Phasix ST Mesh with Open Positioning System 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.

The open positioning system is intended to facilitate the placement, positioning and fixation of the mesh during open ventral hernia repair.

Device Description

Phasix™ ST Mesh with Open Positioning System is a sterile, single-use device for prescription use only. It is a bi-layer mesh comprised of Phasix™ ST Mesh (K173143, forms posterior layer) and Phasix™ Mesh (K161424, forms anterior layer) stitched together with a 10 mil P4HB monofilament. The combination of the two distinct layers forms a pocket to accommodate a preinserted removable accessory. The subject device is designed for reinforcement of soft tissue deficiencies during open ventral hernia repair. The subject device and reference device have identical intended use for the mesh i.e. soft tissue repair/ reinforcement.

The removable open positioning system is an accessory with polypropylene (PP) handle attached to a Polytetrafluoroethylene (PTFE) guide. The accessory comes preinserted into the mesh pocket to aid with placement, positioning, and fixation. The center marking on the positioning guide will aid with proper centering and orientation over the defect. The accessory is removed following the initial fixation and then discarded. The intended use of the accessory is similar to the SorbaFlex Memory Technology utilized in the Ventrio™ ST Hernia Patch (K101920).

AI/ML Overview

The provided text is a 510(k) summary for the Phasix ST Mesh with Open Positioning System, a surgical mesh device. The document details the device's characteristics, indications for use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.

Based on the information provided, here's a description of the acceptance criteria and the study that proves the device meets them:

No specific acceptance criteria table or quantitative performance metrics are explicitly stated in the provided document beyond qualitative "Pass" results for biocompatibility and statements that performance tests "successfully met the established acceptance criteria." The document primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices through various tests rather than setting and meeting independent quantitative acceptance criteria for device performance.

However, we can infer the types of acceptance criteria that were likely in place based on the tests conducted and the general regulatory framework for medical devices. The "study" proving the device meets these (largely implied) acceptance criteria refers to the various performance tests and animal studies conducted.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not provide a specific table of quantitative acceptance criteria with corresponding performance values. Instead, it reports qualitative "Pass" results for biocompatibility and states that "performance test results demonstrate that subject device successfully met the established acceptance criteria."

Here's a conceptual representation based on the tests mentioned:

Acceptance Criteria Category	Specific Test/Attribute	Reported Device Performance/Outcome
Biocompatibility	MEM Cell Cytotoxicity Elution	Pass
	Intracutaneous Reactivity	Pass
	Acute Systemic Toxicity	Pass
	ISO Material Mediated Rabbit Pyrogenicity	Pass
	Guinea Pig Maximization Test (Sensitization)	Pass
	Material/Chemical Characterization	Pass
Material/Mechanical Properties	Mesh Pore Size (Major and Minor)	Met established acceptance criteria
	Gel Disruption	Met established acceptance criteria
	Ball Burst	Met established acceptance criteria
	Tear Strength (Cross and Machine direction)	Met established acceptance criteria
	Suture Retention Strength (Cross and Machine Direction)	Met established acceptance criteria
Open Positioning System Functionality	15 Degree Recoil	Met established acceptance criteria
	Grip Strength	Met established acceptance criteria
	Pocket Integrity	Met established acceptance criteria
	Open Positioning System (accessory) removal force	Met established acceptance criteria
	Handle Attachment Strength	Met established acceptance criteria
	Three Tack Pluck	Met established acceptance criteria
Usability (Design Validation)	IFU (Instructions for Use)	Passed (Usability demonstrated)
	Insertion	Passed (Usability demonstrated)
	Positioning and Placement	Passed (Usability demonstrated)
	Fixation	Passed (Usability demonstrated)
	Removal	Passed (Usability demonstrated)
	Open Ventral Hernia Repair (overall procedure)	Passed (Usability demonstrated)
In vivo Performance (Animal Study)	Mesh conformance	Comparable to predicates
	Peritoneal tissue attachments (% area coverage and tenacity)	Comparable to predicates
	Percentage of mesh contracture	Comparable to predicates
	Histological evaluation (inflammatory/fibrotic response, vascular integration, Collagen deposition/remodeling, tissue ingrowth)	Comparable to predicates
	Mechanical tissue ingrowth properties via T-peel analysis	Comparable to predicates

