RESTORELLE POLYPROPYLENE MESH

K092207 · Mpathy Medical Devices, Inc. · OTP · Aug 4, 2009 · Obstetrics/Gynecology

Device Facts

Record IDK092207
Device NameRESTORELLE POLYPROPYLENE MESH
ApplicantMpathy Medical Devices, Inc.
Product CodeOTP · Obstetrics/Gynecology
Decision DateAug 4, 2009
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 884.5980
Device ClassClass 3
AttributesTherapeutic

Intended Use

RESTORELLE™ polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal 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. RESTORELLE™ polypropylene mesh is a prescriptive device and should only be used by a licensed physician.

Device Story

Restorelle is a non-absorbable, warp-knitted polypropylene mesh; designed for surgical repair of abdominal wall hernias and uterovaginal prolapse. Device provides structural support to fascial deficiencies; permits cutting into custom shapes/sizes without unraveling; maintains isotropic properties. Supplied sterile for use by licensed physicians in open, laparoscopic, or vaginal surgical procedures. Acts as permanent reinforcement material to withstand physiological stresses.

Clinical Evidence

Bench testing only. Biocompatibility and mechanical testing performed to demonstrate substantial equivalence to predicate Minimesh device.

Technological Characteristics

Non-absorbable polypropylene mesh; warp-knitted monofilament construction; isotropic properties; supplied sterile.

Indications for Use

Indicated for patients requiring surgical repair of abdominal wall hernias (inguinal, femoral, incisional), uterovaginal prolapse, or other fascial deficiencies requiring support material. For use by licensed physicians in open, laparoscopic, or vaginal procedures.

Regulatory Classification

Identification

Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K09 2207 page 1 of 2 AUG 0 4 2009 MPATHY MEDICAL DEVICES, LED. RESTORELLE POLYPROFYLENE MESH SPECIAL 510(K) NOTIFICATION ### 15. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS SUBMITTER Ms Melissa Peloquin Director of Office Administration Mpathy Medical Devices Inc. 175 Paramount Drive Raynham, MA 02767 CONTACT PERSON Dr Caroline Stretton Quality & Regulatory Affairs Director Mpathy Medical Devices, Ltd. 208 Wright Business Centre Lonmay Road Glasgow G33 4EL (United Kingdom) DATE PREPARED 15 July 2009 CLASSIFICATION Polymeric Surgical Mesh (Product Code OTP, is a Class II device per 21 CFR 878.3300 COMMON NAME Polymeric Surgical Mesh Restorelle™ polypropylene mesh PROPRIETARY NAME PREDICATE DEVICE - . K041632 & K053361 - Minimesh (Mpathy Medical Ltd) - K010931 Straight In sacral colpopexy mesh . (American Medical Systems) - K071512 Gynecare Prolift (Ethicon) . DEVICE DESCRIPTION Restorelle™ is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene. Restorelle™ polypropylene mesh is constructed using a warp-knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling. It maintains excellent isotropic properties arising from its knitted construction. Restorelle™ polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability PAGE 34 OF 56 {1}------------------------------------------------ K09 2207 page 2 of 2 # MPATITY MEDICAL DEVICES, LTD. RESTORELLE POLYPROPYLENE MESH SPECIAL 510(K) NOTIFICATION properties which permit the correct adaptation to the various stresses encountered in the body. The device is supplied sterile. INDICATIONS Restorelle™ polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal 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. Restorelle™ polypropylene mesh is a prescriptive device and should only be used by a licensed physician. Restorelle™ polypropylene mesh has the same indications as a combination of the predicate devices. TESTING The components of the Restorelle™ device have been subjected to biocompatibility and mechanical testing and are substantially equivalent to the predicate Minimesh device (K041632 & K053361). TECHNOLOGICAL Restorelle™ polypropylene mesh has the same CHARACTERISTICS use, general design, material intended and fundamental scientific technology as the predicate Restorelle™ polypropylene mesh device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mpathy Medical Devices Ltd. % Mpathy Medical Devices, Inc. Ms. Melissa Peloquin Director of Office Administration 175 Paramount Drive RAYNHAM MA 02767 SEP 2 8 2012 Re: K092207 Trade/Device Name: Restorelle polypropylene mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, OTO Dated: July 15, 2009 Received: July 22, 2009 Dear Ms. Peloquin: This letter corrects our substantially equivalent letter of August 4, 2009. 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 {3}------------------------------------------------ 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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 {4}------------------------------------------------ # MPATHY MEDICAL DEVICES, LTD. RESTORELLE POLYPROPYLENE MESH SPECIAL 510(K) NOTIFICATION #### 14. STATEMENT FOR INDICATIONS FOR USE K092207 510(k) Number: _ Device Name: Restorelle polypropylene mesh Indications for Use: RESTORELLE™ polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal 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: Yes #### DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation Daniel Keane Hansen (Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number: K092207 PAGE 33 OF 56
Innolitics
510(k) Summary
Decision Summary
Classification Order
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