(30 days)
AMS Pelvic Floor Repair 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 for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
The TOPAS™ System consists of needles and mesh used to repair the connective and soft tissue in the pelvic floor.
This document is a 510(k) summary statement for a surgical mesh device, not a study report for an AI/ML powered medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance, study design, or ground truth for an AI/ML model.
Specifically:
- Acceptance Criteria and Reported Device Performance: This document states that the components of the TOPAS™ System were "tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device." It does not list specific acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance metrics for the device itself. The equivalence is based on the predicate device, the Apogee™ System.
- Sample size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: None of this information is relevant or present in this document because it describes the regulatory submission for a physical surgical mesh product, not an AI/ML device that requires such evaluation.
In summary, the provided text does not contain the information needed to answer your questions about acceptance criteria, study details, or ground truth for an AI/ML medical device. It's a regulatory document for a traditional surgical mesh product.
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Repair
2.3 510(k) Summary Statement
| Submitter: | American Medical Systems (AMS)10700 Bren Road WestMinnetonka, MN 55343 |
|---|---|
| Contact Person: | Sarah PetersonPhone: 952.933.6431Fax: 952.930.5785 |
| Device Common Name: | Surgical Mesh |
| Device Trade Name: | TOPASTM System |
| Device Classification/Classification Name: | Class II, 21 CFR Part 878.3300Surgical Mesh, polymeric (FTL) |
| Predicate Device: | Apogee™ System, Part of the AMS Pelvic FloorSystem (K051485) |
Indications for Use
AMS Pelvic Floor Repair 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 for the treatment of incontinence, vaginal wall prolapse repairs including anterior and postcrior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
Device Description
The TOPAS™ System consists of needles and mesh used to repair the connective and soft tissue in the pelvic floor.
Summary of Testing
The components of the TOPAS™ System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
American Medical Systems, Inc. % Ms. Sarah Peterson Regulatory Specialist 10700 Bren Road West Minnetonka, Minnesota 55343
MAY - 9 2007
Re: K070993
Trade/Device Name: TOPAS™ System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 6, 2007 Received: April 9, 2007
Dear Ms. Peterson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 – Ms. Sarah Peterson
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Molkerson
Mark N. I Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.2 Indications for Use
510(k) Number (if known): K8570993
Device Name: TOPAS™ System
Indications For Use: AMS Pelvic Floor Repair 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 for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Division of General. Restorative. and Neurological Devices
*10(k) Number / L670993
§ 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.