(30 days)
PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
PSDV-SG can be used for reinforcement of staple lines during bariatric, gastric, small bowel, colon and colorectal procedures.
PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age, originating from the United States.
There are two types of PSDV-SG configurations based on the tissue buttress thickness range. The Standard configuration has a tissue buttress thickness range of 0.20-0.60mm. The Thin configuration has a tissue buttress thickness range of 0.20-0.40mm.
The product consists of a loading unit which includes two (2) buttresses, one for the anvil and one for the cartridge side of the stapler. The buttresses are held in a foam/sheath configuration for loading of the buttress to the stapler jaws. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch.
PSDV-SG utilizes animal tissue; patient must be informed prior to any procedure.
PSDV-SG is provided sterile and intended for single use. Sterilization is accomplished via ethylene oxide (ETO). The bovine pericardium buttress and acrylic adhesive are considered permanent implants per ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
This document describes the PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG) device, which is a surgical mesh intended for staple line reinforcement. It is a Special 510(k) submission, meaning the changes are relatively minor compared to a predicate device.
Based on the provided text, here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner with numerical targets for clinical performance metrics (e.g., specific reduction in anastomotic leaks, burst pressure thresholds). Instead, it focuses on demonstrating substantial equivalence to a predicate device by showing that the technological characteristics and performance (functional, manipulation, dimensional, usability, and shelf-life) are similar.
The "performance" described is largely comparative to the predicate device and verification/validation results. The core of the performance claim is that the device maintains the same intended use, indications for use, materials, and principles of operation as the predicate, despite changes in size and design for stapler compatibility.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit from text) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate device (K192615) | SAME |
| Indications for Use | Same as predicate device (K192615) | SAME |
| Materials | Same as predicate device | SAME (bovine pericardium, acrylic adhesive) |
| Principle of Operation | Same as predicate device | SAME (non-cross-linked collagen tissue technology for neo-collagen formation, neovascularization, and remodeling) |
| Manipulation Testing | Performed to demonstrate device's handling characteristics | Performed, specific results not detailed but support substantial equivalence. |
| Functional Testing | Performed to demonstrate device's operational capabilities | Performed, specific results not detailed but support substantial equivalence. |
| Dimensional Testing | Performed to ensure correct sizing and fit for stapler compatibility | Performed, specific results not detailed but support substantial equivalence. |
| Usability Testing | Performed to assess ease of use and user interaction | Performed, specific results not detailed but support substantial equivalence. |
| Shelf-life | Stability over time | 1 year with testing to 3 years ongoing (predicate had 3 years). This is a difference, but presumably accepted by FDA. |
| Stapler Compatibility | Compatibility with specified stapler models (new models compared to predicate) | Predicate: Ethicon Echelon ENDOPATH Staplers (K163455, K160521, K140560). Subject Device: Medtronic Endo GIA Staplers (K111825) and Intuitive Surgical SureForm Staplers (K173721). This is a key difference addressed by the Special 510(k). |
Note: The document states "Verification and validation of the product have been completed using the same test methods as the predicate device, or accepted industry standard methods. No new issues of safety and effectiveness have been identified." This implies that the results from these tests met the internal acceptance criteria established by the manufacturer, which were aligned with the predicate or industry standards. However, the specific numerical acceptance criteria (e.g., minimum burst pressure, maximum staple pull-through force) are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document states "Testing performed to support the new product models subject of this submission included manipulation, functional, and dimensional testing, as well as usability and shelf-life." It does not provide details on the sample sizes used for these tests.
Regarding data provenance:
- Country of Origin: Not specified for the testing data.
- Retrospective or Prospective: Not specified. These appear to be benchtop and perhaps simulated use tests, not clinical studies involving patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This submission focuses on engineering and bench testing performance for substantial equivalence, not clinical diagnostic accuracy or efficacy. There is no mention of "ground truth" derived from expert review in the clinical sense.
4. Adjudication Method for the Test Set
N/A. As there's no mention of expert review or clinical studies for ground truth establishment, no adjudication method is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. There is no mention of a human reader or AI comparative effectiveness study. This device is a surgical mesh, not a diagnostic imaging or AI-assisted interpretation device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This device is a physical surgical mesh, not a software algorithm.
7. The Type of Ground Truth Used
For the engineering and functional tests conducted, the "ground truth" would be established by:
- Measurement Standards: Adherence to predefined dimensional and physical property specifications.
- Performance Specifications: Meeting functional requirements (e.g., tear strength, adhesion, burst pressure if these were tested) derived from predicate device performance or industry standards.
- Visual Inspection: For manipulation and usability tests, often a qualitative or semi-quantitative assessment against predefined criteria.
No pathology or outcomes data is mentioned as "ground truth" in this context of bench testing for substantial equivalence for the device itself.
8. The Sample Size for the Training Set
N/A. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
N/A. Not an AI/ML device.
§ 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.