MATRIX DETACHABLE COILS

K012985 · Boston Scientific, Target · HCG · Jan 31, 2002 · Neurology

Device Facts

• Record ID: K012985
• Device Name: MATRIX DETACHABLE COILS
• Applicant: Boston Scientific, Target
• Product Code: HCG · Neurology
• Decision Date: Jan 31, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Matrix™ Detachable Coils are intended for embolization of those 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 embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Matrix™ Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.

Device Story

Matrix™ Detachable Coils are platinum wire coils coated with a biocompatible absorbable polymer; used for embolization of intracranial aneurysms, vascular malformations, and peripheral vasculature. System includes coils, delivery wire, and battery-operated SynerG™ Power Supply. Physician (neurosurgeon/interventionalist) navigates coil to target site; power supply applies constant current to delivery wire; electrolytic dissolution detaches coil from wire. Power supply senses resistance to detect detachment, signals completion, and terminates current. Device provides mechanical occlusion of vascular structures; polymer coating intended to enhance healing/occlusion. Used in clinical/OR settings.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included friction, catheter compatibility, tensile/junction strength, coil stiffness, stability in aneurysm, polymer mass loss, deployment/retraction, bond integrity, saline compatibility, detachment time, heating effects (electrolysis/MRI), and electromagnetic compatibility.

Technological Characteristics

Platinum wire coil with biocompatible absorbable polymer coating and UV-curing adhesive. Delivery wire: stainless-steel core with Teflon® jacket. Energy source: battery-operated (two 9V) power supply providing constant current (0.5-2.0 mA). Biocompatibility per ISO 10993-1. Sterilization not specified. Connectivity: wired connection between power supply and delivery wire.

Indications for Use

Indicated for patients with intracranial aneurysms deemed high-risk or inoperable by neurosurgical teams, and for patients with neurovascular abnormalities (arteriovenous malformations, arteriovenous fistulae) or peripheral vascular arterial/venous embolization needs.

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™) and GDC™ Power Supply (K001083)

Submission Summary (Full Text)

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JAN 3 1 2002

### IX. 510(k) Summary of Safety and Effectiveness

SUBMITTER:

Boston Scientific Target 47900 Bayside Parkway Fremont, CA 94538

CONTACT PERSON:

Seth A. Schulman TEL: [phone] FAX: [phone] E-MAIL: [e-mail]

DATE PREPARED: August 28, 2001

CLASSIFICATION NAME: Artificial Embolization Device (21 CFR Section 882.5950)

- COMMON NAME: Occlusion Coil
PROPRIETARY NAME: Matrix™ Detachable Coils

#### Guglielmi Detachable Coil (GDC™) and GDC™ Power PREDICATE DEVICE: Supply (K001083)

DEVICE DESCRIPTION: The Matrix™ Detachable Coil system consists of the following, each of which is sold seperately:

- · GDCTM SynerGTM Power Supply
- · Matrix™ Detachable Coil attached to a delivery wire
- · Set of GDCTM SynerGTM connecting cables
- Patient return electrode
- · Two 9-volt batteries

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

Matrix™ Detachable Coils are manufactured from platinum wire, which is first wound into a primary coil and then formed into a secondary helical shape. Coating the platinum coil is a proprietary biocompatible absorbable polymer mixture.

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 identical to that employed for the predicate GDCTM Coils cleared under K001083.

Image /page/0/Picture/21 description: The image contains the logo for Boston Scientific Target. The words "Boston Scientific" are stacked on top of each other in a large, bold font. Below that, the word "TARGET" is written in a large, bold font with a line above it. The logo is black and white.

510(k) Premarket Notification -Matrix™ Detachable Coil

Page 39 of 98

116

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The GDCTM SynerGTM power supply is a battery-operated, selfcontained unit designed to initiate and control the electrolytic detachment of a GDC™ Coil or Matrix™ Detachable Coil inside an aneurysm.

Kolz985

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 2.0 mA current setting; pressing a second time changes the setting to 0.5 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™ SynerG™ 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 Matrix™ Detachable Coil, 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 Matrix™ Detachable Coil and to recognize those changes, which indicate detachment.

Once those patterns are identified, the GDCTM SynerGTM power supply signals detachment and stops the flow of current through the Matrix™ Detachable Coil.

Matrix™ Detachable Coils are 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.

MatrixTM Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.

All component materials of the Matrix™ Detachable Coils are biocompatible in accordance with ISO 10993-1.

### MATERIALS:

INTENDED USE:

Image /page/1/Picture/14 description: The image shows the logos for Boston Scientific and Target. The Boston Scientific logo is in a serif font, with the words stacked on top of each other. The Target logo is in a sans-serif font, with the word "TARGET" in all caps. The Target logo is underlined.

