(121 days)
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. .
The Boston Scientific Neurovascular Guglielmi Detachable Coil (GDCTM) is a device which facilitates endovascular embolization of intracranial aneurysms and other vascular abnormalities. The GDCTM Detachable Coil is a platinum/tungsten alloy coil attached to a stainless steel delivery wire. The GDCTM Detachable Coil is detached (using the GDCTM Power Supply) 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 acceptance criteria for the Guglielmi Detachable Coil (GDC™) are implicitly met by demonstrating substantial equivalence to the predicate device, specifically regarding an expanded indication for use. The primary basis for this expanded indication is the results of the International Subarachnoid Aneurysm Trial (ISAT).
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (from ISAT study) |
|---|---|
| Safety and Effectiveness for Endovascular Embolization of Intracranial Aneurysms: The device must demonstrate safety and effectiveness for treating all intracranial aneurysms (expanded indication), not solely those considered "very high risk" or "inoperable" by traditional surgical techniques (predicate indication). This implies the device must at least maintain a favorable risk-benefit profile comparable to surgical clipping for a broader range of aneurysms. | The ISAT study comparing endovascular coiling (using GDC™ Detachable Coils) to neurosurgical clipping in patients with ruptured intracranial aneurysms demonstrated a statistically significant reduction in the risk of dependency or death at 1 year post-treatment when patients were treated endovascularly with GDC™ Detachable Coils rather than with neurosurgical clipping. This outcome supports the safety and effectiveness for the broader indication of "intracranial aneurysms," specifically for ruptured cases, by showing a superior outcome for coiling in this critical patient population. The study's conclusion indicates that the device's performance is not only acceptable but demonstrated an improved outcome. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The International Subarachnoid Aneurysm Trial (ISAT) included 2143 patients.
- Data Provenance: The study was an "International Subarachnoid Aneurysm Trial." While specific countries are not listed in the provided text, the name "International" suggests data from multiple countries. The study is a prospective, randomized trial, comparing two treatment methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The provided summary of the ISAT study focuses on the clinical outcomes of the patients rather than the establishment of a "ground truth" for diagnostic purposes by experts in a specific image interpretation scenario. The study's design as a randomized controlled trial inherently establishes the "truth" through patient outcomes (dependency or death at 1 year) following different interventions.
Therefore, the concept of "number of experts used to establish ground truth" with specific qualifications in the context of interpreting medical images for device performance validation (as one might see in an AI/imaging device submission) is not directly applicable here. The "ground truth" is the observed clinical outcome of the patients in the trial, determined by standard clinical follow-up and assessment, not by expert consensus on a set of images.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the test set in the way it might for a diagnostic study. As a clinical trial comparing two interventions and their outcomes, the "adjudication" would refer to how patient outcomes (dependency or death) were assessed and classified during follow-up. While not detailed, such large-scale clinical trials typically employ:
- Standardized outcome measures: e.g., modified Rankin Scale for dependency.
- Blinded assessment (if feasible): Assessors of outcomes (e.g., neurologists) might be blinded to the initial treatment arm (coiling vs. clipping), though this is often challenging in interventional trials due to visible procedural scars or imaging findings that reveal the treatment.
- Independent monitoring committees: These committees often review adverse events and critical outcomes to ensure proper reporting and adherence to the study protocol.
The specific "2+1, 3+1" adjudication methods are typically for image interpretation tasks, which is not the primary focus of this clinical effectiveness study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This was not an MRMC comparative effectiveness study in the traditional sense of evaluating human reader performance with or without AI assistance. The ISAT study was a direct clinical trial comparing two different medical interventions (endovascular coiling vs. neurosurgical clipping) in patients with ruptured intracranial aneurysms. It evaluated the effectiveness of the GDC™ device itself against the predicate surgical clipping, not a diagnostic algorithm's impact on human readers.
Therefore, the effect size of how much human readers improve with AI vs. without AI assistance is not applicable to this study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This was not a standalone performance study of an algorithm. The GDC™ is a physical medical device (detachable coil) for embolization, not a diagnostic algorithm. Its performance is intrinsically linked to the interventional procedure performed by a human clinician.
7. The Type of Ground Truth Used
- Clinical Outcomes Data: The ground truth used was patient clinical outcomes at 1 year post-treatment, specifically the rates of dependency or death. This is based on direct observation of patient health status following the intervention.
8. The Sample Size for the Training Set
The concept of a "training set" is not directly applicable to this premarket notification as it pertains to a physical medical device and a clinical trial. The ISAT study is a pivotal clinical trial designed to test the device's expanded indication, not to train an algorithm. Previous clinical experience and trials would have informed the development and initial indications of the GDC™, but ISAT is the primary evidentiary support mentioned for this specific submission.
9. How the Ground Truth for the Training Set was Established
As explained above, a "training set" in the context of algorithm development is not relevant here. The ISAT study provides the evidence (the "truth" in a clinical trial sense) for the device's performance regarding an expanded indication. This "truth" was established through the rigorous methodology of a randomized controlled clinical trial, where patient characteristics, interventions, and outcomes were systematically recorded and analyzed by the ISAT Collaborative Group.
