|
Bard CK Parastomal Hernia Patch
Device Description
The proposed device is a self-expanding, two-layered polypropylene mesh containing an extruded monofilament PET polymer "ring". The top layer of polypropylene mesh has two slits in it to form pockets. The purpose of the pockets is to facilitate placement, positioning and fixation of the device. The mesh is constructed from knitted polypropylene monofilament. The monofilament PET "ring" adds stability to the device facilitating placement and assurance in the proper placement of the patch. A single layer of expanded polytetrafluoroethylene (ePTFE) is attached to the polypropylene mesh. The attachment is accomplished with an interlocking stitch using polytetrafluoroethylene (PTFE) monofilament. The peripheral edge (excluding the off-center opening) of the polypropylene mesh is heat sealed to the ePTFE layer. An off-centeropening in the proposed device accommodates the stoma and this opening surrounded by an ePTFE collar. The ePTFE collar is attached to the mesh side of the proposed device with an interlocking stitch using PTFE monotilamtent. A slit in the proposed device extends from the opening in the proposed device to the perimeter to facilitate positioning of the proposed device around the stoma. The proposed device is preshaped and presized to offer maximum ready-to-use benefits.
Intended Use
The Bard CK Parastomnal Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of abdominal wall defects and hernias, including parastomal hernias.
Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
The proposed device has the same exact materials as the predicate Composix Kugel, along with similar physical attributes, performance characteristics and manufacturing methods as the predicate Composix Kugel.
The difference between the proposed and predicate device includes the opening in the proposed device surrounded by the ePTFE collar and theslit in the proposed device to access the opening in the proposed device. The predicate device does not have an opening surrounded by an ePTFEcollar and does not have a slit in the device. The shape of the memory recoil "ring" in the proposed device is different from the shape of the memory recoil "ring" in the predicate device.
The Gore SEAMIGUARD Staple Line Reinforcement Material (K00 1789) indication includes the repair of hernias, including paracolostorny hernias. This indication is the same as the proposed device indication statement. The proposed device is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of abdominal wall defects and hernias, including parastomal hernias. The predicate Composix Kugel and the proposed device are both intended for use in hernia repair.
The proposed device provides an additional example of a parastomnal hernia. The parastomal hernia is part of the broader indication of a hernia. A hernia ispart of a broader indication of soft tissue deficiency. Therefore, the predicate Composix Kugel and the proposed device have the same indication statement.
Performance Data
Biocompatibility and bench testing have been completed and support thesafety and effectiveness of the Bard CK Parastomal Hernia Patch for itsintended use. The biocompatibility test results show that the material used in the designand manufacture of the device are non-toxic and non-sensitizing tobiological tissues consistent with their intended use. Laboratory testresults demonstrate that the materials chosen and the design utilized in manufacturing the Bard CK Parastomal Hernia Patch will meet the established specifications necessary for consistent performance duringtheir intended use. Davol Inc.
Premnarket Notification for Bard CK Parastomal Hernia Patch |
HERNIA TREATMENT CENTER™
