VITALA PORCINE DERIVED COLLAGEN MEMBRANE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 15, 2015 Osteogenics Biomedical, Inc. Mr. Shane Shuttlesworth President 4620 71st St. Bldg 78 Lubbock, Texas 79424 Re: K141177 Trade/Device Name: Vitala® Porcine Derived Collagen Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: August 4, 2015 Received: August 6, 2015 Dear Mr. Shuttlesworth: 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. {1}------------------------------------------------ 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 devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Sincerely yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K141177 Device Name Vitala Porcine Derived Collagen Membrane ### Indications for Use (Describe) Vitala Porcine Derived Collagen Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for: -Simultaneous use with implants; -Augmentation around implants placed in immediate extraction sockets; -Augmentation around implants placed in delayed extraction sockets; -Localized ridge augmentation for later implantation; -Alveolar ridge reconstruction for prosthetic treatment; -Alveolar ridge preservation consequent to tooth extraction; -Filling of bone defects after root resection, cystectomy, removal of retained teeth; -Over the window in lateral window sinus elevation procedures; -Furcation defects in multi-rooted teeth; -Treatment of recession defects, together with coronally positioned flap; -In implants with vertical bone loss due to infection, only with satisfactory debridement and implant surface disinfection; -Guided bone regeneration in dehiscence defects; and -Guided tissue regeneration in periodontal defects. Type of Use (Select one or both, as applicable) |×| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ ## 510(k) Summary This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92 and to notify the agency of manufacturing changes that resulted in product specification changes. #### l. SUBMITTER | Applicant Name: | Osteogenics Biomedical, Inc. | |-----------------|------------------------------------------------| | Address: | 4620 71st St, Bldg. 78<br>Lubbock, Texas 79424 | | Phone: | (806) 796-1923 | | Fax: | (806) 796-0059 | | Contact Person: | Shane Shuttlesworth<br>President | | Date Prepared: | September 10, 2015 | #### II. DEVICE | Trade Name: | Vitala® Porcine Derived Collagen Membrane | |--------------------|-------------------------------------------| | Common Name: | Porcine Derived Collagen Membrane | | Regulation Number: | 21 CFR 872.3930 | | Regulation Name: | Bone Grafting Material | | Regulatory Class: | II | | Product Code: | NPL (Barrier, Animal Source, Intraoral) | #### lll. PREDICATE DEVICE | Predicate Device: | Vitala® Resorbable Natural Collagen Membrane (Osteogenics Biomedical, Inc.) K101453 | |-------------------|-------------------------------------------------------------------------------------| |-------------------|-------------------------------------------------------------------------------------| Bio-Gide® Resorbable Bilayer Membrane (K050466) was used as a reference device in this submission. #### IV. DEVICE DESCRIPTION Vitala® Porcine Derived Collagen Membrane is a natural collagen membrane for use in periodontal and/or dental surgical procedures. The membrane is manufactured using a standardized, controlled, multistage process. The pre-slaughter origin of all animals is the United States of America and the source collagen is extracted from veterinary-certified pigs sacrificed in a USDA-inspected facility. The membrane is terminally sterilized in double blister packs by electron beam irradiation. The contents of the unopened, undamaged inner package are sterile. {4}------------------------------------------------ Vitala® Porcine Derived Collagen Membrane functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled and replaced by host tissue. Animal studies have shown that Vitala® Porcine Derived Collagen Membrane is substantially resorbed by 26 weeks. #### INDICATIONS FOR USE V. Vitala® Porcine Derived Collagen Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for: - Simultaneous use with implants; - . Augmentation around implants placed in immediate extraction sockets; - . Augmentation around implants placed in delayed extraction sockets; - Localized ridge augmentation for later implantation; ● - Alveolar ridge reconstruction for prosthetic treatment; - Alveolar ridge preservation consequent to tooth extraction; - Filling of bone defects after root resection, cystectomy, or removal of retained teeth; - . Over the window in lateral window sinus elevation procedures; - Furcation defects in multi-rooted teeth; - Treatment of recession defects, together with a coronally positioned flap; - . In implants with vertical bone loss due to infection, only with satisfactory debridement and implant surface disinfection; - . Guided bone regeneration of dehiscence defects; and - . Guided tissue regeneration in periodontal defects. