ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES

K042297 · Acta Vascular Systems, Inc. · HCG · Jun 1, 2005 · Neurology

Device Facts

• Record ID: K042297
• Device Name: ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES
• Applicant: Acta Vascular Systems, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jun 1, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are intended for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).

Device Story

Ultra IVALON and Ultra DRIVALON are artificial embolization particles used for permanent occlusion of hypervascular lesions and AVMs. Particles are supplied in various size ranges (50-1000 μm) to match lesion requirements. Ultra IVALON is supplied in 0.9% saline; Ultra DRIVALON is supplied dry. Devices are delivered via superselective catheterization under fluoroscopic guidance. By physically blocking blood flow to the target lesion, the particles induce permanent embolization, which can reduce tumor vascularity or treat AVMs. Used in clinical settings by interventional physicians.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

PVA (polyvinyl alcohol) embolization particles. Supplied in size ranges from 50-1000 μm. Compatible with infusion/delivery catheters (0.018" to 0.044" ID). Non-resorbable. Mechanical occlusion principle. No software or electronic components.

Indications for Use

Indicated for embolization of hypervascular tumors and arteriovenous malformations (AVMs) in patients requiring permanent 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

• Contour PVA Particles (K944354)

Submission Summary (Full Text)

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K042297 ps. lot 2

# JUN 1 - 2005

Abbreviated 510(k) Premarket Notification Ultra IVALON and Ultra DRIVALON PVA Embolization Paticies

# 510(k) Summary IV.

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR §807.92.

### A. Date Prepared

August 12, 2004

#### B. General Information

Manufacturer: Acta Vascular Systems, Inc. 247 Marchmont Drive Los Gatos, CA 95032

Contact: Richard M. Ruedy Vice President, Regulatory and Clinical Affairs and Quality Systems [phone] phone [phone] fax

# C. Device Information

760112

| Common, Usual or Classification Name: | Artificial Embolization Device |
|---------------------------------------|--------------------------------|
| Device Classification: | III |
| Product Code: | HCG |
| Classification Regulation: | 21 CFR §882.5950 |

# D. Predicate Device Identification

1000 -1180

| Product<br>(Trade<br>Name) | Manufacturer | 510(k) Premarket<br>Notification<br>Number and Date | Intended Use |
|-----------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Contour<br>PVA<br>Particles | Interventional<br>Therapeutics/Target<br>Therapeutics/Boston<br>Scientific | K944354<br>December 13, 1994 | This device is intended for<br>embolization of hypervascular<br>tumors and arteriovenous<br>malformations. |

Contour PVA Particles are available in the following configurations ! Order No. Particle Size (μm) 760012 45 –150 760022 150 - 250 760032 250 - 355 760042 355 - 200 760062 500 - 710 760082 710 -1000

1 Particle sizes were obtained from the Product Information sheet published by the manufacturer.

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042297 ps. dofa

Abbreviated 510(k) Premarket Notification Ultra IVALON and Ultra DRIVALON PVA Embolization Particles

#### Intended Use E.

Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are intended for the embolization of hypervascular turnors and arteriovenous malformations (AVMs).

# F. Product Description

Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are artificial embolization devices used for permanent embolization of hypervascular lesions and arteriovenous malformations (AVMs) via superselective catheter delivery. The embolization particles are supplied in various size ranges to enable appropriate size selection for the lesion to be treated. Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are designed to be delivered under fluoroscopic guidance through compatible infusion/delivery catheters.

Ultra IVALON PVA Embolization Particles are suspended in 0.9% saline (NaCI) solution. Uttra DRIVALON PVA Embolization Particles are packaged in a dry form. Each unit contains 0.1g of particles.

| Catalog Number | Size Range | Compatible Catheter Inner Diameter |
|-----------------|---------------|------------------------------------|
| UI001 and UD001 | 50 - 150 μm | 0.018" |
| UI002 and UD002 | 150 - 250 μm | 0.018" |
| UI003 and UD003 | 250 - 400 μm | 0.018" |
| UI004 and UD004 | 400 - 600 μm | 0.025" |
| UI005 and UD005 | 600 - 1000 μm | 0.044" |

# Substantial Equivalence G.

The subject device is equivalent in intended use, design, and technological characteristics to the predicate devices listed above.

#### H. Non-clinical Test Results

Testing has shown the subject device to be safe and effective for its intended use.

#### . Summary

New York Callery

Based on the information provided in this notification, the subject device is substantially equivalent to the predicate devices in intended use, technological characteristics, and design.

# J. Signature of Preparer

Richard M. Ruedy

Richard M. Ruedy Vice President, Regulatory and Clinical Affairs and Quality Systems Acta Vascular Systems, Inc.

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JUN 1 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard M. Ruedy Vice President, Regulatory and Clinical Affairs and Quality Systems Acta Vascular Systems Incorporated 247 Marchmont Drive Los Gatos, California 95032

Re: K042297

Trade/Device Name: Ultra IVALON and Ultra DRIVALON PVA Embolization Particles Regulation Number: 21 CFR 882. 5950 Regulation Name: Artificial embolization device Regulatory Class: II Product Code: HCG, KRD Dated: March 30, 2005 Received: April 1, 2005

Dear Mr. Ruedy:

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.

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Page 2- Mr. Richard M. Ruedy

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,

Miriam C. Provost, Ph

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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*Acta Vascular*

Abbreviated 510(k) Premarket Notification

Ultra IVALON and Ultra DRIVALON PVA Embolization Particles

II. Statement of Indications for Use

Indications for Use

| 510(k) Number (if known): | |
|---------------------------|-------------------------------------------------------------------|
| Device Name: | <u>Ultra IVALON and Ultra DRIVALON PVA Embolization Particles</u> |
| Indications for Use: | |

Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are intended for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR | Over-The Counter Use |
|----------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |


Division of General, Restorative

and Neurological Devices

K042297

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