MINITAPE URETHRAL SLING

K091180 · Mpathy Medical Devices, Ltd. · PAH · Jul 14, 2009 · General, Plastic Surgery

Device Facts

Record IDK091180
Device NameMINITAPE URETHRAL SLING
ApplicantMpathy Medical Devices, Ltd.
Product CodePAH · General, Plastic Surgery
Decision DateJul 14, 2009
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 878.3300
Device ClassClass 2
AttributesTherapeutic

Intended Use

Minitape® Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Story

Minitape Urethral Sling is a surgical mesh device used for the treatment of female urinary stress incontinence. The device is provided in a convenience kit including the mesh, disposable needle introducers for placement, polydioxanone absorbable sutures for securing the mesh, and optional polypropylene suture bolsters for tightening. The device is implanted by a surgeon to provide support to the urethra. It functions by restraining urethral tissue to correct hypermobility or intrinsic sphincter deficiency. The device is intended for surgical use in a clinical setting.

Clinical Evidence

No clinical data provided. Evidence consists of in-vitro and in-vivo bench testing demonstrating the device's ability to restrain urethral tissue under conditions exceeding normal clinical use.

Technological Characteristics

Surgical mesh device. Components include mesh, needle introducers, polydioxanone absorbable sutures, and polypropylene suture bolsters. Materials are consistent with predicate devices. The device is designed for surgical implantation to provide urethral support.

Indications for Use

Indicated for female patients with urodynamically proven urinary stress incontinence caused by urethral hypermobility and/or intrinsic sphincter deficiency.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K091180 pg. 1 of 2 · ## 17. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS : | SUBMITTER | Ms Melissa Peloquin<br>Director of Office Administration<br>Mpathy Medical Devices Inc.<br>175 Paramount Drive<br>Raynham, MA 02767 | JUL 1 4 2009 | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | CONTACT PERSON | Dr Caroline Stretton<br>Quality & Regulatory Affairs Director<br>Mpathy Medical Devices, Ltd.<br>208 Wright Business Centre<br>Lonmay Road<br>Glasgow G33 4EL (United Kingdom) | | | DATE PREPARED | 15 April 2009 | | | CLASSIFICATION | Surgical Mesh; ref. 21 CFR 878.3300<br>Product Code <span style="font-style:italic">PAH</span><br>Class II | | | COMMON NAME | Surgical mesh | | | PROPRIETARY<br>NAME | Minitape® Urethral Sling | | | PREDICATE DEVICE | K073646 - Modified Minitape Urethral Sling (Mpathy<br>Medical Devices)<br>K020007 - SAFYRE Sling (Corniche, LLC)<br>K033310 - Remeex System (Remeex)<br>K011251, K013355, K021263 & K020663 - SPARC<br>Sling System (American Medical Systems)<br>K052401 - TVT® Secur (Gynecare)<br>K073703 - MiniArc® (American Medical Systems). | | | DEVICE<br>DESCRIPTION | The subject device is a surgical mesh. The<br>proprietary mesh is supplied along with ancillary tools<br>for placement of the device (convenience kit). The kit<br>consists of: Minitape Urethral Sling (mesh) intended<br>to be used as a pubourethral sling for the treatment<br>of female urinary incontinence resulting from urethral<br>hypermobility and/or intrinsic sphincter deficiency;<br>Disposable needle introducers, optionally used to aid<br>in placement of the Minitape mesh; Polydioxanone<br>absorbable sutures (CP Medical; Portland, OR), used<br>to secure the mesh in place; Polypropylene suture<br>bolsters (Ethicon Inc.; Sommerville, NJ), optionally<br>used to aid in tightening ("snugging") the mesh<br>following surgical placement. | | {1}------------------------------------------------ K091180 pg. 2 of 2 Minitape® Urethral Sling is indicated for the surgical INDICATIONS treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Minitape® Urethral Sling has the same intended use, TECHNOLOGICAL general design, material and fundamental scientific CHARACTERISTICS technology as the predicate Modified Minitape Urethral Sling device, with the exception of a shorter overall sling length. ## TESTING The device has been subjected to in-vitro and in-vivo testing which demonstrate the ability of the device to adequately restrain urethral tissue under conditions in excess of those encountered during normal clinical use. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 MPathy Medical Devices, Ltd. % Dr. Caroline Stretton Quality & Regulatory Affairs Director 208 Wright Business Centre Lonmay Road Glasgow G33 4EL United Kingdom SEP 2 8 2012 Re: K091180 Trade/Device Name: Minitape Urethral Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: July 1, 2009 Received: July 8, 2009 Dear Dr. Stretton: This letter corrects our substantially equivalent letter of July 14, 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 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 (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. Rooks 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. MINITAPE URETHSAL SLING SPECIAL 510(K) NOTIFICATION 16. STATEMENT FOR INDICATIONS FOR USE 510(k) Number: Device Name: Minitape Urethral Sling Indications for Use: Minitape Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Prescription Use: Yes DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation Daniel Kramer for MXM (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K091180 PAGE 43 OF 76 K091180
Innolitics
510(k) Summary
Decision Summary
Classification Order
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