GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES

K033761 · Biocompatibles UK Limited · HCG · Feb 4, 2004 · Neurology

Device Facts

• Record ID: K033761
• Device Name: GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES
• Applicant: Biocompatibles UK Limited
• Product Code: HCG · Neurology
• Decision Date: Feb 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GelSpheres™/BeadBlock™ Compressible Microspheres are indicated for Embolization of hypervascular tumors and arteriovenous malformations (AVM's).

Device Story

GelSpheres™ and BeadBlock™ are preformed, soft, deformable microspheres derived from polyvinyl alcohol (PVA) macromer; 90% water content; compressible to 20-30% diameter. Used for arterial occlusion to block blood flow to hypervascular tumors or AVMs. Delivered via microcatheters (1.8-5Fr). At use, mixed with nonionic contrast agent (30-50% by weight) for visualization. Blue dye aids syringe visibility. Supplied sterile in glass vials or polycarbonate syringes. Used by clinicians in clinical settings. Occlusion benefits patient by reducing blood supply to target tissue.

Clinical Evidence

Bench testing only. Device performance validated against FDA Guidance for Neurological Embolization Products and various ISO/EN standards for biocompatibility (ISO 10993 series), sterilization (ISO 11134, 14937, EN 554), and packaging (ISO 11607). No clinical data presented.

Technological Characteristics

Material: Polyvinyl alcohol (PVA) macromer. Form: Preformed, compressible microspheres (100μm-1200μm diameter). Principle: Mechanical arterial occlusion. Delivery: Microcatheter (1.8-5Fr). Sterilization: Moist heat. Standards: ISO 10993 (biocompatibility), ISO 11607 (packaging), AAMI 11134/ANSI/AAMI/ISO 14937 (sterilization).

Indications for Use

Indicated for embolization of hypervascular tumors and arteriovenous malformations (AVMs) in patients requiring vascular occlusion.

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

• GelSpheres™ Microspheres (K023089)

Submission Summary (Full Text)

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Biocompatibles UK Ltd..

510(k) Pre-Market Notification

GelSpheres™ Compressible Microspheres BeadBlock™ Compressible Microspheres

510(k) Summary

FEB - 4 2004

K033761
014
page 1 of

Submitter: Biocompatibles UK Ltd. Weydon Lane Chapman House Weydon Lane, Farnham, Surrey [phone]

Contact: Dr. Alistair Taylor

### 510/k) Numbers and Product Codes of equivalent devices.

Biocure, Inc, GelSpheres™ Microspheres 510K Number: #023089 Product Code: HCG CFR Section: 882.5950

Indications for Use and Intended Population

"GelSpheres™/BeadBlock™ Compressible Microspheres are indicated for Embolization of hypervascular tumors and arteriovenous malformations (AVM's).

## Device Description

GelSpheres™ and BeadBlock™ Compressible Microspheres are preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a hypervascular tumor or arteriovenous malformations (AVM's). GelSpheres™ and BeadBlock Compressible Microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90% water and is compressible to approximately 20-30% by diameter. GelSpheres™ and BeadBlock Compressible Microspheres is dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.8-5Fr range.

GelSpheres™ Compressible Microspheres is supplied sterile and packaged in sealed glass vials. BeadBlock ™ Compressible Microspheres is supplied sterile and packaged in a polycarbonate syringe. Two quantities will be available in a vial: (1) 1.0 mL GelSpheres™ /BeadBlock™ Compressible

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#### Biocompatibles UK Ltd.. 510(k) Pre-Market Notifica GelSpheres™ Compressible Microspheres BeadBlock™ Compressible Microspheres

Microspheres in sterile physiologic buffered saline (PBS) to a volume of 8 mL., and (2) 2.0mL GelSpheres™/BeadBlock™ Compressible Microspheres in sterile PBS to a volume of 8 mL.

