FortiShield (Biosynthetic Wound Matrix)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. May 2, 2023 Organogenesis Inc. Christina Nichols Program Manager, Regulatory Affairs 150 Dan Rd Canton, Massachusetts 02021 Re: K212579 Trade/Device Name: FortiShield (Biosynthetic Wound Matrix) Regulatory Class: Unclassified Product Code: KGN Dated: November 22, 2022 Received: November 22, 2022 Dear Christina Nichols: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # David Krause -S - for Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212579 Device Name FortiShield™ Biosynthetic Wound Matrix #### Indications for Use (Describe) FortiShield is indicated for: partial thickness wounds, pressure sores, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears) and draining wounds. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------|------------------------------------------------------------------| | <div> <p>☑ Prescription Use (Part 21 CFR 801 Subpart D)</p> </div> | <div> <p> Over-The-Counter Use (21 CFR 801 Subpart C)</p> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary – K212579 - FortiShieId™ (Biosynthetic Wound Matrix) # Date Prepared: May 2, 2023 # Submitted By: Organogenesis Inc. 150 Dan Rd Canton, MA 02021 ## Contact: | Name: | Christina Nichols | |------------|------------------------------------------| | Title: | Associate Director of Regulatory Affairs | | Telephone: | (781) 577-6065 | | Email: | CNichols@organo.com | #### Device: | Trade Name: | FortiShield™<br>(Biosynthetic Wound Matrix) | |----------------------|---------------------------------------------| | Common Name: | Wound Dressing | | FDA Product Code: | KGN | | Classification Name: | Dressing, wound, collagen | | 510(k) Number: | K212579 | # Predicate Devices: The device is substantially equivalent to the following predicate devices: | Primary Predicate: | AWBAT (K082869) | |--------------------|--------------------------------------------------| | Other Predicates: | Biobrane II (K901369) and PermeaDerm B (K153678) | #### Device Description: FortiShield is a sterile, translucent biosynthetic wound matrix made from a knitted tri-filament nylon fabric that is mechanically bonded to a semi-permeable silicone membrane. Denatured porcine dermal collagen is bonded to the nylon/silicone bi-layer membrane to provide a {4}------------------------------------------------ dressing that is designed to adhere to the application site, provide a barrier to the external environment, and allow for excess exudate drainage. FortiShield is not made with natural rubber latex. FortiShield is non-pyrogenic. #### Intended Use: FortiShield is intended for use as a temporary wound covering, and to provide a moist wound healing environment on cleanly debrided wounds after hemostasis has been established. #### Indications for Use: FortiShield is indicated for: partial thickness wounds, pressure sores, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears) and draining wounds. {5}------------------------------------------------ # Technological Characteristics and Performance Data (Predicate Comparison): The device has equivalent design, intended use, material performance, and biocompatibility compared to the predicate devices. The device has equivalent non-clinical performance as the predicate devices. Tensile elongation, water vapor transmission rate, and fatigue properties have been demonstrated as equivalent between the AWBAT predicate device. A comparison of technological characteristics and performance data to the predicate devices is provided in Table 1, below. | | Subject Device | Predicate Devices | | | | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | Organogenesis<br>Inc.