(80 days)
Permacol™ Surgical Implant is intended for use as a soft tissue implant to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical, incisional, parastomal hernias, muscle flap reinforcement and abdominal wall defects.
Permacol ™ Surgical Implant is a sterile, off-white, moist, tough and flexible, fibrous flat sheet of acellular porcine dermal collagen and its constituent elastin fibers. Presented moist in sterile saline, Permacol ™ Surgical Implant is double vacuum packed and heat sealed peel-open aluminum foil (inner) and peel-open polyester/polyethylene (outer) pouches.
The provided text is a 510(k) summary for the Permacol™ Surgical Implant, a surgical mesh device. The submission explicitly states that "No new performance data has been included in this submission." This means that the 510(k) relies on the substantial equivalence to a predicate device (Permacol™ Surgical Implant, K043366) and does not present new studies with acceptance criteria or device performance data for the current submission.
Therefore, the requested information cannot be filled out from the provided document as it does not contain details of an acceptance criteria study for the current device submission.
However, based on the principle of substantial equivalence for a 510(k) submission, the performance of the predicate device (Permacol™ Surgical Implant, K043366) would have been used to establish its safety and effectiveness, and the current device is deemed to meet those same performance characteristics due to its identical nature. The document explicitly states: "Permacol TM Surgical Implant is identical to the predicate device, Permacol TM Surgical Implant, K043366, in terms of its technological characteristics." and "No material changes are proposed in this submission."
Since no new performance data or study is presented in the provided K120605 submission, the table and other details related to a specific study cannot be extracted.
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MAY 1 8 2012
510(k) Summary of Safety and Effectiveness
| SUBMITTER: | Covidien15 Crosby DriveBedford, MA 01730 |
|---|---|
| CONTACT PERSON: | James McMahonManager, Regulatory Affairs15 Crosby DriveBedford MA 01730 |
| DATE PREPARED: | February 22, 2012 |
| TRADE/PROPRIETARY NAME: | Permacol TM Surgical Implant |
| COMMON/USUAL NAME: | Surgical Mesh |
| CLASSIFICATION NAME: | Surgical Mesh |
| PREDICATE DEVICE(S): | Permacol TM Surgical Implant (K043366), Primatrix Ag(K100261) |
| DEVICE DESCRIPTION: | Permacol TM Surgical Implant is a sterile, off-white, moist, toughand flexible, fibrous flat sheet of acellular porcine dermalcollagen and its constituent elastin fibers. Presented moist insterile saline, Permacol TM Surgical Implant is double vacuumpacked and heat sealed peel-open aluminum foil (inner) andpeel-open polyester/polyethylene (outer) pouches. |
| INDICATIONS: | Permacol TM Surgical Implant is intended for use as a softtissue implant to reinforce soft tissue where weakness existsand for the surgical repair of damaged or ruptured soft tissuemembranes. It is specifically indicated for the repair ofabdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical,incisional,parastomal hernias and abdominal wall defects. |
| TECHNOLOGICALCHARACTERISTICS: | Permacol TM Surgical Implant is identical to the predicatedevice, Permacol TM Surgical Implant, K043366, in terms of itstechnological characteristics. |
| MATERIALS: | No material changes are proposed in this submission. |
| PERFORMANCE DATA: | No new performance data has been included in thissubmission. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 8 2012
Covidien LLC % Mr. James McMahon Manager, Regulatory Affairs 15 Crosby Drive Bedford, Massachusetts 01730
Re: K120605
Trade/Device Name: Permacol™ Surgical Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXK Dated: May 08, 2012 Received: May 09, 2012
Dear Mr. McMahon:
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.
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
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Page 2 - Mr. James McMahon
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 (OS) 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 A. Milliken
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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KI20605
Indications for Use
510(k) Number (if known):
Permacol™ Surgical Implant Device Name:
· Indications for Use:
Permacol™ Surgical Implant is intended for use as a soft tissue implant to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical, incisional, parastomal hernias, muscle flap reinforcement and abdominal wall defects.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Kane for NXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K129005
§ 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.