OMNISURE URETHRAL SLING, MODEL OTK52

K092203 · Mpathy Medical Devices, Ltd. · OTN · Aug 12, 2009 · General, Plastic Surgery

Device Facts

Record IDK092203
Device NameOMNISURE URETHRAL SLING, MODEL OTK52
ApplicantMpathy Medical Devices, Ltd.
Product CodeOTN · General, Plastic Surgery
Decision DateAug 12, 2009
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 878.3300
Device ClassClass 2
AttributesTherapeutic

Intended Use

Omnisure™ 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

Omnisure Urethral Sling is a surgical mesh device used for the treatment of female urinary stress incontinence. The device is implanted surgically to provide support to the urethra, addressing urethral hypermobility and intrinsic sphincter deficiency. It is supplied with ancillary placement tools and is intended for use by surgeons in a clinical or hospital setting. The mesh acts as a suburethral sling to restore continence. The device is provided sterile.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Surgical mesh device; Class II; Product Code OTN. Design, materials, and scientific technology are identical to the predicate Minitape Extra Urethral Sling (K073647). Supplied sterile.

Indications for Use

Indicated for female patients with urodynamically proven stress urinary 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}------------------------------------------------ K092203 p. 1 of 2 #### MPATHY MEDICAL DEVICES, LTD. OMNISURE URETHRAL SLING SPECIAL 510(K) NOTIFICATION #### 15. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS AUG 1 2 2009 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 22 July 2009 Surgical Mesh (Product Code OTN) is a Class II device CLASSIFICATION per 21 CFR 878.3300 COMMON NAME Surgical Mesh Omnisure™ Urethral Sling PROPRIETARY NAME - PREDICATE DEVICE K073647 - Minitape® Extra Urethral Sling (Mpathy Medical Devices) K011251, K013355, K021263 & K020663 - SPARC Sling System (American Medical Systems) K974098 - TVT (Ethicon) K091180 - Minitape® O Urethral Sling (Mpathy Medical Devices) Omnisure™ Urethral Sling is a surgical mesh intended DEVICE DESCRIPTION to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The proprietary mesh is supplied along with ancillary tools for placement of the device. The device is supplied sterile. Omnisure™ 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. PAGE 34 OF 52 {1}------------------------------------------------ 092203 p. 2 of 2 ### MPATHY MEDICAL. DEVICES, LTD. OMNISURE URETHRAL SLING SPECIAL 510(K) NOTIFICATION ## TECHNOLOGICAL CHARACTERISTICS Omnisure™ Urethral Sling has the same intended use, general design, material and fundamental scientific technology as the predicate Minitape Extra Urethral Sling (K073647). TESTING The components of the Omnisure™ device are substantially equivalent to the predicate Minitape® Extra device (K073647), which has been subjected to biocompatibility and mechanical testing. PAGE 35 OF 52 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body. The eagle is 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. % Mpathy Medical Devices, Inc. Ms. Melissa Peloquin Director of Office Administration 175 Paramount Drive RAYNHAM MA 02767 SEP 2 8 2012 Re: K092203 Trade/Device Name: Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: July 22, 2009 Received: July 22, 2009 Dear Ms. Peloquin: This letter corrects our substantially equivalent letter of August 12, 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/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. Perkins Beniamin 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}------------------------------------------------ K092203 p. 1 of 1 # MPATHY MEDICAL DEVICES, LTD. OMNISURE URETHRAL SLING SPECIAL 510(K) NOTIFICATION # 14.STATEMENT FOR INDICATIONS FOR USE 510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Device Name: Omnisure™ Urethral Sling Indications for Use: Omnisure™ Urethral Sling is indicated for the surgical mulcations for Ose. Onlinisale Growner 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 Kianefa Mku (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K092203 PAGE 33 OF 52
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%