PERI-GUARD is intended for repair of pericardial structures. PERI-GUARD is also intended for use as a patch for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing.

Device Description

SUPPLE PERI-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. SUPPLE PERI-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation.

SUPPLE PERI-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.

PERI-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. PERI-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. PERI-GUARD is terminally sterilized using gamma irradiation.

PERI-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.

AI/ML Overview

The provided document is a 510(k) premarket notification for two devices: SUPPLE PERI-GUARD Pericardium Patch and PERI-GUARD Repair Patch. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a comparative effectiveness study with human readers or presenting detailed performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of AI or advanced clinical performance studies.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance in the format requested (likely due to the nature of a 510(k) submission not requiring explicit performance metrics in this way for equivalence).
Any details about sample sizes used for a test set, data provenance, ground truth establishment, or expert involvement as typically found in studies for AI/diagnostic devices.
Information on adjudication methods.
A multi-reader multi-case (MRMC) comparative effectiveness study with effect sizes for human reader improvement with AI.
A standalone (algorithm only) performance study.
Sample sizes or ground truth establishment for a training set (as this is not an AI/machine learning device).

Instead, the document focuses on non-clinical testing to demonstrate safety and performance for substantial equivalence. The studies mentioned are:

Bench testing: Assessed aspects like suture retention, thickness, burst strength, ultimate tensile strength, collagenase digestion, chemical residuals, pyrogenicity/LAL, sterilization validation, and packaging/shelf-life. The document states, "Bench testing results support the performance requirements."
Biocompatibility testing: Performed in accordance with ISO 10993-1: 2009.
Animal studies: Conducted to support safety and efficacy.

These studies are conducted to show the new device is "substantially equivalent" to predicate devices, mainly due to changes in packaging and sterilization methods. The document repeatedly states that the devices (SUPPLE PERI-GUARD and PERI-GUARD) are acting as their own predicates.

Summary

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

Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font. The text is aligned to the left and is the only element in the image.

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized symbol of three human profiles, layered on top of each other, creating a sense of depth and connection.

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

April 13, 2015

Synovis Life Technologies Inc. % Jodi Jorgenson Manager, Regulatory Affairs 2575 University Ave. W. St. Paul, Minnesota 55129

Re: K142447

Trade/Device Name: PERI-GUARD Repair Patch SUPPLE PERI-GUARD Pericardium 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: DXZ Dated: August 28, 2014 Received: September 2, 2014

Dear Jodi Jorgenson,

This letter corrects our substantially equivalent letter of January 7, 2015.

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.

{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 (reporting of medical devicerelated 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/ResourcesforYou/Industry/default.htm. 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

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.

Sincerely yours.

Nicole G. Ibrahim -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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

Indications for Use

510(k) Number (if known) K142447

Device Name

SUPPLE PERI-GUARD Pericardium Patch

Indications for Use (Describe)

SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.

Type of Use (Select one or both, as applicable)

2 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 PRAStaff@fda.hhs.gov

"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}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K142447

Device Name PERI-GUARD Repair Patch

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☒ 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."

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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."

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

510(K) SUMMARY: SUPPLE PERI-GUARD PERICARDIUM PATCH

Applicant:

Synovis Life Technologies, Inc. (a subsidiary of Baxter International Inc.) 2575 University Avenue West St. Paul, MN 55114-1024 Tel: 651-796-7300 Fax: 651-642-9018

Contact Person:

Jodi Jorgenson Manager, Regulatory Affairs At address above

Date Prepared:

August 28, 2014

Device Trade Name: SUPPLE PERI-GUARD Pericardium Patch

Common Name:

Intracardiac patch

Classification Name:

Intracardiac patch or pledget 21 CFR 870.3470 Product Code: DXZ

Predicate Devices:

Synovis Life Technologies, SUPPLE PERI-GUARD Pericardium Patch: K983162

Device Description:

SUPPLE PERI-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.

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

Statement of Intended Use:

SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.

Summary/Comparison of Technological Characteristics:

SUPPLE PERI-GUARD Pericardium Patch is acting as its own predicate and is therefore substantially equivalent, having the same technological characteristics and intended use with the exception of the packaging and sterilization method, which are the subject of this premarket notification submission.

The safety and performance of SUPPLE PERI-GUARD Pericardium Patch was evaluated through non-clinical testing.

The bench and pre-clinical testing assessed the following aspects of the device:

Suture retention .
Thickness ●
Burst Strength .
Ultimate Tensile Strength
Collagenase digestion
Chemical residuals ●
Pyrogenicity/ LAL ●
Sterilization validation ●
Packaging and shelf-life ●
Biocompatibility ●
Animal studies ●

Bench testing results support the performance requirements for SUPPLE PERI-GUARD Pericardium Patch. Biocompatibility testing was performed in accordance to ISO 10993-1: 2009 (Biological Evaluation of medical devices - Part 1: Evaluation and testing within a risk management process). Various animal studies were conducted to support the safety and efficacy of SUPPLE PERI-GUARD Pericardium Patch. The bench and preclinical studies indicate that the device is biocompatible and is substantially equivalent to the referenced predicate device.

Conclusions:

The safety and performance of SUPPLE PERI-GUARD Pericardium Patch was evaluated through biocompatibility, bench testing and animal studies. SUPPLE PERI-GUARD Pericardium Patch is substantially equivalent to the predicate device.

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

510(K) SUMMARY: PERI-GUARD REPAIR PATCH

Applicant:

Synovis Life Technologies, Inc. (a subsidiary of Baxter International Inc.) 2575 University Avenue West St. Paul, MN 55114-1024 Tel: 651-796-7300 Fax: 651-642-9018

Contact Person:

Jodi Jorgenson Manager, Regulatory Affairs At address above

Date Prepared: August 28, 2014

Device Trade Name: PERI-GUARD Repair Patch

Common Name: Intracardiac patch

Classification Name:

Intracardiac patch or pledget 21 CFR 870.3470 Product Code: DXZ

Predicate Devices:

Synovis Life Technologies, PERI-GUARD Pericardium with Apex Processing: K983162 and K983602

Device Description:

PERI-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.

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

Statement of Intended Use:

Summary/Comparison of Technological Characteristics:

PERI-GUARD Repair Patch is acting as its own predicate and is therefore substantially equivalent, having the same technological characteristics and intended use with the exception of the packaging and method of sterilization, which is the subject of this premarket notification submission.

The safety and performance of PERI-GUARD Repair Patch was evaluated through non-clinical testing.

The bench and pre-clinical testing assessed the following aspects of the device:

Suture retention
Thickness ●
Burst Strength
Ultimate Tensile Strength ●
Collagenase digestion ●
Chemical residuals
Pyrogenicity/ LAL ●
Sterilization validation
Packaging and shelf-life ●
Biocompatibility
Animal studies

Bench testing results support the performance requirements for PERI-GUARD Repair Patch. Biocompatibility testing was performed in accordance to ISO 10993-1: 2009 (Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process). Various animal studies were conducted to support the safety and efficacy of PERI-GUARD Repair Patch. The bench and preclinical studies indicate that the device is biocompatible and is substantially equivalent to the referenced predicate device.

Conclusions:

The safety and performance of PERI-GUARD Repair Patch was evaluated through biocompatibility, bench testing and animal studies. PERI-GUARD Repair Patch and is substantially equivalent to the predicate device.

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).