<br>FortiShieldTM | Aubrey, Inc.<br>AWBAT-S,<br>AWBAT-D,<br>AWBAT-M<br>(Primary<br>Predicate) | Sterling Drug, Inc.<br>Biobrane II<br>(Other Predicate) | PermeaDerm, Inc.<br>Permeaderm B<br>and Permeaderm<br>CW<br>(Other Predicate) | Comparison | | 510(k) | K212579 | K082869 | K901369 | K153678 | N/A | | FDA Product<br>Code | KGN | KGN | FRO | FRO | The FDA<br>product code<br>is identical to<br>the primary<br>predicate. | | Principles of<br>Operation | Device covers the<br>wound to provide a<br>moist wound<br>environment and<br>allows the passage<br>of exudate. | Devices<br>covers the<br>wound to<br>provide a<br>moist wound<br>environment<br>and allows the<br>passage of<br>exudate. | Devices covers the<br>wound to provide a<br>moist wound<br>environment and<br>allows the passage<br>of exudate. | Devices covers the<br>wound to provide a<br>moist wound<br>environment and<br>allows the passage<br>of exudate. | Equivalent to<br>predicate<br>devices. | | | Subject Device | | Predicate Devices | | | | | Organogenesis<br>Inc. | Aubrey, Inc. | Sterling Drug, Inc. | PermeaDerm, Inc. | | | Characteristic | FortiShield™ | AWBAT-S,<br>AWBAT-D,<br>AWBAT-M | Biobrane II<br>(Other Predicate) | Permeaderm B<br>and Permeaderm<br>CW<br>(Other Predicate) | Comparison | | | | (Primary<br>Predicate) | | | | | Materials and<br>Structure | Porous Silicone<br>and Nylon Knit Bi-<br>layer Scaffold with<br>Cross-Linked<br>Collagen Coating | Porous<br>Silicone and<br>Nylon Knit Bi-<br>layer Scaffold<br>with Collagen<br>Coating | Porous Silicone and<br>Nylon Knit Bi-layer<br>Scaffold with Cross-<br>Linked Collagen<br>Coating | Porous Silicone and<br>Nylon Knit Bi-layer<br>Scaffold with<br>Collagen and Aloe<br>Coating | Equivalent to<br>predicate<br>devices. The<br>construction is<br>equivalent to<br>the primary<br>predicate and<br>the same as<br>the Biobrane II<br>predicate. | | Indications<br>for Use | FortiShield is<br>indicated for: partial<br>thickness wounds,<br>pressure sores,<br>venous ulcers,<br>diabetic ulcers,<br>chronic vascular<br>ulcers, surgical<br>wounds (donor<br>sites/grafts, post-<br>Moh's, post-laser<br>surgery, podiatric,<br>wound<br>dehiscence),<br>trauma wounds<br>(abrasions,<br>lacerations, partial | Temporary<br>wound<br>dressing for<br>coverage of<br>Superficial<br>burns, Donor<br>sites and<br>Meshed<br>autographs.<br>AWBAT-S: is<br>intended for<br>clean<br>Superficial<br>burn wounds. | Covering donor<br>sites, clean,<br>debrided, or<br>excised superficial<br>and medium depth<br>partial (2°)<br>thickness wounds<br>and as a protective<br>covering over<br>meshed autografts.<br>Suggested Uses:<br>To manage clean<br>partial thickness<br>wounds | PermeaDerm B is<br>indicated for partial<br>thickness burn<br>wounds, donor sites<br>and coverage of<br>meshed autograft.<br>PermeaDerm CW is<br>indicated for partial<br>thickness wounds,<br>pressure sores,<br>venous ulcers,<br>diabetic ulcers,<br>chronic vascular<br>ulcers, surgical<br>wounds (donor<br>sites/grafts, post- | Equivalent to<br>predicate<br>devices. The<br>indicated<br>applications<br>are identical to<br>PermeaDerm<br>CW. | | | Subject Device<br>Organogenesis<br>Inc.<br>FortiShield™ | Aubrey, Inc.<br>AWBAT-S,<br>AWBAT-D,<br>AWBAT-M<br>(Primary<br>Predicate) | Predicate Devices<br>Sterling Drug, Inc.<br>Biobrane II<br>(Other Predicate) | PermeaDerm, Inc.<br>Permeaderm B<br>and Permeaderm<br>CW<br>(Other Predicate) | Comparison | | Characteristic | | | | | | | | thickness burns,<br>and skin tears) and<br>draining wounds. | AWBAT-D: is<br>intended for<br>Donor sites<br>after<br>hemostasis<br>has been<br>established.