Parietene Macroporous Mesh

K223218 · Sofradim Production · FTL · Dec 2, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K223218
• Device Name: Parietene Macroporous Mesh
• Applicant: Sofradim Production
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Dec 2, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Parietene™ Macroporous Mesh is intended for the reinforcement of soft tissue where weakness exists during surgical repair.

Device Story

Parietene™ Macroporous Mesh is a non-absorbable, synthetic, bi-dimensional monofilament polypropylene textile mesh. Used for reinforcement of soft tissue during hernia or fascial deficiency repair; applicable for both open and laparoscopic surgical approaches. Provided as flat sheets or pre-cut shapes to facilitate tension-free inguinal hernia repair. Single-use device; supplied sterile in single or multi-unit packaging. Implanted by surgeons during surgical procedures to provide structural support to weakened tissue. Benefits include reinforcement of fascial defects, aiding in successful hernia repair.

Clinical Evidence

Bench testing only. In vitro testing performed to evaluate trocar compatibility for laparoscopic use. Results met acceptance criteria. Sterility, shelf-life, stability, and biocompatibility data were leveraged from the predicate device.

Technological Characteristics

Non-absorbable synthetic surgical mesh; bi-dimensional monofilament polypropylene textile. Form factor: flat sheet or pre-cut. Single-use. Sterile. No changes to materials or manufacturing processes compared to predicate.

Indications for Use

Indicated for the repair of hernias or other fascial deficiencies requiring reinforcing material in patients undergoing surgical repair.

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

• Parietene™ Macroporous Mesh (K142091)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

12/02/2022

Sofradim Production % Wing Ng Regulatory Affairs Senior Director Covidien 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K223218

Trade/Device Name: Parietene™ Macroporous Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: October 13, 2022 Received: October 17, 2022

Dear Wing Ng:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 comply with all the Act's

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Deborah A. Fellhauer -S

Deborah Fellhauer RN. BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K223218

#### Device Name Parietene™ Macroporous Mesh

Indications for Use (Describe)

Parietene™ macroporous mesh is intended for the repair of hemias or other fascial deficiencies that require the addition of a reinforcing material.

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

X 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 PRAStaff(@fda.hhs.gov

"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."

{3}------------------------------------------------

# 510(k) Summary

| Date Prepared: | November 30, 2022 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Sofradim Production (subsidiary of Covidien IIc)<br>116, avenue du Formans<br>01600 Trevoux, France<br>Telephone: [phone]<br>Fax: [phone] |
| Contact: | Jhony Mallet<br>Regulatory Affairs Senior Specialist<br>116, avenue du Formans<br>01600 Trevoux, France<br>Phone: [phone]<br>Email: [e-mail] |
| Name of device: | |
| Trade/Proprietary name: | Parietene™ Macroporous Mesh |
| Common name: | Surgical Mesh |
| Classification name: | Mesh, Surgical, Polymeric |
| Panel: | General and Plastic Surgery (79) |
| Product code: | FTL |
| Regulation number: | 21 CFR 878.3300 |
| Predicate Device: | |
| Trade/Proprietary name: | Parietene™ Macroporous Mesh (K142091) |
| Common name: | Surgical Mesh |
| Classification name: | Mesh, Surgical, Polymeric |
| Panel: | General and Plastic Surgery (79) |
| Product code: | FTL |
| Regulation number: | 21 CFR 878.3300 |
| 510(k) Number: | K142091 |
| Manufacturer: | Sofradim Production (subsidiary of Covidien IIc)<br>116, avenue du Formans<br>01600 Trevoux, France |
| Device Description: | The Parietene™ Macroporous Mesh is a non-absorbable synthetic<br>surgical mesh made of bi-dimensional monofilament polypropylene<br>textile. The Parietene™ Macroporous mesh is offered in a flat sheet<br>and pre-cut mesh. The pre-cut mesh facilitates the repair of inguinal<br>hernias via the anterior approach using a tension free technique. |

{4}------------------------------------------------

Parietene™ Macroporous Mesh is a single use device, presented sterile and unitary packaged in a single pouch and provided in a commercial box or sleeve with the labels and instructions for use. The device can be packaged in single pack (1 unit per sleeve) or multipack (3 or 6 units per box).

Intended Use: Parietene™ Macroporous Mesh is intended for the reinforcement of soft tissue where weakness exists during surgical repair.

Indications for use: Parietene™ Macroporous Mesh is indicated for the repair of hernias or other fascial deficiencies that require the addition of a reinforcing material.

Parietene™ Macroporous Mesh was initially designed to be used via Summary comparing the open or laparoscopic approach. In order to provide the user with technological information related to trocar compatibility during laparoscopic characteristics of the surgeries of the Parietene™ Macroporous Mesh (K142091), predicate subject and modifications of the IFU are proposed. It includes minor changes to the device: IFU which are implemented since clearance of K142091 but did not exceed the threshold for a new 510(k). These modifications have no impact on the substantially equivalence between the subject device and the predicate device in terms of indications and design for the following technological characteristics:

- Indications ●
- Design
- Raw materials
- Packaging
- Biocompatibility
- Stability
- Sterilization

Performance data: The following performance data is provided in support of the substantial equivalence determination:

> In vitro (bench) tests have been performed to evaluate the trocar compatibility of Parietene™ Macroporous Mesh. The results demonstrate that the subject device successfully met the established acceptance criteria and is substantially equivalent to the predicate device.

> Sterility, shelf-life/stability, biocompatibility end points, and other performance testing data are leveraged from the predicate device since there is no change in the materials and manufacturing processes except in the instructions for use.

{5}------------------------------------------------

Conclusion: Covidien believes that the subject device is substantially equivalent to the predicate device Parietene™ Macroporous Mesh (K142091).