NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR

K051560 · Micro Therapeutics, Inc. · HCG · Jun 28, 2005 · Neurology

Device Facts

• Record ID: K051560
• Device Name: NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR
• Applicant: Micro Therapeutics, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jun 28, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nexus Detachable Coils are intended for the endovascular embolization of intracranial aneurysms that -- because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) be inoperable. The Nexus Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.

Device Story

Platinum alloy coils enlaced with absorbable polymer fibers; attached to stainless steel guiding system with radiopaque positioning coil. Used for endovascular embolization of intracranial aneurysms and neurovascular abnormalities. Operated by neurosurgical teams in clinical settings. Designed for use with NXT Detachment System (sold separately) for coil detachment. Provides mechanical occlusion of vascular structures; benefits patients by treating lesions deemed high-risk or inoperable via traditional surgery.

Clinical Evidence

Bench testing only. Testing included coil deformation, dimensional/visual analysis, coating integrity, force transfer, delivery/frictional characteristics, fiber endurance, fatigue/detachment reliability, fiber pull-out, tensile strength, particulate generation, PGLA tensile testing, and packaging integrity. All tests met established criteria.

Technological Characteristics

Platinum alloy coils with absorbable polymer fibers; stainless steel guiding system; radiopaque positioning coil. Dimensions vary by model (Multi-Diameter/Helix). Standalone device used with separate detachment system. Sterilized via validated processes.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms in patients considered high-risk for traditional surgery or inoperable, and for embolization of neurovascular abnormalities including arteriovenous malformations and arteriovenous fistulae.

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

• Nexus Detachable Coil System (K050543)

Submission Summary (Full Text)

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K051560\u2044₂

Micro Therapeutics, Inc.

Special 510(k), Multi Diameter CSR, Helix Super Son

JUN 2 8 2005

| 510(k) Summary | | | |
|-----------------|---------------------------------------------------------|--|--|
| Trade Name: | Nexus Multi-Diameter CSR and Nexus Helix Super Soft CSR | | |
| Generic Name: | Neurovascular Embolization Device | | |
| Classification: | Class II, 21 CFR 882.5950 | | |
| Submitted By: | Micro Therapeutics, Inc. | | |
| | 2 Goodyear | | |
| | Irvine, California 92618 | | |
| Contact: | Florin Truuvert | | |

## Predicate Device:

| Number | Description | Predicate For | Clearance Date |
|---------|---------------------------------|------------------------------------------------|----------------|
| K050543 | Nexus Detachable Coil<br>System | Nexus Detachable Coil, Helix<br>Super Soft CSR | April 27, 2005 |

## Device Description

The Nexus coils are platinum alloy coils, enlaced with absorbable polymer fibers, and attached to a stainless steel guiding system with a radiopaque positioning coil. Nexus coils are designed for use with the NXT Detachment System specifically designed for coil detachment. The NXT Detachment System is sold separately.

### Indication For Use

The Nexus Detachable Coils are intended for the endovascular embolization of intracranial aneurysms that -- because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) be inoperable. The Nexus Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.

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| Bench Testing | Result |
|----------------------------------------------------|--------------------------|
| Coil Deformation | Met established criteria |
| Dimensional & Visual Analysis | Met established criteria |
| Coating Integrity | Met established criteria |
| Force Transfer | Met established criteria |
| Ease of Delivery/Coil Frictional Characteristics | Met established criteria |
| Fiber endurance Testing | Met established criteria |
| Reliability After Fatigue & Premature Detachment | Met established criteria |
| Fiber Pull-Out | Met established criteria |
| Tensile Strength | Met established criteria |
| Particulate Generation - Adjusted Particles / 1 mL | Met established criteria |
| PGLA Tensile Testing | Met established criteria |
| Packaging Integrity | Met established criteria |

## Verification and Test Summary Table

### Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the Nexus Multi-Diameter CSR and Helix Super Soft CSR coils compared with the predicate device Nexus Detachable Coils.

The two 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 processes. .

In summary, the Nexus coils described in this submission are, in our opinion, substantially equivalent to the predicate device.

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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 abstract symbol resembling three stylized human figures or birds in flight, stacked vertically. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 8 2005

Ms. Florin Truuvert Regulatory Affairs Manager Micro Therapeutics Incorporated 2 Goodyear Irvine, California 92618

Re: K051560

Trade/Device Name: Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSR

Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: II Product Code: HCG Dated: June 10, 2005 Received: June 14, 2005

Dear Ms. Truuvert:

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. Florin Truuvert

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/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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05/560

# Indications for Use

510(k) Number (if known):

Device Name: Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSR

Indications For Use:

The Nexus Detachable Coils are intended for the endovascular embolization of intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition – are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) be inoperable. The Nexus Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.

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

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)

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