MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR

K031578 · Micrus Corp. · HCG · Aug 1, 2003 · Neurology

Device Facts

• Record ID: K031578
• Device Name: MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR
• Applicant: Micrus Corp.
• Product Code: HCG · Neurology
• Decision Date: Aug 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Micrus MicroCoil Systems are intended for endovascular embolization of intracranial aneurysms.

Device Story

Micrus MicroCoil System consists of platinum embolic coils attached to a Device Positioning Unit (DPU). Used in endovascular procedures to embolize intracranial aneurysms; operated by clinicians in a clinical setting. The system connects to a Micrus Connecting Cable and a reusable Detachment Control Box (DCB). The clinician navigates the microcatheter to the aneurysm site; the coil is deployed; detachment is achieved by applying current from the DCB to a resistive heating coil on the DPU, which shears a polyethylene fiber holding the coil. The DPU is then removed. The device provides a minimally invasive alternative to surgical clipping, reducing patient disability and dependency as demonstrated in clinical trials.

Clinical Evidence

Evidence based on the International Subarachnoid Aneurysm Trial (ISAT), a multi-center randomized trial comparing endovascular coiling (n=1073) to surgical clipping (n=1070) in patients with ruptured intracranial aneurysms. Primary endpoint: neurological dependency at 1 year (Rankin scale). Results: 23.7% of endovascular patients were dependent/dead vs 30.6% of surgical patients (relative risk reduction 22.6%; absolute risk reduction 6.9%).

Technological Characteristics

Implant materials: platinum/tungsten alloy wire, Au/Sn solder, and non-absorbable polypropylene suture (for stretch-resistant models). Delivery system: stainless steel hypotube/braid and polymer sheathing. Detachment: resistive heating of a polyethylene fiber. MRI compatible. Single-use sterile coils; reusable battery-powered detachment control box. Complies with ISO 10993 for biocompatibility.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms in patients requiring treatment for such conditions.

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)
• Micrus Stretch Resistant MicroCoil System (K022420)

Submission Summary (Full Text)

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K031578

### Safety and Effectiveness Summary II.

#### A. Contact Information

Margaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation 610 Palomar Avenue Sunnyvale, CA 94085

#### Device Name B.

Micrus MicroCoil System Classification: Device, Artificial Embolization Regulation Number: 882.5950 Product Code: HCG Device Class: III

#### C. Predicate Device(s)

This 510k application is for a labeling change to the FDA cleared Micrus MicroCoil Systems listed in the table below:

| Number | Description | Clearance Date |
|---------|-------------------------------------------|----------------|
| K002056 | Micrus MicroCoil Delivery System | 01/11/2001 |
| K022420 | Micrus Stretch Resistant MicroCoil System | 10/22/2002 |

#### Device Description: Unchanged from predicates listed above. D.

Micrus MicroCoil Systems are platinum embolic coils ("MicroCoils") attached to Device Positioning Units (DPUs (single use, sterile). The Micrus MicroCoil Systems are available in a 10-System size (compatible with 10 and 14 sized microcatheters) and 18-System size (compatible with 14 and 18 sized microcatheters). Both 10 and 18 sizes are available in various diameters/dimensions. Shapes can be spherical, helical, or straight. Lengths range from 1 to 30 centimeters and diameters range from 2 to 20 millimeters. Implant material for the non stretch resistant MicroCoils is a platinum alloy: implant material for the stretch resistant MicroCoils is a platinum alloy and a stretch resistant member (non-absorbable polypropylene suture).

A MicroCoil is detached from its Device Positioning Unit through heat shearing of a highly oriented, high tensile strength polyethylene (PE) fiber upon the clinician's command. The Device Positioning Unit is then removed from the microcatheter and discarded.

A Micrus MicroCoil System connects to a Micrus Connecting Cable (single use, sterile) which traverses the sterile field to connect to a Micrus Detachment Control Box (DCB) (reusable, non-sterile). The Connecting Cable and Detachment Control Box are sold separately. A MicroCoil System plus Connecting Cable and Detachment Control Box is referred to as a Micrus MicroCoil Delivery System.

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## Intended Use (Indication for Use Statement) E.

Micrus MicroCoil Systems are intended for endovascular embolization of intracranial aneurysms.

