(125 days)
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 <20 EU per device. | "The device did not elicit a response [in the rabbit pyrogen test]." "All device lots will be tested to ensure the endotoxin level is <20 EU per device." |
| Biocompatibility (in vitro & in vivo) | Pass all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing. Equivalent to predicate in structural and functional properties in an implantation study (maximum tensile strength at graft-host interface, burst strength, clinical and gross pathology, local effects of implantation). | "The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices." "The structural and functional properties of the proposed and predicate devices were also evaluated in an implantation study. Maximum tensile strength at the graft-host interface, burst strength, clinical and gross pathology, and the local effects of implantation were assessed and results demonstrate the proposed and predicate devices are substantially equivalent." "Results from in vitro and animal studies demonstrate that the proposed device is biocompatible, and as safe and effective as the predicate..." |
2. Sample size used for the test set and the data provenance
The document mentions an "implantation study" (animal study) but does not provide a specific sample size for this or any other test set. It does not mention the country of origin of the data. The study appears to be prospective in nature, as it describes evaluations conducted for the purpose of the 510(k submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a surgical mesh, not a diagnostic AI system predicting outcomes. Ground truth in this context would likely refer to objective measurements and observations in the animal study rather than expert consensus on images or other diagnostic data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biomechanical properties, the ground truth would be objective measurements from laboratory tests (tensile testers, burst strength testers, etc.).
For viral inactivation, the ground truth would be laboratory assays measuring viral titers after processing.
For pyrogenicity, the ground truth would be a validated rabbit pyrogen test result and endotoxin levels measured by specific assays.
For the implantation study, the ground truth would be:
* Objective measurements: Maximum tensile strength at the graft-host interface, burst strength.
* Pathology: Clinical and gross pathology assessments (likely by veterinary pathologists).
* Observation: Local effects of implantation (observed by researchers/veterinarians).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that uses training sets.
9. How the ground truth for the training set was established
Not applicable.
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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.
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MAR 0 5 2013
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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 toreinforce soft tissue whereweakness exists and for thesurgical repair of damaged orruptured soft tissue membranes. | Surgical mesh scaffold toreinforce soft tissue whereweakness exists and for thesurgical repair of damaged orruptured soft tissue membranes. |
| Material | Porcine Dermis | Porcine Dermis |
| Design | Terminally sterilized sheets invarious sizes | Terminally sterilized sheets invarious 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 <20 EU per device.
The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices. The structural and functional properties of the proposed and predicate devices were also evaluated in an implantation study. Maximum tensile strength at the graft-host interface, burst strength, clinical and gross pathology, and the local effects of implantation were assessed and results demonstrate the proposed and predicate devices are substantially equivalent. Results from in vitro and animal studies demonstrate that the proposed device is biocompatible, and as safe and effective as the predicate for use as a scaffold to repair soft tissue deficiencies.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center- WO66-G609 Silver Spring, MD 209930002
Letter dated: March 5, 2013
RTI Biologics, Incorporated % Ms. Esther Carbon Regulatory Labeling Specialist 11621 Research Circle P.O. Box 2650 Alachua, Florida 32616-1627
Re: K123356
Trade/Device Name: Fortiva™ porcine dermis,Tutoplast® porcine dermis Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: February 01, 2013 Received: February 04, 2013
Dear Ms. Carbon:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K123356
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 single patient use only.
Prescription Use × (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
JiyoungDang-S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123356
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§ 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.