RELIMESH

K081327 · Herniamesh S.R.L. · FTL · Jun 19, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081327
• Device Name: RELIMESH
• Applicant: Herniamesh S.R.L.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jun 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Relimesh prostheses are intended for use in the reconstruction of soft tissue deficiencies, such as but not limited to the repair of hernias and chest wall defects. Relimesh is a prescriptive device and should only be used by a licensed physician.

Device Story

Relimesh is a sterile, single-use surgical mesh for soft tissue reconstruction; composed of dual-layer non-absorbable monofilament polypropylene and ePTFE. Warp-knitted construction allows cutting into preshaped designs without unraveling; ePTFE layer heat-sealed to polypropylene. Used by physicians in surgical settings to repair hernias and chest wall defects. Provides strength, flexibility, and durability for body stresses; ePTFE side intended to reduce incidence of adhesions/tissue complications. Device is implanted during surgery; provides structural support for tissue healing.

Clinical Evidence

Bench testing only. Testing included biocompatibility (mutagenicity, cytotoxicity, hemolysis, allergic sensitization, systemic toxicity), sterility (SAL 10-6), and chemical residuals (EtO <1 ppm, Ethylene Chlorohydrin <2 ppm). Mechanical performance testing included suture retention (24.60 N), burst strength (378 Kpa), and tensile strength (24 N/cm).

Technological Characteristics

Dual-component surgical mesh; 100% polypropylene and ePTFE. Warp-knitted structure; 0.5 mm thickness; 86.8% porosity. Sterilized via Ethylene Oxide (EtO). Complies with ISO 10993 for biocompatibility. Mechanical properties: 24.60 N suture retention, 378 Kpa burst strength, 24 N/cm tensile strength.

Indications for Use

Indicated for reconstruction of soft tissue deficiencies, including hernia repairs and chest wall defects in patients requiring surgical intervention.

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

• Composite Mesh (K971745)
• Hermesh 7 (K070625)

Submission Summary (Full Text)

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K08/327
Page 1 of 4

# JUN 1 9 2008

# New 510 (k) Notification for Herniamesh Relimesh

# 510(K) SUMMARY OF SAFETY & EFFECTIVENESS

| Submitter: | Herniamesh SRL<br>Via Fratelli Meliga 1/C<br>Chivasso, Italy<br>Tel [phone] Fax [phone] |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Lorena Trabucco<br>8 Orange Dr.<br>Jericho, NY 11753<br>Tel [phone] Fax [phone] |
| Device Name: | Relimesh |
| Predicate Devices: | K971745 Composite Mesh (C.R. Bard Inc.)<br>K070625 Hermesh 7 (Herniamesh Srl) |
| Device Description: | Relimesh prostheses are dual component meshes made of non-absorbable<br>monofilament polypropylene mesh on one side and a layer of ePTFE on<br>the other side. |
| | Relimesh is warp knitted in such a way that the mesh may be cut into<br>preshaped designs without unraveling and will maintain excellent<br>isotropic properties because of its knitted construction. The ePTFE layer<br>is heat sealed to the polypropylene layer |
| | These meshes have the necessary strength, flexibility, and durability for<br>the various stresses which may be encountered in the body. |
| | The devices are supplied as sterile, single-use surgical meshes. |
| Intended Use: | Relimesh prostheses are intended for use in the reconstruction of soft<br>tissue deficiencies, such as but not limited to the repair of hernias and<br>chest wall defects |
| | Relimesh is a prescriptive device and should only be used by a licensed<br>physician. |

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K08/327
page 2 of 4

#### New 510 (k) Notification for Herniamesh Relimesh

#### 510(K) SUMMARY OF SAFETY & EFFECTIVENESS Cont.

The patient contact materials used in these devices are the same as predicate Testing: devices. All are made of 100% Polypropylene with and without ePTFE. They have similar technological characteristics. Polypropylene and ePTFE have a long history of biocompatibility. Relimesh prostheses comply with the requirements of ISO 10993 Biological Evaluation of Medical Devices, In addition appropriate tests have been conducted in accordance with the FDA Guidance Document "Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh" The following tests were performed to show the safety, efficacy and performance of the product. Mutagenicity, Cytotoxicity, Hemolysis, Allergic Sensitization, Systemic Toxicity, Ethylene Oxide Residual <1 ppm, Sterility Assurance level 10-6, and Ethylene Chlorohydrin Level <2ppm. Please refer specific tests for more details. Summary of Similarities Relimesh and the predicate devices have the same intended use, which is for & Differences: the reconstruction of soft tissue deficiencies. The technological characteristics are the same or similar to the predicate devices in that the materials used to manufacture theses products are similar; polypropylene and ePTFE. The differences to predicate devices include mesh thickness, the shape, mesh knit structure, diameter of the filament used to weave the mesh and the thickness of the ePTFE layer. Please refer to charts on following page for specific details.

