(29 days)
The Guglielmi Detachable Coil (GDC) is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be: a) very high risk for management by traditional operative techniques, or, b) inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
The GDC system consists of GDC power supply, GDC occlusion coil attached to a delivery wire, set of GDC connecting cables, patient return electrode, two 9-volt batteries, each of which is sold separately. The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy. GDC occlusion coils are manufactured from platinum wire which is first wound into a primary coil and then formed into a secondary helical shape. Coils are attached to a delivery wire, which consists of a ground stainless-steel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is similar to that employed for the predicate GDC devices cleared variously under K991139, K001183 and K030475. The GDC Power Supply is a battery-operated, self-contained unit designed to initiate and control the electrolytic detachment of a GDC coil inside an aneurysm. Each time the 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 .05 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. The GDC Power Supply is designed to apply a constant current through the GDC System and to detect when coil detachment has occurred. It maintains a constant current by: 1) sensing the amount of resistance to current flow through the GDC System, and 2) adjusting the voltage needed to maintain the desired current setting. It is also designed to identify subtle changes in the way current is flowing through the GDC System and to recognize those changes which indicate detachment. Once those patterns are identified, the GDC Power Supply signals detachment and stops the flow of current through the GDC System.
Here's an analysis of the provided text regarding the Boston Scientific Neurovascular's GDC® 360° Coils, highlighting the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document is a Special 510(k) Notification, which implies substantial equivalence to predicate devices rather than a new device requiring extensive de novo clinical trials. Therefore, the "acceptance criteria" are primarily established by meeting the design and performance characteristics of the previously cleared predicate devices and showing that any changes do not adversely affect safety or effectiveness. The "reported device performance" is essentially a confirmation that the new device (GDC® 360° Coils) meets these established standards.
| Test or Point of Comparison | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength | Unspecified (Implied: Meets predicate's specifications) | Meets acceptance criteria. |
| Friction | Unspecified (Implied: Meets predicate's specifications) | Meets acceptance criteria. |
| Detachment Time | No change made which would affect this test. | No change made which would affect this test. |
| Deployment / Retraction Force | Unspecified (Implied: Meets predicate's specifications) | Meets acceptance criteria. |
| Tip Ball Strength | Unspecified (Implied: Meets predicate's specifications) | Meets acceptance criteria. |
| Coil Stiffness | Unspecified (Implied: Meets predicate's specifications) | Meets acceptance criteria. |
| Heating Effect of Electrolysis | No change made which would affect this test. | No change made which would affect this test. |
| Heating Effect of MRI | Unspecified (Implied: Meets predicate's specifications) | Meets acceptance criteria. |
| Electrostatic Discharge | No change made which would affect this test. | No change made which would affect this test. |
| Electromagnetic Compatibility - Radiated Susceptibility | No change made which would affect this test. | No change made which would affect this test. |
| Electromagnetic Compatibility - Radiated Emissions Class B | No change made which would affect this test. | No change made which would affect this test. |
| Electromagnetic Compatibility - Magnetic Immunity | No change made which would affect this test. | No change made which would affect this test. |
| Operating System Test (Assembly Source Code) | No change made which would affect this test. | No change made which would affect this test. |
| Other Comparisons (Technological Characteristics - Coils) | Same as predicate devices or within established range | See "Technological Characteristics Comparison" tables for details, generally "Same as" or "within range". |
| Other Comparisons (Technological Characteristics - Power Supply | Same as predicate devices | "Same as for predicate devices" |
| Intended Use | Identical to predicate devices | Identical (or at least substantially similar, which is the basis for 510(k)) to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of clinical data for algorithmic performance. This is not a study of AI or a diagnostic device, but rather a Class III medical device (embolic coil) for which the primary "test set" would be engineering and bench testing relevant to the physical characteristics and performance of the coil and power supply.
- Sample Size: Not explicitly stated for specific tests, but implied to be sufficient for engineering validation.
