ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION

{0}------------------------------------------------ K121612 Page 1 of 5 AMS *an oracle health solution* JUL 20 2012 # Section 5 510(k) Summary #### Submitter's Name and Address Ngoc Linh Pham Latchman Sr. Regulatory Affairs Specialist American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343 952-939-7056 (telephone) 952-930-5785 (fax) Linh PhamLatchman@AmericanMedicalSystems.com #### Alternate Contact Name and Information Josh Clarin Manager, Regulatory Affairs American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343 952-939-7072 (telephone) 952-930-5785 (fax) Josh. Clarin@AmericanMedicalSystems.com #### Date the Summary was Prepared July 20, 2012 #### Device Classification Name Mesh, surgical, gynecologic, for pelvic organ prolapse, transvaginally placed (OTP) Mesh, surgical, non-synthetic; urogynecologic, for pelvic organ prolapse, transvaginally placed (PAI) #### Device Common/Usual Name Surgical Mesh #### Device Trade/Proprietary Name Elevate® Anterior and Apical Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP {1}------------------------------------------------ (12/617 lage 2 of 5 Image /page/1/Picture/1 description: The image shows the logo for BAMS. The logo consists of a stylized graphic to the left of the text "AMS". Below the text is smaller text that is illegible. The logo is black and white. #### 510(k) Summary #### Device Trade/Proprietary Name Elevate® Anterior and Apical Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP #### Product Code OTP & PAI : #### Classification of Device Class II / 21 CFR § 878.3300 ### Predicate Device(s) | Device Name | Submission Number | |------------------------------------------------------------------------------|-------------------| | AMS Elevate Anterior and Apical Prolapse Repair System with<br>IntePro Lite | K082677 | | AMS Elevate Apical and Posterior Prolapse Repair System with<br>IntePro Lite | K082730 | | AMS Elevate Apical and Posterior Prolapse Repair System with<br>InteXen LP | | #### Device Description Each Elevate System consists of a permanently-implanted graft and non-implantable surgical instruments that can be used as aids to transvaginally place the graft assembly in the pelvic floor. The graft assemblies for the Elevate Anterior & Apical Prolapse Repair System and Elevate Apical & Posterior Prolapse Repair System are made from polymeric mesh (IntePro Lite), and in the case of the Elevate Apical & Posterior Prolapse Repair System with InteXen LP, the graft assembly is made from a combination of lyophilized porcine dermis and polymeric mesh (IntePro Lite). The devices are identical to the predicate devices, AMS Elevate Prolapse Repair Systems, with the exception of the modification to the Apical Needle Passer Sheath. There are no changes to the implant graft design, shape, size, and material. The revisions to the indications for use of the modified devices are to further clarify the intended use of Elevate System as a kit for transvaginal surgical treatment. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for AMS. The logo consists of a stylized image of two hands cradling something, followed by the letters "AMS" in a bold, sans-serif font. Below the letters, there is a tagline in a smaller font that reads "an agile health solution." #### 510(k) Summary #### Existing Intended Use & Proposed Indication for Use #### Existing indications for use Elevate Anterior and Apical Prolapse Repair System The Elevate Anterior & Apical Repair System is intended for the treatment of anterior and/or apical vaginal prolapse. Elevate Apical and Posterior Prolapse Repair System The Elevate Apical & Posterior Repair System is intended for the treatment of apical and/or posterior vaginal prolapse. Elevate Apical and Posterior Prolapse Repair System with InteXen® LP The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement. #### Proposed indications for use The following are revisions to the indications for use to further clarify that the Elevate System Repair Systems are intended for transvaginal surgical treatment. #### Elevate Anterior and Apical Prolapse Repair System The Elevate Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior wall prolapse and vaginal apical prolapse. #### Elevate Apical and Posterior Prolapse Repair System The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior wall prolapse and vaginal apical prolapse. Elevate Apical and Posterior Prolapse Repair System with InteXen® LP The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse. #### Summary of the Technological Characteristics to the Predicate Device(s) The modification to the Elevate Prolapse Repair Systems are deemed equivalent to the current device and there are no changes to the device intended use and/or device functional scientific technology. The subject devices use the same surgical approach and implant placement procedures as the predicate devices. {3}------------------------------------------------ #### 510(k) Summary 11121617 Bage 4 of 5 #### Summary of Non-Clinical & Clinical Testing The modified sheath of the Elevate Anterior