GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL

K042539 · Boston Scientific Corp · HCG · Oct 19, 2004 · Neurology

Device Facts

• Record ID: K042539
• Device Name: GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL
• Applicant: Boston Scientific Corp
• Product Code: HCG · Neurology
• Decision Date: Oct 19, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Guglielmi Detachable Coil (GDC) is intended for embolizing certain 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) inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

Device Story

GDC system comprises a battery-operated power supply, platinum occlusion coils attached to delivery wires, connecting cables, and patient return electrode. Used in neurosurgical/interventional settings to treat intracranial aneurysms and vascular malformations. Physician operates power supply to initiate electrolytic detachment of platinum coil within target anatomy. Power supply maintains constant current (default 1.0 mA, adjustable to 0.5 or 0.75 mA) by sensing resistance and adjusting voltage; detects detachment via impedance changes; automatically terminates current upon detachment. Provides minimally invasive alternative to traditional surgery for high-risk/inoperable patients.

Clinical Evidence

Bench testing only. No clinical data presented. Verification testing included tensile strength, friction, detachment time, deployment/retraction force, tip ball strength, coil stiffness, heating effects (electrolysis and MRI), and electromagnetic compatibility. All tests met established acceptance criteria.

Technological Characteristics

Platinum wire coils (primary/secondary helical shape); stainless-steel delivery wire with Teflon jacket. Battery-operated power supply (9V alkaline) provides constant current (0.5-1.0 mA) via electrolytic detachment. System includes connecting cables and return electrode. Software is embedded firmware for current regulation and detachment detection. Sterilization method not specified.

Indications for Use

Indicated for patients with intracranial aneurysms deemed high-risk or inoperable via traditional surgery, and for patients with neurovascular arteriovenous malformations or fistulae. Also indicated for arterial and 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 (GDC) System with Version 4 Modifications (K991139)
• Guglielmi Detachable Coil, Additional GDC Version 4 Modifications (K001083)
• Guglielmi Detachable Coil, Modification of a single component of the GDC Stretch Resistant Coil (K030475)

Submission Summary (Full Text)

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## OCT 1 9 2004

K042539 page 1/7

## Special 510(k): Boston Scientific Neurovascular's GDC® 360° Coils

## a. Summary Of Safety And Effectiveness

Contact Person

Jim Leathley Regulatory Affairs Project Manager Boston Scientific Neurovascular 47900 Bayside Parkway Fremont, CA. 94538

Trade Name

Guglielmi Detachable Coil (GDC®), Class III

Common Name

Occlusion Coil

Classification Name

Artificial Embolization Device (21 CFR Section 882.5950)

Predicate Devices

| Number | Description | Predicate for | Clearance Date |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------|
| K991139<br>(Boston<br>Scientific /<br>Target) | Guglielmi Detachable<br>Coil (GDC) System with<br>Version 4 Modifications | coil design of:<br>GDC-10 360° Coil SR<br>GDC-10 360° Soft Coil SR<br>GDC-18 360° Coil | 22 Dec. 1999 |
| K001083<br>(Boston<br>Scientific /<br>Target) | Guglielmi Detachable<br>Coil, Additional GDC<br>Version 4 Modifications | coil design of:<br>GDC-10 360° Coil SR<br>GDC-10 360° Soft Coil SR<br>GDC-18 360° Coil | 3 May 2000 |
| K030475<br>(Boston<br>Scientific /<br>Target) | Guglielmi Detachable<br>Coil, Modification of a<br>single component of the<br>GDC Stretch Resistant<br>Coil (Anchor 'Twister' to<br>Anchor 'Chain') | Anchor Chain component<br>used on:<br>GDC-10 360° Coil SR<br>GDC-10 360° Soft Coil SR | 14 March 2003 |

Special 510(k) Notification, Boston Scientific Neurovascular GDC®-10 and GDC-18 360° Coils

September 2004

Page 1 of 7

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K042539 page 2/7

### Intended Use

### GDC Power Supply

Boston Scientific Neurovascular's Guglielmi Detachable Coil (GDC) Power Supply is intended for use with all versions of Boston Scientific Neurovascular's Guglielmi Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

### Guglielmi Detachable Coil

The Guglielmi Detachable Coil (GDC) is intended for embolizing certain 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) inoperable,
and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.

