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510(k) Data Aggregation
(89 days)
FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS
The device is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and /or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The device is intended for reinforcement of soft tissues in plastic and reconstructive surgery.
The device is intended for single patient use only.
The proposed device is an implantable surgical mesh comprised of non-crosslinked porcine dermis that has been processed, terminally sterilized and is stored hydrated and ready to use. The proposed device is designed to perform as a scaffold that allows for neovascularization and permits replacement of the device with host tissue. The device in its unopened, undamaged package is sterile.
This document is a 510(k) premarket notification for the Fortiva™ porcine dermis and Tutoplast® porcine dermis surgical meshes. The purpose of this submission is to demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device (K123356). The document describes the device's indications for use, technological characteristics, and performance data supporting its substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a numerical or target-based format. Instead, it demonstrates equivalence to a predicate device through various tests. Equivalence is the de-facto acceptance criteria in this context for a 510(k) submission.
| Characteristic / Test | Acceptance Criteria (Implied: Equivalence to Predicate K123356) | Reported Device Performance (Fortiva™ porcine dermis, Tutoplast® porcine dermis) |
|---|---|---|
| Intended Use | Equivalent to predicate (Surgical mesh scaffold to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes) | Proposed device is equivalent to predicate in intended use. |
| Material | Equivalent to predicate (Porcine Dermis) | Proposed device is equivalent to predicate in material. |
| Design | Equivalent to predicate (Terminally sterilized sheets in various sizes) | Proposed device is equivalent to predicate in design. |
| Function | Equivalent to predicate (Scaffold for soft tissue repair) | Proposed device is equivalent to predicate in function. |
| Processing | Equivalent to predicate (Proprietary tissue sterilization process) | Proposed device is equivalent to predicate in processing. |
| Chemical composition | Equivalent to predicate (Not applicable to these devices) | Proposed device is equivalent to predicate in chemical composition. |
| Energy Source | Equivalent to predicate (Not applicable to these devices) | Proposed device is equivalent to predicate in energy source. |
| In vitro Biomechanical Properties | Equivalent to predicate for: |
- Tensile maximum load
- Burst strength
- Suture pullout strength | Unimplanted tensile maximum load, burst strength and suture pullout strength were equivalent for the proposed and predicate devices. |
| Viral Inactivation | Demonstrated ability of process to inactivate model viruses with a wide range of characteristics. | Results demonstrate the ability of the process to inactivate viruses with a wide range of characteristics (enveloped and non-enveloped, RNA and DNA, low resistance and high resistance). |
| Pyrogenicity | Device did not elicit a pyrogen response in rabbit test; Endotoxin level
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(125 days)
FORTIVA PORCINE DERMIS
The device is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and /or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.
The device is intended for single patient use only.
The proposed device is an implantable surgical mesh comprised of non-crosslinked porcine dermis that has been processed, terminally sterilized and is stored hydrated and ready to use. The proposed device is designed to perform as a scaffold that allows for neovascularization and permits replacement of the device with host tissue. The device in its unopened, undamaged package is sterile.
The provided text describes a 510(k) summary for a surgical mesh device, Fortiva™ porcine dermis / Tutoplast® porcine dermis, which focuses on establishing substantial equivalence to a predicate device (Strattice®). The document does not outline specific acceptance criteria in a quantitative sense (e.g., a target sensitivity or specificity for a diagnostic device) or provide a study that explicitly demonstrates the device "meets" such criteria for clinical performance.
Instead, the performance data presented is focused on demonstrating equivalence to a predicate device through various in vitro and in vivo tests related to biomechanical properties, manufacturing process safety, and biocompatibility.
Here's a breakdown based on the information provided, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of quantitative acceptance criteria for clinical performance or any metrics like sensitivity, specificity, or AUC. Instead, it describes equivalence-based performance criteria:
| Characteristic | Acceptance Criteria (Implicit for Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Biomechanical Properties (in vitro) | Equivalent to predicate device (Strattice®) in unimplanted tensile maximum load, burst strength, and suture pullout strength. | "Unimplanted tensile maximum load, burst strength and suture pullout strength were equivalent for the proposed and predicate devices." |
| Viral Inactivation (manufacturing process) | Demonstration of ability to inactivate model viruses with a wide range of characteristics (enveloped and non-enveloped, RNA and DNA, low resistance and high resistance). | "The results demonstrate the ability of the process to inactivate viruses with a wide range of characteristics (enveloped and non-enveloped, RNA and DNA, low resistance and high resistance) when used to process porcine dermis for the proposed device." |
| Pyrogenicity | Non-pyrogenic (rabbit pyrogen test) and endotoxin level |
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