(9 days)
Ventralight™ ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. The Echo PSTM Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic hemia repair.
The proposed Ventralight™ ST Mesh with Echo PSTM Positioning System is comprised of a hernia repair mesh with a pre-attached mesh positioning system (mesh deployment balloon). All sizes of the proposed product with the exception of the largest size will also include an Introducer Tool designed to aid the user in laparoscopic introduction of the mesh/positioning system assembly.
The Ventralight™ ST Mesh is a low profile, sterile, single use device indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. This device is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a PP surface and a PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh is a bioresorbable coating, separating the mesh from underlying tissue and organ surfaces to minimize tissue attachment to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.
The Ventralight™ ST Mesh described above will be packaged preassembled with the Echo PSTM Positioning System, a removable mesh deployment balloon, previously cleared under K102766. The positioning system is an RF welded nylon balloon that is pre-attached to the mesh via the use of polycarbonate connectors, and is designed to help facilitate laparoscopic deployment, including unrolling, positioning, and placement of the Ventralight™ ST Mesh. The positioning system is inflated via use of the included inflation assembly, which is also identical to that cleared with the predicate positioning system under K102766.
For user convenience, all sizes of the proposed product with the exception of the largest size also include an Introducer Tool which is intended to facilitate delivery to the operative site. The largest configuration of the proposed product, the 12" x 14" size does not include an Introducer Tool as this size is recommended for deployment directly through a trocar incision site. The Introducer Tool included with the proposed product is identical to the Introducer Tool cleared under K102766 which consists of a handle with a thin stainless steel rod and a T-cap. The device is split into two pieces along the length of the entire rod and attached on one end to the handle.
The provided text details a 510(k) premarket notification for a medical device called the Ventralight™ ST Mesh with Echo PS™ Positioning System. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
However, the document does not contain specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy, or any quantitative measures for human readers' performance with/without AI assistance), or details about a study that would specifically prove the device meets such criteria in the context of AI/machine learning performance.
Instead, the submission focuses on demonstrating:
- Biocompatibility: In accordance with ISO 10993-1 standards for the mesh and positioning system. The Introducer Tool's material (304 Stainless Steel) is recognized as biocompatible per ASTM F899-09e1, and its polymer handle is non-patient contacting.
- Bench Testing & In Vivo Simulated Use: These were conducted to show the device design meets product specifications and intended uses.
- Substantial Equivalence: By comparing technological characteristics, performance, and intended use to predicate devices (Ventralight™ ST Mesh, K101851, and Composix™ L/P Mesh with Echo PS™ Positioning System, K102766). The proposed device combines components previously cleared under separate 510(k)s.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample size, data provenance, expert truth establishment, adjudication methods, or MRMC studies, as these types of details are not present in the provided 510(k) summary. The submission is for a mesh and positioning system, which are physical medical devices, not an AI/machine learning device that would typically have performance metrics like sensitivity or specificity.
§ 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.