(34 days)
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).
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.
This document presents a 510(k) Summary for the Supple Peri-Guard Pericardium device. However, it does not contain specific acceptance criteria, performance data, or details of a study that proves the device meets acceptance criteria in the format typically requested for AI/diagnostic studies.
Instead, this document is a regulatory submission demonstrating the substantial equivalence of the Supple Peri-Guard Pericardium to a predicate device (which is itself) for purposes of market clearance. The "Technology/Device Testing" section explicitly states: "Supple Peri-Guard is identical to the predicate device, clarification of labeling only." This indicates that no new performance testing was conducted for this specific 510(k) submission because the device itself, and its performance, are considered the same as the already cleared predicate.
Therefore, I cannot populate the table and answer the questions as requested based on the provided text, as the information simply isn't present in this type of regulatory document. This submission relies on the prior clearance of the predicate device (K921895 and K923657) and asserts sameness, rather than presenting new performance data against specific acceptance criteria.
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|<961819 PAGE 111
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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 , 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 iscrosslinked 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 at20-25°C.Supple Peri-Guard is packaged in a container filled with sterile,nonpyrogenic water containing propylene oxide. The contents of theunopened, undamaged container are sterile. |
| Statement of Intended use: | For use as a prosthesis for the surgical repair of 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: | Supple Peri-Guard is identical to the predicate device, clarification oflabeling only. |
| Technology/Device Testing: | Supple Peri-Guard is identical to the predicate device, clarification oflabeling only. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
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
AUG 2 3 2012
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.
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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/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,
FOR
Mark N. Melkerson
Director
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
K961810 510(k) Number (if known):
Supple Peri-Guard® Pericardium Device Name:
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)
David Kameka MM
(Division Sign Off)
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K961810
§ 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.