The Bard® 3DMAX™ Light Mesh will be indicated for use in the reinforcement of soft tissue where weakness exists, such as the repair of hernia defects.

Device Description

The Proposed Bard® 3DMAX™ Light Mesh, is designed to fit the inguinal anatomy. The device is anatomically shaped and preformed with sealed edges that allow for easier positioning of the device than a traditional flat sheet of mesh in a laparoscopic inguinal hernia repair. The device is constructed of knitted polypropylene monofilaments 0.0048 inches in diameter. The knit construction allows the mesh to be stretched in both directions in order to accommodate and reinforce tissue defects. The device contains an orientation marker in an "M" shape to designate the medial edge of the mesh and an arrow pointing to the medial aspect. Both the arrow and "M" will aid the user during positioning and placement of the device. The orientation marker is composed of polypropylene monofilament dyed with Phthalocyaninato(2-) copper colorant.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Bard® 3DMAX™ Light Mesh, based on the provided document:

This device (Bard® 3DMAX™ Light Mesh) is a surgical mesh and not an AI/ML powered device. Therefore, many of the typical questions related to AI/ML device testing (e.g., number of experts, adjudication methods, multi-reader multi-case studies, separate training/test sets, or ground truth establishment for AI) are not applicable to this submission. The device is evaluated through physical and performance testing to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail table format with specific ranges. Instead, it describes a comparative study showing that the Proposed Bard® 3DMAX™ Light Mesh performs similarly to predicate devices across various physical and performance characteristics. The acceptance criterion implicitly is "demonstrates substantial equivalence to predicate devices."

Characteristic	Proposed Device (Bard® 3DMAX™ Light Mesh) Performance	Predicate Device(s) (Bard® Soft Mesh, 3DMAX™ Mesh, Mersilene Mesh) Performance	Acceptance Criteria (Implicit)
Physical Attributes			Substantially Equivalent
Thickness	Tested	Tested	Similar to Predicates
Pore Size	Larger knit construction than Bard 3D Max™ Mesh	Defined for Predicates	Considered acceptable
Density	Tested	Tested	Similar to Predicates
Material Weight	0.0272 grams/square inch	Mersilene Mesh: 0.0274 g/sq in; Soft Mesh: 0.0282 g/sq in	Comparable to Predicates
Mechanical Performance			Substantially Equivalent
Stiffness	Tested	Tested	Similar to Predicates
Tensile Strength	Tested	Tested	Similar to Predicates
Percent Elongation	Tested	Tested	Similar to Predicates
Suture Pullout Strength	Tested	Tested	Similar to Predicates
Burst Strength	Tested	Tested	Similar to Predicates
Tear Resistance	Tested	Tested	Similar to Predicates
Biocompatibility	Acceptable results for polypropylene material and colorant	Acceptable results for predicate materials	Meets Biocompatibility Standards

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

Sample Size for Test Set: The document does not specify exact numerical sample sizes for each laboratory test. It generally states that "Laboratory bench testing was performed."
Data Provenance: The tests were conducted internally by Davol Inc. (a subsidiary of C.R. Bard, Inc.). The data is from laboratory bench testing, presumably conducted prospectively for this submission. The country of origin of the data is not specified but implicitly is the USA, given the submission to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

N/A. This is not an AI/ML device relying on expert interpretation for ground truth. Performance is assessed through objective, quantifiable laboratory bench tests.

4. Adjudication Method for the Test Set

N/A. Adjudication methods are typically used for subjective assessments or when multiple experts are involved in establishing ground truth, which is not the case for material and mechanical property testing of a surgical mesh.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI/ML device that interacts with human readers for diagnostic or interpretive tasks. MRMC studies are not relevant for evaluating the physical and performance characteristics of a surgical mesh.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is not an algorithm. The device's performance is inherently "standalone" in that its physical and mechanical properties are measured directly.

7. The Type of Ground Truth Used

Objective Laboratory Measurements: The "ground truth" for this device's performance relies on established engineering and materials testing standards. For example, tensile strength is measured against a standard procedure, and the result is an objective numerical value. Biocompatibility is assessed against recognized biological evaluation standards (e.g., ISO 10993 series). The comparison is then made against the measured performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device; there is no "training set."

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

N/A. There is no training set as it is not an AI/ML device.

Summary

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K091659 page 43

SECTION 7.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

A. Submitter Information

AUG 0 8 0009

Submitter's Name:

Address:

Davol Inc.

Subsidiary of C.R. Bard, Inc 100 Crossings Boulevard Warwick, R1 02886

Telephone: Fax: Contact Person: Date of Preparation:
(401) 825-8582 (401) 825-8765 Gail Dow June 3, 2009

B. Device Name

Trade Name: Common/Usual Name: Classification Name:

Bard® 3DMAX™ Light Mesh Surgical Mesh Surgical Mesh, Polymeric

C. Predicate Device Name

Bard® Soft Mesh (Davol Inc.) Trade name: Trade name: Bard® 3DMAX™ Mesh (Davol Inc.) Mersilene Mesh (Ethicon, Inc.) Trade name:

D. Device Description

PREMARKET NOTIFICATION FOR THE BARD® 3DMAX™ Light Mesh

-CONFIDENTIAL-

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E. Intended Use

The Bard® 3DMAX™ Light Mesh is a sterile, single use device indicated for use in the reinforcement of soft tissue where weakness exists, such as the repair of hernia defects.

