The Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias.

Device Description

The proposed Phasix™ ST Mesh is a fully resorbable mesh with a resorbable hydrogel coating. It is a sterile mesh prosthesis designed for the reinforcement and reconstruction of soft tissue deficiencies. Phasix ™ ST Mesh is co-knitted using poly-4-hydroxybuterate (P4HB) and polyglycolic acid (PGA) fibers. P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and then knitted into a surgical mesh. P4HB degrades through a process of hydrolysis and a hydrolytic enzymatic digestive process. It has been developed to reinforce areas where weakness exists while minimizing the variability of resorption rate (loss of mass) and strength to provide support throughout the expected healing period. Preclinical implantation studies indicate that resorption of the P4HB fibers is minimal throughout the 12 week expected healing period and up to 26 weeks post implantation. Significant degradation of the mesh fibers observed in preclinical studies within 12 to 18 months indicates loss in mechanical integrity and strength. While fiber segments were observed at 18 months, they continued to degrade. Phasix ™ ST Mesh is coated on the PGA surface with a resorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows for a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth, similar to P4HB mesh alone. The visceral side of the mesh is a resorbable hydrogel coating, separating the mesh from underlying tissues and organ surfaces to help minimize tissue attachment to the mesh. Shortly after hydration, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.

AI/ML Overview

This document is a 510(k) premarket notification for the Phasix™ ST Mesh, a surgical mesh. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies. Therefore, the information typically requested in your prompt (acceptance criteria, specific study designs, sample sizes for training/test sets, ground truth establishment for AI/algorithm-based devices, MRMC studies, etc.) is not present in this document, as it pertains more to software or diagnostic device submissions.

However, I can extract the information provided regarding performance data relevant to establishing substantial equivalence.

Here's a summary of the performance data reported:

1. A table of acceptance criteria and the reported device performance
   - This document does not provide a table of acceptance criteria with specific numerical targets and reported performance values. Instead, it lists the types of tests performed to demonstrate substantial equivalence, implying that the results of these tests were deemed acceptable by the FDA for the purpose of 510(k) clearance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   - Not applicable. This document describes pre-clinical (biocompatibility, bench, and animal) studies, not human clinical trials. Sample sizes for these studies are not specified in this summary. Data provenance (country of origin, retrospective/prospective) is not detailed.

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. Ground truth establishment by experts is typically relevant for diagnostic devices or AI algorithms. This document concerns a surgical mesh.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   - Not applicable. Adjudication methods are relevant for studies involving human interpretation, often in diagnostic contexts.

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. MRMC studies are used for evaluating diagnostic performance, particularly of AI-assisted systems.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   - Not applicable. This device is a physical surgical mesh, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   - Not applicable in the context of an AI/diagnostic device. For the animal studies, the "ground truth" would be established by direct observation and analysis of the implanted mesh and surrounding tissues, likely involving histology/pathology conducted by veterinarians and researchers.

8. The sample size for the training set
   - Not applicable. This device is a physical surgical mesh, not an algorithm that requires a training set.

9. How the ground truth for the training set was established
   - Not applicable. This device is a physical surgical mesh, not an algorithm that requires a training set.

Summary of Performance Data (as provided in the document for K143380):

The performance data provided supports the substantial equivalence determination for the Phasix™ ST Mesh. The general approach was to compare the new device to existing predicate devices (TephaFLEX® Mesh and Ventralight™ ST Mesh) that are already legally marketed.

Category	Tests Performed	Equivalence/Outcome
Biocompatibility	- Cytotoxicity - Genotoxicity - Sensitization - Intracutaneous Reactivity - Local and Systemic Toxicity (4 and 13 week) - Local Toxicity (4, 8, 13, and 20 week) - Systemic Toxicity (Acute) - Pyrogenicity	Demonstrated that the materials (P4HB, PGA, hydrogel coating) are biocompatible, addressing risks associated with component interactions, in accordance with FDA guidance (Blue Book Memorandum #G95-1 and ISO-10993). Implies results met acceptance criteria for biocompatibility.
Electrical Safety / EMC	None required	Not applicable as the device has no electrical or metal components.
Software V&V Testing	None required	Not applicable as the device does not contain software.
Bench Testing	- Mesh weave characteristics - Device stiffness - Mesh pore size - Burst strength - Mesh density - Tear resistance - Mesh thickness - Suture pullout strength - In vitro degradation study	Performed to compare the proposed Phasix™ ST Mesh to the predicate TephaFlex® Mesh and Ventralight™ ST Mesh. The in-vitro degradation study demonstrated that PGA fibers and hydrogel coating do not impact the resorption profile of the P4HB mesh. Implies results demonstrate substantial equivalence for physical and performance characteristics per FDA guidance for surgical mesh.
Animal Studies	In vivo porcine studies at 4, 12, and 24 weeks	Characterized mechanical strength, tissue response, and resorption profile in comparison to predicate devices. The implication is that these studies showed comparable performance to the predicates.
Clinical Study	None required	No clinical study was required to support the 510(k) clearance for Phasix™ ST Mesh, indicating that the preclinical data (biocompatibility, bench, and animal studies) were sufficient to establish substantial equivalence.

Conclusion:

The document states that "All test results provided in this submission demonstrate that the proposed Phasix™ ST Mesh is substantially equivalent to the cited TephaFlex® Mesh and Ventralight™ ST Mesh predicates." This means the conducted tests (biocompatibility, bench, and animal studies) produced results that satisfied the FDA's requirements for demonstrating that the device is as safe and effective as the predicate devices, despite minor technological differences.