The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

## Device Description

The GDC system consists of

- · GDC power supply
- · GDC occlusion coil attached to a delivery wire
- · set of GDC connecting cables
- · patient return electrode
- · two 9-volt batterics

each of which is sold separately.

The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.

GDC occlusion coils are manufactured from platinum wire which is first wound into a primary coil and then formed into a secondary helical shape.

Coils are attached to a delivery wire, which consists of a ground stainless-steel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is similar to that employed for the predicate GDC devices cleared variously under K991139, K001183 and K030475.

Special 510(k) Notification, Boston Scientific Neurovascular GDC®-10 and GDC-18 360° Coils

September 2004

Page 2 of 7

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K042539 page 3/7

The GDC Power Supply is a battery-operated, self-contained unit designed to initiate and control the electrolytic detachment of a GDC coil inside an aneurysm.

Each time the power supply is turned on, the unit defaults to the 1.0 mA current setting. Pressing the "Current" switch one time changes the setting to the .05 mA current setting; pressing a second time changes the setting to 0.75 mA; pressing a third time returns the unit to the default 1.0 mA setting. Each time the switch is pressed, the current display flashes the new current setting.

The GDC Power Supply is designed to apply a constant current through the GDC System and to detect when coil detachment has occurred. It maintains a constant current by:

- 1) sensing the amount of resistance to current flow through the GDC System, and
- 2) adjusting the voltage needed to maintain the desired current setting. It is also designed to identify subtle changes in the way current is flowing through the GDC System and to recognize those changes which indicate detachment.

Once those patterns are identified, the GDC Power Supply signals detachment and stops the flow of current through the GDC System.

## Accessories Description

Accessories consist of the following:

- · Two connecting cables, one black (274 cm long), the other red (152 cm long)
- Two standard 9 volt alkaline batteries

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## Technological Characteristics Comparison (to predicate devices)

## Coil Dimensional Attributes

| | GDC-10 360° Coil SR<br>GDC®-10 360º Soft Coil SR<br>GDC-18 360° Coil |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Coil Wire OD | Same sizes as used with predicate devices |
| Primary Coil OD | Two new primary coil sizes used with GDC-10 360° Coils; both are<br>within the range of sizes used across all current GDC coils |
| Secondary Coil OD | Expanded range of available sizes |
| Distal Tip Diameter<br>(Stretch Resistant Coils only) | Larger distal tip diameters to accommodate new primary coil sizes |
| Delivery Wire Length | Same as for predicate devices |
| Delivery Wire Proximal OD | Same as for predicate devices |
| Delivery Wire Distal OD | Same as for predicate devices |

Special 510(k) Notification, Boston Scientific Neurovascular GDC®-10 and GDC-18 360° Coils

September 2004

Page 4 of 7

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K042539 page 5/7

#### Technological Characteristics Comparison (cont.)

## Materials

| | GDC-10 360° Coil SR<br>GDC®-10 360° Soft Coil SR<br>GDC-18 360° Coil |
|---------------------------------------------------------------------------|----------------------------------------------------------------------|
| Main Coil | Same as predicate devices |
| Stretch Resistant Thread<br>(GDC-10 360° and GDC-10 360° Soft Coils only) | Same as predicate devices |
| Main Coil / delivery wire junction tubing | Same as predicate devices |
| Delivery Wire | |
| Core wire w/coating | Same as predicate devices |
| Proximal Coil | Same as predicate devices |
| Proximal Marker Coil | Same as predicate devices |
| Sheath, Delivery Wire (heat shrink tubing) | Same as predicate devices |
| Proximal Tubing | Same as predicate devices |
| Bushing | Same as predicate devices |
| Anchor Chain<br>(GDC-10 360° and GDC-10 360° Soft Coils only) | Same as predicate devices |
| Inner Coil | Same as predicate devices |

Special 510(k) Notification, Boston Scientific Neurovascular GDC®-10 and GDC-18 360° Coils

.

September 2004

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K042539 page 6/7

Technological Characteristics Comparison (cont.)

