The Bard CollaMend Implant is indicated to reinforce soft tissue where weakness exists, e.g., for repair of hernia and chest wall defects, and for the surgical repair of damaged or ruptured soft tissue membranes or reinforcement in plastic and reconstructive surgery.

Device Description

The proposed device is a sterile, solid, sheet of lyophilized, acellular porcine dermal collagen and its constitucnt elastin fibers. It is processed to remove all non-collagenous cellular components and is cross-linked to increase strength and endurance. The proposed device allows cellular infiltration and replacement by host tissue, forming a strong repair of soft tissue defects. The proposed device will be made available in various sizes and shapes, ranging from a 4" x 6" ellipse to a 10" x 14" rectangle. The thickness of the devices will be approximately 1 mm. Surgeons will need to rehydrate the product before implanting it into the patient. The proposed device will be marketed as a sterile, single use device.

AI/ML Overview

The provided text describes the Bard CollaMend™ Implant, a surgical mesh, and its premarket notification (K063170 and K063178 for the FDA clearance letter). The focus of this submission is to demonstrate substantial equivalence to existing predicate devices, particularly to expand the indications for use of an already marketed Bard CollaMend® Implant.

Based on the provided text, the concept of "acceptance criteria" and quantifiable "device performance" as might be found in a study for a diagnostic AI device is not directly applicable. This is a 510(k) submission for a medical device (surgical mesh), not a software or AI-driven diagnostic tool. The performance is assessed through various tests to confirm the material's properties and biological interactions rather than accuracy metrics like sensitivity or specificity.

Here's an analysis of the provided information, framed as closely as possible to your request, but acknowledging the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a surgical mesh, "acceptance criteria" are typically related to material properties, biocompatibility, and functional performance within the body, rather than diagnostic accuracy. The document states that the device met established specifications. Specific numerical acceptance criteria are not provided in the summary.

Acceptance Criterion (Inferred from text)	Reported Device Performance (Summary)
Biocompatibility	Non-toxic and non-sensitizing to biological tissues consistent with its intended use.
Functionality and in-growth characteristics	Confirmed in animal implant study, comparable to predicate Permacol Implant.
Material choice, manufacturing process, design	Met established specifications necessary for consistent performance during its intended use.
Additional Indication Equivalence	Similar in design, manufacturing, and basic material properties to other predicate devices with the expanded indication.

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

Animal Implant Study: The text mentions "An animal implant study was performed" but does not specify the sample size (number of animals or implants).
Data Provenance: The animal study is the primary "test set" described. No explicit mention of country of origin is made, but it is implied to be within the scope of regulatory standards for a US FDA submission. The study is prospective in nature as it evaluates the implant in an animal model.

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

This information is not provided in the document. For an animal study evaluating tissue integration and functionality of a surgical mesh, ground truth would likely be established through histological analysis and gross observation by veterinary pathologists or experts in tissue engineering/implant biology.

4. Adjudication Method for the Test Set

This information is not provided.

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

Not applicable. This is a physical medical device (surgical mesh), not an AI diagnostic tool that would involve interpretation by human readers.

6. Standalone Performance Study

Yes, in essence, the described studies (biocompatibility testing, animal implant study, and laboratory test results) represent a standalone evaluation of the device's characteristics and performance. These studies are designed to demonstrate the inherent properties and functionality of the Bard CollaMend Implant itself.

7. Type of Ground Truth Used

Biocompatibility: Likely established through standardized in-vitro and in-vivo toxicology tests (e.g., cytotoxicity, irritation, sensitization assays) with defined endpoints.
Animal Implant Study: Ground truth would be based on gross and histological examination of explanted tissues, evaluating parameters such as inflammation, tissue integration, neovascularization, and integrity of the mesh.

8. Sample Size for the Training Set

Not applicable in the context of this device. The term "training set" is relevant to machine learning and AI, which this device is not. The manufacturing process of the device itself would be subject to quality control and process validation, possibly involving "batches" or "lots" of material, but not a "training set."

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

Not applicable. See point 8.

Summary

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K063170

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SECTION 7.0

NOV 2 1 2016

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE BARD® COLLAMEND™ IMPLANT

A. Submitter Information

Submitter's Name:	Davol Inc.
Address:	Subsidiary of C. R. Bard, Inc.100 Sockanossett CrossroadCranston, RI 02920
Telephone:	(401) 215-2252
Fax:	(401) 215-2031
Contact Person:	Stephanie Baker
Date of Preparation:	October 5, 2006

B. Device Name

Trade Name:	Bard CollaMend Implant
Common/Usual Name:	Surgical Mesh
Classification Name:	Surgical Mesh

C. Predicate Device Name

Trade name:	Bard CollaMend® Implant (Davol, Inc.)
Trade name:	Permacol™ Implant (Tissue Science Laboratories, PLC.)
Trade name:	Mersilene® Polyester Fiber Mesh (Ethicon, Inc.)
Trade name:	SIS Plastic Surgery Matrix (Cook Biotech Incorporated)
Trade name:	CosMatrix (TEI Biosciences, Inc.)

