MATRIX STRETCH RESISTANT (SR) COILS
Device Facts
| Record ID | K050700 |
|---|---|
| Device Name | MATRIX STRETCH RESISTANT (SR) COILS |
| Applicant | Boston Scientific Corp |
| Product Code | HCG · Neurology |
| Decision Date | Apr 15, 2005 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.5950 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Matrix2 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. Matrix2 Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.
Device Story
System consists of battery-operated power supply, platinum occlusion coil on delivery wire, connecting cables, and patient return electrode. Used in neurovascular and peripheral procedures by physicians. Power supply applies constant current to electrolytically dissolve delivery wire, detaching coil at target site. Device senses resistance to current flow, adjusts voltage to maintain constant current, and detects detachment by identifying specific electrical resistance patterns; signals detachment and terminates current. Benefits include controlled, precise coil placement for aneurysm occlusion in high-risk or inoperable patients.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices.
Technological Characteristics
Occlusion coils made of platinum-tungsten wire with bioabsorbable polymer. Delivery wire features stainless-steel core with Teflon jacket. Power supply is battery-operated (two 9V batteries), providing constant current (selectable 0.5mA, 0.75mA, 1.0mA). Connectivity is wired via connecting cables. Sterilization method not specified. Software is embedded firmware for current control and detachment detection.
Indications for Use
Indicated for patients with intracranial aneurysms deemed high-risk or inoperable by neurosurgical teams, 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
- Matrix Stretch Resistant Detachable Coils (K031168)
- Matrix Detachable Coils (K012985)
- GDC 360° Coils (K042539)
Submission Summary (Full Text)
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APR 1 5 2005
K050700
# Special 510(k): Boston Scientific Neurovascular's Matrix' Detachable Coils
### Summary Of Safety And Effectiveness
Contact Person
Jim Leathley Regulatory Affairs Project Manager Boston Scientific Neurovascular 47900 Bayside Parkway Fremont, CA. 94538
Trade Name
Matrix2 Detachable Coil, Class II
Common Name
Occlusion Coil
Classification Name
Neurovascular Embolization Device (21 CFR Section 882.5950)
Predicate Devices
| Number | Description | Predicate for | Clearance Date |
|---------------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| K031168<br>(Boston<br>Scientific<br>Target) | Matrix Stretch Resistant<br>Detachable Coils | Matrix2 Stretch Resistant<br>Coils:<br>• Matrix2 Helical UltraSoft<br>SR<br>• Matrix2 2D Soft SR<br>• Matrix2 2D Standard SR<br>• Matrix2 Helical Soft SR<br>• Matrix2 360° UltraSoft SR<br>• Matrix2 360° Soft SR<br>• Matrix2 360° Standard SR | 14 May 2003 |
March 2005
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K050700 2/5
| Number | Description | Predicate for | Clearance Date |
|---------------------------------------------------------|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| K012985<br>(Boston<br>Scientific<br>Target) | Matrix Detachable Coils | Matrix2 2D Firm Coils<br>Matrix2 3D Omega Coils<br>• Matrix2 3D Omega<br>Standard<br>• Matrix2 Omega Firm | 31 January 2002 |
| K042539<br>(Boston<br>Scientific<br>Neuro-<br>vascular) | GDC 360° Coils | Matrix2 360° Coils:<br>• Matrix2 360° Standard<br>• Matrix2 360° Firm<br>Matrix2 360° Stretch Resistant<br>Coils:<br>• Matrix2 360° UltraSoft SR<br>• Matrix2 360° Soft SR<br>• Matrix2 360° Standard SR | 19 October 2004 |
# Special 510(k): Boston Scientific Neurovascular's Matrix' Detachable Coils
Intended Use / Indications for Use
Matrix2 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.
Matrix2 Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.
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K05070 0 3/K
# Special 510(k): Boston Scientific Neurovascular's Matrix Detachable Coils
#### Device Description
Boston Scientific's detachable coil system consists of
- · a detachable coil power supply (GDC Power Supply)
- · an occlusion coil attached to a delivery wire (Matrix or GDC coil)
- · a set of connecting cables for connecting the coil / delivery wire assembly to the power supply (GDC connecting cables)
- · a 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.
Electrolytically detachable 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 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 Matrix SR devices cleared under K031168 and K012985.
The Detachable Coil Power Supply is a battery-operated, self-contained unit designed to initiate and control the electrolytic detachment of a 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 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 detachable coil 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 system and to recognize those changes which indicate detachment.
Once those patterns are identified, the power supply signals detachment and stops the flow of current through the system.
