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

Device 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Ultra IVALON and Ultra DRIVALON PVA Embolization Particles." It mainly focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for the new device. Therefore, much of the requested information cannot be extracted directly from this document.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria or specific performance metrics for the Ultra IVALON and Ultra DRIVALON PVA Embolization Particles. The "Non-clinical Test Results" section vaguely states: "Testing has shown the subject device to be safe and effective for its intended use." This is considered a general claim of performance rather than a quantified report against specific criteria.

Acceptance Criterion	Reported Device Performance
Not specified	Not specified quantitatively, but stated as "safe and effective for its intended use."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "testing" generically, without detailing the nature of the test set, sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document mainly focuses on regulatory aspects of substantial equivalence, not on a clinical or performance study involving expert consensus or ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided in the document. The filing is for an embolization particle device, not an AI or imaging diagnostic device that would typically undergo MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not provided in the document. As mentioned, this is not an AI or algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document. The document describes a medical device (embolization particles), not a machine learning model that would have a training set.

9. How the ground truth for the training set was established

This information is not provided in the document. This concept is not applicable to the type of device described.

Summary

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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 (408) 828-7281 phone (408) 748-1642 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(TradeName)	Manufacturer	510(k) PremarketNotificationNumber and Date	Intended Use
ContourPVAParticles	InterventionalTherapeutics/TargetTherapeutics/BostonScientific	K944354December 13, 1994	This device is intended forembolization of hypervasculartumors and arteriovenousmalformations.

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 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 (240) 276-0115 . 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 (800) 638-2041 or (301) 443-6597 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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042297

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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:	Ultra IVALON and Ultra DRIVALON PVA Embolization Particles
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)

Prescription Use

Signature
Division of General, Restorative

and Neurological Devices

K042297

Regulation Number and Section

§ 882.5950 Neurovascular embolization device.

(a)
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.(b)
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).