GUGLIELMI DETACHABLE COIL (GDC)

K031049 · Boston Scientific, Target · HCG · Aug 1, 2003 · Neurology

Device Facts

• Record ID: K031049
• Device Name: GUGLIELMI DETACHABLE COIL (GDC)
• Applicant: Boston Scientific, Target
• Product Code: HCG · Neurology
• Decision Date: Aug 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for placement in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation. (per 21CFR 882.5950)

Device Story

Guglielmi Detachable Coil (GDC) is an endovascular embolization device for intracranial aneurysms and other vascular abnormalities. Device consists of platinum/tungsten alloy coil attached to stainless steel delivery wire. Operated by neurosurgical team via microcatheter; coil placed within aneurysm or vascular site. Detachment achieved via electrolytic dissolution of delivery wire portion using GDC Power Supply. Multiple coils delivered through same microcatheter to achieve dense packing. Output is physical obstruction of blood flow to aneurysm/malformation. Clinical benefit includes reduced risk of dependency or death compared to surgical clipping, as supported by ISAT trial results.

Clinical Evidence

Evidence based on the International Subarachnoid Aneurysm Trial (ISAT), a randomized trial of 2,143 patients. Results demonstrated a statistically significant reduction in the risk of dependency or death at 1 year post-treatment for patients with ruptured intracranial aneurysms treated endovascularly with GDC coils compared to neurosurgical clipping.

Technological Characteristics

Platinum/tungsten alloy coil; stainless steel delivery wire; electrolytic detachment mechanism; requires external GDC Power Supply; delivered via microcatheter.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities (arteriovenous malformations, arteriovenous fistulae), and arterial/venous embolizations in the 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

• Guglielmi Detachable Coil (GDCTM) (K001083)

Submission Summary (Full Text)

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## AUG - 1 2003

## 510(k) Summary

| Submitter | Boston Scientific Neurovascular<br>47900 Bayside Parkway<br>Fremont, CA 94538-6515 | |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Correspondent | Roxane K. Baxter<br>Boston Scientific Neurovascular<br>47900 Bayside Parkway<br>Fremont, CA 94538-6515 | |
| Contact Information | E-mail:<br>Phone:<br>Facsimile: | [e-mail]<br>510-624-2105<br>510-440-7752 |
| Device Common Name | Occlusion Coil | |
| Device Proprietary Name | Guglielmi Detachable Coil (GDCTM) | |
| Device Classification | Class III, HCG; 21 CFR §882.5950 | |
| Predicate Device<br>Trade Name<br>Manufacturer<br>510(k) Number | Guglielmi Detachable Coil (GDCTM)<br>Boston Scientific Neurovascular<br>K001083 (cleared 5/3/2000) | |
| Device Description | The Boston Scientific Neurovascular Guglielmi Detachable Coil<br>(GDCTM) is a device which facilitates endovascular<br>embolization of intracranial aneurysms and other vascular<br>abnormalities. The GDCTM Detachable Coil is a<br>platinum/tungsten alloy coil attached to a stainless steel delivery<br>wire. The GDCTM Detachable Coil is detached (using the<br>GDCTM Power Supply) by electrolytically dissolving a small<br>portion of the delivery wire upon its desired placement within<br>an aneurysm or other vascular site via a microcatheter. Multiple<br>coils can be delivered into an aneurysm or other vascular site<br>through the same microcatheter until the aneurysm or other<br>vascular site is densely packed. | |
| Purpose of Submission | Change to Indications For Use<br>This Premarket Notification has been submitted to obtain<br>clearance for a change in the indications for use of GDCTM<br>Detachable Coils to include all intracranial aneurysms. The<br>proposed change in indications is based on results of the<br>International Subarachnoid Aneurysm Trial (ISAT). | |
| Intended Use | Intended for placement in a blood vessel to permanently<br>obstruct blood flow to an aneurysm or other vascular<br>malformation. (per 21CFR 882.5950) | |

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Premarket Notification [510(k)] Submission K031049 Boston Scientific Neurovascular Guglielmi Detachable Coil (GDC™)

K031049/P2/2
July 21, 2003

## Comparison to Predicate Device

| Characteristic | Predicate Device | Proposed Device |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Guglielmi Detachable Coil (GDCTM) | SAME |
| 510 (k) | K001083 | CURRENT NOTIFICATION |
| Device Description<br>(Technological<br>Characteristics) | The Boston Scientific Neurovascular Guglielmi<br>Detachable Coil (GDCTM) is a device which<br>facilitates endovascular embolization of<br>intracranial aneurysms and other vascular<br>abnormalities. The GDCTM Detachable Coil is a<br>platinum/tungsten alloy coil attached to a<br>stainless steel delivery wire. The GDCTM<br>Detachable Coil is detached (using the GDCTM<br>Power Supply) by electrolytically dissolving a<br>small portion of the delivery wire upon its<br>desired placement within an aneurysm or other<br>vascular site via a microcatheter. Multiple coils<br>can be delivered into an aneurysm or other<br>vascular site through the same microcatheter<br>until the aneurysm or other vascular site is<br>densely packed. | SAME |
| Intended Use | Intended for placement in a blood vessel to permanently<br>obstruct blood flow to an aneurysm or other vascular<br>malformation. (per 21CFR 882.5950) | SAME |
| Indication for Use | Intended for embolization of those intracranial aneurysms -<br>that because of their morphology, their location, or the<br>patient's general medical condition - are considered by the<br>neurosurgical team to be: a) very high risk for management<br>by traditional operative techniques; or, b) inoperable.<br>GDCTM coils are also intended for embolization of other<br>neuro vascular abnormalities such as arteriovenous<br>malformations and arteriovenous fistulae. GDCTM coils are<br>also intended for arterial and venous embolizations in the<br>peripheral vasculature. | Intended for the endovascular embolization of:<br>● Intracranial aneurysms.<br>● Other neurovascular abnormalities such as<br>arteriovenous malformations and<br>arteriovenous fistulae.<br>● Arterial and venous embolizations in the<br>peripheral vasculature. |
| Manufacturer | Boston Scientific Neurovascular | Same |
| Device<br>Classification | Class III, HCG; 21 CFR §882.5950 | Same |

Boston Scientific Neurovascular submitted the 1-year results of Summary of the International Subarachnoid Trial (ISAT)' that demonstrated Clinical Data a statistically significant reduction in the risk of dependency or death at 1 year post-treatment when patients with ruptured intracranial aneurysms were treated endovascularly with GDC™M Detachable Coils rather than with neurosurgical clipping. Date Summary Prepared July 21, 2003

¹ ISAT Collaborative Group. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial. The Lancet 2002; 360: 1267-74

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2003

Ms. Roxane K. Baxter Manager, Regulatory Affairs Boston Scientific Neurovascular 47900 Bayside Parkway Fremont, California 94538-6515

Re: K031049

Trade/Device Name: Guglielmi Detachable Coil (GDCTM) Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: March 31, 2003 Received: April 14, 2003

Dear Ms. Baxter:

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. Roxane K. Baxter

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]. 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/cdrb/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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K03/049/P/+

Boston Scientific Neurovascular Applicant:

K031049 510(k) Number:

Device Name: Guglielmi Detachable Coil (GDC™)

Indications For Use:

Intended for the endovascular embolization of:

- Intracranial aneurysms. .
- Other neurovascular abnormalities such as arteriovenous . malformations and arteriovenous fistulae.
- Arterial and venous embolizations in the peripheral vasculature. .

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

on Sion-Division of General, Restorative and Neurological Devices

510(k) Number K031049