(12 days)
The AMS Silicone-Coated Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacralcolposuspension.
The AMS Sacral Colpopexy Sling is an alternate version of the AMS Silicone-Coated Sling and Surgical Mesh. The two slings are exactly the same except for the fact that the Sacral Colpopexy Sling is in the shape of a Y.
I am sorry, but based on the provided text, the document is a 510(k) premarket notification letter from the FDA regarding a medical device called "AMS Silicone-Coated Sling and Surgical Mesh."
This document does not contain information about acceptance criteria for a device's performance, nor does it describe a study to prove that the device meets such criteria. Instead, it is an FDA communication regarding the substantial equivalence of the device to legally marketed predicate devices, focusing on regulatory aspects rather than detailed performance study results from the manufacturer.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, training set size, and ground truth establishment for training set) from this document.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 8 2012
Ms. Elsa A. Linke Regulatory Affairs American Medical Systems, Inc. 10700 Bren Road West MINNETONKA MN 55343
Re: K010931 Trade/Device Name: AMS Silicone-Coated Sling and Surgical Mesh
Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: March 27, 2001 Received: March 28, 2001
Dear Ms. Linke:
This letter corrects our substantially equivalent letter of April 9, 2001.
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
{1}------------------------------------------------
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 (OS) 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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
{2}------------------------------------------------
INDICATIONS FOR USE ENCLOSURE
Kolog3)
510(k) Number:
Device Name:
Indications for Use:
AMS Silicone-Coated Sling and Surgical Mesh
The AMS Silicone-Coated Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to the following t procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacralcolposuspension.
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K61093/
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of General and Restorative Devices
510(k) Number
Prescription Use V (Per 21 CFR801.109)
OR
Over the Counter Use
4
{3}------------------------------------------------
APR = 9 2001
510(k) SUMMARY
Submitter's Name:
Address:
Tel:
Fax:
American Medical Systems, Inc.
p. 1/2
10700 Bren Road West Minnetonka, MN 55343
952-933-4666
952-930-6157
Elsa A. Linke
March 27, 2001
Surgical Mesh, Sling
Classification: Class II Product Code: FTL
AMS Sacral Colpopexy Sling
Contact Person:
Date of Summary Preparation:
Device Common Name:
Device Trade Name:
Device Classification Name:
Predicate Device:
AMS Silicone-Coated Sling and Surgical Mesh K002721
Surgical Mesh, polymeric (21 CFR 878.3300)
Device Description
The AMS Sacral Colpopexy Sling is an alternate version of the AMS Silicone-Coated Sling and Surgical Mesh. The two slings are exactly the same except for the fact that the Sacral Colpopexy Sling is in the shape of a Y.
Indications for Use
The AMS Sacral Colpopexy Sling is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacralcolposuspension.
Comparison to Predicate Device
The fundamental scientific technology of the device will not change with the proposed alternative configuration of the device. With the exception of adding an adhesive to form the y-bond, the material characteristics of the device remain the same as in the predicate. The addition of a short arm of sling mesh is the only change to the physical characteristics.
5
{4}------------------------------------------------
K010931 p. 2/2
[510(k) Summary continued]
Supporting Information
The mechanical properties of the new y-configuration of the sling have been tested on the bench and shown to meet performance specifications. In addition, the bonding material has been demonstrated to be biocompatible.
Conclusion
The proposed modification is equivalent to the predicate with respect to intended use, technological characteristics, and performance characteristics.
§ 878.3300 Surgical mesh.
(a)
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.(b)
Classification. Class II.