Predicate Devices

Reference Devices

None

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and biological response of a bovine pericardial patch, with no mention of AI or ML technologies.

Therapeutic

Yes

Explanation: The device is a surgical patch material used for reconstruction and repair, indicating it is intended to mitigate or treat a condition, which aligns with the definition of a therapeutic device.

Diagnostic

No

The XenoSure Biologic Patch is described as a surgical patch material for reconstruction and repair, not for diagnosing conditions. Its function is to reinforce or repair tissue, which is a therapeutic rather than diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical patch made of bovine pericardial tissue, treated and packaged. There is no mention of software as a component or the primary function of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states it's for surgical procedures (cardiac reconstruction, soft tissue repair, reinforcing suture lines). This is an in-vivo (within a living organism) application, not an in-vitro (outside of a living organism) diagnostic test.
Device Description: The description details a surgical patch made from bovine tissue, designed to be implanted in the body. This is consistent with a surgical device, not a diagnostic one.
Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or screen for health issues.
Performance Studies: The performance studies focus on the physical properties of the patch and its biological integration within a living organism (sheep model). This is typical for a surgical implant, not an IVD.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The XenoSure Biologic Patch is intended for use as a surgical patch material for cardiac reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.

Product codes

PSQ

Device Description

The XenoSure consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. XenoSure patch is liquid chemical sterilized and packaged in a plastic jar containing sterile glutaraldehyde storage solution.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cardiac, vascular, soft tissue

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Summary of Product Testing: The following tests have been completed on baseline and aged product to evaluate the XenoSure Biologic Patch (frozen) in comparison to the predicate device (unfrozen patch):
• Longitudinal Tensile test
• Burst strength test
• Suture retention test
• Water Permeability
• Elongation
• Cross Linking test
• Collagenase digestion
• Delamination
Longitudinal Tensile: All XenoSure patches passed the acceptance criteria of >= 2 MPa. The mean of tensile strength of the predicate device (unfrozen) was measured as 12.9 MPa. The mean of tensile strength of XenoSure patch (frozen) was measured as 12.1 MPa. There is no statistical difference.
Elongation: All XenoSure patches passed the acceptance criteria of 5~50% elongation. The mean of elongation of the predicate device was measured as 21.8%. The mean of elongation of XenoSure patch (frozen) was measured as 22.3%. There is no statistical difference.
Burst strength: All XenoSure patches passed the acceptance criteria of >= 12 PSI. The mean of burst strength of the predicate device (unfrozen patch) was measured as 134 PSI. The mean of burst strength of XenoSure patch (frozen) was measured as 113 PSI. They are statistically different. However, since both results are much higher than the clinical specification of 12PSI, the difference does not have any clinical significance.
Suture retention: All XenoSure patches passed the acceptance criteria of >= 300 gf. The mean of suture retention of the predicate device was measured as 1233 gf. The mean of suture retention of XenoSure patch (frozen) was measured as 1235 gf. There is no statistical difference.
Cross Linking: There is no acceptance criteria for this test. The cross linking of the predicate (unfrozen patch) is 29 ppm free amine site per gram. The cross linking of the proposed (frozen) patch is 28 ppm free amine site per gram. The test results show there is no statistical difference between the proposed and predicate devices.
Collagenase Digestion: There is no acceptance criteria for this test. The digestion of the predicate (unfrozen patch) is 0.16%. The digestion of the proposed (frozen patch) is 0.18%. The test results show there is no statistical difference between the proposed and predicate devices.
Water Permeability: The acceptance criteria is

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).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 13, 2020

LeMaitre Vascular John Bradsher Senior Regulatory Affairs Specialist 63 Second Avenue Burlington, Massachusetts 01803

Re: K190882

Trade/Device Name: XenoSure Biologic 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: April 2, 2019 Received: April 4, 2019

Dear John Bradsher:

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 (OS) 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, Ph.D. 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) K190882

Device Name XenoSure Biologic Patch

Indications for Use (Describe)

The XenoSure Biologic Patch is intended for use as a surgical patch material for cardiac reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.

