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510(k) Data Aggregation
(155 days)
BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160
The Bard The PerFix™ Light Plug is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
The Proposed Product, Bard® PERFIX™ Light Plug is a pre-formed three-dimensional (cone shape) device constructed of a fluted outer layer and multiple inner layers of mesh attached at the tip. The device has a large pore design and is constructed of knitted polypropylene monofilaments. The pores in the mesh allow for tissue ingrowth. A separate flat, pre-shaped onlay patch (2.3" x 5.4") will be packaged with each device. The Bard® PERFIX™ Light Plug will be offered in a range of sizes with the largest being the extra large PerFix™ Plug 1.5" x 2.0" (4.1cm x 5.0cm). The extra large size consists of three (3) preformed medium shells held in place, side by side, inside a pre-formed large shell. The small, medium and large sizes consist of an outer cone with 2 pieces of mesh (petals) to help the plug maintain its fluted form. The inner petals and cones are sewn together at the tip with a single polypropylene monofilament thread.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Bard® PERFIX™ Light Plug:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Attribute | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|---|
| Physical Properties | Thickness | Substantially equivalent to predicates | "Laboratory testing discussed in this submission demonstrate that the material chosen and the design utilized in manufacturing the PERFIX™ Light Plug is substantially equivalent to the referenced Predicates." (General statement, no specific values reported) |
| Pore Size | Substantially equivalent to predicates | "Laboratory testing discussed in this submission demonstrate that the material chosen and the design utilized in manufacturing the PERFIX™ Light Plug is substantially equivalent to the referenced Predicates." (General statement, no specific values reported) | |
| Density | Substantially equivalent to predicates | "Laboratory testing discussed in this submission demonstrate that the material chosen and the design utilized in manufacturing the PERFIX™ Light Plug is substantially equivalent to the referenced Predicates." (General statement, no specific values reported) | |
| Stiffness | Substantially equivalent to predicates | "Laboratory testing discussed in this submission demonstrate that the material chosen and the design utilized in manufacturing the PERFIX™ Light Plug is substantially equivalent to the referenced Predicates." (General statement, no specific values reported) | |
| Mechanical Properties | Tensile Strength | Substantially equivalent to predicates | "Laboratory testing discussed in this submission demonstrate that the material chosen and the design utilized in manufacturing the PERFIX™ Light Plug is substantially equivalent to the referenced Predicates." (General statement, no specific values reported) |
| Percent Elongation | Substantially equivalent to predicates | "Laboratory testing discussed in this submission demonstrate that the material chosen and the design utilized in manufacturing the PERFIX™ Light Plug is substantially equivalent to the referenced Predicates." (General statement, no specific values reported) | |
| Suture Pullout Strength | Substantially equivalent to predicates | "Laboratory testing discussed in this submission demonstrate that the material chosen and the design utilized in manufacturing the PERFIX™ Light Plug is substantially equivalent to the referenced Predicates." (General statement, no specific values reported) | |
| Burst Strength | Substantially equivalent to predicates | "Laboratory testing discussed in this submission demonstrate that the material chosen and the design utilized in manufacturing the PERFIX™ Light Plug is substantially equivalent to the referenced Predicates." (General statement, no specific values reported) | |
| Tear Resistance | Substantially equivalent to predicates | "Laboratory testing discussed in this submission demonstrate that the material chosen and the design utilized in manufacturing the PERFIX™ Light Plug is substantially equivalent to the referenced Predicates." (General statement, no specific values reported) | |
| Material Properties | Biocompatibility | Acceptable results obtained | "Biocompatibility testing was completed on the polypropylene material used in the Proposed PERFIX™ Light Plug and has received acceptable results." |
| Overall Equivalence | Substantial Equivalence | Demonstrated through laboratory testing | "The results show that the Proposed Product is substantially equivalent to the currently marketed Predicate Products. Therefore, based on laboratory testing and biocompatibility data, the Proposed Product, PERFIX™ Light Plug, is safe and effective for its intended use." |
Study Description:
The study conducted to demonstrate the safety and effectiveness and to meet the acceptance criteria of the Bard® PERFIX™ Light Plug was a series of laboratory bench tests and biocompatibility testing. This was a comparative study against legally marketed predicate devices: Bard® Soft Mesh, Bard® PERFIX™ Plug, Bard® Mesh Dart, and Ethicon Mersilene Mesh.
The study aimed to show substantial equivalence of the new device to these predicates, as required for a 510(k) premarket notification. The guidance followed was "Guidance for the Preparation of a Premarket Notification for a Surgical Mesh" (March 2, 1999).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes for each of the laboratory bench tests (e.g., number of mesh samples tested for tensile strength).
- Data Provenance: The data is from laboratory bench testing, implying it was conducted in a controlled lab environment. The document does not explicitly state the country of origin, but given it's a 510(k) submission to the FDA, it's presumed the testing was conducted in a manner acceptable for US regulatory purposes, likely either domestically or by a certified international lab. The study is retrospective in the sense that it's comparing a new device against existing, predicate devices using established testing methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for this device, which is a physical surgical mesh, is established through objective, quantifiable laboratory measurements of its physical, mechanical, and biological properties, not by human expert assessment of images or clinical outcomes.
4. Adjudication Method for the Test Set
This is not applicable. The data presented relies on objective laboratory measurements rather than subjective expert consensus or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically relevant for interpretative devices (e.g., imaging AI) where human readers evaluate cases with and without AI assistance. The Bard® PERFIX™ Light Plug is a physical surgical implant, so an MRMC study is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study was performed, but it's not an "algorithm only" study. It's a "device only" study focusing on the intrinsic material and design characteristics of the surgical mesh without human interaction during the performance testing itself. The laboratory bench tests (thickness, pore size, stiffness, tensile strength, etc.) and biocompatibility tests represent the standalone performance of the device's physical and biological properties.
7. Type of Ground Truth Used
The ground truth used was based on objective, quantifiable laboratory measurements of the physical, mechanical, and material properties (biocompatibility) of the device and its predicates. These measurements are considered the "true" performance characteristics against which the new device was compared to demonstrate substantial equivalence.
8. Sample Size for the Training Set
This information is not applicable. The Bard® PERFIX™ Light Plug is a physical medical device, not a machine learning algorithm or AI model that requires a "training set" in the computational sense. The design and manufacturing process for the device would have been developed through R&D and engineering processes, not through machine learning training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as #8. There is no "training set" in the context of this device. The "ground truth" for the device's design and manufacturing would come from engineering specifications, material science principles, and established medical device standards.
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