SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS

K033372 · Micro Therapeutics, Inc. · HCG · Jan 9, 2004 · Neurology

Device Facts

• Record ID: K033372
• Device Name: SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
• Applicant: Micro Therapeutics, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jan 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sapphire Detachable Fibered 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 Sapphire Detachable Fibered Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.

Device Story

Sapphire Detachable Fibered Coil System consists of platinum alloy wire wound into primary coils and secondary helical shapes; nylon fibers secured to primary coil. Device includes positioning wire with stainless steel core, stainless steel coil at distal end, and Teflon jacket. Detachment achieved via battery-operated Sapphire Detachment System (SDS) which dissolves detachment element. Used in neurovascular procedures by neurosurgeons/interventionalists to embolize intracranial aneurysms, AVMs, and fistulae. Coil placement via endovascular approach; detachment triggered by clinician using SDS. Provides mechanical occlusion of vascular abnormalities; benefits include treatment of otherwise inoperable or high-risk intracranial lesions.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by in-vivo and in-vitro studies and technological comparison to predicate devices.

Technological Characteristics

Platinum alloy wire primary coil; secondary helical shape; nylon 6-6 fibers. Positioning wire: stainless steel core, stainless steel distal coil, Teflon jacket. Detachment: electrolytic dissolution via battery-operated power supply. Radiopaque. MRI compatible. Sterile, single-use.

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

• MTI Sapphire Detachable Fibered Coil System (K031852)
• MTI Sapphire Detachable Coil System (K030392)
• Cook, Inc. Hilal Embolization Microcoil (K901337)

Submission Summary (Full Text)

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K03372

JAN - 9 2004

## Micro Therapeutics, Inc. Micro Therapeutics, Inc.
Premarket Notification (510(k) for Sapphire Detachable Fibered Coil System

| 510(k) Summary | |
|-----------------|--------------------------------------------------------------------|
| Trade Name: | Sapphire Detachable Fiber Coils |
| Generic Name: | Artificial Embolization Coil |
| Classification: | Class III, 21 CFR 882.5950 |
| Submitted By: | Micro Therapeutics, Inc.<br>2 Goodyear<br>Irvine, California 92618 |
| Contact: | Florin Truuvert |

#### Predicate Device:

| Number | Description | Clearance Date |
|---------|---------------------------------------------|-------------------|
| K031852 | MTI Sapphire Detachable Fibered Coil System | August 20, 2003 |
| K030392 | MTI Sapphire Detachable Coil System | July 21, 2003 |
| K901337 | Cook, Inc. Hilal Embolization Microcoil | November 13, 1990 |

#### Device Description

The Sapphire Detachable Fibered Coil System is manufactured from a platinum alloy wire, which is first wound into primary coil and then formed into a secondary helical shape. The coil is welded to a positioning wire, which consist of ground stainless steel core wire with a stainless steel coil laser welded at the distal end and a Teflon outer jacket. The coil is detached by the battery operated power supply (Sapphire Detachment System, SDS), which dissolves a small detachment element between the emboliozation coil and the positioning wire. The fibered coil is manufactured with nylon fibers secured into the primary coil. The fibered coils are available in two shapes (Helix and Cyclone) and different sizes.

#### Indication For Use

The Sapphire Detachable Fibered 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 Sapphire Detachable Fibered Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.

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## Micro Therapeutics, Inc. Premarket Notification (510(k) for Sapphire Detachable Fibered Coil System

## Purpose Of the Submission

This Premarket Notification is submitted to obtain marketing clearance for a change in the indication for use of the Sapphire Detachable Fibered Coil System. The Sapphire fibered coils have originally received 510(k) clearance (K031852) on August 20, 2003 for embolization of neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae as well as arterial and venous cmbolization in the peripheral vasculature.

The proposed change in indication is to expand the use of the fibered coils in ancurysm. This is supported by in-vivo, in-vitro studies as well as technological comparison to the predicate device, Cook, Inc. Hilal embolization Microcoil.

| Characteristics | Cook, Hilal Embolization Microcoil | Sapphire Fibered Coils |
|------------------------------|------------------------------------|------------------------|
| Microcoil system supplied as | Sterile, single use | Same |
| Coils shapes | Straight and Curled | Helix and Cyclone |
| Coil length and diameter | Various | Same |
| Catheter compatibility | 18" | 10" and 18" |
| Radiopacity | Radiopaque from Pt alloy wire. | Same |
| MRI Compatibility | Yes | Same |
| Material | | |
| Main Coil | Platinum alloy | Same |
| Fiber Material | Synthetic fiber | Nylon 6-6 |
| Detachment Element | Stainless Steel | Same |

#### Comparison To the Predicate Device

#### Summary of Substantial Equivalence

The above comparison table demonstrates the technological similarity and equivalincy of the Sapphire fibered coils compared with the predicate device, Cook, Inc. Hilal embolization Microcoil. The two devices have the same intended use and incorporate the same basic technological design.

In summary, the Sapphire fibered 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 2004

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

Re: K033372

Trade/Device Name: Sapphire Detachable Fibered Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: October 20, 2003 Received: October 29, 2003

Dear Ms. Truuvert:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications forchenced above and no sure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to regard ment date of the Medical Device Amendments, or to commerce phor to May 20, 1978, as econdance with the provisions of the Federal Food, Drug, devices that have been rochanied in equire approval of a premarket approval application (PMA). alle Cosmette Act (11ct) that ao not required to the general controls provisions of the Act. The I ou may, therefore, mains of the Act include requirements for annual registration, listing of general controls provided on the 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to back as a 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 I reast of advised that I Dris a lossantes complies with other requirements of the Act that I Driving and regulations administered by other Federal agencies. You must or any i edelia all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Hot STequirements,01); good manufacturing practice requirements as set CI K ratt 607); laboring (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualis) 35001 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) I mis letter with anow you've substantial equivalence of your device of your device to a legally promation of neations "The 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 If you desire specific advice 107 Jour a01) 594-4659. Also, please note the regulation entitled, Connact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mornational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincercly 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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# Indications for Use

510(k) Number (if known): KOIJIJZZ

Device Name: Sapphire Detachable Fiber Coil System

Indications For Use:

The Sapphire Detachable Fibered Coils are intended for the endovascular embolization of The Sapphire Detactiable Hibered Couls are interestion, or the pation, or the pation. of the pation.'S intractal aneurysms that — because of the the provention to be a) very general medical condition – are tonsidered by the arranges, or b) be inoperable.

The Sapphire Detachable Fibered Coils are also intended for the embolization of other neuro The Sapphire Detactiable Fibered Oulis are ulos interious and arteriovenous fistulae.
vascular abnormalities, such as, atteriovenous 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)

uriam C. Provost

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

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510(k) Number K033372