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 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 uncoated. Each is offered in a range of particle sizes, from which the clinician may select the particle size most appropriate for the desired effect and targeted vasculature. The devices are intended to be delivered to the selected anatomical site by means of a syringe, through an infusion catheter of appropriate diameter. The devices are provided sterile, non-pyrogenic, and are intended for single-use.

AI/ML Overview

This document is a 510(k) summary for Modified PVA Foam Embolization Particles. It outlines the device details, its intended use, and its comparison to predicate devices. Crucially, it states that no clinical tests were performed because the modification is limited to the packaging configuration. The submission relies entirely on non-clinical tests to establish substantial equivalence to existing predicate devices. Therefore, the questions related to clinical study design, acceptance criteria, sample sizes, expert involvement, and ground truth are largely not applicable in the context of this 510(k) submission.

Here's an analysis based on the provided text, indicating where information is present and where it is explicitly stated as "not applicable" or not provided due to the nature of the submission:

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

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Sterility	Conforms to recognized standards	Conforms to recognized standards
Shelf Life	Conforms to recognized standards	Conforms to recognized standards
Material Composition	Unchanged from predicate devices	Unchanged from predicate devices
Particle Configuration	Unchanged from predicate devices	Unchanged from predicate devices
Range of Sizes Offered	Unchanged from predicate devices	Unchanged from predicate devices
Manufacturing	Unchanged from predicate devices	Unchanged from predicate devices
Biocompatibility	Unchanged from predicate devices	Unchanged from predicate devices
How Supplied	Unchanged from predicate devices (except packaging)	Unchanged from predicate devices (except packaging)
Indications	Unchanged from predicate devices	Unchanged from predicate devices
Method of Use	Unchanged from predicate devices	Unchanged from predicate devices
Packaging Configuration	Facilitates ease of use; does not alter essential device design or indications	Successfully modified to a thermoformed blister with peel-off TYVEK® lid and includes hydration/delivery syringe(s). This modification does not alter essential device design characteristics or indications for use.

Study that proves the device meets the acceptance criteria:

The study that proves the device meets the acceptance criteria is a non-clinical testing program focused on the aspects affected by the packaging change, namely sterility and shelf life. For all other aspects (material, configuration, manufacturing, biocompatibility, indications, method of use), the device is deemed substantially equivalent to the predicate devices because these characteristics are unchanged.

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 in the provided text for sterility and shelf-life testing.
Data Provenance: Not specified for the non-clinical tests.

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)

Not applicable, as this was not a clinical study involving ground truth established by medical experts. The non-clinical tests would have involved laboratory personnel and validated testing methods.

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

Not applicable, as this was not a clinical study requiring adjudication of expert opinions.

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 device is an embolization particle, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This device is an embolization particle, not an algorithm.

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

For the non-clinical tests (sterility, shelf life), the "ground truth" would be established by validated laboratory testing methods and standards (e.g., ISO, ASTM). For the unchanged aspects of the device, the "ground truth" is that they are identical to the predicate devices, which were previously cleared by the FDA based on their own testing or substantial equivalence.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm.

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:

5.1 Submitted By

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

Contact: R. Stephen Reitzler Vice President, Regulatory Affairs & Quality Assurance

Date Prepared: December 19, 2005

Device Name 5.2

	Trade or Proprietary Names: Modified Pva-PlusTM Foam Embolization ParticlesModified MaxiStatTM Pva Foam Embolization ParticlesModified MicroStatTM Pva Foam Embolization Particles
Common or Usual Name:	Polyvinyl alcohol (Pva) foam embolization particles
Classification Name:	Neurovascular embolization device

5.3 Predicate Devices

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

Pva-Plus™ Foam Embolization Particles (Surgica Corp .; K001678) .
MaxiStat™ Pva Foam Embolization Particles (Surgica Corp .; K020033) .
MicroStat™ Pva Foam Embolization Particles (Surgica Corp .; K032619) .

5.4 Device Description

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5.5 Intended Use

Modified Pva-Phus™, Modified MaxiStur™, and Modified MicroStat™ Pva Foam Embolization Particles may be used for vascular occlusion of blood vessels within the neurovascular system. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.

5.6 Comparison to Predicate Devices

The subject devices differ from the predicate devices only in packaging configuration. The primary unit package form has been modified from that of the predicates to facilitate ease of use by the clinician, and the modification does not alter essential device design characteristics or indications for use. Specifically, the primary unit package has been changed from a sealed glass vial to a thermoformed blister with peel-off TYVEK® lid, and now includes the hydration/delivery syringe(s) necessary for administration of the devices. With respect to material composition, particle configuration and range of sizes offered, manufacturing, biocompatibility, how supplied, indications, and method of use, the subject devices are unchanged from the predicate devices.

5.7 Summary of Non-Clinical Tests

In that the modification that is the basis for this 510(k) submission impacts only the unit package configuration, non-clinical testing is restricted to that which verifies or validates sterility, and shelf life. All such tests conform to recognized standards.

5.8 Summary of Clinical Tests

(Not applicable)

Conclusions of Non-Clinical and Clinical Tests 5.9

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 U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, on the right side. On the left side, the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2006

Mr. R. Stephen Reitzler Vice President, Regulatory Affairs and Quality Assurance Protein Polymer Technologies, Inc. 10655 Sorrento Valley Road San Diego, California 92121

Re: K053548

Trade/Device Names: Modified Pva-Plus™ Foam Embolization Particles, Modified MaxiStat™ Pva Foam Embolization Particles, and Modified MicroStat™ Foam Embolization Particles Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: December 19, 2005 Received: December 21, 2005

Dear Mr. Reitzler:

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 - Mr. Reitzler

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" (21 CFR 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,

Вашае Времи

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

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Names: Modified Pva-Plus™ Foam Embolization Particles; Modified MaxiStat™ Pva Foam Embolization Particles; and Modified 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara
(Division Sign-Off)
M

Division of General. Restorative,

Neurological Devices

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510(k) N

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).