D. Device Description

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K063170 puse 2/3

need to rehydrate the product before implanting it into the patient. The proposed device will be marketed as a sterile, single use device.

E. Intended Usc

The Bard CollaMend Implant is indicated to reinforce soft tissue where weakness exists, e.g., for repair of hernia and chest wall defects, and for the surgical repair of damaged or runtured soft tissue membranes or reinforcement in plastic and reconstructive surgery.

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

The proposed device and the predicate CollaMend implant differ only in the intended use. The proposed device has an additional indication for use, "reinforcement in plastic and reconstructive surgery". The remaining predicates Permacol Implant, SIS Plastic Surgery Matrix and CosMatrix are all generally intended for use in plastic and reconstructive surgery. The predicate Mersilene Mesh is intended for use in the repair of soft tissue deficiencies including hernias.

The proposed device exactly the same in design as the predicate CollaMend Implant. The proposed device is similar in its basic design to the predicate devices Permacol Implant, Mersilene Mesh, SIS Plastic Surgery Matrix and CosMatrix. All of these devices are flexible flat sheets of material and are available in a variety of sizes and/or shapes.

The proposed device and all the predicates with the exception of Mersilene Mesh are manufactured from biologic materials. The proposed device and predicates CollaMend Implant and Permacol Implant are manufactured from acellular porcine dermal collagen. The predicate SIS Plastic Surgery Matrix is manufactured from porcine small intestinal submucosa. The predicate CosMatrix is manufactured from bovine derived material. The predicate device Mersilene Mesh is manufactured from multifilament polyester. The proposed device and predicates CollaMend Implant, Permacol Implant, Mersilene Mesh and CosMatrix are one layer thick. The predicate SIS Plastic Surgery Matrix is available in 1-ply and 4-ply thickness.

The manufacturing process for the proposed device and the predicate CollaMend Implant are exactly the same. The proposed device and the predicates CollaMend Implant, Permacol Implant, SIS Plastic Surgerv Matrix and CosMatrix processes contain decontamination/viral inactivation steps. The proposed device and the predicates CollaMend

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K063170

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Implant and Permacol implant processes also contain a cross-linking step. The proposed device and the predicate CollaMend are both chemically crosslinked with 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide hydrochloride (EDAC). The predicates SIS Plastic Surgery Matrix and CosMatrix are not chemically crosslinked.

The proposed device and the predicate CollaMend Implant and SIS Plastic Surgery Matrix are lyophilized before sterilization (Ethylenc Oxide) and must be completely hydrated before use by immersion in sterile saline solution or sterile lactated ringers solution for a minimum of 3 minutes. The predicate Permacol Implant is packaged moist for sterilization (Radiation) and requires that the user rinse the implant before implantation in a patient. The predicate device CosMatrix is also supplied in a dried state and rehydrates in approximately sixty seconds. CosMatrix is sterilized by Ethylene Oxide.

G. Performance Data

Biocompatibility testing on the Bard CollaMend Implant has been completed. The biocompatibility test results show that the material used in the design and manufacture of the proposed device is non-toxic and non-sensitizing to biological tissues consistent with its intended use.

An animal implant study was performed to confirm the functionality and in-growth characteristics of the Bard CollaMend Implant as compared to the predicate Permacol Implant.

Laboratory test results demonstrate that the material chosen, the manufacturing process, and the design utilized for the Bard CollaMend Implant met the established specifications necessary for consistent performance during its intended use.

Davol Inc. Premarket Notification for Bard CollaMend Implant

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Davol, Inc. % Ms. Stephanie Baker Regulatory Affairs Associate 100 Sockanossett Crossroad Cranston, Rhode Island 02920

NUV 2 1 2006

Re: K063178

Trade/Device Name: Bard® CollaMend™ Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: October 13, 2006 Received: October 19, 2006

Dear Ms. Baker:

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 such 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); 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.

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Page 2 - Ms. Stephanie Baker

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

foe
Mark N. Mellerson

Mark N. Director Division of General, Restorative and Neurological 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:

Indications for Use:

KO 63178

Bard® CollaMend™ Implant

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)

Polo R

(Division Sign-C Division of Gene I, Restorative, and Neurological Devices

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510(k) Number

000012

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.