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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K190882 510k Summary

Submitter's Information
Name:	LeMaitre Vascular, Inc.
Address:	63 Second Avenue, Burlington, MA 01803
Phone:	781-425-1706
Fax:	781-425-5049
Contact Person:	Xiang (Vic) Zhang
VP of Regulatory Affairs
LeMaitre Vascular, Inc.
Email: xzhang@lemaitre.com
Date Prepared:	February 13, 2020
Device Name:	XenoSure Biologic Patch
Trade Name:	XenoSure Biologic Patch
Common Name:	Intracardiac patch or pledget
Regulation Number:	21 CFR 870.3470
Classification Panel:	Cardiovascular
Class:	II (2)
Product Code:	PSQ
Establishment
Registration:	1220948
Establishment:	63 Second Avenue
Burlington, MA 01803
Predicate Device:	XenoSure Biologic Patch (K040835)
Reference Device:	None
Device Description:	The XenoSure consists of one piece of bovine pericardial
tissue that has been selected for minimal tissue blemishes.
The tissue is treated with a glutaraldehyde process which
crosslinks the collagen fibers and minimizes antigenicity.
XenoSure patch is liquid chemical sterilized and packaged
in a plastic jar containing sterile glutaraldehyde storage
solution.

4

Indication for Use:	The XenoSure Biologic Patch is intended for use as a surgical patch material for cardiac and vascular reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.
Summary of Technological
Characteristics:	The purpose of this submission is to support the labeling change of removing the warning that XenoSure cannot be frozen. No change to the device design, materials, packaging materials, or manufacturing processes. The only change is to underfill the final package to tolerate the expected expansion if the storage solution is frozen. Comparisons of the XenoSure Biologic Patch (frozen) with the predicate XenoSure Biologic Patch (unfrozen) show that technological characteristics such as materials, biocompatibility, performance, and sterilization of the proposed device are substantially equivalent to the predicate device. The difference between the proposed device and the predicate device is the proposed device labeling will allow the device to be exposed to temperature below 0°C while the predicate device labeling warns against that. For the subject device, the storage solution is under-filled to accommodate potential frozen expansion. This difference was evaluated to demonstrate substantial equivalence via performance testing and an in-vivo animal study.
	Proposed Device		Predicate Device	Comparison
	Product Name:		Product Name:
	XenoSure Biologic Patch		XenoSure Biologic Patch
Manufacturer	LeMaitre Vascular Inc.		LeMaitre Vascular Inc.	Same
Clearance	This submission		K040835
Indications for
Use	The XenoSure® Biologic Patch
is intended for use as a surgical
patch material for cardiac and
vascular reconstruction and
repair, soft tissue deficiency
repair and reinforcing the suture
line during general surgical
procedures.		The XenoSure® Biologic Patch
is intended for use as a surgical
patch material for cardiac and
vascular reconstruction and
repair, soft tissue deficiency
repair and reinforcing the suture
line during general surgical
procedures.	Same
Materials	Bovine pericardium		Bovine pericardium	Same
Design	Various size patches		Various size patches	Same
Sterility	Chemical sterilization with 10-6 SAL		Chemical sterilization with 10-6 SAL	Same
Single Use	Yes		Yes	Same
Medical
Specialists	Cardiovascular		Cardiovascular	Same
Packaging	Jar/Lid, carton		Jar/Lid, carton	Same
Shelf Life	6 years	6 years	Same
Functional/Safety Testing:	The verification activities conducted indicate that
XenoSure biologic patch (frozen) meets the product
performance requirements of the device specifications and
does not raise any additional safety issues.
Sterilization:	XenoSure biologic patch is chemically sterilized
according to ISO14160: 2011, “Sterilization of health care
products -- Liquid chemical sterilizing agents for single-
use medical devices utilizing animal tissues and their
derivatives -- Requirements for characterization,
development, validation and routine control of a
sterilization process for medical devices”.
Biocompatibility:	The material for XenoSure Biologic Patch is bovine
pericardium. It is identical to that in the predicate device
which has established biocompatibility. There is no
change to the materials, manufacturing process, or
packaging for this submission and the biocompatibility is
not affected.
Summary of Product Testing:	The following tests have been completed on baseline and
aged product to evaluate the XenoSure Biologic Patch
(frozen) in comparison to the predicate device (unfrozen
patch):
• Longitudinal Tensile test
• Burst strength test
• Suture retention test
• Water Permeability
• Elongation
• Cross Linking test
• Collagenase digestion
• Delamination
Test	Test method summary	Results
Longitudinal
Tensile	Use Instron pull the sample until it
fails. Record the ultimate tensile
strength in MPa.	All XenoSure patches passed the acceptance
criteria of ≥ 2 MPa. The mean of tensile strength
of the predicate device (unfrozen) was measured
as 12.9 MPa. The mean of tensile strength of
XenoSure patch (frozen) was measured as 12.1
MPa. There is no statistical difference.
Elongation	Use Instron pull the sample until it
fails. Record the elongation at the
failure as percent of the original sample
length.	All XenoSure patches passed the acceptance
criteria of 5~50% elongation. The mean of
elongation of the predicate device was measured
as 21.8%. The mean of elongation of XenoSure
patch (frozen) was measured as 22.3%. There is
no statistical difference.

