PROGRIP LAPAROSCOPIC SELF-FIXATING MESH

K123479 · Sofradim Production · FTL · Dec 11, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K123479
• Device Name: PROGRIP LAPAROSCOPIC SELF-FIXATING MESH
• Applicant: Sofradim Production
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Dec 11, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PROGRIP™ Laparoscopic Self-Fixating Mesh is used for the reinforcement of tissues during surgical repair.

Device Story

PROGRIP™ Laparoscopic Self-Fixating Mesh is a surgical mesh used for soft tissue reinforcement during laparoscopic inguinal hernia repair. Device consists of a knitted monofilament polyester base with resorbable polylactic acid (PLA) grips on one side and a resorbable porcine collagen/glycerol film on the other. Grips facilitate mesh positioning and fixation to surrounding tissue; collagen film aids handling and deployment. Green band provides orientation. Device is used by surgeons in clinical settings. No changes to fundamental technology or intended use were made in this submission; the notification specifically addresses a modification to final product specifications regarding extractible pH limits, supported by existing gripping point testing.

Clinical Evidence

No clinical data. Bench testing only; performance confirmed via existing gripping point test specifications.

Technological Characteristics

Knitted monofilament polyester mesh; resorbable polylactic acid (PLA) grips; resorbable porcine collagen and glycerol film. Anatomical and rectangular shapes. Green orientation band. No electronic components or software.

Indications for Use

Indicated for reinforcement of soft tissues during laparoscopic repair of inguinal hernia 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

• PROGRIP™ Laparoscopic Self-Fixating Mesh (K120897)

Submission Summary (Full Text)

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PROGRIP™ Laparoscopic Self-fixating Mesh

#### Covidien

# DEC 1 1 2012

# 、510(K) SUMMARY

This 510(k) summary of information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.98.

### Submitter Information .

| Name: | Sofradim Production |
|-----------------------------|------------------------------------------|
| Address: | 116, avenue du formans |
| | 01600 Trevoux, |
| | France |
| Phone number | [phone] |
| Fax number: | [phone] |
| Establishment Registration: | 9615742 |
| Name of contact person: | James McMahon (US Agent) |
| | Associate Director, Regulatory Affairs |
| | Covidien |
| | 15 Hampshire Street |
| | Mansfield, MA 02048 USA |
| | Phone: [phone] |
| Date prepared: | December 4, 2012 |
| Name of device | |
| Trade or proprietary name: | 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: | FTL |

Page 1 of 3

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Covidien

PROGRIP™ Laparoscopic Self-fixating Mesh

#### Legally marketed devices to

which equivalence is claimed: PROGRIP™ Laparoscopic Self-Fixating Mesh (K120897)

## Reason for 510(k) Submission:

To propose the removal of a final product specification (lower specification of extractible pH). This change is supported by a final product specification (gripping points test). The combination of the upper extractible pH and the lot release final product specification (gripping point test) ensure the product effectiveness for intended use. This change does not impact the intended use and does not alter the fundamental scientific technology of the device.

#### Device description:

The PROGRIP™ Laparoscopic Self-Fixating Mesh is available in anatomical and rectangular shapes.

The mesh is made of knitted monofilament polyester with monofilament polylactic acid resorbable grips on one side and a resorbable collagen film on the other side. The film is made up of collagen from porcine origin and glycerol. The grips allow positioning and fixation of mesh to the surrounding tissue, while the collagen film facilitates mesh handling and deployment. The mesh presents a green band that facilitates mesh orientation No changes to product have been made in this submission.

Intended use of the device:

The PROGRIP™ Laparoscopic Self-Fixating Mesh is used for the reinforcement of tissues during surgical repair. No changes to the intended use have been made in this submission

#### Indications for use:

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

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K123479

#### Covidien

PROGRIP™ Laparoscopic Self-fixating Mesh

#### Summary comparing the technological characteristics

of the subject and predicate

devices:

The subject PROGRIP™ Laparoscopic Self-Fixating Mesh is identical to the predicate device PROGRIP™ Laparoscopic Self-Fixating Mesh (K120897) in terms of its physical, technological characteristics and performance characteristics.

and predicate (K120897) PROGRIP™ proposed The Laparoscopic Self-Fixating Mesh is a monofilament polyester knit with monofilament polylactic acid resorbable grips on one of the sides. The grips allow positioning and fixation of the mesh to surrounding tissue.

#### Performance data:

The removal of the collagen film lower specification of extractible pH, as a final product specification, does not affect the product performance. The combination of the upper extractible pH and the lot release final product specification (gripping point test) ensure the product effectiveness for intended use.

The change in specification does not alter the performance specifications of the PROGRIP™ Laparoscopic Self-Fixating Mesh (K120897) and does not require additional performance data.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the symbol in a circular fashion. The logo is black and white.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Sofradim Production % Covidien LLC, Soft Tissue Implants Mr. James McMahon Associate Director, Regulatory Affairs 15 Crosby Drive Bedford, Massachusetts 01730

December 11, 2012

Re: K123479

Trade/Device Name: PROGRIP™ Laparoscopic Self-Fixating Mesh

· Regulation Number: 21 CFR 878.3300

Regulation Name: Surgical mesh

Regulatory Class: II Product Code: FTL Dated: November 09, 2012 Received: November 19, 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 (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 vours.

# Peter D. Rumm -S

- Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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# INDICATION FOR USE STATEMENT

510(k) Number (if known):

# Device Name: PROGRIP™ Laparoscopic Self-Fixating Mesh

#### Indications for Use:

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

Prescription Use_ X (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 Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123479