MIROMATRIX BIOLOGICAL MESH

K134033 · Miromatrix Medical, Inc. · FTM · Mar 31, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K134033
• Device Name: MIROMATRIX BIOLOGICAL MESH
• Applicant: Miromatrix Medical, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Mar 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Miromatrix Biological Mesh is intended to be implanted to reinforce soft tissue.

Device Story

Implantable, acellular surgical mesh derived from porcine liver tissue; perfusion decellularization process; composed primarily of collagen type I. Functions as scaffold for tissue incorporation; reinforces soft tissue. Supplied hydrated, moist, and flexible; available in various sizes (1 cm x 2 cm to 20 cm x 30 cm); trimmable/cuttable by surgeon. Used in surgical settings; implanted by physicians. Provides mechanical support for soft tissue repair; promotes tissue integration.

Clinical Evidence

No human clinical data. Evidence includes bench testing (tensile strength, suture retention, burst force, tear resistance, DNA residuals, collagen analysis) and animal testing (30-day rat implantation study). Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, genotoxicity (AMES, chromosome aberration, mammalian cell gene mutation), hemolysis, and pyrogenicity. Results demonstrated comparable safety and mechanical performance to the predicate.

Technological Characteristics

Porcine-derived acellular liver tissue; primary component collagen type I. Dimensions 1 cm x 2 cm to 20 cm x 30 cm. Terminally sterilized. Mechanical properties verified via tensile, suture retention, burst, and tear testing. No electronic or software components.

Indications for Use

Indicated for implantation to reinforce soft tissue in patients requiring surgical repair.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• SurgiSIS Surgical Mesh (K980431)

Submission Summary (Full Text)

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#### ડ. 510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Miromatrix Biological Mesh is provided below.

| Device Common Name: | Surgical Mesh |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name: | Miromatrix Biological Mesh |
| Submitter: | Miromatrix Medical, Inc.<br>18683 Bearpath Trail<br>Eden Prairie, MN 55347<br>www.miromatrix.com |
| Contact: | Stephen Rhodes<br>Biologics Consulting Group, Inc.<br>400 N. Washington St., Suite 100<br>Alexandria, VA 22314<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Alternate Contact: | Jeff Ross<br>VP Product Development<br>Miromatrix Medical, Inc.<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | December 30, 2013 |
| Classification Regulation: | 21 CFR 878.3300 |
| Panel: | General & Plastic Surgery |
| Product Code: | FTM |
| Predicate Device: | K980431, SurgiSIS Surgical Mesh<br>Cook Biotech, Inc. |

CONFIDENTIAL

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#### Indication for Use:

The Miromatrix Biological Mesh is intended to be implanted to reinforce soft tissue.

#### Device Description:

The Miromatrix Biological Mesh is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The Miromatrix Biological Mesh is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.

#### Comparison to the Predicate:

The Miromatrix Biological Mesh has similar indications for use and technological characteristics as the predicate surgical mesh. Both devices are porcine-derived, acellular meshes that are comprised primarily of collagen type I. The meshes reinforce soft tissue while providing a scaffolding for tissue repair.

Mechanical testing, biocompatibility testing and animal testing were conducted per the recommendations in: Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance – Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh," dated March 2, 1999." The following tests were conducted:

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 Intramuscular Implantation In Vitro Hemolysis Pyrogenicity Sub-Chronic Systemic Toxicity

Bench/Laboratory Testing Tensile Strength Suture Retention Strength Burst Force Tear Resistance DNA Residuals Collagen Analysis

CONFIDENTIAL

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Viral Inactivation Endotoxin Expiration Dating

Animal Testing 30-Day Rat Implantation Study

The biocompatibility testing showed the comparable safety profile of the Miromatrix Biological Mesh and the predicate. Bench testing demonstrated that the mechanical properties of the mesh are substantially equivalent for reinforcing soft tissue. Animal testing demonstrated tissue incorporation into the mesh.

### Summary of Substantial Equivalence:

Based on the indications for use, technological characteristics and performance test results, the Miromatrix Biological Mesh is substantially equivalent to the predicate.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

March 31, 2014

Miromatrix Medical, Inc. do Biologics Consulting Group, Inc. Stephen P. Rhodes 400 North Washington Street, Suite 100 Alexandria, Virginia 22314

Re: K134033

Trade/Device Name: Miromatrix Biological Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: December 31, 2013 Received: December 31, 2013

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 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

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### Page 2 - Stephen P. Rhodes

device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 Ashar, MD, MBA, FACS Acting 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

Form Approved: OMB No. 0910-0120 Expiration Date: December 31. 2013 See PRA Statement on last page.

510(k) Number (if known) K134033

Device Name Miromatrix Biological Mesh

Indications for Use (Describe)

The Miromatix Biological Mesh is intended to be implanted to reinforce soft tissue.

Type of Use (Select one or both, as applicable) 网 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

Please do not write Below This Line - continue on a separate Page if Needed.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Jiyoung Dang -S

FORM FDA 3881 (9/13)

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PSC Pac Section Sermon (201) 44)-6789

CONFIDENTIAL

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