SUPPLE PERI-GUARD PERICARDIUM

K961810 · Bio-Vascular, Inc. · FTM · Jun 13, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961810
• Device Name: SUPPLE PERI-GUARD PERICARDIUM
• Applicant: Bio-Vascular, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Jun 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical).

Device Story

Supple Peri-Guard is a surgical mesh prosthesis derived from bovine pericardium; tissue is crosslinked with glutaraldehyde and treated with 1 molar sodium hydroxide. Device serves as a scaffold for soft tissue repair; implanted by surgeons during procedures to address wall defects or hernias. Supplied in sterile, nonpyrogenic water containing propylene oxide; chemically sterilized using ethanol and propylene oxide. Provides structural reinforcement for soft tissue deficiencies.

Technological Characteristics

Bovine pericardium; crosslinked with glutaraldehyde; treated with 1 molar sodium hydroxide; chemically sterilized with ethanol and propylene oxide. Form factor is a surgical mesh.

Indications for Use

Indicated for surgical repair of soft tissue deficiencies, including abdominal/thoracic wall defects, gastric banding, muscle flap reinforcement, and various hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical).

Regulatory Classification

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.

Predicate Devices

• Supple Peri-Guard (K921895)
• Supple Peri-Guard (K923657)

Submission Summary (Full Text)

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K961810
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# 510(K) SUMMARY

| Submitted by: | Synovis Surgical Innovations
2575 University Avenue West
St. Paul, MN 55114-1024
Tel: [phone]
Fax: [phone] |
| --- | --- |
| Contact Person: | Fonda Burley
At address above |
| Device Trade Name: | Supple Peri-Guard Pericardium |
| Common Name: | Surgical Mesh |
| Classification Name: | Mesh, Surgical
21 CFR 878.3300 |
| Product Code: | FTM OWV |
| Predicate devices: | Supple Peri-Guard K921895 and K923657
(Device acting as its own predicate) |
| Device Description: | Supple Peri-Guard® is prepared from bovine pericardium which is crosslinked 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, nonpyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile. |
| Statement of Intended use: | 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 (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical). |
| Technological Comparisons: | Supple Peri-Guard is identical to the predicate device, clarification of labeling only. |
| Technology/Device Testing: | Supple Peri-Guard is identical to the predicate device, clarification of labeling only. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

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

Bio-Vascular, Incorporated
% Bruce A. MacFarlane, Ph.D.
Vice President of Regulatory Affairs & Quality Assurance
2575 University Avenue
Saint Paul, Minnesota 55114-1024

Re: K961810
Trade/Device Name: Supple Peri-Guard® Pericardium
Regulation Number: 21 CFR 878.3300
Regulation Name: Surgical mesh
Regulatory Class: Class 2
Product Code: FTM, OWV
Dated: May 8, 1996
Received: May 10, 1996

Dear Dr. MacFarlane:

This letter corrects our substantially equivalent letter of June 13, 1996

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 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.

AUG 23 2012

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Page 2 - Bruce A. MacFarlane, Ph.D.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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): K961810

Device Name: Supple Peri-Guard® Pericardium

Indications For Use:

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 (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical).

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)


510(k) Number K961810