MIROMATRIX WOUND MATRIX

K140510 · Miromatrix Medical, Inc. · KGN · Jun 19, 2014 · SU

Device Facts

• Record ID: K140510
• Device Name: MIROMATRIX WOUND MATRIX
• Applicant: Miromatrix Medical, Inc.
• Product Code: KGN · SU
• Decision Date: Jun 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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 Story

Miromatrix Wound Matrix is an acellular, porcine-derived wound dressing; processed from porcine liver tissue via perfusion decellularization. Comprised primarily of collagen type I; supplied hydrated, moist, and flexible in terminal packaging. Available in various sizes; trimmable by clinician. Used in clinical settings for management of diverse wound types; provides a scaffold for wound healing. No active electronic components or software.

Clinical Evidence

Bench testing only. No clinical data presented. Safety supported by GLP-compliant biocompatibility studies and laboratory testing including DNA residuals, collagen analysis, viral inactivation, and endotoxin levels.

Technological Characteristics

Acellular porcine liver-derived scaffold; primarily collagen type I. Terminally sterilized. Hydrated, flexible form factor. Sizes 1 cm x 2 cm to 10 cm x 25 cm. No electronic or software components.

Indications for Use

Indicated for management of partial/full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites, grafts, post-Mohs, post-laser, podiatric, dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds.

Predicate Devices

• Oasis Wound Matrix (K061711)

Submission Summary (Full Text)

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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.<br>18683 Bearpath Trail<br>Eden Prairie, MN 55347<br>www.miromatrix.com |
| Prepared By: | Stephen P. Rhodes<br>Senior Consultant<br>Biologics Consulting Group, Inc.<br>Email: [e-mail] |
| Contact: | Jeff Ross. Ph.D.<br>VP Product Development<br>Miromatrix Medical, Inc.<br>18683 Bearpath Trail<br>Eden Prairie, MN 55347<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | February 24, 2014 |
| Classification Regulation: | Unclassified |
| Panel: | General & Plastic Surgery |
| Product Code: | KGN |
| Predicate Device: | K061711, Oasis Wound Matrix<br>Cook 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 [phone] or [phone] 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 [phone] or [phone] 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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