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

For use as a prosthesis for pericardial closure and soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical).

Device Description

Peri-Guard® Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C.

Supple Peri-Guard® is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Supple Peri-Guard is chemically sterilized using ethanol and propylene oxide. Supple Peri-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. Supple Peri-Guard is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.

AI/ML Overview

The provided text describes two devices: "Peri-Guard Repair Patch" and "Supple Peri-Guard Pericardium," both with the same 510(k) number K983162. The information regarding their acceptance criteria and studies is identical across both entries, as they are essentially the same device with a minor manufacturing difference.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Physical Properties	No significant difference compared to control (non-NaOH-treated) samples in shrink, suture, and thickness.	Results showed no significant difference between the test (NaOH-treated) and control (non-NaOH-treated) samples for shrink, suture, and thickness testing.
Biocompatibility	No significant difference in biocompatibility or inflammation compared to non-NaOH-treated samples.	Results showed that the 1 M NaOH treatment did not produce significant differences in biocompatibility or inflammation when comparing the treated versus non-treated pericardium.
Safety Factors	No significant difference in bioburden, sterility, pH, pyrogen, and chemical residuals compared to non-NaOH-treated samples; no additional questions of safety or effectiveness.	Results showed no significant difference between the test and control samples for bioburden, sterility, pH, pyrogen, and chemical residuals testing. The exposure to sodium hydroxide poses no additional questions of safety or effectiveness, and the product performs in a manner substantially equivalent to the product not treated with 1M NaOH.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated. The text mentions "samples" of NaOH-treated and control pericardium were subjected to various tests.
Data Provenance: Not explicitly stated but clinical data is alluded to by "animal testing" and "biocompatibility" but no human data is provided. The bovine pericardium for the device is procured from cattle originating in the United States and the study was conducted by the manufacturer, Synovis Surgical Innovations, based in St. Paul, MN. This suggests it is likely a retrospective study based on laboratory and animal testing, not a prospective human clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable as this study does not involve human readers evaluating images or data against a ground truth established by experts. It's a laboratory and animal study comparing physical, chemical, and biological properties of a medical device.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study that involves expert adjudication of findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This study focuses on the material properties and biological response to the modified implant, not on human interpretation or decision-making with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not applicable. This device is a surgical mesh, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to the established standards for material properties, biocompatibility, and safety within a controlled laboratory and animal testing environment. This includes:
- Physical measurements: Shrinkage, suture retention, thickness.
- Chemical analyses: pH, chemical residuals.
- Biological assays: Bioburden, sterility, pyrogenicity, biocompatibility (e.g., inflammatory response in animal models).
- Comparison to predicate device/control: The non-NaOH-treated pericardium serves as the primary control or "ground truth" against which the modified device is compared to demonstrate substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This study does not involve a training set as it is not an AI/algorithm study.

9. How the Ground Truth for the Training Set Was Established:

Not applicable as there is no training set for this type of device study.

Summary

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K983162

510(K) SUMMARY

Submitted by:	Synovis Surgical Innovations2575 University Avenue WestSt. Paul, MN 55114-1024Tel: 651-796-7300Fax: 651-642-9018
Contact Person:	Fonda BurleyAt address above
Device Trade Name:	Peri-Guard Repair Patch
Common Name:	Surgical Mesh
Classification Name:	Mesh, Surgical21 CFR 878.3300
Product Code:	FTM , OXB
Predicate devices:	Peri-Guard K961811 and K842066(Device acting as its own predicate)
Device Description:	Peri-Guard® Repair Patch (Peri-Guard) is a biologic tissue preparedfrom bovine pericardium cross-linked with glutaraldehyde. Thepericardium is procured from cattle originating in the United States.Peri-Guard is chemically sterilized using ethanol and propylene oxide.Peri-Guard is treated with 1 molar sodium hydroxide for 60-75minutes at 20-25°C.
Statement of Intended use:	Peri-Guard is intended for repair of pericardial structures and for useas a prosthesis for the surgical repair of soft tissue deficiencies whichinclude: defects of the abdominal and thoracic wall, gastric binding,muscle flap reinforcement, and hernias (including diaphragmatic,femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, andumbilical hernias).
Technological Comparisons:	The subject device is technologically identical to the predicate device.The only difference between these devices is that the subject deviceis treated with 1 molar sodium hydroxide (1 M NaOH) for 60-75minutes at 20-25 °C.

