NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR

K051425 · Micro Therapeutics, Inc. · HCG · Jun 22, 2005 · Neurology

Device Facts

• Record ID: K051425
• Device Name: NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR
• Applicant: Micro Therapeutics, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jun 22, 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

Neurovascular embolization device; platinum alloy coils; absorbable polymer fibers; stainless steel guiding system; radiopaque positioning coil. Used for endovascular occlusion of intracranial aneurysms, arteriovenous malformations, and fistulae. Operated by neurosurgical team in clinical setting. Coils delivered via catheter; detached using NXT Detachment System (sold separately). Provides mechanical embolization to reduce blood flow to target vascular abnormality; benefits patient by treating lesions otherwise deemed inoperable or high-risk for 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, and PGLA tensile testing. All tests met established criteria.

Technological Characteristics

Platinum alloy coils; absorbable polymer fibers; stainless steel guiding system; radiopaque positioning coil. Mechanical embolization principle. Sterile. No software or electronic components.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms in patients considered high-risk for traditional surgery or inoperable; also indicated for 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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K051425,

JUN 2 2 2005

### Micro Therapeutics, Inc.

Special 510(k), Nexus Helix Super Soft CSR

| 510(k) Summary | |
|-----------------|-----------------------------------|
| Trade Name: | 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<br>Date |
|---------|---------------------------------|------------------------------------------------|-------------------|
| K050543 | Nexus Detachable Coil<br>System | Nexus Detachable Coil, Helix<br>Super Soft CSR | April 27, 2005 |

### Device Description

The Nexus Helix Super Soft CSR arc platinum alloy coils, enlaced with absorbable polymer fibers, and attached to a stainless steel guiding system with a radiopaque positioning coil. Nexus Helix Super Soft CSR 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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bs14252/v

### Micro Therapeutics, Inc.

Special 510(k), Nexus Helix Super Soft CSR

# Verification and Test Summary Table

| 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 |

### Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and The data prescificul in this submission actively 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 Helix Super Soft CSR coils described in this submission are, 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 2005

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

Re: K051425

Trade/Device Name: Nexus Detachable Coil, Helix Super Soft CSR Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: II Product Code: HCG Dated: May 31, 2005 Received: June 1, 2005

Dear Ms. Truuvert:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreated of the enactment date of the Medical Device Amendments, or to conimered prior to rial) 2011-07-11 in accordance with the provisions of the Federal Food, Drug, uc necs that hat to been require approval of a premarket approval application (PMA). and Cosmetic (110. (110.) that to device, subject to the general controls provisions of the Act. The r ou may, merelore, manes of the Act include requirements for annual registration, listing of general controls provisions 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 it may of subject to bash as Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA oun or found in the ovaouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease of acrised a determination that your device complies with other requirements of the Act that I Dr Hao intatutes and regulations administered by other Federal agencies. You must or any I cach statutes and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fart 607); adoling (21 CFR Part 820); and if applicable, the electronic forth in the quant) 3500210 (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) This letter will allow you to begin maketing your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales of tyour premarket notification. The FDA Iniding of substantal of a levice 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
rs the regularies and 10 10 10 10 115 - Also, masses note the regulation en If you desire specific advice for your de need on our of . Also, please note the regulation entitled,
contact the Office of Compliance at [phone] . Also, please note t contact the Office of Compliatics at (240) 270 - 1712097 Patt 807.97). You may obtain
"Misbranding by reference to premarket notification that attact from the Division of Sm "Misbranding by reference to premarket nouliicanon" (er on the Division of Small)
other general information on your responsibilities under the Act from the Division of Small other general information on your responsionals and its toll-free number [phone] or Manufacturers, International and Colisunier Assistance at to too in industry/support/index.html.

Sincerely yours,

E. E. H.

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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051425

# Indications for Use

510(k) Number (if known):

Nexus Detachable Coil, Helix Super Soft CSR Device Name:

Indications For Use:

The Nexus Detachable Coils are intended for the endovascular embolization of The Next's Delachable Cons are menous to morphology, their location, or the mitfactanial ancearyonis mat
patient's general medical condition -- are considered by the treating patient's general medical very high risk for management by traditional neurosurgical team to oc a) very ing increable. The Nexus Detachable Coils are also a operative techniques, or 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)

signature

ும் நீர்ந்-மரி) ion of General, Restorative and Neurological Devices 5147

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