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 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
1. 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.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification for Boston Scientific Neurovascular's Matrix2 Detachable Coils, focusing on demonstrating substantial equivalence to predicate devices. It covers:

Summary of Safety and Effectiveness: Contact person, trade name, common name, classification name.
Predicate Devices: A table comparing the Matrix2 coils to previously cleared devices (K031168, K012985, K042539).
Intended Use / Indications for Use: Specific medical conditions and locations for which the device is intended.
Device Description: Details on the components (power supply, occlusion coil, delivery wire, cables, batteries) and how the electrolytic detachment works.
Accessories Description: Lists connecting cables and batteries.
Technological Characteristics Comparison (to predicate devices): Tables detailing coil dimensional attributes and materials, showing how they relate to the predicate devices.
FDA Clearance Letter: Official communication from the FDA acknowledging the 510(k) and stating substantial equivalence.
Indications for Use Statement: A formal statement of the device's intended use.

This document serves to demonstrate that the new device is as safe and effective as legally marketed predicate devices, rather than presenting a performance study against specific acceptance criteria. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, or adjudication methods from this text.

Summary

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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(BostonScientificTarget)	Matrix Stretch ResistantDetachable Coils	Matrix2 Stretch ResistantCoils:• Matrix2 Helical UltraSoftSR• Matrix2 2D Soft SR• Matrix2 2D Standard SR• Matrix2 Helical Soft SR• Matrix2 360° UltraSoft SR• Matrix2 360° Soft SR• Matrix2 360° Standard SR	14 May 2003

March 2005

{1}------------------------------------------------

K050700 2/5

Number	Description	Predicate for	Clearance Date
K012985(BostonScientificTarget)	Matrix Detachable Coils	Matrix2 2D Firm CoilsMatrix2 3D Omega Coils• Matrix2 3D OmegaStandard• Matrix2 Omega Firm	31 January 2002
K042539(BostonScientificNeuro-vascular)	GDC 360° Coils	Matrix2 360° Coils:• Matrix2 360° Standard• Matrix2 360° FirmMatrix2 360° Stretch ResistantCoils:• Matrix2 360° UltraSoft SR• Matrix2 360° Soft SR• Matrix2 360° Standard SR	19 October 2004

Special 510(k): Boston Scientific Neurovascular's Matrix' Detachable Coils

Intended Use / Indications for Use

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.

{2}------------------------------------------------

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.

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.

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
1. 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.

{3}------------------------------------------------

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 withinthe range of primary coil OD for the predicate devices.No change to the OD of the primary coil + polymer whichremains within the range of ODs for the predicate devices [seeline item below for 'Primary Coil OD (platinum-tungsten wire +bioabsorbable polymer)'
Secondary Coil OD	Expanded range of available sizes
Distal Tip Diameter(Stretch Resistant Coils only)	Larger distal tip diameters toaccommodate new primary coil sizes
Primary Coil OD (platinum-tungstenwire + bioabsorbable polymer)	Within the range of primary coil OD(platinum-tungsten wire + bioabsorbable polymer)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(Matrix² Stretch Resistant Coils only)	Same as predicate devices
Anchor Chain(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 devicesbut 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: PellethaneTube: PolycarbonateLuer Lock: Polycarbonate

March 2005

{4}------------------------------------------------

KOTOFOO C/K

Special 510(k): Boston Scientific Neurovascular's Matrix2 Detachable Coils

Technological Characteristics Comparison (cont.)

Materials

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100 - 100 -

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.

{6}------------------------------------------------

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

{7}------------------------------------------------

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:

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

Regulation Number and Section

§ 882.5950 Neurovascular embolization device.

(a)
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.(b)
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).