Intracranial aneurysms
Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
Arterial and venous embolizations in the peripheral vasculature .

Device Description

Boston Scientific's GDC® 360° Detachable Coil is a device which facilitates endovascular embolization of intracranial aneurysms and other vascular abnormalities. The GDC® 360° Detachable Coil is a platinum/tungsten alloy coil attached to a stainless steel delivery wire. The GDC® 360° Detachable Coil is detached (using the Boston Scientific Detachable Coil Power Supply or InZone Detachment System) by electrolytically dissolving a small portion of the delivery wire upon its desired placement within an aneurysm or other vascular site via a microcatheter. Multiple coils can be delivered into an aneurysm or other vascular site through the same microcatheter until the aneurysm or other vascular site is densely packed.

The GDC® 360° coil is first wound into a primary or main coil and then into a secondary shape using a secondary shaping (winding) mandrel. The distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil, the diameter of which is 75% that of the main coil to facilitate placement of the coil into an aneurysm.

The GDC 360° Detachable Coil is a line extension to the GDC® family of devices and include the following coil subtypes:

. GDC®-10 360° Coil
GDC -10 360° Soft Coil, and .
GDC®-18 360° Coil .

The primary differences between the GDC® and the GDC® 360° Coil include the following:

a slightly modified shape relative to the predicate GDC® coils (accomplished . through use of a new secondary coil winding mandrel)
an expanded range of coil sizes (i.e., in terms of coil outside, or secondary, . diameter and coil length) and,
minor additional changes related to these two changes noted above. .

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The submission focuses on expanding the indications for use of the GDC® 360° Detachable Coils, rather than on proving the initial safety and effectiveness of the device itself. Therefore, the "acceptance criteria" are primarily related to demonstrating that the expanded indications (for ruptured intracranial aneurysms) do not introduce new safety or effectiveness concerns compared to the existing indications and predicate devices.

The established acceptance criteria for the GDC® 360° Detachable Coils were likely set during the clearance of K042539 (original GDC 360° coils) and K031049 (ISAT indication for all GDC devices). The current submission leverages these previous clearances.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from K042539 & K031049, maintained for current submission)	Reported Device Performance (for GDC® 360° Coils in this submission)
Non-Clinical Performance (Bench Testing):	Conclusion: The GDC® 360° coils demonstrated substantial equivalence to predicate GDC® coils (K03149) in all listed aspects, meaning they met the same acceptance criteria.
Tensile Strength (Main coil to delivery wire)	Meets same acceptance criteria as predicate device (K03149)
Friction (Coil deployment resistance through a microcatheter)	Meets same acceptance criteria as predicate device (K03149)
Detachment Time	No change made which would affect this test.
Deployment / Retraction Force	Meets same acceptance criteria as predicate device (K03149)
Tip Ball Strength	Meets same acceptance criteria as predicate device (K03149)
Coil Stiffness	Meets same acceptance criteria as predicate device (K03149)
Heating Effect of Electrolysis	No change made which would affect this test.
Heating Effect of MRI	Meets same acceptance criteria as predicate device (K03149)
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)	No change made which would affect this test.
Clinical Performance (Safety and Effectiveness for expanded indication):	Clinical Conclusion: Based on the ISAT results, the GDC® 360° Coils with the proposed indications change are as safe and effective as the predicate GDC® 360° Coils with current indications. The risk of death at five years for patients with ruptured intracranial aneurysms treated with endovascular coil embolization was significantly lower compared to surgical clipping. Risk of rebleeding from treated aneurysm was low and no difference in deaths due to rebleeding between coiling and clipping groups in long-term follow-up.
Demonstrate safety and effectiveness for endovascular treatment of ruptured intracranial aneurysms, comparable to or better than existing treatments (e.g., surgical clipping).	The International Subarachnoid Aneurysm Trial (ISAT) demonstrated a statistically significant reduction in the risk of dependency or death at 1 year post-treatment with GDC Detachable Coils compared to neurosurgical clipping. Long-term ISAT data (mean 9 years) confirmed significantly lower risk of death at 5 years for coiled patients.
Ensure expanded indication does not alter fundamental scientific technology or raise new safety/effectiveness questions.	The submission asserts that the requested change in Indications for Use does not alter the fundamental scientific technology and the risk assessment of the modifications raises no new questions of safety and effectiveness.

Study Details for Clinical Performance (Expanded Indications)

The primary evidence for the expanded indications comes from the International Subarachnoid Aneurysm Trial (ISAT).

