← Product Code FRO · K172318 # Endoform Silver Dermal Template (K172318) _Aroa Biosurgery · FRO · Nov 17, 2017 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K172318 ## Device Facts - **Applicant:** Aroa Biosurgery - **Product Code:** FRO - **Decision Date:** Nov 17, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Endoform Silver Dermal Template is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment. ## Device Story Endoform Silver Dermal Template is a sterile, single-use wound dressing derived from ovine forestomach extracellular matrix (ECM). It contains approximately 12 µg/cm² of ionic silver to prevent microbial colonization of the dressing for up to 7 days. The device is supplied as intact or fenestrated sheets. Upon rehydration with wound exudate or saline, it transforms into a soft, conforming sheet that is naturally incorporated into the wound over time. It is intended for use by healthcare professionals in clinical settings for various wound types. The device acts as a physical barrier to protect the wound and maintain a moist environment, while the ionic silver provides antimicrobial properties. It benefits patients by supporting wound management and reducing the risk of microbial colonization within the dressing. ## Clinical Evidence No clinical data. Substantial equivalence is based on bench testing only. In vitro testing demonstrated antimicrobial effectiveness against a panel of 11 microbial species (including MRSA, VRE, and various Candida/Staphylococcus species) for up to 7 days. Bench testing verified physical characteristics (strength, thickness, permeability), composition, endotoxin levels (ANSI/AAMI ST72, USP <85>), sterilization (ISO 11135, ISO 11737), packaging integrity (ISO 11607), shelf life, and biocompatibility (ISO 10993). ## Technological Characteristics Ovine forestomach-derived ECM containing collagen I and III, fibronectin, glycosaminoglycans, laminin, and elastin. Contains ~12 µg/cm² ionic silver. Dimensions: 2x2" and 4x5" sheets (fenestrated/non-fenestrated). Thickness: 0.3 ± 0.1 mm. Sterilization: Ethylene Oxide (ISO 11135). Storage: Room temperature. Non-electronic, non-software device. ## Predicate Devices - PriMatrix Ag Antimicrobial Dermal Repair Scaffold ([K100261](/device/K100261.md)) ## Reference Devices - Endoform Dermal Template ([K092096](/device/K092096.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. November 17, 2017 Aroa Biosurgery Tina O'Brien Director, Regulatory Affairs 2 Kingsford Smith Place Airport Oaks, 2022 NZ Auckland Re: K172318 Trade/Device Name: Endoform Silver Dermal Template Regulatory Class: Unclassified Product Code: FRO Dated: July 31, 2017 Received: August 1, 2017 Dear Tina O'Brien: 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 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 {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) Device Name Endoform Silver Dermal Template Indications for Use (Describe) Endoform Silver Dermal Template is supplied sterile and is intended for single use in the management of the following wounds: - * partial and full-thickness wounds - * pressure ulcers - * venous ulcers - * diabetic ulcers - * chronic vascular ulcers - * tunnelled / undermined wounds - * surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, - wound dehiscence) - * trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) - * draining wounds Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) PSC Publishing Services (301) 443-6740 EF ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for AROA. The logo consists of an orange circular design on the left and the word "AROA" in black on the right. The circular design is made up of several smaller orange circles arranged in a circular pattern. #### 5. 510(k) Summary | Contact person/submitter | Tina O'Brien
Director of Regulatory Affairs
Aroa Biosurgery | |--------------------------|-----------------------------------------------------------------------------------------| | Author | Amelia Ortiz
Regulatory & Quality Engineer | | Date prepared | 31 July 2017 | | Contact details | 2 Kingsford Smith Place
Airport Oaks
Auckland 2022, New Zealand
+64 9 369 3035 | | Trade name | Endoform Silver Dermal Template | | Common name | Dressing, wound, drug | | Predicate device | PriMatrix Ag Antimicrobial Dermal Repair Scaffold
