The Phasix™ Plug and Patch is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.

Device Description

The proposed Phasix™ Plug and Patch utilizes a fully resorbable poly-4-hydroxybutrate (P4HB) polymer material pre-formed into a three-dimensional (cone shape) configuration constructed of a fluted outer layer and multiple inner layers (petals) of mesh attached at the tip. The inner petals and cones are sewn together at the tip with a single P4HB monofilament thread. The inner petals allow the device to conform readily to defects of various sizes while the structure of the small inter-fiber pores of the P4HB mesh allows for a prompt fibroblastic response and allows tissue in-growth. The cone shape configuration of the device allows it to expand and reduce in conformation with the immediate anatomy so that the repair is tension-free. The petals can be removed to customize the Phasix Plug to each individual patient. The Phasix Plug is available in several sizes. A flat mesh onlay patch is packaged with each Phasix Plug. The onlay is also fully resorbable and is made from the same P4HB monofilament as the Phasix Plug. Unlike the plug, the onlay patch is available in only one size but is customizable.

AI/ML Overview

The provided text describes the Phasix™ Plug and Patch device and its predicate devices, focusing on demonstrating substantial equivalence. However, it does not contain the specific type of information requested about acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The document is a 510(k) summary for a surgical mesh, which is a physical medical device, not an AI or algorithm-based diagnostic tool. Therefore, many of the requested points (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable or not present in this type of submission for a physical surgical implant.

Here's a breakdown based on the information available in the provided text, and where it falls short of your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the format requested for a quantifiable acceptance criteria and performance metrics. The document broadly states that "performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device."

Instead of a table with specific acceptance criteria, the document describes the types of tests performed:

Bench Testing:
- Physical characteristics: mesh weave, mesh pore size, device density, device thickness, device stiffness.
- Performance evaluations: burst strength, tear resistance, suture pullout strength.
Preclinical Studies:
- Porcine model (simulated ventral hernia repair): mechanical analysis, histological analysis, molecular weight properties post-implantation.
- In-vivo rat study: percentage area mesh contracture and host inflammatory/fibrotic response post-implantation.
Biocompatibility Testing: Conducted according to ISO 10993-1 standards.

The document concludes that "All test results provided in this submission support the safety and effectiveness of the proposed Phasix Plug and Patch device for its intended use and demonstrate that the proposed Phasix Plug and Patch device is substantially equivalent to its predicate devices, PerFix Light Plug and TephaFlex Mesh." This is the general acceptance criterion for a 510(k) submission – demonstrating substantial equivalence to a legally marketed predicate device.

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not specified for any of the individual tests. The text mentions a "comprehensive study... in a porcine model" and "An in-vivo study... in rats," but doesn't give numbers of animals used.
Data Provenance: Not specified for individual tests. The studies are described as "preclinical" and "in-vivo," indicating animal model testing rather than human clinical data. The country of origin of the data is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. This document describes a physical medical device, not a diagnostic algorithm that would require expert-established ground truth from images or other data. The "ground truth" here would be the physical measurements, biological responses in animal models, and integrity of the device itself.

4. Adjudication Method for the Test Set

N/A. As above, this is not applicable for the type of device and studies 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

N/A. This is a physical surgical mesh, not an AI or imaging diagnostic device. No human readers or AI assistance are involved in its performance or evaluation in this context.

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

N/A. This is not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's evaluation would be:

Pre-defined physical specifications (e.g., mesh weave, pore size, density, thickness, stiffness).
Quantifiable mechanical properties (e.g., burst strength, tear resistance, suture pullout strength).
Biological outcomes in animal models (e.g., mechanical analysis, histological analysis, molecular weight properties post-implantation, percentage area mesh contracture, host inflammatory/fibrotic response).
Biocompatibility as defined by ISO 10993-1 standards.

8. The sample size for the training set

N/A. This is not an AI/ML device that requires a "training set."

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

N/A. Not an AI/ML device.

In summary: The provided document is a 510(k) summary for a surgical mesh, which evaluates the physical and biological properties of the device to demonstrate substantial equivalence to predicate devices. It does not contain the information points typically associated with the development and validation of an AI/algorithm-driven device like acceptance criteria based on diagnostic performance, expert-established ground truth, or multi-reader studies.

Summary

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K120728
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

OCT 2 2 2012 This 510(k) Summary is provided per the requirements of section 807.92(c).