Sample Size used for the test set and the data provenance:
- Sample Size: The original ISAT trial included 2143 patients with ruptured intracranial aneurysms (as stated in reference 1). The follow-up studies mentioned cover these patients for longer durations (e.g., risk of death at five years, mean of 9 years follow-up, range 6-14 years).
- Data Provenance: The trial was an international, prospective, randomized controlled trial. While the specific countries are not enumerated in this summary, the name "International Subarachnoid Aneurysm Trial" strongly suggests data from multiple countries. It is prospective as it involved randomizing patients to treatment arms and following them forward.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the "number of experts" used to establish ground truth for the test set in the way one might for an AI study (e.g., independent review of images).
- Instead, ISAT was a clinical trial comparing two treatment approaches (endovascular coiling vs. surgical clipping) for ruptured intracranial aneurysms. The "ground truth" for the outcomes (e.g., death, dependency, rebleeding) was established through direct patient follow-up, clinical assessments, and medical records by the clinical teams involved in the trial. The qualifications would be neurosurgeons, interventional neuroradiologists, neurologists, and other medical professionals responsible for patient care and data collection in a large-scale international clinical trial.
Adjudication method for the test set:
- The document does not explicitly state an "adjudication method" in the context of independent expert review of a dataset (like 2+1 or 3+1 for image interpretation).
- For clinical trials like ISAT, outcomes (dependency, death, rebleeding events) are typically defined by strict protocols and often assessed by independent committees or masked assessors to minimize bias. The summary mentions "risk of dependency or death" and "risk of recurrent subarachnoid haemorrhage, death, or dependence," implying clearly defined clinical endpoints collected and analyzed according to trial methodology.
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:
- No, a MRMC comparative effectiveness study was not done. This submission is for a medical device (coils for aneurysm embolization) and not an AI-assisted diagnostic or treatment planning system that would involve human "readers" or AI assistance in that specific context. The ISAT trial compared two human-performed interventions.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance study was not done. As above, this is a medical device, not an AI algorithm.
The type of ground truth used:
- The ground truth for the ISAT study was patient clinical outcomes data, including:
  - Mortality (death)
  - Functional neurological outcomes (dependency)
  - Rebleeding events
  - These outcomes were determined directly from patient follow-up and medical records generated during the clinical trial.
The sample size for the training set:
- There is no training set in the typical machine learning sense for this submission. The ISAT study was a clinical trial evaluating a treatment.
How the ground truth for the training set was established:
- Since there was no training set in this context, this question is not applicable. The ISAT trial established its outcomes (ground truth) through direct patient follow-up and clinical assessment.

Summary

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PreMarket Notification 510(lc) Submission K103355; Boston Scientific's GDC * 360° Detachable Coils – Expanded Indications for Use

FEB 16 2011

510(k) SUMMARY
Submitter	Boston Scientific Corporation47900 Bayside ParkwayFremont, CA 94538-6515
Correspondent	Rhoda M. SantosBoston Scientific Corporation47900 Bayside ParkwayFremont, CA 94538-6515
Contact Information	E-mail: rhoda.santos@stryker.comPhone: 510-624-1262Facsimile: 510-440-7752
Date Summary Prepared	21 January 2011

Device Name / Trade Name

The device trade names and common/classification names are as follows:

Device Trade Name:	GDC ® 360° Detachable Coil
Common/Classification Name:	Occlusion Coil; Vascular Embolization Device; Neurovascular embolization device

Address and Establishment Registration Number

The address and registration numbers for the manufacturer and sterilization sites are:

Manufacturer:	Sterilization Site:
Boston Scientific Cork Ltd.Business & Technology ParkModel Farm RoadCork,Ireland	Isotron Ireland Ltd.IDA Business and TechnologyParkTullamore,County OffalyIreland
FDA Registration # 9616684(Establishment Registration Number)

510(k) Submission K103355, Boston Scientific
GDC* 360° Detachable Coils

January 2011

ﺔ ﻣﺴ

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Device Classification Regulation Number and Regulatory Status

GDC® 360° Detachable Coils are vascular and neurovascular embolization devices under 21 CFR 870.3300 (KRD) and 21 CFR 882.5950 (HCG), respectively. The devices are Class II devices (special controls), the special control for which is FDA's guidance document, Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices (issued 29 Dec 2004).

Predicate Device Information

Predicate devices are Boston Scientific's Guglielmi Detachable Coils (GDC) and GDC 360° Detachable Coils cleared under the following submissions:

K031049, ISAT Indication for all GDC® devices (cleared 1 August 2003); .
K042539, Guglielmi Detachable Coil 360° Coils (cleared 19 October 2004 ). .

Device Description

The GDC 360° Detachable Coil is a line extension to the GDC® family of devices and include the following coil subtypes:

. GDC®-10 360° Coil
GDC -10 360° Soft Coil, and .
GDC®-18 360° Coil .