(K100261) | | Reference device | Endoform Dermal Template (K092096) | ## 5.1. Device Description Endoform Silver Dermal Template (Endoform Silver) is an advanced wound care dressing primarily composed of natural, non-reconstituted collagen retaining the native extracellular matrix associated macromolecules including fibronectin, glycosaminoglycans, laminin, and elastin. Endoform Silver is supplied as sterile intact or fenestrated sheets. Endoform Silver contains approximately 12 µg/cm² (~0.3% w/w) ionic silver, intended to prevent microbial colonization of the dressing is effective against a broad spectrum of microbes, including Acinetobacter baumannii, Candida parapsilosis, Candida glabrata, Candida albicans, Escherichia coli, Methicillin Resistant Staphylococcus aureus (MRSA), coagulase-negative Staphylococci, group A (betahemolytic) Streptococci, Pseudomonas aeruginosa, Aspergillus niger, and Vancomycin Resistant Enterococci (VRE). The dressing provides sustained antimicrobial effectiveness within the dressing for up to 7 days. Endoform Silver is derived from ovine (sheep) extracellular matrix and it retains the innate biological structure of the native extracellular matrix. When rehydrated with exudate or sterile saline, Endoform Silver transforms into a soft conforming sheet, which is naturally incorporated into the wound over time. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for AROA. On the left side of the logo is an orange circular design made up of many smaller orange oval shapes. To the right of the design is the word "AROA" in a bold, sans-serif font. ### 5.2. Intended Use and Indications for Use #### 5.2.1. Intended Use Endoform Silver Dermal Template is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment. #### 5.2.2. Indications for Use Endoform Silver Dermal Template is supplied sterile and is intended for single use in the management of the following wounds: - partial and full-thickness wounds - pressure ulcers - venous ulcers ● - diabetic ulcers - chronic vascular ulcers ● - tunnelled / undermined wounds - surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, ● podiatric, - wound dehiscence) - trauma wounds ( abrasions, lacerations, second-degree burns, and skin ● tears) - . draining wounds ## 5.3. Technological Characteristics Comparison The addition of ionic silver to the currently cleared reference device, Endoform Dermal Template (K092096), results in a new device (Endoform Silver) that is substantially equivalent to the predicate in terms of preventing microbial colonization of the device when used within identical indications for use, based on in vitro performance testing. The primary differences between Endoform Silver and the predicate, PriMatrix Ag Antimicrobial Dermal Repair Scaffold, are the raw material origin and the tissue type. | | Subject Device
Endoform Silver Dermal
Template | Predicate Device
PriMatrix Ag Antimicrobial
Dermal Repair Scaffold
(K100261) | Reference Device
Endoform Dermal Template
(K092096) | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Aroa | TEI Biosciences | Aroa | | 510K Number | - | K100261 | K092096 | | Device name | Endoform Silver Dermal
Template | PriMatrix Ag Antimicrobial
Dermal Repair Scaffold | Endoform Dermal Template | | Classification
Name | Dressing, wound, drug
(FRO)
Unclassified | Dressing, wound, drug
(FRO)
Unclassified | Dressing, wound, collagen
(KGN)
Unclassified | | | Subject Device
Endoform Silver Dermal
Template | Predicate Device
PriMatrix Ag Antimicrobial
Dermal Repair Scaffold
(K100261) | Reference Device
Endoform Dermal Template
(K092096) | | Intended use | Endoform Silver Dermal
Template is a sterile,
single use ovine
forestomach-derived
extracellular matrix
intended to cover,
protect, and provide a
moist wound
environment. | Primatrix Ag Antimicrobial
Dermal Repair Scaffold is
intended for the management of
wounds that include:
*Partial and full thickness
wounds
*Pressure, diabetic and venous
ulcers
*Second-degree burns
*Surgical wounds- donor
sites/grafts, post Moh's surgery,
post-laser surgery, podiatric,
wounds dehiscence
*Trauma wounds- abrasions,
lacerations, and skin tears
*Tunneled/undermined wounds
*Draining wounds | Endoform Dermal Template