- Data Provenance: Not applicable in the context of human data. The "provenance" is through engineering testing and comparison to existing predicate devices. The document does not mention any human clinical data or retrospective/prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this type of device submission. There is no mention of "ground truth" being established by experts in the context of human data for the GDC® 360° Coils. The ground truth for the device's physical performance is established through established engineering and quality control standards.
4. Adjudication Method for the Test Set:
This is not applicable as there is no indication of a clinical "test set" or read data requiring adjudication.
5. 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:
This is not applicable. This submission is for an embolic coil, a physical medical device, not an AI or diagnostic algorithm, and thus, no MRMC study or AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This is not applicable as this is not an algorithm or AI device.
7. The Type of Ground Truth Used:
The "ground truth" for the performance of the GDC® 360° Coils and power supply is based on:
- Engineering specifications and standards: Performance characteristics (tensile strength, friction, detachment time, etc.) are judged against predefined engineering requirements.
- Comparison to predicate devices: The crucial aspect of a 510(k) submission is showing substantial equivalence to legally marketed predicate devices. Therefore, the "ground truth" for acceptable performance is largely defined by the performance envelope of the predicate devices.
8. The Sample Size for the Training Set:
This is not applicable as this is not an AI or machine learning device submission. There is no "training set" in the context of data for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no training set mentioned or implied.
Summary of the Study (as described in the document):
The document K042539 is a Special 510(k) Notification for Boston Scientific Neurovascular's GDC® 360° Coils. A Special 510(k) is used when a modification to an existing device is made, and the modification does not affect the device's indications for use or its fundamental scientific technology. The "study" described here is primarily a bench testing and comparison study to demonstrate substantial equivalence to previously cleared predicate devices (K991139, K001083, K030475).
The core of the "study" involves:
- Comparison of Technological Characteristics: Detail tables comparing coil dimensional attributes, materials, and power supply specifications to the predicate devices. The consistent finding is that the new devices are either "Same as predicate devices" or "within the range of sizes used across all current GDC coils."
- Verification Test Summary Table: A list of standard engineering tests performed on the GDC® 360° Coils. For several tests (Tensile Strength, Friction, Deployment/Retraction Force, Tip Ball Strength, Coil Stiffness, Heating Effect of MRI), the device "Meets acceptance criteria." For other tests (Detachment Time, Heating Effect of Electrolysis, Electrostatic Discharge, Electromagnetic Compatibility, Operating System Test), the statement is "No change made which would affect this test," implying that because no relevant change was made from the predicate, and the predicate met these criteria, the new device also meets them by extension.
In essence, the "study" is a demonstration through technical specifications and bench testing that the modified GDC® 360° Coils maintain the safety and effectiveness profile of their predicate devices, and that changes (like two new primary coil sizes and an expanded range of secondary coil sizes) do not introduce new questions of safety or effectiveness. This type of submission relies heavily on engineering verification rather than clinical data or algorithmic performance studies.
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OCT 1 9 2004
K042539 page 1/7
Special 510(k): Boston Scientific Neurovascular's GDC® 360° Coils
a. Summary Of Safety And Effectiveness
Contact Person
Jim Leathley Regulatory Affairs Project Manager Boston Scientific Neurovascular 47900 Bayside Parkway Fremont, CA. 94538
Trade Name
Guglielmi Detachable Coil (GDC®), Class III
Common Name
Occlusion Coil
Classification Name
Artificial Embolization Device (21 CFR Section 882.5950)
Predicate Devices
| Number | Description | Predicate for | Clearance Date |
|---|---|---|---|
| K991139(BostonScientific /Target) | Guglielmi DetachableCoil (GDC) System withVersion 4 Modifications | coil design of:GDC-10 360° Coil SRGDC-10 360° Soft Coil SRGDC-18 360° Coil | 22 Dec. 1999 |
| K001083(BostonScientific /Target) | Guglielmi DetachableCoil, Additional GDCVersion 4 Modifications | coil design of:GDC-10 360° Coil SRGDC-10 360° Soft Coil SRGDC-18 360° Coil | 3 May 2000 |
| K030475(BostonScientific /Target) | Guglielmi DetachableCoil, Modification of asingle component of theGDC Stretch ResistantCoil (Anchor 'Twister' toAnchor 'Chain') | Anchor Chain componentused on:GDC-10 360° Coil SRGDC-10 360° Soft Coil SR | 14 March 2003 |
Special 510(k) Notification, Boston Scientific Neurovascular GDC®-10 and GDC-18 360° Coils
September 2004
Page 1 of 7
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K042539 page 2/7
Intended Use
GDC Power Supply
Boston Scientific Neurovascular's Guglielmi Detachable Coil (GDC) Power Supply is intended for use with all versions of Boston Scientific Neurovascular's Guglielmi Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.
