MatriStem UBM Pericardial Patch

K191734 · Acell, Inc. · PSQ · Nov 22, 2019 · Cardiovascular

Device Facts

• Record ID: K191734
• Device Name: MatriStem UBM Pericardial Patch
• Applicant: Acell, Inc.
• Product Code: PSQ · Cardiovascular
• Decision Date: Nov 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MatriStem UBM™ Pericardial Patch is intended for the reconstruction and repair of the pericardium.

Device Story

MatriStem UBM Pericardial Patch is a 4-layer multi-laminate sheet derived from porcine urinary bladder matrix (UBM). It serves as a resorbable scaffold for pericardial reconstruction and repair. Used in surgical settings by physicians, the patch is applied to the pericardium to restore native anatomy. It functions as a non-crosslinked collagen extracellular matrix that supports cellular infiltration and tissue remodeling. The device is provided sterile in various sizes (7x10 cm, 7x15 cm, 10x15 cm) and is intended for single use. By providing a structural matrix, it facilitates the patient's own tissue repair process, potentially improving clinical outcomes compared to leaving defects unrepaired.

Clinical Evidence

No clinical studies were conducted. Evidence consists of bench testing (suture retention, tensile strength, stiffness, etc.) and a 90-day GLP animal study (n=12 pigs). The study compared the subject device (n=5) to the predicate CorMatrix (n=5) and sham (n=2) in a pericardial defect model. Endpoints included necropsy, histology, and echocardiography. Results demonstrated biocompatibility, similar cardiac function to sham, and comparable cellular infiltration/remodeling to the predicate.

Technological Characteristics

4-layer multi-laminate porcine urinary bladder matrix (UBM) collagen sheet. Non-crosslinked, resorbable. Available in 7x10, 7x15, and 10x15 cm sizes. Terminally sterilized via electron-beam irradiation. Packaged in dual Foil:PET pouches.

Indications for Use

Indicated for patients requiring reconstruction and repair of the pericardium.

Regulatory Classification

Identification

An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

Predicate Devices

• CorMatrix Pericardial Patch/ CorMatrix ECM for Pericardial Closure (K051405)

Reference Devices

• ACell Gentrix Surgical Matrix (2, 3, 6, 8 layer) (K162554)
• ACell Gentrix Surgical Matrix Thick (8 layer) (K170763)
• Edwards Bovine Pericardial Patch (K082139)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

November 22, 2019

ACell, Inc. Michelle Huettner Director of Regulatory Affairs 6640 Eli Whitney Drive Suite 200 Columbia, Maryland 21046

Re: K191734

Trade/Device Name: MatriStem UBM Pericardial Patch Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch Or Pledget Made Of Polypropylene, Polyethylene Terephthalate, Or Polytetrafluoroethylene Regulatory Class: Class II Product Code: PSQ Dated: October 30, 2019 Received: October 31, 2019

Dear Ms. Huettner:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for

combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K191734

#### Device Name MatriStem UBM™ Pericardial Patch

Indications for Use (Describe)

The MatriStem UBM™ Pericardial Patch is intended for the reconstruction and repair of the pericardium.

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(k) SUMMARY MatriStem UBM™ Pericardial Patch

| Submitter: | ACell, Inc.<br>6640 Eli Whitney Drive, Suite 200<br>Columbia, MD 21046 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michelle Huettner |
| Contact Title: | Director of Regulatory Affairs |
| Phone: | 765-464-8198 ext 135 |
| Facsimile: | 410-715-4511 |
| Date Prepared: | November 21, 2019 |
| Trade Name: | MatriStem UBM™ Pericardial Patch |
| Common Name: | Animal-Derived, Extracellular Matrix Pericardial Patch Product |
| Classification Name: | Patch, Pledget and Intracardiac |
| Regulation Number: | 21 C.F.R. §870.3470 |
| Regulatory Class: | Class II |
| FDA Product Code: | PSQ |
| Predicate Device: | CorMatrix Pericardial Patch/ CorMatrix ECM for Pericardial Closure<br>(K051405) |
| Reference Devices: | ACell Gentrix Surgical Matrix (2, 3, 6, 8 layer) (K162554),<br>ACell Gentrix Surgical Matrix Thick (8 layer) (K170763),<br>Edwards Bovine Pericardial Patch (K082139) |

## Device Description

The MatriStem UBM Pericardial Patch is a 4-layer multi-laminate device comprised of stacked urinary bladder matrix (UBM) sheets. The Pericardial Patch serves as a patch to reconstruct the pericardium and restore the native anatomy. The Pericardial Patch is available in three sizes: 7x10 cm, 7x15 cm, and 10x15 cm. Each device is packaged in a double peel-open pouch and an outer carton. The device is terminally sterilized using electron-beam irradiation.

{4}------------------------------------------------

### Intended Use/Indications for Use

The MatriStem UBM Pericardial Patch is intended for the reconstruction and repair of the pericardium.

