(29 days)
GDC Coils (All Versions except GDC 18-Fibered VortX™ Shape): The Guglielmi Detachable Coil is intended for embolization of those 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. The GDC is also intended for embolization of other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
GDC 18-Fibered VortX Shape: This product is intended for embolization of vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. GDC-18 Fibered VortX Shape is also intended for arterial and venous embolizations in the peripheral vasculature.
Guglielmi Detachable Coils (GDC®) are used as part of a system indicated for endovascular occlusion in patients with high surgical risk intracranial aneurysms and other neurovascular abnormalities. The GDC system consists of the following items, each of which is sold separately - · GDC Power Supply - · GDC SynerG TM occlusion coil attached to a delivery wire - · set of GDC connecting cables - · patient return electrode - · two 9-volt batteries GDC SynerG coils are available in regular (secondary helical), 2D (secondary helical with distal helix) and 3D (tertiary) shapes, in a range of sizes, and in Standard, Soft and Stretch Resistant versions, all of which are compatible with Boston Scientific Target Infusion Catheters with two tip markers. GDC is also available as an UltraSoft™ Coil, developed to address physicians' requests for a softer Stretch Resistant coil and a wider range of coil sizes to treat intracranial aneurysms. Boston Scientific Target also offers a Fibered GDC device, GDC 18-Fibered VortX Shape, incorporating synthetic fibers through the main coil for a more rigid coil. All of the coils are manufactured from a platinum-tungsten alloy wire which is wound into a primary or main coil. Depending upon the desired final configuration, a coil is either formed into a secondary helical shape (standard and Stretch Resistant GDC), vortex shape (GDC-18 Fibered VortX) or tertiary shape (3D GDC). The distal tip of the coil is welded to form a smooth tip (with the exception of Stretch Resistant GDC). The coils are attached to a delivery wire, which consists of a ground stainless-steel core with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. Using fluoroscopic guidance and a guiding catheter to access the lesion, the physician delivers the GDC coil to the targeted site through an infusion catheter. Upon desired placement in the anatomy, the coil is detached by use of a battery-operated power supply designed specifically for use with the GDC system. The GDC SynerG Power Supply used to initiate and control detachment is a self-contained unit that applies a constant current through the GDC system until detachment is detected. Each time the GDC Power Supply is turned on, the unit defaults to the 1.0 mA current setting. Pressing the "Current" switch one time changes the setting to the 0.5 mA current setting; pressing a second time changes the setting to 0.75 mA; pressing a third time returns the unit to the default 1.0 mA setting. Each time the switch is pressed, the current display flashes the new current setting. After selecting a current setting and initiating detachment, the current flowing through the delivery wire begins to dissolve, by electrolysis, the exposed stainless steel at the junction with the platinum-tungsten coil. Over a period of several minutes, the exposed steel completely dissolves and the platinum-tungsten coil detaches. When coil detachment is detected, the GDC SynerG Power Supply immediately halts current flow, freezes the displays and emits an audible signal that coil detachment has occurred. Using fluoroscopy, the physician then verifies that the delivery wire can be withdrawn without disturbing the newly placed coil, and can resume electrolysis if necessary. Multiple GDC coils may be placed within a single aneurysm, at the discretion of the interventional team, to achieve optimum occlusion of the lesion.
The provided document describes a Special 510(k) modification for Boston Scientific Target's GDC® Stretch Resistant Detachable Coils, specifically the replacement of an "Anchor Twister" with an "Anchor Chain." The submission aims to demonstrate that the modified device is substantially equivalent to predicate devices. The information provided is primarily focused on the physical and performance characteristics of the device and how the modification does not negatively impact these characteristics.
Crucially, this submission is for a medical device (Guglielmi Detachable Coil) which is a physical product, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (like "human readers improve with AI vs without AI assistance," "standalone performance," "training set size," "ground truth for the training set") are not applicable to this document. The document describes a traditional medical device premarket notification.
Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in a quantitative, pass/fail table format with specific numerical thresholds. Instead, it states that the modified device "Meets acceptance criteria" for various performance characteristics, implying that internal quality and performance standards were met.
The table below summarizes the reported device performance, noting that the modification has no effect on some critical parameters, indicating equivalence to the predicate device.
| Test or Point of Comparison | Reported Device Performance |
|---|---|
| Tensile Strength | Meets acceptance criteria. |
| Friction | Meets acceptance criteria. |
| Detachment Time | Modification has no affect upon detachment time. |
| Deployment / Retraction Force | Meets acceptance criteria. |
| Tip Ball Strength | Meets acceptance criteria. |
| Coil Migration | Modification has no affect upon coil migration. |
| Coil Stiffness | Meets acceptance criteria. |
| Inner Coil Weld Strength | Modification has no affect upon inner coil weld strength. |
Study Information (Based on available document)
Since this is a submission for a physical device modification, the studies mentioned are engineering verification tests to ensure the modified device performs comparably to the predicate. It does not involve a "study" in the typical clinical trial sense with patient data, experts establishing ground truth, or adjudication methods for diagnostic accuracy.
