Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.

Device Description

XenMatrix™ Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix packed hydrated in sterile saline for use in the reconstruction of soft tissue deficiencies.

AI/ML Overview

This document describes a 510(k) submission for the XenMatrix™ Surgical Graft. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily due to proposed changes in the available sizes of the graft.

Here's an analysis of the provided text in relation to your questions:

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

The document doesn't explicitly state "acceptance criteria" with numerical thresholds in a table format. However, it mentions several non-clinical tests performed and that the device "meets the same product specifications and intended uses." The implied acceptance criteria for the expanded sizes are that they perform equivalently to the predicate device in these tests.

Test Category	Specific Test Conducted	Reported Performance (Implicit Acceptance Criteria)
Mechanical Strength	Burst strength	Meets same product specifications as predicate device.
	Tensile strength	Meets same product specifications as predicate device.
	Suture retention strength	Meets same product specifications as predicate device.
Packaging Integrity	Seal strength	Not explicitly stated, but implied to meet requirements for ensuring sterility and product integrity.
	Ship testing	Not explicitly stated, but implied to prevent damage during transport.
Biocompatibility	Biocompatibility	Same as predicate device (acellular porcine dermal matrix).
Histology	Histology examination	Not explicitly detailed, but implied to be acceptable for a surgical graft.

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

The document does not specify the sample sizes used for the non-clinical tests (burst strength, tensile strength, suture retention strength, etc.).
The data provenance is also not specified, but it's presumed to be from Davol Inc. and its testing facilities, likely in the US, as no other location is mentioned. The testing is described as "bench and pre-clinical testing," which suggests it's prospective testing conducted specifically for this submission.

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 question is not applicable. The study performed was non-clinical (bench and pre-clinical testing) on a surgical graft, not a diagnostic device requiring expert interpretation of images or other data to establish a ground truth.

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

This question is not applicable for the same reasons as #3.

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 question is not applicable. This submission is for a surgical graft, not an AI-powered diagnostic tool. No human reader studies were conducted or are relevant to this device.

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

This question is not applicable. This is a physical medical device (surgical graft), not an algorithm or software.

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

For the non-clinical tests, the "ground truth" implicitly refers to pre-defined product specifications and performance characteristics established for the predicate device and expected for the proposed device through accepted engineering and quality control standards. For the histological examination, the ground truth would be established by qualified histologists interpreting the tissue samples according to established biological criteria.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This question is not applicable for the same reasons as #8.

Summary

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

Image /page/0/Picture/2 description: The image shows the logo for BARD DAVOL INC. The word "BARD" is in large, bold, sans-serif font, with each letter connected to the next. Below "BARD" is the text "DAVOL INC.", in a smaller, sans-serif font. The logo is black and white.

TECHNOLOGY TECHNIQUE TRAINING ពេជ្យនេះ

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

APR 2 8 2014

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

Submitter Information:

Submitter's Name:	Tony John, MSRegulatory Affairs Specialist
Company Name:	Davol Inc., Subsidiary of C. R. Bard, Inc
Company Address:	100 Crossings BoulevardWarwick, RI 02886
Telephone:	(401) 825-8692
Fax:	(401) 825-8763
Email:	tony.john@crbard.com
Date Summary Prepared:	April 8, 2014
Device Name:
Trade Name:	XenMatrix™ Surgical Graft
Product Code:	FTM
Classification Name:	Mesh, Surgical
Regulation Number:	21 CFR 878.3300
Device Class:	II

Predicate Device:

Panel:

K081272 "Porcine Dermal Matrix Surgical Mesh" FDA cleared on 31 July 2008 from Brennen Medical, LLC . Davol, Inc. acquired the 510(k) product line in June 2009 and listed it as XenMatrix™ Surgical Graft.

General & Plastic Surgery

Device Descriptions:

XenMatrix™ Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix packed hydrated in sterile saline for use in the reconstruction of soft tissue deficiencies.

Intended Use:

. Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.

PREMARKET NOTIFICATION FOR XENMATRIX™ SURGICAL GRAFT K140501 PAGE 1 OF 2

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

The XenMatrix™ Surgical Graft has the same intended use and fundamental scientific technology as the predicate device. The following technological characteristics of the XenMatrix™ Surgical Graft are the same as the predicate device: material, biocompatibility, and sterilization.

The difference between the predicate device and the proposed device is the proposed device has larger sizes and smaller sizes than the currently cleared predicate. Performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device.

Davol has also conducted a risk analysis to address the potential clinical risks that are associated with meshes that are larger than our previously cleared sizes. Based on our analysis and the results of our validation testing Davol does not expect any different clinical risks due to the larger mesh sizes being proposed.

Summary of Non-Clinical Testing:

Bench and pre-clinical testing was performed on the XenMatrix™ Surgical Graft to support substantial equivalence. Bench testing on the proposed device included burst strength, tensile strength, and suture retention strength. Packaging testing included seal strength and ship testing. Pre-clinical testing includes histology examination. Results of testing demonstrate that the XenMatrix™ Surgical Graft of the expanded sizes meets the same product specifications and intended uses.

Statement of Equivalence:

The test results and risk analysis 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 devices.

PREMARKET NOTIFICATION FOR XENMATRIX™ SURGICAL GRAFT K140501 PAGE 2 OF 2

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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized symbol that resembles an abstract bird or human figure. The symbol is composed of three curved lines that converge at the bottom.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

April 28, 2014

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

Re: K140501

Trade/Device Name: XenMatrix" Surgical Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OWV, OXH Dated: April 9, 2014 Received: April 10, 2014

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 (2 1 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 – Mr. Tony John

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 vou 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/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 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,

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical 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): K140501

Device Name: XenMatrix™ Surgical Graft

Indications for Use:

Prescription Use (Part 2) 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)

Page __ of_

Peter L. Hudson -S

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.