(108 days)
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
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.
The provided document is a 510(k) summary for the Endoform Silver Dermal Template, and it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical study to prove device performance against specific acceptance criteria. Therefore, much of the requested information regarding a study design, sample sizes for training/test sets, expert qualifications, and ground truth establishment is not available in this document.
However, I can extract information related to the non-clinical performance data and the comparison to the predicate device.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of "acceptance criteria" for clinical performance. Instead, it states that "The acceptance criteria were met for all characteristics and comparison against the predicate and reference devices demonstrates equivalent performance" in the non-clinical testing section. The key performance claim for the subject device (Endoform Silver Dermal Template) is antimicrobial effectiveness.
| Acceptance Criteria (Inferred from Non-Clinical Testing) | Reported Device Performance (Endoform Silver Dermal Template) |
|---|---|
| Antimicrobial Effectiveness: Inhibits microbial colonization of the dressing. | Demonstrates antimicrobial effectiveness within the dressing against a broad spectrum of clinically relevant microbes (Acinetobacter baumannii, Candida parapsilosis, Candida glabrata, Candida albicans, Escherichia coli, Methicillin Resistant Staphylococcus aureus (MRSA), coagulase-negative Staphylococci, group A (beta-hemolytic) Streptococci, Pseudomonas aeruginosa, Aspergillus niger, and Vancomycin Resistant Enterococci (VRE)). Effectiveness is sustained for up to 7 days. |
| Physical Characteristics: E.g., Uniaxial strength, burst strength, thickness, permeability, rehydration rate, melt onset temperature. | Met acceptance criteria. Demonstrated equivalent performance to predicate and reference devices. |
| Composition: E.g., Collagen, GAGs, DNA, fibronectin, laminin, silver concentration, moisture content. | Met acceptance criteria. Demonstrated equivalent performance to predicate and reference devices. The device contains approximately 12 µg/cm² (~0.3% w/w) ionic silver, which is within the range of the predicate (≤165 µg/cm²). |
| Endotoxin Levels: In accordance with ANSI/AAMI ST72 and USP 39-NF34:2016 <85>. | Met acceptance criteria. |
| Sterilization: SAL of 10⁻⁶ in accordance with ISO 11135, ISO 11737-1, ISO 11737-2. | Met acceptance criteria. |
| Sterile Packaging: Seal integrity and seal strength against ISO 11607-1 and ISO 11607–2. | Met acceptance criteria. |
| Shelf Life: Stability of biophysical and biochemical characteristics, antimicrobial effectiveness. | Shelf life testing conducted under accelerated and real-time aging conditions demonstrated stability and sustained antimicrobial effectiveness in accordance with ISO 20743: 2013. |
| Biocompatibility: Cytotoxicity, sensitization, systemic toxicity, sub-acute toxicity, genotoxicity, implantation, hemocompatibility, chronic toxicity, carcinogenicity, reproductive and developmental toxicity, biodegradation, toxicokinetics, immunotoxicity. | Assessment results conclude that the device presents no new risk to end-users, in accordance with ISO 10993-1. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for non-clinical tests (e.g., number of dressings tested for antimicrobial effectiveness, physical properties, etc.).
- Data Provenance: The tests are "in vitro performance testing" and "performance bench testing." No information on country of origin of data is provided specifically for these lab tests, but the company (Aroa Biosurgery) is based in New Zealand. These are lab-based tests, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The non-clinical performance data (e.g., antimicrobial effectiveness, physical characteristics) are measured objectively in a lab setting, not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to human interpretation/adjudication in clinical studies, which is not described for the non-clinical tests presented.
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 a medical device (wound dressing) and the information provided refers to non-clinical performance, not an AI-driven diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm. The testing described is "standalone" in the sense that the device's physical and antimicrobial properties are tested independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests:
- Antimicrobial Effectiveness: The "ground truth" is measured by objective laboratory methods against known microbial cultures (e.g., measuring zones of inhibition, reduction in microbial count).
- Physical/Compositional/Safety Tests: The "ground truth" is established by adherence to recognized industry standards (e.g., ISO standards, USP, ANSI/AAMI), which define acceptable ranges and methodologies for measurement.
8. The sample size for the training set
Not applicable. This document describes a medical device undergoing non-clinical performance testing and substantial equivalence review, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as it's not an AI model.
Summary of the Study and Substantial Equivalence:
The document describes a 510(k) premarket notification for the Endoform Silver Dermal Template. The "study" described is a series of non-clinical performance tests conducted to demonstrate that the device is substantially equivalent to a legally marketed predicate device, the PriMatrix Ag Antimicrobial Dermal Repair Scaffold (K100261). A reference device, the Endoform Dermal Template (K092096), was also used for comparison of non-antimicrobial characteristics.
The primary difference of the subject device from the reference device is the addition of ionic silver for antimicrobial properties. The key finding from the non-clinical performance data is that the silver content in Endoform Silver Dermal Template successfully inhibits microbial colonization of the dressing for up to 7 days, making it comparable to the antimicrobial claim of the predicate device. All other physical, compositional, and safety characteristics were shown to meet acceptance criteria and be equivalent to the predicate/reference devices.
