(66 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the embolization coils and delivery system, with no mention of AI or ML for image analysis, decision support, or any other function.
Yes
The device is described as an "embolization coil system" intended for "endovascular embolization of intracranial aneurysms and other neurovascular abnormalities" to "permanently obstruct blood flow," which directly addresses and treats a medical condition.
No
This device is designed for therapeutic embolization by physically obstructing blood flow, not for diagnosing medical conditions.
No
The device description explicitly states it is a "series specialized coils that are inserted into the vasculature" and includes physical components like "an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher with an introducer sheath." This indicates it is a physical medical device, not software-only.
Based on the provided information, the Barricade Coil System is not an IVD (In Vitro Diagnostic) device.
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.
- Barricade Coil System Function: The Barricade Coil System is an implantable medical device used for the physical embolization (blocking) of blood vessels within the body. It is inserted directly into the vasculature to treat conditions like aneurysms and malformations.
- Lack of Specimen Analysis: The device does not analyze any biological specimens outside of the body. Its function is entirely within the patient's circulatory system.
Therefore, the Barricade Coil System falls under the category of an implantable therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The BCS 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; blood vessels within the neurovascular system; 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 (Introduction, Tracking, Reposition/deployment, Detachment), SR tensile, DZ Tensile. The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K134482, K131475, K123338, K140104
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2014
Blockade Medical Ms. Rebecca K. Pine Official Correspondent 18 Technology Drive, Suite 169 Irvine, CA 92618 US
Re: K142513
Trade/Device Name: Barricade Embolization Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: Class II Product Code: HCG Dated: October 13th, 2014 Received: October 15th, 2014
Dear Ms. Pine:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
-S FDA
Carlos Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142513
Device Name Barricade Embolization Coil System
Indications for Use (Describe)
The Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The BCS 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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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5. 510(k) Summary of safety and effectiveness
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: | August 28, 2014 |
| 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: Barricade Embolization Coil System (K134482, K131475) |
Substantially Equivalent To:
The modified Barricade Embolization Coil System is substantially equivalent in intended use, principal of operation and technological characteristics to the Barricade Embolization Coil System cleared under premarket notifications K134482, K131475, K123338 , and K140104.
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 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:
Blockade Medical Modified Barricade Coil System
4
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 device as outlined in the table below:
| | Barricade Embolization
Coil
System | Barricade Embolization Coil
System (K134482, K131475,
K123338, K140104) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of Operation | Facilitates endovascular
embolization of intracranial
aneurysms and other vascular
abnormalities | SAME |
| Primary Coil Diameter | 0.010"-0.014" | SAME |
| Coil Secondary diameter | 1.0mm - 15mm | SAME |
| Coil Wire Diameter | 0.00125"-0.003" | SAME |
| Secondary Shapes | Complex/Helical | SAME |
| Coil Types | Framing, Filling, Finishing | SAME |
| Coil length | 1cm - 50cm | SAME |
| Main Coil Material | Platinum/Tungsten alloy | SAME |
| Coil delivery | Stainless steel wire/pusher | SAME |
| Coil detachment | Electrolytic via detachment
controller | SAME |
| Method of supply (coil/delivery
system) | Sterile, single use | SAME |
| Detachment Zone | .020" (nominal) | .040" (nominal) |
| Labeled Sizes (coils) | Helical Finishing
1mm x 1cm
1mm x 2cm
1mm x 3cm
1mm x 4cm | 10 Framing
2mm - 10mm x 3cm-27cm
18 Framing
6mm - 15mm x 16cm-50cm
Filling
3mm - 10mm x 4cm – 40cm
Helical Finishing
1.5mm - 6mm x 1cm – 10cm
10 Complex Finishing
1mm-5mm x 2cm-13cm |
The modified Barricade Coil System and predicate Barricade Coil System devices differ in the following:
5
- Additional sizes added to product family
- Modified detachment zone
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
- Reposition/deployment o
- o Detachment
- SR tensile ●
- DZ Tensile ●
The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions.
Basis for Determination of Substantial Equivalence:
The Indication/Intended Use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device. The modified Barricade Coil System is found to have a safety and effectiveness profile that is similar to the predicate devices (K134482, K131475, K123338, K140104).