The primary differences between the GDC® and the GDC® 360° Coil include the following:

a slightly modified shape relative to the predicate GDC® coils (accomplished . through use of a new secondary coil winding mandrel)
an expanded range of coil sizes (i.e., in terms of coil outside, or secondary, . diameter and coil length) and,

January 2011

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PreMarket Notification 510(k) Submission K103355; Boston Scientific's GDC® 360° Detachable Coils - Expanded Indications for Use

minor additional changes related to these two changes noted above. .

Purpose of Submission

This Premarket Notification has been submitted to obtain clearance for a change in the indications for use of GDC® 360° Detachable Coils to include patients with ruptured intracranial aneurysms for whom surgical intervention is feasible. The proposed change in indications is based on results of the International Subarachnoid Aneurysm Trial (ISAT). There are no other changes to the GDC® 360° device as a result of the expanded indications, compared to the device described in K042539 (cleared 19 October 2004).

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Comparison to Predicate DeviceCharacteristic	Predicate Device	Predicate Device	Proposed Device
Device Name	Guglielmi Detachable Coil (GDC®)	Guglielmi Detachable Coil (GDC®360°) Detachable Coil	Guglielmi Detachable Coil (GDC®360°) Detachable Coil
510 (k)	K031049 (cleared 1 August 2003)	K042539 (cleared 19 October 2004)	CURRENT NOTIFICATION
Device Description(TechnologicalCharacteristics)	Boston Scientific's GuglielmiDetachable Coil (GDC®) is a devicewhich facilitates endovascularembolization of intracranialaneurysms and other vascularabnormalities. The GDC®Detachable Coil is aplatinum/tungsten alloy coil attachedto a stainless steel delivery wire. TheGDC® Detachable Coil is detached(using the Boston ScientificDetachable Coil Power Supply orInZone™ Detachment System) byelectrolytically dissolving a smallportion of the delivery wire upon itsdesired placement within ananeurysm or other vascular site via amicrocatheter. Multiple coils can bedelivered into an aneurysm or othervascular site through the samemicrocatheter until the aneurysm orother vascular site is densely packed.	Boston Scientific's GuglielmiDetachable Coil (GDC® 360°)Detachable Coil is a device whichfacilitates endovascular embolizationof intracranial aneurysms and othervascular abnormalities. The GDC®360° Detachable Coil is aplatinum/tungsten alloy coil attachedto a stainless steel delivery wire. TheGDC® 360° Detachable Coil detached(using the Boston ScientificDetachable Coil Power Supply orInZone™ Detachment System) byelectrolytically dissolving a smallportion of the delivery wire upon itsdesired placement within an aneurysmor other vascular site via amicrocatheter. Multiple coils can bedelivered into an aneurysm or othervascular site through the samemicrocatheter until the aneurysm orother vascular site is densely packed.	Same as predicate GDC 360°Detachable Coil.
Indications forUse/Intended	Guglielmi Detachable Coils areintended for the endovascular	GDC 360° Detachable Coils areintended for embolization of those	GDC 360° Detachable Coils areintended for the endovascular
Use	embolization of:		embolization of:
		intracranial aneurysms that – becauseof their morphology, their location, orthe patient's general medical condition– are considered by the treatingneurosurgical team to be:a) very high risk for management bytraditional operative techniques, orb) inoperable, and for embolization ofother neurovascular abnormalitiessuch as arteriovenous malformationsand arteriovenous fistulae. GDC 360°Coils are also intended for arterial andvenous embolizations in the peripheralvasculature.
	• Intracranial aneurysms		• Intracranial aneurysms
	• Other neurovascular abnormalitiessuch as arteriovenous malformationsand arteriovenous fistula		• Other neurovascular abnormalitiessuch as arteriovenous malformationsand arteriovenous fistula
	• Arterial and venous embolizationsin the peripheral vasculature		• Arterial and venous embolizationsin the peripheral vasculature
Manufacturer	Boston Scientific Corporation	Same	Same
DeviceClassification	Class II (Special Controls), HCG,21 CFR §882.5950	Same	Same
	Class II (Special Controls), KRD,21 CFR §870.3300

eMarket Notification 510(k) Submission: Boston Scientific's GDC 360° Detachable Coils – Expanded Indications for Use

510(k) Submission K103355, Boston Scientifi
GDC 360° Detachable Coils

January 2011

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PreMarket Notification 510(k) Submission: Boston Scientific's GDC® 360° Detachable Coils – Expanded Indications for Use

510(k) Submission K103355, Boston Scientific
GDC® 360° Detachable Coils

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PreMarket Notification 510(k) Submission: Boston Scientific's GDC® 360° Detachable Coils – Expanded Indications for Use

Summary of Non-Clinical Data

A summary of the Non-clinical bench testing performed on the GDC® 360° coils is provided in Table 1. These test results were previously provided in K042539, cleared 19 October 2004.

