BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM

• K Number: K031295
• Device Name: BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM
• Manufacturer: C.R. BARD, INC.
• Date Cleared: 2003-05-15 ( 22 days)
• Product Code: PAG
• Regulation Number: 878.3300
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: N/A

Intended Use

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:

1. 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.

2. 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.

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):

   • Not Applicable. As no specific performance study with a test set is described, there's no mention of experts establishing ground truth.

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

   • Not Applicable. No test set or associated adjudication method is described.

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:

   • 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.

6. 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.

7. 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.

8. The sample size for the training set:

   • Not Applicable. This device is a surgical mesh, not an AI/ML system requiring a training set.

9. 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.

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.