BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER

K043371 · Biomerix Corporation · KRD · Feb 3, 2005 · Cardiovascular

Device Facts

• Record ID: K043371
• Device Name: BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER
• Applicant: Biomerix Corporation
• Product Code: KRD · Cardiovascular
• Decision Date: Feb 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biomerix Vascular Occlusion Device is intended for arterial and venous embolization in the peripheral vasculature.

Device Story

Biomerix Vascular Occlusion Device is a cylindrical implant made of polycarbonate-urethane; available in 15 mm length and 4, 6, and 8 mm diameters. Device is provided sterile for single use in an uncompressed state. It is compressed and delivered to target peripheral vasculature via commercially available 5-7 F peripheral introducers. A provided loader assists with catheter insertion. Once deployed, the device disrupts blood flow to induce thrombus formation and vessel occlusion. Used by clinicians in a clinical setting. Benefits include effective vascular occlusion comparable to existing coil and plug technologies.

Clinical Evidence

No human clinical data provided. Evidence consists of material testing, bench testing for loading/deliverability/recovery, biocompatibility testing, and animal testing. Animal studies demonstrated performance equivalent to Cook Embolization Coils regarding time to occlusion, migration, recanalization, and tissue response.

Technological Characteristics

Cylindrical implant composed of polycarbonate-urethane. Dimensions: 15 mm length; 4, 6, 8 mm diameters. Delivered via standard 5-7 F peripheral introducers. Mechanical occlusion principle. Sterile, single-use.

Indications for Use

Indicated for arterial and venous embolization in the peripheral vasculature for patients requiring vessel occlusion.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

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 § 870.1(e).

Predicate Devices

• Cook Embolization Coils (K942189)
• Amplatzer® Vascular Plug (K031810)

Submission Summary (Full Text)

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## 510(k) SUMMARY - Biomerix Vascular Occlusion Device

| Applicant Name: | Biomerix Corporation<br>41 West 57th Street, 6th Floor<br>New York, NY 10019<br>Phone: [phone]<br>Fax: [phone] |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Craig Friedman, M.D.<br>VP, Medical Research and Development |
| Date Prepared: | December 7, 2004 |
| Device Trade Name: | Biomerix Vascular Occlusion Device and Loader |
| Device Common Name: | Arterial embolization device |
| Classification Name: | Device, embolization, arterial |
| Predicate Devices: | Cook Embolization Coils, K942189<br>Amplatzer® Vascular Plug, K031810 |
| Device Description: | The Biomerix Vascular Occlusion Device is a cylindrical<br>device made from polycarbonate-urethane. The length<br>of the implant is 15 mm, and it is available in diameters<br>of 4, 6, and 8 mm. The Biomerix Vascular Occlusion<br>Device is provided sterile for single use in its<br>uncompressed state. The device is compressed and<br>delivered to the target location through a commercially<br>available peripheral introducer (5-7 F). A Loader is<br>provided to assist with introducing the implant into the<br>delivery catheter. |
| Intended Use: | The Biomerix Vascular Occlusion Device is intended for<br>arterial and venous embolization in the peripheral<br>vasculature. |
| Device Technological<br>Characteristics and<br>Comparison to<br>Predicate Device(s): | The Biomerix Vascular Occlusion Device is similar in<br>performance to Cook Stainless Steel coils. Both devices<br>disrupt blood flow, causing thrombus formation and<br>occlusion. Coils are composed of stainless steel and<br>synthetic fibers.<br>The Biomerix Vascular Occlusion Device is similar in<br>design to the Amplatzer® Vascular Plug. The<br>Amplatzer® is also a cylindrical plug, which is available in<br>diameter ranging from 4 to 16 mm. The Amplatzer® is<br>composed of Nitinol, platinum, and stainless steel. |
| Performance Data: | Material testing was performed to demonstrate that the material properties are suitable for the intended use. |
| | Bench testing was performed to demonstrate that the devices as manufactured meet the performance specifications for loading, deliverability, and recovery. |
| | Extensive biocompatibility testing was performed to demonstrate that the material is safe and biostable. |
| | Animal testing demonstrates that the device performs equivalently to Cook Embolization Coils in terms of time to occlusion, migration, recanalization, and tissue response. |
| Conclusion: | Based on the material, bench, and animal testing, and the proposed device labeling, the Biomerix Vascular Occlusion Device and Loader is substantially equivalent to the identified predicate devices in terms of intended use, safety, and effectiveness. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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FEB - 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Christina Kichula. RAC Manager. Regulatory Affairs Biomerix Corporation c/o PPD Medical Device 1700 Rockville Pike. Suite 400 Rockville. MD 20852

K043371 Re:

> Trade/Device Name: Biomerix Vascular Occlusion Device Regulation Number: 21 CFR 870.3300 Regulation Name: Arterial Embolization Device Regulatory Class: Class II (two) Product Code: KRD Dated: December 7. 2004 Received: December 8. 2004

Dear Ms. Kichula:

We have reviewed vour 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. Ilsting of devices. good manufacturing practice. labeling, and prohibitions against misbranding and adulteration.

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can he 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): good manufacturing practice requirements as set

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Page 2 - Ms. Christina Kichula, RAC

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quanty systems (Q5) regulation (Sections 531-542 of the Actily 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Scetions 35 described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin marketing your antial equivale of your device to a legally premarket notification. THE PDA midning of backannal of .
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your de rice on other not and the regulation entitled, and the regulation entitled, contact the Office of Comphanes at (301) 37 cart 807.97). You may obtain "Misoranding by reletence to premantee no all reasons bill the set from the Division of Small other geteral information on your responsibility of the manber [phone] or
Manufacturers, International and Consumer Assistance of al (demostern attral Manufacturers, International and Consults: 12015.
[phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duna E. Lochner

1) Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): _ K043371

Device Name:__Biomerix Vascular Occlusion Device

Indications For Use:

The Biomerix Vascular Occlusion Device is intended for arterial and venous embolization in the peripheral vasculature.

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Divina P. Lechuer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number k04337

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