The Ventralex ST Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair of hernias and deficiencies caused by trocars.

Device Description

The proposed device. Ventralex ST Hernia Patch, is a self-expanding bioresorbable coated, partially absorbable, sterile prosthesis, containing 2 distinct layers stitched with PTFE monofilament, forming a positioning pocket and strap. The top layer is knitted polypropylene mesh, 0.004" in monofilament diameter, and the bottom layer is Sepramesh IP Mesh. Sepramesh IP Mesh is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a PP surface and a PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, allowing for tissue ingrowth into the mesh. The visceral side of the mesh is a bioresorbable coating the mesh from underlying tissue and organ surfaces to minimize tissue attachment to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days. A depth marker on the positioning strap for the small Ventralex ST Hernia Patch is designed to facilitate placement of the small patch through a trocar. The device contains Sorbaflex Memory Technology which provides memory and stability to the device, facilitating ease of initial insertion, proper placement, and fixation of the device. The Sorbaflex Memory Technology is comprised of an extruded polydioxanone (PDO) absorbable monofilament that is contained within a knitted polypropylene mesh tube. The Sorbaflex PDO monofilament fully degrades in vivo by means of hydrolysis. Absorption is essentially complete in 6-8 months.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Ventralex ST Hernia Patch, focusing on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria with a new study. Therefore, the concept of "acceptance criteria" as applied to a new diagnostic accuracy study or a clinical trial for a new therapeutic device is not directly applicable in the same way.

However, the sponsor did perform various tests to show that the new device characteristics perform similarly to the predicate devices. I will interpret "acceptance criteria" as a comparison of the new device's performance to that of its predicate devices to demonstrate substantial equivalence for safety and effectiveness. The "study" refers to these comparative bench and preclinical tests.

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

Test Category	Specific Test	Acceptance Criteria (Implicit)	Reported Device Performance
Physical Characteristics	Mesh Weave	Similar to predicate devices	Similar to predicate devices
	Mesh Pore Size	Similar to predicate devices	Similar to predicate devices
	Device Density	Similar to predicate devices	Similar to predicate devices
	Device Thickness	Similar to predicate devices	Similar to predicate devices
	Device Stiffness	Similar to predicate devices	Similar to predicate devices
Performance Evaluations	Burst Strength	Similar to predicate devices	Similar to predicate devices
	Suture Pullout Strength	Similar to predicate devices	Similar to predicate devices
	Strap Strength	Similar to predicate devices	Similar to predicate devices
	PDO Ring Weld Tensile Strength	Similar to predicate devices	Similar to predicate devices
	PGA Pullout Strength	Similar to predicate devices	Similar to predicate devices
	Dry Bond Strength	Similar to predicate devices	Similar to predicate devices
	Mass/Area Measurements	Similar to predicate devices	Similar to predicate devices
	Deployment/Hydrogel Disruption Testing	Similar to predicate devices	Similar to predicate devices
Preclinical Studies (Pigs)	Peritoneal Tissue Attachment	Comparable to predicate devices	Overall performance studies in pigs indicated comparability
	Percent Area Coverage	Comparable to predicate devices	Overall performance studies in pigs indicated comparability
	Mesh Contracture	Comparable to predicate devices	Overall performance studies in pigs indicated comparability
	Tissue Ingrowth	Comparable to predicate devices	Overall performance studies in pigs indicated comparability
	Host Inflammatory/Fibrotic Response	Comparable to predicate devices	Overall performance studies in pigs indicated comparability
Degradation Study (Rats)	Host Inflammatory/Fibrotic Response	Acceptable and similar during degradation of materials	In vivo degradation study in rats indicated acceptable response and absorption
	Absorption Characteristics	Acceptable and similar for bioresorbable coating, PGA fibers, and PDO monofilament during degradation	In vivo degradation study in rats indicated acceptable response and absorption
Biocompatibility	Biocompatibility (ISO 10993)	Meets ISO 10993 standards	Device is biocompatible per ISO 10993 standards

Note: The document states "The results demonstrate that the proposed device is substantially equivalent to the currently marketed predicate devices," implying that the performance of the proposed device met the implicit acceptance criteria of being similar or comparable to the predicate devices across all tested parameters.

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

The document does not explicitly state the specific sample sizes for each bench test (e.g., number of patches tested for burst strength) or for the preclinical animal studies (number of pigs or rats).

Provenance: This was a premarket regulatory submission; therefore, the data would have been generated prospectively by the manufacturer (Davol Inc., a subsidiary of C.R. Bard, Inc.) for the purpose of demonstrating substantial equivalence.
Country of Origin: The submitter's address is Warwick, RI, USA. The testing was presumably conducted either within the US or at facilities commissioned by the US-based manufacturer. The document does not specify the exact locations of the test facilities.

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 section is not applicable. The studies performed were bench and preclinical in vivo (animal) studies, not studies requiring human expert interpretation or ground truth establishment in the clinical diagnostic sense. Performance was measured by objective physical/mechanical tests and observations in animal models by scientists/researchers involved in the studies.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human expert consensus scenarios, typically in diagnostic imaging or clinical trials. The studies described here are laboratory and animal studies with objective measurements or observations by trained personnel, not human interpretation requiring adjudication.

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 section is not applicable. The submission is for a surgical mesh device, not a diagnostic AI device requiring human reader interpretation or assistance. Therefore, no MRMC study was performed, and no effect size regarding human reader improvement with AI is relevant to this submission.

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

This section is not applicable. The submission is for a physical surgical device, not a standalone algorithm.

