(261 days)
No
The device description details a purely electromechanical system for detaching a coil. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The controls and displays are for monitoring basic electrical parameters and time.
Yes
The device is intended for embolizing certain intracranial aneurysms and vascular malformations, which is a therapeutic intervention.
No
Explanation: The device is a Guglielmi Detachable Coil (GDC) system, which is intended for embolizing vascular malformations. It is a therapeutic device used for treatment, not for diagnosing conditions.
No
The device description explicitly lists multiple hardware components including a power supply, occlusion coil, connecting cables, patient return electrode, and batteries.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Guglielmi Detachable Coil (GDC) system is an implantable medical device used for embolization. It is physically placed within the patient's vasculature to block blood flow to treat conditions like aneurysms and vascular malformations.
- Intended Use: The intended use clearly describes a therapeutic intervention performed in vivo (within the living body), not an in vitro analysis of a specimen.
The device description and intended use focus on the physical placement and detachment of a coil within the patient's blood vessels, which is a surgical/interventional procedure, not an in vitro diagnostic test.
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.
Fibered GDC is intended for the embolization of vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. Fibered GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
Boston Scientific/Target's Guglielmi Detachable Coil (GDC) Power Supply is intended for use with all versions of Boston Scientific/Target's Guglielmi Detachable Coils in the embolization of intracranial anewrysms and other vascular malformations of the neuro and 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, Neuro vasculature, 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K962503, K971395, K914786, K930738
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
12/22/99
Section 2 - 510 (k) Summary of Safety and Effectiveness and Class III Certification and Summary
a. Summary Of Safety And Effectiveness
Contact Person
Jim Leathley Senior Regulatory Affairs Specialist 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 | All GDC devices which
are the subject of this
premarket notification | 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 |
| K914786
(Boston
Scientific /
Target) | Platinum Fibered
Occlusion Coils | For Dacron / Polyester
fiber of Fibered GDC | April 1992 |
| K930738
(Deknatel,
Division of
Howmedica,
Inc.) | Surgical Sutures | Suture material for
Stretch Resistant GDC | 26 July 1994 |
223
510(k) Notification, Boston Scientific/Target, GDC Version 4 March 1999
Section 2, Page 2 of 47
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.
Fibered GDC is intended for the embolization of vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. Fibered GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
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.
334
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.
225
3
Image /page/3/Picture/1 description: The image shows a logo with a stylized bird in flight, enclosed within a broken circle. The bird is represented by three curved lines that suggest movement and feathers. The circle is incomplete, giving the impression of an open or dynamic form. The logo is rendered in black and white, with a simple and clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 1999
Mr. Jim Leathley Senior Regulatory Affairs Specialist Boston Scientific/Target 47900 Bayside Parkway Fremont, California 94538
Re: K991139 Trade Name: Guglielmi Detachable Coil (GDC) Power Supply Regulatory Class: III Product Code: HCG and KRD Dated: September 29, 1999 Received: October 1, 1999
Dear Mr. Leathley:
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.
4
Page 2 - Mr. Jim Leathley
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,
Neil R.P. Ogden
James F. Dillard III
James E. Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the logo for Boston Scientific Target. The words "Boston Scientific" are stacked on top of each other in a bold, sans-serif font. Below "Scientific" is the word "TARGET" in a larger, bolder, sans-serif font. There is a horizontal line separating "Scientific" and "TARGET".
INDICATIONS FOR USE STATEMENT
510(k) Number: K991139
Device Name: GDC (Guglielmi Detachable Coil) Power Supply
Indications for Use:
Boston Scientific/Target's Guglielmi Detachable Coil (GDC) Power Supply is intended for use with all versions of Boston Scientific/Target's Guglielmi Detachable Coils in the embolization of intracranial anewrysms and other vascular malformations of the neuro and ﺴ peripheral vasculature.
| PROOF for JZD | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K991139 |
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use (Per 21 CFR 801.109)
Over The Counter Use _________________________________________________________________________________________________________________________________________________________