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI. Vitala® Porcine Derived Collagen Membrane has been determined to be substantially equivalent to the predicate device having similar technological characteristics as follows: | Parameter | Vitala® Porcine Derived Collagen<br>Membrane (This submission) | Vitala® Resorbable Natural Collagen<br>Membrane (Predicate Device) | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Vitala® is intended for use during the<br>process of guided bone regeneration<br>(GBR) and guided tissue<br>regeneration (GTR) as a<br>biodegradable barrier for:<br>●<br>Simultaneous use with<br>implants;<br>●<br>Augmentation around<br>implants placed in<br>immediate extraction<br>sockets;<br>Augmentation around<br>● | Vitala® is intended for use during the<br>process of guided bone regeneration<br>(GBR) and guided tissue<br>regeneration (GTR) as a<br>bi odegradable barrier for:<br>●<br>Simultaneous use with<br>implants;<br>●<br>Augmentation around<br>implants placed in<br>immediate extraction<br>sockets :<br>Augmentation around<br>● | | | | | | | implants placed in delayed extraction sockets; Localized ridge augmentation for later implantation; Alveolar ridge reconstruction for prosthetic treatment; Alveolar ridge preservation consequent to tooth extraction; Filling of bone defects after root resection, cystectomy, removal of retained teeth; Over the window in lateral window sinus elevation procedures; Furcation defects in multi-rooted teeth; Treatment of recession defects, together with coronally positioned flap; In implants with vertical bone loss due to infection, only with satisfactory debridement and implant surface disinfection; Guided bone regeneration in dehiscence defects; and Guided tissue regeneration in periodontal defects. | implants placed in delayed extraction sockets; Localized ridge augmentation for later implantation; Alveolar ridge reconstruction for prosthetic treatment; Alveolar ridge preservation consequent to tooth extraction; Filling of bone defects after root resection, cystectomy, removal of retained teeth; Over the window in lateral window sinus elevation procedures; Furcation defects in multi-rooted teeth; Treatment of recession defects, together with coronally positioned flap; In implants with vertical bone loss due to infection, only with satisfactory debridement and implant surface disinfection; Guided bone regeneration in dehiscence defects; and Guided tissue regeneration in periodontal defects. | | | Rx Only | Rx Only | | Design | The membrane is manufactured using a standardized, controlled, multistage process. The pre-slaughter origin of all animals is the United States of America and the source collagen is extracted from veterinary-certified pigs sacrificed in a USDA-inspected facility. The membrane is terminally sterilized in double blister packs by electron beam irradiation. The contents of the unopened, undamaged inner package are sterile. | The membrane is manufactured using a standardized, controlled, multistage process. The pre-slaughter origin of all animals is the United States of America and the source collagen is extracted from veterinary-certified pigs sacrificed in a USDA-inspected facility. The membrane is terminally sterilized in double blister packs by electron beam irradiation. The contents of the unopened, undamaged inner package are sterile. | | Mode of Action | Vitala® functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled and | Vitala® functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled and | | | resorbed and replaced by host<br>tissue. Animal studies have shown | resorbed and replaced by host<br>tissue. Animal studies have shown | | | that Vitala is substantially resorbed | that Vitala is substantially resorbed | | | by 26 weeks | by 26 weeks | | Operating Principles | Cell-Occlusive<br>Implantable<br>Resorbable<br>Biocompatible | Cell-Occlusive<br>Implantable<br>Resorbable<br>Biocompatible | | Material | Intact purified collagen tissue | Intact purified collagen tissue | | Collagen Source | Porcine pericardium | Porcine pericardium | | Form | Membrane | Membrane | | Color | White to off-white | White to off-white | | Sizes | Variety of sizes | Variety of sizes | | Resorption Time | Substantially resorbed by 26 Weeks | Substantially resorbed by 26 weeks | | Sterilization Method | Irradiation | Irradiation | | Sterility | Sterile, SAL 10° | Sterile, SAL 10° | | Singe Use/Reuse | Single use only | Single use only | | Packaging | Double blister pack | Double blister pack | {5}------------------------------------------------ {6}------------------------------------------------ Additional steps in the manufacturing process of Vitala® Porcine Derived Collagen Membrane were added. Minor differences exist in thickness and tensile strength. Non-clinical performance data was compared against the reference device, Bio-Gide® Resorbable Bilayer Membrane, to substantiate thickness and tensile specifications for the subject device. #### VII. PERFORMANCE DATA ## Nonclinical Tests Submitted The substantial equivalence of Vitala® Porcine Derived Collagen Membrane and its predicate was demonstrated based on in vitro characterization studies, biocompatibility studies, in vivo animal studies, and clinical history of the predicate device. Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA guidelines as follows: ISO 22442-1 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices – Part 1 Analysis and Risk Management ISO 22442-2 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices – Part 2 Controls on Sourcing, Collection, and Handling ISO 22442-3 Animal Tissues and Their Derivatives Utilizedin the Manufacture of Medical Devices – Part 3 Validation of the Elimination and/or Inactivation of Viruses and Transmissible Agents ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for in vitro cytotoxicity {7}------------------------------------------------ ISO 10993-6 Biological Evaluation of Medical Devices – Part 6: Test for local effects after implantation ISO 10993-18 Biological Evaluation of Medical Devices – Part 18: Chemical characterization of materials In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate device. A series of bench tests were conducted to evaluate material properties, biological properties, chemical and physical properties. Tensile strength was characterized and compared to the reference device, Bio-Gide® Resorbable Bilayer Membrane, in order to establish a minimum acceptable specification. | Test | Test Method | Results | |-------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------| | Tensile Strength | ASTM D1708 | Tensile strength ≥ reference device. | | Denaturation<br>Transition<br>Temperature | Internal test method using<br>differential scanning calorimetry | Denaturation transition<br>temperature similar to predicate | | Protein Analysis | Internal test method using sodium<br>dodecyl sulfate polyacrylamide gel<br>electrophoresis | Protein analysis similar to predicate<br>device. | The comparative bench testing is summarized in the table below. A series of in vitro and in vivo biocompatibility testing was performed to assess biocompatibility of the Vitala® Porcine Derived Collagen Membrane as an implantable material. An animal study was conducted in a rabbit intra-oral model following ISO 10993-6 Biological Evaluation of Medical Devices – Part 6: Tests for Local Effects After Implantation comparing the subject device, Vitala® Porcine Derived Collagen Membrane, to the reference device, Bio-Gide® Resorbable Bilayer Membrane. The subject device passed the following FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices. | Test | Test Method/Model | Results | |--------------|-------------------------------------|------------------------------------| | Cytotoxicity | ISO MEM Elution Assay with L-929 | Non-cytotoxic. | | | Mouse Fibroblast Cells, ISO 10993-5 | | | Implantation | Assessment of Local Tissue | The subject device is considered a | | | Reaction in an Intra-Oral Implant | non-irritant compared to the | | | Model in Rabbits, ISO 10993-6 | reference device at 2, 13, and 26 | | | | weeks of implantation. | | Pyrogenicity | USP Bacterial Endotoxin Testing, | Non-pyrogenic. The test article | {8}------------------------------------------------ | | Kinetic Chromogenic Method | extract met the requirements of<br>the test. | |------------------------------|---------------------------------------------------------|---------------------------------------------------------| | Chemical<br>Characterization | Chemical Characterization of<br>Materials, ISO 10993-18 | All compounds have an acceptable<br>margin of exposure. | Additionally, an animal study was conducted in a canine mandibular molar furcation defect model to characterize tissue reaction and resorption. #### VIII. CONCLUSION Additional steps in the manufacturing process of Vitala® Porcine Derived Collagen Membrane were added to the predicate device, resulting in the subject device. Minor differences exist in thickness and tensile strength. Non-clinical performance data was compared against the reference device, Bio-Gide® Resorbable Bilayer Membrane, to substantiate thickness and tensile specifications for the subject device. The results of in vitro device characterization tests show that the subject device, Vitala® Porcine Derived Collagen Membrane, is substantially equivalent to the predicate device. Tensile strength tests show that the subject device is at least as strong as the reference device. Biocompatibility testing demonstrated that the subject device is a non-irritant compared to the reference device. An animal study conducted in a canine mandibular molar furcation defect model characterized resorption.