- Sample size used for the test set and the data provenance: Not explicitly stated. The document refers to "Verification Test Summary Table: Predicate GDC Devices vs Modified Devices," implying in vitro or bench testing. No human or animal data is mentioned. Data provenance (country of origin, retrospective/prospective) is not applicable for this type of engineering test.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance tests is typically established through standard engineering measurements and specifications, not expert consensus on diagnostic images.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective assessments, primarily in clinical or image-based studies.
- 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: Not applicable. This is for a physical medical device, not an AI/ML product.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device, not an AI/ML product.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For engineering verification, the "ground truth" would be established by predefined engineering specifications, material properties, and physical testing standards (e.g., measuring tensile strength against a specified minimum).
- The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
- How the ground truth for the training set was established: Not applicable.
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Special 510(k): Modification to Boston Scientific Target's GDC® Stretch Resistant Detachable Coils: Replacement of Anchor "Twister" with Anchor "Chain"
a. Summary Of Safety And Effectiveness
Contact Person
MAR 1 4 2003
Jim Leathley Regulatory Affairs Project Manager Boston Scientific Target 47900 Bayside Parkway Fremont, CA. 94538
Trade Name
Guglielmi Detachable Coil (GDC®)
Common Name
Occlusion Coil
Classification Name
Artificial Embolization Device (21 CFR Section 882.5950)
Predicate Devices
| Number | Description | Predicate for | Clearance Date |
|---|---|---|---|
| K001083(BostonScientificTarget) | Guglielmi Detachable Coil(GDC) - Additional Version4 Modifications | GDC 10-Soft SRGDC 10-Soft 2D SR | 3 May 2000 |
| K002181(BostonScientificTarget) | GDC 10-UltraSoft Coil | GDC 10-UltraSoft | 11 August 2000 |
Boston Scientific Target
February 2003
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Device Description
Guglielmi Detachable Coils (GDC®) are used as part of a system indicated for endovascular occlusion in patients with high surgical risk intracranial aneurysms and other neurovascular abnormalities.
The GDC system consists of the following items, each of which is sold separately
- · GDC Power Supply
- · GDC SynerG TM occlusion coil attached to a delivery wire
- · set of GDC connecting cables
- · patient return electrode
- · two 9-volt batteries
GDC SynerG coils are available in regular (secondary helical), 2D (secondary helical with distal helix) and 3D (tertiary) shapes, in a range of sizes, and in Standard, Soft and Stretch Resistant versions, all of which are compatible with Boston Scientific Target Infusion Catheters with two tip markers. GDC is also available as an UltraSoft™ Coil, developed to address physicians' requests for a softer Stretch Resistant coil and a wider range of coil sizes to treat intracranial aneurysms. Boston Scientific Target also offers a Fibered GDC device, GDC 18-Fibered VortX Shape, incorporating synthetic fibers through the main coil for a more rigid coil.
All of the coils are manufactured from a platinum-tungsten alloy wire which is wound into a primary or main coil. Depending upon the desired final configuration, a coil is either formed into a secondary helical shape (standard and Stretch Resistant GDC), vortex shape (GDC-18 Fibered VortX) or tertiary shape (3D GDC). The distal tip of the coil is welded to form a smooth tip (with the exception of Stretch Resistant GDC). The coils are attached to a delivery wire, which consists of a ground stainless-steel core with a stainless-steel coil welded at the distal end and a Teflon® outer jacket.
Using fluoroscopic guidance and a guiding catheter to access the lesion, the physician delivers the GDC coil to the targeted site through an infusion catheter.
Upon desired placement in the anatomy, the coil is detached by use of a battery-operated power supply designed specifically for use with the GDC system. The GDC SynerG Power Supply used to initiate and control detachment is a self-contained unit that applies a constant current through the GDC system until detachment is detected.
Each time the GDC Power Supply is turned on, the unit defaults to the 1.0 mA current setting. Pressing the "Current" switch one time changes the setting to the 0.5 mA current setting; pressing a second time changes the setting to 0.75 mA; pressing a third time returns the unit to the default 1.0 mA setting. Each time the switch is pressed, the current display flashes the new current setting.
After selecting a current setting and initiating detachment, the current flowing through the delivery wire begins to dissolve, by electrolysis, the exposed stainless steel at the junction with the platinum-tungsten coil. Over a period of several minutes, the exposed steel completely dissolves and the platinum-tungsten coil detaches. When coil detachment is detected, the GDC SynerG Power Supply immediately halts current flow, freezes the displays and emits an audible signal that coil detachment has occurred. Using fluoroscopy, the physician then verifies that the
Boston Scientific Target
February 2003
Page 73 Confidential
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delivery wire can be withdrawn without disturbing the newly placed coil, and can resume electrolysis if necessary.
