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 a 510(k) summary for the Barricade Embolization Coil System, focusing on demonstrating substantial equivalence to a predicate device. It details the technical characteristics and the performance data that was collected.

Here's an analysis of your requested information based on the provided text:

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

Acceptance Criteria (Specified Criteria)	Reported Device Performance
Visual inspection performance	"The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions."
Dimensional measurement performance	"The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions."
Simulated Use Performance:	"The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions."
- Introduction	"The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions."
- Tracking	"The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions."
- Reposition/deployment	"The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions."
- Detachment	"The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions."
- Overall Performance	"The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions."
Detachment Zone tensile performance	"The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions."

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

The document states: "All testing was performed on test units representative of finished devices." However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).

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 text. The testing conducted was focused on engineering performance (visual inspection, dimensional measurement, simulated use, detachment zone tensile) rather than clinical evaluation requiring expert ground truth in the context of diagnostic or interpretive tasks.

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

This information is not applicable and therefore not provided in the text. The type of testing described (engineering verification and validation) does not involve adjudication by multiple human experts in the way clinical studies or image-based diagnostic device studies do.

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

No MRMC comparative effectiveness study was done or mentioned. This document pertains to a medical device (embolization coil system) and its physical and functional performance, not an AI-powered diagnostic or interpretive tool that would involve human readers.

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 embolization coil system, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here.

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

The "ground truth" for the engineering performance tests would be the engineering specifications and design requirements for the device. For example, a "visual inspection" would verify that the device meets visual quality standards, a "dimensional measurement" would confirm it meets specified dimensions, and "simulated use" would confirm its functional performance in a simulated environment as designed. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these tests.

8. The sample size for the training set

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

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

This is not applicable. As mentioned in point 8, there is no training set for this device.

Summary

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Section 5

510(k) Summary of Safety and Effectiveness

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:	June 24, 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: Barricade Embolization Coil System (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 notification K 123338.

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

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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 Embolization CoilSystem	Barricade Embolization Coil System (K123338)
	Facilitates endovascularembolizationof intracranial aneurysms andothervascular abnormalities	SAME
Primary Coil Diameter	0.010"-0.014"	SAME
Coil Secondary diameter	1.5mm – 15mm	SAME
Coil Wire Diameter	0.00125"-0.003"	SAME
Secondary Shapes	Complex/Helical	SAME
Coil Types	Framing, Filling, Finishing	SAME
Coil length	1cm – 40cm	SAME
Main Coil Material	Platinum/Tungsten alloy	SAME
Coil delivery	Stainless steel wire/pusher	SAME
Coil detachment	Electrolytic	SAME
Detachment equipment	Detachment Control PowerSupply, ED2-BL	SAME
Method of supply (coil/delivery system)	Sterile, single use	SAME
Delivery Wire	.012" dia SSTL100005-005	.010" dia. SSTL100005-001
Labeled Sizes (coils)	10FramingNew sizes:4mm x13cm5mm x 17cm6mm x 20cm7mm x 24cm8mm x 27cm9mm x 30cm10mm x 34cm	10 Framing2mm – 10mm x 3cm-27cm
	18 Framing6mm x 20cm7mm x 24cm8mm x 27cm9mm x 30cm10mm x 34cm11mm x 37cm12mm x 40cm13mm x 43cm14mm x 47cm15mm x 50cm	18 Framing6mm – 15mm x 16cm-50cmFilling3mm – 10mm x 4cm – 40cmFinishing1.5mm – 6mm x 1cm – 10cm
Filing4mm x 15cm4mm x 20cm5mm x 20cm5mm x 25cm6mm x 25cm6mm x 30cm10mm x 40cm
Finishing1.5mm x 4cm1.5mm x 6cm2mm x 6cm2mm x 8 cm2.5mm x 8cm3mm x 8cm3mm x 10cm4mm x 10cm

Blockade Medical Modified Barricade Coil System

Page 12 of 84 Premarket Notification

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

Additional sizes added to product family .
Change in delivery wire diameter .

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
- o Reposition/deployment
- o Detachment
- o Overall Performance
. Detachment Zone 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:

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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 123338).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of an eagle or bird-like figure. The emblem is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the emblem.

July 25, 2013

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

Re: K131475

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, 2013 Received: June 26, 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 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.

Public Health Service

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

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Page 2 - Ms. Rebecca K. Pine

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/ResourcesforYou/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,

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

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Indications for Use

510(k) Number (if known): _K131475

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 CDRH, Office of Device Evaluation (ODE)

Victor Krauthamer - S

2013.07.25 18:20:24 -04'00'

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

510(k) Number K131475

Page 1 of 1

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).