5

6

| Burst strength | Sample is secured in the testing fixture
as a membrane between two chambers.
One side of the sample is slowly
pressurized using water. Record the
pressure at the time of burst or leak. | All XenoSure patches passed the acceptance
criteria of ≥ 12 PSI. The mean of burst strength
of the predicate device (unfrozen patch) was
measured as 134 PSI. The mean of burst strength
of XenoSure patch (frozen) was measured as
113 PSI. They are statistically different.
However, since both results are much higher
than the clinical specification of 12PSI, the
difference does not have any clinical
significance. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Suture retention | Make sutures on the edge of the patch.
Pull the suture using Instron until either
patch or suture fail. Record the force at
the failure. | All XenoSure patches passed the acceptance
criteria of ≥ 300 gf. The mean of suture retention
of the predicate device was measured as 1233 gf.
The mean of suture retention of XenoSure patch
(frozen) was measured as 1235 gf. There is no
statistical difference. |
| Cross Linking | This test is to determine the degree of
cross-linking of collagen based
materials by measuring the amounts of
unreacted amino groups. Free amino
groups will bind to
2,4,6-trinitrobenzenesulfonic acid
(TNBS) and the remaining TNBS is
reacted with glycine to
produce a complex that absorbs
strongly at 340 nm and can be
quantitatively measured by UV-Vis
Spectrophotometry. The number of free
amine sites is calculated using a pre-
and post-test calibration curve and the
absorbance of the test sample. | There is no acceptance criteria for this test. The
cross linking of the predicate (unfrozen patch) is
29 ppm free amine site per gram. The cross
linking of the proposed (frozen) patch is 28 ppm
free amine site per gram. The test results show
there is no statistical difference between the
proposed and predicate devices. |
| Collagenase
Digestion | This test is to determine the digestion
rates of biological tissue by collagenase
digestion. Collagenase will cleave
glycine bonds in collagen, breaking
tissue down into peptides. Depending
on the type of tissue and crosslinking
used, the biologic tissues can exhibit
different digestion rates. | There is no acceptance criteria for this test. The
digestion of the predicate (unfrozen patch) is
0.16%. The digestion of the proposed (frozen
patch) is 0.18%. The test results show there is no
statistical difference between the proposed and
predicate devices. |
| Water
Permeability | This test is to measure the water
permeability of the tissue under 120
mmHg pressure. | The acceptance criteria is