The Miromatrix Biological Mesh RS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

Device Description

The Miromatrix Biological Mesh RS 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 device 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.

AI/ML Overview

This document is a 510(k) premarket notification for the Miromatrix Biological Mesh RS, declaring its substantial equivalence to a previously cleared predicate device, the Miromatrix Biological Mesh (K134033). As such, it does not describe a study involving acceptance criteria and device performance in the typical sense of a rigorous clinical or standalone performance study for an AI/device algorithm.

Instead, the core of this submission is to demonstrate that the new device (Miromatrix Biological Mesh RS) is substantially equivalent to a legally marketed predicate device (Miromatrix Biological Mesh, K134033). This means that the acceptance criteria are implicitly met by demonstrating sameness or very similar characteristics and performance to the predicate device, which has already been deemed safe and effective.

Here's an breakdown based on the provided text, addressing your questions where applicable, and noting where information is not present due to the nature of a 510(k) substantial equivalence submission for a physical medical device (not an AI algorithm):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as numerical thresholds in this document for a "new" device performance study. Instead, the "acceptance criteria" are effectively that the new device (Miromatrix Biological Mesh RS) is identical in materials and design and has similar indications for use and the same intended use as the predicate device (Miromatrix Biological Mesh, K134033). The "reported device performance" is essentially the equivalence shown in the comparison table.

Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (Proposed Device)
Materials & Design	Single-layer biologic mesh derived from porcine liver tissue; acellular, not cross-linked; provides scaffold; terminally sterilized, hydrated, moist, flexible.	Identical: Single-layer biologic mesh derived from porcine liver tissue. The mesh is acellular and not cross-linked. The mesh provides a scaffold during tissue repair. The mesh is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened.
Indication for Use	Intended to be implanted to reinforce soft tissue.	Similar: For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. (The document argues this extension to plastic/reconstructive surgery does not raise new safety/effectiveness questions and thus is similar, not a new intended use). Note: This is the primary point of differentiation from the predicate, but it's argued not to be a significant difference.
Sizes	Available in various sizes; can be cut to shape.	Identical: Available in sizes ranging from 1x2cm to 20x30cm. Can be cut to shape.
Thickness	0.5-3 mm	Identical: 0.5-3 mm
Tissue Origin	Porcine	Identical: Porcine
Single Use	Yes	Identical: Yes
Sterile	Yes	Identical: Yes
Biocompatibility, Bench, Animal Testing	(Met by predicate device, K134033)	No New Testing Required: "Because the materials and design of the subject Miromatrix Biological Mesh RS are identical to that of the predicate Miromatrix Biological Mesh (K134033), no new biocompatibility, bench or animal testing is required to support the substantial equivalence to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. This is not a study assessing performance on a test set of data. It's a regulatory submission demonstrating equivalence of a physical medical device to an existing one.
Data Provenance: Not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This is not an AI/algorithm submission requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI algorithm.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This is not an AI algorithm.

7. Type of Ground Truth Used

Not applicable in the context of an AI algorithm. For this physical device, the "ground truth" for its safety and effectiveness is established by the prior clearance of the predicate device (K134033) and the demonstration that the subject device is essentially the same.

8. Sample Size for the Training Set

Not applicable. This is not an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI algorithm.

In summary: The provided text is a 510(k) premarket notification for a physical medical device (surgical mesh), not an AI algorithm. The core of such a submission is to argue that a new device is "substantially equivalent" to an already cleared predicate device. Therefore, the questions related to studies, test sets, training sets, ground truth, and expert adjudication, which are typical for AI/algorithm performance evaluations, are not addressed in this type of document. The "acceptance criteria" here are met by the demonstration of material, design, and functional similarity to the predicate device.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three abstract human profiles facing to the right, resembling a bird in flight. The profiles are depicted in a simple, flowing line style.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 27, 2015

Miromatrix Medical Incorporated % Miriam Provost, Ph.D. Biologics Consulting Group Incorporated 400 North Washington Street, Suite 100 Alexandria, Virginia 22314

Re: K150341

Trade/Device Name: Miromatrix Biological Mesh RS Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXH Dated: February 9, 2015 Received: February 11, 2015

Dear Dr. Provost:

This letter corrects our substantially equivalent letter of May 12, 2015.

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

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Page 2 – Dr. Miriam Provost

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as sea forth io 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" (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) K150341

Device Name Miromatrix Biological Mesh RS

Indications for Use (Describe)

The Miromatrix Biological Mesh RS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Device Common Name:	Surgical Mesh
Device Trade Name:	Miromatrix Biological Mesh RS
Applicant:	Miromatrix Medical, Inc.
	18683 Bearpath Trail
	Eden Prairie, MN 55347
Contact:	Jeff Ross
	VP Product Development
	Miromatrix Medical, Inc.
	Phone: 763-458-8801
	Email: jross@miromatrix.com
Date Prepared:	February 9, 2015
Classification Regulation:	21 CFR 878.3300, Class II
Panel:	General and Plastic Surgery
Product Code:	OXH
Predicate Device:	Miromatrix Biological Mesh (K134033)

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

Indication for Use:

The Miromatrix Biological Mesh RS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

Device Description:

The Miromatrix Biological Mesh RS is identical in materials and design to the predicate Miromatrix Biological Mesh (K134033). The design is consistent with other FDA-cleared meshes indicated for use for plastic and reconstructive surgery. There is no change to the fundamental scientific technology and, thus, no new questions of safety or effectiveness compared to the predicate device.

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Performance Data:

Because the materials and design of the subject Miromatrix Biological Mesh RS are identical to that of the predicate Miromatrix Biological Mesh (K134033), no new biocompatibility, bench or animal testing is required to support the substantial equivalence to the predicate device.

	Proposed Device	Predicate Device
510(k)Number	K150341	K134033
Applicant	Miromatrix Medical Inc.	Miromatrix Medical Inc.
Device Name	Miromatrix Biological Mesh RS	Miromatrix Biological Mesh
ClassificationRegulation	21 CFR 888.3300	same
Product Code	OXH	FTM
Indication	The Miromatrix Biological Mesh RS is forimplantation to reinforce soft tissue whereweakness exists in patients requiring soft tissuerepair or reinforcement in plastic andreconstructive surgery.	The Miromatrix BiologicalMesh is intended to beimplanted to reinforce softtissue.
Design	Single-layer biologic mesh that is derived fromporcine liver tissue. The mesh is acellular and notcross-linked. The mesh provides a scaffold duringtissue repair. The mesh is terminally sterilized inits packaging and is hydrated, moist and flexiblewhen its packaging is opened.	same
Sizes	Available in sizes ranging from 1x2cm to20x30cm. Can be cut to shape.	same
Thickness	0.5-3 mm	same
Tissue Origin	porcine	same
Single Use	Yes	Yes
Sterile	Yes	Yes

Device Comparison Table:

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Substantial Equivalence Conclusion:

The proposed indication for the subject device is different than that of the predicate device. However, the use of the mesh for plastic and reconstructive surgery does not raise any new safety or effectiveness questions compared to its previous indication for reinforcement of soft tissue. Furthermore, similar to other surgical meshes that have been cleared for plastic and reconstructive surgery (e.g., SIS Plastic Surgery Mesh, K034039), the Miromatrix Biological Mesh RS does not provide full mechanical support when used for this indication. Therefore, this proposed indication does not represent a new intended use.

In conclusion, based on identical materials and design, similar indications, and the same intended use, the subject Miromatrix Biological Mesh RS is substantially equivalent to the predicate device, the Miromatrix Biological Mesh (K134033).

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
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.(b)
Classification. Class II.