The Phasix™ Mesh is indicated to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. or for use in procedures involving soft tissue repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Description

The proposed Phasix™ Mesh utilizes a fully resorbable poly-4-hydroxybutyrate (P4HB) polymer material. The P4HB is produced from a naturally occurring monomer and is processed into monofilament fiber then knitted into a surgical mesh. The Phasix™ Mesh is packaged individually as a sterile, single flat mesh available in several rectangular sizes and one small circle. Phasix™ Mesh provides immediate short term support and provides a scaffold that enables tissue in-growth over time while the mesh predictably and gradually degrades via hydrolysis and a hydrolytic enzymatic digestive process. Preclinical implantation studies indicate that Phasix™ Mesh retains approximately 70% of its strength at 12 weeks. Absorption of the mesh material will be essentially complete within 12 to 18 months.

AI/ML Overview

This document describes the premarket notification for the Phasix™ Mesh, a surgical mesh, and its comparison to a predicate device, the TephaFLEX® Mesh. The submission focuses on demonstrating substantial equivalence rather than presenting an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance and study design are not applicable to this document.

Here's an attempt to answer the questions based on the provided text, noting where information is not available due to the nature of the device:

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

Acceptance Criteria (Bench Testing)	Reported Device Performance (Phasix™ Mesh)
Mesh weave characteristics comparable to predicate TephaFLEX® Mesh	Same as predicate TephaFLEX® Mesh
Mesh pore size comparable to predicate TephaFLEX® Mesh	Same as predicate TephaFLEX® Mesh
Mesh density comparable to predicate TephaFLEX® Mesh	Same as predicate TephaFLEX® Mesh
Mesh thickness comparable to predicate TephaFLEX® Mesh	Same as predicate TephaFLEX® Mesh
Device stiffness comparable to predicate TephaFLEX® Mesh	Same as predicate TephaFLEX® Mesh
Burst strength comparable to predicate TephaFLEX® Mesh	Same as predicate TephaFLEX® Mesh
Tear resistance comparable to predicate TephaFLEX® Mesh	Same as predicate TephaFLEX® Mesh
Suture pullout strength comparable to predicate TephaFLEX® Mesh	Same as predicate TephaFLEX® Mesh
Cytotoxicity met acceptance criteria	Passing results
Biocompatibility (Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Genotoxicity, Chronic Toxicity, Implantation, Haemocompatibility) met acceptance criteria	All met acceptance criteria (leveraged from predicate)
Resorption profile (retains approx. 70% strength at 12 weeks, complete within 12-18 months)	Same as predicate TephaFLEX® Mesh (leveraged from predicate)

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

Bench Testing: The document does not specify the exact sample sizes for each bench test. It states "Bench testing was performed to compare the proposed Phasix™ Mesh to the predicate TephaFLEX® Mesh."
Biocompatibility/Animal Studies: The data was largely leveraged from the predicate device (TephaFLEX® Mesh), which was FDA cleared. Specific sample sizes for these studies are not detailed in this document. The provenance is implied through FDA clearance and adherence to international and FDA guidance documents. These were likely prospective studies conducted for the predicate.

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)

This is not applicable as the device is a surgical mesh, not an AI/ML diagnostic tool. Ground truth in this context would refer to objective material properties and biological responses, measured through standardized tests, rather than expert interpretation of data.

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

This is not applicable as the device is a surgical mesh and no expert adjudication for a test set is mentioned or relevant to its evaluation for substantial equivalence.

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

This is not applicable as the device is a surgical mesh and not an AI-assisted diagnostic or intervention system. No human readers or AI assistance are involved in its primary function or evaluation for this premarket notification.

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

This is not applicable as the device is a surgical mesh and not an algorithm.

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

The "ground truth" for this device's evaluation is based on:

Objective Material Properties: Measurements of mesh weave characteristics, pore size, density, thickness, stiffness, burst strength, tear resistance, and suture pullout strength.
Biocompatibility Standards: Results demonstrating adherence to ISO 10993 standards for various biological responses (cytotoxicity, sensitization, systemic toxicity, etc.).
In vivo Animal Study Data: Characterization of mechanical strength retention and resorption profile.
Comparison to Predicate: Demonstrating equivalence to a legally marketed predicate device (TephaFLEX® Mesh) with an established safety and effectiveness profile.

8. The sample size for the training set

This is not applicable as there is no "training set" in the context of an AI/ML powered device. The evaluation is based on in vitro and in vivo testing of the physical device.

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

This is not applicable as there is no "training set." The ground truth for the evaluation was established through standardized testing procedures, leveraging data from the predicate device that had undergone similar rigorous testing and obtained FDA clearance.

