MICRUS MICROCOIL SYSTEM

K032872 · Micrus Corp. · HCG · Nov 28, 2003 · Neurology

Device Facts

• Record ID: K032872
• Device Name: MICRUS MICROCOIL SYSTEM
• Applicant: Micrus Corp.
• Product Code: HCG · Neurology
• Decision Date: Nov 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Micrus MicroCoil System is intended for endovascular embolization of intracranial aneurysms.

Device Story

Long Spherical MicroCoil System is a line extension of existing Micrus Spherical MicroCoils; designed for endovascular embolization of intracranial aneurysms. Device consists of platinum/tungsten alloy embolic coil attached to variable stiffness Device Positioning Unit (DPU). Clinician uses fluoroscopic guidance to navigate microcatheter to aneurysm site; coil is deployed to frame aneurysm wall/neck. Detachment is achieved via electrical energy delivered from external Detachment Control Box (DCB) through connecting cable to resistive heating coil on DPU, which shears polyethylene fiber. System provides improved aneurysm wall/neck coverage for 6-10 mm aneurysms. Used in clinical/interventional settings by physicians. Output is physical occlusion of aneurysm; benefits include reduced risk of aneurysm rupture.

Clinical Evidence

Bench testing only. Testing included durability (6 cycles of deployment/retraction in tortuous anatomy flow model), functional performance (advancement, retraction, framing, and packing capability), and frictional force analysis compared to existing helical and spherical microcoil systems.

Technological Characteristics

Materials: Platinum/Tungsten alloy wire, Au/Sn solder, polyethylene fiber. Sensing/Actuation: Resistive heating for mechanical detachment. Energy: 6.5 VDC from alkaline-battery-powered DCB. Form factor: 3D spherical coil, 6-10 mm diameter, 20-30 cm length. Connectivity: Proprietary wired connection to DCB. Sterilization: Sterile, single-use (coils/cables); DCB is non-sterile/reusable.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms in patients requiring aneurysm framing and filling.

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

• Micrus MicroCoil Delivery System (K002056)

Submission Summary (Full Text)

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### II. Safety and Effectiveness Summary

#### Contact Information A.

Margaret Webber Director, Regulatory & Clinical Affairs Micrus Corporation 610 Palomar Avenue Sunnyvale, CA 94085 Tel: [phone], ext. 108 Fax: [phone]

#### B. Device Name

Long Spherical MicroCoil System (member of MicroCoil Delivery System)

Device, Artificial Embolization

Regulation Number: 882.5950

Product Code: HCG

Device Class: Ill

#### C. Predicate Device

510k# K002056: Micrus MicroCoil Delivery System, cleared on Jan 11, 2001.

#### Device Description D.

The current Micros Spherical MicroCoil System (510k # K002056) is available in 10 and 18 system sizes.

- The 10 System Spherical MicroCoils are available in diameters ranging from 2 mm to 10 mm and in lengths ranging from 2 cm to 20 cm.
- . The 18 System Spherical MicroCoils are available in diameters ranging from 2 mm to 19 mm and in lengths ranging from 2 cm to 30 cm.

The proposed longer Spherical MicroCoil, which is the focus of this submission, is designed to provide move aneurysm-framing loops to provide better aneurysm wall and aneurysm neck coverage in aneurysms ranging from 6 to 10 mm in size:

- 트 The "Long 10 System Spherical" MicroCoils will be available in diameters ranging from 6 mm to 10 mm and in lengths ranging from 20 cm to 30 cm.
These long Spherical MicroCoils are a line extension of the current regular length Micrus Spherical MicroCoils. The table below shows the lengths of both the regular and proposed long Spherical MicroCoils.

Comparison Table: Long Spherical MicroCoils Vs. Current Spherical MicroCoils

| Long Spherical<br>MicroCoil Sizes | Current Spherical<br>MicroCoil Sizes |
|-----------------------------------|--------------------------------------|
| 6 mm x 20 cm | 6 mm x 12cm |
| 7 mm x 20 cm | 7 mm x 14cm |
| 8 mm x 25 cm | 8 mm x 16 cm |
| 9 mm x 25 cm | 9 mm x 18.5 cm |
| 10 mm x 30 cm | 10 mm x 20.5 cm |

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Both the original length and long length Spherical MicroCoil Systems are "framing" coils, to be used interchangeably to frame the inner wall of the aneurysm prior to filling it with Helical MicroCoils. All Micrus MicroCoils are part of the complete Micrus MicroCoil Delivery System, which has three components (sold and provided individually):

- Micrus Platinum MicroCoil Systems, Spherical, Straight, and Stretch 1) Resistant configurations, consist of an embolic coil attached to a variable stiffness Device Positioning Unit (DPU). The DPU has a radiopaque marker band located three (3) centimeters from its distal end for compatibility with infusion microcatheters with 2 tip markers.
- 2) Detachment Control Boxes (DCB). This device provides the energy to detach the MicroCoil from the DPU at the clinician's command. The DCB is provided NON-STERILE.
- 3) Connecting Cable. The Connecting Cable is used to bring the energy from the DCB to the MicroCoil System, and is approximately 5-ft (1.5 m) long.