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

Bard® 3DMAX™ Light Mesh, the currently marketed Bard® 3DMAX™ Mesh, Bard® Soft Mesh and Ethicon Mersilene Mesh devices are all indicated for repair of hernia defects. The intended use for the 3DMAX™ Light Mesh is the same as the Predicate devices, Soft Mesh and 3DMAX™ Mesh, with the exception of the indication for repair of chest wall defects.

The Predicate Bard® Soft Mesh is a major component of the Proposed 3DMAX™ Light Mesh and both are made from the same polypropylene monofilaments with a diameter of approximately 0.0048 inches. The Proposed 3DMAX™ Light Mesh has similar physical attributes and performance characteristics as the Predicates 3DMAX™ Mesh, Soft Mesh, and Mersilene Mesh. Furthermore, it has similar materials and manufacturing methods as the Predicate 3DMAX™ Mesh.

The key differences in the Proposed 3DMAX™ Light Mesh compared to the currently marketed 3DMAX™ Mesh are the diameter of the polypropylene monofilament and the knit pattern of the mesh. In order to create a thin lightweight mesh and reduce the amount of material used in the mesh compared to traditional monofilament polypropylene meshes, the Proposed 3DMAX™ Light Mesh is constructed from monofilaments with a diameter of approximately 0.0048 inches. However, the weights (grams/square inch) of Mersilene Mesh (0.0274) and Soft Mesh (0.0282) are comparable to the 3DMAX™ Light Mesh (0.0272). In addition, the Proposed 3DMAX™ Light Mesh has larger pore knit construction than the Predicate Bard 3D Max™ Mesh.

The 3DMAX™ Light Mesh, and the Predicate 3DMAX™ Mesh are similar as both are designed to fit the inquinal anatomy. Unlike the Predicates. Mersilene Mesh and Soft Mesh, which are flat mesh sheets, the Proposed 3DMAX™ Light Mesh is anatomically shaped and preformed with sealed edges that allow for easier positioning in a laparoscopic inguinal hernia repair. The edge seal design will be the same as the currently marketed 3DMAX™ Mesh, however a layer of polypropylene mesh will be added during the edge seal lamination process to provide sufficient material to create a smooth, non-porous edge.

Unlike the Predicates, Mersilene Mesh and Soft Mesh, the Proposed 3DMAX™ Light Mesh and the currently marketed 3DMAX™ Mesh contain a medial marker composed of polypropylene monofilament and Phthalocyaninato(2-) copper colorant.

PREMARKET NOTIFICATION FOR THE BARD® 3DMAX™ Light Mesh

-CONFIDENTIAL-

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K091659 Page 3/3

G. Performance Data

Laboratory bench testing was performed to assess the effects of the new characteristics of the Proposed 3DMAX™ Light Mesh. These tests compared the Proposed Product against the Predicate Products Soft Mesh, 3DMAX™ Mesh and Mersilene Mesh. In accordance with FDA's "Guidance for the Preparation of a Premarket Notification for a Surqical Mesh" (March 2. 1999), tests included physical and performance evaluations of the products in terms of thickness, pore size, density, stiffness, tensile strength, percent elongation, suture pullout strength, burst strength and tear resistance. Laboratory testing discussed in this submission demonstrates that the material chosen and the design utilized in manufacturing 3DMAX™ Light Mesh is substantially equivalent to the referenced Predicate Products. The results of this testing are in Section 15.

Additionally, biocompatibility testing covering the polypropylene material used in the Proposed 3DMAX™ Light Mesh, as well as the orientation marker composed of polypropylene monofilament and Phthalocyaninato(2-) copper colorant have received acceptable results. Results are summarized in Section 14.0 and copies of the test reports are in Exhibit 4.

The results show that the 3DMAX™ Light Mesh is substantially equivalent to the currently marketed Predicate devices. Therefore, based on laboratory testing and biocompatibility data, the Proposed 3DMAX™ Light Mesh, is safe and effective for its intended use.

PREMARKET NOTIFICATION FOR THE BARD® 3DMAX™ Light Mesh

-CONFIDENTIAL-

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 3 2009

C.R. Bard, Inc. % Ms. Gail Dow Regulatory Affairs Associate 100 Crossings Boulevard Warwick, Rhode Island 02886

Re: K091659

Trade/Device Name: Bard® 3DMax"" Light Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: June 3, 2009 Received: June 9, 2009

Dear Ms. Dow:

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.

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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Page 2 - Ms. Gail Dow

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/CDRH0ffices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

sincerely yours,

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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INDICATION FOR USE STATEMENT

510(k) Number (if known):

Not Known

Bard® 3DMAx™ Light Mesh Device Name:

The Bard® 3DMAX™ Light Mesh will be indicated for use in Indications for Use: the reinforcement of soft tissue where weakness exists, such as the repair of hernia defects.

Over-The-Counter AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ X Use (21 CFR 801 (Part 21 CFR 801 Subpart D) Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Keane for mxm
(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091659

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.