(92 days)
No
The device description and performance studies focus on the physical properties and clinical outcomes of a platinum/tungsten alloy coil used for embolization, with no mention of AI or ML technology.
Yes
The device is intended for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, which is a therapeutic intervention. The clinical data also shows it reduces dependency or death in patients with ruptured intracranial aneurysms, explicitly mentioning its use for treatment.
No
The device, GDC® 360° Detachable Coils, is described as a treatment device for embolization of aneurysms and other vascular abnormalities, not for diagnosis. Its description and intended use clearly state its role in interventional procedures rather than diagnostic imaging or assessment.
No
The device description clearly details a physical medical device (platinum/tungsten alloy coil attached to a stainless steel delivery wire) used for endovascular embolization. It also mentions associated hardware like a power supply or detachment system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The GDC® 360° Detachable Coils are implantable medical devices used for the physical embolization (blocking) of blood vessels in the body. They are delivered directly into the vasculature.
- Intended Use: The intended use clearly states endovascular embolization of intracranial aneurysms and other vascular abnormalities. This is a therapeutic procedure performed in vivo (within the living body), not a diagnostic test performed in vitro (outside the living body).
- Device Description: The description details a physical coil and delivery system for placement within the body.
- Performance Studies: The performance studies focus on bench testing of physical properties and clinical outcomes related to the therapeutic procedure (embolization).
Therefore, the GDC® 360° Detachable Coils are a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
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)
- minor additional changes related to these two changes noted above.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
| Test or Point of Comparison | GDC-10 360° Coil SR GDC®-10 360° Soft Coil SR GDC-18 360° Coil |
|---|---|
| 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. |
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).
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Corporation |
| 47900 Bayside Parkway | |
| Fremont, CA 94538-6515 | |
| Correspondent | Rhoda M. Santos |
| Boston Scientific Corporation | |
| 47900 Bayside Parkway | |
| Fremont, CA 94538-6515 | |
| Contact Information | E-mail: rhoda.santos@stryker.com |
| Phone: 510-624-1262 | |
| Facsimile: 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 Park | |
| Model Farm Road | |
| Cork, | |
| Ireland | Isotron Ireland Ltd. |
| IDA Business and Technology | |
| Park | |
| Tullamore, | |
| County Offaly | |
| Ireland | |
| FDA Registration # 9616684 | |
| (Establishment Registration Number) |
510(k) Submission K103355, Boston Scientific
GDC* 360° Detachable Coils
January 2011
ﺔ ﻣﺴ
1
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
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,
January 2011
2
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).
3
| Comparison to Predicate Device
| Characteristic | 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 | |||
| (Technological | |||
| Characteristics) | Boston Scientific's Guglielmi | ||
| Detachable Coil (GDC®) is a device | |||
| which facilitates endovascular | |||
| embolization of intracranial | |||
| aneurysms and other vascular | |||
| abnormalities. The GDC® | |||
| Detachable Coil is a | |||
| platinum/tungsten alloy coil attached | |||
| to a stainless steel delivery wire. The | |||
| GDC® 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. | Boston Scientific's Guglielmi | ||
| Detachable Coil (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 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. | Same as predicate GDC 360° | ||
| Detachable Coil. | |||
| Indications for | |||
| Use/Intended | Guglielmi Detachable Coils are | ||
| intended for the endovascular | GDC 360° Detachable Coils are | ||
| intended for embolization of those | GDC 360° Detachable Coils are | ||
| intended for the endovascular | |||
| Use | embolization of: | embolization of: | |
| 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 neurovascular abnormalities | |||
| such as arteriovenous malformations | |||
| and arteriovenous fistulae. GDC 360° | |||
| Coils are also intended for arterial and | |||
| venous embolizations in the peripheral | |||
| vasculature. | |||
| • Intracranial aneurysms | • Intracranial aneurysms | ||
| • Other neurovascular abnormalities | |||
| such as arteriovenous malformations | |||
| and arteriovenous fistula | • Other neurovascular abnormalities | ||
| such as arteriovenous malformations | |||
| and arteriovenous fistula | |||
| • Arterial and venous embolizations | |||
| in the peripheral vasculature | • Arterial and venous embolizations | ||
| in the peripheral vasculature | |||
| Manufacturer | Boston Scientific Corporation | Same | Same |
| Device | |||
| Classification | 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
:
4
PreMarket Notification 510(k) Submission: Boston Scientific's GDC® 360° Detachable Coils – Expanded Indications for Use
i
510(k) Submission K103355, Boston Scientific
GDC® 360° Detachable Coils
5
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 SR
GDC®-10 360° Soft Coil SR
GDC-18 360° Coil |
|---------------------------------------------------------------------|----------------------------------------------------------------------|
| 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. |
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
6
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.
7
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.
、・
8
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,
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
9
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