### Technological Comparison F.

There is no change in the technology from that of 510k numbers K002056 and K022420. The Micrus MicroCoil System remains the same. The only change is the Indication for Use (to be justified in the Section I, "Justification for Labeling Change Based Upon Clinical Outcomes of ISAT"

| | MicroCoil System (Unchanged) | |
|----------------|------------------------------------|---------------------|
| Characteristic | Micrus MicroCoil System Predicate | Current Application |
| MicroCoil | Sterile, single use. | Same as predicate |
| System | MicroCoil attached to DPU. | Same as predicate |
| supplied as: | Polyethylene introducer over coil. | Same as predicate |
| | In plastic package hoop. | Same as predicate |

| Implantable Embolic Coil (Unchanged) | | |
|---------------------------------------------------------------|---------------------------------------------------------------------|---------------------|
| Characteristic | Micrus MicroCoil System Predicate | Current Application |
| Materials of<br>Construction | Platinum/Tungsten alloy wire &<br>Au/Sn solder | Same as predicate |
| Shape | Spherical, helical, & straight | Same as predicate |
| Dimensions | Various diameters & lengths to treat<br>a variety of aneurysm sizes | Same as predicate |
| Radiopacity | Radiopaque from Pt alloy wire | Same as predicate |
| MRI<br>Compatibility | Yes | Same as predicate |
| Method of<br>Attachment to<br>Device<br>Positioning<br>Unit | High tensile strength, highly<br>oriented polyethylene fiber | Same as predicate |
| Method of<br>Detachment<br>from Device<br>Positioning<br>Unit | Shear polyethylene fiber with a loop<br>of resistively heated coil | Same as predicate |
| Provided: | Sterile, single use | Same as predicate |

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| Device Positioning Unit (Unchanged) | | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Characteristic | Micrus MicroCoil System Predicate | Current Application |
| Physical | Variable stiffness.<br>Composite introducer.<br>Most flexible distally, medium<br>flexibility in mid-section and stiffest<br>proximally to allow pushing of the<br>embolic coil through the tortuous<br>cerebral vasculature. | Same as predicate |
| Construction | Stainless steel hypotube (proximal),<br>stainless steel braid (mid) and<br>polymer (distal) sheathing for 2<br>conduction wires and distal RH coil. | Same as predicate |
| Working<br>Length | 175 cm | Same as predicate |
| Package<br>Configuration | In plastic packaging hoop.<br>Introducer in place (for introduction<br>of MicroCoil into the microcatheter). | Same as predicate |
| Compatible<br>with: | Microcatheters with minimum 0.14"<br>i.d. ("10" sized systems), or 0.16"<br>i.d. ("18" sized systems).<br>2 radiopaque tip markers 3 cm apart<br>(examples: Tracker 10, Tracker 18,<br>Excel 14, Prowler 10, Prowler 14). | Same as predicate |

| Connecting Cable (Unchanged) | | |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Characteristic | Micrus MicroCoil Delivery System<br>Predicate | Current Application |
| How supplied: | Sterile, single use | Same as predicate |
| Physical | Single cable with proprietary<br>connectors to fit only the Micrus<br>Detachment Control Box and the<br>Micrus MicroCoil System | Same as predicate |
| Length | 262 cm. | Same as predicate |

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| Detachment Control Box (Unchanged) | | |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Characteristic | Micrus MicroCoil Delivery System<br>Predicate | Current Application |
| How supplied | Non-Sterile, reusable.<br>Used outside the sterile field. | Same as predicate |
| Power Source | Alkaline batteries. | Same as predicate |
| Displays | Voltage, Current, Low Battery,<br>Fault, Detach Cycle | Same as predicate |
| Detachment<br>Cycle<br>Duration | 5 seconds | Same as predicate |
| Output<br>Voltage | 6.5 VDC | Same as predicate |
| Output<br>Current | 125 mA nominal, 200 mA max. | Same as predicate |
| "Detach"<br>feedback | "Detach Cycle" light goes from<br>illuminated to off. Also, a beep<br>sounds once a second for 5 seconds<br>to provide an audible countdown of<br>the 5 second detachment time.<br>Clinician verifies detachment<br>fluoroscopically per device labeling. | Same as predicate |
| Method to<br>attach<br>Connecting<br>Cable to<br>Detachment<br>Box | Proprietary connector; fits only one-<br>way to assure proper polarity. | Same as predicate |
| Flow of<br>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. | Same as predicate |

