Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh

K142900 · Sofradim Production · FTL · Oct 28, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K142900
• Device Name: Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
• Applicant: Sofradim Production
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Oct 28, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ProGrip™ Self-Gripping Polyester Mesh is intended for the reinforcement of tissue during surgical repair. Parietex™ Plug and Patch System is intended for the reinforcement of soft tissues during surgical repair. ProGrip™ Laparoscopic Self-Fixating Mesh is intended for the reinforcement of tissue during surgical repair.

Device Story

Surgical mesh systems for hernia repair; includes ProGrip™ Self-Gripping Polyester Mesh, Parietex™ Plug and Patch System, and ProGrip™ Laparoscopic Self-Fixating Mesh. Devices consist of knitted monofilament polyester mesh; some versions incorporate bioresorbable polylactic acid (PLA) pins/grips for tissue fixation or porcine-derived collagen film for handling. Used by surgeons in clinical settings for hernia reinforcement. PLA components degrade via hydrolysis into CO2 and H2O over at least 8 weeks. Submission addresses change in polyester raw material formulation from existing supplier. Devices function as permanent implants to reinforce soft tissue defects.

Clinical Evidence

Bench testing only. Performance characteristics evaluated per FDA Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh (1999). Biocompatibility testing performed per ISO 10993-1 for permanent implants. Stability studies confirmed shelf life.

Technological Characteristics

Knitted monofilament polyester mesh; bioresorbable polylactic acid (PLA) pins/grips; porcine-derived collagen/glycerol film (in laparoscopic version). Permanent implant. Biocompatibility per ISO 10993-1. No software or electronic components.

Indications for Use

Indicated for reinforcement of soft tissues during repair of inguinal, incisional, or groin hernia defects via open or laparoscopic approach.

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 (K103682)
• Parietex™ Plug and Patch (K101519)
• ProGrip™ Laparoscopic Self-Fixating Mesh (K123479)

Submission Summary (Full Text)

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

October 28, 2014

Sofradim Production % Ms. Mary Mellows Surgical Devices, a global business unit of Covidien 60 Middletown Avenue North Haven, Conneticut 06473

Re: K142900

Trade/Device Name: ProGrip™ Self-Gripping Polyester Mesh Parietex™ Plug and Patch System ProGrip™ Laparoscopic Self-Fixating Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: October 3, 2014 Received: October 6, 2014

Dear Ms. Mellows:

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 or any Federal statutes and regulations administered by other Federal agencies. You must

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K142900

Device Name Parietex TM Plug and Patch System

Indications for Use (Describe)

Parietex In Plug and Patch System is indicated for the reinforcement of soft tissues during repair of groin hernia defects by open approach

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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## Indications for Use

510(k) Number (if known) K142900

Device Name

ProGrip™ Laparoscopic Self-Fixating Mesh

Indications for Use (Describe)

ProGrip™ Laparoscopic Self-Fixating Mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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## Indications for Use

510(k) Number (if known) K142900

#### Device Name

ProGrip™ Self-Gripping Polyester Mesh

Indications for Use (Describe)

ProGrip™ Self-Gripping Polyester Mesh is indicated for inguinal and incisional hernias repair.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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### 510(k) Summary

| Submitter Information<br>Name: | Sofradim Production (subsidiary of Covidien LLC) |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Address: | 116, avenue du formans<br>01600 Trevoux, France |
| Phone number | [phone] |
| Fax number: | [phone] |
| Establishment Registration: | 9615742 |
| Name of contact person: | Mary Mellows<br>Senior Regulatory Specialist<br>60 Middletown Avenue<br>North Haven, CT 06473 |
| Phone: | 203-492-5284 |
| Date prepared: | October 3, 2014 |
| Name of device: | |
| Trade or proprietary name: | ProGrip™ Self-Gripping Polyester Mesh<br>Parietex™ Plug and Patch System<br>ProGrip™ Laparoscopic Self-Fixating Mesh |
| Common or usual name: | Surgical Mesh |
| Classification name: | Mesh, Surgical, Polymeric |
| Classification panel: | General and Plastic Surgery (79) |
| Regulation: | 21 CFR 878.3300 |
| Product Code: | FTI |

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Legally marketed devices to which equivalence is claimed:

ParietexTM Progrip™ Mesh (K103682) ParietexTM Pluq and Patch (K101519) Progrip™ Laparoscopic Self-Fixating Mesh (K123479)

Reason for 510(k) Submission:

> The purpose of this 510(k) is to notify the Agency of the addition of another formulation of raw material, polyester, from the yarn supplier who manufactures the monofilament yarns used in the proposed devices. Eventually the current polvester will no longer be available by the supplier.

