EMBOSPHERE MICROSPHERES

K991549 · Biosphere Medical · HCG · Apr 26, 2000 · Neurology

Device Facts

• Record ID: K991549
• Device Name: EMBOSPHERE MICROSPHERES
• Applicant: Biosphere Medical
• Product Code: HCG · Neurology
• Decision Date: Apr 26, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

EMBOSPHERE® Microspheres are indicated for embolization of hypervascular tumors and arteriovenous malformations.

Device Story

EMBOSPHERE® Microspheres are spherical microbeads composed of acrylic polymer impregnated with gelatin; used for arterial embolization of hypervascular tumors and arteriovenous malformations. Delivered via microcatheter to target vessels; physician selects appropriate bead size (ranging 40-120 to 900-1200 microns) based on vessel diameter. Radiopacity agent mixed with beads prior to injection allows visualization under radiographic imaging to ensure accurate placement. Single-use device; intended to occlude blood flow to target lesions. Benefits include controlled embolization for preoperative or therapeutic management of vascular anomalies.

Clinical Evidence

Evidence includes biocompatibility testing (ISO 10993), bench testing, and animal studies evaluating injection ease, penetration depth, and tissue reaction. Clinical evidence includes European experience in treating hypervascular tumors and arteriovenous malformations, and a comparative clinical study of EMBOSPHERE® vs. PVA particles for preoperative embolization of meningiomas.

Technological Characteristics

Spherical microbeads made of acrylic polymer impregnated with gelatin. Available in six size ranges (40-120 to 900-1200 microns). Delivered via microcatheter. Radiopacity achieved by mixing with contrast agent prior to injection. Supplied sterile for single use. Biocompatibility per ISO 10993.

Indications for Use

Indicated for embolization of hypervascular tumors and arteriovenous malformations in patients requiring arterial embolization.

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

• ITC Contour Emboli (K944354)
• ITC Radiopaque Spherical Emboli (RSE) (K871047)
• Target Therapeutics Berenstein Coil (K961923, K964112)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a series of numbers and letters written in a stylized, calligraphic font. The characters appear to be 'K961549'. The font is bold and the characters are closely spaced, giving the impression of a continuous, flowing design. The image is in black and white, with the characters standing out against a white background.

# 510(k) Summary for Biosphere Medical, Inc. EMBOSPHERE® Microspheres

#### 1. SPONSOR

Biosphere Medical, Inc. 1050 Hingham Street Rockland, MA 02370 [phone] Telephone: [phone] Fax:

Contact Individual: Jon McGrath

#### 2. DEVICE NAME ·

EMBOSPHERE® Microspheres Proprietary Name: Artificial embolization device Common/Usual Name: Artificial embolization device Classification Name:

#### 3. PREDICATE DEVICES

- ITC Contour Emboli (K944354) .
- ITC Radiopaque Spherical Emboli (RSE) (K871047) �
- Target Therapeutics Berenstein Coil (K961923, K964112) .

## DEVICE DESCRIPTION 4.

EMBOSPHERE® Microspheres are spherical microbeads for arterial embolization, made of acrylic polymer impregnated with gelatin. They are delivered with the help of a microcatheter in an amount appropriate to the area to be embolized. Six ranges of EMBOSPHERE® Microspheres are available in order to allow the physician to choose the calibration necessary for the vessel being embolized:

- 40-120 microns
- 100-300 microns
- 300-500 microns
- 500-700 microns
- 700-900 microns · 1
- 900-1200 microns -

Biosphere Medical, Inc.
EMBOSPHERE® Microspheres

April 24, 2000

{1}------------------------------------------------

### ಳು INTENDED USE

EMBOSPHERE® Microspheres are indicated for embolization of hypervascular tumors and arteriovenous malformations.

# TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE હ.

The method of application for EMBOSPHERE® Microspheres and all of the predicate devices is the same. All are intended to be delivered to selected sites through catheters with a diameter appropriate for the vascular target and the size of the emboli. Accurate placement of all of the embolization devices is assured through visualization of the embolization process using radiographic imaging. The RSE silicone elastomer microspheres and the Berenstein Coils are both radiopaque, while the PVA particles and EMBOSPHERE® Microspheres are mixed with a radiopacity agent prior to injection to permit visualization. The EMBOSPHERE® Microspheres, like the predicate devices, are available in a range of sizes to permit selection of the most appropriate size for target vessels. EMBOSPHERE Microspheres and all of the substantially equivalent embolization devices are intended for single use. The ITC RSE silicone microspheres are supplied non-sterile, while the EMBOSPHERE® Microspheres, and all of the other predicate devices, are supplied sterile.

### 7. PERFORMANCE TESTING

The substantial equivalence of EMBOSPHERE® Microspheres was supported by both in-vitro and in-vivo performance testing, which included the following:

- biocompatibility testing conducted in accordance with ISO 10993 .
- bench testing conducted during the development of the product ●
- animal testing to examine ease of injection, depth of penetration, and 0 tissue reaction"
- . clinical data describing the European experience with using EMBOSPHERE® Microspheres to treat a variety of hypervascular tumors and arteriovenous malformations'
- the results of a clinical study comparing EMBOSPHERE® Microspheres . to PVA for preoperative embolization of meningiomas.4

Biosphere Medical, Inc. EMBOSPHERE® Microspheres

:5 :00 :00 :00 :00 :

AMERICA (1) 2017-1917 (1978) 1997-1999

April 24, 2000

¹ Laurent A, Beaujeux R, Wassef M, et al.: Trisacryl gelatin microspheres for the therapeutic embolization, I: Development and in vitro evaluation. AJNR, 17:533-40, Mar 1996.

² Derdeya CP, Graves VB, Salamat MS, et al .: Collagen-coated acrylic microspheres for embolotherapy: In vivo and in vitro characteristics. AINR, 18:647-53, Apr 1997.

³ Beaujeux R, Laurent A, Wassef M, et al.: Trisacryl gelain microspheres for therapeutic embolization, II: Preliminary clinical evaluation in tumors and arteriovenous malformations. AJNR, 17:541-48, Mar 1998

⁴ Bendszus M, Klein R, Burger R, et al .: Efficacy of trisacryl gelatin microspheres versus polyvinyl alcohol particles in the prooperative embolization of meningiomas. AJNR, 21(2):255-61, Feb 2000.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes above it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biosphere Medical, Inc. c/o Ms. Sheila Hemeon-Hever, J.D., R.A.C. Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

APR 26 2000

K991549 Re: Trade Name: EMBOSPHERE® Microspheres Regulatory Class: III Product Code: HCG

> Dated: January 26, 2000 Received: January 27, 2000

Dear Ms.Hemeon-Heyer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

# Page 2 - Ms. Sheila Hemeon-Heyer, J.D., R.A.C.

This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

s R lehner.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known): K991G45

Device Name: _BioSepra EMBOSPHERE® Microspheres

Indications For Use:

EMBOSPHERE® Microspheres are indicated for embolization of hypervascular tumors and arteriovenous malformations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dulles R. lochner.
(Divi
Devices
K991549
510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use