PERI-GUARD is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, scrotal, and umbilical hernias).

SUPPLE PERI-GUARD is intended for use as a prosthesis for soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral. incisional, inguinal, lumbar, scrotal, and umbilical hernias).

Device Description

PERI-GUARD Repair Patch (PERI-GUARD) and SUPPLE PERI-GUARD Repair Patch (SUPPLE PERI-GUARD) are derived from bovine pericardium procured from cattle originating in the United States. The pericardium is cross linked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25℃ (68-77°F).

PERI-GUARD and SUPPLE PERI-GUARD are terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.

PERI-GUARD and SUPPLE PERI-GUARD are MR Safe.

PERI-GUARD and SUPPLE PERI-GUARD utilize animal tissue; patient must be informed prior to any procedure.

AI/ML Overview

The provided document is a 510(k) summary for medical devices, specifically Peri-Guard and Supple Peri-Guard surgical meshes. This type of document is used to demonstrate substantial equivalence to a predicate device, not to present a study proving a device meets specific acceptance criteria for AI/ML performance.

Therefore, the information required to answer your prompt regarding acceptance criteria and performance studies (e.g., sample sizes, expert involvement, adjudication methods, MRMC studies, ground truth establishment, training set details) is not present in the provided text. The document focuses on demonstrating the safety and effectiveness of a material and physical design change (sterilization method and packaging) for a surgical mesh, not on evaluating the performance of an AI-driven medical device.

To directly address your request for a table of acceptance criteria and study details, based solely on the provided text, I must state that this information is not available.

The document details non-clinical bench testing and animal studies to support the substantial equivalence claim for the modified surgical mesh. These studies are focused on material properties, biocompatibility, and physical performance of the mesh, and not on the performance of an AI model.

Here's how I would summarize the relevant information from the document, while acknowledging the absence of AI/ML-specific details you requested:

Acceptance Criteria and Device Performance (as described for the surgical mesh, not an AI device):

The document does not present a table of quantitative acceptance criteria for the mesh's performance in the way one would for an AI model (e.g., sensitivity, specificity, AUC thresholds). Instead, it discusses the equivalence of the modified device to its predicate through various non-clinical and animal studies. The overall "acceptance criterion" implicit in a 510(k) is the demonstration of substantial equivalence to a predicate device, meaning the new device is as safe and effective as the legally marketed predicate.

Reported Device Performance (for the surgical mesh):

The document states that the results of performance testing demonstrate that the modified PERI-GUARD and SUPPLE PERI-GUARD devices are substantially equivalent to the predicate devices.

Specific performance aspects evaluated include:

Bench Testing: Visual, Suture retention, Dimensional, Burst strength, Collagenase digestion, Denaturation Temperature, Water Permeability, Pliability, Chemical and heavy metal residuals, Bioburden, Pyrogenicity/Endotoxins, Temperature Excursion Testing.
- Conclusion: The results of these tests support substantial equivalence.
Animal Studies:
- Implantation (Porcine incisional hernia repair model for 6 months per ISO 10993-6): "No test material-related changes among clinical observations, bodyweights, veterinary physicals, clinical pathology parameters, mortality, significant macroscopic or microscopic differences, tensile or burst strength, or clinical performance between the subject and predicate devices..."
  - Conclusion: "The subject and predicate devices performed equivalently and had an equivalent safety profile in the in vivo porcine model for incisional hernia repair."
- 3-week Rat Calcification Potential Study: "No significant mineralization was noted microscopically for either the subject or predicate device."
  - Conclusion: "No significant difference in calcification potential."
Biocompatibility: Demonstrated biocompatibility in accordance with ISO 10993-1:2018 for a permanent implant, including cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, genotoxicity, implantation, hemolysis, and subchronic toxicity endpoints.
Shelf Life: 1-year shelf life claim supported by aging testing.
Sterilization and Packaging: Validation per ISO 11137 parts 1 and 2 (sterilization) and ISO 11607-1 (packaging integrity, supported by ASTM F88-15 and ASTM F2096-11).
Human Factors Testing: Confirmed that redesigned packaging allows for aseptic transfer without compromising sterility and does not impact the tissue patch surface.

Detailed breakdown of AI/ML specific information (Not Found in these documents):

A table of acceptance criteria and the reported device performance: Not applicable, as this is not an AI/ML device.
Sample size used for the test set and the data provenance: Not applicable. Studies conducted were animal (porcine and rat) and bench tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for the mesh's performance attributes (e.g., tensile strength, burst strength, calcification) is established through standardized laboratory and animal model measurements, not expert consensus interpreting images/data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance relies on direct physical measurements (e.g., tensile strength, burst strength), chemical analysis (e.g., residuals), and histopathological evaluation in animal models. It's not a diagnostic AI that generates predictions requiring expert-adjudicated ground truth labels.
The sample size for the training set: Not applicable. This device is a physical product, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA 510(k) summary is for a traditional medical device (surgical mesh) and lacks any information pertaining to AI/ML device performance, acceptance criteria, or study methodologies.

Summary

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Synovis Life Technologies, Inc. Megan Sajjad Sr. Manager Regulatory Affairs A Subsidiary of Baxter International Inc.) 2575 University Ave. W. St. Paul, Minnesota 55114

Re: K223052

Trade/Device Name: Peri-Guard and Supple Peri-Guard Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: March 27, 2023 Received: March 28, 2023

Dear Megan Sajjad:

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.

