PELVIMESH / HERMESH 7

K070625 · Marketing Solutions, Inc. · FTL · Aug 1, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070625
• Device Name: PELVIMESH / HERMESH 7
• Applicant: Marketing Solutions, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Aug 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hermesh 7 monofilament polypropylene mesh may be used for repair of abdominal wall hernia, including inguinal, femoral, and incisional, in open or laparoscopic abdominal procedures. Hermesh 7 are prescriptive devices and should only be used by a licensed physician.

Device Story

Hermesh 7 is a non-absorbable, warp-knitted monofilament polypropylene surgical mesh. Designed for abdominal wall hernia repair (inguinal, femoral, incisional); used in open or laparoscopic procedures. Device provides strength, flexibility, and durability for internal body stresses; knitted construction allows cutting into preshaped designs without unraveling. Supplied sterile for single-use by licensed physicians. Clinical benefit derived from reinforcing tissue during hernia repair.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993), mutagenicity, cytotoxicity, hemolysis, sensitization, systemic toxicity, and sterilization validation (EO residuals <1ppm, ECH <2ppm, SAL 10^-8).

Technological Characteristics

Material: 100% non-absorbable monofilament polypropylene. Construction: Warp-knitted mesh. Properties: Isotropic, flexible, high strength. Sterilization: Ethylene Oxide. Form factor: Preshapeable surgical mesh.

Indications for Use

Indicated for patients requiring repair of abdominal wall hernias, including inguinal, femoral, and incisional, via open or laparoscopic abdominal procedures. Prescription use only.

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

• POPMESH (K053424)
• MINIMESH® (K041632)
• Herniamesh surgical meshes (K973955)
• BioBlanket (K043259)

Submission Summary (Full Text)

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K070625 Page 1/2

August 1, 2007

## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

Submitter: Herniamesh SRL Via Fratelli Meliga 1/C Chivasso, Italy Tel [phone] Fax [phone]

Contact: Lorena Trabucco 540 MUTTONTOWN EASTWOODS ROAD Syosset, NY 11791 Tel [phone] -- 516 584 6818 e-mail: [e-mail]

April 16, 2012

Date Prepared:

Classification: Polymeric Surgical Mesh (product code FTL) Class II device per 21 CFR 87.8.330

Acres Ad

Common Name: Polymeric Surgical Mesh

Proprietary Name: Hermesh 7

Predicate Devices: K053424 POPMESH (Caldera Medical Inc.) K041632 MINIMESH® (Mpathy Medical Devices LTD.) K973955 Herniamesh surgical meshes (Herniamesh Srl) K043259 BioBlanket (Kensey Nash)

Device Description: Hermesh 7 prosthesis are non- absorbable monofilament polypropylene meshes constructed from knitted monofilaments of extruded polypropylene.

> They are warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling. They maintain excellent isotropic properties because of its knitted construction.

Hermesh 7 polypropylene meshes have the necessary strength, flexibility, and durability for the various stresses which may be encountered in the body.

The devices are supplied as sterile, single-use surgical meshes.

Intended Use: May be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional in open or laparoscopic abdominal procedures.

> Hermesh 7 are prescriptive devices and should only be used by a licensed physician.

Hermesh 7 have the same indications as predicate devices.

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The patient contact materials used in these devices are the same as predicate Testing: devices. All are made of 100% Polypropylene and have similar technological characteristics. Please see Material Safety Data Sheet on page 85 and technological characteristics Comparison table on page 8.

Polypropylene has a long history of biocompatibility.

Hermesh 7 polypropylene meshes 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 Allergic Herniamesh T-Sling. Mutagenicity, Cytotoxicity, Hemolysis, the Sensitization, Systemic Toxicity, Ethylene Oxide Residual <1ppm, Sterility Assurance level 10-8, and Ethylene Chlorohydrin Level <2ppm. Please refer to pages 11 and 14-80 for details of tests.

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

Marketing Solutions, Incorporated/Herniamesh SRL % Ms. Lorena Trabucco 540 Muttontown Eastwoods Road Syosset, New York 11791

JUL 12 2012

Re: K070625

Trade/Device Name: Hermesh 7 Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: July 25, 2007 Received: July 27, 2007

Dear Ms. Trabucco:

This letter corrects our substantially equivalent letter of August 1, 2007.

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 (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 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

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## 2 - Ms. Lorena Trabucco

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/Resourcesfor You/Industry/default.htm.

Sincerely,

Mark Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Form

510(k) Number (if known) K070625

Device Name: Hermesh 7

Indications For Use:

Hermesh 7 monofilament polypropylene mesh may be used for repair of abdominal wall hernia, including inguinal, femoral, and incisional, in open or laparoscopic abdominal procedures.

Prescription Use__x

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Daniel Krome by MM
(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K070625

HERNIAMESH SRL Sede legale Via Fratelli Meliga 1/C - 10034 Chivasso (TO) Cap. Soc. € 98.800 I.v. - P.I. 02791540616 - C. F. 02245180613 - N. Iscrizione Rea Torino TO-860622 Tel. [phone] - fax [phone] Mall: [e-mail] - Mail certificata: [e-mail] - Sito internet www.hemiamesh.com