PARIETEX PROGRIP

K103682 · Sofradim Production · FTL · Mar 4, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K103682
• Device Name: PARIETEX PROGRIP
• Applicant: Sofradim Production
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Mar 4, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Parietex Progrip™ mesh is indicated for inguinal and incisional hernia repair.

Device Story

Parietex Progrip™ Mesh (TEM2015G and TEM3015G) is a rectangular surgical mesh; composed of knitted monofilament polyester; features integrated resorbable polylactic acid (PLA) pins on one side. Pins facilitate mesh placement, positioning, and fixation to surrounding tissue during hernia repair. Device is used by surgeons in clinical settings for inguinal and incisional hernia repair. No electronic components, software, or algorithms involved.

Clinical Evidence

No clinical data; bench testing only. Performance data from the predicate device (K081050) is leveraged as materials and design are identical.

Technological Characteristics

Knitted monofilament polyester mesh with integrated monofilament polylactic acid (PLA) resorbable fixation pins. Biocompatible materials compliant with ISO 10993-1. Rectangular form factor. No energy source, software, or connectivity.

Indications for Use

Indicated for inguinal and incisional hernia repair in patients requiring surgical mesh.

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

• Parietex Progrip™ Mesh (K081050)

Submission Summary (Full Text)

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Special 510(k) – Parietex Progrip™: TEM2015G and TEM3015G references

## 510(k) Summary of Safety and Effectiveness

| SUBMITTER: | Sofradim Production<br>116, avenue du formans<br>01600 Trevoux, France<br>Phone: [phone] | MAR - 4 201 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT PERSON: | James McMahon<br>Manager, Regulatory Affairs<br>Covidien<br>15 Crosby Avenue<br>Bedford, MA 01730<br>Phone: [phone] | |
| DATE PREPARED: | December 16th, 2010 | |
| TRADE/PROPRIETARY NAME: | Parietex Progrip™ Mesh (TEM2015G and TEM3015G) | |
| COMMON/USUAL NAME: | Surgical Mesh | |
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric | |
| PREDICATE DEVICE(S): | Parietex Progrip™ Mesh (K081050) | |
| DEVICE DESCRIPTION: | Parietex Progrip™ TEM2015G and TEM3015G are rectangular<br>meshes made of knitted monofilament polyester with polylactic<br>acid (PLA) resorbable pins on one of the sides. The PLA pins<br>facilitate placement, positioning and fixation of the mesh to the<br>surrounding tissue. | |
| INDICATION: | Parietex Progrip™ mesh is indicated for inguinal and incisional<br>hernia repair. | |
| TECHNOLOGICAL<br>CHARACTERISTICS: | Parietex Progrip™ meshes are made with knitted monofilament<br>polyester and monofilament polylactic acid resorbable pins. The<br>intended use and fundamental technology of the two additional<br>sizes, of Parietex Progrip™ Mesh are equivalent to that of the<br>predicate Parietex Progrip™mesh. | |
| MATERIALS: | Parietex Progrip™ mesh is comprised of biocompatible materials<br>that are in compliance with ISO 10993-1 standard. | |
| PERFORMANCE DATA: | No additional bench testing has been conducted. The materials of<br>the new Parietex Progrip™ references are identical to the<br>predicate Parietex Progrip™ and therefore, the performance data<br>submitted in the predicate Parietex Progrip™ Traditional 510k<br>(K081050) applies to the two additional sizes. | |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The graphic is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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

Sofradim Production % Covidien Mr. James McMahon 15 Crosby Drive Bedford; Masschusetts 01730

MAR - 4 2011

Re: K103682

Trade/Device Name: Parietex ProGrip™ Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: February 15, 2011 Received: February 16, 2011

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 (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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Aling B. R.te
fa

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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Special 510(k) – Parietex Progrip™: TEM2015G and TEM3015G references P

## Indications For Use

K103682 510(k) Number (if known):

Parietex Progrip™ Mesh Device Name:

Indications For Use:

Parietex Progrip™ Mesh is indicated for inguinal and incisional hernia repair.

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)

Daniel Kromefh MXM

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

510(k) Number