MICROSTAT PVA FOAM EMBOLIZATION PARTICLES

K032619 · Surgica Corp. · HCG · Feb 13, 2004 · Neurology

Device Facts

• Record ID: K032619
• Device Name: MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
• Applicant: Surgica Corp.
• Product Code: HCG · Neurology
• Decision Date: Feb 13, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Surgica Corporation MicroStat™ PVA Foam Embolization Particles are intended for the following indication: PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.

Device Story

MicroStat™ PVA foam particles are artificial embolization devices used to obstruct or reduce blood flow to hypervascular or neoplastic lesions. Particles are supplied in various sizes for selection based on lesion size. Delivered via superselective catheter under fluoroscopic guidance. Used by clinicians in endovascular procedures. Device provides mechanical occlusion of vessels; benefits include reduced blood flow to target lesions prior to surgery. Single-use, radiation-sterilized, nonpyrogenic.

Clinical Evidence

No clinical data.

Technological Characteristics

Polyvinyl alcohol (PVA) foam particles; various size ranges; radiation sterilized; nonpyrogenic; single-use; delivered via infusion catheter under fluoroscopic guidance.

Indications for Use

Indicated for vascular occlusion of neurovascular blood vessels, specifically for endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions requiring 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

• EMB™ PVA Foam Embolization Particle (K001678)

Submission Summary (Full Text)

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## FFB 1 3 2004

K032619
Page 1 of 1

## Special 510(k) Summary

| Contact Information: | Surgica Corporation<br>5090 Robert J. Mathews Pkwy., #4<br>El Dorado Hills, CA 95762<br>Telephone: [phone]<br>Facsimile: 1(916) 933-5260<br>Contact Person: Lou Matson |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | MicroStat™ Polyvinyl Alcohol Foam Embolization Particles |
| Common Name: | PVA Foam Embolization Particles |
| Classification Name: | Artificial Embolization Device |
| Device Product Code: | HCG |
| Regulation Number: | 882.5950 |

Substantial Equivalence: The Surgica Corporation MicroStaTM Polyvinyl Alcohol Fourn Embolizaion Particles are similar in their basic design, construction for use, and performance characteristics to other commercially available polyvinyl alcohol particles.

Device Description: Surgica Corporation MicroStat™ Polyvinyl Alcohol (PVA) foam cmbolization particles are artificial embolization devices used to obstruct or reduce the blood flow to hypervascular or neoplastic lesions via superselective catheter delivery. The embolization particles are supplied in various size ranges to enable appropriate size selection for the lesion to be treated. Polyviny) Alcohol (PVA) foam embolization particles are designed to be delivered under fluoroscopic guidance through compatible infusion catheters. The product is delivered sterilized with radiation, is nonpyrogenic, and is for single use only.

Indications For Use: The MicroStat™ Surgica Corporation Polyvinyl Alcohol Foam Embolizaion Particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.

Predicate Devices: The EMB™ PVA Foam Embolization Particle devices marketed by Surgica Corporation (K001678) is the predicate device for the Surgica Corporation MicroStat™ Polyvinyl Foam Embolizaion Particles.

Clinical Tests: None

Adverse S&E Information: None

Louies K. Miotti

Louis R. Matson President & C.E.O.

8-19-03

Date

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2004

Mr. Louis R. Matson President & CEO Surgica Corporation 5090 Robert J. Mathews Pkwy., #4 El Dorado Hills, California 95762

Re: K032619

Trade/Device Name: PVA Foam Embolization Particles Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: January 15, 2004 Received: January 16, 2004

Dear Mr. Matson:

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 cither 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 - Mr. Louis R. Matson

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/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provoost
C

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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510(k) Number (if known):_

Device Name: PVA Foam Embolization Particles

Indications For Use:

The Surgica Corporation MicroStat™ PVA Foam Embolization Particles are intended for the following indication:

PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.

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Concurrence of CDRH, Office of Device Evaluation (ODE) miriam C. Movert (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number_4033 k19 OR Over-The-Counter Use_ Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)