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K050700 YK
# Special 510(k): Boston Scientific Neurovascular's Matrix' Detachable Coils
### 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
## Technological Characteristics Comparison (to predicate devices)
#### Coil Dimensional Attributes
| | Matrix2 Detachable Coils |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Coil Wire OD | Within the ranges of wire sizes used with predicate devices |
| Primary Coil OD | With the exception of one new primary coil size, all are within<br>the range of primary coil OD for the predicate devices.<br>No change to the OD of the primary coil + polymer which<br>remains within the range of ODs for the predicate devices [see<br>line item below for 'Primary Coil OD (platinum-tungsten wire +<br>bioabsorbable polymer)' |
| Secondary Coil OD | Expanded range of available sizes |
| Distal Tip Diameter<br>(Stretch Resistant Coils only) | Larger distal tip diameters to<br>accommodate new primary coil sizes |
| Primary Coil OD (platinum-tungsten<br>wire + bioabsorbable polymer) | Within the range of primary coil OD<br>(platinum-tungsten wire + bioabsorbable polymer)<br>for predicate devices |
| Maximum Coil OD | Less than or equal to maximum coil OD for predicate devices |
| 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 |
| | Matrix² Detachable Coils |
| Main Coil | Same as predicate devices |
| Stretch Resistant Thread<br>(Matrix² Stretch Resistant Coils only) | Same as predicate devices |
| Anchor Chain<br>(Matrix² Stretch Resistant Coils only) | Same as predicate devices |
| Main Coil / delivery wire junction tubing | Same as predicate devices |
| Bioabsorbable Polymer | Same as for predicate Matrix SR devices |
| Adhesive | Same as predicate devices<br>but with formulation change |
| 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 |
| Inner Coil | Same as predicate devices |
| Packaging | |
| Dispenser Coil | Same as predicate devices |
| Introducer Sheath | Same as predicate devices |
| Flush Port (new component) | Funnel: Pellethane<br>Tube: Polycarbonate<br>Luer Lock: Polycarbonate |
March 2005
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KOTOFOO C/K
# Special 510(k): Boston Scientific Neurovascular's Matrix2 Detachable Coils
# Technological Characteristics Comparison (cont.)
#### Materials
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Special 510(k) Notification, Boston Scientific Neurovascular
Matrix² Detachable Coils Attachment 6
:
:
March 2005
Page 5 of 8
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of an eagle with three lines representing its wings.
APR 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James Leathley Regulatory Affairs Project Manager Boston Scientific Neurovascular 47900 Bayside Parkway Fremont, California 94538-6615
Re: K050700
R050700
Trade/Device Name: Matrix2 Detachable Coils [Matrix ² Stretch Resistant (SR) Coils, Matrix 2 2D Firm Coils, Matrix 2 3D Omega Coils, Matrix 2 360 ° Coils, Matrix 2 360 ° Stretch Resistant (SR) Coils] Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: II Product Code: HCG Dated: March 16, 2005 Received: March 18, 2005
Dear Mr. Leathley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your bection 510(t) probstantially equivalent (for the indications for use stated in above and nave decemined the ac-needicate devices marketed in interstate commerce prior to the enclosure) to regally manetee produceded Device Amendments, or to devices that have been May 26, 1970, the elacifican date of the Frederal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the do not require approval of a promatic appions of the Act. The general controls provisions of the device, subject to the goneral controls prefection, listing of devices, good manufacturing practice, Act fierage requibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may If your device is classified (Sec above) into time the regulations affecting your device can be found be subject to such additional controls. Existing mayor organization, 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 Please be advised that 1177 s issualled of a vith other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Federal statues and regulations administered 19 registration and listing (21 CFR Part 807); abeling Act sTequirements, metuding, but not mineer we requirements as set forth in the quality systems (QS) (21 CFR Fart 807), good manations 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 will anow you to begin manceing your avoice of your device of your device to a legally premarket nothcation. THE PDA mailie of saosantal vijar mailer 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 for your do not on our car and on on one one one one the regulation entitled, and contact the Office of Compliance at (210) 210 - 12.07.97). You may obtain other "Misbranding by relerence to premaincel nothrome (2) vision of Small Manufacturers, general miormation on your responsibilities ander the reserved on the 1100) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
En Ch
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K050700
Special 510(k): Boston Scientific Neurovascular's Matrix' Detachable Coils
#### INDICATIONS FOR USE STATEMENT
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Matrix2 Detachable Coils [Matrix2 Stretch Resistant (SR) Coils, Matrix2 2D Firm Doils, Matrix2 3D Omega Coils, Matrix2 360° Coils, Matrix2 360° Stretch Resistant (SR) Coils]
Indications for Use:
Matrix2 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.
Matrix2 Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.
Prescription Use V (Per 21 CFR 801 Subpart D) OR
Over The Counter Use (Per 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)
Special 510(k) Notification, Boston Scientific Neurovascular
Matrix² Detachable Coils
Attachment 3 (Sign-Off)
Division of General, Restorative Confidential
and Neurological Devices
March 2005
Page 1
