MatriStem® Surgical Matrix RS (2-layer) and PSM (3-layer) are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hemia and body wall repair, colon and rectal prolapse repair, and esophageal repair.

MatriStem® Surgical Matrix PSMX (6-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

MatriStem® Pelvic Floor Matrix (6-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological or gynecological surgery. Reinforcement of soft tissue within urological and gynecological surgery includes, but is not limited to, the following procedures: pubourethral support, urethral repair, transabdominal reconstruction of pelvic floor and vaginal prolapse, bladder support, and sacrocolposuspension. By providing pubourethral support, MatriStem Pelvic Floor Matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency.

Device Description

MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix devices are composed of porcine-derived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in multi-layer sheet configurations in sizes up to 10 cm x 15 cm, and packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation.

AI/ML Overview

The provided text describes a medical device premarket notification (510(k)) for MatriStem® Surgical Matrix products, which are composed of porcine-derived extracellular matrix scaffolds. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested criteria for studies proving device performance may not be directly applicable or available in this document. The document primarily details biocompatibility and mechanical testing to support substantial equivalence.

Here's the information extracted and interpreted based on the provided text:

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

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics, as it is a 510(k) submission focused on substantial equivalence based on material and mechanical properties, and intended use. The "performance" reported relates to these characteristics and their comparison to predicate devices.

Acceptance Criteria (Implied from testing)	Reported Device Performance
Biocompatibility (per ISO-10993-1 standard) - Cytotoxicity - Sensitization - Irritation/Intracutaneous reactivity - Acute systemic toxicity - Pyrogenicity - Subacute and subchronic toxicity and implantation - Genotoxicity - Hemocompatibility - LAL endotoxin	"The results of these tests provided evidence that the MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem Pelvic Floor Matrix meet biocompatibility requirements of the ISO standard." (The document states compliance without providing specific quantitative results for each test.)
Mechanical Strength (Adequate for respective applications) - Tensile strength - Suture retention strength - Delamination strength - Tear strength - Stiffness test	"The mechanical testing provided evidence that MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix provide adequate mechanical strength for their respective applications." (Specific quantitative values are not provided, but the document states that the devices have "comparable performance to the predicates" and the "available sizes...are consistent with the range of sizes of the predicate devices.")
Substantial Equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, safety, and effectiveness.	"MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix have the same intended use as predicate surgical meshes...The technological characteristics...are substantially similar to the cleared predicates...The minor differences...do not raise different questions of safety or efficacy and performance testing demonstrates that the devices have comparable performance to the predicates." "Based on direct testing and comparison to predicate devices, MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix do not raise different questions of safety and effectiveness and the results support a determination of substantial equivalence..."

The following points are generally not applicable to this 510(k) submission, as it focuses on demonstrating substantial equivalence through non-clinical testing (biocompatibility, mechanical) and comparison to predicates, rather than a prospective clinical study proving specific performance criteria in patients.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as no clinical test set data from a study involving patients is presented. The "test set" for biocompatibility and mechanical testing would refer to samples of the device material itself. The document does not specify the number of material samples tested or their provenance beyond being the device materials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable; relevant for clinical studies with expert review.

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

Not applicable; relevant for clinical studies with expert review.

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

Not applicable; this is for AI/CAD-related devices.

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

Not applicable; this is for AI/CAD-related devices.

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

For the biocompatibility and mechanical testing, the "ground truth" would be established by validated scientific methodologies and ISO standards, rather than expert consensus or patient outcomes data. For substantial equivalence, the predicates serve as a comparative standard.

8. The sample size for the training set

Not applicable; this is for AI/machine learning models.

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

Not applicable; this is for AI/machine learning models.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo, which features a stylized human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the agency in blue text.

August 10, 2021

ACell, Inc. % Salman Elmi, VP/Deputy General Counsel, Chief Compliance Officer 6640 Eli Whitney Drive Columbia, MD 21046 Telephone: 410-953-8500 Email: salelmi4ace11.com

Re: K141084

Trade/Device Name: Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXH

Dear Mr. Salman Elmi:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 17, 2015. Specifically, FDA is updating this SE Letter to remove the indications for use for transvaginal repair of pelvic organ prolapse from the SE package and labeling in accordance with FDA's final rule, dated January 5, 2016 in which such devices were upclassified from Class II to Class III.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jason Roberts, OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices, 240-402-6400, jason.roberts(@fda.hhs.gov.