Note: The MicroCoil System and the Connecting Cable are provided sterile and nonpyrogenic, if in their unopened packages.

#### E. Intended Use

The Micrus MicroCoil System is intended for endovascular embolization of intracranial aneurysms.

#### Intended Use (Predicate) F.

The Micrus MicroCoil System is intended for endovascular embolization of intracranial aneurysms.

| Characteristic | Micrus Current Spherical<br>MicroCoil (10-System) | Proposed Longer Spherical<br>MicroCoil (10-System) | Comparison |
|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| MicroCoil System | | | |
| How supplied | Sterile, single use. MicroCoil<br>attached to the DPU, polyethylene<br>introducer over MicroCoil, in plastic<br>packaging hoop. | Sterile, single use. Embolic coil<br>attached to the pusher wire,<br>polyethylene introducer over<br>embolic coil, in plastic packaging<br>hoop. | Identical |
| Implantable<br>Embolic Coil | | | |
| Materials of<br>construction | Platinum/Tungsten alloy wire &<br>Au/Sn solder. | Platinum/Tungsten alloy wire &<br>Au/Sn solder. | Identical |
| Shape | 3D Spherical shape with atraumatic<br>tip. | 3D Spherical shape with atraumatic<br>tip. | Identical |
| Dimensions | Various diameters and lengths to<br>treat a variety of aneurysm sizes.<br>Diameters from 2 - 12 mm<br>Lengths from 2.5 cm to 20.5 cm. | Various diameters and lengths to<br>treat a variety of aneurysm sizes.<br>Diameters from 6 -10 mm<br>Lengths from 20 - 30 cm | Within same<br>diameter range.<br>Longer lengths<br>available. |
| Radiopacity | Radiopaque from Pt alloy wire. | Radiopaque from Pt alloy wire. | Identical |
| MRI Compatibility | Yes | Yes | Identical |
| Method of<br>attachment to<br>device positioning<br>unit | High tensile strength, highly oriented<br>polyethylene fiber. | High tensile strength, highly oriented<br>polyethylene fiber. | Identical |
| Method of<br>detachment from<br>device positioning<br>unit | Shear PE fiber with a loop of a<br>resistively heated coil. | Shear PE fiber with a loop of a<br>resistively heated coil. | Identical |
| Provided: | Sterile, single use | Sterile, single use | Identical |
| Characteristic | Micrus Current Spherical<br>MicroCoil (10-System) | Proposed Longer Spherical<br>MicroCoil (10-System) | Comparison |
| Device<br>Positioning Unit | | | |
| Physical | Variable stiffness composite<br>introducer (most flexible distally,<br>medium flexibility in mid-section and<br>stiffest proximally) to allow pushing<br>of the embolic coil through the<br>tortuous cerebral vasculature. | Variable stiffness composite<br>introducer (most flexible distally,<br>medium flexibility in mid-section and<br>stiffest proximally) to allow pushing<br>of the embolic coil through the<br>tortuous cerebral vasculature. | Identical |
| Construction | Stainless steel hypotube (proximal),<br>stainless steel braid (mid) and<br>polymer (distal) sheathing for 2<br>conduction wires and distal RH coil. | Stainless steel hypotube (proximal),<br>stainless steel braid (mid) and<br>polymer (distal) sheathing for 2<br>conduction wires and distal RH coil. | Identical |
| Working Length | 195 cm | 195 cm | Identical |
| Package<br>Configuration | In plastic packaging hoop, with<br>introducer in place (for introduction<br>of MicroCoil into the microcatheter) | In plastic packaging hoop, with<br>introducer in place (for introduction<br>of coil into the microcatheter) | Identical |
| Compatible with: | Microcatheters with minimum 0.14"<br>i.d. ("10" sized systems) with 2<br>radiopaque tip markers 3 cm apart<br>(examples: Tracker 10, Excel 14,<br>Prowler 10, Prowler 14) | Microcatheters with minimum 0.14"<br>i.d. ("10" sized systems) with 2<br>radiopaque tip markers 3 cm apart<br>(examples: Tracker 10, Excel 14,<br>Prowler 10, Prowler 14) | Identical |
| Connecting<br>Cables | | | |
| How supplied | Sterile, single use | Sterile, single use | Identical |
| Physical | Single cable with proprietary<br>connectors to fit only the Micrus DCB<br>and the Micrus MicroCoil System | Single cable with proprietary<br>connectors to fit only the Micrus<br>DCB and the Micrus MicroCoil<br>System | Identical |
| Length | 262 cm. | 262 cm. | Identical |
| Detachment Box | | | |
| How supplied | Non-Sterile, reusable. Used outside<br>the sterile field. | Non-Sterile, reusable. Used outside<br>the sterile field. | Identical |
| Power Source | Alkaline batteries. | Alkaline batteries. | Identical |
| Displays | Voltage, Current, Low Battery, Fault,<br>Detach Cycle | Voltage, Current, Low Battery, Fault,<br>Detach Cycle | Identical |
| Detachment Cycle<br>Duration | 5 seconds | 5 seconds | Identical |
| Output Voltage | 6.5 VDC | 6.5 VDC | Identical |
| Output Current | 125 mA nominal, 200 mA max. | 125 mA nominal, 200 mA max. | Identical |
| "Detach" feedback | "Detach Cycle" light goes from<br>illuminated to off. Clinician verifies<br>detachment fluoroscopically per<br>device labeling. | "Detach Cycle" light goes from<br>illuminated to off. Clinician verifies<br>detachment fluoroscopically per<br>device labeling. | Identical |
| Method of attaching<br>Connecting Cable<br>to Detachment Box | Proprietary connector fits only one<br>way to assure proper polarity. | Proprietary connector fits only one<br>way to assure proper polarity. | Identical |
| Flow of Current | From positive terminal, through<br>positive lead in connecting cable,<br>through positive conductor of DPU,<br>through resistance heating coil,<br>through negative conductor of DPU,<br>through negative lead in connecting<br>cable, back to negative terminal of<br>detachment control box. | From positive terminal, through<br>positive lead in connecting cable,<br>through positive conductor of DPU,<br>through resistance heating coil,<br>through negative conductor of DPU,<br>through negative lead in connecting<br>cable, back to negative terminal of<br>detachment control box. | Identical |
| Characteristic | Micrus Current Spherical MicroCoil (10-System) | Proposed Longer Spherical MicroCoil (10-System) | Comparison |
| Accessory<br>Products Required<br>to Perform the<br>Procedure. | Micrus Sterile Connecting Cable | Micrus Sterile Connecting Cable | Identical |
| | Micrus Detachment Control Box<br>5-7F Guide Catheter*<br>Microcatheter (see above)*<br>Guide wire compatible with microcatheter*<br>Continuous saline/heparin saline flush*<br>Rotating hemostatic valves*<br>3-Way stopcock*<br>1-Way valve*<br>IV pole*<br>Femoral Sheath*<br>Alkaline Batteries* | Micrus Detachment Control Box<br>5-7F Guide Catheter*<br>Microcatheter (see above)*<br>Guide wire compatible with microcatheter*<br>Continuous saline/heparin saline flush*<br>Rotating hemostatic valves*<br>3-Way stopcock*<br>1-Way valve*<br>IV pole*<br>Femoral Sheath*<br>Alkaline Batteries* | |
| * - Not provided as<br>part of the system,<br>chosen based upon<br>physician<br>experience and<br>preference. | | | |

