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K Number
K060713
Device Name
PROCEED SURGICAL MESH
Manufacturer
ETHICON INC.
Date Cleared
2006-05-25

(69 days)

Product Code
FTL
Regulation Number
878.3300
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

PROCEED Surgical Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Description

PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh deigned for the repair of hernias and other fascial deficiencies. The mesh product is comprised of an oxidized regenerated cellulose (ORC) fabric, and PROLENE* Soft Mesh, a nonabsorbable polypropylene mesh, which is encapsulated by a polydioxanone polymer. The polypropylene mesh side of the product allows for tissue ingrowth while the ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh. The polydioxanone provides a bond to the ORC layer.

AI/ML Overview

This document is a 510(k) summary for the PROCEED Surgical Mesh, comparing it to a predicate device. It confirms substantial equivalence based on technological characteristics and intended use, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document discusses:

  • Submitter and contact information
  • Trade Name, Common Name, Classification Name, and Product Code
  • Predicate Device: PROCEED Trilaminate Surgical Mesh
  • Device Description: A sterile, thin, flexible laminate mesh for hernia repair, comprised of oxidized regenerated cellulose (ORC) fabric and PROLENE* Soft Mesh, encapsulated by polydioxanone polymer. The polypropylene mesh side allows for tissue ingrowth, while the ORC side provides a bioresorbable layer to minimize tissue attachment.
  • Intended Use: For the repair of hernias and other fascial deficiencies requiring reinforcing or bridging material.
  • Technological Characteristics: Stated as "identical to the predicate device, PROCEED SURGICAL Mesh."
  • Conclusions: "The descriptive information provided about PROCEED Surgical Mesh demonstrates substantial equivalence to the predicate device."
  • FDA Clearance Letter: Confirming substantial equivalence.
  • Indications for Use Statement: Reiterating the intended use.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth, or MRMC studies, as none of this information is present in the provided text.

§ 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.