(76 days)
Not Found
No
The summary describes a surgical mesh and instruments, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is described as a "permanently-implanted mesh sling assembly" used to "reinforce soft tissues where weakness exists" and for "reconstruction of the pelvic floor and tissue repair," indicating its role in treating conditions rather than diagnosing or merely supporting.
No
The device is described as a permanently-implanted mesh sling assembly used to reinforce soft tissues and repair anatomical weaknesses, which indicates a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The device description explicitly states it consists of a permanently-implanted mesh sling assembly and non-implantable surgical instruments, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant and instruments used to repair and reinforce soft tissues within the body (urological, gynecological, and gastroenterological anatomy, pelvic floor). This is a therapeutic and structural intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a permanently-implanted mesh sling assembly and non-implantable surgical instruments. This aligns with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The 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, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
Product codes
OTP, PAI
Device Description
The AMS Elevate System is a modification of the Apogee System, part of the AMS Pelvic Floor Repair System family of devices. It consists of a permanently-implanted mesh sling assembly and non-implantable surgical instruments that can be used as aids to place the mesh sling assembly in the pelvic floor. The sling assemblies are made from polymeric mesh, or a combination of polymeric mesh and surgical mesh derived from porcine dermis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological, gynecological, and gastroenterological anatomy (pelvic floor)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The components of the AMS Elevate Prolapse Repair System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
5.3 510(k) Summary Statement
| Submitter: | American Medical Systems (AMS)
10700 Bren Road West
Minnetonka, MN 55343 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mona Inman
Phone: 952.930.6204
Fax: 952.930.5785 |
| Device Common Name: | Surgical Mesh |
| Device Trade Names: | AMS Elevate™ with IntePro® Lite™ Prolapse Repair
System
AMS Elevate™ with InteXen® LP Prolapse Repair
System |
| Device Classification/ | Class II, 21 CFR Part 878.3300 |
| Classification Name: | Surgical Mesh, polymeric (OTP, PAI) |
| Predicate Device: | AMS Pelvic Floor Repair System (K051485) |
Indications for Use
The 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, 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 System is a modification of the Apogee System, part of the AMS Pelvic Floor Repair System family of devices. It consists of a permanently-implanted mesh sling assembly and non-implantable surgical instruments that can be used as aids to place the mesh sling assembly in the pelvic floor. The sling assemblies are made from polymeric mesh, or a combination of polymeric mesh and surgical mesh derived from porcine dermis.
Summary of Testing
The components of the AMS Elevate Prolapse Repair System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device.
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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 caduceus symbol, which is a staff with two snakes coiled around it, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 2 8 2012
American Medical Systems (AMS) % Ms. Mona Inman 10700 Bren Road West Minnetonka, MN 55343
Re: K080185
Trade/Device Name: AMS Elevate™ with IntePro® Lite™ Prolapse Repair System AMS Elevate™ with InteXen® LP Prolapse Repair System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, PAI Dated: March 12, 2008 Received: March 13, 2008
Dear Ms. Inman:
This letter corrects our substantially equivalent letter of April 10, 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/ReportalProblem/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. Fuchs
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
3
Indications for Use 5.2
Indications for Use
510(k) Number (if known):
Device Names:
AMS Elevate™ with IntePro® Lite™ Prolapse Repair System AMS Elevate™ with InteXen® LP Prolapse Repair System
Indications For Use:
The 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, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
Prescription Use × (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 NEEDED)
Neil A.P. Ogden for
१०४०।१८२
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
AMS Elevater Prolaps 194455 Number Special 510(k) Device Modification
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