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.

AI/ML Overview

This document describes the regulatory submission for the MatriStem UBM™ Pericardial Patch, a medical device intended for the reconstruction and repair of the pericardium. It is a 510(k) premarket notification, which means the manufacturer (ACell, Inc.) is seeking to demonstrate that their device is substantially equivalent to legally marketed predicate devices, and therefore does not require a full premarket approval (PMA).

The information provided covers bench testing and an animal study to support the substantial equivalence claim. However, it's important to note that this submission does not involve an AI/ML-based device and therefore the questions relating to AI-specific acceptance criteria, multi-reader multi-case studies, expert adjudication methods, and training/test set ground truth establishment for an AI algorithm are not applicable to this document. The device is a biological patch, not a diagnostic or prognostic AI tool.

Therefore, many of the requested items regarding AI/ML aspects will be answered as "Not Applicable" or "No" as the study described is for a physical medical device.

Here's the breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since this is a physical medical device and not an AI model, the acceptance criteria are based on physical, chemical, and biological properties, and functionality in an in vivo model.

Acceptance Criteria Category	Specific Test/Measurement	Acceptance Criteria	Reported Device Performance
Material Properties	Basement Membrane Presence	Present	Met
	Hydration Uptake	(Not specified, assumed within acceptable range for function)	Met
	Moisture Content	(Not specified, assumed within acceptable range for function)	Met
	Hydrated Onset Temperature	(Not specified, assumed within acceptable range for function)	Met
Biocompatibility/Safety	Endotoxin	(Not specified, assumed below regulatory limits)	Met
	Bioburden Enumeration	(Not specified, assumed below regulatory limits)	Met
	Cytotoxicity	Non-cytotoxic	Passed
	Sterilization Validation	Sterility achieved	Met (leveraged from reference devices)
	Biocompatibility	Biocompatible	Met (leveraged from reference devices)
	Viral Inactivation	Effective viral inactivation	Met (leveraged from reference devices)
Mechanical Properties	Suture Retention Strength	(Not specified, assumed meets or exceeds predicate)	Met
	Tensile Strength	(Not specified, assumed meets or exceeds predicate)	Met
	Device Stiffness	(Not specified, assumed meets or exceeds predicate)	Met
	Tearing Strength	(Not specified, assumed meets or exceeds predicate)	Met
	Ball Burst Strength	(Not specified, assumed meets or exceeds predicate)	Met
Dimensional & Packaging	Dimensional Confirmation	Conforms to specified sizes (7x10 cm, 7x15 cm, 10x15 cm)	Met
	Packaging Testing	Maintains sterility and integrity	Met (leveraged from reference devices)
In Vivo Performance	Device Biocompatibility (Animal Study)	Full necropsy and histology evaluation of local tissues post-implantation showing biocompatibility over 90 days.	All acceptance criteria met.
	Cardiac Function (Animal Study)	Similar or improved echocardiography measurements compared to sham.	All acceptance criteria met.
	Cellular Infiltration & Remodeling (Animal Study)	Similar or improved histopathologic outcomes versus predicate CorMatrix device.	All acceptance criteria met.
Overall Function	Functioned as Intended	Yes	Yes

Note: Specific quantitative acceptance criteria for most bench tests are not provided in this public summary but are typically part of internal design control documentation and would have been submitted to the FDA. The document states "All acceptance criteria were met" for the animal study, indicating the successful completion of the pre-defined endpoints.

2. Sample sizes used for the test set and the data provenance

Test Set Sample Size (Animal Study):
- Total pigs: 12
- Sham group (no repair): 2 pigs
- ACell MatriStem UBM Pericardial Patch group: 5 pigs
- Predicate CorMatrix Pericardial Patch group: 5 pigs
Data Provenance: The study was a "90-day Good Laboratory Practices (GLP) animal study" performed in a porcine (pig) model. The country of origin is not specified but generally, GLP studies adhere to international standards. It is a prospective animal study designed to evaluate the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable (N/A) for an AI/ML context. This is a physical medical device.
For the animal study, the ground truth was established through objective biological and physiological assessments:
- Histology evaluation: Performed by pathologists.
- Full necropsy examination: Performed by veterinary pathologists.
- Echocardiography measurements: Performed by specialists in echocardiography (likely veterinary cardiologists or trained technicians).
- The document implies that these assessments were performed by qualified personnel as part of a GLP study, but the specific number and qualifications of individuals are not detailed in this summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A for an AI/ML context. This pertains to consensus among human readers for image interpretation, which is not relevant for this device.
For the animal study, the "adjudication" of results would rely on standardized GLP protocols for sample collection, pathology, and data analysis to ensure consistency and objectivity. Any disagreements in interpretation (e.g., in histology slides) would typically be resolved by senior pathologists or consensus panels within the pathology group, but this is not an "adjudication method" in the AI sense.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC study was not done. This is a study for a physical implantable medical device, not an AI diagnostic/assistance tool.
The comparative effectiveness was demonstrated by comparing the subject device to a predicate device and a sham in an animal model based on biological and physiological outcomes, not human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Pathology and Outcomes Data (from an animal model).
- Histology evaluation: Provides microscopic ground truth on tissue response, cellular infiltration, and remodeling.
- Full necropsy examination: Provides macroscopic ground truth on device integration and tissue health.
- Echocardiography measurements: Provides functional ground truth on cardiac performance.
- The "ground truth" for the device's performance in vivo was established by these objective biological and physiological assessments in directly implanted animals.