is supplied sterile and is
intended for single use in
the
treatment of the following
wounds:
* partial and full-thickness
wounds
* pressure ulcers
* venous ulcers
* diabetic ulcers
* chronic vascular ulcers
* tunneled / undermined
wounds
* surgical wounds (donor
sites/grafts, post-Moh's
surgery, post-laser surgery,
podiatric,
wound dehiscence)
* trauma wounds
(abrasions, lacerations,
second-degree burns, and
skin tears)
* draining wounds | | Indications
for Use | Endoform Silver Dermal
Template is supplied
sterile and is intended
for single use in the
management of the
following wounds:
* partial and full-
thickness wounds
* pressure ulcers
* venous ulcers
* diabetic ulcers
* chronic vascular ulcers
* tunneled / undermined
wounds
* surgical wounds (donor
sites/grafts, post-Moh's
surgery, post-laser
surgery, podiatric,
wound dehiscence)
* trauma wounds
(abrasions, lacerations,
second-degree burns,
and skin tears)
* draining wounds | Primatrix Ag Antimicrobial is
intended for the management of
wounds that include:
*Partial and full thickness
wounds
*Pressure, diabetic and venous
ulcers
*Second-degree burns
*Surgical wounds- donor
sites/grafts, post Moh's surgery,
post-laser surgery, podiatric,
wounds dehiscence
*Trauma wounds- abrasions,
lacerations, and skin tears
*Tunneled/undermined wounds
*Draining wounds | Endoform Dermal Template
is supplied sterile and is
intended for single use in
the treatment of the
following wounds:
* partial and full-thickness
wounds
* pressure ulcers
* venous ulcers
*diabetic ulcers
* chronic vascular ulcers
* tunneled / undermined
wounds
* surgical wounds (donor
sites/grafts, post-Moh's
surgery, post-laser surgery,
podiatric,
wound dehiscence)
* trauma wounds
(abrasions, lacerations,
second-degree burns, and
skin tears)
* draining wounds | | Animal origin | Ovine | Bovine | Ovine | | Tissue type | Forestomach | Dermis | Forestomach | | Nominal sizes | 2x2" and 4x5"
fenestrated or non-
fenestrated sheets | Fenestrated, non-fenestrated, or
meshed sheets ranging from 4x4
cm to 10x25cm | 2x2" and 4x5"
fenestrated or non-
fenestrated sheets | | | Subject Device
Endoform Silver Dermal
Template | Predicate Device
PriMatrix Ag Antimicrobial
Dermal Repair Scaffold
(K100261) | Reference Device
Endoform Dermal Template
(K092096) | | | | | ranging in size up to 400
cm² | | Thickness | $0.3 \pm 0.1$ mm | 0.65mm | $0.25\pm 0.01$ mm | | Presentation | Sterile, lyophilized single
sheets in peel pouch | Sterile, single sheets | Sterile, lyophilized single
sheets in peel pouch | | Components | Ovine derived collagen
and associated ECM
components
-collagen I
-collagen III | Bovine derived collagen and
associated ECM components
-collagen I
-collagen III | Ovine derived collagen and
associated ECM
components
-collagen I
-collagen III | | Sterilization
method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | | Antimicrobial
content | Ionic Silver
approximately 12 µg/cm² | Ionic Silver ≤165 µg/cm² | N/A, device is not
antimicrobial | | Storage
conditions | Room temperature | Room temperature (15-30°C) | Ambient temperature | ### Table 5-1 Technological Characteristics Comparison {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the logo for AROA. The logo consists of an orange circular design on the left, which is made up of several smaller oval shapes arranged in a circular pattern. To the right of the circular design is the text "AROA" in a simple, sans-serif font. The text is black and appears to be the name of the company or organization. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for AROA. On the left side of the logo is a circular design made up of many small orange oval shapes. To the right of the design is the text "AROA" in a simple, sans-serif font. The text is black and the letters are evenly spaced. ### 5.4. Non-Clinical Performance Data Based on in vitro performance testing, antimicrobial effectiveness of the dressing and wear time testing conducted against a panel of clinically relevant microbial species demonstrates that the device inhibits microbial colonization of the dressing. Tested micro-organisms included: - Acinetobacter baumannii ● - Candida albicans . - Candida parapsilosis ● - Candida glabrata . - Escherichia coli ● - Methicillin Resistant Staphylococcus aureus (MRSA) - Staphylococcus epidermidis . - Streptococcus pyrogenes . - Pseudomonas aeruginosa - Aspergillus niger ● - Vancomycin Resistant Enterococci (VRE) ● The results of in vitro testing verify the antimicrobial silver in the device is effective in inhibiting microbial colonization of the dressing, with antimicrobial effectiveness within the dressing sustained for up to 7 days. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image contains the logo for AROA Biosurgery. The logo consists of an abstract orange circular design on the left, resembling a cluster of interconnected dots or cells. To the right of the circular design is the word "AROA" in bold, black sans-serif font. The overall design is clean and modern. Performance bench testing was completed on various device characteristics to ensure product requirements were satisfied, as well as for comparison against the predicate product. The acceptance criteria were met for all characteristics and comparison against the predicate and reference devices demonstrates equivalent performance. Performance tests included: - Physical characteristics Uniaxial strength, burst strength, thickness, dimensions, permeability, rehydration rate, melt onset temperature - . Composition Collagen, GAGs, DNA, fibronectin, laminin, silver concentration, moisture content - . Endotoxin levels were tested in accordance with ANSI/AAMI ST72 - Bacterial Endotoxins -Test Methodologies, routine monitoring, and alternatives to batch testing and USP 39-NF34:2016 <85> Bacterial Endotoxin Test - To ensure an SAL of 10°, sterilization was conducted in accordance ● with ISO 11135 Sterilization of health care products-Ethylene Oxide -Requirements for the development, validation, and routine control of a sterilization process for medical devices; ISO 11737-1 Sterilization of Medical Devices - Microbiological Methods - Part 1: Determination of a Population of Microogranisms on Products; and ISO 11737-2 Sterilisation of medical devices -Microbiological methods – Part 2: Tests of sterility performed in the validation of a sterilisation process - . Sterile packaging was evaluated for seal integrity and seal strength against ISO 11607-1 Packaging for Terminally Sterilized Medical Devices Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging, and ISO 11607–2 Packaging for Terminally Sterilized Medical Devices Part 2: Validation Requirements for Forming, Sealing and Assembly Process. - . Shelf life testing was conducted under accelerated and real time aging conditions to ensure the stability of the biophysical and biochemical characteristics, as well as antimicrobial effectiveness in accordance with ISO 20743: 2013 Textiles --Determination of antibacterial activity of textile products. - Biocompatibility was assessed for cytotoxicity, sensitization, systemic toxicity, sub-acute toxicity, genotoxicity, implantation, hemocompatibility, chronic toxicity, carcinogenicity, reproductive and developmental toxicity, biodegradation, toxicokinetics, and immunotoxicity in accordance with ISO 10993-1 Biological Evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Assessment results conclude that the device presents no new risk to end-users. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image contains the logo for AROA. The logo consists of an orange circular design made up of smaller oval shapes on the left, and the word "AROA" in bold black letters on the right. The circular design is abstract and resembles a sun or a flower. As the proposed predicate and reference devices are technologically equivalent, safety and performance of the proposed device is based on the in vivo performance of the predicate and reference devices. ### 5.5. Clinical Performance Data Substantial equivalence was not based on an assessment of clinical performance data. ### 5.6. Conclusions The Endoform Silver Dermal Template is substantially equivalent to the PriMatrix Ag Antimicrobial Dermal Repair Scaffold (K100261) device. Bench performance testing demonstrates the two devices are substantially equivalent for their intended use. --- **Source:** [https://fda.innolitics.com/device/K172318](https://fda.innolitics.com/device/K172318) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com