(624 days)
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.
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.
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 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.
This is a 510(k) premarket notification for the FortiShield device, a biosynthetic wound matrix. The document asserts the device's substantial equivalence to predicate devices based on technological characteristics and performance data.
Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define formal "acceptance criteria" in a quantitative manner as one might expect for a diagnostic AI device (e.g., minimum sensitivity/specificity). Instead, the assessment focuses on demonstrating equivalence to predicate devices. The "acceptance criteria" are implicitly met by showing comparable performance against the predicate devices across several characteristics.
| Characteristic | Acceptance Criteria (Implicit: Equivalent to Predicate) | Reported Device Performance |
|---|---|---|
| Formulation/Materials | Porous Silicone and Nylon Knit Bi-layer Scaffold with Collagen Coating | Porous Silicone and Nylon Knit Bi-layer Scaffold with Cross-Linked Collagen Coating |
| Principles of Operation | Device covers the wound to provide a moist wound environment and allows the passage of exudate. | Device covers the wound to provide a moist wound environment and allows the passage of exudate. |
| Indications for Use | Equivalent to PermeaDerm CW predicate for various wound types. | FortiShield is indicated for: partial thickness wounds, pressure sores, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds, trauma wounds, and draining wounds. |
| Device Dimensions | Range of sizes within the maximum offered for predicate devices. | 2" x 2" through 15" x 30" |
| Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Biocompatibility | Biocompatible based on ISO 10993 testing for intended nature and duration of contact. | Biocompatible based on ISO 10993-1 and FDA General Guidance evaluation, including various biological endpoints. |
| Tensile Elongation | Equivalent to AWBAT predicate device. | Demonstrated as equivalent. |
| Fatigue Properties | Equivalent to AWBAT predicate device. | Demonstrated as equivalent. |
| Water Vapor Transmission Rate | Equivalent to AWBAT predicate device. | Demonstrated as equivalent. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a "test set" in the context of a typical AI/software performance study with a specific number of cases. The "study" here is a series of non-clinical mechanical and biocompatibility tests on the device itself and direct comparison to predicate devices, not an evaluation of diagnostic performance on patient data.
- Sample Size for Mechanical Testing: Not explicitly stated, but these would be a number of FortiShield device samples and predicate device samples.
- Sample Size for Biocompatibility Testing: Not explicitly stated, but this refers to samples of the FortiShield device tested according to ISO 10993 protocols.
- Data Provenance: Not applicable in the sense of patient data. The data originates from laboratory testing of the physical devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. "Ground truth" in the context of this device is established through:
* Material characterization and manufacturing specifications.
* Standard ISO and FDA-recognized mechanical testing protocols.
* Standard ISO and FDA-recognized biocompatibility testing protocols.
* Comparison to the known characteristics of legally marketed predicate devices.
4. Adjudication Method for the Test Set:
Not applicable. There is no human adjudication process described here for establishing ground truth, as it's a conformity assessment against physical and material properties and a comparison to known predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a wound dressing, not a diagnostic imaging AI algorithm. There is no human interpretation component where AI assistance would be evaluated.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
Not applicable. This is not an AI algorithm. The performance evaluation is for the physical device itself.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance is established based on:
* Material and Device Specifications: Characteristics like composition, structure, dimensions, and manufacturing standards.
* Validated Laboratory Testing: Results from mechanical tests (tensile elongation, fatigue, water vapor transmission rate) and biocompatibility tests (ISO 10993 endpoints like irritation, toxicity, cytotoxicity, etc.).
* Predicate Device Characteristics: The known, legally marketed properties and performance of the substantially equivalent predicate devices.
8. Sample Size for the Training Set:
Not applicable. This is not an AI device or a machine learning model, so there is no training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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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. 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 of medical device-related adverse events) (21 CFR 803) for
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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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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™(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
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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.
