MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)

K040694 · Micro Therapeutics, Inc. · HCG · Mar 25, 2004 · Neurology

Device Facts

• Record ID: K040694
• Device Name: MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
• Applicant: Micro Therapeutics, Inc.
• Product Code: HCG · Neurology
• Decision Date: Mar 25, 2004
• Decision: SESE
• Submission Type: Special
• 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 Sapphire "N Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.

Device Story

Sapphire Tetris 3-D Detachable Coil System; platinum alloy wire wound into primary coil, formed into secondary 3D spherical cage; inner Nickel-Titanium filament; welded to positioning wire (stainless steel core, stainless steel coil, Teflon jacket). Used for endovascular embolization of intracranial aneurysms and neurovascular abnormalities. Operated by neurosurgical team in clinical setting. Detachment achieved via battery-operated power supply (SDS) dissolving detachment element. Provides mechanical occlusion of vascular defects; benefits patients by offering minimally invasive alternative to traditional operative techniques for high-risk or inoperable conditions.

Clinical Evidence

Bench testing only. Evaluated coil deformation, delivery/frictional characteristics, fatigue reliability, premature detachment, coil knotting, detachment time, and physical dimensions. Physician/marketing laboratory side-by-side comparison with predicate performed. All tests met established acceptance criteria.

Technological Characteristics

Platinum alloy wire coil; Nickel-Titanium inner filament; stainless steel positioning wire with Teflon jacket. 3D spherical cage geometry. Detachment via battery-operated power supply (electrolytic dissolution). Standalone device. Sterilized using standard 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

• Sapphire Detachable Coil System (K993418)

Reference Devices

• Sapphire Atlas 3-D

Submission Summary (Full Text)

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#### Micro Therapeutics, Inc.

## MAR 2 5 2004

| 510(k) Summary | |
|-----------------|--------------------------------------------------------------------|
| Trade Name: | Sapphire Detachable Coil System (Tetris 3-D) |
| 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 | Predicate For | Clearance Date |
|---------|------------------------------------|--------------------|----------------|
| K993418 | Sapphire Detachable Coil<br>System | Sapphire Atlas 3-D | July 21, 2003 |

### Device Description

The Sapphire Tetris 3-D coil is manufactured from a platinum alloy wire which is first wound into primary coil and then formed into a secondary three-dimensional structure, which forms a spherical cage of loops. The Tetris is manufactured with an inner filament made of a Nickel-Titanium. The Tetris 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 (SDS), which dissolves a small detachment element between the emboliozation coil and the positioning wire.

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

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### Verification and Test Summary Table

| Bench Testing | Sapphire Fibered Coils |
|-----------------------------------------------------------------------------------|--------------------------------------|
| Coil Deformation | Meet established acceptance criteria |
| Ease of Delivery/Coil Frictional Characteristics | Meet established acceptance criteria |
| Reliability After Fatigue & Premature Detachment | Meet established acceptance criteria |
| Coil Knotting | Meet established acceptance criteria |
| Detachment Time | Meet established acceptance criteria |
| Physical Dimensions | Meet established acceptance criteria |
| Physician/Marketing Laboratory Evaluation (side-by-side<br>comparison with Atlas) | Meet established acceptance criteria |

## Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the Sapphire Tetris 3-D coils compared with the predicate device Sapphire Atlas 3-D coils.

The two devices have the same intended use,

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

In summary, the Sapphire Tetris 3-D 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 is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 2004

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

Re: K040694

Trade/Device Name: Sapphire Tetris 3-D Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: March 16, 2004 Received: March 17, 2004

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 10 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 (sec 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 vours

Authority, 2012,

Mark N Milliman

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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K040694

# Indications for Use

510(k) Number (if known):

Sapphire Tetris 3-D Detachable Coil System Device Name:

Indications For Use:

The Sapphire™ Detachable Coils are intended for the endovascular cmbolization 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 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)

Mark N. Millman

Division of General, Restorative. and Neurological Devices

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510(K) Number K040694