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.

The indications for use for GDC-10 3D Shape and GDC-18 3D Shape are identical to those for the predicate GDC device cleared under K962503.

Device Description

The GDC system consists of

· GDC power supply
· GDC occlusion coil attached to a delivery wire
· set of GDC connecting cables
· 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.

GDC 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 stainlesssteel core wire 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 GDC cleared under K962503.

The GDC Power Supply is a self-contained, battery-operated unit designed to initiate and control detachment of a GDC coil. It has an on/off button, connections for the GDC cables, and the following controls and displays:

· Current setting switch and display Allows for selection of the different current settings. The selected current (mA) is briefly displayed after which the unit displays the current flowing through the system.
· Voltage diplay and indicator Displays the DC output voltage.
· Time display · Displays the elapsed time that the current has been flowing through the GDC system.
Check indicator Flashes on and off at the beginning of a detachment procedure if there is a poor connection to the patient.
· Detach indicator Flashes on and off when the power supply has detected detachment. Detachment is accompanied by five beeps.
· Battery indicator Illuminates when the voltage of the internal 9-volt batteries falls below specification.

AI/ML Overview

This document describes the GDC-10 and GDC-18 3D Shape Guglielmi Detachable Coils, which are artificial embolization devices. The submission focuses on demonstrating substantial equivalence to a predicate device (K962503). As such, the acceptance criteria and study information provided are primarily focused on the technological characteristics comparison and verification testing to show that the new device performs as well as the predicate.

Here's the breakdown of the information requested, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the 3D Shape GDC are primarily established by demonstrating that its performance "Meets acceptance criteria established for predicate device" or shows "No change made which would influence" certain characteristics, or establishes "equivalency."

Test or Point of Comparison	Acceptance Criteria	Reported Device Performance
Friction	Meets acceptance criteria established for predicate device.	Meets acceptance criteria established for predicate device.
Tensile Strength, Main Coil Weld	Meets acceptance criteria established for predicate device.	Meets acceptance criteria established for predicate device.
Detachment Time	Meets acceptance criteria established for predicate device.	Meets acceptance criteria established for predicate device.
Detachment in Saline w/ particulate analysis	No change made which would result in the generation of particulate during detachment.	No change was made which would result in the generation of particulate during detachment.
Heating Effect of Electrolysis	No change made which would influence heating effect.	No change made which would influence heating effect.
Heating Effect of MRI	No change made which would increase heating effect of MRI.	No change made which would increase heating effect of MRI.
Coil Stiffness Test (Forces Exerted Test)	Established equivalency of the 3D Shape GDC to the predicate device.	Established equivalency of the 3D Shape GDC to the predicate device.
Coil Migration Test	No movement of the device after 24 hours in a blood analog pulsatile model.	Demonstrated no movement of the 3D Shape device after 24 hours in a blood analog pulsatile model.

Note: The document only refers to "acceptance criteria established for predicate device" without providing specific numerical values for those criteria. It focuses on the comparison and equivalence rather than absolute performance metrics for the new device.

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

The provided document does not specify the sample sizes used for the test sets in the verification tests. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). The tests described (e.g., friction, tensile strength, detachment time, heating effects) are typically conducted in a lab setting on device samples rather than with patient data.

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

This information is not provided in the document. The tests seem to be primarily engineering and bench-top evaluations of physical and functional characteristics of the device, rather than studies requiring expert medical interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (bench-top/engineering), an adjudication method as typically used in clinical studies with human readers would not be applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided text. This document describes a 510(k) submission for a medical device (embolization coil), which typically relies on demonstrating substantial equivalence through technological comparison and verification testing, rather than clinical efficacy studies involving human readers and interpretations of medical cases.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant (embolization coil) and does not involve an algorithm or AI component in the sense of image analysis or diagnostic support.

7. Type of Ground Truth Used

The "ground truth" for the verification tests is based on engineering specifications and established performance criteria for the predicate device. For tests like "Friction" or "Tensile Strength," the ground truth is a measurable physical property that must meet a predefined standard. For a test like "Coil Migration," the ground truth is the observation of "no movement" within the specified test conditions. These are objective engineering measurements rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set

This information is not applicable/not provided. As this is a physical medical device (embolization coil) and not an AI/algorithm-based product, there is no "training set" in the context of machine learning.

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

This information is not applicable/not provided for the same reasons as above.

Summary

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Section 2 - 510 (k) Summary of Safety and Effectiveness and Class III Certification and Summary

a. Summary Of Safety And Effectiveness

Contact Person

Roxane Baxter Regulatory Affairs Manager Boston Scientific / Target 47900 Bayside Parkway Fremont, CA. 94538

Trade Name

Guglielmi Detachable Coil (GDC), Class III

Common Name

Occlusion Coil

Classification Name

Artificial Embolization Device (21 CFR Section 882.5950)

Predicate Devices

Number	Description	Predicate for	ClearanceDate
K962503(BostonScientific /Target)	Guglielmi Detachable Coil	GDC-10 andGDC-18 GuglielmiDetachable Coil (3DShape GDC)	20 Sept. 1996
K971395(BostonScientific /Target)	Shelf Life, Various Class IIand Class III Devices for	For shelf-life validationmethod and subsequentplacement of shelf-lifeinformation on devicelabel	14 July 1997

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Intended 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.

