BARRICADE EMBOLIZATION COIL SYSTEM

K140104 · Blockade Medical · HCG · Feb 13, 2014 · Neurology

Device Facts

• Record ID: K140104
• Device Name: BARRICADE EMBOLIZATION COIL SYSTEM
• Applicant: Blockade Medical
• Product Code: HCG · Neurology
• Decision Date: Feb 13, 2014
• Decision: SESE
• Submission Type: Special
• 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 consists of platinum/tungsten alloy coils attached to delivery pushers; 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 thrombosis. Coils detached electrolytically from pusher via external controller. Used in clinical settings by physicians; system includes various shapes, lengths, and sizes to facilitate framing, filling, and finishing of aneurysms. Benefits include permanent obstruction of blood flow to vascular malformations.

Clinical Evidence

Bench testing only. Verification and validation included visual inspection, dimensional measurement, and simulated use testing (introduction, tracking, repositioning/deployment, and detachment). Testing demonstrated performance equivalent to predicate devices.

Technological Characteristics

Platinum/tungsten alloy embolization coils; stainless steel wire/pusher; electrolytic detachment mechanism via external controller. Available in complex/helical shapes; sizes 1.0mm-15mm diameter and 1cm-50cm length. Sterile, single-use. Connectivity: None (mechanical/electrical detachment).

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae; vascular occlusion of neurovascular blood vessels to obstruct flow to aneurysms or malformations; 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

• Barricade Embolization Coil System (K134482)
• Barricade Embolization Coil System (K131475)
• Barricade Embolization Coil System (K123338)

Submission Summary (Full Text)

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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 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 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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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:

| Embolization<br>Barricade<br>Coil<br>System | Barricade Embolization Coil<br>System (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 |
| Electrolytic<br>via<br>detachment | 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 intracranial<br>aneurysms and other vascular<br>10 Complex Finishing<br>1 .5mmx2cm<br>1.5mm x 3cm<br>1.5mmx 4cm<br>2.5mm x 2cm<br>2.5mm x 3cm<br>2.5mm x 4cm<br>3mm x 3cm<br>3mm x 4cm<br>3mm x 6cm<br>3mm x 8cm<br>3mm x 10cm<br>4mm x 4cm<br>4mm x 6cm |

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| | Barricade Embolization Coil<br>System | Coil | Barricade Embolization Coil<br>System (K134482, K131475,<br>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 [phone] or [phone] 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 [phone] or [phone] 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 [phone] EP

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