<br>AWBAT-M: is<br>intended to be<br>used as a<br>protective<br>covering for<br>Meshed<br>autografts. | For wet wound<br>management to<br>minimize fluid<br>accumulation<br>For use in<br>situations where<br>maximum passage<br>of transudate is<br>desired | Moh's, post-laser<br>surgery, podiatric,<br>wound dehiscence,<br>trauma wounds<br>(abrasions,<br>lacerations,<br>second-degree<br>burns, and skin<br>tears) and draining<br>wounds. | | | Device<br>Dimensions | 2" x 2" through 15"<br>x 30" | Unknown | 2.5" x 5"<br>5" x 5"<br>5" x 7.5"<br>5" x 15"<br>10" x 15" | Permeaderm B:<br>5"x10<br>10"x15"<br>15"x30"<br>Permeaderm: CW<br>2.5" x 5"<br>5" x 5" | Equivalent to<br>predicate<br>devices. The<br>range of sizes<br>is within the<br>maximum size<br>offered for the<br>predicate<br>devices. | | Sterility | Sterile, SAL 10-6 | Sterile | Sterile | Sterile, SAL 10-6 | Equivalent to<br>predicate | | | Subject Device | Predicate Devices | | | | | | Organogenesis<br>Inc.<br>FortiShield™ | Aubrey, Inc.<br>AWBAT-S,<br>AWBAT-D,<br>AWBAT-M<br>(Primary<br>Predicate) | Sterling Drug, Inc.<br>Biobrane II<br>(Other Predicate) | PermeaDerm, Inc.<br>Permeaderm B<br>and Permeaderm<br>CW<br>(Other Predicate) | Comparison | | Characteristic | | | | | | | Pyrogenicity | Non-pyrogenic | Unknown | Non-pyrogenic | Unknown | devices. All devices are provided sterile.<br>Equivalent to predicate devices. Both the subject and primary predicate devices are non-pyrogenic. | | Bio-<br>compatibility | Biocompatible | Biocompatible | Biocompatible | Biocompatible | Equivalent to predicate devices. All devices are deemed biocompatible based on ISO 10993 testing for their intended nature and | | Characteristic | Subject Device<br>Organogenesis<br>Inc.<br>FortiShield™ | Predicate Devices | | | Comparison | | | | Aubrey, Inc.<br>AWBAT-S,<br>AWBAT-D,<br>AWBAT-M<br>(Primary<br>Predicate) | Sterling Drug, Inc.<br>Biobrane II<br>(Other Predicate) | PermeaDerm, Inc.<br>Permeaderm B<br>and Permeaderm<br>CW<br>(Other Predicate) | duration of<br>contact. | #### Table 1: Comparison to Predicate Devices {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ ## Non-Clinical Mechanical Testing: Mechanical testing conducted on the FortiShield device and the Biobrane II predicate device demonstrates that the following performance properties of the devices are equivalent: tensile elongation, fatigue, and water vapor transmission rate. ## Biocompatibility Testing: FortiShield was determined to be biocompatible based on ISO 10993-1 and "FDA General Guidance on Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within a risk management process." Based on the intended use of FortiShield, the device is classified according to ISO 10993-1 as a surface device with prolonged (>24 hours to 30 days) contact with breached, compromised surfaces. The following biological endpoints were included in the evaluation of the biological safety of FortiShield: irritation or intracutaneous reactivity, acute systemic toxicity, implantation, cytotoxicity, genotoxicity, hemolysis, material-mediated pyrogenicity, and chemical characterization (extractables) with toxicological risk assessment. The tests and chemical characterization were performed on the final, finished and sterile subject device and the device is considered to be biocompatible based on these results. ## Conclusions: The subject device and the predicate devices underwent evaluation that confirms equivalence in the intended use of each device, biocompatibility, performance, environment of use, and the principles of operation. Therefore, the subject device demonstrates substantial equivalence to the predicate devices.