Ventralight™ ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. The Echo PSTM Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair.

Device Description

The proposed Ventralight™ ST Mesh with Echo PS™ Positioning System is comprised of a permanently implantable mesh with a pre-attached disposable mesh positioning system (mesh deployment balloon). All product sizes include an inflation assembly to be used with the mesh positioning system and some will also include an Introducer Tool designed to aid the user in laparoscopic introduction of the entire mesh/positioning system assembly.

The Ventralight™ ST Mesh is a low profile, sterile, single use device 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 complete tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh is a bioresorbable coating, separating 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 30days. The Ventralight ST Mesh to be used with the proposed device is identical to that cleared via K 122436.

The Ventralight™ ST Mesh described above will be packaged preassembled with the Echo PSTM Positioning System, a removable mesh deployment balloon that is preattached to the mesh and is designed to help facilitate laparoscopic deployment, including unrolling, positioning, and placement. The positioning system is inflated via use of the included inflation assembly, which is also identical to that cleared with the predicate positioning system under K122436.

For user convenience, specific sizes of the proposed product will also include an Introducer Tool which is intended to facilitate delivery to the operative site. The Introducer Tool included with the proposed product is identical to the Introducer Tool cleared under K122436 which consists of a handle with a thin stainless steel rod and a Tcap. The device is split into two pieces along the length of the entire rod and attached on one end to the handle.

AI/ML Overview

The provided text describes a medical device submission (K130968) for the Ventralight™ ST Mesh with Echo PST™ Positioning System. This submission is a 510(k) for a line extension, indicating it's considered substantially equivalent to a previously cleared device (K122436). As such, the performance data provided relies heavily on the predicate device.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a line extension and the key components (mesh, positioning system, introducer tool, inflation assembly) are identical to the predicate device, specific acceptance criteria in terms of numerical performance metrics (like accuracy, sensitivity, specificity) for a diagnostic AI device are not explicitly defined in the provided text. Instead, the "acceptance criteria" are based on demonstrating substantial equivalence to the predicate device.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Biocompatibility: Device is biocompatible as per its intended use and ISO 10993 requirements.	Biocompatibility testing previously conducted (K122436) applies and indicates biocompatibility.
Product Specifications Met: Device design meets product specifications and intended uses.	Bench testing results and in vivo simulated use experiments demonstrate the device meets product specifications and intended uses.
Safety and Effectiveness: Demonstrate safety and effectiveness for intended use.	All test results (biocompatibility, bench, in vivo simulated use) support safety and effectiveness.
Identical Technological Characteristics: Key components (mesh, positioning system, introducer tool, inflation assembly) are identical to the predicate.	The Ventralight™ ST Mesh, Echo PSTM Positioning System, and (where applicable) the Introducer Tool and inflation assembly are all identical to those cleared under K122436.
Same Intended Use & Performance Characteristics: The mesh and positioning system maintain the same intended use and performance as the predicate.	The mesh has the same indications for use and performance characteristics. The positioning system maintains the same intended use and performance characteristics.
Line Extension Justification: The modification is a line extension to offer additional sizes.	The proposed modification is a line extension to offer four (4) additional sizes.

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

The document does not specify a separate "test set" in the context of an AI/diagnostic device's performance evaluation (e.g., number of cases or images). Instead, it mentions:

Biocompatibility testing: "previously conducted (as presented via K122436)". No sample size or provenance given in this document.
Bench testing: "Bench testing results". No sample size or specific provenance given.
In vivo simulated use experiments: "in vivo simulated use experiments". No sample size or specific provenance given.

Given the nature of the device (surgical mesh and deployment system) and the fact that it's a 510(k) for a line extension, this is typical. The evaluation focuses on the physical and performance attributes of the device itself rather than the analysis of a dataset.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a surgical mesh and a deployment system, not an AI or diagnostic device that requires expert adjudication for ground truth of medical conditions.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the context of expert adjudication for medical condition assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is typically conducted for AI-assisted diagnostic devices to assess how AI impacts human reader performance. This device is a surgical mesh and deployment system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This type of study is for AI/algorithm performance. This device is a physical medical implant and surgical tool.