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| Accessories (Unchanged) | | |
|---------------------------------------------------------------------------------------------------------------|-------------------------------------------|------------------------|
| Characteristic | Micrus MicroCoil System<br>Predicate | Current<br>Application |
| Accessory<br>Products Required<br>to Perform the<br>Procedure. | Micrus Sterile Connecting Cable | Same as predicate |
| | Micrus Detachment Control Box | Same as predicate |
| | 5-7F Guide Catheter* | Same as predicate |
| | Microcatheter (see above)* | Same as predicate |
| | Guide wire compatible with microcatheter* | Same as predicate |
| | Continuous saline/heparin saline flush* | Same as predicate |
| * - Not provided as<br>part of the system,<br>chosen based upon<br>physician<br>experience and<br>preference. | Rotating haemostatic valves* | Same as predicate |
| | 3-Way stopcock* | Same as predicate |
| | 1-Way valve* | Same as predicate |
| | IV pole* | Same as predicate |
| | Femoral Sheath* | Same as predicate |
| | Alkaline Batteries* | Same as predicate |

This technological comparison demonstrates the Micrus MicroCoil Delivery System remains equivalent to 510k numbers K002056 and K022420

#### Discussion of Non Clinical Tests and Conclusions (Unchanged) G.

The non-clinical tests performed on the Micrus MicroCoil System were reviewed in 510k numbers K002056 and K022420. A summary of non-clinical tests and results are supplied here as a reference.

| Test | Results (Unchanged) | Substantial<br>Equivalence |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Aneurysm Packing /<br>Detachment<br>Reliability | Characteristic:<br>■ Complete occlusion of<br>aneurysms.<br>■ Detachment Reliability.<br>Test data:<br>■ No filling defects evident on<br>angio.<br>■ No premature detachment /<br>auto-detach caused by<br>exposure to blood, body<br>fluids, body temperatures or<br>repeated manipulation. 100%<br>first detach-cycle detachment<br>achieved. | Equivalent |
| Coil Stability<br>Aneurysm Occlusion | Characteristic: Positional<br>stability and aneurysm<br>occlusion.<br>Test data: Positional stability and<br>aneurysm occlusion maintained<br>through 6 months of implant. No<br>coil compaction present at 6-<br>month angio. | Equivalent |
| GDC Bench<br>Marking | Characteristic: Established<br>specifications for delivery force,<br>tensile strength, and stiffness.<br>The Micrus Stretch Resistant<br>MicroCoil must be substantially<br>equivalent to predicates.<br>Test data: Showed substantial<br>equivalence in delivery force,<br>tensile, and stiffness. | Equivalent |
| Coil<br>Stiffness/Softness | Characteristic: Stiffness limit<br>desired for Finishing Stretch<br>Resistant MicroCoil.<br>Test data: Finishing Stretch<br>Resistant MicroCoil and Helical<br>Stretch Resistant MicroCoil<br>stiffness is within desired<br>stiffness limit. | Equivalent |
| Friction in the<br>Microcatheter<br>(Delivery Force) | Characteristic: Average push<br>force must be substantially<br>equivalent to predicates.<br>Test data: Finishing Stretch<br>Resistant MicroCoil and Helical<br>Stretch Resistant MicroCoil<br>average push force exhibit<br>comparable delivery forces. | Equivalent |
| MDR Database<br>Review | Characteristic: MDR review for<br>clinical risks.<br>Test data: MSR01 risk<br>assessment includes and<br>addresses all risks encountered<br>in review of predicate device<br>MDR review. | Equivalent |
| Biocompatibility of<br>Materials | Characteristics: Meets the<br>requirements of ISO 10993.<br>Test data: The only new material<br>in the Micrus Stretch Resistant | Equivalent |
| | MicroCoil is polypropylene<br>monofilament # 6523. It is<br>identical to the pre-approved<br>GDC stretch resistant suture. | |
| Sterilization<br>Validation | Characteristic: Minimum<br>Sterility Assurance Level of 10-6.<br>Test data: Passed minimum<br>sterility assurance level of 10-6. | Equivalent |
| Shelf Life Test | Characteristic: No performance<br>degradation after 1 year of shelf<br>life aging.<br>Test data: Minimum tensile<br>strength after 1 year accelerated<br>aging shows no degradation. | Equivalent |
| Tensile Strength | Characteristic: Tensile strength<br>of suture ball tip and MicroCoil<br>to DPU must be substantially<br>equivalent to predicates.<br>Test data: Tensile strength meets<br>desired strength criteria. | Equivalent |
| Durability<br>(Reliability after<br>Fatigue) | Characteristic: Withstand<br>deployment and retraction 6<br>times in a tortuous anatomy.<br>Test data: No knotting, no<br>breakage, no stretching occurred.<br>Durability meets desired<br>durability criteria. | Equivalent |
| MRI Compatibility<br>of Implant | No change was made which<br>would impact MRI<br>compatibility. | Equivalent |

