PIVIT A/B ST is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The resorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surgical implantation.

PIVIT A/BTM ST is intended for single patient one-time use only.

Device Description

PIVIT A/B ST is identical to the PIVIT A/B device cleared via K053656. This filing is meant to provide for a line extension to the PIVIT A/B device and provide for uses consistent with other surgical mesh devices. This summary is repeated from the original PIVIT A/B clearance as reference.

PIVIT A/B ST is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. PIVIT A/B ST is constructed of a nonresorbable mesh comprised of knitted filaments of polypropylene and a bioresorbable polyarylate coating on the mesh containing the antimicrobial agents, rifampin and minocycline. The purpose of the resorbable coating is to provide additional stiffness to the mesh in order to facilitate interoperative handling during placement and act as a carrier for antimicrobial agents. Once placed, the polymer resorbs in approximately 90 days leaving a lighter permanent mesh incorporated into the tissue.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called PIVIT A/B ST, which is a polymeric surgical mesh. The document focuses on establishing substantial equivalence to previously cleared predicate devices rather than detailing a specific performance study with acceptance criteria and results.

Therefore, many of the requested sections about acceptance criteria, performance studies, sample sizes, ground truth establishment, and expert involvement cannot be extracted directly from this document.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

Cannot be extracted. The document states "Performance data on the enclosed devices are provided by reference to the previously cleared PIVIT A/B device per K053656." It does not provide specific acceptance criteria or performance results for PIVIT A/B ST in this document. The basis for clearance is substantial equivalence to predicates, not specific performance metrics.

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

Cannot be extracted. No new performance study or test set is described for PIVIT A/B ST. The clearance is based on equivalence to predicate devices.

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):

Cannot be extracted. This information is relevant to performance studies, which are not detailed in this 510(k) summary for PIVIT A/B ST.

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

Cannot be extracted. This information is relevant to performance studies, which are not detailed in this 510(k) summary for PIVIT A/B ST.

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:

Cannot be extracted. This device is a surgical mesh, not an AI or imaging diagnostic device. Therefore, an MRMC study is not applicable.

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

Cannot be extracted. This device is a physical surgical mesh, not an algorithm, so this question is not applicable.

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

Cannot be extracted. This information is relevant to performance studies, which are not detailed in this 510(k) summary for PIVIT A/B ST.

8. The sample size for the training set:

Cannot be extracted. This device is a physical surgical mesh, not an AI/ML algorithm requiring a training set.

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

Cannot be extracted. This device is a physical surgical mesh, not an AI/ML algorithm.

Summary of what is known:

Device Name: PIVIT A/B ST (Polymeric Surgical Mesh)
Intended Use: As a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue, including hernias and/or body wall defects. The resorbable polymer coating also contains antimicrobial agents (rifampin and minocycline) to help protect from microbial colonization.
Basis for Clearance: Substantial equivalence to predicate devices (PIVIT A/B (K053656), Strattice (K070560), HydroCoat Mesh (K090271)).
Performance Data: Provided by reference to the previously cleared PIVIT A/B device (K053656). This summary introduces a line extension for PIVIT A/B ST, stating it is "identical to the PIVIT A/B device cleared via K053656."

In conclusion, this 510(k) summary does not contain the detailed performance study information with acceptance criteria, sample sizes, and ground truth establishment that you are requesting. Its purpose is to demonstrate substantial equivalence to existing devices for a medical device that is a physical implant, not a diagnostic or AI-driven system.

Summary

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K093524
Page 1/2

510(K) Summary

. .

MAR 2 3 2010

510(K) SUMMARY AS REQUIRED BY 21 CFR 807.92

Pursuant to Section 12, Part (a)(i)3A of the Safe Medical Devices Act of 1990, TYRX Inc. is providing a summary of the safety and effectiveness information available for PIVIT A/B ST as well as the information used in the substantial equivalence decision making process for PIVIT A/B ST.

Sponsor/Applicant Name and Address TYRX Pharma, Inc. 1 Deer Park Drive, Suite G Monmouth Junction, N.J. 08852 Registration Number: 3005619263

Sponsor Contact Information:

Mark Citron Vice President Regulatory Affairs and Quality Systems Phone: 732-246-8676 Fax: 732-246-8677 E-mail: mark@tyrx.com

Date of preparation of 510(k) summary: March 24, 2010

New Device Trade/Proprietary Name: PIVIT A/B ST

Device Common/Classification Name: Polymeric Surgical Mesh

Predicate Devices Name and 510(k) Numbers:

PIVIT A/B	(K053656)
Strattice	(K070560)
HydroCoat Mesh	(K090271)

Device Description:

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K093524¢ page 2/2

rifampin and minocycline. The purpose of the resorbable coating is to provide additional stiffness to the mesh in order to facilitate interoperative handling during placement and act as a carrier for antimicrobial agents. Once placed, the polymer resorbs in approximately 90 days leaving a lighter permanent mesh incorporated into the tissue.

Intended Use:

PIVIT A/B 100 ST is intended for single patient one-time use only.

Performance Data :

Performance data on the enclosed devices are provided by reference to the previously cleared PIVIT A/B device per K053656.

Conclusions:

Based on the 510(k) summaries (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Devices under the Federal Food Drug and Cosmetic Act.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird in flight, composed of three curved lines that suggest the wings and body of the bird.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAR 2 3 2010

TYRX Pharma, Inc. % Mr. Mark Citron VP, Regulatory Affairs and Quality Systems 1 Deer Park Drive, Suite G Monmouth Junction, New Jersey 08852

Re: K093524

Trade/Device Name: PIVIT A/B™ ST Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: March 16, 2010 Received: March 17, 2010

Dear Mr. Citron:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Mark Citron

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Sincerely yours,

For

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication For Use Statement

Indications for Use

510(k) Number ( If known):	K093524
Device Name:	PIVIT A/B ST

Indications for Use:

PIVIT A/BTM ST is intended for single patient one-time use only.

Prescription Use

AND/OR

Over the Counter Use

( 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

(Division Sign-O Concurrence of CDRH, Office of Device Everying (Drivision Sign-Off) 0
Concurrence of CDRH, Office of Device Everified, Orthopedic, and Restorative Devices

510(k) Number K093524

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.