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

The provided text describes the 510(k) summary for the Barricade Embolization Coil System, a neurovascular embolization device. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI/software device studies is not available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific quantitative targets for device performance in the way an AI/software device would. Instead, it lists various verification and validation tests and their results, primarily focusing on proving safety and substantial equivalence to predicate devices. The "acceptance criteria" are implied by the successful completion of these tests and their favorable outcomes, indicating non-toxicity, appropriate mechanical properties, and similar performance to predicate devices.

Test Category	Implied Acceptance Criterion (from results)	Reported Device Performance (from results)
Biocompatibility (Implant)	Non-cytotoxic, non-sensitizing, non-irritant, non-hemolytic, non-toxic, non-pyrogenic, non-mutagenic, non-reactive.	97% cell viability (Non-cytotoxic), No reaction (Non-sensitizing), No significant greater biological reaction than controls (Non-irritant), < 2% hemolysis (Non-hemolytic), Normal range PT (No adverse effect), No increase in complement activation (Doesn't induce), No significantly greater reaction than controls (Non-toxic), No individual temperature increase ≥ 0.5°C (Non-pyrogenic), No significant increase in revertant colonies (Not mutagenic), No significant increase in mutant frequency (Non-mutagenic), No statistical increase in micronucleated erythrocytes (Non-mutagenic), Bioreactivity rating 3.6 (Non-reactive), No local or systemic signs of toxicity (Non-toxic).
Biocompatibility (Delivery System)	Non-cytotoxic, non-sensitizing, non-irritant, non-toxic, non-hemolytic, non-pyrogenic.	< Grade 2 (Non-cytotoxic), Stimulation Indices < 3.0 (Not sensitizing), Mean score difference from control ≤ 1.0 (Non irritant), No mortality or systemic toxicity (Non-toxic), Mean hemolytic index 0% (Non-hemolytic), No individual temperature increase ≥ 0.5°C (Non-pyrogenic).
Mechanical/Functional Tests	Device performs as intended and is substantially equivalent to predicate devices.	Successful completion of: Visual inspection, Dimensional measurement, Simulated Use (Introduction, Tracking, Reposition/deployment, Detachment, Overall Performance), Detachment Zone tensile, Stretch Resistance tensile, Corrosion resistance, MR compatibility.
Acute Animal Studies	Achieves angiographic occlusion.	BCS product provided angiographic occlusion immediately following treatment.

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

This information is not provided in the document. The text mentions "test units representative of finished devices" for various tests but doesn't specify the sample size for individual tests or the provenance of any data beyond the internal testing performed by Blockade Medical.

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

This information is not applicable and not provided. This device is a medical implant (embolization coil system), not an AI/software device that requires expert review for "ground truth" establishment in a clinical performance study. The "ground truth" for this type of device typically relates to its physical and biological performance as measured through objective tests (e.g., tensile strength, biocompatibility assays, observed occlusion in animal models), not expert consensus on image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As explained above, the tests are primarily objective measurements of physical and biological properties. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation (e.g., medical imaging reads) and are not used here.

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

This information is not applicable and not provided. The Barricade Embolization Coil System is a physical medical device, not an AI/software product designed to assist human readers. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

This information is not applicable and not provided. The device is not an algorithm or software. It is a physical embolization coil system.

7. The Type of Ground Truth Used

For the biocompatibility and mechanical tests, the "ground truth" is established by:

Objective laboratory measurements: Assays for cytotoxicity, hemolysis, tensile strength, corrosion, etc., against predefined scientific standards or benchmarks.
Observation in animal models: Direct observation of angiographic occlusion in acute animal studies.
Comparison to predicate devices: The overall performance is benchmarked against established characteristics of legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of its development and validation.

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

This information is not applicable and not provided as there is no training set for this type of device.

Summary

{0}------------------------------------------------

Section 6 6. 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:	March 19, 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
CLASSIFICATIONNAME:	Neurovascular embolization device
DEVICECLASSIFICATION:	Class 2, per 21 CFR 882.5950
PRODUCT CODE	HCG
PREDICATE DEVICES:	Guglielmi Detachable Coils- GDC 360° (K10335K093142)Hydrocoil Embolic System (K120908)Microplex Coil System (K093358)

Substantially Equivalent To:

The Barricade Embolization Coil System is substantially equivalent in intended use, principal of operation and technological characteristics to the Guglielmi Detachable Coils (K103355) the Microplex Coil System (K093358) and the Hydrocoil Embolic System (K120908).