#### Technological Comparison G.

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KO32872

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This technological comparison demonstrates the substantially equivalent technologies used in the proposed longer MicroCoil System and the predicate Micrus MicroCoil System.

#### Discussion of Non-Clinical Tests and Conclusions H.

The non-clinical tests performed on the Micrus longer Spherical MicroCoil System were based upon the intended use of the device and the performance of the predicate Micrus regular length Spherical MicroCoil System.

The following table outlines the important device characteristics and the non-clinical test data generated:

| Test | Proposed Long Spherical MicroCoil System | Substantial<br>Equivalence to the<br>current Micrus<br>Spherical MicroCoil<br>System |
|-------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| V0381 | The 10 System long Spherical MicroCoil<br>System demonstrates the durability to<br>withstand 6 cycles of deployment and<br>retraction through the tip of the microcatheter<br>in a tortuous anatomy flow model without<br>stretching, knotting, or breaking. | Substantially<br>equivalent |
| V0384 | The long Spherical MicroCoil System is able to<br>advance, retract, frame the aneurysm, and<br>enable packing of the framed aneurysm with<br>helical filler coils. | Substantially<br>equivalent |
| V0387 | The frictional forces of the long Spherical<br>MicroCoil System were equal or less than the<br>currently marketed helically shaped and<br>spherically shaped MicroCoil systems. | Substantially<br>equivalent |

This non-clinical testing has demonstrated the substantially equivalent performance of the Micrus Long Spherical MicroCoil System with the predicate Micrus Regular Length Spherical MicroCoil System.

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NOV 2 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Margaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation 610 Palomar Avenue Sunnyvale, California 94085

Re: K032872

Trade/Device Name: MicroCoil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: September 11, 2003 Received: September 15, 2003

Dear Ms. Webber:

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 preval application (PM) \). You may, therefore, market the device, subject to the general controls provisions of the Act. Hhe general controls provisions of the Act include requirements for annual registration. Insting 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 (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. Margaret Webber

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 Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely vours.

Mark N Millerm

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name:

510(k) Number (if known):

Indications for Use:

The MicroCoil System is intended for endovascular embolization of intracranial aneurysms.

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

## CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Over the Counter Use: or Prescription Use: (Per 21 CFR 801.109)

fo Mark N. Millerson

JIVISION Sign-Ciff) Division of Cercral, Restorative and Neurological Devices

Number K032872