PROLENE Soft Polypropylene Mesh

K172089 · ETHICON, Inc. · FTL · Oct 5, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K172089
• Device Name: PROLENE Soft Polypropylene Mesh
• Applicant: ETHICON, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Oct 5, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PROLENE™ Soft Mesh is indicated for the repair of abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

Device Story

PROLENE Soft Polypropylene Mesh is a sterile, nonabsorbable synthetic surgical mesh; composed of knitted filaments of extruded polypropylene; features blue monofilament contrast striping. Designed for abdominal wall hernia and deficiency repair; provides reinforcement to surgical site. Knitted construction interlinks fiber junctions; allows cutting into desired shapes without unraveling; provides bidirectional elasticity. Approximately 50% more flexible than standard PROLENE Mesh. Used by surgeons in clinical settings. Implanted to provide permanent structural support to abdominal wall; polypropylene material is non-reactive and retains strength indefinitely.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical technological characteristics and materials to legally marketed predicate devices.

Technological Characteristics

Sterile, nonabsorbable synthetic surgical mesh; material: extruded polypropylene monofilaments; construction: knitted with interlinked fiber junctions; features blue polypropylene monofilament contrast striping; provides bidirectional elasticity; cut-to-size without unraveling; 50% more flexible than standard PROLENE mesh.

Indications for Use

Indicated for patients requiring repair of abdominal wall hernias and deficiencies needing reinforcing material.

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

• PROLENE™ Soft Polypropylene Mesh (K163152)
• PROLENE™ Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh (K001122)

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 5, 2017

Ethicon Incorporated Ms. Stephanie Saati Senior Regulatory Affairs Specialist Route 22 West, P.O. Box 151 Somerville, New Jersey 08876-0151

Re: K172089

Trade/Device Name: PROLENE Soft Polypropylene Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: July 10, 2017 Received: July 11, 2017

Dear Ms. Saati:

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 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 devicerelated 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.

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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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

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

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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely.

# 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) K172089

Device Name PROLENE™ Soft Polypropylene Mesh

Indications for Use (Describe)

PROLENE™ Soft Mesh is indicated for the repair of abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

| 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)

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100540783 | Rev. 1 K172089 page 1 of 3

# HICON a John huson company

## 510(k) Summary

| Submitter: | Ethicon, Inc. a Johnson & Johnson company<br>P.O. Box 151<br>Route 22 West<br>Somerville, NJ 08876-0151 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephanie Saati<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | June 30, 2017 |
| Device Trade Name: | PROLENE™ Soft Polypropylene Mesh |
| Device Common Name: | PROLENE Soft Mesh |
| Class: | Class II |
| Classification: | 21 CFR 878.3300 – Surgical Mesh |
| Product Code: | FTI |

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| Device | Company | Product Code | 510(k) Number | Predicate for |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------|---------------|---------------------------------------------------------------------------------------------------------------------------|
| PROLENE™ Soft<br>Polypropylene<br>Mesh<br>Product Code:<br>SPM3XL | Ethicon, Inc. | FTL | K163152 | Fundamental Scientific<br>Technology, Design,<br>Intended Use, Materials,<br>Construction, Performance<br>Characteristics |
| PROLENE™ Soft<br>(Polypropylene),<br>Nonabsorbabale<br>Synthetic<br>Surgical Mesh<br>Product Codes:<br>SPMH<br>SPMII<br>SPMLI<br>SPMS<br>SPMXS<br>SPMXXL | Ethicon, Inc. | FTL | K001122 | Fundamental Scientific<br>Technology, Design,<br>Intended Use, Materials,<br>Construction, Performance<br>Characteristics |

### Predicate Device:

#### Device Description:

PROLENE™ Soft Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of abdominal wall hernias and abdominal wall deficiencies. The implant device is composed of knitted filaments of extruded polypropylene. Blue PROLENE™ monofilaments have been integrated to produce contrast striping in the mesh.

PROLENE™ Soft Mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE™ Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). Blue PROLENE™ monofilaments have been incorporated to produce contrast striping in the mesh. The mesh is constructed of reduced diameter monofilament fibers, knitted into a unique design that results in a mesh that is approximately 50 percent more flexible than standard PROLENE™ Mesh. Polypropylene material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use.

PROLENE™ Soft Mesh is knitted by a process which interlinks each fiber junction and which provides for elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling.

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#### Indications for Use:

PROLENE™ Soft Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

#### Summary of Technological Characteristics:

PROLENE™ Soft Polypropylene Mesh is identical to the PROLENE™ Soft Polypropylene Mesh (K163152) and PROLENE™ Soft (Polypropylene). Nonabsorbabale Synthetic Surgical Mesh (K001122) marketed mesh with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices differ only in the labeling (Instructions for Use) which has been revised to add a new Contraindication. Additionally, several other sections of the Instructions for Use of the subject device have been reworded reformatted for clarity to address evolving regulatory expectations and bring the contents of the Instructions for Use up to date.

#### Substantial Equivalence:

PROLENE™ Soft Polypropylene Mesh is identical to the PROLENE™ Soft Polypropylene Mesh (K163152) and PROLENE™ Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh (K001122) marketed mesh with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices differ only in the labeling (Instructions for Use) which has been revised to add a new Contraindication. Additionally, several other sections of the Instructions for Use of the subject device have been reworded reformatted for clarity to address evolving regulatory expectations and bring the contents of the Instructions for Use up to date. The Indication statement of the subject mesh has been modified to add clarity. The Indication of the subject device does not introduce any new indications or expand patient population of the predicate mesh.

#### Conclusion:

The subject mesh, PROLENE™ Soft Polypropylene Mesh is identical to the two predicate marketed meshes, PROLENE™ Soft Polypropylene Mesh (K163152) and PROLENE™ Soft (Polypropylene). Nonabsorbabale Synthetic Surgical Mesh (K001122) with respect to intended use, technological characteristics, material, construction, specification, manufacturing and sterilization. In conclusion, the subject PROLENE™ Soft Polypropylene Mesh is substantially equivalent to the two predicate meshes.