(111 days)
The Miromatrix Wound Matrix is intended for the management of wounds including:
- Partial and full thickness wounds;
- Pressure ulcers;
- Venous ulcers;
- Diabetic ulcers;
- Chronic vascular ulcers;
- Tunneled, undermined wounds;
- Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence);
- Trauma wounds (abrasions, lacerations, second-degree bums, and skin tears);
- Draining wounds.
The Miromatrix Wound Matrix is an animal-sourced, acellular wound dressing that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting wound dressing is comprised primarily of collagen type I. The device is intended for use in the management of wounds. The Miromatrix Wound Matrix is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The dressing is available in sizes ranging from 1 cm x 2 cm to 10 cm x 25 cm, and may be trimmed or cut as required.
Here's an analysis of the provided text regarding the Miromatrix Wound Matrix, focusing on acceptance criteria and the supporting study information:
This document describes a 510(k) premarket notification for the Miromatrix Wound Matrix, which is a medical device. For devices seeking 510(k) clearance, the primary acceptance criteria revolve around demonstrating substantial equivalence to an already legally marketed predicate device. This is typically shown through comparison of indications for use, technological characteristics, and performance data.
1. A table of acceptance criteria and the reported device performance
For a 510(k) device, the "acceptance criteria" are not explicit numerical targets for diagnostic performance like sensitivity/specificity, but rather a demonstration of sufficient similarity and safety to a predicate device. The "reported device performance" is the outcome of the studies aiming to demonstrate this similarity.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Identical Indications for Use | The Miromatrix Wound Matrix has identical indications for use as the predicate device (K061711, Oasis Wound Matrix). |
| Similar Technological Characteristics | Both devices are porcine-derived, acellular dressings primarily comprised of collagen type I. Both are intended for wound management. |
| Comparable Safety Profile (Biocompatibility) | GLP compliant biocompatibility studies were conducted (In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, In Vitro Bacterial Reverse Mutation (AMES), In Vitro Chromosome Aberration, In Vitro Mammalian Cell Gene Mutation, Pyrogenicity, Sub-Chronic Systemic Toxicity). The testing showed a comparable safety profile to the predicate. |
| Other Laboratory Studies (Shelf-life, Sterilization, Animal-derived material) | DNA Residuals, Collagen Analysis, Viral Inactivation, Endotoxin, and Expiration Dating studies were conducted. No direct performance metrics are provided, but their completion supports substantial equivalence. |
2. Sample size used for the test set and the data provenance
The provided text does not specify sample sizes for human clinical test sets or the data provenance (country of origin, retrospective/prospective) for any clinical studies. The studies mentioned are primarily laboratory and biocompatibility tests, which typically don't involve human test subjects in the same way a diagnostic AI study would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided as this submission focuses on a wound matrix (a physical device) and its equivalence to a predicate, not a diagnostic AI or image analysis device that would require expert ground truth labeling.
4. Adjudication method for the test set
This information is not applicable and not provided for the same reasons as above.
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
No MRMC comparative effectiveness study was done or reported. This type of study is relevant for AI-assisted diagnostic devices, which the Miromatrix Wound Matrix is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the Miromatrix Wound Matrix is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biocompatibility studies, the "ground truth" would be established by standardized laboratory testing methods and controls, with results interpreted against established safety benchmarks for medical devices. For the other laboratory tests (DNA residuals, collagen analysis, etc.), the ground truth is the measured biochemical or physical property of the device against predefined specifications or comparison to the predicate. There is no "expert consensus" or "pathology" in the human clinical sense mentioned here.
