V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System

K162999 · MicroVention, Inc. · HCG · Mar 29, 2017 · Neurology

Device Facts

• Record ID: K162999
• Device Name: V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
• Applicant: MicroVention, Inc.
• Product Code: HCG · Neurology
• Decision Date: Mar 29, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

MicroPlex Coil System and HydroCoil Embolic System: The MicroPlex Coil System and HydroCoil Embolic System are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MicroPlex Coil System and HydroCoil Embolic System 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. AZUR Peripheral Coil System: The AZUR Peripheral Coil System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

Device Story

The V-Grip and AZUR Detachment Controllers are handheld, battery-powered accessories used with MicroVention coil systems. The system consists of an implantable platinum alloy coil (with or without hydrogel core) attached to a delivery pusher via a polyolefin elastomer filament. During interventional procedures, the physician inserts the proximal end of the pusher into the controller. Upon activation, the controller delivers electrical current to heat the polyolefin filament, causing the coil to detach from the pusher and remain in the target vessel to obstruct blood flow. The subject modification updates the controller housing and power source (from three 12V batteries to one removable 9V battery) to facilitate battery disposal. The device is used in clinical settings by physicians. The output (electrical current) directly enables the mechanical detachment of the implant, facilitating permanent vascular occlusion and providing therapeutic benefit for aneurysms and vascular malformations.

Clinical Evidence

No clinical data. Bench testing only. Testing included output voltage/time verification, detachment performance, battery voltage monitoring, LED/buzzer sequence testing, EMC compatibility (IEC 60601-1-2:2014), electrical safety (IEC 60601-1:2012), and shelf-life/shipping validation (ISTA 3A). All tests passed.

Technological Characteristics

Handheld, battery-powered controller. Housing: ABS 633/Polyac 747 plastic. Power: 9V alkaline battery. Output: 9.00 VDC ± 0.50V, 170 mA nominal. Detachment principle: resistive heating of polyolefin elastomer filament. Sterilization: Ethylene oxide. Connectivity: None. Software: Embedded firmware for detachment cycle control.

Indications for Use

Indicated for patients requiring endovascular embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae, and other neurovascular or peripheral vascular lesions to reduce or block 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

• V-Grip Detachment Controller (K050954)
• AZUR Detachment Controller (K050954)

Submission Summary (Full Text)

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Image /page/0/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 a stylized image of three human profiles facing to the right, stacked on top of each other.

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

March 27, 2017

MicroVention, Inc. Laraine Pangelina Senior Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, California 92780

Re: K162999

Trade/Device Name: MicroPlex Coil System, HydroCoil Embolic System, AZUR Peripheral Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: February 21, 2017 Received: February 22, 2017

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Carlos L. Pena -S

Carlos L. Peña, PhD, MS 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) K162999

#### Device Name

MicroPlex Coil System, HydroCoil Embolic System, AZUR Peripheral Coil System

#### Indications for Use (Describe)

MicroPlex Coil System and HydroCoil Embolic System:

The MicroPlex Coil System and HydroCoil Embolic System are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MicroPlex Coil System and HydroCoil Embolic System 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.

#### AZUR Peripheral Coil System:

The AZUR Peripheral Coil System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

| Type of Use (Select <i>one</i> or <i>both</i> , as applicable) |
|----------------------------------------------------------------|
|----------------------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image contains the logo for MicroVention. The logo features a stylized, abstract graphic to the left of the company name. Below the company name is the word "TERUMO" in a smaller, sans-serif font.

## 510(K) SUMMARY

(Prepared October 24, 2016)

The primary purpose of the subject 50(k) is a modification to the V-Grip Detachment Controller and the AZUR Detachment Controller. The V-Grip Detachment Controller is an accessory for use with the MicroVention MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES). The AZUR Detachment Controller is for use with the MicroVention AZUR Peripheral Coil System (AZUR)