Guglielmi Detachable Coil
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.
Device Description
The GDC system consists of
- · GDC power supply
- · GDC occlusion coil attached to a delivery wire
- · set of GDC connecting cables
- · patient return electrode
- · two 9-volt batterics
each of which is sold separately.
The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.
GDC occlusion coils are manufactured from platinum wire which is first wound into a primary coil and then formed into a secondary helical shape.
Coils are attached to a delivery wire, which consists of a ground stainless-steel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is similar to that employed for the predicate GDC devices cleared variously under K991139, K001183 and K030475.
Special 510(k) Notification, Boston Scientific Neurovascular GDC®-10 and GDC-18 360° Coils
September 2004
Page 2 of 7
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K042539 page 3/7
The GDC Power Supply is a battery-operated, self-contained unit designed to initiate and control the electrolytic detachment of a GDC coil inside an aneurysm.
Each time the 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 .05 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.
The GDC Power Supply is designed to apply a constant current through the GDC System and to detect when coil detachment has occurred. It maintains a constant current by:
-
- sensing the amount of resistance to current flow through the GDC System, and
-
- adjusting the voltage needed to maintain the desired current setting. It is also designed to identify subtle changes in the way current is flowing through the GDC System and to recognize those changes which indicate detachment.
Once those patterns are identified, the GDC Power Supply signals detachment and stops the flow of current through the GDC System.
Accessories Description
Accessories consist of the following:
- · Two connecting cables, one black (274 cm long), the other red (152 cm long)
- Two standard 9 volt alkaline batteries
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Technological Characteristics Comparison (to predicate devices)
Coil Dimensional Attributes
| GDC-10 360° Coil SRGDC®-10 360º Soft Coil SRGDC-18 360° Coil | |
|---|---|
| Coil Wire OD | Same sizes as used with predicate devices |
| Primary Coil OD | Two new primary coil sizes used with GDC-10 360° Coils; both arewithin the range of sizes used across all current GDC coils |
| Secondary Coil OD | Expanded range of available sizes |
| Distal Tip Diameter(Stretch Resistant Coils only) | Larger distal tip diameters to accommodate new primary coil sizes |
| Delivery Wire Length | Same as for predicate devices |
| Delivery Wire Proximal OD | Same as for predicate devices |
| Delivery Wire Distal OD | Same as for predicate devices |
Special 510(k) Notification, Boston Scientific Neurovascular GDC®-10 and GDC-18 360° Coils
September 2004
Page 4 of 7
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K042539 page 5/7
Technological Characteristics Comparison (cont.)
Materials
| GDC-10 360° Coil SRGDC®-10 360° Soft Coil SRGDC-18 360° Coil | |
|---|---|
| Main Coil | Same as predicate devices |
| Stretch Resistant Thread(GDC-10 360° and GDC-10 360° Soft Coils only) | Same as predicate devices |
| Main Coil / delivery wire junction tubing | Same as predicate devices |
| Delivery Wire | |
| Core wire w/coating | Same as predicate devices |
| Proximal Coil | Same as predicate devices |
| Proximal Marker Coil | Same as predicate devices |
| Sheath, Delivery Wire (heat shrink tubing) | Same as predicate devices |
| Proximal Tubing | Same as predicate devices |
| Bushing | Same as predicate devices |
| Anchor Chain(GDC-10 360° and GDC-10 360° Soft Coils only) | Same as predicate devices |
| Inner Coil | Same as predicate devices |
Special 510(k) Notification, Boston Scientific Neurovascular GDC®-10 and GDC-18 360° Coils
.
