Bard Modified Extra Large Composix Kugel Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.

Device Description

The modified XL Composix Kugel Mesh is a self-expanding, two-layered mesh with two extruded monofilament PET polymer "rings". The mesh is constructed of knitted polypropylene monofilament approximately 0.006" in diameter. The mesh is knitted to form a strong, porous, support material. The knit structure of the polypropylene mesh is identical to that of the predicate Composix Kugel Mesh product and allows for repair of the defect. The monofilament PET polymer "rings" add stability to the device enabling greater simplicity and assurance in the proper placement of the patch.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "Modified XL Composix Kugel Mesh." It is a submission to the FDA seeking to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing a new device to an existing one, rather than presenting a detailed study proving the new device's performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested details about acceptance criteria, clinical study specifics, and ground truth establishment are not present in this document because they are generally not required for a 510(k) submission that relies on equivalence to a predicate device.

Here's an attempt to answer the questions based only on the provided text, noting where information is absent:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria Reported Device Performance
N/A N/A

Explanation: The document does not explicitly state acceptance criteria or provide a table of device performance against such criteria. The submission is based on demonstrating "substantial equivalence" to a predicate device, not on meeting predefined performance metrics through a clinical study.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable. No test set for a clinical study is described.
- Data Provenance: Not applicable. The "Performance Data" section mentions "Bench testing," which is typically laboratory-based and doesn't involve patient data from specific countries or study designs (retrospective/prospective).
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):
- Number of Experts: Not applicable. No clinical test set requiring expert ground truth establishment is described.
- Qualifications of Experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.
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:
- MRMC Study: No. This document describes a medical mesh device, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant or mentioned.
- Effect Size: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: Not applicable. This is a medical device (mesh), not a software algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not applicable for a clinical study. For bench testing, the "ground truth" would be engineering specifications and validated measurement methods to assess the device's physical properties.
The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that would require training data.
How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable.

Acceptance Criteria	Reported Device Performance
N/A	N/A

Summary

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K061314

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE MODIFIEDCOMPOSIX KUGEL MESH

A. Submitter Information

Submitter's Name:	Davol, Inc.
Address:	Subsidiary of C. R. Bard, Inc.
	100 Sockanossett Crossroad
	Cranston, RI 02920
Telephone:	401-463-7000 ext. 2389
Fax:	401-463-3845
Contact Person:	Robin M. Drago
Date of Preparation:	May 24, 2006

B. Device Name

XL Composix Kugel Mesh

C. Predicate Device Name

Trade name: Composix Kugel Mesh

D. Device Description

E. Intended Use

The modified XL Composix Kugel Mesh is intended for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. It has the same intended use as the predicate Composix Kugel Mesh.

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

The overall design of the modified XL Composix Kugel is still equivalent to the predicate Composix Kugel describe in K003323. Both the modified XL Composix Kugel and the predicate Composix Kugel described in K003323 consist of two layers of polypropylene mesh and one layer of ePTFE and a PET recoil ring. The rings add stability to the device enabling greater simplicity and assurance in the proper placement of the device. K003323 covered product with both 0.030" and 0.042" diameter recoil rings. The current proposed design modifications involve using only the 0.030" ring in the XL Composix Kugel and increasing the strength specification of the ring weld in the XL size Composix Kugel codes. In order to achieve this a manufacturing change is being proposed which will increase the weld strength. Although the weld strength will be increased the ring will still have the same intended use (i.e. to add stability to the device enabling greater simplicity and assurance in the proper placement of the device.

G. Performance Data

Bench testing has been completed and supports the safety and effectiveness of the modified XL Composix Kugel Mesh for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is a symbol of medicine and healthcare, and it is depicted with a staff entwined by two snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 2 2006

Davol. Inc. % Ms. Robin M. Drago VP, Regulatory and Clinical Affairs 100 Scokanossett Crossroad Cranston, Rhode Island

Re: K061314

Trade/Device Name: Bard® Modified Extra Large Composix® Kugel® Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: May 10, 2006 Received: May 11, 2006

Dear Ms. Drago:

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

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Page 2 - Ms. Robin M. Drago

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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

Mark N. Melke 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):

K061314

Device Name: Hernia Patch

Bard® Modified Extra Large Composix® Kugel®

Indications For Use:

Bard Modified Extra Large Composix Kugel Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.

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)

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

KOGI314 510(k) Number_

CONFIDENTIAL

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.