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K031578

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# Justification for Labeling Change of "Indication for Use" Statement H. Background

Endovascular coiling of intracranial aneurysms has been in clinical practice in Europe since 1992 and since 1995 in the U.S. Prior to the advent of safe, detachable coil systems, patients with intracranial aneurysms had only one option: craniotomy and clipping. In the past 10 years, coiling has gained acceptance world wide as a viable option to surgical clipping.

Initially, endovascular coiling was viewed as an alternative to be used only when surgery was ill advised due to an aneurysm's shape or location, or to a patient's poor condition. Therefore, initially it was appropriate to label coils as intended for use in cases where the surgery was deemed to be high risk or impossible.

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K031578

Over the past 10 years many improvements have been made in endovascular techniques making coiling a superior option to surgery, as demonstrated in a recent multi-center study published in the Lancet. The purpose of the study was to compare outcomes of endovascular coiling to surgical clipping. Based upon the results of this study, in which MicroCoils were used (along with GDC and Cook coils) Micrus Corporation is requesting a change to its "Indication for Use" statement.

Micrus Corporation received CE Marking for the Micrus MicroCoil System in May 2000. followed by FDA market clearance in January 2001. After regulatory clearance, Micrus applied to the International Subarachnoid Aneurysm Trial Steering Committee for inclusion in their multi-center study. Permission was granted in February 2001. MicroCoils continued to be used in the study until study enrollment ended in June 2002.

# Brief Overview of the International Subarachnoid Aneurysm Trial (ISAT)

# Reason for the Study

ISAT was designed to establish the relative benefits of endovascular coiling versus surgical clipping for intracranial aneurysms in patients with ruptured intracranial aneurysms.

Methods

- ISAT enrolled 2143 patients with ruptured intracranial aneurysms and randomly assigned them to neurosurgical clipping (n = 1070) or endovascular treatment with platinum coils (n = 1073).
- · Clinical outcomes were assessed at 2 months and at 1 year.
- The primary outcome was a neurological assessment of dependency at 1 year (using the Rankin neurological outcome scale).

Findings

- 23.7% of endovascular patients were dependant or dead at 1 year.
- 30.6% of surgical patients were dependant or dead at 1 year.
- The relative risk reduction for endovascular patients (versus surgical) was 22.6%.
- The absolute risk reduction for endovascular patients (versus surgical) was 6.9%.
- The risk of rebleeding at 1 year for the endovascular patients was 2 per 1276.
- The risk of rebleeding at 1 year for the surgical patients was 0 per 1081. Interpretation
- The outcome in terms of survival, free of disability at 1 year, is significantly better with endovascular coiling.
- Long-term risks of further bleeding are low from either therapy, although slightly more frequent with endovascular coiling.

# Proposed Labeling Change to "Instruction for Use" pamphlet

Based upon the results of ISAT, Micrus Corporation proposes changing the current "Indication for Use" statement.

- The proposed "Indication for Use" labeling is as follows:
The ACT Platinum MicroCoil Systems are intended for endovascular embolization of intracranial aneurysms.

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Kc31578

### Summary of Safety and Effectiveness l.

Based upon the clinical trail results cited in the Lancet, it is concluded that the Micrus MicroCoil System (one of 3 platinum embolic coil systems used in this scientifically rigorous randomized trial) demonstrated treatment outcome is significantly better with endovascular coiling than with surgical clipping.

Margaret Webber Director, Regulatory & Clinical Affairs Micrus Corporation May 07, 2003

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Image /page/9/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 an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2003

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

Re: K031578

Trade/Device Name: Micrus MicroCoil Systems Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: May 7, 2003 Received: June 3, 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 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 (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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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 yours,

Miriam C. Provost

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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K 03/578

Device Name: Micrus MicroCoil Systems

510(k) Number (if known):

Indications for Use:

Micrus MicroCoil Systems are 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: V (Per 21 CFR 801.109)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K031578

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