench testing demonstrate that the subject device is saf<br>and effective when used according to the instructions for use and performs equivalent to th<br>predicate device. The testing was used in support of the risk analysis documentation for the<br>subject device. | |

Page 10

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| Predicate / Subject<br>Technological<br>Comparison: | . .<br>Feature<br>ﺎ ﺗ<br>ﺇ | Predicate Devices | Subject Device |
|-----------------------------------------------------|-----------------------------------|-------------------------------------------|----------------|
| | Coil shape | 3D | Same |
| | Coil OD (mm) | 3 - 15 | 1 |
| | Restrained coil length (cm) | 6 - 45 | 3 |
| | Main coil wire material | Platinum/Tungsten (92/8%) alloy | Same |
| | Coupler Material | Platinum (90%)/ iridium (10%) | Same |
| | Adhesive Material | DYMAX 1128-AM-VT UV Adhesive | Same |
| | Stretch resistance filar material | Polyolefin Elastomer or PET | Same |
| | Implant-to-pusher material | Polyolefin elastomer | Same |
| | Delivery method | V-Trak delivery pusher | Same |
| | MRI compatibility | Yes | Yes |
| | Method of supply | Sterile, single use | Same |
| | Packaging configuration | Dispenser coil, pouch,<br>shipping carton | Same |

Summary of Substantial Equivalence: The devices 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/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird-like figure, which is the department's symbol. The logo is black and white.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 20, 2013

MicroVention, Inc. Ms. Laraine Pangelina Sr. Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780

Re: K132317

Trade/Device Name: MicroPlex Coil System (MCS), VFC Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG Dated: August 22, 2013 Received: August 23, 2013

Dear Ms. Pangelina:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We 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.

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 1000-1050.

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### Page 2 - Ms. Laraine Pangelina

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K132317

Device Name: MicroPlex Coil System (MCS), VFC

Indications For Use: The MicroPlex Coil System 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 embolization in the peripheral vasculature.

AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

# Joyce M.

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K132317

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