### Summary of Technological Characteristics

The technological characteristics of the ACell MatriStem UBM Pericardial Patch are substantially equivalent to the cleared CorMatrix Pericardial Patch (K051405). Both are singleuse only, resorbable porcine animal tissue-derived collagen extracellular matrix (ECM) sheet devices in rectangular configurations. The CorMatrix Pericardial Patch (K051405) is manufactured from porcine sub intestinal submucosa (SIS) and the subject device is manufactured from porcine urinary bladder matrix (UBM). The porcine small intestine tissue and porcine bladder tissue have similar mechanical properties and similar composition. The ACell MatriStem UBM Pericardial Patch is technologically very similar to ACell's cleared MatriStem UBM devices such as the Gentrix Surgical Matrix and Gentrix Surgical Matrix Thick (K162554, K170763) which are also multi-laminate sheets manufactured from the same porcine urinary bladder matrix material, packaged in the same sterile barrier system with dual Foil:PET pouches, and also undergo terminal sterilization with electron beam irradiation.

A table comparing the key features of the subject and predicate devices is provided in Table 1: Comparison of Subject Device and Predicate Devices.

{5}------------------------------------------------

# K191734 Page 3 of 5

#### Table 1: Comparison Table of Subject Device and Predicate Devices

| | ACell, Inc.<br>Subject Device<br>MatriStem UBMTM<br>Pericardial Patch | CorMatrix<br>Cardiovascular, Inc.<br>Primary Predicate Device<br>CorMatrix Pericardial<br>Patch (CorMatrix ECM<br>for Pericardial Closure) | ACell, Inc.<br>Reference Device<br>Gentrix® Surgical Matrix (2-Layer, 3-Layer, 6-Layer, 8-<br>Layer), Gentrix® Surgical Matrix Thick | Edwards Lifesciences<br>Reference Device<br>Bovine Pericardial Patch |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K191734 | K051405 | K162554, K170763 | K082139 |
| Device Class | Class II | Class II | Class II | Class II |
| Product Code | PSQ | DXZ | FTM, OXH | DXZ |
| Classification | Patch, Pledget and<br>Intracardiac | Patch, Pledget and<br>Intracardiac | Surgical Mesh | Patch, Pledget and Intracardiac |
| Intended Use /<br>Indications<br>for Use | The MatriStem UBMTM<br>Pericardial Patch is<br>intended for the<br>reconstruction and repair<br>of the pericardium. | The CorMatrix Pericardial<br>Patch is intended for the<br>reconstruction and repair<br>of the pericardium. | K162554 Indications for Use:<br>Gentrix® Surgical Matrix 2-layer and 3-layer is<br>intended for implantation to reinforce soft tissue where<br>weakness exists in patients requiring urological,<br>gastroenterological, or plastic & reconstructive surgery.<br>Reinforcement of soft tissue within urological,<br>gastroenterological, and plastic & reconstructive<br>surgery includes, but is not limited to, the following<br>procedures: hernia and body wall repair, colon and<br>rectal prolapse repair, tissue repair, and esophageal<br>repair.<br>Gentrix® Surgical Matrix 6-layer and 8-layer are<br>intended for implantation to reinforce soft tissue where<br>weakness exists in patients requiring<br>gastroenterological or plastic & reconstructive surgery.<br>Reinforcement of soft tissue within gastroenterological<br>and plastic & reconstructive surgery includes, but is not<br>limited to, the following procedures: hernia and body<br>wall repair, colon and rectal prolapse repair, tissue<br>repair, and esophageal repair.<br>K170763 Indications for Use:<br>Gentrix® Surgical Matrix Thick and Gentrix® Surgical<br>Matrix Extend are intended for implantation to reinforce<br>soft tissue where weakness exists in patients requiring<br>gastroenterological or plastic & reconstructive surgery.<br>Reinforcement of soft tissue within gastroenterological | The pericardial patch is intended for<br>use as a surgical patch material for:<br>augmenting the patient's own<br>pericardium to assist in closure<br>following open-heart surgery,<br>intracardiac defects, septal defects and<br>annulus repairs, cardiac and vascular<br>reconstruction and repairs, peripheral<br>vascular reconstruction and repairs,<br>great vessel reconstruction and repairs,<br>and suture-line buttressing. |
| | ACell, Inc.<br>Subject Device | CorMatrix<br>Cardiovascular, Inc.<br>Primary Predicate Device | ACell, Inc.<br>Reference Device | Edwards Lifesciences<br>Reference Device |
| | MatriStem UBMTM<br>Pericardial Patch | CorMatrix Pericardial<br>Patch (CorMatrix ECM<br>for Pericardial Closure) | Gentrix® Surgical Matrix (2-Layer, 3-Layer, 6-Layer, 8-<br>Layer), Gentrix® Surgical Matrix Thick | Bovine Pericardial Patch |
| | | | and plastic & reconstructive surgery includes, but is not<br>limited to, the following procedures: hernia and body<br>wall repair, colon and rectal prolapse repair, tissue<br>repair, and esophageal repair. | |
| Material<br>Source | Porcine Urinary Bladder<br>Matrix (UBM) | Porcine Sub Intestinal<br>Submucosa (SIS) | Porcine Urinary Bladder Matrix (UBM) | Bovine Pericardium |
| Material Type | Collagen, Extracellular<br>Matrix | Collagen, Extracellular<br>Matrix | Collagen, Extracellular Matrix | Bovine Tissue |
| Crosslinked<br>Collagen | No | No | No | Yes |
| Resorbable | Yes | Yes | Yes | Yes |
| Configuration | Rectangular Sheets | Rectangular Sheets | Rectangular Sheets | Rectangular Sheets |
| # of Layers | 4 | 4 | Gentrix Surgical Matrix: 2, 3, 6, 8<br>Gentrix Surgical Matrix Thick: 8 | Tissue Thickness 0.5 mm +/- 0.25 mm |
| Nominal Sizes<br>(cm) | 7 x 10 cm<br>7 x 15 cm<br>10 x 15 cm | 7 x 10 cm<br>7 x 15 cm | Gentrix Surgical Matrix: Up to 10 x 15 cm<br>Gentrix Surgical Matrix Thick: Up to 30 x 40 cm | 10 x 15 cm |
| Reusable or<br>Single Use | Single Use Device | Single Use Device | Single Use Device | Single Use Device |
| Packaging | Dual Foil:PET Pouch<br>System | Dual Pouch System | Dual Foil:PET Pouch System | Packaged sterile in container with<br>glutaraldehyde |
| Sterilization | Electron beam irradiation | Ethylene oxide | Electron beam irradiation | XenoLogiX process, terminally<br>sterilized in glutaraldehyde |

