(63 days)
Not Found
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 suggest the use of AI or ML. The performance studies focus on the physical properties and functionality of the coils and delivery system.
Yes
The device is used for embolization of intracranial aneurysms and other neurovascular abnormalities to obstruct blood flow, which is a therapeutic intervention.
No
Explanation: The device is an embolization coil system used for treating neurovascular abnormalities and occluding blood vessels. It is a therapeutic device designed to obstruct blood flow, not to diagnose conditions.
No
The device description clearly states it is a system of physical coils made of platinum/tungsten, a delivery pusher, and an introducer sheath, which are hardware components.
Based on the provided information, the Barricade Coil System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities. This is a therapeutic procedure performed within the body to treat a condition.
- Device Description: The device is a physical implant (coils) inserted into the vasculature.
- Mechanism of Action: The coils physically obstruct blood flow.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Barricade Coil System does not perform any such analysis on biological samples.
The device is a therapeutic medical device used for interventional procedures.
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 (comma separated list FDA assigned to the subject device)
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, 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 modified 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. Functional testing demonstrated that the Barricade Embolization Coil System is substantially equivalent to the predicate devices. Testing included:
Test: Simulated Use
Results: The modified device achieved the same results as that of the predicate device (K123338).
Conclusion: Change verified. The optional Handheld Detachment Cable has no adverse effect on the established performance characteristics of the device.
Test: Tensile Test
Results: The modified device demonstrated adequate tensile strength to withstand anticipated forces during use.
Conclusion: Change verified. The optional Handheld Detachment Cable has no adverse effect on the established performance characteristics of the device.
Test: Packaging Validation
Results: All packaging demonstrated adequate seal strength and intact sterile barrier.
Conclusion: Change verified. The optional Handheld Detachment Cable has no adverse effect on the established sterile barrier characteristics of the device.
Test: Sterility
Results: Sterility Assurance Level 10-6.
Conclusion: Change verified. The optional Handheld Detachment Cable has no adverse effect on the established sterility characteristics of the device.
The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions. The results of the risk control measures employed for the device change demonstrated that the device modifications had no adverse effect on the established performance characteristics of the 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
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: | August 5, 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: Barricade Embolization Coil System (K123338, 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 K123338 and K131475.
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 The system consists of an embolization coil implant comprised of vascular anomalies. 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:
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
1
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
System | Embolization
Coil | Barricade Embolization Coil System
(K123338, K131475) |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------------------------|
| | Facilitates
endovascular
embolization
of intracranial aneurysms and other
vascular abnormalities | SAME | SAME |
| Primary Coil Diameter | 0.010"-0.014" | SAME | SAME |
| Coil Secondary diameter | 1.5mm - 15mm | SAME | SAME |
| Coil Wire Diameter | 0.00125"-0.003" | SAME | SAME |
| Secondary Shapes | Complex/Helical | SAME | SAME |
| Coil Types | Framing, Filling, Finishing | SAME | SAME |
| Coil length | 1cm - 40cm | SAME | SAME |
| Main Coil Material | Platinum/Tungsten alloy | SAME | SAME |
| Coil delivery | Stainless steel wire/pusher | SAME | SAME |
| Coil detachment | Electrolytic | SAME | SAME |
| Detachment equipment | Detachment Control Power Supply,
ED2-BL, optional Handheld
Detachment Cable | Detachment Control Power Supply,
ED2-BL | SAME |
| Method of supply (coil/delivery
system) | Sterile. single use | SAME | SAME |
Performance Data:
All necessary verification and validation testing has been performed for the modified 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. Functional testing demonstrated that the Barricade Embolization Coil System is substantially equivalent to the predicate devices.
Testing included:
| Test | Results | Conclusion |
|---|---|---|
| Simulated Use | The modified device achieved the | |
| same results as that of the | ||
| predicate device (K123338). | Change verified. The optional | |
| Handheld Detachment Cable has | ||
| no adverse effect on the | ||
| established performance | ||
| characteristics of the device. | ||
| Tensile Test | The modified device | |
| demonstrated adequate tensile | ||
| strength to withstand anticipated | ||
| forces during use. | Change verified. The optional | |
| Handheld Detachment Cable has | ||
| no adverse effect on the | ||
| established performance | ||
| characteristics of the device. | ||
| Packaging Validation | All packaging demonstrated | Change verified. The optional |
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| | adequate seal strength and intact
sterile barrier | Handheld Detachment Cable has
no adverse effect on the
established sterile barrier
characteristics of the device. |
|-----------|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterility | Sterility Assurance Level 10-6. | Change verified. The optional
Handheld Detachment Cable has
no adverse effect on the
established sterility
characteristics of the device. |
The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions. The results of the risk control measures employed for the device change demonstrated that the device modifications had no adverse effect on the established performance characteristics of the device.
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 determined by Blockade Medical, to be substantially equivalent to the Barricade Coil System (K123338 and K131475).
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 10, 2013
Blockade Medical % Ms. Rebecca K. Pine Official Correspondent 18 Technology Drive, Suite 169 Irvine, CA 92618
Re: K132482
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: September 9, 2013 Received: September 10, 2013
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 11 (Special Controls) or class 111 (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
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Page 2 - Ms. Rebecca K. Pine
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K132482
Device Name: Barricade Embolization Coil System
Indications For Use:
The Barricade Coil System is intended for the endovascular embolization of intracranial aneurysm 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ · (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
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