## Power Supply

| | GDC-10 360° Coil SR<br>GDC®-10 360º Soft Coil SR<br>GDC-18 360° Coil |
|-----------------------|----------------------------------------------------------------------|
| Power | Same as for predicate devices |
| Batteries | Same as for predicate devices |
| Expected Battery Life | Same as for predicate devices |
| Red Cable | Same as for predicate devices |
| Black Cable | Same as for predicate devices |
| Current Settings | Same as for predicate devices |
| Current | Same as for predicate devices |
| Voltage | Same as for predicate devices |
| Operating Temp. | Same as for predicate devices |
| Storage Temp. | Same as for predicate devices |
| Relative Humidity | Same as for predicate devices |
| Unit Size | Same as for predicate devices |
| Unit Weight | Same as for predicate devices |

Special 510(k) Notification, Boston Scientific Neurovascular GDC®-10 and GDC-18 360° Coils

September 2004

Page 6 of 7

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K042539 Page 7/7

| Test or Point of Comparison | GDC-10 360° Coil SR<br>GDC®-10 360° Soft Coil SR<br>GDC-18 360° Coil |
|--------------------------------------------------------------|----------------------------------------------------------------------|
| Tensile Strength | Meets acceptance criteria. |
| Friction | Meets acceptance criteria. |
| Detachment Time | No change made which would affect this test. |
| Deployment / Retraction Force | Meets acceptance criteria. |
| Tip Ball Strength | Meets acceptance criteria. |
| Coil Stiffness | Meets acceptance criteria. |
| Heating Effect of Electrolysis | No change made which would affect this test. |
| Heating Effect of MRI | Meets acceptance criteria. |
| Electrostatic Discharge | No change made which would affect this test. |
| Electromagnetic Compatibility-<br>Radiated Susceptibility | No change made which would affect this test. |
| Electromagnetic Compatibility-<br>Radiated Emissions Class B | No change made which would affect this test. |
| Electromagnetic Compatibility-<br>Magnetic Immunity | No change made which would affect this test. |
| Operating System Test<br>(Assembly Source Code) | No change made which would affect this test. |

## Verification Test Summary Table: Predicate GDC Devices vs GDC-10 and GDC-18 360° Coils

Special 510(k) Notification, Boston Scientific Neurovascular GDC®-10 and GDC-18 360° Coils

September 2004

Page 7 of 7

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2004

Mr. James Leathley Regulatory Affairs Project Manager Boston Scientific Neurovascular 47900 Bayside Parkway Fremont, California 94538

Re: K042539

KU42339
Trade/Device Name: Guglielmi Detachable Coil (GDC =10 360° Coil SR; GDC-10 360° Soft Coil SR, and GDC-18 360° Coil) Regulation Number: 21 CFR 882.5950 Regulation Name: Artifical embolization device Regulatory Class: III Product Code: HCG Dated: September 17, 2004 Received: September 20, 2004

Dear Mr. Leathley:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of the reserved in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic Fee (110) has the device, subject to the general controls provisions of the Act. The r ou may) ateres, provisions of the Act include requirements for annual registration, listing of general controls pro resuring 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 If your device is exassinod (vonal controls. Existing major regulations affecting your device can may be subject to back adderal 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 r load be actived a determination that your device complies with other requirements of the Act that I Dr Has maas a a regulations administered by other Federal agencies. You must or any I 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 - Mr. James Leathley

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter witi anow you to oegin manteing of substantial equivalence of your device to a legally premaired notincation. The PDA maing of casification 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 If you desire specific advice ion your ac now of the regulation entitled, Colliact the Office of Companisonarket notification" (21CFR Part 807.97). You may obtain Misolanumig by reference to premailsonibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Soless http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

uriam 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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#### INDICATIONS FOR USE STATEMENT

510(k) Number: K042539

Device Name: Guglielmi Detachable Coil (GDC®-10 360° Coil SR, GDC-10 360° Soft Coil SR and GDC-18 360° Coil)

Indications for Use:

The Guglielmi Detachable Coil (GDC) is intended for embolizing certain 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) inoperable,

and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.

The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

V 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)

Miriam C. Provost

(Division Sign-Off)

Division of Gen eral. Restorative.

Special 510(k) Notification, Boston Scientifient Regio Devices

GDC®-10 and GDC-18 360° Coils

Page 1 of 1

September 2004

K642539 510(k) Number_________________________________________________________________________________________________________________________________________________________________