{6}------------------------------------------------

# K191734
Page 4 of 5

{7}------------------------------------------------

#### Performance Data and Animal Testing

The following bench testing was performed to ensure the MatriStem UBM Pericardial Patch met its clinically relevant design input requirements and specifications: basement membrane presence, hydration uptake, moisture content, hydrated onset temperature, endotoxin, bioburden enumeration, suture retention strength, tensile strength, dimensional confirmation, device stiffness, tearing strength, and ball burst strength. Existing test data was leveraged from the cleared Gentrix Surgical Matrix reference devices (K162554, K170763) for the following tests because they were not impacted for the MatriStem UBM Pericardial Patch made of the same porcine urinary bladder matrix material: sterilization validation, biocompatibility, shelf-life, viral inactivation, and packaging testing. Confirmatory cytoxicity testing was also performed on production-equivalent MatriStem UBM Pericardial Patch (subject device).

In addition, the performance of the MatriStem UBM Pericardial Patch was shown to be substantially equivalent to the predicate CorMatrix Pericardial Patch (also referred to as the CorMatrix ECM for Pericardial Closure) through design validation testing. This was demonstrated via a 90-day Good Laboratory Practices (GLP) animal study on 12 total pigs. A pericardial defect was created on each pig. Two (2) pigs did not have the pericardial defect repaired (sham), five (5) pigs had the defect repaired with the ACell MatriStem UBM Pericardial Patch, and five (5) pigs had the defect repaired with the predicate CorMatrix Pericardial Patch. All acceptance criteria were met for this animal study including: demonstration of device biocompatibility through a full necropsy examination and histology evaluation of the local tissues post device implantation and observation for 90 days, demonstration of similar or improved cardiac function through echocardiography measurements compared to the sham, and demonstration of similar or improved cellular infiltration and remodeling histopathologic outcomes versus the predicate CorMatrix device. The animal study successfully evaluated the safety and biological response of the MatriStem UBM Pericardial Patch in a porcine model of pericardial repair.

The MatriStem UBM Pericardial Patch functioned as intended during all tests. The results of the bench testing and animal testing demonstrate that the device is substantially equivalent to the predicate device. There were no clinical studies conducted to support the substantial equivalence of the subject device to the predicate device.

## Conclusions

The MatriStem UBM Pericardial Patch is as safe and effective as the CorMatrix Pericardial Patch/ CorMatrix ECM for Pericardial Closure (K051405). The MatriStem UBM Pericardial Patch has the same intended use and indications for use, and similar technological characteristics and principles of operation as its predicate device. The minor technological differences between the MatriStem UBM Pericardial Patch and its predicate devices raise no new issues of safety or effectiveness. Performance data and animal testing demonstrates that the MatriStem UBM Pericardial Patch is as safe and effective as the CorMatrix Pericardial Patch. Thus, the MatriStem UBM Pericardial Patch is substantially equivalent.