(112 days)
Not Found
No
The device description focuses on the mechanical and electrical components for coil detachment and does not mention any AI/ML capabilities or data processing for decision making.
Yes
The device is intended for embolization of vascular abnormalities, which is a medical treatment.
No
The device is intended for embolization of vascular abnormalities, which is a therapeutic procedure, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a power supply, occlusion coil, cables, electrode, and batteries. The software component appears to be limited to the control and display functions of the power supply, which is integral to the hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the embolization of vascular abnormalities within the neurovasculature and peripheral vasculature. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a system of components used to deliver and detach an occlusion coil within blood vessels. This is an interventional device.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed for testing biological samples in vitro (outside the living organism). This device is designed for in vivo (within the living organism) therapeutic intervention.
N/A
Intended Use / 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 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.
Product codes
HCG, KRD
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.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, neurovasculature, peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
treating neurosurgical team
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)
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. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K962503, K914786, K971395, K901337 and/or K940982
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 | Clearance
Date |
|----------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------|
| K962503
(Boston Scientific /
Target) | Guglielmi
Detachable Coil | Fibered GDC-18 VortX
Shape Guglielmi Detachable
Coils | 20 Sept. 1996 |
| K914786
(Boston Scientific /
Target) | Occlusion Coils | Dacron, polyester fiber
material | 20 April 1992 |
| K971395
(Boston Scientific /
Target) | Shelf Life, Various
Class II and Class
III Devices for | For shelf-life validation
method and subsequent
placement of shelf-life
information on device label | 14 July 1997 |
| K901337
and/or
K940982
(Cook, Inc.) | Tornado™
Embolization Coils | Graduated Helical Shape | 13 Nov. 1990
14 Oct. 1994 |
1
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.
2
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.
3
Technological Characteristics Comparison
Coil Dimensional Attributes
| Predicate GDC | Fibered GDC | Fibered GDC | ||
|---|---|---|---|---|
| Coil Primary Wind | ||||
| OD | 0.010" - 0.015" | 0.012" | Main Coil | Same as predicate device |
| Secondary Coil OD | GDC-10: 2 mm - 30 mm | |||
| GDC-18: 2 mm - 30 mm | GDC-10: N/A | |||
| GDC-18: | ||||
| Secondary Coil Apex OD: | ||||
| 2 mm | ||||
| Secondary 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 in
the production of GDC
devices are:
GDC-10: 0.00175", 0.002"
GDC-18: 0.00225", 0.003",
0.004" | GDC-10: N/A
GDC-18: 0.003" | Delivery Wire: | |
| Delivery Wire
Length | 50 - 200 cm | 175 cm | Core wire w/coating | Same as predicate device |
| Delivery Wire
Proximal OD | GDC-10: 0.010"
GDC-18: 0.010" | GDC-10: N/A
GDC-18: 0.014" | Proximal Coil | Same as predicate device |
| Delivery Wire
Distal OD | GDC-10: 0.0028"
GDC-18: 0.0028" | GDC-10: N/A
GDC-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 | | | |
4
Technological Characteristics Comparison (cont.)
Materials
.
5
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. |
6
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. |
7
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.
8
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