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 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.

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.

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:

sensing the amount of resistance to current flow through the Matrix™ Detachable Coil, and
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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Matrix™ Detachable Coils, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish novel performance criteria. Therefore, the information typically requested for a software algorithm/AI device, such as detailed acceptance criteria with specific performance metrics (e.g., sensitivity, specificity), sample sizes for test/training sets, blinding protocols, and expert ground truth establishment, is largely absent or not applicable in this context.

However, based on the information provided, I can infer and extract the relevant details as much as possible for a device of this nature.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are predominantly demonstrated by showing that the Matrix™ Detachable Coils are substantially equivalent to the Guglielmi Detachable Coil (GDC™) and GDC™ Power Supply (K001083), the predicate device. The performance is assessed against criteria established for the predicate device, indicating no degradation in safety or effectiveness with the modifications made (addition of a biocompatible absorbable polymer and ultraviolet curing adhesive).

Test or Point of Comparison	Acceptance Criteria (established for predicate device)	Reported Device Performance (Matrix™ Detachable Coils)
Friction	Meets acceptance criteria	Meets acceptance criteria established for predicate device.
Catheter / Coil Compatibility	Meets acceptance criteria	Meets acceptance criteria established for predicate device.
Main Coil Tensile Strength	No change made which would affect this test	No change made which would affect this test.
Main Coil Junction Strength	Meets acceptance criteria	Meets acceptance criteria established for predicate device.
Coil Stiffness Test	Meets acceptance criteria	Meets acceptance criteria established for predicate device.
Coil Stability in Aneurysm Test	Meets acceptance criteria	Meets acceptance criteria established for predicate device.
Polymer Mass Loss Tests	Meets acceptance criteria	Meets acceptance criteria established for device.
Deployment / Retraction Test	Meets acceptance criteria	Meets acceptance criteria established for device.
Polymer to Platinum Bond Integrity Testing	Meets acceptance criteria	Meets acceptance criteria established for device.
Polymer Integrity Tensile Strength Test	Meets acceptance criteria	Meets acceptance criteria established for device.
Compatibility with Saline Test	Meets acceptance criteria	Meets acceptance criteria established for device.
Detachment Time	No change made which would affect this test	No change made which would affect this test.
Heating Effect of Electrolysis	No change made which would affect this test	No change made which would affect this test.
Heating Effect of MRI	No change made which would affect this test	No change made which would affect this test.
Electrostatic Discharge	No change made which would affect this test	No change made which would affect this test.
Electromagnetic Compatibility - Radiated Susceptibility	No change made which would affect this test	No change made which would affect this test.
Electromagnetic Compatibility - Radiated Emissions Class B	No change made which would affect this test	No change made which would affect this test.
Electromagnetic Compatibility - Magnetic Immunity	No change made which would affect this test	No change made which would affect this test.
Operating System Test (Assembly Source Code)	Meets acceptance criteria	Meets acceptance criteria established for predicate device.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of diagnostic performance involving patient data or images (as would be common for AI/software devices). Instead, the "tests" refer to engineering and biocompatibility evaluations on the physical device components and system. The sample sizes for these specific engineering tests are not described in this summary. The data provenance is associated with the device manufacturing and testing process by Boston Scientific Target. This is a premarket notification, not a clinical trial report, so concepts like "country of origin of the data" are not directly applicable to an AI device's test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physical medical implant (embolization coil) and associated power supply, not an AI/software diagnostic device that requires expert-established ground truth from images or patient data for performance evaluation. The "ground truth" for these engineering tests would be the established specifications and performance parameters for medical devices of this type, ensuring manufacturing quality and safety.

4. Adjudication method for the test set

Not applicable. There is no "adjudication method" in the traditional sense of resolving discrepancies among experts for diagnostic interpretation, as this is not an AI/software diagnostic device. The "tests" described are physical and electrical engineering evaluations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document pertains to a physical medical device (embolization coil) and its power supply. It is not an AI/software device intended to assist human readers (e.g., radiologists) in diagnostic tasks, so an MRMC study is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm or AI system. Its function is to physically embolize aneurysms and vascular malformations, with human intervention for placement and detachment control.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests performed on the Matrix™ Detachable Coils is based on established engineering specifications, safety standards (e.g., ISO 10993-1 for biocompatibility), and performance metrics defined for the predicate device (GDC™ Coils). For example, "Friction" would have a specified acceptable range of frictional force, and "Polymer Mass Loss Tests" would have a maximum allowable mass loss over a given period. The overall "ground truth" for the submission is demonstrating substantial equivalence to a device already deemed safe and effective.

8. The sample size for the training set

Not applicable. As this is not an AI/software device, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable. As this is not an AI/software device, there is no "training set" or corresponding ground truth to establish in that context.

Summary

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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: 510-440-7753 FAX: 510-440-7752 E-MAIL: schulmas@bsci.com

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.

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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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:

sensing the amount of resistance to current flow through the Matrix™ Detachable Coil, and
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(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(The Matrix™ detachable Coilsadditionally incorporate a biocompatibleabsorbable polymer and ultraviolet curingadhesive 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

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

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 IntegrityTesting	Meets acceptance criteria established for device.
Polymer Integrity Tensile StrengthTest	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-Radiated Susceptibility	No change made which would affect this test.
Electromagnetic Compatibility-Radiated Emissions Class B	No change made which would affect this test.
Electromagnetic Compatibility-Magnetic Immunity	No change made which would affect this test.
Operating System Test(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 (301) 591-1097 Tice of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.

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

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).