Summary

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

June 5, 2015

C. R. Bard Incorporated Mr. Tony John Regulatory Affairs Specialist 100 Crossing Boulevard Warwick, Rhode Island 02886

Re: K143380

Trade/Device Name: Phasix™ ST Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OWT, OOD, FTL Dated: November 24, 2014 Received: November 25, 2015

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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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/ResourcesforYou/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.

Sincerely yours.

Jennifer R. Stevenson -S

For 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)

K143380

Device Name Phasix™ ST Mesh

Indications for Use (Describe)

The Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias.

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 807.92(c).

Submitter Information:

Company Name:	Davol Inc., Subsidiary of C. R. Bard, Inc.
Company Address:	100 Crossings BoulevardWarwick, RI 02886
Telephone:	(401) 825-8692
Fax:	(401) 825-8765
Submitter's Name:	Tony John, MSRegulatory Affairs Specialist
Date Summary Prepared:	June 4, 2015

Device Identification:

Trade Name:	Phasix TM ST Mesh
Common/Usual Name:	Surgical Mesh
Classification Name:	Mesh, Surgical, Absorbable, Abdominal Hernia
Device Class:	Class II
Regulation Number:	21 CFR § 878.3300
Product Code:	OWT, OOD, FTL

Predicate Device Names:

. TephaFLEX® Mesh , K070894/K111946/K113723 (Tepha Inc), FDA cleared on: April 13, 2007, September 26, 2011, and February 15, 2012, respectively.
Ventralight ST Mesh, K101851 (Davol Inc), FDA cleared on : July 15, 2010 ●

PREMARKET NOTIFICATION PHASIX™ ST MESH

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Davol Inc. Subsidiary of C.R. Bard, Inc. 100 Crossings Blvd. Warwick. RI 02886 (401) 463-7000

Image /page/4/Picture/1 description: The image shows the logo for Bard Davol Inc. The logo features the word "BARD" in a bold, sans-serif font, with a green outline. Below the word "BARD" is the text "DAVOL INC." in a smaller font. To the right of the logo is the text "K143380 Pat", followed by the words "TECHNOLOGY", "TECHNIQUE", "TRAINING", and "TRUST" stacked vertically.

Device Description

Indications for Use

Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias.

Comparison of Technological Characteristics with the Predicate Device

The proposed Phasix™ ST Mesh has the same materials and design as the predicate TephaFlex® Mesh and Ventralight™ ST Mesh devices.

The base mesh in the proposed Phasix™ ST Mesh is constructed of the same P4HB . monofilament and knit pattern as the predicate TephaFlex® Mesh. The base mesh component of the predicate Ventralight™ ST Mesh is made of polypropylene.
Both the proposed Phasix™ ST Mesh and predicate Ventralight™ ST Mesh contain a HA/CMC . PEG based hydrogel. These devices also contain PGA fibers co-knit into the mesh to allow the

PREMARKET NOTIFICATION PHASIX™ ST MESH

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Image /page/5/Picture/1 description: The image shows the Bard Davol Inc. logo. The logo is green and features the word "BARD" in a stylized font. Below the word "BARD" is the text "DAVOL INC." On the right side of the image, there are four words stacked vertically: "TECHNOLOGY", "TECHNIQUE", "TRAINING", and "TRUST". The image also includes the text "K143380 Page 3 of 4" at the top.

hydrogel to adhere to the mesh. The purpose of the hydrogel coating is to minimize tissue attachment to the mesh. The TephaFLex® Mesh predicate does not contain a hydrogel coating or PGA fibers.

The proposed and predicate devices have the same intended use and similar indications for use statements. In addition, all three devices are sterilized via ethylene oxide and packaged in a Tyveke envelope and foil pouch. Where minor technological differences exist between the proposed and predicate devices, testing demonstrates that the differences do not adversely affect the performance of the proposed device.

Performance Data:

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

Biocompatibility Testing

The materials used in the construction of the proposed Phasix™ ST Mesh are known to be biocompatible as demonstrated by their safe clinical use in the predicate devices. However, in order to address any risks associated with interactions between the three device components (i.e. P4HB, PGA, and the hydrogel coating), complete biocompatibility testing in accordance with FDA's Blue Book Memorandum #G95-1 issued on May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and FDA Guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process". The following studies were completed:

. Cytotoxicity
. Genotoxicity
Sensitization
- Intracutaneous Reactivity .
Local and Systemic Toxicity (4 and 13 week) ● Local Toxicity (4, 8, 13, and 20 week)
. Systemic Toxicity (Acute)
Pyrogenicity

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 PhasixTM Mesh does not contain software.

PREMARKET NOTIFICATION PHASIX™ ST MESH

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Image /page/6/Picture/1 description: The image shows the logo for BARD DAVOL INC. The logo is green and features the word "BARD" in a stylized font. To the right of the logo are the words "TECHNOLOGY", "TECHNIQUE", "TRAINING", and "TRUST" stacked vertically. At the top right of the image is the text "K143380 Page 4 of 4".

Bench Testing

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

. Mesh weave characteristics
. Device stiffness
. Mesh pore size
Burst strength
Mesh density
Tear resistance ●
. Mesh thickness
. Suture pullout strength.
Additionally an in vitro degradation study was completed to demonstrate that the degradation of the PGA fibers and hydrogel coating present on the proposed Phasix™ ST Mesh construct do not impact the resorption profile of the P4HB mesh.

Animal Studies

In vivo porcine studies were performed to characterize the mechanical strength, tissue response, and resorption profile of the proposed Phasix™ ST Mesh device in comparison to the cited predicates at 4, 12, and 24 weeks.

Clinical Study

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

Conclusion:

All test results provided in this submission demonstrate that the proposed Phasix™ ST Mesh is substantially equivalent to the cited TephaFlex® Mesh and Ventralight™ ST Mesh predicates.

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.