(261 days)
The Ventrio™ Light Hernia Patch is indicated for use in the reconstruction of soft tissue in procedures involving soft tissue repair where weakness exists, such as for the repair of hernias. The TRM Antimicrobial Coating has been shown to reduce or inhibit microbial colonization on the device.
The proposed Ventrio Light Hernia Patch with TRM Antimicrobial Coating is a selfexpanding, nonabsorbable, sterile prosthesis. It contains two primary layers of monofilament polypropylene mesh to form a positioning pocket. This pocket is stitched with a polytetrafluroethylene (PTFE) monofilament thread to an expanded polyfluoroethylene (ePTFE) sheet. The two primary layers of polypropylene mesh are constructed of a lighter weight, "larger-pore" (as defined below), knitted polypropylene monofilament approximately 0.0043" in diameter. The polypropylene mesh used in the proposed device weighs approximately 51% less per unit area than the polypropylene mesh used in the posterior layer of the predicate Ventrio Hernia Patch (0.024 g/in' versus 0.049 g/in2). The pore size of the mesh used in the proposed product is 0.082 in2 as compared to 0.019 in for the mesh used in the posterior layer of the predicate Ventrio Hernia Patch. The device contains SorbaFlex™ Memory Technology, which provides memory and stability to the device, facilitating ease of initial insertion, proper placement, The SorbaFlex Memory Technology is comprised of an extruded and fixation. polydioxanone (PDO) monofilament that is contained within a knitted polypropylene mesh sleeve. The PDO monofilament is dyed violet with D&C Violet No. 2 and fully degrades in vivo by means of hydrolysis with absorption essentially complete in 6-8 months.
The proposed Ventrio Light Hernia Patch surfaces are coated with TRM Antimicrobial Coating, which is comprised of a bioresorbable L-tyrosine succinate polymer (T) and antimicrobial agents rifampin (R) and minocycline (M). The coating is shaded orange in color due to the color of the antimicrobial agents. The TRM Antimicrobial Coating has been shown to reduce or inhibit microbial colonization on the device during the initial healing process for up to 7 days following surgery. The bioresorbable L-Tyrosine succinate polymer is essentially absorbed in 6 - 8 months based on in vitro studies.
The fascial side of the Ventrio Light Hernia Patch (polypropylene) allows a prompt fibroblastic response through the interstices of the mesh, allowing for tissue in-growth into the device. The visceral side of the device (ePTFE) has a submicronic porosity to minimize tissue attachment to the device.
Acceptance Criteria and Device Performance for Ventrio™ Light Hernia Patch with TRM Antimicrobial Coating (K113229)
This submission (K113229) outlines the substantial equivalence of the Ventrio™ Light Hernia Patch with TRM Antimicrobial Coating to its predicate devices. The "acceptance criteria" here refers to demonstrating that the new device is as safe and effective as the predicate devices, particularly regarding its modified characteristics and the addition of an antimicrobial coating. The study performed aims to support this substantial equivalence claim.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present acceptance criteria in a quantitative table format with corresponding performance results. Instead, the "acceptance criteria" are implied by the need to demonstrate substantial equivalence to predicate devices across various attributes, particularly that differences do not adversely affect safety and effectiveness. The "reported device performance" is a summary of the outcomes of the various tests conducted to support this claim.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Device is biocompatible per ISO 10993 series standards. |
| Physical and Functional Characteristics (compared to Ventrio Hernia Patch predicate) | Laboratory bench testing demonstrated that differences stemming from: |
- Lighter weight, larger pore polypropylene mesh (primary layers)
- Polypropylene mesh sleeve for PDO monofilament
- Reduced number of sizes (5 vs 9)
do not adversely affect safety and effectiveness. |
| Peritoneal Tissue Attachment (in vivo) | Evaluated in porcine study. (Specific outcomes not detailed, but implied to be acceptable for substantial equivalence). |
| Mesh Contracture (in vivo) | Evaluated in porcine study. (Specific outcomes not detailed, but implied to be acceptable for substantial equivalence). |
| Mechanical Tissue In-growth (in vivo) | Evaluated in porcine study. (Specific outcomes not detailed, but implied to be acceptable for substantial equivalence). |
| Host Inflammatory Response (in vivo) | Evaluated in porcine study. (Specific outcomes not detailed, but implied to be acceptable for substantial equivalence). |
| Antimicrobial Efficacy (TRM coating) | Speed to Kill: Tested analytically and in vitro.