2. Sample Size Used for the Test Set and Data Provenance

Biocompatibility Testing: The specific sample sizes for each in vitro biocompatibility test (e.g., number of cells for cytotoxicity, number of animals for systemic toxicity/sensitization) are not explicitly stated in the summary.
Product (Bench) Testing: The specific sample sizes (n-values) for each mechanical test (e.g., number of meshes tested for tear strength, number of accessories for removal force) are not explicitly stated.
Animal Studies: The study was "a comprehensive 4 week GLP study in a porcine model." The number of porcine subjects is not specified.
Data Provenance: All data appears to be prospective testing conducted specifically for this 510(k) submission. The country of origin for the data generation (where the tests were performed) is not specified, but given the submitter (Davol Inc., C. R. Bard, Inc. located in Warwick, RI, USA), it's highly likely the studies were conducted in the USA or by labs compliant with US regulations.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable in the context of this 510(k) summary. The device is a physical surgical mesh, not an AI/software device that requires ground truth derived from expert consensus for image interpretation or diagnosis. The "ground truth" for the performance sections is established through validated laboratory testing methods and histological/mechanical evaluation in the animal study.
For the "Design Validation Usability Test," it implicitly involves users (likely surgeons or medical professionals) to validate the device's usability, but the number or their qualifications are not specified.

4. Adjudication Method for the Test Set

This information is not applicable as it typically refers to the process of reconciling disagreements among multiple human readers for diagnostic interpretation (e.g., in AI studies).
For the bench and animal studies, "adjudication" would involve standard laboratory practices for data collection, analysis, and statistical evaluation, overseen by internal quality systems. The specific mechanisms for resolving data discrepancies, if any, are not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging AI devices where the performance of human readers with and without AI assistance is evaluated. The Phasix ST Mesh is a physical surgical device, not a diagnostic tool.

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

No, this is not applicable. The device is a surgical mesh; it does not involve algorithms or AI that would have a standalone performance. Performance is evaluated through bench testing and preclinical animal models.

7. The Type of Ground Truth Used

Biocompatibility Testing: Ground truth is established by standard, recognized in vitro and in vivo biological assays with predefined endpoints and pass/fail criteria (e.g., cytotoxicity, systemic toxicity, sensitization).
Product (Bench) Testing: Ground truth is established by engineering specifications, material science principles, and validated test methods to measure physical and mechanical properties. The "acceptance criteria" for these tests would be derived from these engineering specifications and comparison to predicate device characteristics.
Animal Studies: Ground truth is established by histopathological evaluation, gross anatomical observation (e.g., tissue attachments, mesh contracture), and mechanical testing of tissue samples (e.g., T-peel analysis) by qualified personnel (e.g., pathologists, veterinary specialists), against predefined biological response expectations and comparative analysis with predicate devices.

8. The Sample Size for the Training Set

Not applicable. The Phasix ST Mesh is not an AI/machine learning device; therefore, there is no "training set." The testing performed is for device validation and verification, not for training a model.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set, this question is irrelevant.

Summary

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June 12, 2019

C.R. Bard, Inc. Shirin Mate Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886

Re: K190185

Trade/Device Name: Phasix ST Mesh with Open Positioning System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWT, OOD, FTL Dated: May 13, 2019 Received: May 14, 2019

Dear Shirin Mate:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For David Krause, Ph.D. Acting Division Director Division of Infection Control and Plastic Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190185

Device Name

Phasix ST Mesh with Open Positioning System

Indications for Use (Describe)

The open positioning system is intended to facilitate the placement, positioning and fixation of the mesh during open ventral hernia repair.

