PVA particles are indicated for arterial embolization of arteriovenous malformations (AVMs) and hypervascular tumors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.

Device Description

The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (PVA) foam. The devices do not contain any colorant or other additive, and are uncol ted. Each is offered in a range of particle sizes, from which the clinician may saleot the particle size most appropriate for the desired effect and targeted vasculature. The devices are delivered to the selected vascular location by means of a syringe, through an infusion catheter of diameter appropriate for the selected particle size.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the PVA Foam Embolization Particles:

It's important to note that this document is a 510(k) summary for a medical device submitted to the FDA. Unlike a detailed clinical trial report for an AI-powered diagnostic device, this type of submission focuses on demonstrating substantial equivalence to predicate devices based on performance, material, and intended use, rather than setting specific acceptance criteria and proving them through a standalone efficacy study for a new, complex AI algorithm.

Therefore, many of the requested points, especially those related to AI-specific study design (like MRMC studies, training set details, or expert ground truth for AI performance), are not applicable to this type of device and submission. The "study" here refers to non-clinical tests demonstrating equivalence to existing, cleared devices.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Equivalence)	Reported Device Performance
Material Composition	Chemically identical to predicate devices (PVA foam)	"Substantially equivalent" to predicate devices. The devices are particles of nonabsorbable synthetic polyvinyl alcohol (PVA) foam, without colorant or other additive, and uncolored.
Particle Configuration	Same physical characteristics as predicate particles	"Substantially equivalent" to predicate devices. Each is offered in a range of particle sizes.
Range of Sizes Offered	Matches or falls within the range of predicate devices	"Substantially equivalent" to predicate devices. Offered in a range of particle sizes.
Biocompatibility	Demonstrates equivalent biocompatibility as predicate devices	"Substantially equivalent" to predicate devices. Nonclinical tests demonstrated equivalence.
Packaging	Comparable to predicate devices for sterility and integrity	"Substantially equivalent" to predicate devices.
How Supplied	Comparable to predicate devices (e.g., individual packs, sterile)	"Substantially equivalent" to predicate devices.
Indications for Use	Identical or substantially similar to predicate devices	"Substantially equivalent" as stated in the intended use: arterial embolization of AVMs and hypervascular tumors in the peripheral vasculature, and vascular occlusion within the neurovascular system for AVMs and neoplastic lesions.
Method of Use	Consistent with predicate devices (syringe delivery through catheter)	"Substantially equivalent" to predicate devices. Delivered to selected vascular location by syringe, through an infusion catheter.
Performance (In vitro/In vivo)	Equivalent structural integrity, flow characteristics, and occlusive properties to predicate devices.	"Nonclinical tests, both in vitro and in vivo, have demonstrated the substantial equivalence of the subject devices to commercially-available predicates in terms of performance."

Study Information (as derived from the 510(k) summary)

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

Sample Size for Test Set: Not specified. The submission states "Nonclinical tests, both in vitro and in vivo, have demonstrated the substantial equivalence." This implies various lab tests and potentially animal studies (in vivo), but specific sample sizes are not provided in this summary.
Data Provenance: Not explicitly stated. Non-clinical tests are typically performed in a laboratory setting. For "in vivo" tests, this could imply animal studies, but the origin country is not mentioned. The manufacturer is Protein Polymer Technologies, Inc. (PPTI) in San Diego, California, USA, and manufacturing is by Surgica Corporation in El Dorado Hills, CA, USA, suggesting the tests were likely conducted in the US.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a medical device submission, not an AI diagnostic submission. "Ground truth" in the context of AI refers to verified labels used to evaluate algorithm performance. For a physical device, performance is typically assessed against established engineering and biological standards, or compared directly to predicate devices through physical observation and measurement, not against an expert-established "ground truth" in the AI sense.

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

Not Applicable. Pertains to expert review for AI diagnostic performance, not physical device testing.

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

Not Applicable. This is a medical device submission for physical embolization particles, not an AI device. No human-reader studies for diagnostic improvement are relevant or mentioned.

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

Not Applicable. This is a medical device, not an AI algorithm.