GelSpheres™ and BeadBlock Compressible Microspheres are supplied in several unit sizes covering the range from 100μm to 1200μm diameter. At the time of use, GelSpheres™/BeadBlock™ Compressible Microspheres is mixed with a nonionic contrast agent, e.g. Omnipaque, to make a 30-50% by weight solution. The bolus of contrast agent elutes from the vascular bed to leave a radiolucent, embolized vessel.

#### Similarities and Differences to Predicates

The Intended Use of GelSpheres™ /BeadBlock™ Compressible Microspheres and the predicate device are the same and unchanged other than product names. This pre-market notification addresses the change of the final packager from Biocure, inc to Biocompatibles UK LTD.

There are more similarities than differences when comparing Biocompatibles, GelSpheres ™/BeadBlock™ to the predicate devices.

#### Performance Standards

GelSpheres™/BeadBlock Compressible Microspheres meet the following Performance Standards:

- Guidance For Industry; 2000: FDA Guidance for Neurological . Embolization Products
- ISO/EN 10993-1; 1997 Biological Evaluation of Medical Devices, . Part I: Evaluation and Testing
- ISO/EN 10993-3; 1993 Biological Evaluation of Medical Devices, . Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
- ISO/EN 10993-4; 1993 Biological Evaluation of Medical Devices. . Part 4: Selection of tests for interaction with blood.
- ISO/EN 10993-6; 1995 Biological Evaluation of Medical Devices, . Part 6: Test for local effects after implantation.
- ISO/EN 10993-10; 1995 Biological Evaluation of Medical Devices, . Part 10: Tests for Irritation and Sensitization.
- ISO/EN 10993-11; 1993 Biological Evaluation of Medical Devices, . Part 11: Tests for Systemic Toxicity.

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Biocompatibles UK Ltd..

# 510(k) Pre-Market Notit

### GelSpheres™ Compressible Microspheres BeadBlock™ Compressible Microspheres

Ka33 761

- ISO/EN 10993-13; 1995 Biological Evaluation of Medical Devices, t Part 13: Identification and Quantification of potential degradation products from polymers.
- ISO/EN 11607; 1997 Packaging for terminally sterilized products. .
- AAMI TIR 22;1998 Guidance for application of EN 11607, . Packaging for terminally sterilized products
- AAMI 11134; 1993 Sterilization of Health Care Products -� Requirements for validation and routine control - Industrial moist heat sterilization 200 edition.
- ANSI/AAMI/ISO 14937; 2000 Sterilization of Health Care . Products - Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices.
- EN 554: Sterilization of Medical Devices validation and Routine . Control of Sterilization by Moist Heat

### Conclusion

There are more similarities than differences between the predicate device and the Biocompatibles GelSpheres™/BeadBlock™ Compressible Microspheres. The product and primary packaging are identical and unchanged from K023089. The predicate device and GelSpheres™/BeadBlock™ Compressible Microspheres have the same intended use, warnings and contraindications. The predicate device and GelSpheres™/BeadBlock™ Compressible Microspheres are identical in design, and unchanged from K023089. When used in accordance with the instructions for use, by qualified personnel, the Biocompatibles GelSpheres™/BeadBlock™ Compressible Microspheres are safe and effective, as indicated, for the intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by three horizontal lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 4 2004

Biocompatibles U.K. Ltd c/o Mr. John Greenbaum Generic Devices Consulting 20310 SW 4811 Street Ft. Lauderdale, Florida 33332

Re: K033761

Trade/Devicc Name: Gelspheres™ Embolic Agent/Beadlock™ Embolic Agent Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: November 28, 2003 Received: December 8, 2003

Dear Mr. Greenbaum:

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 10 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 I'DA 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 sct forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Scctions 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. John Greenbaum

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 cntitled. "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/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

(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

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#### Indications for Use

Kossztel

510(k) Number (if known): K033761

Device Name: Gelspheres™ Embolic Agent/Beadlock™ Embolic Agent

Indications For Use: GelSpheres™ Compressible Microsphere and BeadBlock™ Compressible Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.

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 PAGF IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

lvision Sign-Ofl) f vision of General, Restorative ୍ୟ Neurological Devices

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