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# TECHNOLOGICAL CHARACTERISTICS COMPARISON:

| Coil Dimensional Attributes | Matrix Detachable Coils |
|------------------------------------------------------|---------------------------|
| Coil Primary Wind OD<br>(Platinum alloy and Polymer) | Same as predicate device. |
| Secondary Coil OD | Same as predicate device. |
| Coil Wire OD | Same as predicate device. |
| Delivery Wire Length | Same as predicate device. |
| Delivery Wire Proximal OD | Same as predicate device. |
| Delivery Wire Distal OD | Same as predicate device. |

# Boston

## Scientific

### TARGET

510(k) Premarket Notification -Matrix™ Detachable Coil

K012985

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| Materials | Matrix™ Detachable Coils |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Main Coil | |
| Main Coil Wire | Same as predicate device<br>(The Matrix™ detachable Coils<br>additionally incorporate a biocompatible<br>absorbable polymer and ultraviolet curing<br>adhesive in the Main Coil.) |
| Main Coil / delivery wire junction tubing | Same as predicate device |
| Delivery Wire | |
| Core wire w/coating | Same as predicate device |
| Proximal Coil | Same as predicate device |
| Proximal Marker Coil | Same as predicate device |
| Sheath, Delivery Wire (heat shrink tubing) | Same as predicate device |
| Proximal Tubing | Same as predicate device |
| Bushing | Same as predicate device |
| Inner Coil | Same as predicate device |

Technological Characteristics Comparison (cont.):

Image /page/3/Picture/4 description: The image shows the logo for Boston Scientific Target. The words "Boston Scientific" are stacked on top of each other in a large, bold font. There is a line underneath the words "Boston Scientific". The word "TARGET" is in a large, bold font and is located underneath the line.

510(k) Premarket Notification

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| Power Supply | Matching Detachable Coils |
|-----------------------|-------------------------------|
| Power | Same as for predicate device. |
| Batteries | Same as for predicate device. |
| Expected Battery 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. |

Technological Characteristics Comparison (cont.):

Image /page/4/Picture/4 description: The image shows the logo for Boston Scientific Target. The words "Boston Scientific" are stacked on top of each other, with "Boston" on top and "Scientific" below it. There is a line underneath the word "Scientific". Below the line is the word "TARGET" in a larger, bolder font.

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### Verification Test Summary Table: Predicate GDC™ Coils vs Matrix™ Detachable Coils

| Test or Point of Comparison | Matrixy Detachable Coils |
|--------------------------------------------------------------|-------------------------------------------------------------|
| Friction | Meets acceptance criteria established for predicate device. |
| Catheter / Coil Compatibility | Meets acceptance criteria established for predicate device. |
| Main Coil Tensile Strength | No change made which would affect this test. |
| Main Coil Junction Strength | Meets acceptance criteria established for predicate device. |
| Coil Stiffness Test | Meets acceptance criteria established for predicate device. |
| Coil Stability in Aneurysm Test | Meets acceptance criteria established for predicate device. |
| Polymer Mass Loss Tests | Meets acceptance criteria established for device. |
| Deployment / Retraction Test | Meets acceptance criteria established for device. |
| Polymer to Platinum Bond Integrity<br>Testing | Meets acceptance criteria established for device. |
| Polymer Integrity Tensile Strength<br>Test | Meets acceptance criteria established for device. |
| Compatibility with Saline Test | Meets acceptance criteria established for device. |
| Detachment Time | No change made which would affect this test. |
| Heating Effect of Electrolysis | No change made which would affect this test. |
| Heating Effect of MRI | No change made which would affect this test. |
| 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) | Meets acceptance criteria established for predicate device. |

Image /page/5/Picture/4 description: The image shows the logo for Boston Scientific Target. The words "Boston Scientific" are stacked on top of each other in a large, bold font. Below that, the word "TARGET" is written in a larger, bold font and is underlined. The logo is simple and professional.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 3 1 2002

Mr. Seth A. Schulman Senior Regulatory Affairs Specialist Boston Scientific, Target 47900 Bayside Parkway Fremont, California 94538

Re: K012985

Trade/Device Name: Matrix™ Detachable Coil Regulation Number: 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: December 12, 2001 Received: December 14, 2001

Dear Mr. Schulman:

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 - Mr. Seth A. Schulman

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis iction with and w you'ls cognifinding of substantial equivalence of your device to a legally premaired predicated 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 If you desire specific art 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF IC For at 659. Additionally, for questions on the promotion and advertising of Compliance at [phone] Tice of Compliance at [phone]. Also, please note the your do rest, titled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation chities, "Thiordians on your responsibilities under the Act may be obtained from the Oiner general mistmational 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

Go 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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### IX. 510(k) Summary of Safety and Effectiveness

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Name: Matrix™ Detachable Coil

Indications For Use:

The Matrix™ Detachable Coils have the same indications for use as the predicate GDC" coils.

Matrix™ Detachable Coils are intended for embolization of those 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 embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The Matrix™ Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Evaluation (ODE)

OR Over-The-Counter Use:______________________________________________________________________________________________________________________________________________________ Prescription Use: (Per 21 CFR §801.109)

Miriam C. Provost

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

510(k) Number .

# Boston

Scientific
TARGET