(111 days)
Not Found
No
The device description and performance studies focus on the material properties and biological compatibility of the wound dressing, with no mention of AI or ML technologies.
Yes
The device is described as a "wound dressing" intended for the "management of wounds," indicating its use in treating or alleviating a condition, which aligns with the definition of a therapeutic device.
No
The device is described as an "animal-sourced, acellular wound dressing" intended for the "management of wounds," which indicates a therapeutic rather than a diagnostic function.
No
The device description clearly states it is an "animal-sourced, acellular wound dressing" derived from porcine liver tissue, which is a physical material, not software.
Based on the provided information, the Miromatrix Wound Matrix is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the management of various types of wounds. This is a therapeutic application, not a diagnostic one. IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a wound dressing made from animal tissue. It is applied directly to the wound. This is consistent with a therapeutic device, not a diagnostic one that analyzes samples.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue biopsies, etc.) to provide diagnostic information.
The device is clearly intended for the treatment and management of wounds, which falls under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
KGN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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 Trail | |
| Eden Prairie, MN 55347 | |
| www.miromatrix.com | |
| Prepared By: | Stephen P. Rhodes |
| Senior Consultant | |
| Biologics Consulting Group, Inc. | |
| Email: srhodes@bcg-usa.com | |
| Contact: | Jeff Ross. Ph.D. |
| VP Product Development | |
| Miromatrix Medical, Inc. | |
| 18683 Bearpath Trail | |
| Eden Prairie, MN 55347 | |
| Phone: 763-458-8801 | |
| Email: jross@miromatrix.com | |
| Date Prepared: | February 24, 2014 |
| Classification Regulation: | Unclassified |
| Panel: | General & Plastic Surgery |
| Product Code: | KGN |
| Predicate Device: | K061711, Oasis Wound Matrix |
| Cook Biotech, Inc. |
1
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
2
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or flowing lines, positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
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
4
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
5
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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