EMBOZENE MICROSPHERES

K073417 · Celonova Biosciences, Inc. · KRD · Dec 15, 2008 · Cardiovascular

Device Facts

• Record ID: K073417
• Device Name: EMBOZENE MICROSPHERES
• Applicant: Celonova Biosciences, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Dec 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Embozene™ Microspheres are indicated for the embolization of hypervascular tumors and arteriovenous malformations. Embozene™ Microspheres may be used for vasculturion of blood vessels within the neurovascular system.

Device Story

Embozene™ Microspheres are spherical embolic hydrogels designed to obstruct or reduce blood flow to hypervascularized tumors or arteriovenous malformations. Available in seven sizes (40-900 µm), particles are opaque under fluoroscopy to facilitate placement. Used in clinical settings under fluoroscopic guidance; delivered via compatible microcatheters by physicians. By selectively occluding target vessels, the device reduces blood supply to the lesion, potentially benefiting patients by shrinking tumors or treating malformations. Device is sterile, non-pyrogenic, and single-use.

Clinical Evidence

No clinical data required.

Technological Characteristics

Spherical embolic hydrogel particles. Available in seven diameter sizes: 40, 100, 250, 400, 500, 700, and 900 µm. Opaque under fluoroscopy. Steam sterilized. Single-use, non-pyrogenic.

Indications for Use

Indicated for embolization of hypervascular tumors and arteriovenous malformations, including vessels within the neurovascular system.

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

• Biocompatibles Gelspheres™ Microspheres (K033761)
• Biocompatibles Bead Block™ Microspheres (K033761)
• Boston Scientific Contour SE™ Microspheres (K032707)
• Boston Scientific Contour SE™ Microspheres (K034068)
• Boston Scientific Contour SE™ Microspheres (K071634)

Submission Summary (Full Text)

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K073417

## DEC 1 5 2008

# 510(k) Summary

Contact Information: CeloNova BioSciences, Inc.

49 Spring Street Newnan, GA 30263 Telephone: [phone] Facsimile: [phone]

Trade Name: Embozene™ Microspheres Embozene™ Color Advanced Microspheres

Common Name: Vascular Embolization Particles

Classification Name: Artificial Embolization Device

Device Product Codes: KRD

Regulation Numbers: 21 CFR 870.3300

Substantial Equivalence: The CeloNova BioSciences, Inc. Embozene™ Microspheres and Embozene™ Color Advanced Microspheres are substantially equivalent in basic design, construction, indication for use, and performance characteristics to other commercially available vascular embolization particles.

Device Description: Celonova BioSciences, Inc. Embozene™ Microspheres are spherical embolic hydrogels. They are artificial embolization devices used to obstruct or reduce blood flow to hypervascularized tumors or artenovenous mall ormations via selective microcatheter delivery.

The embolization particles are available in seven (7) size ranges of 40, 100, 250, 400, 500, 700 and 900 um diameters to enable appropriate size selection for the turnor or malformation to be treated. Embozene™ Microspheres are designed for use under fluoroscopic guidance through compatible delivery catheters. The product is provided as a sterile, non pyrogenic, single use device. It is an uncolored or color-coded particle that is opaque under fluoroscopy. The product and its delivery container are steam sterlized.

Indications for Use: Embozene™ Microspheres are indicated for the embolization of hypervascular tumors and arteriovenous malformations. Embozene™ Microspheres may be used for vasculturion of blood vessels within the neurovascular system.

Predicate Devices: Embozene™ Microspheres are substantially equivalent to these predicate devices:

Biocompatibles Gelspheres™ Microspheres (Vial) (colored) - K033761 Biocompatibles Bead Block™ Microspheres (Syringe) (colored) · K033761 Boston Scientific Contour SE™ Microspheres K032707 Boston Scientific Contour SE™ Microspheres K034068 Boston Scientific Contour SE™ Microspheres K071634

Clinical Data: None required.

Adverse Safety & Effectiveness Information: None.

**Signature**

Ralph E. Gaskins, Jr, MD, JD Vice President, Legal and Intellectual Property

**Date** 28 Apr 2008

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

#### Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 2008

CeloNova BioSciences, Inc. c/o Mr. Thomas A. Gordy President and Chief Executive Officer 49 Spring Street Newnan, GA 30263

Re: K073417

Enbozene™ Microspheres Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 8, 2008 Received: October 9, 2008

Dear Mr. Gordy:

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.

If your 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 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.

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### Page 2 - Mr. Thomas A. Gordy

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 not 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 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 1000-1000. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 1 legally marketed predicate device results in a classification for your device and thus, perceite your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliary, pro [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at ites toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

R.V.Ames

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

. Enclosure

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# Indications for Use

510(k) Number (if known): K073417 Device

Name: Embozene™ Microspheres Indications

For Use:

Embozene™ Microspheres are indicated for the embolization of hypervascular tumors and arteriovenous malformations.

X___ AND/OR Over-The-Counter Use ________________ (Part 21 CFR Prescription Use _ 801 Subpart D) (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)

uma R. Varlines
(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K073417

K073417, Embozene™ Microspheres Reply to FDA letter of January 22, 2008 May 8, 2008

CONFIDENTIAL INFORMATION CELONOVA BIOSCIENCES, INC. Page 52 of 1002