SAPPHIRE DETACHABLE FIBER COILS

K031852 · Micro Therapeutics, Inc. · HCG · Aug 20, 2003 · Neurology

Device Facts

• Record ID: K031852
• Device Name: SAPPHIRE DETACHABLE FIBER COILS
• Applicant: Micro Therapeutics, Inc.
• Product Code: HCG · Neurology
• Decision Date: Aug 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sapphire 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 intended uses of the Sapphire fiber coils are narrowed relative to the predicate device GDC, but still fall within the 510(k) cleared intended use. Sapphire Detachable Fibered Coil - The Sapphire fibered coil is intended for embolization of neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Fibered Sapphire is also intended for arterial and venous embolizations in the peripheral vasculature.

Device Story

Platinum alloy wire wound into primary coil and secondary helical shape; attached to stainless steel positioning wire with Teflon jacket. Detachment achieved via battery-operated Sapphire Detachment System (SDS) which dissolves detachment element. Used by neurosurgeons in clinical/OR settings for endovascular embolization. Device provides mechanical occlusion of aneurysms/vascular abnormalities; nylon fibers on coil promote embolization. Physician monitors placement via fluoroscopy; detachment confirmed by SDS. Benefits include minimally invasive treatment of high-risk/inoperable intracranial aneurysms and vascular malformations.

Clinical Evidence

Bench testing (coil strength, fatigue, tensile strength, radiopacity, shelf life, fiber endurance) met acceptance criteria. Animal testing compared to predicate showed comparable coil-per-aneurysm, detachment time, and angiographic assessment at 1-3 months; Sapphire demonstrated higher detachment reliability. Physician evaluation confirmed comparable ease of use, trackability, and fluoroscopic visibility.

Technological Characteristics

Platinum alloy wire coil; stainless steel positioning wire with Teflon jacket; nylon fibers. Detachment via electrolytic dissolution (SDS). Available in Helix and Cyclone shapes. MRI compatible (1.5 Tesla).

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms in patients at high risk for traditional surgery or inoperable; also indicated for embolization of neurovascular abnormalities (AVMs, arteriovenous fistulae) and arterial/venous embolizations in peripheral vasculature.

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

• Fibered GDC VortX Shape Guglielmi Detachable Coil (K993418)

Submission Summary (Full Text)

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AUG 2 0 2003

K03 i852/P.13

Premarket Notification (510(k) for Sapphire Detachable Fibered C

| 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. |
| | 2 Goodyear |
| | Irvine, California 92618 |
| Contact: | Florin Truuvert |

#### Predicate Device:

Micro Therapeutics, Inc.

| Number | Description | Predicate For | Clearance Date |
|---------|------------------------------------------------------|---------------------------------------|----------------|
| K993418 | Fibered GDC VortX Shape<br>Guglielmi Detachable Coil | Sapphire Fibered Helix<br>and Cyclone | 1/21/2000 |

### Device Description

The Sapphire Detachable Coil (SDC) 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 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 intended uses of the Sapphire fiber coils are narrowed relative to the predicate device GDC, but still fall within the 510(k) cleared intended use.

Sapphire Detachable Fibered Coil - The Sapphire fibered coil is intended for embolization of neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Fibered Sapphire is also intended for arterial and venous embolizations in the peripheral vasculature.

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K031852/P2/3

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

## Verification and Test Summary Table

| Bench Testing | Sapphire Fibered Coils |
|--------------------------------------------------------|----------------------------------------------|
| Coil Strength (Coil Deformation and Softness Testing) | Meet established acceptance criteria |
| Ease of Delivery | Meet established acceptance criteria |
| Reliability After Fatigue & Premature Detachment | Meet established acceptance criteria |
| Tensile Strength of Coil & Detachment Zone | Meet established acceptance criteria |
| Tensile Strength of Delivery Wire | Meet established acceptance criteria |
| Delivery Wire Flexibility | Meet established acceptance criteria |
| Detachment Time | Meet established acceptance criteria |
| Radiopacity | Meet established acceptance criteria |
| Particulate Generation of Detachment Zone | Meet established acceptance criteria |
| Aging and Shelf Life (3 year) | Meet established acceptance criteria |
| Fiber Pull Out | Meet established acceptance criteria |
| Fiber Endurance | Meet established acceptance criteria |
| Packaging validation after 3-year accelerated aging | Meet established acceptance criteria |
| Animal Testing | Comparison to the Predicate Device |
| Coil Per Aneurysm (Avg./S.D.) | Comparable |
| Detachment Time (seconds) | Comparable |
| Coil Detachment Reliability (detachment attempts/coil) | The Sapphire demonstrated higher reliability |
| Post Embolization Angiographic Assessment | Comparable |
| Angiographic Assessment One-Month Follow-Up | Comparable |
| Angiographic Assessment Three-Month Follow-Up | Comparable |
| Physician Device Evaluation | Acceptance Criteria |
| Ease of Coil Preparation | Comparable |
| Ability to move coil within Catheter | Comparable |
| Access | Acceptance Criteria |
| Ability to Place catheter tip in desired location | Comparable |
| Trackability, Friction of coil through catheter | Comparable |
| Coil Visualization | Acceptance Criteria |
| Fluoroscopic visibility of Coil | Comparable |
| Fluoroscopic visibility of Detachment Markers | Comparable |
| Coil Delivery Procedure | Acceptance Criteria |
| Ability to Position Coil in Sac | Comparable |
| Detachment Time | Comparable |
| Ability to Pack Aneurysm Sac | Comparable |
| Ability to Reposition | Comparable |
| Ease of use of the SDS Detachment System | Comparable |
| Coil Positional Stability/Aneurysm Occlusion | Comparable |
| Overall | Acceptance Criteria |
| Ease of Use | Comparable |
| Overall performance | Comparable |
| MRI Compatibility | Compatible with 1.5 Tesla |

. •

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K031852/P3/3

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

#### Summary of Substantial Equivalence

The above comparison table demonstrates the technological similarity and equivalency of the Sapphire fibered coils compared with the predicate device, Target GDC fibered coils. The two devices have the same intended use,

- Use the same operating principle,
- Incorporate the same basic design, .
- Have the same Intended Use, ●
- Are packaged and sterilized using similar materials and processes.

In summary, the Sapphire fibered 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/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2003

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

Re: K031852

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: June 13, 2003 Received: June 24, 2003

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/dsma/dsmamain.html

Sincerely yours.

Mark N. Melson

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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K031852

0

# Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Sapphire Detachable Fibered Coil System

Indications for Use:

#### Sapphire Detachable Coils (Non-Fiber)

The Sapphire 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 intended uses of the Sapphire fiber coils are narrowed relative to the predicate device GDC, but still fall within the 510(k) cleared intended use.

Sapphire Detachable Fibered Coil - The Sapphire fibered coil is intended for embolization of neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Fibered Sapphire is also intended for arterial and venous embolizations in the peripheral vasculature.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div>OR</div> <div>(Per 21 CFR 801.109)</div> | Over the Counter Use |
|------------------|-----------------------------------------------|----------------------|
|------------------|-----------------------------------------------|----------------------|

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

| 510(k) Number | K031852 |
|---------------|---------|
|---------------|---------|