The Bard® InnerLace™ BioUrethral Support System is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for use as a pubourethral sling for the treatment of stress urinary incontinence in women resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

The Bard® InnerLace" BioUrethral Support System consists of a Bard InnerLace™ System Pelvicol® implant and an introducer device to facilitate quick and simple placement of the implant. The Bard® InnerLace™ System Pelvicol® Implant is positioned suburethrally to provide a natural backboard for the urethra during abdominal pressure increases.

The introducer allows a choice of either suprapubic or retropubic implantation techniques depending on physician preference. The introducer set includes a removable handle, two introducer needles, and four snap-on tissue connectors.

AI/ML Overview

The provided document describes a 510(k) summary for the Bard® InnerLace™ BioUrethral Support System. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way a new device's efficacy or safety study would.

Therefore, an acceptance criteria table and a detailed study proving the device meets those criteria, as typically understood for AI/ML device evaluations, are not present in this document.

Here's an analysis of the provided information in the context of the requested sections:

A table of acceptance criteria and the reported device performance:
- Not Applicable. This document does not present specific quantitative acceptance criteria or performance metrics for the device. The 510(k) submission aims to demonstrate substantial equivalence, not to meet pre-defined performance thresholds through a new clinical or technical study as would be seen for a novel device. The "Performance Data Summary" explicitly states: "The Bard® InnerLace™ BioUrethral Support System is substantially equivalent to the predicate devices with regard to biocompatibility, materials and product characterization. The modified design of the Bard® InnerLace™ System Pelvicol® Implant does not raise any new types of safety or efficacy issues." This indicates a comparison to an existing device, not a new performance study against specific criteria.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. The document does not describe a test set or data provenance for a study. The information focuses on the device description and its intended use, asserting equivalence to a predicate device.
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):
- Not Applicable. As no specific performance study with a test set is described, there's no mention of experts establishing ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or associated adjudication method 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:
- Not Applicable. This device is a surgical mesh, not an AI/ML-driven diagnostic or imaging device. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (surgical mesh), not an algorithm. Standalone algorithm performance is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No ground truth is established in the context of a new performance study. The substantial equivalence relies on the established safety and efficacy of the predicate device.
The sample size for the training set:
- Not Applicable. This device is a surgical mesh, not an AI/ML system requiring a training set.
How the ground truth for the training set was established:
- Not Applicable. Not an AI/ML system; no training set or ground truth for training is relevant.

In summary, the provided 510(k) submission for the Bard® InnerLace™ BioUrethral Support System is a regulatory document focused on demonstrating substantial equivalence to a legally marketed predicate device (Permacol® Acellular Collagen Matrix) based on manufacturing processes, materials, and product characterization, rather than presenting a performance study with specific acceptance criteria and test results for a novel device or AI/ML system.

Summary

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MAY 1 5 2003

K031295/ppk

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

A. SUBMITTER INFORMATION:

Submitter's Name:

Address:

Contact Person: Contact Person's Telephone Number: Contact Person's Fax: Date of Preparation:

C.R. Bard, Inc. Bard Urological Division 8195 Industrial Blvd. Covington, GA 30014 Frances E. Harrison, RAC 770-784-6257 770-784-6419 April 17, 2003

B. DEVICE NAME:

Trade Name: Bard® InnerLace™ BioUrethrai Support System Common / Usual Name: Surgical Mesh Polymeric Surgical Mesh Classification Name:

C. PREDICATE DEVICE NAME:

Trade Name: Permacol® Acellular Collagen Matrix

D. DEVICE DESCRIPTION:

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Image /page/1/Picture/0 description: The image contains a handwritten alphanumeric string. The string appears to be "K031295/P2/2". The characters are written in black ink on a white background. The writing style is cursive.

E. INTENDED USE:

F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:

The fundamental technology of processing the Bard® InnerLace™ System Pelvicol® Implant and the predicate device, Permacol® implant, are the same.

G. PERFORMANCE DATA SUMMARY:

The Bard® InnerLace" BioUrethral Support System is substantially equivalent to the predicate devices with regard to biocompatibility, materials and product characterization. The modified design of the Bard® InnerLace™ System Pelvicol® Implant does not raise any new types of safety or efficacy issues.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest the wings and body of the bird.

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

Ms. Frances E. Harrison, RAC Director, Regulatory Affairs C.R. Bard, Inc. Bard Urological Division 8195 Industrial Boulevard COVINGTON GA 30014

SEP 2 8 2012

Re: K031295 Trade/Device Name: Bard® InnerLace™ BioUrethral Support System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAG Dated: April 16, 2003 Received: April 23, 2003

Dear Ms. Harrison:

This letter corrects our substantially equivalent letter of May 15, 2003.

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 (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

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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 of medical device-related adverse events) (21 CFR 803); 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.

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/CDRHOffices/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" (21 CFR 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/ReportaProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Perkins

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K031295

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):	K031295
Device Name:	Bard® InnerLace™ BioUrethral Support System

Indications for Use:

Muriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

ﺮ Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use _____________

(Optional Format 1/2/96)

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.