Submitter Information:

Submitter's Name:

Tony John, MS Regulatory Affairs Specialist

Address:

Telephone:

Fax:

Davol, Inc., Subsidiary of C. R. Bard, Inc. 100 Crossings Boulevard Warwick, RI 02886 (401) 825-8692 (401) 825-8765

Device Name:

Trade Name:	Phasix™ Plug and Patch
Common/Usual Name:	Surgical Mesh
Classification Name:	Mesh, Surgical, Polymeric

Classification Code:

Class II, § 878.3300, Product Code OWT (primary), OOD

Predicate Device Names:

TephaFLEX® Mesh , K111946 and K070894 (Tepha Inc.), FDA cleared on ● September 26, 2011 and April 13, 2007
Bard® PerFix™ Light Plug, K092032 (Davol Inc.), FDA cleared on December 8, . 2009

PREMARKET NOTIFICATION FOR PHASIX™ PLUG AND PATCH

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Device Description:

Intended Use:

The Phasix Plug and Patch is indicated for reinforcement of soft tissue, where weakness exists. in procedures involving soft tissue repair, such as groin hernia defects.

Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:

The proposed, Phasix Plug and Patch, is similar in intended use and in technological characteristics and performance when compared to the predicate devices TephaFlex Mesh and PerFix Light Plug. All devices are intended for use in the reconstruction and repair of soft tissue deficiencies where weakness exists such as hernia repair. In addition, the proposed device and the predicate devices are similar in technological characteristics with regard to materials, design, sterilization, packaging and labeling. Where minor

PREMARKET NOTIFICATION FOR PHASIX™ PLUG AND PATCH

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KI20728
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devices

technological differences exist between the proposed device and the predicate devices, performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device.

The proposed Phasix Plug and Patch device and the predicate TephaFlex Mesh are both constructed of P4HB monofilament mesh. The proposed device is constructed of P4HB monofilament mesh in a plug formation similar to the predicate Perfix Light Plug while the predicate TephaFlex Mesh is constructed of P4HB monofilament in a flat sheet formation.

The proposed Phasix Plug and Patch will have the same design as the predicate PerFix Light Plug with two modifications as described below. The first modification involves material used in the proposed device. The proposed device is made from a fully resorbable polyester mesh, P4HB, while the predicate PerFix Light Plug is made from a permanent polypropylene mesh. As discussed above this fully resorbable polyester mesh, P4HB, is identical to that used to manufacture the predicate TephaFlex Mesh. The second modification involves a reduction in the number of petals in the proposed device. Both the proposed and predicate device designs contain inner petals. However, the number of inner petals in the proposed device is less than the number of inner petals in the predicate Perfix Light Plug. In the proposed device, there are 4 inner petals in the small, medium, and large configurations and 8 inner petals in the extra large configuration. In the predicate, Perfix Light Plug, there are 8 inner petals in the small, medium, and large configurations and three medium inner cones inside one large cone in the extra-large configuration. The reduction in the number of petals in the proposed device has no impact on overall product performance as demonstrated in preclinical studies.

Similar to the predicate PerFix Light Plug, the proposed device will be packaged with a separate pre-shaped onlay patch. Additionally, both the proposed and the predicate PerFix Light Plug are packaged in the same materials, blister tray and DuPont™ Tyvek lid. All three devices undergo ethylene oxide (EtO) sterilization.

PREMARKET NOTIFICATION FOR PHASIX™ PLUG AND PATCH

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Performance Data:

Bench testing was performed to compare the proposed device, Phasix Plug and Patch to the predicate devices, PerFix Light Plug and TephaFlex Mesh. In accordance with FDA's "Guidance for the Preparation of a Premarket Notification for a Surgical Mesh" (March 2, 1999), the tests included physical characteristics including mesh weave, mesh pore size, device density, device thickness, device stiffness as well as performance evaluations including burst strength, tear resistance and suture pullout strength. In addition, preclinical studies were performed. A comprehensive study was performed in a porcine model of simulated ventral hernia repair. In the porcine model, mechanical analysis, histological analysis and molecular weight properties were assessed following implantation. An in-vivo study was performed in rats to evaluate the percentage area mesh contracture and host inflammatory/fibrotic response post-implantation. Additionally, all biocompatibility testing presented in this submission was conducted in accordance to ISO 10993-1 standards and the results indicate that the device is biocompatible per these standards.

Conclusion:

All test results provided in this submission support the safety and effectiveness of the proposed Phasix Plug and Patch device for its intended use and demonstrate that the proposed Phasix Plug and Patch device is substantially equivalent to its predicate devices, PerFix Light Plug and TephaFlex Mesh.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 2 2 2012

C.R. Bard, Incorporated
% Mr. Tony John, MS
Regulatory Affairs Specialist
100 Crossings Boulevard
Warwick, Rhode Island 08226

Re: K120728

Trade/Device Name: Phasix™ Plug and Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OWT, OOD Dated: October 03, 2012 Received: October 04, 2012

Dear Mr. John:

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 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

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Page 2 - Mr. Tony John, MS

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/ucm115809.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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

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K/20728

INDICATION FOR USE STATEMENT

510(k) Number (if known): not known

Device Name:

Phasix™ Plug and Patch

The Phasix™ Plug and Patch is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kravebiumm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

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.