Table 1: Verification Test Summary
Predicate GDC® Devices vs GDC®-10 and GDC®-18 360° Coils

Test or Point of Comparison	GDC-10 360° Coil SRGDC®-10 360° Soft Coil SRGDC-18 360° Coil
Tensile Strength(Main coil to delivery wire)	Meets same acceptance criteria as predicate device (K03149)
Friction(Coil deployment resistance through amicrocatheter)	Meets same acceptance criteria as predicate device (K03149)
Detachment Time	No change made which would affect this test.
Deployment / Retraction Force	Meets same acceptance criteria as predicate device (K03149)
Tip Ball Strength	Meets same acceptance criteria as predicate device (K03149)
Coil Stiffness	Meets same acceptance criteria as predicate device (K03149)
Heating Effect of Electrolysis	No change made which would affect this test.
Heating Effect of MRI	Meets same acceptance criteria as predicate device (K03149)
Electrostatic Discharge	No change made which would affect this test.
Electromagnetic Compatibility-RadiatedSusceptibility	No change made which would affect this test.
Electromagnetic Compatibility-RadiatedEmissions Class B	No change made which would affect this test.
Electromagnetic Compatibility-MagneticImmunity	No change made which would affect this test.
Operating System Test(Assembly Source Code)	No change made which would affect this test.

Conclusion

The Non-clinical testing has demonstrated that the GDC® 360° coils are substantially equivalent to the predicate GDC® coils (K03149, cleared 1 August 2003).

510(k) Submission K103355, Boston Scientific GDC 360° Detachable Coils

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PreMarket Notification 510(k) Submission: Boston Scientific's GDC® 360° Detachable Coils -Expanded Indications for Use

Summary of Clinical Data

Boston Scientific Corporation previously submitted the 1-year results of the International Subarachnoid Aneurysm Trial (ISAT) with K031049, which demonstrated a statistically significant reduction in the risk of dependency or death at 1 year post-treatment when patients with ruptured intracranial aneurysms were treated endovascularly with GDC Detachable Coils rather than with neurosurgical clipping. Subsequent long term studies of the ISAT trial have been published in the Lancet Neurology by the investigators. The data showed that the risk of death at five years for patients with a ruptured intracranial aneurysm treated with endovascular coil embolization was significantly lower compared to patients who underwent surgical clipping. Overall, the ISAT follow-up data for a mean of 9 years (range 6-14 years) demonstrate that the risk of rebleeding from a treated aneurysm is low and although there were more rebleeds from the treated aneurysm in the coiling group than in the clipping group, there was no difference between the two groups in the number of deaths due to rebleeding. This improvement in patient outcomes compared to surgical clipping demonstrates that the GDC® 360° Coils with the proposed indications change is as safe and effective as the predicate GDC® 360° Coils with current indications.

Conclusion

Based on the results of the clinical data of the ISAT, which demonstrate improvement in patient outcomes, and the similarities of the design, materials, and processes of the GDC® 360° Detachable Coil to the predicate GDC® Detachable Coil, Boston Scientific requests clearance for the Indications for Use on the GDC® 360° Detachable Coil to be the same as is currently referenced for our GDC devices. Since the requested change in Indications for Use does not alter the fundamental scientific technology of the underlying predicate device and the risk assessment of the modifications raises no new questions of safety and effectivess, Boston Scientific has determined that the subject device is substantially equivalent to the predicate devices cleared under K031049 and K042539.

1 ISAT Collaborative Group. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial. The Lancet 2002; 360: 1267-74

2 Molyneux, A. J., et al., Risk of recurrent subarachnoid haemorrhage, death, or dependence and standardized mortality ratios after clipping or coiling of an intracranial aneurysm in the International Subarachnoid Aneurysm Trial (ISAT): long term follow-up. Lancet Neurol, 2009. 8(5): p. 427-33.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three lines forming a stylized bird-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Boston Scientific Neurovascular c/o Ms. Rhoda M. Santos Senior Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, CA 94538

FEB 1 6 2011

Re: K103355

Trade/Device Name: GDC® 360° Detachable Coils Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: December 8, 2010 Received: December 9, 2010

Dear Ms. Santos:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

、・

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Page 2 - Ms. Rhoda M. Santos

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm175809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

for

N
I
I
O

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: GDC® 360° Detachable Coils

Indications for Use:

GDC® 360° Detachable Coils are intended for the endovascular embolization of:

Intracranial aneurysms ●
Other neurovascular abnormalities such as arteriovenous malformations and ● arteriovenous fistulae
Arterial and venous embolizations in the peripheral vasculature .

Prescription Use
(Per 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

JEFFREY Toy

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K103355

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).