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

For the bench tests, the "ground truth" was established by the physical and mechanical properties of the predicate devices. The new device's performance was measured against these established properties. For the preclinical animal studies, the "ground truth" was established by histological examination (for tissue ingrowth, inflammatory response, degradation) and gross observation (peritoneal tissue attachment, percent area coverage, mesh contracture) based on established scientific and veterinary pathology standards.

8. The sample size for the training set

This section is not applicable. This submission describes bench and animal studies for a physical medical device, not a machine learning model. There is no "training set" in the context of this regulatory submission.

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

This section is not applicable for the reasons stated in point 8.

Summary

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K101928
p. 1 of 4

MAR 2 3 2011

Section 8.0 510(k) Summary of Safety and Effectiveness

Submitter Information A.

Submitter's Name: Davol Inc. Address: Subsidiary of C.R. Bard, Inc. 100 Crossings Boulevard Warwick, RI 02886 Telephone: (401) 825-8589 Fax: (401) 825-8765 Contact Person: Michelle Godin Date of Preparation: July 8, 2010 Device Name Trade Name: Bard Ventralex ST Hernia Patch Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh, Polymeric Predicate Device Name Trade name: Ventrio Hernia Patch (Davol Inc.) K100229, K081777 Sepramesh IP Mesh (Davol Inc.) Trade name: K040868, K053066, K063739 Ventralex Hernia Patch (Davol Inc.) Trade name: K021736, K024008

D. Device Description

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is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, allowing for tissue ingrowth into the mesh. The visceral side of the mesh is a bioresorbable coating the mesh from underlying tissue and organ surfaces to minimize tissue attachment to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.

A depth marker on the positioning strap for the small Ventralex ST Hernia Patch is designed to facilitate placement of the small patch through a trocar.

The device contains Sorbaflex Memory Technology which provides memory and stability to the device, facilitating ease of initial insertion, proper placement, and fixation of the device. The Sorbaflex Memory Technology is comprised of an extruded polydioxanone (PDO) absorbable monofilament that is contained within a knitted polypropylene mesh tube. The Sorbaflex PDO monofilament fully degrades in vivo by means of hydrolysis. Absorption is essentially complete in 6-8 months.

E. Intended Use

The proposed device, Ventralex ST Hernia Patch, is a sterile, single use device indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair of hernias and deficiencies caused by trocars. The intended use for the proposed device, Ventralex ST Hernia Patch, is the same as the predicate devices, Ventralex Hernia Patch, Ventrio Hernia Patch,a nd Sepramesh IP Mesh.

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

The proposed device, Ventralex ST Hernia Patch, has the same base design as the currently marketed Ventralex Hernia Patch (K021736, K024008) with the following modifications:

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the posterior polypropylene mesh layer and the single layer of expanded polytetrafluoroethylene (ePTFE) have been replaced by Sepramesh IP Mesh which is a coknitted polypropylene/PGA mesh with a bioresorbable coating. The Sepramesh IP Mesh used in the proposed device is exactly the same as the currently marketed device. Sepramesh IP Mesh. The polyethylene terephthalate (PET)ring has been replaced with a PDO monofilament ring contained within a knitted tube mesh and the anterior polypropylene slit mesh and strap are the same lighter weight polypropylene monofilament as the predicate device, Ventrio Hernia Patch (K100229). The interlocking stitch using polytetrafluoroethylene (PTFE) monofilament to sew the patch remains the same as the predicate device, Ventralex Hernia Patch.

Laboratory bench testing was performed to verify that the proposed device's performance characteristics are similar to that of the predicate devices.

G. Performance Data

Bench testing was performed to assess the effects of the new characteristics of the proposed device, Ventralex ST Hernia Patch. The tests compared the proposed device against the predicate devices, Ventralex Hernia Patch, Ventrio Hernia Patch, and Sepramesh IP Mesh. In accordance with FDA's "Guidance for the Preparation of a Premarket Notification Application 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, suture pullout strength, strap strength, PDO ring weld tensile strength, PGA pullout strength, dry bond strength, mass/area measurements, and deployment/hydrogel disruption testing. In addition, preclinical studies were performed. Overall performance studies in pigs were performed to evaluate peritoneal tissue attachment, percent area coverage, mesh contracture, tissue ingrowth, and host inflammatory/fibrotic response. An in vivo degradation study was performed in rats to evaluate the host inflammatory/fibrotic response and absorption characteristics of the bioresorbable coating, PGA fibers, and the PDO monofilament during degradation of the material in vivo. The testing presented in this

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submission demonstrates that the proposed device, Ventralex ST Hernia Patch, is substantially equivalent to the predicate devices. The results of the testing can be found in Section 16.

Biocompatibility testing in accordance with the ISO 10993 standards was conducted. The results indicate that the device is biocompatible per these standards. Results are summarized in Section 15 and copies of the test reports are in Attachment 3.

The results demonstrate that the proposed device is substantially equivalent to the currently marketed predicate devices and therefore, the proposed device, Ventralex ST Hernia Patch, is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The caduceus is positioned to the right of the text, and the text is arranged in a circular fashion around the symbol.

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

C.R. Bard, Inc. % Ms. Michelle Godin, MS, RAC Regulatory Affairs Project Manager 100 Crossings Boulevard Warwick, Rhode Island 02886

Re: K101928

MAR 2 3 201

Trade/Device Name: Ventralex ST Hernia Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 11, 2011 Received: March 14, 2011

Dear Ms. Godin:

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 10 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 - Ms. Michelle Godin, MS, RAC

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/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.

Fr. Mts. P. Ruesmann

1912

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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Indications for Use

510(k) Number (if known):

Device Name: Ventralex ST Hernia Patch

Indications for Use:

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 Kuczewski MXM

(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101928

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.