Description of the Device Subject to Premarket Notification:

Blockade Medical Barricade Embolization Coil System

Page 31 of 146 Premarket Notification

{1}------------------------------------------------

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:

Technical Characteristics:

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

	BarricadeEmbolizationCoil System	GDC 360°(K103355,K093142)	HydrocoilEmbolic System(K120908)	Microplex CoilSystem (K093358)
	Facilitatesendovascularembolizationof intracranialaneurysms andothervascularabnormalities	SAME	SAME	SAME
Primary CoilDiameter	0.010"-0.014"	0.010"-0.015"	0.008"-0.015"	0.0095"-0.015"
Coil Secondarydiameter	1.5mm - 15mm	1.5mm - 25mm	2mm-24mm	2-24mm
Coil WireDiameter	0.00125"-0.003"	Unknown	0.002"-0.004"	0.00125"-0.004"
Secondary Shapes	Complex/Helical	Complex/Helical	Helical	Complex/Helical
Coil Types	Framing, Filling,Finishing	Framing, Filling,Finishing	Framing, Filling,Finishing	Framing, Filling,Finishing
Coil length	1cm - 40cm	1cm - 50cm	2cm-50cm	2-68cm
Main CoilMaterial	Platinum/Tungstenalloy	Platinum/Tungstenalloy	Platinum/Tungsten alloy	Platinum/Tungsten.alloy
Coil delivery	Stainless steelwire/pusher	Stainless steelwire/pusher	Stainless steelwire/pusher	Stainless steelwire/pusher
Coil detachment	Electrolytic	Electrolytic	Thermo-mechanical	Thermo-mechanical
Detachmentequipment	DetachmentControl PowerSupply, ED2-BL	Boston ScientificDetachable CoilPower Supply orInZone DetachmentSystem	V-GripDetachmentController	V-Grip DetachmentController
Method of supply(coil/deliverysystem)	Sterile, single use	Sterile, single use	Sterile, single use	Sterile, single use

Blockade Medical Barricade Embolization Coil System

Page 32 of 146 Premarket Notification

{2}------------------------------------------------

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
- o Reposition/deployment
- o Detachment
- Overall Performance o
Detachment Zone tensile .
Stretch Resistance tensile .
Corrosion resistance .
. MR compatibility

Biocompatibility and animal testing was performed as follows:

Test	Results	Conclusions
Cytotoxicity Testing - NeutralRed Uptake (NRU)/MEM(implant)	97% cell viability	Non-cytotoxic
Sensitization Testing - KligmanMaximization(implant)	No reaction	Non-sensitizing
Intracutaneous Reactivity(implant)	No significant greater biologicalreaction than the controls	Non-irritant
Hemolysis(implant)	< 2% hemolysis	Non-hemolytic
Prothrombin Time(implant)	Normal range (10-14sec)	No adverse effect on prothrombincoagulation time
Complement Activation(implant)	No increase observed comparedto controls	Does not induce complementactivation.
Acute Systemic Toxicity(implant)	Did not induce a significantlygreater reaction than controls	Non-toxic
Materials Mediated Pyrogen(implant)	No individual temperatureincrease of ≥ 0.5°C	Non-pyrogenic
Ames Assay(implant)	No significant increase in thenumber of revertant coloniescompared to controls	Not considered mutagenic
Mouse Lymphoma(implant)	No significant increase in mutantfrequency	Non-mutagenic
Micronucleus Assay	No statistical increase in	Non-mutagenic (non-genotoxic,

Blockadc Medical Barricade Embolization Coil Page 33 of 146 Premarket Notification

System

{3}------------------------------------------------

Test	Results	Conclusions
w/confirmation(implant)	micronucleated erythrocytes compared to controls	non-clastogenic)
Implantation, intramuscular(implant)	Bioreactivity rating 3.6	Non-reactive
Systemic Toxicity, 90 day(implant)	The test article did not appear to demonstrate local or systemic signs of toxicity	Non-toxic
Cytotoxicity- MEM Elution(delivery system)	< Grade 2	Non-cytotoxic
Sensitization- Murine LocalLymph Node Assay(delivery system)	Stimulation Indices calculated < 3.0.	Not considered to be sensitizing
ISO Intracutaneous Study(delivery system)	Mean score difference from control ≤ 1.0.	Non irritant
ISO Systemic Toxicity Study(delivery system)	No mortality or systemic toxicity observed.	Non-toxic
Hemolysis(delivery system)	Mean hemolytic index was 0%	Non-hemolytic
Materials Mediated Pyrogen(delivery system)	No individual temperature increase of ≥ 0.5°C	Non-pyrogenic
Acute Animal Studies	BCS product provided angiographic occlusion immediately following treatment

Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Barricade Embolization Coil System is determined by Blockade Medical, to be substantially equivalent to existing legally marketed devices.

Blockade Medical Barricade Embolization Coil System

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three tail feathers, representing the department's commitment to health, services, and people. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

March 28,2013

Public Health Service

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

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

Re: K123338

Trade/Device Name: Barricade Embolization Coi! System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG Dated: February 8, 2013 Received: February 11, 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. Iisting 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

{5}------------------------------------------------

Page 2 - Ms. Rebecca K. Pine

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Victor krauthamer -S

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K123338

Device Name: Barricade Embolization Coil System

Indications for Use:

AND/OR

Prescription Use _ X_ (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Victor Krauthamo 2013.03.28 12:07:28

(Division Sign-Off) Division of Neurological and Physical Medicine Devices

510(k) Number K123338

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).