Crucially, the document explicitly states in section 5.5: "Substantial equivalence was not based on an assessment of clinical performance data." This means that no human clinical trials were conducted or presented in this submission to demonstrate the device's effectiveness in wound management on patients; the FDA clearance was based on equivalence of technological characteristics and non-clinical performance data to existing devices.
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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.
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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
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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
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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'BrienDirector of Regulatory AffairsAroa Biosurgery |
|---|---|
| Author | Amelia OrtizRegulatory & Quality Engineer |
| Date prepared | 31 July 2017 |
| Contact details | 2 Kingsford Smith PlaceAirport OaksAuckland 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.
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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 DeviceEndoform Silver DermalTemplate | Predicate DevicePriMatrix Ag AntimicrobialDermal Repair Scaffold(K100261) | Reference DeviceEndoform Dermal Template(K092096) | |
|---|---|---|---|
| Manufacturer | Aroa | TEI Biosciences | Aroa |
| 510K Number | - | K100261 | K092096 |
| Device name | Endoform Silver DermalTemplate | PriMatrix Ag AntimicrobialDermal Repair Scaffold | Endoform Dermal Template |
| ClassificationName | Dressing, wound, drug(FRO)Unclassified | Dressing, wound, drug(FRO)Unclassified | Dressing, wound, collagen(KGN)Unclassified |
| Subject DeviceEndoform Silver DermalTemplate | Predicate DevicePriMatrix Ag AntimicrobialDermal Repair Scaffold(K100261) | Reference DeviceEndoform Dermal Template(K092096) | |
| Intended use | Endoform Silver DermalTemplate is a sterile,single use ovineforestomach-derivedextracellular matrixintended to cover,protect, and provide amoist woundenvironment. | Primatrix Ag AntimicrobialDermal Repair Scaffold isintended for the management ofwounds that include:*Partial and full thicknesswounds*Pressure, diabetic and venousulcers*Second-degree burns*Surgical wounds- donorsites/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 Templateis supplied sterile and isintended for single use inthetreatment of the followingwounds:* partial and full-thicknesswounds* pressure ulcers* venous ulcers* diabetic ulcers* chronic vascular ulcers* tunneled / underminedwounds* surgical wounds (donorsites/grafts, post-Moh'ssurgery, post-laser surgery,podiatric,wound dehiscence)* trauma wounds(abrasions, lacerations,second-degree burns, andskin tears)* draining wounds |
| Indicationsfor Use | Endoform Silver DermalTemplate is suppliedsterile and is intendedfor single use in themanagement of thefollowing wounds:* partial and full-thickness wounds* pressure ulcers* venous ulcers* diabetic ulcers* chronic vascular ulcers* tunneled / underminedwounds* surgical wounds (donorsites/grafts, post-Moh'ssurgery, post-lasersurgery, podiatric,wound dehiscence)* trauma wounds(abrasions, lacerations,second-degree burns,and skin tears)* draining wounds | Primatrix Ag Antimicrobial isintended for the management ofwounds that include:*Partial and full thicknesswounds*Pressure, diabetic and venousulcers*Second-degree burns*Surgical wounds- donorsites/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 Templateis supplied sterile and isintended for single use inthe treatment of thefollowing wounds:* partial and full-thicknesswounds* pressure ulcers* venous ulcersdiabetic ulcers chronic vascular ulcers* tunneled / underminedwounds* surgical wounds (donorsites/grafts, post-Moh'ssurgery, post-laser surgery,podiatric,wound dehiscence)* trauma wounds(abrasions, lacerations,second-degree burns, andskin 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, ormeshed sheets ranging from 4x4cm to 10x25cm | 2x2" and 4x5"fenestrated or non-fenestrated sheets |
| Subject DeviceEndoform Silver DermalTemplate | Predicate DevicePriMatrix Ag AntimicrobialDermal Repair Scaffold(K100261) | Reference DeviceEndoform Dermal Template(K092096) | |
| ranging in size up to 400cm² | |||
| Thickness | $0.3 \pm 0.1$ mm | 0.65mm | $0.25\pm 0.01$ mm |
| Presentation | Sterile, lyophilized singlesheets in peel pouch | Sterile, single sheets | Sterile, lyophilized singlesheets in peel pouch |
| Components | Ovine derived collagenand associated ECMcomponents-collagen I-collagen III | Bovine derived collagen andassociated ECM components-collagen I-collagen III | Ovine derived collagen andassociated ECMcomponents-collagen I-collagen III |
| Sterilizationmethod | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Antimicrobialcontent | Ionic Silverapproximately 12 µg/cm² | Ionic Silver ≤165 µg/cm² | N/A, device is notantimicrobial |
| Storageconditions | Room temperature | Room temperature (15-30°C) | Ambient temperature |
Table 5-1 Technological Characteristics Comparison
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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.
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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.
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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.
N/A