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

For the non-clinical tests, the "ground truth" would be the established performance characteristics and safety profiles of the predicate devices, against which the new device was compared using engineering measurements, laboratory assays, and potentially animal study observations. The goal was to prove the new device performed equivalently to these established benchmarks.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI algorithm requiring a "training set."

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

Not Applicable. As above, no training set for an AI algorithm is involved.

Summary

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5.0 510(k) SUMMARY

In accordance with Title 21 of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

SEP 1 9 2006

5.1 Submitted By

Protein Polymer Technologies, Inc. (PPTI) 10655 Sorrento Valley Road, San Diego, California 92121 Telephone: (858) 558-6064

Radine Ganz Pobuda, RAC Contact: Director, Quality Systems & Regulatory Affairs

Date Prepared: May 5, 2006

5.2 Device Name

	Trade or Proprietary Names:	PVA Plus ™ Foam Embolization Particles
		MaxiStat ™ PVA Foam Embolization Particles
		MicroStat ™ PVA Foam Embolization Particles
	Common or Usual Name:	Polyvinyl alcohol (PVA) foam embolization particles
	Classification Name:	Vascular embolization device

ર્ટ.૩ Predicate Devices

The subject devices are substantially equivalent to the following predicate devices:

PVA Plus™ Foam Embolization Particles (PPTI; K053548) .
. MaxiStar™ PVA Foam Embolization Particles (PPTI; K053548)
MicroStat™ PVA Foam Embolization Particles (PPTI; K053548) .
Contour SETM Microspheres (Boston Scientific; K034068)
. Contour® Emboli PVA (Boston Scientific; K030966)
Embosphere® Microspheres (Biosphere Medical; K021397) .

Device Description 5.4

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5.5 Intended Use

PVA Plus™, MaxiStat™, and MicroStat™ PVA Foam Embolization Particles may be used for vascular occlusion of blood vessels within the neurovascular and peripher a vascular system. They are intended for arterial embolization of arteriovenous malformations (AVMs) and hypervascular turnors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.

ર્ટ ર્ Comparison to Predicate Devices

The subject devices do not differ in any regard from PPTI's predicate PVA Plus™ MaxiStar™, and MicroStat™ devices currently cleared for market in the U.S. Further, the subject devices are substantially equivalent to other predicate devices cleared for commercial distribution in the U.S., in terms of material composition, particle configuration, range of sizes offered, biocompatibility, packaging, how supplied, indications, and method of use. Among these predicates are the Contour® Emboli PVA and Contour SE™ Microsphere devices marketed by Boston Scientific (K030966 and K034068, respectively), and Embosphere® Microspheres, marketed by Biosphere Medical (K021397).

5.7 Summary of Non-Clinical Tests

Nonclinical tests, both in vitro and in vivo, have demonstrated the substantial equivalence of the subject devices to commercially-available predicates in terms of performance.

5.8 Summary of Clinical Tests

(Not applicable)

5.9 Conclusions of Non-Clinical and Clinical Tests

The results of all testing demonstrated the substantial equivalence of the subject devices to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Protein Polymer Technologies, Inc. % Radine Pobuda, RAC Director, Quality Systems and Regulatory Affairs 10655 Sorrento Valley Road San Diego, California 92121

SEP 1 9 2006

Re: K061790

Trade/Device Name: PVA Plus™ Foam Embolization Pareticles; MaxiStat™ PVA Foam Embolization Particles: and MicroStat™ PVA Foam Embolization Particles Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular embolization device Regulatory Class: II Product Code: KRD, HCG Dated: June 23, 2006 Received: June 26, 2006

Dear Radine Pobuda:

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

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Page 2 - Radine Pobuda, RAC

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.

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 nuraber (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Protein Polymer Technologies, Inc

Indications for Use

510(k) Number (if known): K061790

PVA Plus™ Foam Embolization Particles; Device Names: MaxiStar™ PVA Foam Embolization Particles; and MicroStat™ PVA Foam Embolization Particles

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

ಕ್ಟಾ. ಸ

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-On)

Division of General, Restorative,
and Neurological Devices

510(k) Number: 061790

Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).