GELSPHERES EMBOLIC AGENT

K023089 · Biocure, Inc. · HCG · Dec 16, 2002 · Neurology

Device Facts

• Record ID: K023089
• Device Name: GELSPHERES EMBOLIC AGENT
• Applicant: Biocure, Inc.
• Product Code: HCG · Neurology
• Decision Date: Dec 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GelSpheres™ Embolic Agent is intended for embolization of hypervascular tumors and arteriovenous malformations.

Device Story

GelSpheres™ Embolic Agent consists of preformed, soft, deformable microspheres derived from polyvinyl alcohol (PVA) macromer. Device is ~90% water and compressible to 20-30% of diameter. Used for arterial occlusion to block blood flow to target tissues like hypervascular tumors or AVMs. Delivered via microcatheters (1.8-5Fr). At use, mixed with nonionic contrast agent (e.g., Omnipaque) for radiographic visualization. Physician injects mixture into target vascular site; contrast elutes, leaving radiolucent, embolized vessel. Blue dye aids visualization in syringe. Supplied sterile in vials or pre-filled syringes. Benefits include targeted vessel occlusion for tumor/AVM management.

Clinical Evidence

Bench testing only. No clinical data presented. Device performance validated against ISO/EN 10993 standards for biocompatibility (genotoxicity, systemic toxicity, irritation, sensitization, implantation effects), sterilization validation (AAMI/ISO 14937, EN 554), and packaging integrity (ISO 11607).

Technological Characteristics

Material: Polyvinyl alcohol (PVA) macromer. Form: Preformed, deformable microspheres (100-1200μm diameter). Energy: None (mechanical occlusion). Connectivity: None. Sterilization: Moist heat. Standards: ISO/EN 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).

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

• Embospheres® Microspheres (K991549)
• EmboGold™ Microspheres (K010026)

Submission Summary (Full Text)

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K02 3089

Original 510(k) Pre-Market Notification GelSpheres™ Embolic Agent

# 510(k) Summary

## DEC 1 6 2002

September 13, 2002

Submitter: BioCure, Inc 2975 Gateway Drive Suite 100 Norcross, GA [phone]

Contact: Dennis Goupil. PhD

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

#### Biosphere Medical, Inc.

Embospheres® Microspheres 510K Number: #K991549 Product Code: HCG CFR Section: 882.5950

### Biosphere Medical, Inc.

EmboGold™ Microspheres 510K Number: #K010026 Product Code: HCG CFR Section: 882.5950

## Indications for Use and Intended Population

GelSpheres™ Embolic Agent are indicated for Embolization of hypervascular tumors and arteriovenous malformations (AVM's)

#### Device Description

GelSpheres™ Embolic Agent are preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a hypervascualr tumor or arteriovenous malformations (AVM's). GelSpheres™ Embolic Agent consists 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™ Embolic Agent 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.

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The product is supplied sterile and packaged in sealed glass bottles for V-Series Model numbers, and in pre-filled syringes for S- Series model numbers. Two quantities will be available in a vial: (1) 1.0 mL GelSpheres™ Embolic Agent in sterile physiologic buffered saline (PBS) to a volume of 8 mL. and (2) 2.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 8 mL. Two quantities will be available in a pre-filled syringe: (1) 1.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 5 mL, and (2) 2.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 5 mL.

GelSpheres™ Embolic Agent is supplied in several units covering the range from 100um to 1200um diameter. The product size ranges are listed below:

| Size Range | 1 ML Vial<br>(7-11) | 2 ML Vial<br>(7-11) | 1 ML Syringe<br>(7-1) | 2 ML Syringe<br>(7-1) |
|------------|---------------------|---------------------|-----------------------|-----------------------|
| 100-300μm | V210GS | V220GS | S210GS | S220GS |
| 300-500μm | V410GS | V420GS | S410GS | S420GS |
| 500-700μm | V610GS | V620GS | S610GS | S620GS |
| 700-900μm | V810GS | V820GS | S810GS | S820GS |
| 900-1200μm | V1010GS | V1020GS | S1010GS | S1020GS |

At the time of use, GelSpheres™ Embolic Agent 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™ Embolic Agent and the predicate devices is the same. All devices 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. All of the devices are mixed with a radiopacity agent prior to iniection to permit visualization. GelSpheres™ Embolic Agent, like the predicate devices are available in a range of sizes to permit selection of the most appropriate size for target vessels. GelSpheres™ Embolic Agent are made from polyvinyl alcohol, whereas Embospheres® Microspheres and EmboGold™ Microspheres are comprised of acrylic polymer impregnated with gelatin. GelSpheres™ Embolic Agent and Embospheres® Microspheres are deformable microspheres. GelSpheres™ Embolic Agent and EmboGold™ microspheres are colored to make the device more visible to the physician when preparing and injecting the embolic agents in a syringe. GelSpheres™ Embolic Agent and the substantially equivalent

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devices are intended for single use and are supplied sterile and non pyrogenic. GelSpheres™ Embolic Agent , Embospheres™ Microspheres and EmboGold™ are all supplied in both bottles and syringes.

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

## Performance Standards

The BioCure GelSpheres™ Embolic Agent meets 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.
- ISO/EN 10993-13: 1995 Biological Evaluation of Medical Devices, . 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 2nd 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.

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- 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 devices and the BioCure, Inc. GelSpheres™ Embolic Agent. Both the predicate devices and GelSpheres™ have the same intended use, warnings and contraindications. Both the predicate devices and GelSpheres are similar in design. When used in accordance with the instructions for use, by qualified personnel, the BioCure, Inc. GelSpheres™ are safe and effective, as indicated, for the intended use.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN" around the top half and what appears to be "SERVICES" around the bottom half. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 6 2007

BioCure, Inc. c/o Mr. John Greenbaum Generic Devices Consulting, Inc. 20310 SW 48th Street Fort Lauderdale, Florida, 33332

Re: K023089

Trade/Device Name: GelSpheres Embolic Agent Regulation Number: 21 CFR 882,5950; 21 CFR 870,3300 Regulation Name: Artificial embolization device; Arterial Embolization Device Regulatory Class: III Product Code: HCG; KRD Dated: September 13, 2002 Received: September 17, 2002

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 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. 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.

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Page 2 - Mr. John Greenbaum

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Miriam 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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KOZ 3089

000008

Page 1 of 1

510(k) Number(if known):_

Device Name: GelSpheres™ Embolic Agent

Indications For Use:

"GelSpheres™ Embolic Agent is intended for embolization of hypervascular tumors and arteriovenous malformations."

: :

## PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use_X_<br>(Per 21 CRF 801.109) | OR | Over-The-Counter Use_ |
|---------------------------------------------|----|-----------------------|
|---------------------------------------------|----|-----------------------|

(Optional Format 1-2-96)

Miriam C. Provost

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

| 510(k) Number | K023089 |
|---------------|---------|
|---------------|---------|