(99 days)
Not Found
No
The document describes a surgical mesh system and instruments, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is permanently implanted to repair and reinforce soft tissues in cases of rupture or weakness in urological, gynecological, and gastroenterological anatomy, clearly indicating a therapeutic purpose.
No
The device is described as an implantable mesh assembly used to reinforce soft tissues, not to diagnose conditions or diseases. Its purpose is repairing tissues, not detecting or identifying medical conditions.
No
The device description explicitly states it consists of a permanently-implanted mesh assembly and non-implantable surgical instruments, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for surgical implantation to reinforce soft tissues in the urological, gynecological, and gastroenterological anatomy. This is a surgical device used in vivo (within the body).
- Device Description: The device is described as a permanently-implanted mesh assembly and non-implantable surgical instruments. This is consistent with a surgical implant and associated tools, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for structural support.
N/A
Intended Use / 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.
Product codes
OTP
Device Description
The AMS Elevate Anterior and Apical Prolapse Repair System is a modification of the Perigee System, part of the AMS Pelvic Floor Repair System family of devices. It 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 assembly is made from knitted polymeric mesh.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological, gynecological, and gastroenterological anatomy (pubourethral, vaginal wall, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The components of the AMS Elevate Anterior and Apical Prolapse Repair System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
ize (i) of (i)
K(.) 2677
510(k) Summary Statement 5.3
DEC 2 3 2008
| 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™ Anterior and Apical Prolapse Repair
System with IntePro® Lite™ | |
| Device Classification/ | Class II, 21 CFR Part 878.3300 | |
| Classification Name: | Surgical Mesh, polymeric (OTP) | |
| Predicate Device: | AMS Pelvic Floor Repair System (K051485) | |
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 Anterior and Apical Prolapse Repair System is a modification of the Perigee System, part of the AMS Pelvic Floor Repair System family of devices. It 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 assembly is made from knitted polymeric mesh.
Summary of Testing
The components of the AMS Elevate Anterior and Apical Prolapse Repair System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device.
5.4 Standard Data Report for 510(k)s
Standard Data Reports for 510(k)s (Form FDA 3654) are attached in Appendix E.
AMS Elevate™ Anterior & Apical Prolapse Repair System Special 510(k) Device Modification
Image /page/0/Picture/13 description: The image shows a word in black ink on a white background. The word appears to be 'Page', but the 'g' and 'e' are connected and somewhat obscured. The font is bold and slightly stylized.
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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 three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
American Medical Systems, Inc. % Ms. Mona Inman Senior Regulatory Affairs Specialist 10700 Bren Road West MINNETONKA MN 55343
SEP 2 8 2012
Re: K082677
Trade/Device Name: AMS Elevate™ Anterior and Apical Prolapse Repair System with IntePro® Lite™ Regulation Number: 21 CFR 878.3300
Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: November 26, 2008 Received: November 28, 2008
Dear Ms. Inman:
This letter corrects our substantially equivalent letter of December 23, 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
2
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/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. 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
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5.2 Indications for Use
Indications for Use
510(k) Number (if known):
Device Names:
AMS Elevate™ Anterior and Apical Prolapsc Repair System with IntePro® Lite™
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.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) | |
| ------------------------------------------------- | --- | -------- | ------------------------------------------------ | -- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
AMS Elevate
TM Anterior & Apical (Prolapse) Repair System
| 510(k) Number | K082627 |
|---|---|
| Special 510(k) Device Modification |
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