(112 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 indications for use for Stretch Resistant GDC are identical to those for the predicate GDC device cleared under K962503.
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 stainlesssteel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is the same as that employed for the predicate GDC cleared under K962503.
The GDC Power Supply is a self-contained, battery-operated unit designed to initiate and control detachment of a GDC coil. It has an on/off button, connections for the GDC cables, and the following controls and displays:
- · Current setting switch and display Allows for selection of the different current settings. The selected current (mA) is briefly displayed after which the unit displays the current flowing through the system.
- · Voltage diplay and indicator Displays the DC output voltage.
- · Time display Displays the elapsed time that the current has been flowing through the GDC system.
- Check indicator Flashes on and off at the beginning of a detachment procedure if there is a poor connection to the patient.
- · Detach indicator Flashes on and off when the power supply has detected detachment. Detachment is accompanied by five beeps.
- · Battery indicator Illuminates when the voltage of the internal 9-volt batteries falls below specification.
This document describes the safety and effectiveness of the Guglielmi Detachable Coil (GDC), a Class III artificial embolization device. The information provided focuses on the "Stretch Resistant GDC" and its comparison to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes a "Verification Test Summary Table: Comparison of Stretch Resistant GDC Devices to the Predicate Device". The acceptance criteria for most tests were established by the predicate device (K962503). For the "Main Coil Stretch Test," acceptance criteria were established for the modified device.
| Test or Point of Comparison | Acceptance Criteria (explicitly stated or inferred from predicate comparison) | Reported Device Performance (Stretch Resistant GDC) |
|---|---|---|
| Friction | Meets acceptance criteria established for predicate device. | Meets acceptance criteria established for predicate device. |
| Tensile Strength, Main Coil Weld | Meets acceptance criteria established for predicate device. | Meets acceptance criteria established for predicate device. |
| Detachment Time | Meets acceptance criteria established for predicate device. | Meets acceptance criteria established for predicate device. |
| Detachment in Saline w/ particulate analysis | No change made that would result in particulate generation. | No change was made which would result in the generation of particulate during detachment. |
| Heating Effect of Electrolysis | No change made that would influence or increase heating effect. | No change made which would influence or increase heating effect. |
| Heating Effect of MRI | No change made that would increase heating effect of MRI. | No change made which would increase heating effect of MRI. |
| Tip Ball Strength | Meets acceptance criteria established for strength of tip ball. | Meets acceptance criteria established for strength of tip ball. |
| Main Coil Stretch Test | Meets acceptance criteria for the modified device. | Meets acceptance criteria for the modified device. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test mentioned in the "Verification Test Summary Table". It is a descriptive summary of test outcomes rather than a detailed study report with sample sizes.
The data provenance is not specified. However, given that this is a 510(k) submission for a medical device in the US, the testing and data generation would typically follow US regulatory guidelines and standards. It is retrospective in the sense that these tests were conducted to demonstrate substantial equivalence to a previously cleared device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This document is a technical summary for regulatory submission, focusing on material and functional comparisons of a medical device (GDC coils). It does not involve "ground truth" derived from expert consensus on diagnostic interpretations (like for an AI algorithm). Instead, the performance is assessed against established engineering and safety standards, benchmarks set by the predicate device, or specific acceptance criteria defined for the modified device. Therefore, information about the number or qualifications of experts used to establish "ground truth" in this context is not applicable.
4. Adjudication Method for the Test Set:
Not applicable. The tests described are objective engineering and material performance assessments, not subjective diagnostic interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:
Not applicable. This document pertains to a physical medical device (embolization coil), not an AI algorithm for diagnostic assistance. Therefore, an MRMC study or the effect size of AI assistance on human readers is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used:
The "ground truth" in this context refers to established engineering specifications, performance benchmarks derived from the predicate device (K962503), or specific design requirements for the new "Stretch Resistant GDC." For example:
- Friction: Measured against a specific frictional force threshold.
- Tensile Strength, Main Coil Weld: Compared against a minimum tensile strength value.
- Detachment Time: Evaluated against a specified temporal range for detachment.
- Particulate Analysis: Absence of particulate generation.
- Heating Effects (Electrolysis, MRI): No increase beyond acceptable thresholds or predicate device performance.
- Tip Ball Strength: Compared against a minimum strength requirement.
- Main Coil Stretch Test: Evaluated against specific criteria established for the elasticity and resistance of the modified device.
These benchmarks and criteria are based on established medical device safety and efficacy standards and the performance history of the predicate device.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
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Section 2 - 510 (k) Summary of Safety and Effectiveness and Class III Certification and Summary
a. Summary Of Safety And Effectiveness
Contact Person
Roxane Baxter Regulatory Affairs Manager Boston Scientific / Target 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)
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Predicate Devices
| Number | Description | Predicate for | ClearanceDate |
|---|---|---|---|
| K962503(Boston Scientific /Target) | Guglielmi Detachable Coil | GDC-10 and GDC-10(2D) Stretch ResistantGuglielmiDetachable CoilsandGDC-18 and GDC-18(2D) Stretch ResistantGuglielmiDetachable Coils | 20 Sept. 1996 |
| K930738 (Deknatel,Division ofHowmedica, Inc.) | Implantable SurgicalSutures | Suture material | 26 July 1994 |
| K971395(Boston Scientific /Target) | Shelf Life, Various Class IIand Class III Devices for | For shelf-lifevalidation methodand subsequentplacement of shelf-life information ondevice label | 14 July 1997 |
Intended 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.
The indications for use for Stretch Resistant GDC are identical to those for the predicate GDC device cleared under K962503.