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AUG - 1 2003
510(k) Summary
| Submitter | Boston Scientific Neurovascular47900 Bayside ParkwayFremont, CA 94538-6515 | |
|---|---|---|
| Correspondent | Roxane K. BaxterBoston Scientific Neurovascular47900 Bayside ParkwayFremont, CA 94538-6515 | |
| Contact Information | E-mail:Phone:Facsimile: | baxterr@bsci.com510-624-2105510-440-7752 |
| Device Common Name | Occlusion Coil | |
| Device Proprietary Name | Guglielmi Detachable Coil (GDCTM) | |
| Device Classification | Class III, HCG; 21 CFR §882.5950 | |
| Predicate DeviceTrade NameManufacturer510(k) Number | Guglielmi Detachable Coil (GDCTM)Boston Scientific NeurovascularK001083 (cleared 5/3/2000) | |
| Device Description | The Boston Scientific Neurovascular Guglielmi Detachable Coil(GDCTM) is a device which facilitates endovascularembolization of intracranial aneurysms and other vascularabnormalities. The GDCTM Detachable Coil is aplatinum/tungsten alloy coil attached to a stainless steel deliverywire. The GDCTM Detachable Coil is detached (using theGDCTM Power Supply) by electrolytically dissolving a smallportion of the delivery wire upon its desired placement withinan aneurysm or other vascular site via a microcatheter. Multiplecoils can be delivered into an aneurysm or other vascular sitethrough the same microcatheter until the aneurysm or othervascular site is densely packed. | |
| Purpose of Submission | Change to Indications For UseThis Premarket Notification has been submitted to obtainclearance for a change in the indications for use of GDCTMDetachable Coils to include all intracranial aneurysms. Theproposed change in indications is based on results of theInternational Subarachnoid Aneurysm Trial (ISAT). | |
| Intended Use | Intended for placement in a blood vessel to permanentlyobstruct blood flow to an aneurysm or other vascularmalformation. (per 21CFR 882.5950) |
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Premarket Notification [510(k)] Submission K031049 Boston Scientific Neurovascular Guglielmi Detachable Coil (GDC™)
K031049/P2/2
July 21, 2003
Comparison to Predicate Device
| Characteristic | Predicate Device | Proposed Device |
|---|---|---|
| Device Name | Guglielmi Detachable Coil (GDCTM) | SAME |
| 510 (k) | K001083 | CURRENT NOTIFICATION |
| Device Description(TechnologicalCharacteristics) | The Boston Scientific Neurovascular GuglielmiDetachable Coil (GDCTM) is a device whichfacilitates endovascular embolization ofintracranial aneurysms and other vascularabnormalities. The GDCTM Detachable Coil is aplatinum/tungsten alloy coil attached to astainless steel delivery wire. The GDCTMDetachable Coil is detached (using the GDCTMPower Supply) by electrolytically dissolving asmall portion of the delivery wire upon itsdesired placement within an aneurysm or othervascular site via a microcatheter. Multiple coilscan be delivered into an aneurysm or othervascular site through the same microcatheteruntil the aneurysm or other vascular site isdensely packed. | SAME |
| Intended Use | Intended for placement in a blood vessel to permanentlyobstruct blood flow to an aneurysm or other vascularmalformation. (per 21CFR 882.5950) | SAME |
| Indication for Use | Intended for embolization of those intracranial aneurysms -that because of their morphology, their location, or thepatient's general medical condition - are considered by theneurosurgical team to be: a) very high risk for managementby traditional operative techniques; or, b) inoperable.GDCTM coils are also intended for embolization of otherneuro vascular abnormalities such as arteriovenousmalformations and arteriovenous fistulae. GDCTM coils arealso intended for arterial and venous embolizations in theperipheral vasculature. | Intended for the endovascular embolization of:● Intracranial aneurysms.● Other neurovascular abnormalities such asarteriovenous malformations andarteriovenous fistulae.● Arterial and venous embolizations in theperipheral vasculature. |
| Manufacturer | Boston Scientific Neurovascular | Same |
| DeviceClassification | Class III, HCG; 21 CFR §882.5950 | Same |
Boston Scientific Neurovascular submitted the 1-year results of Summary of the International Subarachnoid Trial (ISAT)' that demonstrated Clinical Data 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™M Detachable Coils rather than with neurosurgical clipping. Date Summary Prepared July 21, 2003
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
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2003
Ms. Roxane K. Baxter Manager, Regulatory Affairs Boston Scientific Neurovascular 47900 Bayside Parkway Fremont, California 94538-6515
Re: K031049
Trade/Device Name: Guglielmi Detachable Coil (GDCTM) Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: March 31, 2003 Received: April 14, 2003
Dear Ms. Baxter:
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 - Ms. Roxane K. Baxter
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), 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) you may obtain. 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/cdrb/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
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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K03/049/P/+
Boston Scientific Neurovascular Applicant:
K031049 510(k) Number:
Device Name: Guglielmi Detachable Coil (GDC™)
Indications For Use:
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. .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
on Sion-Division of General, Restorative and Neurological Devices
510(k) Number K031049
§ 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).