The Barricade Embolization Coil System is intended for the endovascular embolization of intracranial anewysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Barricade Embolization 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 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 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.

AI/ML Overview

This document describes the Barricade Embolization Coil System, a medical device, and its acceptance criteria as demonstrated by performance data. It is a 510(k) Summary, meaning the device is being compared to previously cleared predicate devices to establish substantial equivalence.

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide a direct "acceptance criteria" table with specific numerical limits for each test. Instead, it states that the modified device met all specified criteria and performed as intended, demonstrating substantial equivalence to the predicate devices. The performance data section lists the types of tests conducted and concludes that the modified device "met all specified criteria and did not raise new safety or performance questions."

Acceptance Criteria (Implied)	Reported Device Performance
Device performs as intended during simulated use (Introduction, Tracking, Reposition/deployment, Detachment)	Met all specified criteria and demonstrated substantial equivalence to predicate devices
Visual inspection meets standards	Met all specified criteria
Dimensional measurements meet specifications	Met all specified criteria
SR (Stress-Rupture) tensile strength meets standards	Met all specified criteria
DZ (Detachment Zone) Tensile strength meets standards	Met all specified criteria

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size: The document does not explicitly state the sample size for the "test units representative of finished devices."
Data provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It describes "comparative simulated use testing," which implies laboratory or in-vitro testing rather than human clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The testing described (visual inspection, dimensional measurement, simulated use, tensile tests) does not typically involve expert review for "ground truth" in the way clinical studies or diagnostic AI algorithms do. It's focused on engineering and performance specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable to the type of engineering and performance testing described. Adjudication methods are typically used in clinical studies where multiple human readers interpret data that may be ambiguous.

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

There was no MRMC comparative effectiveness study and no discussion of human readers or AI assistance. This device is a physical medical device (embolization coils), not an AI algorithm for diagnosis or interpretation.

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

This question is not applicable as the device is a physical embolization coil system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" as it applies to an AI model or diagnostic test is not directly applicable here. For this physical device, the "truth" is whether it meets its engineering specifications and performs its intended function safely and effectively in simulated environments. This would be verified through:

Engineering specifications and measurements (dimensional, tensile).
Functional performance in controlled simulated environments (e.g., fluid dynamics models for embolization).

8. The sample size for the training set

This information is not applicable. The device is a physical product, not an AI model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this physical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol composed of three stylized human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 27, 2015

Blockade Medical Ms. Rebecca K. Pine Official Correspondent 18 Technology Drive, Suite 169 Irvine, California 92618

Re: K151760

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: June 24, 2015 Received: June 29, 2015

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

Carlos L. Peña, PhD, MS 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) K151760

Device Name Barricade Embolization Coil System

Indications for Use (Describe)

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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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:	July 22, 2015
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
CLASSIFICATIONNAME:	Neurovascular embolization device
DEVICECLASSIFICATION:	Class 2, per 21 CFR 882.5950
PRODUCT CODE	HCG
PREDICATE DEVICES:	Barricade Embolization Coil System (K132482, K131475

K123338, K140104, K142513)

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 K132482. K131475. K123338 , K140104 and K142513.

Description of the Device Subject to Premarket Notification:

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Indication for Use:

The Barricade Embolization Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Barricade Embolization 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 CoilSystem	Barricade Embolization Coil System (K132482, K131475, K123338, K140104, K142513)
Principle of Operation	Facilitates endovascularembolization of intracranialaneurysms and other vascularabnormalities	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 detachmentcontroller	SAME
Method of supply (coil/deliverysystem)	Sterile, single use	SAME
Attachment Zone Length	.020" (nominal)	SAME
Labeled Sizes (coils)	10 Complex Finishing1mm x 1cm1mm x 3cm3.5mm x 3cm3.5mm x 4cm3.5mm x 6cm3.5mm x 8cm	10 Framing2mm – 10mm x 3cm-27cm18 Framing6mm – 15mm x 16cm-50cmFilling3mm – 10mm x 4cm – 40cmHelical Finishing1mm – 6mm x 1cm – 10cm10 Complex Finishing1mm-5mm x 2cm-13cm

The modified Barricade Coil System and predicate Barricade Coil System devices differ

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in the following:

Additional sizes added to product family .

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
- o Tracking
- 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 (K132482, K131475, K123338, K140104).

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).