(153 days)
The Mirragen™ Advanced Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, first and second degree burns, skin tears) and draining wounds.
The Mirragen™ Advanced Wound Matrix is composed solely of biocompatible and resorbable borate glass fibers and particulate. The borate glass constituent is medical-grade. The device is a resorbable fiber dressing that covers the wound. It may be used for a period of 3 to 7 days. The porosity of the device allows for absorption of fluid.
This document describes the Mirragen™ Advanced Wound Matrix and its substantial equivalence to predicate devices, but it does not provide specific acceptance criteria or a study designed to prove the device meets such criteria in the format requested.
The document is a 510(k) summary for the device, which aims to demonstrate that a new medical device is at least as safe and effective as a legally marketed predicate device. This is different from a performance study demonstrating a device meets predefined numerical acceptance criteria for, for example, diagnostic accuracy.
Therefore, most of the requested information cannot be directly extracted from the provided text.
Here's an attempt to answer based on the information available, highlighting what is not provided:
1. A table of acceptance criteria and the reported device performance
This information is not provided in a quantified, tabular format within the document. The document states that the device "meets its specifications" and "functioned as intended," and showed "similar wound healing response" to predicate devices, but no specific numerical acceptance criteria or performance metrics are given.
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 for Test Set: Not explicitly stated as a numerical sample size for a test set. The document refers to "samples of the Mirragen™ dressing" for characterization and states, "The dressing was also tested against the predicate devices in full and partial thickness wounds in a clinically relevant porcine model." The number of porcine subjects or wounds is not specified.
- Data Provenance: The document does not specify the country of origin for the data. The porcine model study would be considered prospective for that specific animal study.
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)
This information is not applicable/provided. The studies described are preclinical (bench testing and animal studies), not clinical studies involving human expert assessment for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. The studies described are preclinical.
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
This information is not applicable/provided. The device is a wound matrix, not an AI-powered diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is a wound matrix, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the preclinical characterization tests, the "ground truth" would be the direct measurements and observations of the physical and chemical properties of the device (e.g., mass, density, composition, dissolution time, fluid absorption capacity).
- For the porcine wound healing study, the "ground truth" was established through:
- Macroscopic assessment of wound healing
- Planimetric measurement of wound closure
- Histopathology
- Histomorphometry
These are objective measurements and histological examinations rather than expert consensus on subjective findings.
8. The sample size for the training set
This information is not applicable/provided. The device is a physical wound matrix, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. The device is a physical wound matrix, not a machine learning model.
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December 15, 2022
Engineered Tissue Solutions, LLC % Mr. Randy Prebula Partner Hogan Lovells US, LLP 555 Thirteenth Street, Northwest Washington, District of Columbia 20009
Re: K161067
Trade/Device Name: Mirragen™ Advanced Wound Matrix Regulatory Class: Unclassified Product Code: QSZ
Dear Mr. Randy Prebula:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 15, 2016. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSZ.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie. Morabito@fda. hhs. gov.
Sincerely.
Julie A. Morabito -S
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2016
Engineered Tissue Solutions, LLC % Mr. Randy Prebula Partner Hogan Lovells US, LLP 555 Thirteenth Street, Northwest Washington, District of Columbia 20009
Re: K161067
Trade/Device Name: Mirragen™ Advanced Wound Matrix Regulatory Class: Unclassified Product Code: FRO Dated: August 19, 2016 Received: August 19, 2016
Dear Mr. Randy Prebula:
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 (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.
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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,
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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Indications for Use
510(k) Number (if known) K161067
Device Name Mirragen™ Advanced Wound Matrix
Indications for Use (Describe)
The Mirragen™ Advanced Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tumneled/ undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, first and second degree burns, 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 K161067
1. Submitter Information:
Engineered Tissue Solutions, LLC 4030 Hypoint North Rolla, MO 65401 Phone: (573)-458-5966 Fax: (573)-755-0588 Contact Person: Mark Borden, Ph.D.
