(147 days)
No
The device description and performance studies focus on the material properties and biological response of a surgical patch, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the reconstruction and repair of the pericardium, which is a therapeutic function aimed at restoring proper physiological function.
No
The device is a surgical patch intended for reconstructing and repairing the pericardium, not for diagnosing medical conditions.
No
The device description clearly states it is a physical, multi-laminate patch made of biological material (UBM sheets) intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reconstruction and repair of the pericardium." This is a surgical procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The device is a physical patch made of biological material (UBM) intended to be implanted. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring specific substances (analytes).
- Providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical properties of the patch (tensile strength, stiffness, etc.) and its biological response in an animal model (biocompatibility, cellular infiltration, remodeling). These are relevant to a surgical implant, not a diagnostic test.
- Key Metrics: The "Not Applicable" for key metrics like Sensitivity, Specificity, PPV, and NPV further confirms it's not a diagnostic device. These metrics are used to evaluate the performance of diagnostic tests.
In summary, the MatriStem UBM Pericardial Patch is a surgical implant used for tissue repair, not a device used to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The MatriStem UBM™ Pericardial Patch is intended for the reconstruction and repair of the pericardium.
Product codes
PSQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pericardium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
CorMatrix Pericardial Patch/ CorMatrix ECM for Pericardial Closure (K051405)
Reference Device(s)
ACell Gentrix Surgical Matrix (2, 3, 6, 8 layer) (K162554), ACell Gentrix Surgical Matrix Thick (8 layer) (K170763), Edwards Bovine Pericardial Patch (K082139)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 (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
2
Indications for Use
510(k) Number (if known)
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)
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3
510(k) SUMMARY MatriStem UBM™ Pericardial Patch
| Submitter: | ACell, Inc.
6640 Eli Whitney Drive, Suite 200
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
(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
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.
Subject Device
MatriStem UBMTM
Pericardial Patch | CorMatrix
Cardiovascular, Inc.
Primary Predicate Device
CorMatrix Pericardial
Patch (CorMatrix ECM
for Pericardial Closure) | ACell, Inc.
Reference Device
Gentrix® Surgical Matrix (2-Layer, 3-Layer, 6-Layer, 8-
Layer), Gentrix® Surgical Matrix Thick | Edwards Lifesciences
Reference Device
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
Intracardiac | Patch, Pledget and
Intracardiac | Surgical Mesh | Patch, Pledget and Intracardiac |
| Intended Use /
Indications
for Use | The MatriStem UBMTM
Pericardial Patch is
intended for the
reconstruction and repair
of the pericardium. | The CorMatrix Pericardial
Patch is intended for the
reconstruction and repair
of the pericardium. | K162554 Indications for Use:
Gentrix® Surgical Matrix 2-layer and 3-layer is
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: hernia and body wall repair, colon and
rectal prolapse repair, tissue repair, and esophageal
repair.
Gentrix® Surgical Matrix 6-layer and 8-layer are
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.
K170763 Indications for Use:
Gentrix® Surgical Matrix Thick and Gentrix® Surgical
Matrix Extend are intended for implantation to reinforce
soft tissue where weakness exists in patients requiring
gastroenterological or plastic & reconstructive surgery.
Reinforcement of soft tissue within gastroenterological | The pericardial patch is intended for
use as a surgical patch material for:
augmenting the patient's own
pericardium to assist in closure
following open-heart surgery,
intracardiac defects, septal defects and
annulus repairs, cardiac and vascular
reconstruction and repairs, peripheral
vascular reconstruction and repairs,
great vessel reconstruction and repairs,
and suture-line buttressing. |
| | ACell, Inc.
Subject Device | CorMatrix
Cardiovascular, Inc.
Primary Predicate Device | ACell, Inc.
Reference Device | Edwards Lifesciences
Reference Device |
| | MatriStem UBMTM
Pericardial Patch | CorMatrix Pericardial
Patch (CorMatrix ECM
for 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 not
limited to, the following procedures: hernia and body
wall repair, colon and rectal prolapse repair, tissue
repair, and esophageal repair. | |
| Material
Source | Porcine Urinary Bladder
Matrix (UBM) | Porcine Sub Intestinal
Submucosa (SIS) | Porcine Urinary Bladder Matrix (UBM) | Bovine Pericardium |
| Material Type | Collagen, Extracellular
Matrix | Collagen, Extracellular
Matrix | Collagen, Extracellular Matrix | Bovine Tissue |
| Crosslinked
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
Gentrix Surgical Matrix Thick: 8 | Tissue Thickness 0.5 mm +/- 0.25 mm |
| Nominal Sizes
(cm) | 7 x 10 cm
7 x 15 cm
10 x 15 cm | 7 x 10 cm
7 x 15 cm | Gentrix Surgical Matrix: Up to 10 x 15 cm
Gentrix Surgical Matrix Thick: Up to 30 x 40 cm | 10 x 15 cm |
| Reusable or
Single Use | Single Use Device | Single Use Device | Single Use Device | Single Use Device |
| Packaging | Dual Foil:PET Pouch
System | Dual Pouch System | Dual Foil:PET Pouch System | Packaged sterile in container with
glutaraldehyde |
| Sterilization | Electron beam irradiation | Ethylene oxide | Electron beam irradiation | XenoLogiX process, terminally
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.