GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1

K993415 · Boston Scientific, Target · HCG · Jan 21, 2000 · Neurology

Device Facts

• Record ID: K993415
• Device Name: GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1
• Applicant: Boston Scientific, Target
• Product Code: HCG · Neurology
• Decision Date: Jan 21, 2000
• Decision: SESE
• Submission Type: Traditional
• 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

System consists of platinum occlusion coil attached to delivery wire, power supply, connecting cables, and patient return electrode. Used for embolization of intracranial aneurysms and vascular malformations. Operated by neurosurgical team in clinical setting. Coil placed in target anatomy; detachment initiated via electrolytic dissolution of delivery wire connection using battery-operated power supply. Power supply provides current control, voltage/time displays, and detachment detection via audible beeps. Stretch-resistant version incorporates polymer filament to improve structural integrity. Device enables minimally invasive treatment for high-risk or inoperable aneurysms, reducing need for traditional open surgery.

Clinical Evidence

Bench testing only. No clinical data presented. Verification testing included friction, tensile strength of main coil weld, detachment time, particulate analysis during detachment, heating effects of electrolysis and MRI, tip ball strength, and main coil stretch testing. All tests met acceptance criteria established for the predicate device.

Technological Characteristics

Platinum occlusion coil with polymer stretch-resistant filament. Delivery wire: stainless steel core with Teflon jacket. Power supply: battery-operated (two 9-volt), provides controlled DC current for electrolytic detachment. Dimensions: coil primary wind 0.0095"-0.015"; secondary coil 2-30 mm. Connectivity: wired connection between power supply, cables, and delivery wire. Sterilization: not specified.

Indications for Use

Indicated for patients with intracranial aneurysms deemed high-risk or inoperable by neurosurgical teams, and for patients with vascular malformations (arteriovenous malformations/fistulae) of the neurovasculature. 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 (K962503)
• Implantable Surgical Sutures (K930738)
• Shelf Life, Various Class II and Class III Devices (K971395)

Submission Summary (Full Text)

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### Section 2 - 510 (k) Summary of Safety and Effectiveness and Class III Certification and Summary

### a. Summary Of Safety And Effectiveness

Contact Person

Roxane Baxter Regulatory Affairs Manager Boston Scientific / Target 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)

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#### Predicate Devices

| Number | Description | Predicate for | Clearance<br>Date |
|-------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| K962503<br>(Boston Scientific /<br>Target) | Guglielmi Detachable Coil | GDC-10 and GDC-10<br>(2D) Stretch Resistant<br>Guglielmi<br>Detachable Coils<br>and<br>GDC-18 and GDC-18<br>(2D) Stretch Resistant<br>Guglielmi<br>Detachable Coils | 20 Sept. 1996 |
| K930738 (Deknatel,<br>Division of<br>Howmedica, Inc.) | Implantable Surgical<br>Sutures | Suture material | 26 July 1994 |
| K971395<br>(Boston Scientific /<br>Target) | Shelf Life, Various Class II<br>and Class III Devices for | For shelf-life<br>validation method<br>and subsequent<br>placement of shelf-<br>life information on<br>device label | 14 July 1997 |

#### 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.

The indications for use for Stretch Resistant GDC are identical to those for the predicate GDC device cleared under K962503.

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#### 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 batteries

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 stainlesssteel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is the same as that employed for the predicate GDC cleared under K962503.

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The GDC Power Supply is a self-contained, battery-operated unit designed to initiate and control detachment of a GDC coil. It has an on/off button, connections for the GDC cables, and the following controls and displays:

- · Current setting switch and display Allows for selection of the different current settings. The selected current (mA) is briefly displayed after which the unit displays the current flowing through the system.
- · Voltage diplay and indicator Displays the DC output voltage.
- · Time display Displays the elapsed time that the current has been flowing through the GDC system.
- Check indicator Flashes on and off at the beginning of a detachment procedure if there is a poor connection to the patient.
- · Detach indicator Flashes on and off when the power supply has detected detachment. Detachment is accompanied by five beeps.
- · Battery indicator Illuminates when the voltage of the internal 9-volt batteries falls below specification.

