GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 by BOSTON SCIENTIFIC, TARGET

Boston Scientific Target's Guglielmi Detachable Coil (GDC) Power Supply is intended for use with all versions of Boston Scientific Target's Guglielmi Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

Device Description

The GDC system consists of the following items, each of which is sold separately

· GDC Power Supply
· GDC occlusion coil attached to a delivery wire
· set of GDC connecting cables
· patient return electrode
two 9-volt batteries

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

GDC coils are manufactured from a platinum / tungsten alloy wire which is wound into a primary or main coil. Depending upon the desired final configuration, the coil is either formed into a secondary helical shape (standard and Stretch Resistant GDC), vortex shape (GDC-18 Fibered VortX) or tertiary shape (3D GDC).

GDC 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 a Teflon® outer jacket. The delivery wire is similar to that employed for the predicate GDC cleared under K991139.

GDC coils are available in a range of sizes for use with either Boston Scientific Target's -10 or -18 Infusion Catheters with two tip markers.

The GDC Power Supply is a battery-operated, self-contained unit designed to initiate and control the electrolytic detachment of a GDC coil inside an aneurysm.

Each time the GDC 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 0.5 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 GDC 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 GDC 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 GDC System and to recognize those changes which indicate detachment.

Once those patterns are identified, the GDC Power Supply signals detachment and stops the flow of current through the GDC System.

AI/ML Overview

This document describes a Special 510(k) submission for a modification to the Boston Scientific Target's GDC™ Power Supply. A Special 510(k) is typically used for device modifications that do not significantly alter the device's fundamental technology or intended use, meaning extensive new clinical studies are often not required. The information provided focuses on demonstrating that the modified device remains substantially equivalent to its predicate.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria and reported device performance" in the way one might expect for a new device requiring rigorous performance evaluation. Instead, it details changes made to the GDC Power Supply and asserts that for most attributes, no change was made, and it remains the same as the predicate device. For the one functional change—the current settings—it's presented as a modification rather than a performance target with a specific metric.

The implicit acceptance criterion for most parameters is "no change from the predicate." For the current settings, the acceptance criterion is that the device now offers the specific new settings.

Acceptance Criteria (Implicit)	Reported Device Performance
Power is unchanged from predicate.	No change made which affects this attribute; same as the predicate device.
Batteries are unchanged from predicate.	No change made which affects this attribute; same as the predicate device.
Expected Battery Life is unchanged from predicate.	No change made which affects this attribute; same as the predicate device.
Red Cable is unchanged from predicate.	No change made which affects this attribute; same as the predicate device.
Black Cable is unchanged from predicate.	No change made which affects this attribute; same as the predicate device.
Current Settings offer new configurations.	From current settings of: 1 mA (default), 2 mA, 0.5 mA To current settings of: 1 mA (default), 0.5 mA, 0.75 mA
Current (overall operation) is unchanged from predicate.	No change made which affects this attribute; same as the predicate device.
Voltage is unchanged from predicate.	No change made which affects this attribute; same as the predicate device.
Operating Temperature is unchanged from predicate.	No change made which affects this attribute; same as the predicate device.
Storage Temperature is unchanged from predicate.	No change made which affects this attribute; same as the predicate device.
Relative Humidity is unchanged from predicate.	No change made which affects this attribute; same as the predicate device.
Unit Size is unchanged from predicate.	No change made which affects this attribute; same as the predicate device.
Unit Weight is unchanged from predicate.	No change made which affects this attribute; same as the predicate device.
Electromagnetic Compatibility - Radiated Susceptibility is unchanged from predicate.	No change made which affects this attribute; same as the predicate device.
Electromagnetic Compatibility - Radiated Emissions Class B is unchanged from predicate.	No change made which affects this attribute; same as the predicate device.
Electromagnetic Compatibility - Magnetic Immunity is unchanged from predicate.	No change made which affects this attribute; same as the predicate device.
Operating System Test (Assembly Source Code) is unchanged from predicate.	No change made which affects this attribute; same as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not mention any clinical test set, sample size, or data provenance (country of origin, retrospective/prospective). This is typical for a Special 510(k) for a device modification, where the focus is on engineering verification and validation that the changes do not negatively impact safety or effectiveness, rather than a new clinical performance study. The "Verification Test Summary Table" lists various engineering/technical tests (e.g., EMC, Operating System Test), but not clinical trials.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. No clinical test set requiring expert ground truth establishment is described in this submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. No MRMC study or any comparative effectiveness study with human readers is mentioned or implied. The device (GDC Power Supply) is an accessory used by a neurosurgical team, not an AI-assisted diagnostic tool.

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

Not applicable in the context of AI/algorithms. The GDC Power Supply is a hardware device that controls the detachment of coils. Its function is to apply current and detect detachment. The "Operating System Test (Assembly Source Code)" mentioned in the verification table hints at internal software verification, but this is a standard engineering test for embedded systems, not an AI algorithm performance test.