and Apical Prolapse Repair System, Elevate Apical & Posterior Prolapse Repair System, and Elevate Apical & Posterior Prolapse Repair System with InteXen LP has been tested for design verification and biocompatibility (cytotoxicity & physiochemical testing). Design verification testing of the sheath included the following tests: - sheath compression strength and depth stop strength, . - trigger/sheath locking interface push strength, ● - sheath cutout shear off strength and trigger/sheath locking interface pull . strenath - sheath engagement force into lock . There were no modifications made to the packaging or sterilization of the devices as a result of the change; thus, no additional testing was required. There was no change to the intended use or the implant procedure as a result of the change: thus the Elevate Prolapse Repair Systems have equivalent clinical performance to the predicate devices and no clinical testing was required to support the sheath modification American Medical Systems considers the Elevate Anterior & Elevate Posterior devices' product performance to be substantially equivalent to the predicate devices. #### Substantial Equivalence The modified Elevate Anterior and Elevate Posterior devices use the same surgical approach and implant placement procedures as the predicate devices, Elevate Anterior & Elevate Posterior. The modified Elevate Anterior and Elevate Posterior devices have identical intended use, identical implant materials, identical sterilization methods; and similar delivery tool materials/characteristics as the predicate. The proposed Elevate Anterior and Elevate Posterior device performance and fundamental scientific technology remains unchanged. The differences between the proposed device and the predicate device do not negatively affect the safety and effectiveness of the device. #### Conclusion AMS considers the modified Elevate Anterior and Elevate Posterior devices to be substantially equivalent to the predicate devices. {4}------------------------------------------------ 11121612 se Sof 5 #### 510(k) Summary ## Manufacturing Facility American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343 Establishment Registration Number: 2183959 #### Sterilization Facility Sterigenics US, Inc. 7775 S Quincy St. Willowbrook, IL 60527 Establishment Registration Number: 1450293 {5}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three stylized lines forming the body and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Ms. Ngoc Linh Pham Latchman Senior Regulatory Affairs Specialist American Medical Systems, Inc. 10700 Bren Road West MINNETONKA MN 55343 JUL 20 2012 Re: K121612 > Trade/Device Name: Elevate® Anterior and Apical Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OTP, PAI Dated: May 31, 2012 Received: June 28, 2012 #### Dear Ms. Latchman: 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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 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 {6}------------------------------------------------ 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 (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. Fisher, Ph.D. 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 {7}------------------------------------------------ # Statement of Indications for Use # Section 6 510(k) Number: K121612 Device Name: Elevate® Anterior and Apical Prolapse Repair System ## Indications for Use: Elevate Anterior and Apical Prolapse Repair System The Elevate Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior wall prolapse and vaginal apical prolapse. Prescription Use _ × (Per 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 IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | |--------------------------------------------------------| |--------------------------------------------------------| | | 7/20/12 | |-------------------------------------------------------------------|---------| | (Division Sign-Off) | | | Division of Reproductive, Gastro-Renal, and<br>Urological Devices | | | 510(k) Number | K121612 | {8}------------------------------------------------ Section 6 510(k) Number: K121612 Elevate® Apical and Posterior Prolapse Repair System Device Name: Indications for Use: Elevate Apical and Posterior Prolapse Repair System The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior wall prolapse and vaginal apical prolapse. Prescription Use __ X (Per 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 !F NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division/Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number K121612 {9}------------------------------------------------ ## Section 6 ## Statement of Indications for Use, 510(k) Number: K121612 Device Name: Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP Indications for Use: Elevate Apical and Posterior Prolapse Repair System with InteXen® LP The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse. Prescription Use _ X (Per 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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Beutun R. Fuch 20 July 2012 vision Sign-Off of Reproductiv