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

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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 mediation-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,

Deborah A. Fellhauer -S

Deborah Fellhauer, RN, BSN Assistant Director DHT4B:Division of Infection Control and Plastic Surgery Devices OHT4:Office of Surgical And Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223052

Device Name PERI-GUARD Repair Patch SUPPLE 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)

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510k SUMMARY: PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Repair Patch

I. SUBMITTER

Synovis Life Technologies, Inc. (Synovis) (A Subsidiary of Baxter International Inc.) 2575 University Avenue West St. Paul, MN 55114-1024 Phone: 651-796-7410 Fax: 224-270-4119

Contact Person: Megan Sajjad, Sr. Manager, Regulatory Affairs

Date prepared: March 27, 2023

II. DEVICE

Device Trade Names: PERI-GUARD and SUPPLE PERI-GUARD

Common Name: Repair Patch

Regulation: 21 CFR 878.3300 - Surgical Mesh

Product Codes: FTM (Mesh, Surgical), OWV (mesh, surgical, collagen, diaphragmatic hernia), OXB (mesh, surgical, collagen, thoracic, chest wall reconstruction);

III. PREDICATE DEVICE

PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Repair Patch, K983162

Manufacturer: Synovis Life Technologies, Inc., (A Subsidiary of Baxter International Inc.)

Additionally, Synovis PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Pericardium Patch (K142447) and PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (K192615) serve as Reference devices for this 510k.

IV. DEVICE DESCRIPTION

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linked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25℃ (68-77°F).

PERI-GUARD and SUPPLE PERI-GUARD are terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.

PERI-GUARD and SUPPLE PERI-GUARD are MR Safe.

PERI-GUARD and SUPPLE PERI-GUARD utilize animal tissue; patient must be informed prior to any procedure.

See Table 1 for PERI-GUARD and SUPPLE PERI-GUARD product models and sizes.

PERI-GUARD Model Number	Size (cm)
PG0404	4 x 4
PG0608	6 x 8
PG0814	8 x 14
PG1016	10 x 16
PG1225	12 x 25
SUPPLE PERI-GUARD Model Number	Size (cm)
SPG0404	4 x 4
SPG0406	4 x 6
SPG0608	6 x 8
SPG0814	8 x 14

Table 1 - PERI-GUARD and SUPPLE PERI-GUARD Product Models and Sizes

V. INTENDED USE/INDICATIONS FOR USE

Statement of Intended Use:

PERI-GUARD and SUPPLE PERI-GUARD are intended to be used as a surgical mesh.

Indications for Use:

SUPPLE PERI-GUARD is intended for use as a prosthesis for soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric

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banding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, scrotal, and umbilical hernias).

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

PERI-GUARD and SUPPLE PERI-GUARD are substantially equivalent to the predicate PERI-GUARD and SUPPLE PERI-GUARD devices based on having the same fundamental technology and intended use. The changes between the subject and predicate device include a change in sterilization method and redesigned packaging. The safety and performance of the subject devices has been evaluated through non-clinical testing.

The subject and predicate devices are identical in the following respects:

Intended Use
Patch material ●
Viral inactivation processing steps ●
Strength, chemical and physical specifications ●

The following technological differences exist between the subject and predicate devices:

Modified sterilization method from chemical sterilization to gamma . irradiation
Modified packaging from a jar to a double foil pouch ●

PERFORMANCE DATA VII.

The following bench testing performance data were provided in support of the substantial equivalence determination:

Visual
Suture retention
Dimensional
Burst strength
Collagenase digestion ●
Denaturation Temperature ●
Water Permeability
. Pliability
. Chemical and heavy metal residuals
Bioburden ●
Pyrogenicity/Endotoxins ●
. Temperature Excursion Testing
Biocompatibility Assessment ●

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The results of performance testing demonstrate that the modified PERI-GUARD and SUPPLE PERI-GUARD devices are substantially equivalent to the predicate devices.

Animal Studies

Two animal studies were performed to support the substantial equivalence of the chemically sterilized and gamma irradiated PERI-GUARD and SUPPLE PERI-GUARD devices.

Test	Results	Conclusions
Implantation:Porcine incisionalhernia repair modelfor 6 months perISO 10993-6	No test material-relatedchanges among clinicalobservations, bodyweights,veterinary physicals, clinicalpathology parameters,mortality, significantmacroscopic or microscopicdifferences, tensile or burststrength, or clinicalperformance between thesubject and predicate devices atDay $113\pm3$ or Day $203\pm3$ .	The subject and predicatedevices performedequivalently and had anequivalent safety profile in thein vivo porcine model forincisional hernia repair.
3-week RatCalcificationPotential Study	No significant mineralizationwas noted microscopically foreither the subject or predicatedevice.	No significant difference incalcification potential.

Biocompatibility

The results of biocompatibility testing demonstrate the biocompatibility of the product in accordance with ISO 10993-1:2018 requirements for a permanent (long term) implant with tissue, bone or (non-direct) blood contact. As per FDA Guidance, testing included cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, genotoxicity, implantation, hemolysis, and subchronic toxicity endpoints.

Shelf Life

Synovis has performed aging testing to support a 1 year shelf life claim.

Sterilization and Packaging

Sterilization validation was conducted according to ISO 11137 parts 1 and 2.

The modified packaging was designed and evaluated in accordance with ISO 11607-1. The integrity of the sterile barrier is supported by testing conducted in accordance with ASTM F88-15 and ASTM F2096-11.

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Validation Studies

Human factors testing was conducted to confirm that the re-designed packaging allows for aseptic transfer of the product to the sterile field without compromising sterility, and that the modified packaging design does not impact the surface of the tissue patch.

VII. CONCLUSION

The subject PERI-GUARD and SUPPLE PERI-GUARD devices share the same intended use and technological characteristics as the predicate devices. The physical, functional and performance specifications for the devices are substantially equivalent. Testing supports that the subject devices are as safe and effective as the predicate devices when used according to their labeling.

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.