8. The sample size for the training set

N/A. This is a physical medical device. There is no "training set" in the context of machine learning.
The development process for this device would involve extensive internal research and development, materials characterization, and process optimization, but this does not constitute a "training set" for an AI model.

9. How the ground truth for the training set was established

N/A. As there is no AI training set, this question is not applicable.

Summary

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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.

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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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.

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510(k) SUMMARY MatriStem UBM™ Pericardial Patch

Submitter:	ACell, Inc.6640 Eli Whitney Drive, Suite 200Columbia, 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(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)

Device Description

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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.

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K191734 Page 3 of 5

Table 1: Comparison Table of Subject Device and Predicate Devices

	ACell, Inc.Subject DeviceMatriStem UBMTMPericardial Patch	CorMatrixCardiovascular, Inc.Primary Predicate DeviceCorMatrix PericardialPatch (CorMatrix ECMfor Pericardial Closure)	ACell, Inc.Reference DeviceGentrix® Surgical Matrix (2-Layer, 3-Layer, 6-Layer, 8-Layer), Gentrix® Surgical Matrix Thick	Edwards LifesciencesReference DeviceBovine 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 andIntracardiac	Patch, Pledget andIntracardiac	Surgical Mesh	Patch, Pledget and Intracardiac
Intended Use /Indicationsfor Use	The MatriStem UBMTMPericardial Patch isintended for thereconstruction and repairof the pericardium.	The CorMatrix PericardialPatch is intended for thereconstruction and repairof the pericardium.	K162554 Indications for Use:Gentrix® Surgical Matrix 2-layer and 3-layer isintended for implantation to reinforce soft tissue whereweakness exists in patients requiring urological,gastroenterological, or plastic & reconstructive surgery.Reinforcement of soft tissue within urological,gastroenterological, and plastic & reconstructivesurgery includes, but is not limited to, the followingprocedures: hernia and body wall repair, colon andrectal prolapse repair, tissue repair, and esophagealrepair.Gentrix® Surgical Matrix 6-layer and 8-layer areintended for implantation to reinforce soft tissue whereweakness exists in patients requiringgastroenterological or plastic & reconstructive surgery.Reinforcement of soft tissue within gastroenterologicaland plastic & reconstructive surgery includes, but is notlimited to, the following procedures: hernia and bodywall repair, colon and rectal prolapse repair, tissuerepair, and esophageal repair.K170763 Indications for Use:Gentrix® Surgical Matrix Thick and Gentrix® SurgicalMatrix Extend are intended for implantation to reinforcesoft tissue where weakness exists in patients requiringgastroenterological or plastic & reconstructive surgery.Reinforcement of soft tissue within gastroenterological	The pericardial patch is intended foruse as a surgical patch material for:augmenting the patient's ownpericardium to assist in closurefollowing open-heart surgery,intracardiac defects, septal defects andannulus repairs, cardiac and vascularreconstruction and repairs, peripheralvascular reconstruction and repairs,great vessel reconstruction and repairs,and suture-line buttressing.
	ACell, Inc.Subject Device	CorMatrixCardiovascular, Inc.Primary Predicate Device	ACell, Inc.Reference Device	Edwards LifesciencesReference Device
	MatriStem UBMTMPericardial Patch	CorMatrix PericardialPatch (CorMatrix ECMfor Pericardial Closure)	Gentrix® Surgical Matrix (2-Layer, 3-Layer, 6-Layer, 8-Layer), Gentrix® Surgical Matrix Thick	Bovine Pericardial Patch
			and plastic & reconstructive surgery includes, but is notlimited to, the following procedures: hernia and bodywall repair, colon and rectal prolapse repair, tissuerepair, and esophageal repair.
MaterialSource	Porcine Urinary BladderMatrix (UBM)	Porcine Sub IntestinalSubmucosa (SIS)	Porcine Urinary Bladder Matrix (UBM)	Bovine Pericardium
Material Type	Collagen, ExtracellularMatrix	Collagen, ExtracellularMatrix	Collagen, Extracellular Matrix	Bovine Tissue
CrosslinkedCollagen	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, 8Gentrix Surgical Matrix Thick: 8	Tissue Thickness 0.5 mm +/- 0.25 mm
Nominal Sizes(cm)	7 x 10 cm7 x 15 cm10 x 15 cm	7 x 10 cm7 x 15 cm	Gentrix Surgical Matrix: Up to 10 x 15 cmGentrix Surgical Matrix Thick: Up to 30 x 40 cm	10 x 15 cm
Reusable orSingle Use	Single Use Device	Single Use Device	Single Use Device	Single Use Device
Packaging	Dual Foil:PET PouchSystem	Dual Pouch System	Dual Foil:PET Pouch System	Packaged sterile in container withglutaraldehyde
Sterilization	Electron beam irradiation	Ethylene oxide	Electron beam irradiation	XenoLogiX process, terminallysterilized in glutaraldehyde

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K191734

Page 4 of 5

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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.

Regulation Number and Section

§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

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