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

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Phasix™ ST Mesh with Open Positioning System 510(k) Summary 21 CFR 807.92

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (D)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:

1.Submitter Information:

Davol Inc., C. R. Bard, Inc. 100 Crossings Boulevard Warwick, RI 02886 Phone: (401) 825-8569 Fax: (401) 825-8765

Contact Person: Shirin Mate Title: Regulatory Affairs Specialist Email: shirin.s.mate@crbard.com

Date: June 6, 2019

2.Subject Device:

510(k) Type:	Traditional 510(k)
Trade Name:	Phasix™ ST Mesh with Open Positioning System
Common or Usual Name:	Surgical Mesh
Classification Name:	Mesh, Surgical, Absorbable, Abdominal Hernia
Classification Panel:	General and Plastic Surgery
Regulatory Class:	Class II (Phasix™ ST Mesh with Open Positioning System)
	Class I ( Open Positioning System Accessory)
Regulation Number:	21 CFR § 878.3300 (Phasix™ ST Mesh with Open PositioningSystem)
	21 CFR § 878.4800 (Open Positioning System Accessory)
Product Code:	OWT, OOD, FTL (Phasix™ ST Mesh with Open PositioningSystem)
	MDM (Open Positioning System Accessory)
3.Primary Predicate Device:

Name of Device:

K101920 - Ventrio™ ST Hernia Patch

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Common or Usual Name:	Surgical Mesh
Classification Name:	Mesh, Surgical, Polymeric
Classification Panel:	General & Plastic Surgery
Regulatory Class:	Class II
Regulation Number:	21 CFR § 878.3300
Product Code:	FTL

4.Reference Device:

Name of Device:	K173143 - Phasix™ ST Mesh
Common or Usual Name:	Surgical Mesh
Classification Name:Classification Panel:Regulatory Class:	Mesh, Surgical, Absorbable, Abdominal HerniGeneral and Plastic SurgeryClass II
Regulation Number:	21 CFR § 878.3300
Product Code:	OWT, OOD, FTL, OWZ, OXC

5.Reference Device:

Name of Device:	K161424 - Phasix™ Mesh
Common or Usual Name:	Surgical Mesh
Classification Name:	Surgical Film
Classification Panel:	General and Plastic Surgery
Regulatory Class:	Class II
Regulation Number:	21 CFR § 878.3300
Product Code:	OOD

6.Device Description:

Open Positioning System

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7.Indications for Use:

Phasix™ ST Mesh with Open Positioning System 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.

The open positioning system is intended to facilitate the placement, positioning and fixation of the mesh during open ventral hernia repair.

8.Technological Comparison to Predicate and Reference Devices:

The subject device, Phasix™ ST Mesh with Open Positioning System has the following similarities to the predicate and reference devices:

The intended use of the mesh, i.e. for the repair / reinforcement of soft tissue, is identical . to the Ventrio™ ST Hernia Patch (K101920), Phasix™ ST Mesh (K173143) and Phasix™ Mesh (K161424).
The intended use of the open positioning accessory, i.e. to facilitate the ease of insertion, . placement, positioning and fixation of the mesh, is similar to the SorbaFlex Memory Technology (PDO) utilized in the Ventrio™ ST Hernia Patch (K101920 with the exception of the removal of the open positioning accessory).
The mesh and mesh materials are identical to the Phasix™ ST Mesh (K173143) and ● Phasix™ Mesh (K161424).
The mesh pocket design is similar to the Ventrio™ ST Hernia Patch (K101920). .
The principle of operation for open ventral hernia repair is identical to the Ventrio™ ST . Hernia Patch (K101920), Phasix™ ST Mesh (K173143) and Phasix™ Mesh (K161424)

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with the exception of the open positioning accessory removal, i.e. insertion, placement/ positioning and fixation.

The mesh sizes are within the similar range of the Ventrio™ ST Hernia Patch (K101920), . Phasix™ ST Mesh (K173143) and Phasix™ Mesh (K161424).
The base materials utilized in open positioning accessory, Polypropylene and PTFE are . similar to the Polypropylene mesh material and PTFE monofilament sew line utilized in the Ventrio™ ST Hernia Patch (K101920).

The subject device, the Phasix™ ST Mesh with Open Positioning System incorporates following change as compared to the predicate and reference devices:

. It consists of a removable accessory instead of the embedded SorbaFlex Memory Technology (PDO) material as compared to Ventrio™ ST Hernia Patch (K101920). None of the cited predicate/reference devices consists of a removable accessory.
The subject device has similar intended use, indication for use, principle of operation, mesh materials/ manufacturing processes, packaging, sterilization (ethylene oxide) method and utilizes the same manufacturing facility. Any differences in the technological characteristics were thoroughly tested and the results demonstrate that there are no new questions of safety and effectiveness.

