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.

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

Here's an analysis of the provided text regarding the Barricade Embolization Coil System's acceptance criteria and study information:

This document is a 510(k) summary for a medical device (Barricade Embolization Coil System), which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical trial with detailed acceptance criteria for a novel AI algorithm. Therefore, many of the requested points related to AI performance, ground truth, and expert adjudication are not applicable to this type of submission.

The "study" in this context refers to the non-clinical performance testing conducted to show the device functions as intended and is comparable to previously cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Visual inspection	Met all specified criteria
Dimensional measurement	Met all specified criteria
Simulated Use (Introduction, Tracking, Reposition/deployment, Detachment)	Met all specified criteria; demonstrated substantial equivalence to predicate devices
SR tensile	Met all specified criteria

2. Sample size used for the test set and the data provenance

Sample size: Not explicitly stated. The document mentions "test units representative of finished devices," but does not provide specific numbers for each test.
Data provenance: Not explicitly stated. The testing was performed internally by the manufacturer, Blockade Medical. Given it's a 510(k) summary, the tests are typically conducted in a laboratory setting. No information on country of origin of data (likely USA, where Blockade Medical is located) or retrospective/prospective nature is provided, as these are non-clinical engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physical medical implant, not an AI algorithm requiring expert ground truth for image or data analysis. The "ground truth" here is adherence to engineering specifications and functional performance.

4. Adjudication method for the test set

Not applicable. See point 3. Testing involved standard engineering measurements and visual inspections against predefined specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI diagnostic, prognostic, or assistive device. It is a physical embolization coil system. Therefore, no MRMC study or AI-assisted human reader improvement analysis was performed or is relevant.

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

Not applicable. See point 5.

7. The type of ground truth used

Engineering Specifications and Functional Performance Benchmarks: The "ground truth" for this device's performance is adherence to established engineering specifications (e.g., dimensions, material properties, detachment mechanism) and functional performance observed during simulated use testing that demonstrates its intended operation and comparability to predicate devices.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI. Performance is based on physical device testing, not data training.

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

Not applicable. See point 8.

Summary

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K140104

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:	January 13, 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
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

K123338)

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 and K123338.

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. JUpon 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:

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Technical Characteristics:

The Barricade Embolization Coil System has similar physical and technical characteristics to the predicate device as outlined in the table below:

EmbolizationBarricadeCoilSystem	Barricade Embolization CoilSystem (K134482, K131475,
	K123338)
Facilitates endovascular	SAME

abnormalities
0.010"-0.014"	SAME
1.0mm - 15mm	1.5mm-15mm
0.00125"-0.003"	SAME
Complex/Helical	SAME
Framing. Filling, Finishing	SAME
1cm - 50cm	SAME
Platinum/Tungsten alloy	SAME
Stainless steel wire/pusher	SAME
Electrolyticviadetachment	SAME
controller
Sterile, single use	SAME
.012" dia SSTL	SAME
	10 Framing
lmm x2cm	2mm - 10mm x 3cm-27cm
2mm x 2cm
2mm x 3cm	18 Framing
2mm x 4cm	6mm - 15mm x 16cm-50cm
2mm x 6cm
	Filling
	3mm - 10mm x 4cm - 40cm

	Finishing
	1.5mm - 6mm x 1cm - 10cm







4mm x 8cm
	embolization of intracranialaneurysms and other vascular10 Complex Finishing1 .5mmx2cm1.5mm x 3cm1.5mmx 4cm2.5mm x 2cm2.5mm x 3cm2.5mm x 4cm3mm x 3cm3mm x 4cm3mm x 6cm3mm x 8cm3mm x 10cm4mm x 4cm4mm x 6cm

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	Barricade Embolization CoilSystem	Barricade Embolization CoilSystem (K134482, K131475,K123338)
	4mm x 10cm
	4mm x 13cm
	5mm x 6cm
	5mm x 8cm
	5mm x 10cm
	5mm x 13cm
Framing Coil secondary shape	Reduced initial loop size	Nominal initial loop size

The modified Barricade Coil System and predicate Coil System devices differ 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
- Tracking o
- Reposition/deployment
- o Detachment
. SR tensile

The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions.

Determination Basis for 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 (K K134482, K131475, K123338).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

February 13, 2014

Ms. Rebecca K. Pine Blockade Medical 18 Technology Dr., Suite 169 Irvine, CA 92618

Re: K140104

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 and KRD Dated: January 13, 2014 Received: January 15, 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 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.

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Page 2 - Ms. Rebecca K. Pine

ale bagan lunk

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joyce M. Whang -S

for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140104

Device Name Barricade Embolization Coil System

Indications for Use (Describe)

The Barricade Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and atteriovenous fistulae. The Baricade 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)

区 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

PSC Publishing Services (101) 443-6740 EP

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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).