(125 days)
Not Found
No
The summary describes a biological implantable mesh and does not mention any computational or analytical capabilities, let alone AI/ML.
No.
The device is a surgical mesh intended to reinforce or bridge soft tissue for conditions like hernias, acting as a scaffold for host tissue replacement, rather than providing direct therapy or treatment of symptoms itself.
No
This device is an implantable surgical mesh intended for reinforcing and repairing soft tissue, functioning as a scaffold for tissue regeneration, not for diagnosing conditions.
No
The device description clearly states it is an "implantable surgical mesh comprised of non-crosslinked porcine dermis," which is a physical, hardware component. The summary focuses on the material properties and biological evaluation of this physical mesh.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical repair of soft tissue defects by implanting a patch. This is a therapeutic and structural function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device is an implantable surgical mesh. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
The device is clearly intended for surgical implantation and tissue reinforcement, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
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 device is comprised of non-crosslinked porcine dermis that has been processed, terminally sterilized and stored hydrated and ready to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The biomechanical properties of the proposed and predicate devices were evaluated in a series of in vitro tests. Unimplanted tensile maximum load, burst strength and suture pullout strength were equivalent for the proposed and predicate devices.
The ability of the manufacturing process to inactivate model viruses was evaluated using porcine dermis at the stage in the chemical processing applicable to the chemical being evaluated. 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 of the device was evaluated using the rabbit pyrogen test on the final sterilized device. The device did not elicit a response. All device lots will be tested to ensure the endotoxin level is
§ 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.
0
ADVANCING SCIENCE, SAFETY & INNOVATION
05 510(k) Summary
Date: March 04, 2013
Submitted By:
Esther Carbon RTI Biologics, Inc. 11621 Research Circle Alachua, FL 32615 Tel: 386-418-8888 Fax: 386-418-1627
Trade Name:
Fortiva™ porcine dermis, Tutoplast porcine dermis
Common Name: Surgical mesh
Classification Name and Code: Mesh, surgical (21 CFR 878.3300, product code FTM)
Substantial Equivalence:
The proposed device is substantially equivalent to the predicate device Strattice® (K070560) in intended use, material, design, and function.
Description:
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.
Indications for Use:
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.
page 1 of 2
MAR 0 5 2013
1
Summary of Technological Characteristics:
This device is comprised of non-crosslinked porcine dermis that has been processed, terminally sterilized and stored hydrated and ready to use. The device has the same technological characteristics as the predicate device in material, design and function as listed in the table below:
| Characteristic | Proposed Device | Predicate Device |
|---|---|---|
| Intended Use | Surgical mesh scaffold to | |
| reinforce soft tissue where | ||
| weakness exists and for the | ||
| surgical repair of damaged or | ||
| ruptured soft tissue membranes. | Surgical mesh scaffold to | |
| reinforce soft tissue where | ||
| weakness exists and for the | ||
| surgical repair of damaged or | ||
| ruptured soft tissue membranes. | ||
| Material | Porcine Dermis | Porcine Dermis |
| Design | Terminally sterilized sheets in | |
| various sizes | Terminally sterilized sheets in | |
| various sizes | ||
| Function | Scaffold for soft tissue repair | Scaffold for soft tissue repair |
| Chemical composition | Not applicable to these devices. | Not applicable to these devices. |
| Energy Source | Not applicable to these devices. | Not applicable to these devices. |
Performance Data Supporting Substantial Equivalence Determination:
The proposed device is equivalent to the predicate device in intended use, material, design, and function. The biomechanical properties of the proposed and predicate devices were evaluated in a series of in vitro tests. Unimplanted tensile maximum load, burst strength and suture pullout strength were equivalent for the proposed and predicate devices.
The ability of the manufacturing process to inactivate model viruses was evaluated using porcine dermis at the stage in the chemical processing applicable to the chemical being evaluated. 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 of the device was evaluated using the rabbit pyrogen test on the final sterilized device. The device did not elicit a response. All device lots will be tested to ensure the endotoxin level is