Multiple GDC coils may be placed within a single aneurysm, at the discretion of the interventional team, to achieve optimum occlusion of the lesion.
Intended Use
GDC Coils (All Versions except GDC 18-Fibered VortX™ Shape):
The Guglielmi Detachable Coil is intended for embolization of those 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. The GDC is also intended for embolization of other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
GDC 18-Fibered VortX Shape:
This product is intended for embolization of vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. GDC-18 Fibered VortX Shape is also intended for arterial and venous embolizations in the peripheral vasculature.
Page 74 Confidential
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Technological Characteristics Comparison
Coil Dimensional Attributes (compared to the predicate device)
| GDC 10-Soft SR with anchor chainGDC 10-Soft 2D SR with anchor chainGDC 10-UltraSoft™ Coil with anchor chain | |
|---|---|
| Coil Primary Wind OD | Same as predicate device. |
| Secondary Coil OD | Same as predicate device. |
| Coil Wire OD | Same as predicate device. |
| Delivery Wire Length | Same as predicate device. |
| Delivery Wire Proximal OD | Same as predicate device. |
| Delivery Wire Distal OD | Same as predicate device. |
Boston Scientific Target
Page 75 Confidential
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Special 510(k): Modification to Boston Scientific Target's GDC® Stretch Resistant Detachable Coils: Replacement of Anchor "Twister" with Anchor "Chain"
Technological Characteristics Comparison (cont.)
Materials
| GDC 10-Soft SR with anchor chainGDC 10-Soft 2D SR with anchor chainGDC 10-UltraSoft™ Coil with anchor chain | |
|---|---|
| Main Coil | Same as predicate device |
| Stretch Resistant Thread | Same as predicate device |
| Main Coil / delivery wire junction tubing | Same as predicate device |
| Anchor (for Stretch Resistant Thread) | Two-piece anchor chain(replaces one-piece anchor twister) |
| Delivery Wire | |
| Core wire w/coating | Same as predicate device |
| Proximal Coil | Same as predicate device |
| Proximal Marker Coil | Same as predicate device |
| Sheath, Delivery Wire (heat shrink tubing) | Same as predicate device |
| Proximal Tubing | Same as predicate device |
| Bushing | Same as predicate device |
| Inner Coil | Same as predicate device |
Boston Scientific Target
Page 76 Confidential February 2003
{5}------------------------------------------------
| Test or Point of Comparison | GDC 10-Soft SR with anchor chainGDC 10-Soft 2D SR with anchor chainGDC 10-UltraSoft™ Coil with anchor chain |
|---|---|
| Tensile Strength | Meets acceptance criteria. |
| Friction | Meets acceptance criteria. |
| Detachment Time | Modification has no affect upon detachment time. |
| Deployment / Retraction Force | Meets acceptance criteria. |
| Tip Ball Strength | Meets acceptance criteria. |
| Coil Migration | Modification has no affect upon coil migration. |
| Coil Stiffness | Meets acceptance criteria. |
| Inner Coil Weld Strength | Modification has no affect upon inner coil weld strength. |
Verification Test Summary Table: Predicate GDC Devices vs Modified Devices
Boston Scientific Target
Page 77 Confidential February 2003
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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized image of a bird, possibly an eagle, with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2003
Mr. Jim Leathley Regulatory Affairs Project Manger Boston Scientific Target 47900 Bayside Parkway Fremont, California 94538
Re: K030475
Trade/Device Name: Guglielmi Detachable Coil (GDC®) Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: February 12, 2003 Received: February 13, 2003
Dear Mr. Leathley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (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 - Mr. Jim Leathley
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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/cdrh/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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Special 510(k): Modification to Boston Scientific Target's GDC® Stretch Resistant Detachable Coils: Replacement of Anchor "Twister" with Anchor "Chain"
Image /page/8/Picture/2 description: The image shows the logo for Boston Scientific Target. The words "Boston" and "Scientific" are stacked on top of each other in a serif font. Underneath those words is a horizontal line, and below that is the word "TARGET" in a bold, sans-serif font. The word "TARGET" is slightly slanted to the right.
INDICATIONS FOR USE STATEMENT
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
GDC 10-Soft SR Device Name: GDC 10-Soft 2D SR GDC 10-UltraSoft
Indications for Use:
GDC / Stretch Resistant GDC
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.
(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) OR
Over The Counter Use _________________________________________________________________________________________________________________________________________________________
Muriam C. Provost
General, Restorative and Neurological Devices
February 2003
510(k) Number K030475
Boston Scientific Target
§ 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).