9.Performance Data:

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

Performance Standards

No performance standards have been established for this device under Section 514 of the Federal Food, Drug, and Cosmetic Act.

Biocompatibility Testing:

The biocompatibility evaluation for the Phasix™ ST Mesh with Open Positioning System was conducted in accordance with the Guidance for Industry and Food and Drug Administration Staff Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" June 16, 2016, and International

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Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process," as recognized by the FDA.

The subject device mesh materials are identical to the mesh materials utilized in the successful clearance of the Phasix™ ST Mesh (K173143) and Phasix™ Mesh (K161424) and therefore considered safe and biocompatible. Thus, the tests specific to Phasix™ ST Mesh and Phasix™ Mesh were not repeated. However, in order to address any risks associated with interaction between the materials of the subject device mesh and the accessory (guide and handle), a biocompatibility testing was completed to demonstrate the subject device; Phasix™ ST Mesh with Open Positioning System is biocompatible for its intended use. Refer to Table 1.

Table 1: Biocompatibility Testing: Phasix™ ST Mesh with Open Positioning System

Test Method	Results
MEM Cell Cytotoxicity Elution	Pass
Intracutaneous Reactivity	Pass
Acute Systemic Toxicity	Pass
ISO Material Mediated Rabbit Pyrogenicity	Pass
Guinea Pig Maximization Test (Sensitization)	Pass
Material/ Chemical Characterization	Pass

The biocompatibility test results demonstrate that the subject device is biocompatible and there are no interactions between the subject device mesh and the accessory to affect its safety and effectiveness. Thus the subject device is safe and biocompatible for its intended use.

Electrical safety and electromagnetic compatibility (EMC)

The Phasix™ ST Mesh with Open Positioning System is not an electro-mechanical medical device nor is it medical system; therefore this section does not apply.

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Software Verification and Validation Testing

The Phasix™ ST Mesh with Open Positioning System does not contain software therefore this section does not apply.

Product Testing

The performance test results demonstrate that subject device successfully met the established acceptance criteria and is substantially equivalent to the Ventrio™ ST Hernia Patch (K101920), Phasix™ ST Mesh (K173143) and Phasix™ Mesh (K161424). Performance testing completed on the subject device is listed in Table 2.

Table 2: Performance Testing - bench

Performance Testing- Bench	Test Method
Substantial equivalency testing	Mesh Pore Size (Major and Minor), Gel Disruption, Ball Burst,Tear Strength (Cross and Machine direction), Suture RetentionStrength (Cross and Machine Direction).
Additional mechanical testing toevaluate features unique to thesubject device.	15 Degree Recoil, Grip Strength, Pocket Integrity, OpenPositioning System (accessory) removal force, HandleAttachment Strength, Three Tack Pluck.
Design Validation Usability Test.	Attributes: IFU, Insertion, Positioning and Placement, Fixation,Removal, Open Ventral Hernia Repair.

Animal studies:

A comprehensive 4 week GLP study in a porcine model was performed on the subject device as compared to Ventrio™ ST Hernia Patch (K101920) and Phasix™ ST Mesh (K173143) to evaluate the following:

. Mesh conformance
. Peritoneal tissue attachments (% area coverage and tenacity)
Percentage of mesh contracture
Histological evaluation of the host inflammatory/fibrotic response, vascular integration, Collagen deposition/remodeling and tissue ingrowth
Mechanical tissue ingrowth properties via T-peel analysis .

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The subject device results were found to be comparable and therefore. Phasix™ ST Mesh with Open Positioning System is substantially equivalent to the Ventrio™ ST Hernia Patch (K101920) and Phasix™ ST Mesh (K173143). .

Clinical Study:

Clinical Study was not required in support of the subject device, Phasix™ ST Mesh with Open Positioning System.

Conclusion:

The subject device has similar intended use, indications for use, principle of operation, mesh technological characteristics, packaging materials/ components, manufacturing process and sterilization (ethylene oxide). Any differences in the technological characteristics between the subject device and the predicate/reference devices were assessed and evaluated. All test results provided in support of the subject device demonstrate safety and effectiveness similar to the predicate/reference devices. Therefore, Phasix™ ST Mesh with Open Positioning System is substantially equivalent to the predicate device, Ventrio™ ST Hernia Patch (K101920).

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.