(148 days)
No
The summary describes a physical medical device (embolization coils) and its delivery system. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The "Not Found" entries for mentions of AI/ML and descriptions of training/test sets further support this conclusion.
Yes
Explanation: The device is intended for endovascular embolization and vascular occlusion to treat neurovascular abnormalities, which are therapeutic interventions.
No
The device description clearly states that the Barricade Coil System is a series of specialized coils inserted into the vasculature to embolize intracranial aneurysms and other vascular anomalies. This describes a therapeutic, not a diagnostic, function.
No
The device description explicitly states the system consists of physical components like specialized coils made of platinum/tungsten, a delivery pusher, and an introducer sheath, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Barricade Coil System is a medical device that is implanted into the body to physically block blood flow in blood vessels. It is used for embolization, which is a therapeutic procedure, not a diagnostic test.
- Intended Use: The intended use clearly states "endovascular embolization" and "vascular occlusion," which are interventional procedures performed within the body.
- Device Description: The description details a physical implantable coil and its delivery system, not a test kit or analytical instrument for analyzing biological samples.
- Input: The input is "angiographic visualization," which is an imaging technique used to guide the placement of the device within the body, not a biological sample.
Therefore, the Barricade Coil System is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Barricade Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Barricade Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
Product codes
HCG
Device Description
The Barricade Embolization Coil System (BCS) is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher with an introducer sheath to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are electrolytically detached from the delivery pusher in serial manner until the aneurysm is occluded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic visualization
Anatomical Site
intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. vascular occlusion of blood vessels within the neurovascular system. arterial and venous embolizations in the peripheral vasculature.
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)
All necessary verification and validation testing has been performed for the Barricade Embolization Coil System to assure substantial equivalence to the predicate devices and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Comparative simulated use testing demonstrated that the Barricade Embolization Coil System is substantially equivalent to the predicate devices. Testing included:
- Visual inspection .
- Dimensional measurement .
- Simulated Use .
- o Introduction
- Tracking o
- o Reposition/deployment
- o Detachment
- Overall Performance o
- Detachment Zone tensile .
- Stretch Resistance tensile .
- Corrosion resistance .
- . MR compatibility
Biocompatibility and animal testing was performed as follows:
| Test | Results | Conclusions |
|---|---|---|
| Cytotoxicity Testing - Neutral Red Uptake (NRU)/MEM (implant) | 97% cell viability | Non-cytotoxic |
| Sensitization Testing - Kligman Maximization (implant) | No reaction | Non-sensitizing |
| Intracutaneous Reactivity (implant) | No significant greater biological reaction than the controls | Non-irritant |
| Hemolysis (implant) |
§ 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 6
6. 510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | Blockade Medical |
|---|---|
| DATE PREPARED: | March 19, 2013 |
| CONTACT PERSON: | Rebecca K Pine |
| Blockade Medical | |
| 18 Technology Dr. | |
| Suite 169 | |
| Irvine, CA 92618 | |
| Phone: (760) 809.5178 | |
| TRADE NAME: | Barricade Embolization Coil System |
| COMMON NAME: | Neurovascular embolization device |
| CLASSIFICATION | |
| NAME: | Neurovascular embolization device |
| DEVICE | |
| CLASSIFICATION: | Class 2, per 21 CFR 882.5950 |
| PRODUCT CODE | HCG |
| PREDICATE DEVICES: | Guglielmi Detachable Coils- GDC 360° (K10335 |
| K093142) | |
| Hydrocoil Embolic System (K120908) | |
| Microplex Coil System (K093358) |
Substantially Equivalent To:
The Barricade Embolization Coil System is substantially equivalent in intended use, principal of operation and technological characteristics to the Guglielmi Detachable Coils (K103355) the Microplex Coil System (K093358) and the Hydrocoil Embolic System (K120908).
Description of the Device Subject to Premarket Notification:
The Barricade Embolization Coil System (BCS) is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher with an introducer sheath to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon
Blockade Medical Barricade Embolization Coil System
Page 31 of 146 Premarket Notification
1
positioning coils into the aneurysm, the coils are electrolytically detached from the delivery pusher in serial manner until the aneurysm is occluded.
Indication for Use:
The Barricade Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Barricade Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
Technical Characteristics:
The Barricade Embolization Coil System has similar physical and technical characteristics to the predicate devices as outlined in the table below:
| | Barricade
Embolization
Coil System | GDC 360°
(K103355,
K093142) | Hydrocoil
Embolic System
(K120908) | Microplex Coil
System (K093358) |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------|------------------------------------|
| | Facilitates
endovascular
embolization
of intracranial
aneurysms and
other
vascular
abnormalities | SAME | SAME | SAME |
| Primary Coil
Diameter | 0.010"-0.014" | 0.010"-0.015" | 0.008"-0.015" | 0.0095"-0.015" |
| Coil Secondary
diameter | 1.5mm - 15mm | 1.5mm - 25mm | 2mm-24mm | 2-24mm |
| Coil Wire
Diameter | 0.00125"-0.003" | Unknown | 0.002"-0.004" | 0.00125"-0.004" |
| Secondary Shapes | Complex/Helical | Complex/Helical | Helical | Complex/Helical |
| Coil Types | Framing, Filling,
Finishing | Framing, Filling,
Finishing | Framing, Filling,
Finishing | Framing, Filling,
Finishing |
| Coil length | 1cm - 40cm | 1cm - 50cm | 2cm-50cm | 2-68cm |
| Main Coil
Material | Platinum/Tungsten
alloy | Platinum/Tungsten
alloy | Platinum/Tungsten alloy | Platinum/Tungsten.
alloy |
| Coil delivery | Stainless steel
wire/pusher | Stainless steel
wire/pusher | Stainless steel
wire/pusher | Stainless steel
wire/pusher |
| Coil detachment | Electrolytic | Electrolytic | Thermo-
mechanical | Thermo-mechanical |
| Detachment
equipment | Detachment
Control Power
Supply, ED2-BL | Boston Scientific
Detachable Coil
Power Supply or
InZone Detachment
System | V-Grip
Detachment
Controller | V-Grip Detachment
Controller |
| Method of supply
(coil/delivery
system) | Sterile, single use | Sterile, single use | Sterile, single use | Sterile, single use |
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2
Performance Data:
All necessary verification and validation testing has been performed for the Barricade Embolization Coil System to assure substantial equivalence to the predicate devices and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Comparative simulated use testing demonstrated that the Barricade Embolization Coil System is substantially equivalent to the predicate devices. Testing included:
- Visual inspection .
- Dimensional measurement .
- Simulated Use .
- o Introduction
- Tracking o
- o Reposition/deployment
- o Detachment
- Overall Performance o
- Detachment Zone tensile .
- Stretch Resistance tensile .
- Corrosion resistance .
- . MR compatibility
Biocompatibility and animal testing was performed as follows:
| Test | Results | Conclusions |
|---|---|---|
| Cytotoxicity Testing - Neutral | ||
| Red Uptake (NRU)/MEM | ||
| (implant) | 97% cell viability | Non-cytotoxic |
| Sensitization Testing - Kligman | ||
| Maximization | ||
| (implant) | No reaction | Non-sensitizing |
| Intracutaneous Reactivity | ||
| (implant) | No significant greater biological | |
| reaction than the controls | Non-irritant | |
| Hemolysis | ||
| (implant) |