7. The Type of Ground Truth Used

For the design verification that was performed, the "ground truth" would be established engineering specifications and performance standards for electrical devices, EMC, and software functionality. For example, for current settings, the ground truth is simply whether the device outputs the specified 0.5 mA, 0.75 mA, or 1.0 mA when selected, and whether it correctly detects coil detachment as designed. This is assessed through bench testing and functional verification, not clinical expert consensus or pathology.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. This device does not involve machine learning or AI.

Summary

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6 2002 JUN

K021494(P.1 of 6)

Special 510(k): Modification to Boston Scientific Target's GDC™ Power Supply

a. Summary Of Safety And Effectiveness

Contact Person

Jim Leathley Regulatory Affairs Project Manager Boston Scientific Target 47900 Bayside Parkway Fremont, CA. 94538

Trade Name

Guglielmi Detachable Coil (GDC) Power Supply

Common Name

Occlusion Coil, accessory

Classification Name

Artificial Embolization Device (21 CFR Section 882.5950), accessory

Predicate Devices

Number	Description	Predicate for	Clearance Date
K991139(BostonScientificTarget)	Guglielmi Detachable Coil(GDC) System with Version4 Modifications	GDC Power Supplymodifications that are thesubject of this Special510(k)	22 Dec. 1999
K001083(BostonScientificTarget)	Guglielmi Detachable Coil(GDC) System withadditional Version 4Modifications	GDC Power Supplymodifications that are thesubject of this Special510(k)	3 May 2000

Intended Use

GDC Power Supply

Boston Scientific Target

Page 110

April 2002

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Guglielmi Detachable Coil

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 Description

The GDC system consists of the following items, each of which is sold separately

· GDC Power Supply
· GDC occlusion coil attached to a delivery wire
· set of GDC connecting cables
· patient return electrode
two 9-volt batteries

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

GDC coils are available in a range of sizes for use with either Boston Scientific Target's -10 or -18 Infusion Catheters with two tip markers.

The GDC Power Supply is a battery-operated, self-contained unit designed to initiate and control the electrolytic detachment of a GDC coil inside an aneurysm.

Boston Scientific Target

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021494(P.3 of 6)

The GDC 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 GDC 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 GDC System and to recognize those changes which indicate detachment.

Once those patterns are identified, the GDC Power Supply signals detachment and stops the flow of current through the GDC System.

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

Boston Scientific Target

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Technological Characteristics Comparison

GDC Power Supply

Component/Parameter	Affect on GDC Power Supply
Power	No change made which affects this attribute;same as the predicate device.
Batteries	No change made which affects this attribute;same as the predicate device.
Expected Battery Life	No change made which affects this attribute;same as the predicate device.
Red Cable	No change made which affects this attribute;same as the predicate device.
Black Cable	No change made which affects this attribute;same as the predicate device.
Current Settings	From current settings of: 1 mA (default), 2 mA, 0.5 mATo current settings of: 1 mA (default), 0.5 mA, 0.75 mA
Current	No change made which affects this attribute;same as the predicate device.
Voltage	No change made which affects this attribute;same as the predicate device.
Operating Temperature	No change made which affects this attribute;same as the predicate device.
Storage Temperature	No change made which affects this attribute;same as the predicate device.

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021494 (P. 5 of 6)

Technological Characteristics Comparison (cont.)

GDC Power Supply

Component/Parameter	Affect on GDC Power Supply
Relative Humidity	No change made which affects this attribute;same as the predicate device.
Unit Size	No change made which affects this attribute;same as the predicate device.
Unit Weight	No change made which affects this attribute;same as the predicate device.

Boston Scientific Target

April 2002

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Ko21494 (P.6or6)

Verification Test Summary Table: Predicate GDC Device vs Modified GDC

Test or Point of Comparison	GDC with modifications described in this submission
Electromagnetic Compatibility-Radiated Susceptibility	No change made which affects this attribute;same as the predicate device.
Electromagnetic Compatibility-Radiated Emissions Class B	No change made which affects this attribute;same as the predicate device.
Electromagnetic Compatibility-Magnetic Immunity	No change made which affects this attribute;same as the predicate device.
Operating System Test(Assembly Source Code)	No change made which affects this attribute;same as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three intertwined strands, representing health and well-being. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

6 2002 ווא

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James Leathley Regulatory Affairs Project Management Boston Scientific Target 47900 Bayside Parkway Fremont, CA 94538

Re: K021494

Trade/Device Name: Guglielmi Detachable Coil (GDC) Power Supply Regulation Number: 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: May 8, 2002 Received: May 9, 2002

Dear Mr. Leathley:

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 (OS) 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. James Leathley

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,

sincerely yours,

Mark McMullen

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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K021494

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INDICATIONS FOR USE STATEMENT

510(k) Number: _______________________

Device Name: Guglielmi Detachable Coil (GDC) Power Supply: 1 mA, 0.5 mA and 0.75 mA current settings

Indications for Use:

Guglielmi Detachable Coil Power Supply

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

April 2002

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR Over The Counter Use

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

Boston Scientific Target

510(k) Numberge 23
Confidential

K021494

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).