The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

The indications for use for GDC-10 3D Shape and GDC-18 3D Shape are identical to those for the predicate GDC device cleared under K962503.

Device Description

The GDC system consists of

· GDC power supply
· GDC occlusion coil attached to a delivery wire
· set of GDC connecting cables
· 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.

GDC occlusion coils are manufactured from platinum wire which is first wound into a primary coil and then formed into a secondary helical shape.

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· Current setting switch and display Allows for selection of the different current settings. The selected current (mA) is briefly displayed after which the unit displays the current flowing through the system.
· Voltage diplay and indicator Displays the DC output voltage.
· Time display · Displays the elapsed time that the current has been flowing through the GDC system.
Check indicator Flashes on and off at the beginning of a detachment procedure if there is a poor connection to the patient.
· Detach indicator Flashes on and off when the power supply has detected detachment. Detachment is accompanied by five beeps.
· Battery indicator Illuminates when the voltage of the internal 9-volt batteries falls below specification.

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Technological Characteristics Comparison

Coil Dimensional Attributes

	GDC(Predicate device clearedunder K962503)	3D Shape GDC
Coil Primary Wind OD	0.010" - 0.015"	GDC-10: 0.010"GDC-18: 0.014", 0.0145" or0.015"
Secondary Coil OD	GDC-10: 2 mm - 30 mmGDC-18: 2 mm - 30 mm	Secondary Coil(Large Loop) ODGDC-10: 3, 4, 5, 6, 7, 8 or 10 mmGDC-18: 6, 8, 10, 12, 14, 16, 18 or 20 mm
Coil Wire OD	Range: 0.001" - 0.005"Current wire sizes used in theproduction of GDC devices are:GDC-10: 0.00175", 0.002"GDC-18: 0.00225", 0.003",0.004"	For GDC 3D Shape:GDC-10: 0.002"GDC-18: 0.0025", 0.00275",0.003", 0.004"
Delivery Wire Length	50 - 200 cm	175 cm
Delivery WireProximal OD	GDC-10: 0.010"GDC-18: 0.010"	GDC-10: 0.010"GDC-18: 0.014"
Delivery WireDistal OD	GDC-10: 0.0028"GDC-18: 0.0028"	GDC-10: 0.0028"GDC-18: 0.0028"
	3D Shape GDC
Main Coil	Same as predicate device
Delivery Wire:
Core wirew/coating	Same as predicate device
Proximal Coil	Same as predicate device
Proximal MarkerCoil	Same as predicate device
Sheath, DeliveryWire (heat shrinktubing)	Same as predicate device
Proximal Tubing	Same as predicate device
Bushing	Same as predicate device
Hypotube	Same as predicate device

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K993417

Technological Characteristics Comparison (cont.)

Materials

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Technological Characteristics Comparison (cont.)

Power Supply

	GDC Power Supply,3D Shape GDC
Power	Same as for predicate device.
Batteries	Same as for predicate device.
Expected BatteryLife	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.

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Test or Point of Comparison	3D Shape GDC
Friction	Meets acceptance criteria established forpredicate device.
Tensile Strength, Main Coil Weld	Meets acceptance criteria established forpredicate device.
Detachment Time	Meets acceptance criteria established forpredicate device.
Detachment in Saline w/ particulateanalysis	No change was made which would resultin the generation of particulate duringdetachment.
Heating Effect of Electrolysis	No change made which would influenceheating effect.
Heating Effect of MRI	No change made which would increaseheating effect of MRI.
Coil Stiffness Test(Forces Exerted Test)	Established equivalency of the 3D ShapeGDC to the predicate device.

Verification Test Summary Table: Comparison of 3D Shape GDC to the Predicate Device

Additional test conducted during design feasibility testing

Coil Migration Test	Demonstrated no movement of the 3DShape device after 24 hours in a bloodanalog pulsatile model.

510(k) Notification, Boston Scientific/Target, GDC-10 and GDC-18 3D Shape September 1999 Confidential

Section 2, Page 8 of 21

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Public Health Service

JAN 2 1 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Roxane K. Baxter, RAC Manager, Regulatory Affairs Boston Scientific/Target 47900 Bayside Parkway Fremont, California 94538

Rc: K993417

Trade Name: GDC-10 Guglielmi Detachable Coil (3D Shape GDC) GDC-18 Guglielmi Detachable Coil (3D Shape GDC) Regulatory Class: III Product Code: HCG and KRD Dated: September 29, 1999 Received: October 01, 1999

Dear Ms. Baxter:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Mcdical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the generals 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations

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Ms. Roxane K. Baxter, RAC

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices 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 809.10 for in vitro diagnostic devices), please contact the Office af Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 504-4639. Also, please note the regulation entitled, "Misbranding by reference to promarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address. "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

James E. Dillard III

James E. Dillard III Acting Director Division of General and Restorative Deviccs Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: GDC-10 Guglielmi Detachable Coil (3D Shape GDC) GDC-18 Guglielmi Detachable Coil (3D Shape GDC)

Indications for Use:

a) very high risk for management by traditional opcrative 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	X
---------------------------------------	-----------------------------------------

Over The Counter Use
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K993417

510(k) Notification, Boston Scientific/Target, GDC-10 and GDC-18 3D Shape
September 1999 Confidential Section 3, Page 2 of 3

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).