V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503

K090001 · MicroVention, Inc. · HCG · Mar 5, 2009 · Neurology

Device Facts

• Record ID: K090001
• Device Name: V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503
• Applicant: MicroVention, Inc.
• Product Code: HCG · Neurology
• Decision Date: Mar 5, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The V-Grip Plus Detachment Controller is used to detach the MicroVention MicroPlex Coil System and the HydroCoil Embolization System. As an accessory to the coils, the indications for use for the Detachment Controller remain the same as the coils and is as follows: The MicroPlex Coil System and Hydrocoil Embolization System are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, The MCS and HES are 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

Hand-held, battery-operated accessory for MicroVention MicroPlex and HydroCoil embolization systems. Clinician inserts proximal end of coil delivery pusher into controller; activation triggers coil detachment at treatment site. Used in neurovascular/peripheral vascular procedures. Facilitates permanent obstruction of blood flow to aneurysms or vascular malformations. Benefits patient by enabling precise, controlled release of embolic coils.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical output verification, functional testing, detachment testing, software validation, electrical safety, and electromagnetic compatibility, all of which met established criteria.

Technological Characteristics

Hand-held, battery-operated controller. Designed for detachment of MicroVention coil systems. Includes software for detachment control. Sterilized using same processes as predicate.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae; vascular occlusion of neurovascular blood vessels; and arterial/venous embolizations in 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

• MicroPlex Coil and HydroCoil Embolization System (V-Grip Detachment Controller) (K050954)

Submission Summary (Full Text)

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K090001
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## 510(k) Summary

.

MAR - 5 2009

| Trade Name: | V-Grip Plus Detachment Controller |
|-----------------|--------------------------------------------------------------------|
| Generic Name: | Neurovascular Embolization Device, accessory |
| Classification: | Class II, 21 CFR 882.5950 |
| Submitted By: | MicroVention, Inc<br>75 Columbia<br>Aliso Viejo, California U.S.A. |
| Contact: | Naomi Gong |

## Predicate Device:

| Number | Description | Clearance Date |
|---------|---------------------------------------------------------------------------------------|----------------|
| K050954 | MicroPlex Coil and HydroCoil<br>Embolization System (V-Grip<br>Detachment Controller) | June 28, 2005 |

## Device Description

The V-Grip Plus Detachment Controller is a hand held, battery operated device designed specifically to detach the MicroVention MicroPlex and HydroCoil family of coils. When the coil is delivered to the treatment site, the proximal end of the delivery pusher (of coil) is inserted into the Detachment Controller. When the Detachment Controller is activated, coil detachment occurs.

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### Indication For Use

The V-Grip Plus Detachment Controller is used to detach the MicroVention MicroPlex Coil System and the HydroCoil Embolization System. As an accessory to the coils, the indications for use for the Detachment Controller remain the same as the coils and is as follows:

The MicroPlex Coil System and Hydrocoil Embolization System are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, The MCS and HES are 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.

| Bench Testing | Result |
|---------------------------------------|--------------------------|
| Electrical output verification | Met established criteria |
| Functional testing | Met established criteria |
| Detachment testing | Met established criteria |
| Software validation | Met established criteria |
| Electrical safety testing | Met established criteria |
| Electromagnetic compatibility testing | Met established criteria |

#### Verification and Test Summary Table

#### Summary of Substantial Equivalence

The data presented in this submission demonstrates the similarity and equivalency of the V-Grip Plus Detachment Controller when compared with the predicate device MicroVention V-Grip Detachment Controller (K050954).

The devices,

- . Have the same intended use,
- Use the same operating principle, .
- . Incorporate the same basic design,
- Use similar construction and material,
- � Are packaged and sterilized using same material and processes.

In summary, the V-Grip Plus Detachment Controller described in this submission is, in our opinion, substantially equivalent to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 emblem featuring a stylized eagle with its wings spread, clutching a caduceus, a symbol associated with medicine and healthcare.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MicroVention, Inc. % Ms. Naomi Gong . Regulatory Affairs Project Manager 75 Columbia, Suite A Aliso Viejo, California 92656

MAR - 5 2009

Re: K090001

Trade/Device Name: V-Grip Plus Detachment Controller Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: February 5, 2009 Received: February 6, 2009

Dear Ms. Gong:

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.

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 (OS) 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. Naomi Gong

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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours,

L.K. m.D. for

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):

V-Grip Plus Detachment Controller Device Name:

Indications For Use:

The V-Grip Plus is used to detach the MicroVention MicroPlex Coil System and the HydroCoil Embolization System. As an accessory to the coils, the indications for use for the Detachment Controller remain the same as the coils and is as follows:

The MicroPlex Coil System and Hydrocoil Embolization System are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS and HES are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct hlood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

Prescription Use X AND/OR (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 CDRH, Office of Device Evaluation (ODE)

Daniel Kuone kumu
(Division Sign-Off)

3/4/2009

Division of Gener . . Restorative, and Neurological Devices

**510(k) Number** K090001