(112 days)
The Fibered GDC is intended for embolization of vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. Fibered GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
The GDC system consists of the following components, each of which is sold separately:
- · GDC power supply
- · GDC occlusion coil attached to a delivery wire
- · set of GDC connecting cables
- · patient return electrode
- · two 9-volt batteries
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 similar to 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 display 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Guglielmi Detachable Coil (GDC), specifically the Fibered GDC-18 VortX Shape Guglielmi Detachable Coil:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the device Fibered GDC-18 VortX Shape Guglielmi Detachable Coil is being compared to its predicate device, the original Guglielmi Detachable Coil (GDC). The acceptance criteria are "established for predicate devices," and the reported device performance indicates that the Fibered GDC "Meets acceptance criteria established for predicate device."
| Acceptance Criteria (Established for Predicate Devices) | Reported Device Performance (Fibered GDC) |
|---|---|
| Friction | Meets acceptance criteria established for predicate devices. |
| Tensile Strength, Main Coil Weld | Meets acceptance criteria established for predicate device. |
| Detachment Time | Meets acceptance criteria established for predicate device. |
| Detachment in Saline w/ particulate analysis | No change was made which would result in the generation of particulate during detachment. |
| Heating Effect of Electrolysis | No change made which would influence heating effect. |
| Heating Effect of MRI | No change made which would increase heating effect of MRI. |
| Main Coil Stretch Test | Meets acceptance criteria established for predicate device. |
| Fiber Retention Strength | Meets acceptance criteria established for predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The verification tests listed are device-specific mechanical and physical tests, not clinical studies. Therefore, these tests typically involve a relevant number of devices to demonstrate reproducibility and meet statistical significance for product specifications, but the exact number is not provided.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable and not provided in the document. The "tests" described are engineering/bench tests comparing the new device to its predicate, not studies requiring expert interpretation or ground truth establishment in a clinical context.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. As mentioned above, these are bench tests, not studies requiring adjudication by multiple readers or experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance
This information is not applicable and not provided in the document. This document describes a medical device (embolic coil), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided in the document. As stated, this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the verification tests is based on the acceptance criteria established for the predicate devices. This implies that the performance targets (e.g., specific friction values, tensile strength ranges, detachment times) of the predicate device serve as the benchmark for the new Fibered GDC. The document does not describe "pathology" or "outcomes data" as ground truth for these specific verification tests.
8. The Sample Size for the Training Set
This information is not applicable and not provided in the document. As this is a medical device, there is no "training set" in the context of machine learning or AI. The development of such a device involves design specifications, material testing, and manufacturing process controls rather than data for algorithm training.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided in the document. There is no concept of "training set" or "ground truth for a training set" for this type of medical device submission.
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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)
Predicate Devices
| Number | Description | Predicate for | ClearanceDate |
|---|---|---|---|
| K962503(Boston Scientific /Target) | GuglielmiDetachable Coil | Fibered GDC-18 VortXShape Guglielmi DetachableCoils | 20 Sept. 1996 |
| K914786(Boston Scientific /Target) | Occlusion Coils | Dacron, polyester fibermaterial | 20 April 1992 |
| K971395(Boston Scientific /Target) | Shelf Life, VariousClass II and ClassIII Devices for | For shelf-life validationmethod and subsequentplacement of shelf-lifeinformation on device label | 14 July 1997 |
| K901337and/orK940982(Cook, Inc.) | Tornado™Embolization Coils | Graduated Helical Shape | 13 Nov. 199014 Oct. 1994 |
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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 neuro vasculature.
The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
The intended uses of Fibered GDC have been narrowed relative to the predicate GDC, but still fall within the 510(k) cleared intended uses.
Fibered GDC is intended for embolization of vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae of the neuro Fibered GDC is also intended for arterial and venous vasculature. embolizations in the peripheral vasculature.
Device Description
The GDC system consists of the following components, each of which is sold separately:
- · GDC power supply
- · GDC occlusion coil attached to a delivery wire
- · set of GDC connecting cables
- · patient return electrode
- · two 9-volt batteries
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.
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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 similar to 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 display 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
| Predicate GDC | Fibered GDC | Fibered GDC | ||
|---|---|---|---|---|
| Coil Primary WindOD | 0.010" - 0.015" | 0.012" | Main Coil | Same as predicate device |
| Secondary Coil OD | GDC-10: 2 mm - 30 mmGDC-18: 2 mm - 30 mm | GDC-10: N/AGDC-18:Secondary Coil Apex OD:2 mmSecondary Coil Base OD:3, 4, 5 and 6 mm | Fiber Material | Same as predicate device |
| Coil Wire OD | Range: 0.001" - 0.005"Current wire sizes used inthe production of GDCdevices are:GDC-10: 0.00175", 0.002"GDC-18: 0.00225", 0.003",0.004" | GDC-10: N/AGDC-18: 0.003" | Delivery Wire: | |
| Delivery WireLength | 50 - 200 cm | 175 cm | Core wire w/coating | Same as predicate device |
| Delivery WireProximal OD | GDC-10: 0.010"GDC-18: 0.010" | GDC-10: N/AGDC-18: 0.014" | Proximal Coil | Same as predicate device |
| Delivery WireDistal OD | GDC-10: 0.0028"GDC-18: 0.0028" | GDC-10: N/AGDC-18: 0.0028" | 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 | |||
| Hypotube | Same as predicate device |
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Technological Characteristics Comparison (cont.)
Materials
.
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Technological Characteristics Comparison (cont.)
Power Supply
| GDC Power Supply,Fibered GDC | |
|---|---|
| Power | Same as for predicate device. |
| Batteries | Same as for predicate device. |
| Expected Battery Life | 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 Fibered GDC Devices to the Predicate Devices
| Test or Point of Comparison | Fibered GDC |
|---|---|
| Friction | Meets acceptance criteria established for predicate devices. |
| Tensile Strength, Main Coil Weld | Meets acceptance criteria established for predicate device. |
| Detachment Time | Meets acceptance criteria established for predicate device. |
| Detachment in Saline w/ particulate analysis | No change was made which would result in the generation of particulate during detachment. |
| Heating Effect of Electrolysis | No change made which would influence heating effect. |
| Heating Effect of MRI | No change made which would increase heating effect of MRI. |
| Main Coil Stretch Test | Meets acceptance criteria established for predicate device. |
| Fiber Retention Strength | Meets acceptance criteria established for predicate device. |
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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread. The bird is depicted in a simple, graphic style with flowing lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2000
Ms. Roxane K. Baxter, RAC Manager, Regulatory Affairs Boston Scientific/Target 47900 Bayside Parkway Fremont, California 94538
Re: K993418
Trade Name: Fibered GDC-18 VortX Shape Guglielmi 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 (OS) 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 Acting Director Division of General and Restorative 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 Target. The words "Boston Scientific" are stacked on top of each other in a serif font. Below that is a horizontal line, and below that is the word "TARGET" in a bold sans-serif font.
INDICATIONS FOR USE STATEMENT
510(k) Number: __
Device Name: Fibered GDC-18 VortX Shape Guglielmi Detachable Coil
Indications for Use:
The Fibered GDC is intended for embolization of vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. Fibered 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
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 4993418
Boston Scientific/Target CONFIDENTIAL
§ 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).