September 2004
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K042539 page 6/7
Technological Characteristics Comparison (cont.)
Power Supply
| GDC-10 360° Coil SRGDC®-10 360º Soft Coil SRGDC-18 360° Coil | |
|---|---|
| Power | Same as for predicate devices |
| Batteries | Same as for predicate devices |
| Expected Battery Life | Same as for predicate devices |
| Red Cable | Same as for predicate devices |
| Black Cable | Same as for predicate devices |
| Current Settings | Same as for predicate devices |
| Current | Same as for predicate devices |
| Voltage | Same as for predicate devices |
| Operating Temp. | Same as for predicate devices |
| Storage Temp. | Same as for predicate devices |
| Relative Humidity | Same as for predicate devices |
| Unit Size | Same as for predicate devices |
| Unit Weight | Same as for predicate devices |
Special 510(k) Notification, Boston Scientific Neurovascular GDC®-10 and GDC-18 360° Coils
September 2004
Page 6 of 7
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K042539 Page 7/7
| Test or Point of Comparison | GDC-10 360° Coil SRGDC®-10 360° Soft Coil SRGDC-18 360° Coil |
|---|---|
| Tensile Strength | Meets acceptance criteria. |
| Friction | Meets acceptance criteria. |
| Detachment Time | No change made which would affect this test. |
| Deployment / Retraction Force | Meets acceptance criteria. |
| Tip Ball Strength | Meets acceptance criteria. |
| Coil Stiffness | Meets acceptance criteria. |
| Heating Effect of Electrolysis | No change made which would affect this test. |
| Heating Effect of MRI | Meets acceptance criteria. |
| 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. |
Verification Test Summary Table: Predicate GDC Devices vs GDC-10 and GDC-18 360° Coils
Special 510(k) Notification, Boston Scientific Neurovascular GDC®-10 and GDC-18 360° Coils
September 2004
Page 7 of 7
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2004
Mr. James Leathley Regulatory Affairs Project Manager Boston Scientific Neurovascular 47900 Bayside Parkway Fremont, California 94538
Re: K042539
KU42339
Trade/Device Name: Guglielmi Detachable Coil (GDC =10 360° Coil SR; GDC-10 360° Soft Coil SR, and GDC-18 360° Coil) Regulation Number: 21 CFR 882.5950 Regulation Name: Artifical embolization device Regulatory Class: III Product Code: HCG Dated: September 17, 2004 Received: September 20, 2004
Dear Mr. Leathley:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of the reserved in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic Fee (110) has the device, subject to the general controls provisions of the Act. The r ou may) ateres, provisions of the Act include requirements for annual registration, listing of general controls pro resuring 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 If your device is exassinod (vonal controls. Existing major regulations affecting your device can may be subject to back adderal 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 r load be actived a determination that your device complies with other requirements of the Act that I Dr Has maas a a regulations administered by other Federal agencies. You must or any I 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.
{8}------------------------------------------------
Page 2 - Mr. James Leathley
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter witi anow you to oegin manteing of substantial equivalence of your device to a legally premaired notincation. The PDA maing of casification 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 If you desire specific advice ion your ac now of the regulation entitled, Colliact the Office of Companisonarket notification" (21CFR Part 807.97). You may obtain Misolanumig by reference to premailsonibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Soless http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
uriam 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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Image /page/9/Picture/1 description: The image shows the logo for Boston Scientific. The words "Boston Scientific" are stacked on top of each other. The font is a serif font and the text is black.
INDICATIONS FOR USE STATEMENT
510(k) Number: K042539
Device Name: Guglielmi Detachable Coil (GDC®-10 360° Coil SR, GDC-10 360° Soft Coil SR and GDC-18 360° Coil)
Indications for Use:
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.
V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off)
Division of Gen eral. Restorative.
Special 510(k) Notification, Boston Scientifient Regio Devices
GDC®-10 and GDC-18 360° Coils
Page 1 of 1
September 2004
K642539 510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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).