SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT

K032497 · Micro Therapeutics, Inc. · HCG · Sep 25, 2003 · Neurology

Device Facts

• Record ID: K032497
• Device Name: SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT
• Applicant: Micro Therapeutics, Inc.
• Product Code: HCG · Neurology
• Decision Date: Sep 25, 2003
• 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.

Device Story

Sapphire Detachable VDS Tension Safe Coil System is an endovascular embolization device; platinum alloy wire wound into primary coil and secondary helical shape; features multiple segments with polymer caps. Device welded to positioning wire (stainless steel core, Teflon jacket). Operated by neurosurgeons in clinical settings; detachment achieved via battery-operated power supply (SDS) which dissolves a detachment element. System provides mechanical occlusion of intracranial aneurysms; benefits patients by offering minimally invasive alternative to traditional operative techniques for high-risk or inoperable aneurysms.

Clinical Evidence

Bench testing only. Testing included coil deformation, ease of delivery, frictional characteristics, fatigue reliability, tensile strength of detachment zone, detachment time, particulate generation, physical dimensions, radiopacity, and shelf life. All tests met established acceptance criteria.

Technological Characteristics

Platinum alloy wire coil; stainless steel positioning wire with Teflon jacket; polymer end caps. Detachment via electrolytic dissolution of a detachment element using a battery-operated power supply. Dimensions and radiopacity meet established specifications. Sterilization processes are identical to the predicate device.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms in patients considered high-risk for traditional surgery or inoperable due to aneurysm morphology, location, or general medical condition.

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)

Submission Summary (Full Text)

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# SEP 2 5 2003

Micro Therapeutics, Inc.

Special (510(k), Sapphire Detachable Coil System, VDS™ Tension Safe

510(k) Summary Sapphire Detachable VDS™ Tension Safe Coil System Trade Name: Artificial Embolization Coil Generic Name: Class III, 21 CFR 882.5950 Classification: Micro Therapeutics, Inc. Submitted By: 2 Goodyear Irvine, California 92618 Florin Truuvert Contact:

## Predicate Device:

| Number | Description | Predicate For | Clearance Date |
|---------|------------------------------------|-------------------|----------------|
| K993418 | Sapphire Detachable Coil<br>System | Sapphire VDS Coil | July 21, 2003 |

## Device Description

The Sapphire Detachable VDS™ Tension Safe Coil is manufactured from a platinum alloy wire which is first wound into primary coil and then formed into a secondary helical shape. The VDS Tension Safe has multiple coil segments with polymer "cap" at each segment ends, integrated into one coil system. 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 (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.

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K032447

# Micro Therapeutics, Inc. Special (510(k), Sapphire Detachable Coil System, VDS™ Tension Safe

# 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 |
| Tensile Strength of Coil & Detachment Zone | Meet established acceptance criteria |
| Detachment Time | Meet established acceptance criteria |
| Particulate Generation | Meet established acceptance criteria |
| Physical Dimensions | Meet established acceptance criteria |
| Radiopacity | Meet established acceptance criteria |
| Aging and Shelf Life (6 months) | Meet established acceptance criteria |

## Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the Sapphire VDS Tension Safe coils compared with the predicate device Sapphire VDS standard 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 the same materials and processes. .

In summary, the Sapphire VDS Tension Safe coils described in this submission are, in our opinion, substantially equivalent to the predicate device.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2003

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

Re: K032497

Trade/Device Name: Sapphire Detachable VDS™ Tension Safe Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: August 11, 2003 Received: August 26, 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,

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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# 103249

# Indications for Use Statement

510(k) Number (if known): ________

Device Name:

Sapphire VDS™ Tension Safe Detachable Coil System

Indications for Use:

#### Sapphire Detachable Coils

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over the Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use______________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)

Muriam C. Provost

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

510(k) Number K032477