SAPPHIRE DETACHABLE COIL SYSTEM

K030392 · Micro Therapeutics, Inc. · HCG · Jul 21, 2003 · Neurology

Device Facts

• Record ID: K030392
• Device Name: SAPPHIRE DETACHABLE COIL SYSTEM
• Applicant: Micro Therapeutics, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jul 21, 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 Sapphire™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.

Device Story

System consists of platinum/iridium alloy coils attached to positioning wire and Sapphire Detachment System (SDS) power supply. Used in neurovascular procedures to embolize aneurysms, AVMs, and fistulae. Physician advances coil through microcatheter to target site; once positioned, SDS power supply delivers current to dissolve detachment element, releasing coil. Provides mechanical occlusion of vascular abnormalities. Used in clinical/neurosurgical settings. Benefits include minimally invasive alternative to traditional open surgery for high-risk or inoperable patients.

Clinical Evidence

Bench testing included coil strength, delivery friction, detachment time, fatigue (10 cycles), tensile strength, radiopacity, and particulate generation. Materials evaluated for MRI compatibility. Animal studies validated performance parameters: coil maneuverability, fluoroscopic visibility, positioning, repositionability, aneurysm packing, and detachment system reliability. SDS power supply tested for electrical safety, EMI/EMC, and firmware functionality. All tests met acceptance criteria.

Technological Characteristics

Platinum/iridium alloy coils; spherical or helical shapes. Detachment via electrolytic dissolution of a sacrificial element using SDS power supply. Connectivity: SDS is an electrical power supply unit. Sterilization: validated sterile. Software: firmware controls detachment modes and states.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms in patients considered high-risk for 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

• Target Therapeutics' Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)

Submission Summary (Full Text)

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K030392/P1/2

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## 510(k) Summary

JUL 21 2003

| Trade Name | Sapphire Detachable Coil System |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | Target Therapeutics' Detachable Platinum Coil (Guglielmi<br>Detachable Coil, GDC) |
| Device<br>Description | The Sapphire Detachable Coil (SDC) is manufactured from a<br>platinum alloy attached to a positioning wire. The coil is detached<br>by the Sapphire Detachment System (SDS) power supply, which<br>dissolves a small detachment element between the emboliozation<br>coil and the positioning wire. This occurs after desired placement of<br>the coil in the anatomy. The Sapphire coils are manufactured from<br>platinum/iridium alloy wire that is first wound into the primary coil,<br>and then formed into a secondary (spherical or helical) shape.<br>The Sapphire Detachment Coils are manufactured in different<br>shapes and sizes. These coils are available in spherically shaped<br>configurations, as well as, helically shaped configurations of<br>various diameters and lengths. |
| Indication For<br>Use | The Sapphire™ Detachable Coils are intended for the endovascular<br>embolization of intracranial aneurysms that - because of their<br>morphology, their location, or the patient's general medical<br>condition - are considered by the treating neurosurgical team to be<br>a) very high risk for management by traditional operative<br>techniques, or b) be inoperable. The Sapphire™ Detachable Coils<br>are also intended for the embolization of other neuro vascular<br>abnormalities, such as, arteriovenous malformations and<br>arteriovenous fistulae. |
| Testing | The Sapphire Detachable Coil (SDC) series have been tested and<br>evaluated in performance characteristics including: Coil strength,<br>e.g., the force required to deform the coil shape; the ease of delivery<br>as measured by friction when advancing and retracting the coil<br>through various catheters positioned in a simulated tortuosity, and<br>the detachment time. In addition, reliability after fatigue (10<br>cycles), coil, detachment zone & coil weld tensile strength, delivery<br>wire flexibility, radiopacity and particulate generation were<br>measured and evaluated. The materials of the Sapphire Detachable<br>Coil series were evaluated with respect to compatibility with<br>Magnetic Resonance Imaging. All performance characteristics met<br>the acceptance criteria. All the above tests were performed and<br>evaluated after 1-year simulated aging and met the acceptance<br>criteria. |
| The Sapphire Detachable Coil (SDC) series have been tested and<br>evaluated with respect to packaging, sterile integrity and sterility<br>validation. The Sapphire Detachable Coil series has been validated<br>in animal studies addressing a wide range of performance<br>parameters, including: the ability to move coil within a<br>microcatheter, fluoroscopic visibility of coil ability to position coil<br>in aneurysm, coil reposition-ability, ability to pack the aneurysm<br>sac, ease of use of the detachment system, coil detachment time,<br>detachment reliability & coils stability.<br>The Sapphire Detachment System (SDS) has been tested and<br>evaluated for conductance of current, compliance with its product<br>specifications, detachment reliability, in-vitro and in-vivo, and has<br>met all acceptance criteria. The Sapphire Detachment System has<br>been tested and evaluated for electrical safety, radiated emission,<br>radio disturbance and Electro-Static Discharge immunity. The<br>firmware as part of the Sapphire Detachment System was tested and<br>evaluated with respect to the expression of its modes and states as<br>described in its Design Specifications. All testing demonstrated<br>compliance with the appropriate standard and/or met the acceptance<br>criteria. | |
| Summary of<br>Substantial<br>Equivalence | The Sapphire Detachable Coil System is substantially equivalent to<br>the predicate device, Target Therapeutics' Detachable Platinum<br>Coil (Guglielmi Detachable Coil, GDC) in<br>- Use the same operational principle<br>- Incorporate the same basic design<br>- Have the same intended use<br>- Are packaged and sterilized using similar materials, and processes<br>In summary, the Sapphire Detachable Coil system described in this<br>submission is, in our opinion, substantially equivalent to the<br>predicate device. |

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K030392/P2/2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2003

Ms. Florin Truuvert Regulatorv Affairs Manager Microtherapeutics, Inc. 2 Goodyear Irvine, California 92618

Re: K030392

Trade/Device Name: Sapphire Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: May 7, 2003 Received: May 8, 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 (OS) 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 vour 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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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

fe 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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## K030392

## Indications for Use Statement

510(k) Number (if known): _________

Device Name:

Sapphire Detachable Coil System

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Miriam C. Provost

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

510(k) Number K030392

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