| Trade Name: | 1. MicroPlex Coil System and HydroCoil Embolic System<br>2. AZUR Peripheral Coil System |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Generic Name: | 1. Neurovascular Embolization Device (MicroPlex Coil System and<br>HydroCoil Embolic System)<br>2. Vascular Embolization Device (AZUR Peripheral Coil System) |
| CFR Classification: | Class II, 21 CFR 882.5950 (MicroPlex Coil System and<br>HydroCoil Embolic System)<br>Class II, 21 CFR 870.3300 (AZUR Peripheral Coil System) |
| Product Code: | HCG (MicroPlex Coil System and<br>HydroCoil Embolic System)<br>KRD (AZUR Peripheral Coil System) |
| Submitted By: | MicroVention, Inc<br>1311 Valencia Avenue<br>Tustin, California 92780<br>U.S.A. |
| Contact: | Laraine Pangelina<br>Sr. Regulatory Affairs Manager<br>MicroVention, Inc. |
| Predicate Device: | 1. V-Grip Detachment Controller (for use with MicroPlex Coil System and<br>HydroCoil Embolic System), K050954<br>2. AZUR Detachment Controller (for use with AZUR Peripheral Coil<br>System), K050954 |
| Indications for Use: | NOTE: The V-Grip Detachment Controller is an accessory for use with the<br>MicroVention MicroPlex Coil System (MCS) and HydroCoil Embolic System<br>(HES). The AZUR Detachment Controller is for use with the MicroVention<br>AZUR Peripheral Coil System (AZUR). As an accessory to the coil systems,<br>the indications for use for the Detachment Controller are the same as that for<br>the coil systems with which they are used: |
| | MicroPlex Coil System and HydroCoil Embolic System: |
| | The MicroPlex Coil System and HydroCoil Embolic System are intended for the<br>endovascular embolization of intracranial aneurysms and other neurovascular<br>abnormalities such as arteriovenous |

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malformations and arteriovenous fistulae. The MicroPlex Coil System and HydroCoil Embolic System 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.

AZUR Peripheral Coil System:

The AZUR Peripheral Coil System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

The V-Grip Detachment Controller is an accessory for use with the Device Description: MicroVention MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES). The AZUR Detachment Controller is for use with the MicroVention AZUR Peripheral Coil System (AZUR).

> The MCS and AZUR devices consist of an implantable coil made of a platinum alloy (Platinum/Tunqsten). The HES and AZUR metal/gel devices consist of an implantable coil made of the same platinum alloy with a hydrogel inner core.

The implantable coil is attached to a delivery pusher via a polyolefin elastomer material. The proximal end of the delivery pusher is inserted into a hand held, battery powered Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implantable coil. The Detachment Controller is packaged and sold separately.

The primary purpose of the subject submission is a modification to the V-Grip/AZUR Detachment Controller to facilitate battery removal and disposal after use of the device. The table below provides a summary of the differences between the current and modified Detachment Controller.

| Characteristic | Current V-Grip/AZUR<br>Detachment Controller<br>(K050954) | Modified V-Grip/AZUR<br>Detachment Controller<br>(Subject Device) |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Power Source | Three - 12 V alkaline<br>batteries, not removable or<br>replaceable | One - 9 V alkaline<br>battery, removable, not<br>replaceable |
| Output Voltage | 8 VDC ± 1V | 9.00 VDC ± 0.50V |
| Output Current | 170 mA nominal, 246 mA<br>maximum | 170 mA nominal, 256 mA<br>maximum |
| Housing/Funnel | ABS 633 Plastic<br>ABS Polyac 747<br>Funnel:<br>Color Science #CS4B627A<br>(V-Grip) and #CS3W768A-<br>2 (AZUR)<br>Housing:<br>Color Science #CS2Y457A<br>(V-Grip) and # CS3G257A<br>(AZUR) | Same materials. Modified<br>dimensions and<br>configuration to allow<br>battery removal |

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Image /page/5/Picture/0 description: The image shows the logo for MicroVention, a company that specializes in neurovascular products. The logo features the company name in a stylized font, with the word "MicroVention" in a larger font size than the word "TERUMO" which is located underneath. The logo is primarily blue in color, with a gradient effect that gives it a modern and professional look. There is also a graphic to the left of the company name.

