The CollaMend FM 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.

Device Description

The proposed device is a sterile, fenestrated, off-white sheet of lyophilized, acellular porcine dermal collagen and its constituent 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 via fenestrations 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

This is a 510(k) summary for a medical device called the CollaMend FM Implant, which is a surgical mesh. This document does not describe a study involving an algorithm or AI. It focuses on demonstrating substantial equivalence to predicate devices based on material and manufacturing process similarities, with a minor design difference (fenestrations). Therefore, many of the requested categories are not applicable.

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

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

This document does not present quantitative acceptance criteria or specific performance metrics in a table format as would be typical for an AI/algorithm study. Instead, it relies on demonstrating substantial equivalence to existing predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility (non-toxic, non-sensitizing)	Meets this criterion based on testing of the predicate CollaMend Implant, as the CollaMend FM Implant is made from the same source material.
Structural Integrity (strength, endurance)	Cross-linked to increase strength and endurance; fenestrations are the only design difference from the predicate, implying similar overall structural integrity with added benefits for tissue ingrowth.
Ability to reinforce soft tissue, e.g., hernia repair	Indicated for this use, similar to predicate devices.
Allows cellular infiltration and replacement by host tissue	Fenestrations are explicitly designed for this purpose, improving upon the predicate CollaMend Implant in this aspect for "a more convenient pathway for tissue ingrowth in-vivo."
Sterility verification (Ethylene Oxide)	Sterilized similarly to predicate.
Rehydration properties (before implantation)	Requires rehydration for a minimum of 3 minutes, similar to one predicate, and differing from another predicate (SIS Hernia Repair Device) which requires 10 minutes.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. This document is a 510(k) submission for a device, not a study evaluating an AI/algorithm's performance on a specific test set. The "test set" for this submission refers to the device itself and its material properties.
Data Provenance: Not applicable in the context of an AI/algorithm. Biocompatibility data was derived from testing on the predicate CollaMend Implant. The materials used are porcine dermal collagen.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There isn't a "ground truth" established by experts in the context of an AI/algorithm's performance evaluation. The "ground truth" for device safety and effectiveness is established through biocompatibility testing, material characterization, and comparison to legally marketed predicate devices, as reviewed by FDA regulatory experts.

4. Adjudication method for the test set:

Not applicable. No adjudication method for an AI/algorithm test set is mentioned.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a medical device (surgical mesh), not an AI/algorithm.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used:

Not applicable in the context of AI. The closest equivalent to "ground truth" here is the established safety and effectiveness of the predicate devices (Bard CollaMend Implant and SIS Hernia Repair Device) through prior regulatory clearance and documented biocompatibility. The performance data relies on the inherent material properties and design, validated by comparison to these predicates.

8. The sample size for the training set:

Not applicable. This is not an AI/algorithm, so there is no training set.

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

Not applicable. As this is not an AI/algorithm, there is no training set or associated ground truth establishment process in that context.

Summary

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K082657
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SECTION 7.0

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE COLLAMEND FM IMPLANT

OCT 1 7 2008

Submitter Information A.

Submitter's Name:	Davol Inc.
Address:	Subsidiary of C. R. Bard, Inc.100 Crossings BoulevardWarwick, RI 02886
Telephone:	(401) 825-8583
Fax:	(401) 825-8765
Contact Person:	Kevin G. Stevens
Date of Preparation:	Friday, September 12, 2008

B. Device Name

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

C. Predicate Device Name

Bard CollaMend Implant (Davol, Inc.) Trade name:

SIS Hernia Repair Device (Cook Medical) Trade name:

D. Device Description

E. Intended Use

PREMARKET NOTIFICATION FOR THE COLLAMEND FM IMPLANT

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

The proposed device and the predicate CollaMend Implant differ only in design with CollaMend FM Implant having a pre-determined pattern of holes throughout the implant to allow for a more convenient pathway for tissue ingrowth in-vivo. The fenestrations allow for cellular infiltration. The "FM" in the name CollaMend FM Implant stands for fenestrated matrix.

The proposed device follows the same current manufacturing process as the predicate CollaMend Implant until the final manufacturing step (die cutting). At this point the fenestrations are added while simultaneously the device is cut to size. All other processes before and after this manufacturing step are identical. This results in a fenestrated implant similar to the predicate SIS Hernia Repair Device (Cook Medical).

The proposed device and both predicates are manufactured from animal (porcine) tissue materials. The proposed device and predicate CollaMend Implant are manufactured from acellular porcine dermis collagen. SIS Hernia Repair Device is manufactured from porcine intestinal collagen. All three devices are flexible flat sheets of material and are available in a variety of sizes and/or shapes.

The proposed device and the predicate CollaMend Implant are lyophilized before sterilization (Ethylene Oxide). Before use, both must be completely hydrated by immersion in sterile saline solution or sterile lactated Ringer's solution for a minimum of 3 minutes or until the clinical deems appropriate for the application. SIS Hernia Repair Device requires a minimum of 10 minutes for rehydration.

G. Performance Data

Biocompatibility testing on the predicate CollaMend Implant has been completed. The biocompatibility test results show that the implant is nontoxic and non-sensitizing to biological tissues consistent with its intended use.

Given that the predicate CollaMend Implant and proposed CollaMend FM Implant are manufactured from the same source material and are identical

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aside from the presence of fenestrations throughout the implant, no further biocompatibility testing was performed. The performance data provided clearly demonstrates that CollaMend FM Implant is substantially equivalent to CollaMend Implant and/or SIS Hernia Repair Device.

PREMARKET NOTIFICATION FOR THE COLLAMEND FM IMPLANT

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2008

C.R. Bard, Inc. % Mr. Kevin G. Stevens Sr. Regulatory Affairs Associate 100 Crossings Boulevard Warwick, Rhode Island 02886

Re: K082687

Trade/Device Name: CollaMend FM Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: September 12, 2008 Received: September 15, 2008

Dear Mr. Stevens:

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 - Mr. Kevin G. Stevens

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

Mark M. Wilkerson

Mark N. Melkerson 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):

K08 2687

Device Name:

CollaMend FM Implant

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)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K082687

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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.