(112 days)
No
The device description and performance studies focus on the mechanical and electrical aspects of the coil detachment system, with no mention of AI or ML.
Yes
The device is intended for embolizing certain intracranial aneurysms and other vascular malformations, which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
The device is an embolization coil, used for treating conditions like intracranial aneurysms and vascular malformations by occluding them. It is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a power supply, occlusion coil, cables, electrode, and batteries. While the power supply has software-controlled functions, the device as a whole is a system of hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for embolizing (blocking off) blood vessels in the neurovasculature and peripheral vasculature. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device components (coils, delivery wire, power supply) are designed for delivering and detaching a physical implant within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a 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 neurovasculature.
The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
Product codes
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 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.
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 Stretch Resistant GDC Devices to the Predicate Device
| Test or Point of Comparison | Stretch Resistant 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 or increase heating effect. |
| 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. |
| Main Coil Stretch Test | Meets acceptance criteria for the modified device. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
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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)
1
Predicate Devices
| Number | Description | Predicate for | Clearance
Date |
|-------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| K962503
(Boston Scientific /
Target) | Guglielmi Detachable Coil | GDC-10 and GDC-10
(2D) Stretch Resistant
Guglielmi
Detachable Coils
and
GDC-18 and GDC-18
(2D) Stretch Resistant
Guglielmi
Detachable Coils | 20 Sept. 1996 |
| K930738 (Deknatel,
Division of
Howmedica, Inc.) | Implantable Surgical
Sutures | Suture material | 26 July 1994 |
| 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 |
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.
2
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.
3
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.
4
Technological Characteristics Comparison
Coil Dimensional Attributes
| | GDC
(Predicate device cleared
under K962503) | Stretch Resistant GDC |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Coil Primary Wind OD | 0.010" - 0.015" | 0.0095", 0.010", 0.0135" or
0.015" |
| 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 the
production of GDC devices
are:
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 Wire
Proximal OD | GDC-10: 0.010"
GDC-18: 0.010" | GDC-10: 0.010"
GDC-18: 0.010" |
| | Delivery Wire
Distal OD | GDC-10: 0.0028"
GDC-18: 0.0028" |
5
.
Technological Characteristics Comparison (cont.)
Materials
| Stretch Resistant GDC | |
|---|---|
| Main Coil | Same as predicate device |
| Stretch Resistant | |
| Filament | Polymer |
| 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 | 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 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 Stretch Resistant GDC Devices to the Predicate Device
| Test or Point of Comparison | Stretch Resistant 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 |
| or increase heating effect. | |
| 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. | |
| Main Coil Stretch Test | Meets acceptance criteria for the |
| modified 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.
9
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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Image /page/10/Picture/0 description: The image contains a sequence of handwritten alphanumeric characters. The characters appear to be "K993415". The characters are written in a cursive style, with some connections between the letters and numbers. The image is in black and white.
Image /page/10/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. Below that, the word "TARGET" is written in a larger, bolder font, and it is underlined. The logo is simple and professional.
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