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K081327
page 3 of 4

### New 510 (k) Notification for Herniamesh Relimesh

# 510(K) SUMMARY OF SAFETY & EFFECTIVENESS Cont.

| Product | Mesh<br>Weight<br>g / sq. m | Filament<br>Diameter μ | Thickness<br>Mesh mm | Material | % Porosity | Sizes<br>Cm |
|------------------------------------------------|-----------------------------|------------------------|----------------------|--------------------------|------------|---------------------------------------------------|
| Relimesh<br>Herniamesh SRL | 78 ± 6% | 120 | 0.5 ± 10% | Polypropylene<br>& ePTFE | 86.8 | flat sheets<br>of various<br>sizes &<br>preshapes |
| Hermesh 7<br>Herniamesh SRL<br>(K070625) | 19 | 80 | 0.27 mm | 100 %<br>Polypropylene | 91.9 | flat sheets<br>of various<br>sizes &<br>preshapes |
| Composite Mesh<br>C.R. Bard Inc.<br>(K 971745) | 214 | 160 | 1.5 mm | Polypropylene<br>& ePTFE | 83 | flat sheets<br>of various<br>sizes &<br>preshapes |

Technological Characteristics Comparison Table

| Product | Suture Retention<br>N | Burst strength<br>Kpa | Tensile strength<br>N/cm |
|-------------------------------------------------|-----------------------|-----------------------|--------------------------|
| Relimesh<br>Herniamesh SRL | 24.60 | 378 | $24 \pm 6$ |
| Hermesh 7<br>Herniamesh SRL<br>(K070625) | 8.75 | 359 | 17.7 |
| Composite Mesh<br>C.R. Bard Inc.<br>( K 971745) | $26 \pm 7.56$ | $1316 \pm 3.8$ | N/A |

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K081327
perr +074

### New 510 (k) Notification for Herniamesh Relimesh

## 510(K) SUMMARY OF SAFETY & EFFECTIVENESS Cont.

#### Table of Similarities and Differences / Substantial Equivalence to Predicate Devices

| Feature | Herniamesh<br>Relimesh | Bard<br>Composix EX Mesh | Herniamesh<br>Hermesh 7 |
|---------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| 510(k) No. | To be determined | K971745 | K070625 |
| Classification | Class II: Polymeric<br>Surgical Mesh | Class II: Polymeric<br>Surgical Mesh | Class II: Polymeric<br>Surgical Mesh |
| Indication | mesh used for the<br>reconstruction of soft<br>tissue deficiencies | mesh used for the<br>reconstruction of soft<br>tissue deficiencies | mesh used for the<br>reconstruction of soft<br>tissue deficiencies |
| Product<br>Design | monofilament<br>polypropylene / ePTFE | monofilament<br>polypropylene / ePTFE | Polypropylene |
| Materials | Polypropylene / ePTFE | Polypropylene / ePTFE | Polypropylene |
| Sterilization | EtO | EtO | EtO |
| Packaging | Double tyvek pouch | Double tyvek pouch | Double tyvek pouch |
| Tissue In<br>growth | Complete tissue<br>incorporation of<br>implant, ePTFE side<br>reduces incidence of | Complete tissue<br>incorporation of implant,<br>ePTFE side reduces<br>incidence of | Complete tissue<br>incorporation of implant |

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2008

Herniamesh S.R.L. % Marketing Solutions Inc. Ms. Lorena Trabucco 8 Orange Drive Jericho, New York 11753

Re: K081327

Trade/Device Name: Relimesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: June 3, 2008 Received: June 5, 2008

Dear Ms. Trabucco:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Page 2 - Ms. Lorena Trabucco

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K081327

.

Device Name: Relimesh

Indications For Use:

Relimesh prostheses are intended for use in the reconstruction of soft tissue deficiencies such as but not limited to hernia repairs and chest wall defects.

Prescription Use X (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)

Milne QL. Forman

(Divisi Division of General, Restorative, and Neurological Devices

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510(k) Number K081327

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