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.

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 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.

AI/ML Overview

The provided text describes a 510(k) summary for the Barricade Embolization Coil System, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics for a new or significantly modified device. Therefore, much of the requested information regarding "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of a new AI or diagnostic device is not applicable here.

This submission is for a modification to an existing neurovascular embolization device (Barricade Embolization Coil System) and aims to show that the modified device is substantially equivalent to the previously cleared predicate devices (K123338 and K131475). The modifications primarily relate to the inclusion of an optional Handheld Detachment Cable.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied/Inferred)	Reported Device Performance
Simulated Use	The modified device performs equivalently to the predicate device (K123338) and the optional Handheld Detachment Cable has no adverse effect on established performance characteristics.	"The modified device achieved the same results as that of the predicate device (K123338)." "The optional Handheld Detachment Cable has no adverse effect on the established performance characteristics of the device."
Tensile Test	The modified device demonstrates adequate tensile strength to withstand anticipated forces during use, and the optional Handheld Detachment Cable has no adverse effect.	"The modified device demonstrated adequate tensile strength to withstand anticipated forces during use." "The optional Handheld Detachment Cable has no adverse effect on the established performance characteristics of the device."
Packaging Validation	All packaging demonstrates adequate seal strength and intact sterile barrier, and the optional Handheld Detachment Cable has no adverse effect on these characteristics.	"All packaging demonstrated adequate seal strength and intact sterile barrier." "The optional Handheld Detachment Cable has no adverse effect on the established sterile barrier characteristics of the device."
Sterility	Sterility Assurance Level 10^-6 is achieved, and the optional Handheld Detachment Cable has no adverse effect.	"Sterility Assurance Level 10^-6." "The optional Handheld Detachment Cable has no adverse effect on the established sterility characteristics of the device."

Note on Acceptance Criteria: The document does not explicitly state numerical or specific performance acceptance criteria. Instead, the acceptance criteria are implicitly defined by "sameness" or "no adverse effect" compared to the predicate device's established performance, and meeting general standards like "adequate tensile strength" and "Sterility Assurance Level 10^-6". This is typical for 510(k) submissions demonstrating substantial equivalence for minor modifications.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "All testing was performed on test units representative of finished devices." However, it does not specify the exact sample size (N) for each test (Simulated Use, Tensile Test, Packaging Validation, Sterility).

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." Given that these are bench and lab tests, the data would originate from the testing facility (most likely in the US, where Blockade Medical is located). These tests are typically conducted prospectively as part of the verification and validation process for the device modification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of information is not applicable to this 510(k) submission. "Ground truth" and "experts" in this context typically refer to clinical or diagnostic evaluation where human interpretation is involved (e.g., radiologists reading images). This submission pertains to the physical and functional performance of a medical device, evaluated through engineering and laboratory tests.

4. Adjudication Method for the Test Set

This is not applicable as there is no clinical test set requiring adjudication of findings (e.g., image interpretations). The tests performed are objective, quantitative measurements in a laboratory setting.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a physical embolization coil system, not an AI or diagnostic software. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests (e.g., tensile strength, sterility) is based on objective engineering and laboratory measurements against established standards and internal specifications, and comparison to the predicate device's known performance. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reasons as above.

Summary

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K132482

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 PineBlockade Medical18 Technology Dr.Suite 169Irvine, CA 92618Phone: (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:

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

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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:

	BarricadeSystem	EmbolizationCoil	Barricade Embolization Coil System(K123338, K131475)
	Facilitatesendovascularembolizationof intracranial aneurysms and othervascular 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 HandheldDetachment Cable	Detachment Control Power Supply,ED2-BL	SAME
Method of supply (coil/deliverysystem)	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 thesame results as that of thepredicate device (K123338).	Change verified. The optionalHandheld Detachment Cable hasno adverse effect on theestablished performancecharacteristics of the device.
Tensile Test	The modified devicedemonstrated adequate tensilestrength to withstand anticipatedforces during use.	Change verified. The optionalHandheld Detachment Cable hasno adverse effect on theestablished performancecharacteristics of the device.
Packaging Validation	All packaging demonstrated	Change verified. The optional

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	adequate seal strength and intactsterile barrier	Handheld Detachment Cable hasno adverse effect on theestablished sterile barriercharacteristics of the device.
Sterility	Sterility Assurance Level 10-6.	Change verified. The optionalHandheld Detachment Cable hasno adverse effect on theestablished sterilitycharacteristics 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:

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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Regulation Number and Section

§ 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).