Summary

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

March 31, 2015

Davol Incorporated, Subsidiary of C. R. Bard Incorporated Mr. Steve Keenan Regulatory Affairs Engineer 100 Crossings Boulevard Warwick, Rhode Island 02886

Re: K142818

Trade/Device Name: Phasix" Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OOD Dated: February 18, 2015 Received: February 19, 2015

Dear Mr. Keenan:

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

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

for

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142818

Device Name Phasix™ Mesh

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

This 510(k) Summary is provided per the requirements of section 21 CFR 807.92

I. Submitter

Company Name:	Davol, Inc., Subsidiary of C. R. Bard, Inc
Company Address:	100 Crossings BoulevardWarwick, RI 02886
Telephone:	(401) 825-8499
Fax:	(401) 825-8765
Submitter's Name:	Steve KeenanRegulatory Affairs Engineer
Email:	steve.keenan@crbard.com
Date Prepared:	September 26, 2014
II.
Device
Trade Name:	Phasix™ Mesh
Common/Usual Name:	Surgical Mesh
Classification Name:	Surgical Film (21 CFR § 878.3300)

Regulatory Class: Product Code:

III. Predicate Device

TephaFLEX® Mesh ●
- K113723 (Tepha, Inc.), FDA cleared on February 15, 2012 o

Class II

OOD

K111946 (Tepha Inc.), FDA cleared on September 26, 2011 O
K070894 (Tepha Inc.), FDA cleared on April 13, 2007 O

PREMARKET NOTIFICATION FOR PHASIX™ MESH

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Device Description IV.

Indications for Use v.

Phasix™ Mesh is indicated to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Comparison of Technological Characteristics with the Predicate Device VI.

The proposed Phasix™ Mesh has the same materials and design as the predicate TephaFLEX® Mesh. The proposed and predicate devices are constructed of the same P4HB monofilament knitted to create a mesh with the same weave characteristics. Both devices have the same indications for use statement and 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 device are packaged in the same materials including a DuPont™ Tyvek® envelop and foil pouch that undergo the same ethylene oxide sterilization method. Where minor process technology differences

PREMARKET NOTIFICATION FOR PHASIX™ MESH

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exist, or manufacturing facilities have been changed between the proposed device and the predicate device, performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device.

Performance Data: VII.

The following performance data are provided in support of the substantial equivalence determination.

Biocompatibility Testing

The proposed Phasix™ Mesh uses the same P4HB monofilament as the predicate TephaFLEX® Mesh. Therefore, biocompatibility testing previously conducted for the predicate TephaFLEX® Mesh was leveraged in support of the proposed device. Additional cytotoxicity testing was performed on the proposed device to confirm that the manufacturing facility changes and minor process modifications had no impact on the device. The cytotoxicity results met acceptance criteria with passing results. The biocompatibility evaluation for the TephaFLEX® Mesh was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The proposed Phasix™ Mesh and predicate TephaFLEX® Mesh are considered tissue/bone contacting permanent implants. Therefore, the following tests were leveraged from the predicate device in support of this premarket notification:

Cytotoxicity .
Sensitization ●
Intracutaneous Reactivity ●
Systemic Toxicity .
Genotoxicity .

PREMARKET NOTIFICATION FOR PHASIX™ MESH

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Chronic Toxicity .
Implantation ●
Haemocompatibility o

All biocompatibility data leveraged from the predicate TephaFLEX® Mesh and the additional cytotoxicity testing on proposed Phasix™ Mesh met acceptance criteria.

Electrical safety and electromagnetic compatibility (EMC)

There are no electrical or metal components in the Phasix™ Mesh; therefore the proposed device does not require EMC and Electrical Safety evaluation.

Software Verification and Validation Testing

The proposed Phasix™ Mesh does not contain software.

Bench Testing

Bench testing was performed to compare the proposed Phasix™ Mesh to the predicate TephaFLEX® Mesh. In accordance with FDA's "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh" published March 2, 1999, the following physical and performance characteristics were evaluated:

Mesh weave characteristics ●
Mesh pore size o
Mesh density
Mesh thickness ●
Device stiffness ●
Burst strength ●

PREMARKET NOTIFICATION FOR PHASIX™ MESH

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Tear resistance .
Suture pullout strength. ●

Animal Studies

In vivo studies were performed to characterize the mechanical strength and resorption profile of the P4HB monofilament mesh and were originally provided in support of the predicate TephaFLEX® Mesh via K113723. Since the proposed Phasix™ Mesh is constructed of the same P4HB monofilament knitted into a mesh with the same weave characteristics as the predicate TephaFLEX® Mesh, these resorption studies were adopted and provided in support of the Phasix™ Mesh.

Clinical Study

No clinical study was required in support of the Phasix™ Mesh.

Conclusion: VIII.

All test results provided in this submission support and demonstrate that the proposed Phasix™ Mesh is substantially equivalent to the cited TephaFLEX® Mesh predicate.

PREMARKET NOTIFICATION FOR PHASIX™ MESH

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.