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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 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 stainlesssteel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is the same as that employed for the predicate GDC cleared under K962503.
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The GDC Power Supply is a self-contained, battery-operated unit designed to initiate and control detachment of a GDC coil. It has an on/off button, connections for the GDC cables, and the following controls and displays:
- · Current setting switch and display Allows for selection of the different current settings. The selected current (mA) is briefly displayed after which the unit displays the current flowing through the system.
- · Voltage diplay and indicator Displays the DC output voltage.
- · Time display Displays the elapsed time that the current has been flowing through the GDC system.
- Check indicator Flashes on and off at the beginning of a detachment procedure if there is a poor connection to the patient.
- · Detach indicator Flashes on and off when the power supply has detected detachment. Detachment is accompanied by five beeps.
- · Battery indicator Illuminates when the voltage of the internal 9-volt batteries falls below specification.
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Technological Characteristics Comparison
Coil Dimensional Attributes
| GDC(Predicate device clearedunder K962503) | Stretch Resistant GDC | |
|---|---|---|
| Coil Primary Wind OD | 0.010" - 0.015" | 0.0095", 0.010", 0.0135" or0.015" |
| Secondary Coil OD | GDC-10: 2 mm - 30 mm | GDC-10: 2 mm - 30 mm |
| GDC-18: 2 mm - 30 mm | GDC-18: 2 mm - 30 mm | |
| Coil Wire OD | Range: 0.001" - 0.005"Current wire sizes used in theproduction of GDC devicesare:GDC-10: 0.00175", 0.002"GDC-18: 0.00225", 0.003",0.004" | GDC-10: 0.0175", 0.002"GDC-18: 0.00225", 0.003" |
| Delivery Wire Length | 50 - 200 cm | 175 cm |
| Delivery WireProximal OD | GDC-10: 0.010"GDC-18: 0.010" | GDC-10: 0.010"GDC-18: 0.010" |
| Delivery WireDistal OD | GDC-10: 0.0028"GDC-18: 0.0028" |
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.
Technological Characteristics Comparison (cont.)
Materials
| Stretch Resistant GDC | |
|---|---|
| Main Coil | Same as predicate device |
| Stretch ResistantFilament | Polymer |
| Delivery Wire: | |
| Core wirew/coating | Same as predicate device |
| Proximal Coil | Same as predicate device |
| Proximal MarkerCoil | Same as predicate device |
| Sheath, DeliveryWire (heat shrinktubing) | Same as predicate device |
| Proximal Tubing | Same as predicate device |
| Bushing | Same as predicate device |
| Hypotube | N/A |
| Anchor Coil | Platinum |
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Technological Characteristics Comparison (cont.)
Power Supply
| GDC Power Supply,Stretch Resistant GDC | |
|---|---|
| Power | Same as for predicate device. |
| Batteries | Same as for predicate device. |
| Expected BatteryLife | Same as for predicate device. |
| Red Cable | Same as for predicate device. |
| Black Cable | Same as for predicate device. |
| Current Settings | Same as for predicate device. |
| Current | Same as for predicate device. |
| Voltage | Same as for predicate device. |
| Operating Temp. | Same as for predicate device. |
| Storage Temp. | Same as for predicate device. |
| Relative Humidity | Same as for predicate device. |
| Unit Size | Same as for predicate device. |
| Unit Weight | Same as for predicate device. |
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Verification Test Summary Table: Comparison of Stretch Resistant GDC Devices to the Predicate Device
| Test or Point of Comparison | Stretch Resistant GDC |
|---|---|
| Friction | Meets acceptance criteria established forpredicate device. |
| Tensile Strength, Main Coil Weld | Meets acceptance criteria established forpredicate device. |
| Detachment Time | Meets acceptance criteria established forpredicate device. |
| Detachment in Saline w/ particulateanalysis | No change was made which would resultin the generation of particulate duringdetachment. |
| Heating Effect of Electrolysis | No change made which would influenceor increase heating effect. |
| Heating Effect of MRI | No change made which would increaseheating effect of MRI. |
| Tip Ball Strength | Meets acceptance criteria established forstrength of tip ball. |
| Main Coil Stretch Test | Meets acceptance criteria for themodified device. |
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Image /page/8/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human figures connected by flowing lines, representing health and human services.
Public Health Service
JAN 2 1 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Roxane K. Baxter, RAC Manager, Regulatory Affairs Boston Scientific/Target 47900 Bayside Parkway Freemont, California 94538
Re: K993415
Trade Name: GDC-10 Stretch Resistant Guglielmi Detachable Coil GDC-10 (2D) Stretch Resistant Guglielmi Detachable Coil GDC-18 Stretch Resistant Guglielmi Detachable Coil GDC-18 (2D) Stretch Resistant Geglielmi Detachable Coil Regulatory Class: III Product Code: HCG and KRD Dated: September 29, 1999 Received: October 1, 1999
Dear Ms. Baxter:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Roxane K. Baxter, RAC
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
James E. Dillard III
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number: __
Device Name: GDC-10 Stretch Resistant Guglielmi Detachable Coil GDC-10 (2D) Stretch Resistant Guglielmi Detachable Coil and GDC-18 Stretch Resistant Guglielmi Detachable Coil GDC-18 (2D) Stretch Resistant Guglielmi Detachable 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 yenous embolizations in the peripheral vasculature.
(Division Sign-Off)
Division of General Restorative Devices K993415
510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
510(k) Notification, Boston Scientific/Target, GDC-10 and GDC-18 Stretch Resistant GDC CONFIDENTIAL Section 3, Page 2 September 1999
§ 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).