Date Prepared: September 15, 2016
2. Contact Information:
Randy Prebula Hogan Lovells U.S., LLP 555 Thirteenth Street, NW Washington, DC 20004
3. Device Name and Classification:
| Trade/Proprietary Name: | MirragenTM Advanced Wound Matrix |
|---|---|
| Common/Usual Name: | Wound dressing |
| Classification Name: | Unclassified |
| Classification Panel: | General and Plastic Surgery |
| Product Code: | FRO (Dressing, Wound, Drug) |
| Device Class: | Unclassified |
4. Predicate Devices
- Medline Industries, Inc. Puracol® Plus Ag+ MicroScaffold™ Wound Dressing (K071552)
- · W.L. Gore & Associates, Inc. GORE® BIO-A® Wound Matrix (K132397)
5. Intended Use / Indications for Use
The Mirragen™ Advanced Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, first and second degree burns, skin tears) and draining wounds.
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6. Device Description
The Mirragen™ Advanced Wound Matrix is composed solely of biocompatible and resorbable borate glass fibers and particulate. The borate glass constituent is medical-grade. The device is a resorbable fiber dressing that covers the wound. It may be used for a period of 3 to 7 days. The porosity of the device allows for absorption of fluid.
7. Performance Data
The company performed a variety of preclinical testing to support the safety and effectiveness of the Mirragen™ Advanced Wound Matrix for its intended use. This testing is described in full in the 510(k) submission, and is summarized below.
For characterization of the dressing, the volume, mass, and density of samples of the Mirragen™ dressing were first measured and recorded. Samples were also subjected to various functional tests, including X-ray fluorescence spectroscopy for composition analysis, X-ray diffraction to analyze the product's crystallinity, and physical manipulation (cutting and handling) to assess friability, durability, and ease of use. Further structural characterization was performed through SEM imaging and analysis that evaluated the distributions of fiber sizes and particle sizes in the dressing. In addition, the company measured weight loss from samples incubated in 37°C water at various time points, which established the dressing's 45-day aqueous dissolution time, and measured the weight of the dressing before and after fluid saturation to determine the fluid absorption capacity. Results showed that the device meets its specifications, which are similar to those of the predicate devices that have similar resorbable fiber structures. In all instances, the Mirragen™ dressing functioned as intended and the qualities observed were as expected.
The dressing was also tested against the predicate devices in full and partial thickness wounds in a clinically relevant porcine model. Wound healing analyses included macroscopic assessment of wound healing, planimetric measurement of wound closure, histopathology, and histomorphometry. Test results showed that the Mirragen™ Advanced Wound Matrix and the predicate devices had a similar wound healing response and exhibited no adverse tissue responses.
In accordance with ISO 10993, the company conducted the biocompatibility tests recommended for a surface device that is in prolonged contact with breached or compromised skin. This included tests for cytotoxicity, sensitization, and irritation/intracutaneous reactivity. The company also conducted additional tests per ISO 10993 to supplement the biocompatibility evaluation of the Mirragen™ dressing, including sub-acute toxicity and a variety of genotoxicity tests (Ames, chromosomal aberration, and erythrocyte micronucleus). All results were passing, demonstrating the biocompatibility of the Mirragen™ Advanced Wound Matrix.
8. Substantial Equivalence
The Mirragen™ Advanced Wound Matrix is as safe and effective as the Puracol® Plus Ag+ MicroScaffold™ Wound Dressing and the GORE® BIO-A® Wound Matrix. The subject device has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Mirragen™
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Advanced Wound Matrix and its predicate devices raise no different questions of safety or effectiveness. Performance data further support the product's safety and effectiveness in comparison to the predicates. Thus, the Mirragen™ Advanced Wound Matrix is substantially equivalent.
9. Conclusions
The Mirragen™ Advanced Wound Matrix has similar structure and principles of operation as the cleared predicate devices; bench and animal testing further support that the device performs as intended. Thus, the device is substantially equivalent to the predicate devices.
N/A