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.

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 is a 510(k) premarket notification for the Barricade Embolization Coil System. It does not describe an AI/ML powered medical device, but rather a traditional medical device (embolization coil system). Therefore, most of the requested information regarding AI/ML device performance and study design (sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or cannot be extracted from this document.

However, I can provide the acceptance criteria and a summary of the study performed based on the provided text, as it relates to the substantial equivalence determination for this particular medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance (Did it meet the criteria?)
Visual Inspection	Met specified criteria
Dimensional Measurement	Met specified criteria
Simulated Use: Introduction	Performed as intended
Simulated Use: Tracking	Performed as intended
Simulated Use: Reposition/Deployment	Performed as intended
Simulated Use: Detachment	Performed as intended
SR (Set Retention) Tensile (Strength of coil retention)	Met specified criteria
DZ (Detachment Zone) Tensile (Strength of detachment zone)	Met specified criteria
Overall safety and effectiveness profile	Similar to predicate devices
No new safety or performance questions	Met specified criteria

Study Proving Device Meets Acceptance Criteria:

The study was a series of verification and validation tests comparing the modified Barricade Embolization Coil System to its predicate devices (K134482, K131475, K123338, K140104). The goal was to assure substantial equivalence and demonstrate that the device performs as intended.

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

Sample Size for Test Set: The document states that "All testing was performed on test units representative of finished devices," but does not explicitly provide the specific number of units or data points used for each test.
Data Provenance: The data is generated from laboratory testing ("verification and validation testing") on the device itself. This is not clinical data from patients (e.g., country of origin is not applicable in this context). The testing is prospective for the purpose of this 510(k) submission.

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

This is not applicable as the tests performed are primarily engineering and simulated use performance tests on the physical device, not interpretative tasks requiring expert ground truth (e.g., radiology interpretation).

4. Adjudication Method for the Test Set:

Not applicable for the types of engineering and simulated use performance tests described. The results are objective measurements against defined specifications.

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:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for these performance tests is based on pre-defined engineering specifications and performance standards. For example, a tensile strength test would have a specific range of acceptable values, or a simulated use test would have defined operational outcomes (e.g., successful deployment, detachment). The comparison is also made against the performance of predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning.

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

Not applicable. As above, this is not an AI/ML device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K142513

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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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 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 (K134482, K131475)

K123338, K140104)

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:

Indication for Use:

Blockade Medical Modified Barricade Coil System

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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 EmbolizationCoilSystem	Barricade Embolization CoilSystem (K134482, K131475,K123338, K140104)
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
Detachment Zone	.020" (nominal)	.040" (nominal)
Labeled Sizes (coils)	Helical Finishing1mm x 1cm1mm x 2cm1mm x 3cm1mm x 4cm	10 Framing2mm - 10mm x 3cm-27cm18 Framing6mm - 15mm x 16cm-50cmFilling3mm - 10mm x 4cm – 40cmHelical Finishing1.5mm - 6mm x 1cm – 10cm10 Complex Finishing1mm-5mm x 2cm-13cm

The modified Barricade Coil System and predicate Barricade Coil System devices differ in the following:

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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).

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).