Kinetic Drug Release (KDR): Tested analytically and in vitro.
Drug Content and Impurity: Tested analytically and in vitro.
Microbial Colonization/Abscess Formation: Two in vivo dorsal rabbit infection model studies performed, showing the coating reduces or inhibits microbial colonization and macroscopic abscess formation. |
| Polymer Degradation (TRM coating) | Tested analytically and in vitro. |
| Interaction with Device Components (ePTFE, PDO) | Testing showed no interaction with ePTFE and PDO, and no adverse effect on the release profile of rifampin and minocycline. |
Note: The document focuses on demonstrating that the new device is "substantially equivalent" to predicate devices, meaning it has the same intended use, and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The specific quantitative acceptance limits for each test are not provided in this summary.
2. Sample Sizes Used for the Test Set and Data Provenance
- Laboratory Bench Testing: Not specified.
- In vivo Porcine Study: The sample size is not explicitly stated in the summary.
- In vivo Dorsal Rabbit Infection Model Studies: "Two in vivo dorsal rabbit infection model studies" were performed. The number of animals per study is not specified.
- Analytical and in vitro testing (speed to kill, KDR, drug content/impurity, polymer degradation): Not specified.
Data Provenance:
- The studies mentioned (porcine, rabbit) are "in vivo" studies, implying prospective animal studies designed specifically for this submission.
- The country of origin for the data is not specified, but given the US FDA submission context, it is presumed to be conducted either in the US or in facilities compliant with relevant US regulations for animal studies.
3. Number of Experts and Qualifications for Ground Truth
The provided document describes non-clinical performance testing (bench, animal, in vitro) for substantial equivalence. It does not involve human clinical data, diagnostic interpretation, or visual assessment by experts defining ground truth in the way an AI/ML device study would. Therefore, this section is not applicable to this 510(k) summary. No radiologists, pathologists, or similar experts were used to establish ground truth in this context.
4. Adjudication Method
As this is a non-clinical device submission not involving human interpretation or diagnosis, an adjudication method for a test set is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted. This device is a surgical mesh, not a diagnostic imaging or AI-assisted interpretation device. Therefore, a study to measure human reader improvement with or without AI assistance is not applicable.
6. Standalone Performance Study
The primary studies conducted (laboratory bench testing, in vivo animal studies, analytical and in vitro testing) assessed the standalone performance of the device's physical properties, biological interactions, and antimicrobial efficacy. These are not "algorithm only without human-in-the-loop performance" in the context of AI, but rather directly evaluate the device's functional characteristics.
7. Type of Ground Truth Used
The "ground truth" for the various tests was established through:
- Direct physical measurements and engineering specifications: For bench testing of physical and functional characteristics.
- Histopathological analysis and visual observation: For in vivo animal studies (peritoneal tissue attachment, mesh contracture, tissue in-growth, host inflammatory response, microbial colonization, abscess formation). This would involve trained veterinary pathologists or researchers.
- Chemical and microbiological assays: For analytical and in vitro testing of antimicrobial efficacy (speed to kill, KDR, drug content, impurity) and polymer degradation.
8. Sample Size for the Training Set
The concept of a "training set" is relevant for AI/ML models. This submission is for a physical medical device (surgical mesh), not an AI/ML device. Therefore, a "training set" in this context is not applicable. The device's design, materials, and manufacturing processes are developed through traditional engineering and R&D, not machine learning training.
9. How Ground Truth for the Training Set Was Established
As there is no AI/ML training set, this question is not applicable.
§ 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.