8. The sample size for the training set
This information is not applicable and not provided as this is not an AI/machine learning device. The "training set" concept does not apply.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
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Miromatrix Wound Matrix
ડ. 510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Miromatrix Wound Matrix (K140510) is provided below.
| Device Common Name: | Animal-derived, extracellular matrix wound care product |
|---|---|
| Device Proprietary Name: | Miromatrix Wound Matrix |
| Submitter: | Miromatrix Medical, Inc.18683 Bearpath TrailEden Prairie, MN 55347www.miromatrix.com |
| Prepared By: | Stephen P. RhodesSenior ConsultantBiologics Consulting Group, Inc.Email: srhodes@bcg-usa.com |
| Contact: | Jeff Ross. Ph.D.VP Product DevelopmentMiromatrix Medical, Inc.18683 Bearpath TrailEden Prairie, MN 55347Phone: 763-458-8801Email: jross@miromatrix.com |
| Date Prepared: | February 24, 2014 |
| Classification Regulation: | Unclassified |
| Panel: | General & Plastic Surgery |
| Product Code: | KGN |
| Predicate Device: | K061711, Oasis Wound MatrixCook Biotech, Inc. |
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Miromatrix Wound Matrix
Indication for Use:
The Miromatrix Wound Matrix is intended for the management of wounds including:
- Partial and full thickness wounds: ●
- . Pressure ulcers;
- Venous ulcers: �
- Diabetic ulcers; .
- Chronic vascular ulcers; .
- Tunneled, undermined wounds; .
- Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, . wound dehiscence);
- Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears); .
- Draining wounds. �
Device Description:
The Miromatrix Wound Matrix is an animal-sourced, acellular wound dressing that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting wound dressing is comprised primarily of collagen type I. The device is intended for use in the management of wounds. The Miromatrix Wound Matrix is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The dressing is available in sizes ranging from 1 cm x 2 cm to 10 cm x 25 cm, and may be trimmed or cut as required.
Comparison to the Predicate:
The Miromatrix Wound Matrix has the identical indications for use as the predicate device. The technical characteristics are similar to the technological characteristics of the predicate wound dressing. Both devices are porcine-derived, acellular dressings that are comprised primarily of collagen type I. The dressings are both intended for the management of wounds.
The following GLP compliant, biocompatibility studies were conducted to evaluate the safety of the Miromatrix Wound Matrix:
Biocompatibility Testing In Vitro Cytotoxicity Skin Sensitization (Maximization Method) Intracutaneous Reactivity Acute Systemic Toxicity In Vitro Bacterial Reverse Mutation (AMES) In Vitro Chromosome Aberration In Vitro Mammalian Cell Gene Mutation Pyrogenicity Sub-Chronic Systemic Toxicity
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Miromatrix Wound Matrix
Per FDA guidance on shelf life, sterilization, and devices containing animal-derived material, the following laboratory studies were also conducted:
Laboratory Testing
- DNA Residuals Collagen Analysis Vira! Inactivation Endotoxin Expiration Dating
The biocompatibility testing showed the comparable safety profile of the Miromatrix Wound Matrix and the predicate.
Summary of Substantial Equivalence:
Based on the indications for use, technological characteristics and performance test results, the Miromatrix Wound Matrix is substantially equivalent to the predicate.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2014
Maromatrix Medical Incorporated % Mr. Stephen P. Rhodes Biologics Consulting Group, Inc. Senior Consultant 400 N. Washington Street, Suite 100 Alexandria, Virginia 22314
Re: K140510
Trade/Device Name: Miromatrix Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: March 24, 2014 Received: March 25, 2014
Dear Mr. Rhodes:
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 or any 1 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Stephen P. Rhodes
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. 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" (21CFR 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140510
Device Name Miromatrix Wound Matrix
Indications for Use (Describe)
The Miromatrix Wound Matrix is intended for the management of wounds including:
- · Partial and full thickness wounds;
- · Pressure ulcers;
- · Venous ulcers;
- · Diabetic ulcers;
- · Chronic vascular ulcers;
- · Tunneled, undermined wounds;
- · Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence);
- · Trauma wounds (abrasions, lacerations, second-degree bums, and skin tears);
- · Draining wounds.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Jiyoung Dang -S
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