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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 | OrganogenesisInc.FortiShieldTM | Aubrey, Inc.AWBAT-S,AWBAT-D,AWBAT-M(PrimaryPredicate) | Sterling Drug, Inc.Biobrane II(Other Predicate) | PermeaDerm, Inc.Permeaderm Band PermeadermCW(Other Predicate) | Comparison |
| 510(k) | K212579 | K082869 | K901369 | K153678 | N/A |
| FDA ProductCode | KGN | KGN | FRO | FRO | The FDAproduct codeis identical tothe primarypredicate. |
| Principles ofOperation | Device covers thewound to provide amoist woundenvironment andallows the passageof exudate. | Devicescovers thewound toprovide amoist woundenvironmentand allows thepassage ofexudate. | Devices covers thewound to provide amoist woundenvironment andallows the passageof exudate. | Devices covers thewound to provide amoist woundenvironment andallows the passageof exudate. | Equivalent topredicatedevices. |
| Subject Device | Predicate Devices | ||||
| OrganogenesisInc. | Aubrey, Inc. | Sterling Drug, Inc. | PermeaDerm, Inc. | ||
| Characteristic | FortiShield™ | AWBAT-S,AWBAT-D,AWBAT-M | Biobrane II(Other Predicate) | Permeaderm Band PermeadermCW(Other Predicate) | Comparison |
| (PrimaryPredicate) | |||||
| Materials andStructure | Porous Siliconeand Nylon Knit Bi-layer Scaffold withCross-LinkedCollagen Coating | PorousSilicone andNylon Knit Bi-layer Scaffoldwith CollagenCoating | Porous Silicone andNylon Knit Bi-layerScaffold with Cross-Linked CollagenCoating | Porous Silicone andNylon Knit Bi-layerScaffold withCollagen and AloeCoating | Equivalent topredicatedevices. Theconstruction isequivalent tothe primarypredicate andthe same asthe Biobrane IIpredicate. |
| Indicationsfor Use | FortiShield isindicated for: partialthickness wounds,pressure sores,venous ulcers,diabetic ulcers,chronic vascularulcers, surgicalwounds (donorsites/grafts, post-Moh's, post-lasersurgery, podiatric,wounddehiscence),trauma wounds(abrasions,lacerations, partial | Temporarywounddressing forcoverage ofSuperficialburns, Donorsites andMeshedautographs.AWBAT-S: isintended forcleanSuperficialburn wounds. | Covering donorsites, clean,debrided, orexcised superficialand medium depthpartial (2°)thickness woundsand as a protectivecovering overmeshed autografts.Suggested Uses:To manage cleanpartial thicknesswounds | PermeaDerm B isindicated for partialthickness burnwounds, donor sitesand coverage ofmeshed autograft.PermeaDerm CW isindicated for partialthickness wounds,pressure sores,venous ulcers,diabetic ulcers,chronic vascularulcers, surgicalwounds (donorsites/grafts, post- | Equivalent topredicatedevices. Theindicatedapplicationsare identical toPermeaDermCW. |
| Subject DeviceOrganogenesisInc.FortiShield™ | Aubrey, Inc.AWBAT-S,AWBAT-D,AWBAT-M(PrimaryPredicate) | Predicate DevicesSterling Drug, Inc.Biobrane II(Other Predicate) | PermeaDerm, Inc.Permeaderm Band PermeadermCW(Other Predicate) | Comparison | |
| Characteristic | |||||
| thickness burns,and skin tears) anddraining wounds. | AWBAT-D: isintended forDonor sitesafterhemostasishas beenestablished.AWBAT-M: isintended to beused as aprotectivecovering forMeshedautografts. | For wet woundmanagement tominimize fluidaccumulationFor use insituations wheremaximum passageof transudate isdesired | Moh's, post-lasersurgery, podiatric,wound dehiscence,trauma wounds(abrasions,lacerations,second-degreeburns, and skintears) and drainingwounds. | ||
| DeviceDimensions | 2" x 2" through 15"x 30" | Unknown | 2.5" x 5"5" x 5"5" x 7.5"5" x 15"10" x 15" | Permeaderm B:5"x1010"x15"15"x30"Permeaderm: CW2.5" x 5"5" x 5" | Equivalent topredicatedevices. Therange of sizesis within themaximum sizeoffered for thepredicatedevices. |
| Sterility | Sterile, SAL 10-6 | Sterile | Sterile | Sterile, SAL 10-6 | Equivalent topredicate |
| Subject Device | Predicate Devices | ||||
| OrganogenesisInc.FortiShield™ | Aubrey, Inc.AWBAT-S,AWBAT-D,AWBAT-M(PrimaryPredicate) | Sterling Drug, Inc.Biobrane II(Other Predicate) | PermeaDerm, Inc.Permeaderm Band PermeadermCW(Other Predicate) | Comparison | |
| Characteristic | |||||
| Pyrogenicity | Non-pyrogenic | Unknown | Non-pyrogenic | Unknown | devices. All devices are provided sterile.Equivalent to predicate devices. Both the subject and primary predicate devices are non-pyrogenic. |
| Bio-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 DeviceOrganogenesisInc.FortiShield™ | Predicate Devices | Comparison | ||
| Aubrey, Inc.AWBAT-S,AWBAT-D,AWBAT-M(PrimaryPredicate) | Sterling Drug, Inc.Biobrane II(Other Predicate) | PermeaDerm, Inc.Permeaderm Band PermeadermCW(Other Predicate) | duration ofcontact. |
Table 1: Comparison to Predicate Devices
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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.
N/A