(61 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 PFR Sling System is a sterile, single use procedure kit that consists of stainless steel, curved needle passers and an implantable mesh assembly.
The provided text describes a 510(k) summary for the "PFR Sling System, Part of the AMS Pelvic Floor Repair System," which is a surgical mesh. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study with a device output.
Therefore, the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies cannot be extracted from the provided text.
The document states:
- "The components of the PFR Sling System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices." (Page 1, under "Summary of Testing")
This indicates that a comparison was made against existing, legally marketed devices. However, the details of what "performance requirements" were and how "substantial equivalence" was demonstrated in terms of specific metrics, acceptance criteria, or a detailed study are not included in this summary.
In summary, the provided document does not contain the information necessary to fulfill the request as it describes a regulatory submission based on substantial equivalence, not a detailed performance study with quantifiable acceptance criteria and device performance metrics.
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510(k) Summary Statement
| Submitter: | American Medical Systems (AMS)10700 Bren Road WestMinnetonka, MN 55343 |
|---|---|
| Contact Person: | Sarah J.P. MeyerPhone: 952.930.6431Fax: 952.930.5785 |
| JUN - 2 2005 | |
| Device Common Name: | Surgical Mesh |
| Device Trade Name: | PFR Sling System, Part of the AMS Pelvic FloorRepair System |
| Device Classification/Classification Name: | Class II, 21 CFR Part 878.3300Surgical Mesh, polymeric (FTL) |
| Predicate Device: | PFR Sling System (K070993), Part of the AMSPelvic Floor Repair 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.
Device Description
The PFR Sling System is a sterile, single use procedure kit that consists of stainless steel, curved needle passers and an implantable mesh assembly.
Summary of Testing
The components of the PFR Sling System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2009
American Medical Systems, Incorporation % Ms. Sarah Meyer Senior Regulatory Specialist 10700 Bren Road, West Minnetonka, Minnesota 55343
Re: K090934
Trade/Device Name: PFR Sling System, Part of the AMS Pelvic Floor Repair System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: May 6, 2009 Received: May 7, 2009
Dear Ms. Meyer:
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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing
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Page 2- Ms. Sarah Meyer
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/cdrh/comp/ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Rra. Robl
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K090934
Indications for Use Statement
| 510(k) Number:(if known) | K090934 |
|---|---|
| Device Name: | PFR Sling System, Part of the AMS Pelvic FloorRepair System |
| Indications For Use: | AMS Pelvic Floor Repair System is intended for usewhere the connective tissue has ruptured or forimplantation to reinforce soft tissues where weaknessexists in the urological, gynecological andgastroenterological anatomy. This includes but is notlimited to the following procedures: pubourethralsupport, including urethral slings for the treatment ofincontinence, vaginal wall prolapse repairs includinganterior and posterior wall repairs, vaginalsuspension, reconstruction of the pelvic floor andtissue 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
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krone for MxM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090934 35 of 72
Page 1 of 1
§ 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.