(28 days)
Not Found
No
The device description details a system that uses electrical current and resistance sensing to detach a coil. There is no mention of AI or ML algorithms for image processing, pattern recognition beyond simple electrical changes, or any learning capabilities. The "recognize those changes which indicate detachment" refers to detecting specific electrical patterns, not complex AI/ML pattern recognition.
Yes
The device, a GDC Power Supply, is part of a system intended for the embolization of intracranial aneurysms and other vascular malformations, which is a therapeutic intervention.
No
The device is used for the embolization of intracranial aneurysms and other vascular malformations, which is a therapeutic (treatment) procedure, not a diagnostic one. It facilitates the detachment of coils to block blood flow, rather than to identify or characterize a disease.
No
The device description clearly outlines multiple hardware components including a power supply, occlusion coil, delivery wire, connecting cables, and batteries. The power supply itself is described as a battery-operated, self-contained unit designed to initiate and control electrolytic detachment, indicating it is a physical device, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Function: The description clearly states that the Boston Scientific Target's Guglielmi Detachable Coil (GDC) Power Supply is used to electrolytically detach a coil inside an aneurysm or vascular malformation within the patient's body. This is an in vivo procedure (performed within a living organism), not an in vitro procedure (performed outside the body).
- Lack of Specimen Analysis: The device does not analyze any specimens derived from the human body. Its function is to deliver an electrical current to facilitate the detachment of a medical implant.
Therefore, the device's intended use and mechanism of action fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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 aneurysms and other vascular malformations of the neuro and peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
HCG
Device Description
The GDC system consists of the following items, 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 GDC is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.
GDC coils are manufactured from a platinum / tungsten alloy wire which is wound into a primary or main coil. Depending upon the desired final configuration, the coil is either formed into a secondary helical shape (standard and Stretch Resistant GDC), vortex shape (GDC-18 Fibered VortX) or tertiary shape (3D GDC).
GDC coils are attached to a delivery wire, which consists of a ground stainless-steel core with a stainless-steel coil welded at the distal end a Teflon® outer jacket. The delivery wire is similar to that employed for the predicate GDC cleared under K991139.
GDC coils are available in a range of sizes for use with either Boston Scientific Target's -10 or -18 Infusion Catheters with two tip markers.
The GDC Power Supply is a battery-operated, self-contained unit designed to initiate and control the electrolytic detachment of a GDC coil inside an aneurysm.
Each time the GDC Power Supply is turned on, the unit defaults to the 1.0 mA current setting. Pressing the "Current" switch one time changes the setting to the 0.5 mA current setting; pressing a second time changes the setting to 0.75 mA; pressing a third time returns the unit to the default 1.0 mA setting. Each time the switch is pressed, the current display flashes the new current setting.
The GDC Power Supply is designed to apply a constant current through the GDC System and to detect when coil detachment has occurred. It maintains a constant current by:
-
- sensing the amount of resistance to current flow through the GDC System, and
-
- adjusting the voltage needed to maintain the desired current setting. It is also designed to identify subtle changes in the way current is flowing through the GDC System and to recognize those changes which indicate detachment.
Once those patterns are identified, the GDC Power Supply signals detachment and stops the flow of current through the GDC System.
Accessories consist of the following:
- Two connecting cables, one black (274 cm long), the other red (152 cm long)
- Two standard 9 volt alkaline batteries
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial (aneurysms), neuro and peripheral vasculature (vascular malformations), peripheral vasculature (arterial and venous embolizations)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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: Predicate GDC Device vs Modified GDC
- Electromagnetic Compatibility-Radiated Susceptibility: No change made which affects this attribute; same as the predicate device.
- Electromagnetic Compatibility-Radiated Emissions Class B: No change made which affects this attribute; same as the predicate device.
- Electromagnetic Compatibility-Magnetic Immunity: No change made which affects this attribute; same as the predicate device.
- Operating System Test (Assembly Source Code): No change made which affects this attribute; same as the predicate device.
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
6 2002 JUN
K021494(P.1 of 6)
Special 510(k): Modification to Boston Scientific Target's GDC™ Power Supply
a. Summary Of Safety And Effectiveness
Contact Person
Jim Leathley Regulatory Affairs Project Manager Boston Scientific Target 47900 Bayside Parkway Fremont, CA. 94538
Trade Name
Guglielmi Detachable Coil (GDC) Power Supply
Common Name
Occlusion Coil, accessory
Classification Name
Artificial Embolization Device (21 CFR Section 882.5950), accessory
Predicate Devices
| Number | Description | Predicate for | Clearance Date |
|---|---|---|---|
| K991139 | |||
| (Boston | |||
| Scientific | |||
| Target) | Guglielmi Detachable Coil | ||
| (GDC) System with Version | |||
| 4 Modifications | GDC Power Supply | ||
| modifications that are the | |||
| subject of this Special | |||
| 510(k) | 22 Dec. 1999 | ||
| K001083 | |||
| (Boston | |||
| Scientific | |||
| Target) | Guglielmi Detachable Coil | ||
| (GDC) System with | |||
| additional Version 4 | |||
| Modifications | GDC Power Supply | ||
| modifications that are the | |||
| subject of this Special | |||
| 510(k) | 3 May 2000 |
Intended Use
GDC Power Supply
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 aneurysms and other vascular malformations of the neuro and peripheral vasculature.
Boston Scientific Target
Page 110
April 2002
1
Guglielmi Detachable Coil
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.