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Technology/Device Testing:

Cross-linked pericardium was treated with 1 molar sodium hydroxide (1 M NaOH) for 60-75 minutes at 20 -25 C, rinsed with deionized (DI) water and neutralized with citrate solution, followed by a final DI water rinse. Sodlum hydroxide treated and control (non-NaOHtreated) samples were subjected to shrink, suture, and thickness testing. Results showed no significant difference between the test and control samples. The test and control samples were subjected to bioburden, sterility, pH, pyrogen, and chemical residuals testing. Results showed no significant difference between the test and control samples. Samples of the NaOH-treated pericardium were also subjected to biocompatibility and animal testing. Results showed that the 1 M NaOH treatment did not produce significant differences in biocompatibility or inflammation when comparing the treated versus non-treated pericardium. Product subjected to 1 M NaOH treatment performs in a manner substantially equivalent to the product not treated with 1M NaOH, and that the exposure to sodium hydroxide poses no additional questions of safety or effectiveness.

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K983162
Page 3/4

510(K) SUMMARY

Submitted by:	Synovis Surgical Innovations2575 University Avenue WestSt. Paul, MN 55114-1024Tel: 651-796-7300Fax: 651-642-9018
Contact Person:	Fonda BurleyAt address above
Device Trade Name:	Supple Peri-Guard Pericardium
Common Name:	Surgical Mesh
Classification Name:	Mesh, Surgical21 CFR 878.3300
Product Code:	FTM
Predicate devices:	Supple Peri-Guard K961810 and K921895(Device acting as its own predicate)
Device Description:	Supple Peri-Guard® is prepared from bovine pericardium which iscross-linked with glutaraldehyde. The pericardium is procured fromcattle originating in the United States. Supple Peri-Guard is chemicallysterilized using ethanol and propylene oxide. Supple Peri-Guard hasbeen treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C.Supple Peri-Guard is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of theunopened, undamaged container are sterile.
Statement of Intended use:	For use as a prosthesis for pericardial closure and soft tissuedeficiencies which include: defects of the abdominal and thoracicwall, gastric banding, muscle flap reinforcement, and hernias(diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy,scrotal and umbilical).
Technological Comparisons:	The subject device is technologically identical to the predicate device.The only difference between these devices is that the subject deviceis treated with 1 molar sodium hydroxide (1 M NaOH) for 60-75minutes at 20 -25 C.

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K983162
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Technology/Device Testing:

Cross-linked pericardium was treated with 1 molar sodium hydroxide (1 M NaOH) for 60-75 minutes at 20 -25 C, rinsed with deionized (DI) water and neutralized with citrate solution, followed by a final DI water rinse. Sodium hydroxide treated and control (non-NaOHtreated) samples were subjected to shrink, suture, and thickness testing. Results showed no significant difference between the test and control samples. The test and control samples were subjected to bioburden, sterility, pH, pyrogen, and chemical residuals testing. Results showed no significant difference between the test and control samples. Samples of the NaOH-treated pericardium were also subjected to biocompatibility and animal testing. Results showed that the 1 M NaOH treatment did not produce significant differences in biocompatibility or inflammation when comparing the treated versus non-treated pericardium. Product subjected to 1 M NaOH treatment performs in a manner substantially equivalent to the product not treated with 1M NaOH, and that the exposure to sodium hydroxide poses no additional questions of safety or effectiveness.

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Image /page/4/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem depicting a stylized eagle with three lines forming its body and wings. The eagle is oriented towards the right.

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

Bio-Vascular, Incorporated % Ms. Dianna L. Geck Regulatory Affairs Associate 2575 University Avenue St. Paul, Minnesota 55114-1024

AUG 2 7 2012

Re: K983162 Trade/Device Name: Peri-Guard® Repair Patch Supple Peri-Guard® Pericardium Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM OxB Dated: September 9, 1998 Received: September 10, 1998

Dear Ms. Geck:

This letter corrects our substantially equivalent letter of October 9, 1998.

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 (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.

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 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

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Page 2 -Ms. Dianna L. Geck

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K983162

Device Name:

Peri-Guard Repair Patch

Indications For Use:

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of _

510(k) Number K983162

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Indications for Use

510(k) Number (if known): K983162

Device Name:

Supple Peri-Guard® Pericardium

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kracfer MM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K983162

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.