PERMACOL SURGICAL IMPLANT

K120605 · Covidien, LLC · FTM · May 18, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120605
• Device Name: PERMACOL SURGICAL IMPLANT
• Applicant: Covidien, LLC
• Product Code: FTM · General, Plastic Surgery
• Decision Date: May 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 and abdominal wall defects.

Device Story

Permacol Surgical Implant is a sterile, flexible, fibrous flat sheet composed of acellular porcine dermal collagen and elastin fibers. Provided moist in sterile saline within double vacuum-packed pouches. Used by surgeons in clinical settings for soft tissue reinforcement and repair of hernias and abdominal wall defects. Device acts as a scaffold for tissue integration. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data included; bench testing only.

Technological Characteristics

Acellular porcine dermal collagen and elastin fibers. Sterile, moist, flexible flat sheet. Supplied in sterile saline. Double vacuum-packed in aluminum foil and polyester/polyethylene pouches. No electronic or software components.

Indications for Use

Indicated for patients requiring soft tissue reinforcement or repair of damaged/ruptured membranes, specifically for abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical, incisional, parastomal hernias, muscle flap reinforcement, and abdominal wall defects.

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

• Permacol™ Surgical Implant (K043366)
• Primatrix Ag (K100261)

Submission Summary (Full Text)

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K120605

# MAY 1 8 2012

### 510(k) Summary of Safety and Effectiveness

| SUBMITTER: | Covidien<br>15 Crosby Drive<br>Bedford, MA 01730 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | James McMahon<br>Manager, Regulatory Affairs<br>15 Crosby Drive<br>Bedford 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<br>(K100261) |
| DEVICE DESCRIPTION: | Permacol ^TM Surgical Implant is a sterile, off-white, moist, tough<br>and flexible, fibrous flat sheet of acellular porcine dermal<br>collagen and its constituent elastin fibers. Presented moist in<br>sterile saline, Permacol ^TM Surgical Implant is double vacuum<br>packed and heat sealed peel-open aluminum foil (inner) and<br>peel-open polyester/polyethylene (outer) pouches. |
| INDICATIONS: | Permacol ^TM Surgical Implant is intended for use as a soft<br>tissue implant to reinforce soft tissue where weakness exists<br>and for the surgical repair of damaged or ruptured soft tissue<br>membranes. It is specifically indicated for the repair of<br>abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical,<br>incisional,parastomal hernias and abdominal wall defects. |
| TECHNOLOGICAL<br>CHARACTERISTICS: | Permacol ^TM Surgical Implant is identical to the predicate<br>device, Permacol ^TM Surgical Implant, K043366, in terms of its<br>technological characteristics. |
| MATERIALS: | No material changes are proposed in this submission. |
| PERFORMANCE DATA: | No new performance data has been included in this<br>submission. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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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 [phone] or [phone] 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