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 (AVM's) and neoplastic lessions 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 submission (K073419) is for PVA PLUS™ Vial PVA Foam Embolization Particles and related convenience kits. It is a 510(k) premarket notification for a Class II medical device (neurovascular embolization device, product code HCG).

Here's an analysis of the provided text in relation to your questions:

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

The provided document does not contain any acceptance criteria or reported device performance metrics in the way you would typically see for an AI/algorithm-based device. This submission is for a physical medical device (PVA foam embolization particles), not a diagnostic or prognostic algorithm.

The document states:

"5.7 Summary of Non-Clinical Tests (Not Applicable)"
"5.8 Summary of Clinical Tests (Not Applicable)"
"5.9 Conclusions of Non-Clinical and Clinical Tests (Not Applicable)"

This "Not Applicable" designation is crucial. It means the manufacturer did not conduct new non-clinical or clinical studies for this submission because they are claiming substantial equivalence to existing predicate devices based on the product being identical to previously cleared devices from Surgica Corporation and Protein Polymer Technologies, Inc. The only changes are the manufacturer and distributor.

Therefore, a table of acceptance criteria and device performance cannot be generated from this document because such data was not central to this particular 510(k) clearance process. The acceptance criteria were essentially met by demonstrating the new manufacturer could produce the same device as the predicate.

Regarding your other questions (2-9), these are primarily relevant to studies involving AI/ML algorithms, especially those that involve diagnostic or predictive capabilities and require evaluation against a ground truth established by experts. Since this submission is for a physical medical device and explicitly states "Not Applicable" for clinical and non-clinical tests, the information requested for AI/ML evaluation is not present and not relevant to this specific K073419 submission.

However, to directly address each point based on the absence of such information in the document:

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: Not applicable (no test set discussed).
Data Provenance: Not applicable (no data discussed).

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)

Number of Experts: Not applicable (no ground truth established for a test set).
Qualifications of Experts: Not applicable (no experts used for this purpose in this submission).

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

Adjudication Method: Not applicable (no test set or adjudication process described).

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

MRMC Study: No. This is not an AI/ML device, so such a study would not be relevant.
Effect Size: Not applicable.

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

Standalone Performance Study: No. This is not an AI/ML device.

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

Type of Ground Truth: Not applicable (no ground truth established for an AI/ML evaluation).

8. The sample size for the training set

Sample Size for Training Set: Not applicable (no training set for an AI/ML model).

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

Ground Truth Establishment for Training Set: Not applicable (no training set or associated ground truth discussed).

In Summary:

This 510(k) submission (K073419) is a resubmission for a physical PVA foam embolization device under a new manufacturer/distributor. The substantial equivalence was established by demonstrating the device's identity to already-cleared predicate devices, rather than through new performance studies using test sets, expert ground truth, or AI/ML evaluations. Therefore, the information requested regarding acceptance criteria and study details relevant to AI/ML devices is not present in this document.

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 section 807), and in particular section 807.92, the following summary of safety and effectiveness information is provided:

5.1 Submitted By:

RJ Medical, Inc. 4921 Robert J. Mathews Pkwy., #2 El Dorado Hills, CA 95762 Telephone: 1(916)941-6913 Contact: Jim Innes President Date Prepared:

December 3, 2007

5.2 Device Name:

Trade or Proprietary Names:

PVA PLUS" Vial PVA Foam Embolization Particles

PVA PLUS" Convenience Kit PVA Foam Embolization Particles

MicroStat" Convenience Kit PVA Foam Embolization Particles

MaxiStat" Convenience Kit PVA Foam Embolization Particles

Common or Usual Name:

Classification Name:

particles

Polyvinyl alcohol (PVA) foam embolization

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)

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K073419

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· Modified PVA PLUS™, Modified MaxiStat™, and Modified MicroStat™ PVA Foam Embolization Particles (Protein Polymer Technologies, Inc .; K053548)

5.4 Device Description

ર્સ્ટ Intended Use

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 (AVM's) and neoplastic lesions when presurgical devascularization is desirable.

ર્ડ.6 Comparison to Predicate Devices

The subject devices are identical to both the Surgica product (K001678) PVA Foam Embolization Particles and the Corporation Protein Polymer Technologies, Inc. product (K053548) Modified PVA PLUS™, Modified MaxiStat™, and Modified MicroStat™ PVA Foam Embolization Particles. Surgica Corporation was the exclusive developer and only manufacturer of all of these products. Surgica Corporation recently sold all of the assets, including Patents, Trademarks, Fixtures, Quality Systems, Procedures, Specifications, etc. to RJ Medical. Former Surgica management has transferred everything to RJ Medical, including training, to resume manufacturing and distribution of the devices. The only changes to the products are the manufacturer and the distributor identifications. Names on the labeling will reflect these items.

5.7 Summary of Non-Clinical Tests

(Not Applicable)

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5.8 Summary of Clinical Tests

(Not Applicable)

5.9 Conclusions of Non-Clinical and Clinical Tests

(Not Applicable)

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird with outstretched wings. The symbol is composed of three curved lines that converge at the center and then extend outward.

FEB 14 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

RJ Medical, Inc. % Mr. Jim Innes President 4921 Robert J. Mathews Parkway #2 El Dorado Hills, California 95762

Re: K073419

Trade/Device Name: PVA PLUSTM Vial PVA Foam Embolization Particles PVA PLUSTM Convenience Kit PVA Foam Embolization Particles MicroStat™ Convenience Kit PVA Foam Embolization Particles MaxiStat™ Convenience Kit PVA Foam Embolization Particles Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: December 3, 2007 Received: December 5, 2007

Dear Mr. Innes:

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

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Page 2 - Mr. Jim Innes

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Millerson

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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RJ Medical, Inc.

Indications for Use

510(k) Number (if known): _________________

Devicc Names:

PVA PLUS™ Vial PVA Foam Embolization Particles PVA PLUS™ Convenience Kit PVA Foam Embolization Particles MicroStat™ Convenience Kit PVA Foam Embolization Particles MaxiStat™ Convenience Kit PVA Foam Embolization Particles

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use (21 CFR 801 Subpart C)
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(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	2073419
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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).