HEPASPHERE MICROSPHERES

K052742 · Biosphere Medical, Inc. · KRD · Nov 7, 2006 · Cardiovascular

Device Facts

• Record ID: K052742
• Device Name: HEPASPHERE MICROSPHERES
• Applicant: Biosphere Medical, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Nov 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioSphere QuadraSphere™ Microspheres are intended for embolization of hypervascularized tumors and peripheral vascular arteriovenous malformations (AVMs).

Device Story

QuadraSphere™ Microspheres are sterile, biocompatible, hydrophilic, non-resorbable, acrylic copolymer microspheres used for vascular embolization. Provided in dry form in vials, they are available in three nominal sizes (50-100 um, 100-150 um, 150-200 um). During clinical use, the physician mixes the microspheres with contrast media and delivers them via catheter to the target vessel. Placement is guided by fluoroscopic imaging. The microspheres act as an embolic agent to occlude blood flow to hypervascularized tumors or arteriovenous malformations. The device is intended for single use.

Clinical Evidence

Bench testing only. In-vitro and in-vivo design verification and validation testing demonstrated that the device fulfills design and performance specifications.

Technological Characteristics

Materials: hydrophilic, non-resorbable, acrylic copolymer. Form factor: microspheres in three nominal size ranges (50-100 um, 100-150 um, 150-200 um). Delivery: catheter-based, fluoroscopic visualization. Sterilization: sterile. Energy source: none (mechanical).

Indications for Use

Indicated for embolization of hypervascularized tumors and peripheral vascular arteriovenous malformations (AVMs).

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 UK Ltd., GelSpheres, BeadBlock Compressible Microspheres (K042231)
• Boston Scientific Corporation, Contour SE (K022427, K032542)
• Interventional Therapeutics Corporation, Contour Emboli (K944354)
• BioSphere Medical, Inc., Embospheres (K991549)

Submission Summary (Full Text)

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K05 2742

## 510(k) Summary for the BioSphere Medical, Inc. QuadraSphere™ Microspheres

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#### SUBMITTER/510(K) HOLDER 1.

BioSphere Medical, Inc. 1050 Hingham Street Rockland, MA 02370 USA

NGV - 7 2006

Contact Person: Irina Kulinets Telephone: [phone]

Date Prepared: September 29, 2005

#### 2. DEVICE NAME

Proprietary Name: QuadraSphere™ Microspheres Common/Usual Name: Embolization device Classification Name: Vascular embolization device

#### 3. PREDICATE DEVICES

- Biocompatibles UK Ltd., GelSpheres, BeadBlock Compressible . Microspheres (K042231)
- Boston Scientific Corporation, Contour SE (K022427, K032542) .
- Interventional Therapeutics Corporation, Contour Emboli (K944354) .
- BioSphere Medical, Inc., Embospheres (K991549) .

#### DEVICE DESCRIPTION 4.

BioSphere Medical, Inc., QuadraSphere™ Microspheres are sterile, biocompatible, hydrophilic (absorbent), non-resorbable, acrylic copolymer microspheres. They are provided in three (nominal) microsphere sizes: 50 to 100 um, 100 to 150 um, and 150 to 200 um in containers (vials) containing 50 mg of the dry spheres.

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#### 5. INTENDED USE

The BioSphere QuadraSphere™ Microspheres are intended for embolization of hypervascularized tumors and peripheral vascular arteriovenous malformations (AVMs).

### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

BioSphere Medical, Inc. bases its claim of the substantial equivalence of the QuadraSphere™ Microspheres with the cited predicate devices based on intended use, indications for use, fundamental technological characteristics, and fundamental operational characteristics. In all cases, the embolization agent is delivered to selected sites through catheters with a diameter that is appropriate for the vascular target and the size of the embolization agent. Accurate placement is assured through visualization of the injection process using fluoroscopic imaging. Embolization agents are mixed with the contrast media before injection to optimize visualization of the embolization procedure. Like predicate devices the QuadraSphere™ Microspheres are available in a range of sizes to permit selection of the most appropriate size for target vessels. All cited embolization agents are intended for single use and are provided sterile.

#### 7. PERFORMANCE TESTING

In-vitro and in-vivo design verification and validation testing demonstrates that the BioSphere Medical, Inc. QuadraSphere™ Microspheres fulfill design and performance specifications.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biosphere Medical, Inc. % Medical Device Consultants, Inc. Rosina Robinson, RN, Med, RAC Principal Consultant 49 Plain Street North Attleboro, Massachusetts 02760

NOV - 7 2006

Re: K052742

Trade/Device Name: QuadraSphere™ Microspheres Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular embolization device Regulatory Class: II Product Code: KRD, HCG Dated: August 15, 2006 Received: August 16, 2006

Dear Ms. Robinson:

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

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Page 2 – Rosina Robinson, RN, Med, RAC

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.

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.

Sincerely yours,

Mark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices

Rumm
DEA
ARECTOR

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K052742

# Indications for Use

510(k) Number (if known): ____K052742_________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

QuadraSphere Microspheres are indicated for embolization of hypervascularized arteriovenous malformations.

| Prescription Use | X (Part 21 CFR 801 Subpart D) | | |
|------------------|-------------------------------|----------------------|------------------------|
| | AND/OR | Over-The-Counter Use | (21 CFR 801 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

| 510(k) Number | 4052742 |
|---------------|---------|
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