Device Description
The GDC system consists of the following items, 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 GDC is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.
GDC coils are manufactured from a platinum / tungsten alloy wire which is wound into a primary or main coil. Depending upon the desired final configuration, the coil is either formed into a secondary helical shape (standard and Stretch Resistant GDC), vortex shape (GDC-18 Fibered VortX) or tertiary shape (3D GDC).
GDC coils are attached to a delivery wire, which consists of a ground stainless-steel core with a stainless-steel coil welded at the distal end a Teflon® outer jacket. The delivery wire is similar to that employed for the predicate GDC cleared under K991139.
GDC coils are available in a range of sizes for use with either Boston Scientific Target's -10 or -18 Infusion Catheters with two tip markers.
The GDC Power Supply is a battery-operated, self-contained unit designed to initiate and control the electrolytic detachment of a GDC coil inside an aneurysm.
Each time the GDC Power Supply is turned on, the unit defaults to the 1.0 mA current setting. Pressing the "Current" switch one time changes the setting to the 0.5 mA current setting; pressing a second time changes the setting to 0.75 mA; pressing a third time returns the unit to the default 1.0 mA setting. Each time the switch is pressed, the current display flashes the new current setting.
Boston Scientific Target
2
021494(P.3 of 6)
The GDC Power Supply is designed to apply a constant current through the GDC System and to detect when coil detachment has occurred. It maintains a constant current by:
-
- sensing the amount of resistance to current flow through the GDC System, and
-
- adjusting the voltage needed to maintain the desired current setting. It is also designed to identify subtle changes in the way current is flowing through the GDC System and to recognize those changes which indicate detachment.
Once those patterns are identified, the GDC Power Supply signals detachment and stops the flow of current through the GDC System.
Accessories Description
Accessories consist of the following:
- · Two connecting cables, one black (274 cm long), the other red (152 cm long)
- · Two standard 9 volt alkaline batteries
Boston Scientific Target
3
Technological Characteristics Comparison
GDC Power Supply
| Component/Parameter | Affect on GDC Power Supply |
|---|---|
| Power | No change made which affects this attribute; |
| same as the predicate device. | |
| Batteries | No change made which affects this attribute; |
| same as the predicate device. | |
| Expected Battery Life | No change made which affects this attribute; |
| same as the predicate device. | |
| Red Cable | No change made which affects this attribute; |
| same as the predicate device. | |
| Black Cable | No change made which affects this attribute; |
| same as the predicate device. | |
| Current Settings | From current settings of: 1 mA (default), 2 mA, 0.5 mA |
| To current settings of: 1 mA (default), 0.5 mA, 0.75 mA | |
| Current | No change made which affects this attribute; |
| same as the predicate device. | |
| Voltage | No change made which affects this attribute; |
| same as the predicate device. | |
| Operating Temperature | No change made which affects this attribute; |
| same as the predicate device. | |
| Storage Temperature | No change made which affects this attribute; |
| same as the predicate device. |
4
021494 (P. 5 of 6)
Technological Characteristics Comparison (cont.)
GDC Power Supply
| Component/Parameter | Affect on GDC Power Supply |
|---|---|
| Relative Humidity | No change made which affects this attribute; |
| same as the predicate device. | |
| Unit Size | No change made which affects this attribute; |
| same as the predicate device. | |
| Unit Weight | No change made which affects this attribute; |
| same as the predicate device. |
Boston Scientific Target
April 2002
5
Ko21494 (P.6or6)
Verification Test Summary Table: Predicate GDC Device vs Modified GDC
| Test or Point of Comparison | GDC with modifications described in this submission |
|---|---|
| Electromagnetic Compatibility- | |
| Radiated Susceptibility | No change made which affects this attribute; |
| same as the predicate device. | |
| Electromagnetic Compatibility- | |
| Radiated Emissions Class B | No change made which affects this attribute; |
| same as the predicate device. | |
| Electromagnetic Compatibility- | |
| Magnetic Immunity | No change made which affects this attribute; |
| same as the predicate device. | |
| Operating System Test | |
| (Assembly Source Code) | No change made which affects this attribute; |
| same as the predicate device. |
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three intertwined strands, representing health and well-being. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
6 2002 ווא
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James Leathley Regulatory Affairs Project Management Boston Scientific Target 47900 Bayside Parkway Fremont, CA 94538
Re: K021494
Trade/Device Name: Guglielmi Detachable Coil (GDC) Power Supply Regulation Number: 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: May 8, 2002 Received: May 9, 2002
Dear Mr. Leathley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
7
Page 2 - Mr. James Leathley
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
sincerely yours,
Mark McMullen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Image /page/8/Picture/2 description: The image shows the logo for Boston Scientific Target. The words "Boston Scientific" are in a serif font, with "Boston" stacked on top of "Scientific". There is a line underneath "Scientific". Below the line, the word "TARGET" is in a bold, sans-serif font.
INDICATIONS FOR USE STATEMENT
510(k) Number: _______________________
Device Name: Guglielmi Detachable Coil (GDC) Power Supply: 1 mA, 0.5 mA and 0.75 mA current settings
Indications for Use:
Guglielmi Detachable Coil Power Supply
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 aneurysms and other vascular malformations of the neuro and peripheral vasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
April 2002
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR Over The Counter Use
(Division Sign-Off)
Milk
Division of General, Restorative
and Neurological Devices
Boston Scientific Target
510(k) Numberge 23
Confidential