7. Type of Ground Truth Used

The "ground truth" for this device is based on:

Physical and material properties: Biocompatibility (ISO 10993 standards), material specifications (polypropylene, polyglycolic acid, hydrogel coating).
Functional performance: Bench testing to ensure the device meets specified functional design requirements (e.g., deployment, unrolling, positioning).
Simulated use outcomes: In vivo simulated use experiments to assess how the device performs in a simulated surgical environment.

These are not "ground truths" in the sense of a medical diagnosis, but rather objective measurements and observations against engineering and performance specifications.

8. Sample Size for the Training Set

Not applicable. There is no training set for this type of medical device.

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

Not applicable, as there is no training set. The "ground truth" for the device's design and performance is established through engineering design, material science, and performance testing as described in point 7.

Summary

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K130968
page 1/3

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

MAY 0 1 2013

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

Submitter Information:

Submitter's Name:	Davol, Inc., Subsidiary of C. R. Bard, Inc.
Contact Person:	Keti Sino
	Senior International Regulatory Affairs Specialist
Address:	100 Crossings Boulevard
	Warwick, RI 02886
Telephone:	(401) 825-8575
Fax:	(401) 825-8765
Email:	Keti.sino@crbard.com
Device Name:
Trade Name:	Ventralight™ ST Mesh with Echo PST™
	Positioning System
Common/Usual Name:	- Surgical Mesh
	- Endoscope & Accessories
	- Mesh Deployment Balloon
Classification Name:	- Mesh, Surgical, Polymeric
	- Mesh Deployment Balloon
	- Laparoscope, General & Plastic Surgery
Classification Code:	- Class II, § 878.3300, Product Code FTL
Subsequent Codes:	- Class II, § 878.3300, Product Code OQL
	- Class II, § 876.1500, Product Code GCJ

Predicate Device Names:

Ventralight™ ST Mesh with Echo PS ™ Positioning System, K 122436 (Davol Inc.), . FDA cleared on 11/02/2012

Device Description:

PREMARKET NOTIFICATION FOR THE VENTRALIGHT™ ST MESH WITH ECHO PSTM POSITIONING SYSTEM

SECTION 8

, I

. 11:4

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K130968 Page 2/3

Intended Use:

The Ventralight™ ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

The Echo PSTM Positioning System is intended to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair.

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

The Ventralight™ ST Mesh to be utilized with Echo PSTM Positioning System for the proposed device has the same indications for use and performance characteristics as the mesh cleared via the predicate K 122436.

The proposed Echo PSTM Positioning System maintains the same intended use and performance characteristics as the Echo PSTM Positioning System cleared via the predicate K122436.

The proposed modification to the device is a line extension to offer four (4) additional sizes of Ventralight STTM Mesh with Echo PSTM Positioning System. The new codes will also include an Introducer Tool (where applicable) and inflation assembly, both identical to those previously cleared under the predicate K122436.

PREMARKET NOTIFICATION FOR THE VENTRALIGHT™ ST MESH WITH ECHO PSTM POSITIONING SYSTEM

SECTION 8

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K130968 page 3/3

Performance Data:

Biocompatibility testing previously conducted (as presented via K122436) is also applicable to the proposed device and thus will not be repeated. All testing conducted to date (as per the requirements of ISO 10993) indicate that the device is biocompatible as per its intended use.

Bench testing results and in vivo simulated use experiments demonstrate that the proposed device design meets product specifications and intended uses.

All test results provided in this submission support the safety and effectiveness of the device for its intended use and demonstrate that the proposed device is substantially equivalent to its predicate.

PREMARKET NOTIFICATION FOR THE VENTRALIGHT™ ST MESH WITH ECHO PSTM POSITIONING SYSTEM

· SECTION 8

રૂદ

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

May 1, 2013

C.R. Bard, Inc % Davol. Inc. Keti Sino Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886

Re: K130968

Trade/Device Name: Ventralight " ST Mesh with Echo PS " Positioning System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL, OQL, GCJ Dated: April 05, 2013 Received: April 08, 2013

Dear Keti Sino:

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. Ilsting 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 vour 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

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Page 2 - Keti Sino

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 forth in the quality systems (OS) 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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours, FOR

Peter D库Ruimm -S

Mark N. Melkerson Acting 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): K130968

Device Name:

Ventralight™ STMesh with Echo PSTM Positioning System

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number:K130968

Page 1 of

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.