Sincerely,

Jason Roberts -S

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three faces in profile, one behind the other, with a stylized bird above them.

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

June 17, 2015

ACell Incorporated Mr. Miles Grody Senior Vice President, General Counsel 6640 Eli Whitney Drive, Suite 200 Columbia, Maryland 21046

Re: K141084

Trade/Device Name: MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXH Dated: June 16, 2015 Received: June 17, 2015

Dear Mr. Grody:

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

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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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

David Krause -S

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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510(K) SUMMARY

Submission Date:	July 6, 2018
Manufacturer Name:	ACell, Inc.
Submitted by:	6640 Eli Whitney DriveColumbia, MD 21046
Contact Person:	Andrea Pilon ArtmanSr. Regulatory Affairs ManagerACell, Inc.Phone: (410) 953-8549Email: andreaartman@acell.comFax: 410-715-4511

DEVICE NAME AND CLASSIFICATION

510 (k) Number:	K141084
Trade/Proprietary Name:	MatriStem® Surgical Matrix RS, PSM, PSMX,MatriStem® Pelvic Floor Matrix
Common/Usual Name:	Surgical Mesh, ECM, Surgical Scaffold
Regulation Name:	Surgical Mesh
Device Class:	Class II, 21 CFR 878.3300
Product Code:	FTM, OXH
Reviewing Panel:	General & Plastic Surgery
Predicate Devices:	ACell UBM Surgical Mesh (K040621)ACell Surgical Mesh ML and ML Plus (K041140)SIS Plastic Surgery Matrix (K034039)

DEVICE DESCRIPTION

INDICATIONS FOR USE

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includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

EQUIVALENCE TO MARKETED DEVICES

MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix have the same intended use as predicate surgical meshes, which is to reinforce or repair soft tissue. The additional indications are identical to those included in the identified predicate devices. The technological characteristics of the MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix are substantially similar to the cleared predicates, as all are comprised of animal tissuederived, collagen extracellular matrix (ECM) scaffolds supplied in a sheet configuration that are packaged and terminally sterilized. The available sizes of the subject device (8 - 150 cm) are consistent with the range of sizes of the predicate devices (16 - 1350 cm -). The minor differences between the MatriStem® Surgical Matrix RS. PSM, PSMX, and MatriStem® Pelvic Floor Matrix and the identified predicates do not raise different questions of safety or efficacy and performance testing demonstrates that the devices have comparable performance to the predicates.

Biocompatibility Testing

MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix underwent the following biocompatibility testing on sterilized devices per ISO-10993-1 standard: cytotoxicity. sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, pyrogenicity, subacute and subchronic toxicity and implantation, genotoxicity, hemocompatibility, and LAL endotoxin. The results of these tests provided evidence that the MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem Pelvic Floor Matrix meet biocompatibility requirements of the ISO standard.

Mechanical Testing

The MatriStem Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix material were tested for the following: tensile strength, suture retention strength, delamination strength, tear strength, and stiffness test. The mechanical testing provided evidence that MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix provide adequate mechanical strength for their respective applications.

CONCLUSION

Based on direct testing and comparison to predicate devices, MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix do not raise different questions of safety and effectiveness and the results support a determination of substantial equivalence through this 510(k) Premarket Notification.

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Indications for Use

510(k) Number (if known) K141084

Device Name

MatriStem Surgical Matrix RS, PSM, PSMX, and MatriStem Pelvic Floor Matrix

Indications for Use (Describe)

MatriStem Surgical Matrix RS (2-layer) are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, and esophageal repair.

MatriStem Surgical Matrix PSMX (6-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, and esophageal repair.

MatriStem Pelvic Floor Matrix (6-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological or gynecological surgery. Reinforcement of soft tissue within urological and gynecological surgery includes, but is not limited to, the following procedures: pubourethral repair, transabdominal reconstruction of pelvic floor and vaginal prolapse repair, bladder support, and sacrocolposuspension. By providing pubourethral support, Matristem Pelvic Floor Matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency.

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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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.