BARRICADE EMBOLIZATION COIL SYSTEM

K123338 · Blockade Medical · HCG · Mar 28, 2013 · Neurology

Device Facts

• Record ID: K123338
• Device Name: BARRICADE EMBOLIZATION COIL SYSTEM
• Applicant: Blockade Medical
• Product Code: HCG · Neurology
• Decision Date: Mar 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Barricade Embolization Coil System (BCS) consists of platinum/tungsten alloy coils attached to a stainless steel delivery pusher; used for endovascular embolization of intracranial aneurysms and vascular anomalies. Device inserted into vasculature under angiographic visualization; coils placed into aneurysm to create blood stasis and induce thrombosis. Coils detached electrolytically from pusher in serial manner until occlusion achieved. Used in clinical settings by physicians; requires external Detachment Control Power Supply (ED2-BL). Benefits include permanent obstruction of blood flow to aneurysms or malformations, reducing rupture risk.

Clinical Evidence

Bench testing only. Included visual inspection, dimensional measurement, simulated use (introduction, tracking, repositioning, deployment, detachment), tensile testing, corrosion resistance, and MR compatibility. Biocompatibility testing (cytotoxicity, sensitization, reactivity, hemolysis, prothrombin time, complement activation, systemic toxicity, pyrogenicity, mutagenicity, implantation) confirmed safety. Acute animal studies demonstrated successful angiographic occlusion.

Technological Characteristics

Platinum/tungsten alloy coils; stainless steel delivery pusher; electrolytic detachment mechanism. Coil diameters 0.010"-0.014"; secondary diameters 1.5mm-15mm; lengths 1cm-40cm. Available in complex/helical shapes. Sterile, single-use. Requires external Detachment Control Power Supply (ED2-BL).

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae; vascular occlusion of neurovascular blood vessels; and arterial/venous embolizations in peripheral vasculature.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Guglielmi Detachable Coils- GDC 360° (K103355, K093142)
• Hydrocoil Embolic System (K120908)
• Microplex Coil System (K093358)

Submission Summary (Full Text)

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# 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 Pine<br>Blockade Medical<br>18 Technology Dr.<br>Suite 169<br>Irvine, CA 92618<br>Phone: [phone] |
| TRADE NAME: | Barricade Embolization Coil System |
| COMMON NAME: | Neurovascular embolization device |
| CLASSIFICATION<br>NAME: | Neurovascular embolization device |
| DEVICE<br>CLASSIFICATION: | Class 2, per 21 CFR 882.5950 |
| PRODUCT CODE | HCG |
| PREDICATE DEVICES: | Guglielmi Detachable Coils- GDC 360° (K10335<br>K093142)<br>Hydrocoil Embolic System (K120908)<br>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:

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

Blockade Medical Barricade Embolization Coil System

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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:

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 devices as outlined in the table below:

| | Barricade<br>Embolization<br>Coil System | GDC 360°<br>(K103355,<br>K093142) | Hydrocoil<br>Embolic System<br>(K120908) | Microplex Coil<br>System (K093358) |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------|------------------------------------|
| | Facilitates<br>endovascular<br>embolization<br>of intracranial<br>aneurysms and<br>other<br>vascular<br>abnormalities | SAME | SAME | SAME |
| Primary Coil<br>Diameter | 0.010"-0.014" | 0.010"-0.015" | 0.008"-0.015" | 0.0095"-0.015" |
| Coil Secondary<br>diameter | 1.5mm - 15mm | 1.5mm - 25mm | 2mm-24mm | 2-24mm |
| Coil Wire<br>Diameter | 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,<br>Finishing | Framing, Filling,<br>Finishing | Framing, Filling,<br>Finishing | Framing, Filling,<br>Finishing |
| Coil length | 1cm - 40cm | 1cm - 50cm | 2cm-50cm | 2-68cm |
| Main Coil<br>Material | Platinum/Tungsten<br>alloy | Platinum/Tungsten<br>alloy | Platinum/Tungsten alloy | Platinum/Tungsten.<br>alloy |
| Coil delivery | Stainless steel<br>wire/pusher | Stainless steel<br>wire/pusher | Stainless steel<br>wire/pusher | Stainless steel<br>wire/pusher |
| Coil detachment | Electrolytic | Electrolytic | Thermo-<br>mechanical | Thermo-mechanical |
| Detachment<br>equipment | Detachment<br>Control Power<br>Supply, ED2-BL | Boston Scientific<br>Detachable Coil<br>Power Supply or<br>InZone Detachment<br>System | V-Grip<br>Detachment<br>Controller | V-Grip Detachment<br>Controller |
| Method of supply<br>(coil/delivery<br>system) | Sterile, single use | Sterile, single use | Sterile, single use | Sterile, single use |

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### 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 - Neutral<br>Red Uptake (NRU)/MEM<br>(implant) | 97% cell viability | Non-cytotoxic |
| Sensitization Testing - Kligman<br>Maximization<br>(implant) | No reaction | Non-sensitizing |
| Intracutaneous Reactivity<br>(implant) | No significant greater biological<br>reaction than the controls | Non-irritant |
| Hemolysis<br>(implant) | < 2% hemolysis | Non-hemolytic |
| Prothrombin Time<br>(implant) | Normal range (10-14sec) | No adverse effect on prothrombin<br>coagulation time |
| Complement Activation<br>(implant) | No increase observed compared<br>to controls | Does not induce complement<br>activation. |
| Acute Systemic Toxicity<br>(implant) | Did not induce a significantly<br>greater reaction than controls | Non-toxic |
| Materials Mediated Pyrogen<br>(implant) | No individual temperature<br>increase of ≥ 0.5°C | Non-pyrogenic |
| Ames Assay<br>(implant) | No significant increase in the<br>number of revertant colonies<br>compared to controls | Not considered mutagenic |
| Mouse Lymphoma<br>(implant) | No significant increase in mutant<br>frequency | Non-mutagenic |
| Micronucleus Assay | No statistical increase in | Non-mutagenic (non-genotoxic, |

Blockadc Medical Barricade Embolization Coil Page 33 of 146 Premarket Notification

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| Test | Results | Conclusions |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------|----------------------------------|
| w/confirmation<br>(implant) | micronucleated erythrocytes compared to controls | non-clastogenic) |
| Implantation, intramuscular<br>(implant) | Bioreactivity rating 3.6 | Non-reactive |
| Systemic Toxicity, 90 day<br>(implant) | The test article did not appear to demonstrate local or systemic signs of toxicity | Non-toxic |
| Cytotoxicity- MEM Elution<br>(delivery system) | < Grade 2 | Non-cytotoxic |
| Sensitization- Murine Local<br>Lymph Node Assay<br>(delivery system) | Stimulation Indices calculated < 3.0. | Not considered to be sensitizing |
| ISO Intracutaneous Study<br>(delivery system) | Mean score difference from control ≤ 1.0. | Non irritant |
| ISO Systemic Toxicity Study<br>(delivery system) | No mortality or systemic toxicity observed. | Non-toxic |
| Hemolysis<br>(delivery system) | Mean hemolytic index was 0% | Non-hemolytic |
| Materials Mediated Pyrogen<br>(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

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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

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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 [phone] or [phone] 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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5. Indications for Use Statement

### INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K123338

#### Device Name: Barricade Embolization Coil System

Indications for Use:

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.

### 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