(89 days)
Not Found
No
The device description and performance studies focus on the material properties and biological integration of a surgical mesh, with no mention of AI or ML technologies.
Yes
The device is intended to repair and reinforce soft tissue, hernias, and body wall defects, which are therapeutic interventions.
No
The provided text indicates the device is an implantable surgical mesh intended to reinforce or repair soft tissue. It makes no mention of diagnosing conditions. Its purpose is to physically support and allow for tissue regeneration.
No
The device description clearly states it is an "implantable surgical mesh comprised of non-crosslinked porcine dermis," which is a physical, hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical repair and reinforcement of soft tissue within the body. IVDs are used to examine specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as an "implantable surgical mesh." This is a device that is placed inside the patient's body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
The device described is a surgical implant used for structural support and repair within the body, which falls under a different category of medical devices than IVDs.
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 reinforcement of soft tissues in plastic and reconstructive surgery.
The device is intended for single patient use only.
Product codes (comma separated list FDA assigned to the subject device)
FTM, OXF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, hernias and /or body wall defects
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 equivalent for the evaluated 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
Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2014
RTI Surgical Incorporated Ms. Kristina Hall Manager, Regulatory Affairs Submissions 11621 Research Circle Alachua, Florida 32615
Re: K142070
Trade/Device Name: Fortiva™ porcine dermis, Tutoplast® porcine dermis Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXF Dated: July 29, 2014 Received: July 30, 2014
Dear Ms. Hall:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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004 Indications for Use
510(k) Number (if known): K142070
| Device Names: | Fortiva™ porcine dermis |
|---|---|
| Tutoplast® porcine dermis |
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 reinforcement of soft tissues in plastic and reconstructive surgery.
The device is intended for single patient use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Image /page/3/Picture/2 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in a blue rounded square, with a small green square on top of the "i". To the right of the blue square, the word "surgical" is written in gray. The logo is simple and modern, and the colors are bright and eye-catching.
005 510(k) Summary
Date: July 28, 2014
Submitted By: Kristina Hall Manager, Regulatory Affairs Submissions RTI Surgical, Inc. 11621 Research Circle Alachua, FL 32615 Tel: 386-418-8888 Fax: 386-418-1627
Trade Name:
Fortiva™ porcine dermis, Tutoplast® porcine dermis
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 Fortiva™ porcine dermis and Tutoplast® porcine dermis (K123356) in intended use, material, design, function and processing.
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 reinforcement of soft tissues in plastic and reconstructive surgery.
The device is intended for single patient use only.
4
Image /page/4/Picture/2 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in blue, with a small green square above the "i". To the right of "rti" is the word "surgical" in gray. A small trademark symbol is located in the upper right corner of the logo.
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, function, and processing as listed in the table below:
| Characteristic | Proposed Device | Predicate Device
(K123356) |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Intended Use | 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 | |
| Design | Terminally sterilized sheets in various sizes | |
| Function | Scaffold for soft tissue repair | |
| Processing | Proprietary tissue sterilization process | |
| Chemical composition | Not applicable to these devices | |
| Energy Source | 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, function, and processing. The biomechanical properties of the proposed and predicate devices were equivalent for the evaluated 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