#### Bench Test Summary:

| Test | Test Method Summary | Result |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Output Voltage<br>and Time | All 22 samples (minimum) before and after<br>sterilization shall have a measurement rating of<br>$9.0 \pm 0.5V$ and $0.75 \pm 0.10$ seconds for a<br>minimum of 20 cycles, to meet 90% confidence<br>of 90% reliability for the voltage, time, and<br>number of cycles. | PASS |
| Detachment | All 22 samples (minimum) before and after<br>sterilization shall detach the implants at the 11th<br>and 20th cycles in under three detachment<br>attempts. | PASS |
| Battery Voltage<br>Measurement | All 22 samples (minimum) before and after<br>sterilization shall meet the acceptance criteria of<br>> 7V. | PASS |
| LED and Buzzer<br>Sequence | All 22 samples (minimum) before and after<br>sterilization shall pass the conditional LED and<br>buzzer sequence tests for standard operation,<br>detachment testing, and functional testing<br>beyond 20 cycles. | PASS |
| EMC<br>Compatibility | Test samples were subjected to five EMC tests<br>in accordance with IEC 60601-1-2:2014. Testing<br>was conducted for MicroVention by TUV<br>America in San Diego, CA. | PASS |
| Software<br>Validation | Software validation testing was performed to<br>demonstrate that the modified V-Grip/Azur<br>Detachment Controller met the requirements of<br>Design Specifications and the Software<br>Requirements Specification. | PASS |
| Electrical Safety | The modified V-Grip/AZUR Detachment<br>Controller was evaluated by TUV SUD America<br>in accordance with IEC 60601-1:2012 Edition 3.1<br>and other related standards. The evaluation<br>included the risk management file review and<br>safety testing, which concluded that the subject<br>device meets the selected requirements of the<br>test specifications. | PASS |
| Shelf Life,<br>Accelerated<br>Aging 1 year | Shelf life testing was performed on 22 samples<br>that had been subjected to the equivalent of 1-<br>year accelerated aging. The test samples were<br>sterilized according to the sterilization cycle that<br>will be utilized for commercialized product, and<br>subjected to simulated shipping hazard per ISTA<br>3A. Visual inspection and output performance<br>were tested. | PASS |

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Image /page/6/Picture/0 description: The image contains the logo for MicroVention, a company specializing in neurovascular products. The logo features the company name in a stylized font, with the word "MicroVention" in a larger, bolder font and the word "TERUMO" underneath in a smaller font. The logo also includes a graphic element to the left of the company name, consisting of a series of curved lines that create a sense of movement and flow.

| Predicate / Subject<br>Technological<br>Comparison: | Characteristic | Current V-Grip/AZUR<br>Detachment Controller<br>(K050954) | Modified V-Grip/AZUR<br>Detachment Controller |
|-----------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| | V-Grip Device General<br>Description | A self-contained,<br>disposable, hand held,<br>battery powered<br>detachment controller<br>provides the controlled<br>electrical energy for the<br>detachment of the coil<br>from the delivery<br>pusher. | Same |
| | Power Source | Three - 12 V alkaline batteries,<br>not removable or replaceable | One - 9 V alkaline battery,<br>removable, not replaceable |
| | Output Voltage | $8 VDC \pm 1V$ | $9.00 VDC \pm 0.50V$ |
| | Output Current | 170 mA nominal, 246 mA<br>maximum | 170 mA nominal, 256 mA<br>maximum |
| | Printed Circuit Board | Qty. 1: PD00285 - Printed<br>Circuit Board | Qty. 1: PD110285 - Printed<br>Circuit Board |
| | Housing/Funnel | ABS 633 Plastic<br>ABS Polyac 747<br>Funnel: Color Science<br>#CS4B627A (V-Grip) and<br>#CS3W768A-2 (AZUR)<br>Housing: Color Science #<br>CS2Y457A (V-Grip) and #<br>CS3G257A (AZUR) | Same materials. Modified<br>dimensions and configuration<br>to allow battery removal |
| | Detachment cycle time | 0.75 seconds | Same |
| | Detachments per unit | 20 | Same |
| | Method of Supply | Sterile and single patient<br>use | Same |
| | Package Configuration | Placed in sealed pouch<br>5 units per carton box | Same |
| | Method of Sterilization | Ethylene oxide | Same |

Summary of Substantial Equivalence:

The devices that are the subject of this submission are substantially equivalent to the predicate devices with regard to intended use, patient population, device design, materials, processes, and operating principal.