(69 days)
The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension. reconstruction of the pelvic floor and tissue repair.
The AMS Elevate Apical and Posterior System consists of a permanently-implanted mesh assembly and non-implantable surgical instruments that can be used as aids to place the mesh assembly in the pelvic floor. The mesh assemblies are made from polymeric mesh, or a combination of polymeric mesh and surgical mesh derived from non-viable porcine dermis.
The provided text is a 510(k) summary statement for a surgical mesh device, the AMS Elevate™ Apical and Posterior Prolapse Repair System. It details the device's description, indications for use, and a summary of testing for biocompatibility and performance.
However, the text does not contain any information about:
- Specific acceptance criteria (e.g., quantifiable performance metrics like sensitivity, specificity, accuracy, or physical properties thresholds).
- A detailed study proving device meets acceptance criteria. It only states that components were "tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device." This is a high-level statement, not a detailed study description.
- Sample sizes for test sets, training sets, or data provenance.
- Number of experts or their qualifications.
- Adjudication methods.
- MRMC comparative effectiveness study or its effect size.
- Standalone algorithm performance.
- Type of ground truth used or how it was established.
This document is a regulatory submission for a medical device (surgical mesh), not an AI or diagnostic device that would typically involve the kind of performance studies expected in your request. The "Summary of Testing" section indicates that the testing revolved around biocompatibility and meeting performance requirements for substantial equivalence to a predicate device, which is different from a clinical performance study with statistical metrics.
Therefore, I cannot populate the table or answer the specific questions based on the provided text, as the information is not present.
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Koryz3u
NOV 2 6 2008
5.3 510(k) Summary Statement
| Submitter: | American Medical Systems (AMS)10700 Bren Road WestMinnetonka, MN 55343 |
|---|---|
| Contact Person: | Mona InmanPhone: 952.930.6204Fax: 952.930.5785 |
| Device Common Name: | Surgical Mesh |
| Device Trade Names: | AMS Elevate™ Apical and Posterior Prolapse RepairSystem with IntePro® Lite™AMS Elevate™ Apical and Posterior Prolapse RepairSystem with InteXen® LP |
| Device Classification/ | Class II, 21 CFR Part 878.3300 |
| Classification Name: | Surgical Mesh, polymeric (OTP, PAI) |
| Predicate Device: | AMS Elevate Prolapse Repair Systems (K080185) |
Indications for Use
The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension. reconstruction of the pelvic floor and tissue repair.
Device Description
The AMS Elevate Apical and Posterior System consists of a permanently-implanted mesh assembly and non-implantable surgical instruments that can be used as aids to place the mesh assembly in the pelvic floor. The mesh assemblies are made from polymeric mesh, or a combination of polymeric mesh and surgical mesh derived from non-viable porcine dermis.
Summary of Testing
The components of the AMS Elevate Apical and Posterior Prolapse Repair System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device.
AMS Elevate™ Apical and Posterior Prolapse Repair System Special 510(k) Device Modification
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The logo is rendered in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
American Medical Systems (AMS) % Ms. Mona Inman Senior Regulatory Affairs Specialist 10700 Bren Road West MINNETONKA MN 55343
SEP 2 8 2012
Re: K082730
Trade/Device Name: AMS Elevate™ Apical and Posterior Prolapse Repair System with IntePro® Lite™ and AMS 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: October 31, 2008 Received: November 3, 2008
Dear Ms. Inman:
This letter corrects our substantially equivalent letter of November 26, 2008.
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Benjamin R. Weeks
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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5.2 Indications for Use
Indications for Use
510(k) Number (if known):
Device Names:
AMS Elevate™ Apical and Posterior Prolapse Repair System with IntePro® Lite™ AMS Elevate™ Apical and Posterior Prolapse Repair System with InteXen® LP
Indications For Use:
The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
Mark M. Mulkerr
(Division Sign-3ff) (Division of General, Restorative, aad Neurological
510(k) Number
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
AND/OR
AMS Elevate™ Apical and Posterior Prolapse Repair System Special 510(k) Device Modification
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§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
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).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.