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# Technological Characteristics Comparison

## Coil Dimensional Attributes

| | GDC<br>(Predicate device cleared<br>under K962503) | Stretch Resistant GDC |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Coil Primary Wind OD | 0.010" - 0.015" | 0.0095", 0.010", 0.0135" or<br>0.015" |
| Secondary Coil OD | GDC-10: 2 mm - 30 mm | GDC-10: 2 mm - 30 mm |
| | GDC-18: 2 mm - 30 mm | GDC-18: 2 mm - 30 mm |
| Coil Wire OD | Range: 0.001" - 0.005"<br><br>Current wire sizes used in the<br>production of GDC devices<br>are:<br>GDC-10: 0.00175", 0.002"<br><br>GDC-18: 0.00225", 0.003",<br>0.004" | GDC-10: 0.0175", 0.002"<br><br>GDC-18: 0.00225", 0.003" |
| Delivery Wire Length | 50 - 200 cm | 175 cm |
| Delivery Wire<br>Proximal OD | GDC-10: 0.010"<br><br>GDC-18: 0.010" | GDC-10: 0.010"<br><br>GDC-18: 0.010" |
| | Delivery Wire<br>Distal OD | GDC-10: 0.0028"<br><br>GDC-18: 0.0028" |

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.

# Technological Characteristics Comparison (cont.)

## Materials

| | Stretch Resistant GDC |
|--------------------------------------------------|--------------------------|
| Main Coil | Same as predicate device |
| Stretch Resistant<br>Filament | Polymer |
| Delivery Wire: | |
| Core wire<br>w/coating | Same as predicate device |
| Proximal Coil | Same as predicate device |
| Proximal Marker<br>Coil | Same as predicate device |
| Sheath, Delivery<br>Wire (heat shrink<br>tubing) | Same as predicate device |
| Proximal Tubing | Same as predicate device |
| Bushing | Same as predicate device |
| Hypotube | N/A |
| Anchor Coil | Platinum |

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# Technological Characteristics Comparison (cont.)

# Power Supply

| | GDC Power Supply,<br>Stretch Resistant GDC |
|--------------------------|--------------------------------------------|
| Power | Same as for predicate device. |
| Batteries | Same as for predicate device. |
| Expected Battery<br>Life | Same as for predicate device. |
| Red Cable | Same as for predicate device. |
| Black Cable | Same as for predicate device. |
| Current Settings | Same as for predicate device. |
| Current | Same as for predicate device. |
| Voltage | Same as for predicate device. |
| Operating Temp. | Same as for predicate device. |
| Storage Temp. | Same as for predicate device. |
| Relative Humidity | Same as for predicate device. |
| Unit Size | Same as for predicate device. |
| Unit Weight | Same as for predicate device. |

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### Verification Test Summary Table: Comparison of Stretch Resistant GDC Devices to the Predicate Device

| Test or Point of Comparison | Stretch Resistant GDC |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Friction | Meets acceptance criteria established for<br>predicate device. |
| Tensile Strength, Main Coil Weld | Meets acceptance criteria established for<br>predicate device. |
| Detachment Time | Meets acceptance criteria established for<br>predicate device. |
| Detachment in Saline w/ particulate<br>analysis | No change was made which would result<br>in the generation of particulate during<br>detachment. |
| Heating Effect of Electrolysis | No change made which would influence<br>or increase heating effect. |
| Heating Effect of MRI | No change made which would increase<br>heating effect of MRI. |
| Tip Ball Strength | Meets acceptance criteria established for<br>strength of tip ball. |
| Main Coil Stretch Test | Meets acceptance criteria for the<br>modified device. |

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Public Health Service

JAN 2 1 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Roxane K. Baxter, RAC Manager, Regulatory Affairs Boston Scientific/Target 47900 Bayside Parkway Freemont, California 94538

Re: K993415

> Trade Name: GDC-10 Stretch Resistant Guglielmi Detachable Coil GDC-10 (2D) Stretch Resistant Guglielmi Detachable Coil GDC-18 Stretch Resistant Guglielmi Detachable Coil GDC-18 (2D) Stretch Resistant Geglielmi Detachable Coil Regulatory Class: III Product Code: HCG and KRD Dated: September 29, 1999 Received: October 1, 1999

Dear Ms. Baxter:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Roxane K. Baxter, RAC

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE STATEMENT

510(k) Number: __

Device Name: GDC-10 Stretch Resistant Guglielmi Detachable Coil GDC-10 (2D) Stretch Resistant Guglielmi Detachable Coil and GDC-18 Stretch Resistant Guglielmi Detachable Coil GDC-18 (2D) Stretch Resistant Guglielmi Detachable 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 yenous embolizations in the peripheral vasculature.

(Division Sign-Off)
Division of General Restorative Devices K993415
510(k) Number.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

510(k) Notification, Boston Scientific/Target, GDC-10 and GDC-18 Stretch Resistant GDC CONFIDENTIAL Section 3, Page 2 September 1999