#### Device description:

#### ProGrip™ Self-Gripping Polyester Mesh

The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polyester and have polylactic acid monofilament resorbable pins on one of the sides. These pins facilitate placing, positioning and fixation of the overlapping flap and the mesh to the surrounding tissue. A colored yarn marker on the medial edge of the pre-cut mesh helps orientation.

The monofilament polylactic acid pins are bioresorbable and contribute to the fixation of the mesh to surrounding tissue during at least 8 weeks. The polylactic acid pins degrade and resorb in vivo by hydrolysis and are metabolized by the body into CO and H2O.

#### Parietex™ Plug and Patch System

The Parietex™ Plug and Patch System is a kit composed of:

- . a pre-cut patch made from monofilament polyester
- . a semi-resorbable disk which is a bi-component made of polyester monofilament and polylactic acid.

#### ProGrip™ Laparoscopic Self-Fixating Mesh

The mesh is made of knitted monofilament polyester with monofilament polylactic acid resorbable grips on one side and a resorbable film made of collagen from porcine origin and glycerol, on the other side. The grips allow positioning and fixation of the mesh to the surrounding tissue, while the collagen film facilitates mesh handling and deployment. The mesh presents a green band (polyester dyed with D&C green no. 6) to facilitate their orientation.

The monofilament polylactic acid grips are bioresorbable and provide the fixation of the mesh to surrounding tissue for at least 8 weeks. The polylactic acid grips degrade and resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O.

#### Intended use of the device:

#### ProGrip™ Self-Gripping Polyester Mesh

ProGrip™ Self-Gripping Polyester Mesh is intended for the reinforcement of tissue during surqical repair.

No changes to the intended use have been made in this submission.

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#### Parietex™ Pluq and Patch System

Parietex™ Pluq and Patch System is intended for the reinforcement of soft tissues during surqical repair.

No changes to the intended use have been made in this submission.

#### ProGrip™ Laparoscopic Self-Fixating Mesh

ProGrip™ Laparoscopic Self-Fixating Mesh is intended for the reinforcement of tissue during surqical repair.

No changes to the intended use have been made in this submission.

#### Indications for use:

#### ProGrip™ Self-Gripping Polvester Mesh

ProGrip™ Self-Gripping Polyester Mesh is indicated for inguinal and incisional hernias repair.

No changes to the indication for use have been made in this submission.

#### Parietex™ Plug and Patch System

Parietex™ Plug and Patch System is indicated for the reinforcement of soft tissues during repair of groin hernia defects by open approach.

No changes to the indication for use have been made in this submission.

#### ProGrip™ Laparoscopic Self-Fixating Mesh

ProGrip™ Laparoscopic Self-Fixating Mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach. No changes to the indication for use have been made in this submission.

#### Summary comparing the technoloqical characteristics of the subject and predicate devices:

The proposed ProGrip™ Self-Gripping Polyester Mesh, Parietex™ Plug and Patch System and ProGrip™ Laparoscopic Self-Fixating Mesh manufactured with another formulation of raw material, polyester, from the same yarn supplier as the current polyester are equivalent to predicate Parietex™ Progrip™ Mesh (K103682), Parietex™ Plug and Patch (K101519) and Progrip™ Laparoscopic Self-Fixating Mesh (K123479) in terms of the following technological characteristics:

- -Indication
- Raw materials -
- -Performance characteristics
- -Biocompatibility
- Stability -
- -Design

Performance data: This change consists of the addition of another formulation of raw material, polyester, for the subject devices.

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Bench testing has been conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh issued March 2, 1999 to evaluate the performance characteristics of proposed devices.

Stability Studies have been conducted and the proposed devices shelf life has been demonstrated.

Biocompatibility studies have been conducted on the proposed polyester based devices in accordance with ISO 10993-1 for a permanent implant, a recognized standard by FDA (#2-156).

- Conclusion: Bench testing and preclinical tests results demonstrate that proposed devices are substantially equivalent to the predicates Parietex™ Progrip™ Mesh (K103682), Parietex™ Plug and Patch (K101519) and Progrip™ Laparoscopic Self-Fixating Mesh (K123479).