MODIFICATION TO: MINIMESH POLYPROPYLENE MESH

K053361 · Mpathy Medical Devices, Ltd. · OTO · Feb 6, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053361
• Device Name: MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
• Applicant: Mpathy Medical Devices, Ltd.
• Product Code: OTO · General, Plastic Surgery
• Decision Date: Feb 6, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Minimesh® polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, uterological prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

Device Story

Minimesh® is a non-absorbable surgical mesh composed of knitted monofilaments of extruded polypropylene. Designed for surgical repair of hernias and fascial deficiencies; warp-knit construction allows cutting to desired shape/size without unraveling. Provides strength, flexibility, and durability to support body tissues under stress. Used by surgeons in clinical settings during open, laparoscopic, or vaginal procedures. Supplied sterile; intended to provide permanent structural support to damaged or weakened fascial tissue.

Clinical Evidence

Bench testing only. Accelerated and real-time stability studies support a three-year expiration date.

Technological Characteristics

Non-absorbable surgical mesh; material: extruded polypropylene monofilaments; construction: warp-knit; form factor: cut-to-size mesh; sterilization: sterile.

Indications for Use

Indicated for patients requiring surgical repair of abdominal wall hernias (inguinal, femoral, incisional), uterological prolapse, or other fascial deficiencies requiring support material. Suitable for open or laparoscopic abdominal procedures or vaginal route 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

• Minimesh® polypropylene mesh (K041632)

Submission Summary (Full Text)

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K053361
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FEB 6 2006

MPATHY MEDICAL DEVICE:5 L. D. SPECIAL 5 : O(K) 05 336 1 : Modificiation

## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

| SUBMITTER | Mpathy Medical Devices, Ltd.<br>6.05 Kelvin Campus<br>West of Scotland Science Park<br>Glasgow G20 OSP<br>U.K. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Louis J. Mazzarese<br>(U.S. Agent for Mpathy Medical Devices Ltd.) |
| DATE PREPARED | January 30, 2006 |
| CLASSIFICATION | Polymeric Surgical Mesh (Product Code OTO) is a Class II device<br>per 21 CFR 878.3300 |
| COMMON NAME | Polymeric Surgical Mesh |
| PROPRIETARY NAME | Minimesh® polypropylene mesh |
| PREDICATE DEVICES | K041632 Minimesh® polypropylene mesh |
| DEVICE DESCRIPTION | Minimesh® is a non-absorbable polypropylene mesh constructed<br>from knitted monofilaments of extruded polypropylene. |
| | Minimesh® polypropylene mesh is constructed using a warp-knit<br>process to a unique design that permits the mesh to be cut into any<br>desired shape or size without unraveling. |
| | Minimesh® polypropylene mesh has the necessary strength,<br>flexibility, durability and surgical adaptability. These properties<br>permit the correct adaptation to the various stresses encountered in<br>the body. |
| | The device is supplied sterile. |
| INDICATIONS FOR USE | Minimesh® polypropylene mesh may be used for the repair of<br>abdominal wall hernia, including inguinal, femoral, and incisional,<br>uterological prolapse and other fascial deficiencies that require<br>support material. It may be used in open or laparoscopic<br>abdominal procedures or for repair by the vaginal route. |

Replacement Page 16 of 18 January 30, 2006

MINIME SHO®

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K053361
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MPATHY MEDICAL DEVICES I... D SPECIAL 5 1 O(K) 05:3361 : Modification

## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS (Cont'd.)

TESTING

Accelerated and real time stability studies have been conducted and support use of a three year expiration date for the product. The results of these studies demonstrate that Minimesh® polypropylene mesh, when stored under the conditions specified in the product labeling, can be used safely and effectively throughout this dating period (see Addendum A).

> Additional Page 16A of 18 January 30, 2006

MINIME SHI®

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

Mpathy Medical Devices Ltd. % Mr. Louis J. Mazzarese Designated U.S. Agent 150 Aran Hill Road FAIRFIELD CT 06824

SEP 2 8 2012

K053361 Re: Trade/Device Name: Minimesh® polypropylene mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO, OTP Dated: January 5, 2006 Received: January 10, 2006

Dear Mr. Mazzarese:

This letter corrects our substantially equivalent letter of February 6, 2006.

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 Federal agencies. You must

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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" (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 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 yours,

Sincerely yours,

Benjamin R. Perkins

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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MPATHY MEDICAL. DEVICES LTD. SPECIAL 510(K): MODIFICATION

## Indications for Use

210(k) Number: ان جي جي جي جي

Device Name: Mpathy Medical Devices Ltd Minimesh® polypropylene mesh

Indications for Use:

MINIMESH® polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, uterological prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

| Prescription Use | X |
|-----------------------------|---|
| (Part 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 OF NEEDED)

| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K053361 |

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MINIMESH®

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