(112 days)
Not Found
No
The device description and performance studies focus on the mechanical and electrical properties of the coil and detachment system, with no mention of AI or ML.
Yes.
The device is intended for embolizing intracranial aneurysms and vascular malformations, which is a therapeutic intervention for certain medical conditions.
No.
The device is a Guglielmi Detachable Coil (GDC) system used for embolizing intracranial aneurysms and vascular malformations. Its function is therapeutic (embolization) rather than diagnostic (identifying or characterizing a medical condition).
No
The device description clearly outlines multiple hardware components including a power supply, occlusion coil, cables, and electrode.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for embolizing intracranial aneurysms and other vascular malformations within the patient's body. This is an in vivo procedure, meaning it is performed inside a living organism.
- Device Description: The device description details a system for delivering and detaching a coil within the anatomy. This further supports its use within the body.
- Anatomical Site: The specified anatomical sites are the intracranial neurovasculature and peripheral vasculature, both of which are internal to the patient.
In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) outside the body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 neurovasculature.
The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial (aneurysms, neurovasculature, arteriovenous malformations and arteriovenous fistulae), peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Treating neurosurgical team, Prescription Use
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)
Coil Migration Test: Demonstrated no movement of the 3D Shape device after 24 hours in a blood analog pulsatile model.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 | GDC-10 and
GDC-18 Guglielmi
Detachable Coil (3D
Shape GDC) | 20 Sept. 1996 |
| 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 |
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 neurovasculature.
The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
The indications for use for GDC-10 3D Shape and GDC-18 3D Shape are identical to those for the predicate GDC device cleared under K962503.
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 similar to that employed for the predicate GDC cleared under K962503.
2
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.
3
Technological Characteristics Comparison
Coil Dimensional Attributes
| | GDC
(Predicate device cleared
under K962503) | 3D Shape GDC |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Coil Primary Wind OD | 0.010" - 0.015" | GDC-10: 0.010"
GDC-18: 0.014", 0.0145" or
0.015" |
| Secondary Coil OD | GDC-10: 2 mm - 30 mm
GDC-18: 2 mm - 30 mm | Secondary Coil
(Large Loop) OD
GDC-10: 3, 4, 5, 6, 7, 8 or 10 mm
GDC-18: 6, 8, 10, 12, 14, 16, 18 or 20 mm |
| 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" | For GDC 3D Shape:
GDC-10: 0.002"
GDC-18: 0.0025", 0.00275",
0.003", 0.004" |
| Delivery Wire Length | 50 - 200 cm | 175 cm |
| Delivery Wire
Proximal OD | GDC-10: 0.010"
GDC-18: 0.010" | GDC-10: 0.010"
GDC-18: 0.014" |
| Delivery Wire
Distal OD | GDC-10: 0.0028"
GDC-18: 0.0028" | GDC-10: 0.0028"
GDC-18: 0.0028" |
| | 3D Shape GDC | |
| Main Coil | Same as predicate device | |
| 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 | |
| Hypotube | Same as predicate device | |
4
Technological Characteristics Comparison (cont.)
.
Materials
5
Technological Characteristics Comparison (cont.)
Power Supply
| | GDC Power Supply,
3D Shape 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
| Test or Point of Comparison | 3D Shape GDC |
|---|---|
| Friction | Meets acceptance criteria established for |
| predicate device. | |
| 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. | |
| Coil Stiffness Test | |
| (Forces Exerted Test) | Established equivalency of the 3D Shape |
| GDC to the predicate device. |
Verification Test Summary Table: Comparison of 3D Shape GDC to the Predicate Device
Additional test conducted during design feasibility testing
| Coil Migration Test | Demonstrated no movement of the 3D
Shape device after 24 hours in a blood
analog pulsatile model. |
|---------------------|---------------------------------------------------------------------------------------------------------|
| | |
510(k) Notification, Boston Scientific/Target, GDC-10 and GDC-18 3D Shape September 1999 Confidential
Section 2, Page 8 of 21
7
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 Fremont, California 94538
Rc: K993417
Trade Name: GDC-10 Guglielmi Detachable Coil (3D Shape GDC) GDC-18 Guglielmi Detachable Coil (3D Shape GDC) Regulatory Class: III Product Code: HCG and KRD Dated: September 29, 1999 Received: October 01, 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 Mcdical 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 generals 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
Image /page/7/Picture/10 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
8
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 devices 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 af Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 504-4639. Also, please note the regulation entitled, "Misbranding by reference to promarket 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 Deviccs Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
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 large, bold font. Underneath the words "Boston Scientific" is a horizontal line, and underneath the line is the word "TARGET" in a large, bold font.
INDICATIONS FOR USE STATEMENT
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: GDC-10 Guglielmi Detachable Coil (3D Shape GDC) GDC-18 Guglielmi Detachable Coil (3D Shape GDC)
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 opcrative 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) | X |
|---|---|
| --------------------------------------- | ----------------------------------------- |
OR
| Over The Counter Use | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K993417 |
510(k) Notification, Boston Scientific/Target, GDC-10 and GDC-18 3D Shape
September 1999 Confidential Section 3, Page 2 of 3