M-BOLUS EMBOLIC MICROSPHERES

K052509 · Scion Cardio-Vascular, Inc. · HCG · Dec 11, 2006 · Neurology

Device Facts

• Record ID: K052509
• Device Name: M-BOLUS EMBOLIC MICROSPHERES
• Applicant: Scion Cardio-Vascular, Inc.
• Product Code: HCG · Neurology
• Decision Date: Dec 11, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The M-BOLUS™ Embolic Microspheres are intended for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors. They may be used for vascular occlusion of vessels within the neurovascular system when presurgical devascularization is desirable.

Device Story

M-BOLUS Embolic Microspheres are biocompatible, non-degradable, non-absorbable polyvinyl alcohol (PVA) spheres; supplied in hydrated 0.9% sodium chloride state. Spheres are soft, flexible, and compressible to facilitate delivery through catheters into the vasculature. Used by clinicians for embolization of AVMs and hypervascular tumors or presurgical vascular occlusion. Device acts as a mechanical embolic agent to block blood flow to target lesions. Benefits include controlled vascular occlusion.

Clinical Evidence

Bench testing only; biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Material: Polyvinyl Alcohol (PVA). Form: Hydrated, soft, flexible, compressible spheres with smooth, lightly porous surface. Energy source: None (mechanical). Sterilization: Not specified. Connectivity: None.

Indications for Use

Indicated for embolization of arteriovenous malformations (AVMs) and hypervascular tumors, and for vascular occlusion of neurovascular vessels for presurgical devascularization.

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

• Contour SETM Microspheres (K032707)

Submission Summary (Full Text)

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K052509

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| Submitted by: | Scion Cardio-Vascular, Inc.<br>14256 SW 119th Avenue<br>Miami, FL 33186<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Suzana Otaño-Lata |
| Date Prepared: | October 26, 2005 |
| Proprietary Name: | M-BolusTM Embolic Microspheres |
| Common Name: | Embolic Microspheres |
| Classification Name: | Neurovascular Embolization Device (21 CFR § 882.5950)<br>ProCode: HCG |
| Predicate Device: | Boston Scientific Corporation K032707 Contour SETM Microspheres |
| Device Description: | M-BOLUSTM Embolic Microspheres are made out of a<br>biocompatible, non-degradable and non-absorbable synthetic<br>polymer called Polyvinyl Alcohol (PVA).<br><br>The M-BOLUSTM Embolic Microspheres are precisely<br>manufactured spheres, with a smooth and lightly porous<br>surface with hydrophilic characteristics.<br><br>The M-BOLUSTM Embolic Microspheres, which are supplied in<br>a hydrated state (0.9% Sodium Chloride), are soft and flexible<br>allowing them to be compressed/deformed as they travel<br>through the lumen of a delivery catheter or the vasculature.<br><br>The Scion Cardio-Vascular M-BOLUSTM Embolic Microspheres<br>are substantially equivalent to the predicate devices. |
| Intended Use: | The M-BolusTM Embolic Microspheres are intended for the<br>embolization of arteriovenous malformations (AVMs) and<br>hypervascular tumors. They may be used for vascular<br>occlusion of vessels within the neurovascular system when<br>presurgical devascularization is desirable. |
| Technological | The technological characteristics of the M-BolusTM Embolic |

Section 5 — 510(k) Summary

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**Characteristics:** Microspheres are the same as the predicate devices, including design and material. The M-Bolus™ successfully completed biocompatibility testing per ISO 10993-1.

**Summary of Substantial Equivalence:** The Scion Cardio-Vascular M-BOLUS™ is substantially equivalent to the currently marketed Contour SE™ Microspheres. No new issues of safety or efficacy have been raised. Scion Cardio-Vascular has provided information

and Neurovascular Embolization Devices.

supporting acceptability for use and substantial equivalence per Class II Special Controls Guidance Document: Vascular

KIT 2009

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's commitment to health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEC 1 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Scion Cardio-Vascular % Ms. Suzana Otaño-Lata Consultant 14256 S.W. 119th Aenue Miami, Florida 33186

Re: K052509

Trade/Device Name: M-BOLUS™ Embolic Microspheres Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: October 12, 2006 Received: October 13, 2006

Dear Ms. Otaño-Lata:

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.

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 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. Suzana Otaño-Lata

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 a legally 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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/cdrh/industry/support/index.html.

Sincercly vours

for
Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Korosos

## SECTION 4 - INDICATIONS FOR USE STATEMENT

510(k) Number: K052509

M-BロLUs™ Embolic Microspheres Device Name:

Indications For Use: The M-BOLUS™ Embolic Microspheres are intended for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors. They may be used for vascular occlusion of vessels within the neurovascular system when presurgical .............................................................................................................................................................................. devascularization is desirable.

× Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter (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)

ర్ల

ign-Off) (Division Page 1 of 1 Division of General, Restorative, and Neurological Devices

**510(k) Number** K052505