(26 days)
Not Found
No
The summary describes a surgical mesh kit and instrumentation for prolapse repair. There is no mention of AI, ML, image processing, or any computational analysis of data. The focus is on the physical components and their equivalence to a predicate device.
Yes
The device is a surgical mesh kit intended for the transvaginal surgical treatment of vaginal prolapse, which directly addresses a medical condition.
No
The device is a surgical mesh kit intended for transvaginal surgical treatment to correct prolapse, not for diagnosis.
No
The device description explicitly states that the system consists of a mesh assembly, non-implantable needle passers, and other surgical aids, which are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and vaginal apical prolapse" and "posterior vaginal wall prolapse and vaginal apical prolapse." This describes a surgical implant and associated tools used in vivo (within the body) for treatment.
- Device Description: The description details a "mesh assembly, non-implantable needle passers, and other surgical aids" designed for placement in the "pelvic floor." This further confirms its use as a surgical device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Performing tests in vitro (outside the body)
Therefore, this device is a surgical implant and associated instrumentation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
AMS Elevate PC Anterior and Apical Prolapse Repair System with IntePro Lite The Elevate PC Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.
AMS Elevate PC Apical and Posterior Prolapse Repair System with IntePro Lite The Elevate PC Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.
Product codes (comma separated list FDA assigned to the subject device)
FTL, OTP
Device Description
The AMS Elevate PC Prolapse Repair Systems with IntePro Lite consist of a mesh assembly, non-implantable needle passers, and other surgical aids that are designed to help place the mesh assembly in the pelvic floor.
The devices are identical to the predicate device AMS Elevate PC Prolapse Repair The devilous are noonidate with the following exception of the modification of the Apical Needle Passer Sheath. There are no changes to the mesh design, shape, size, material or Indications for Use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor, anterior vaginal wall, vaginal apical, posterior vaginal wall
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 PC Anterior and Apical Prolapse Repair Systems and AMS Elevate PC Apical and Posterior with IntePro Lite have been subjected to design verification, biocompatibility, sterilization, and packaging. The test results for design verification, biocompatibility, sterilization, and packaging are equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 2 5 2011 K112842
P 1/4
Section 6
510(k) Summary [21 CFR 807.92]
Submitter's Name and Address
Matthew D. Stepanek Senior Regulatory Affairs Specialist American Medical Systems, Inc. 952-939-7023 (telephone) 952-930-5785 (fax) matt.stepanek@ameircanmedicalsystems.com
Alternate Contact Name and Information
Josh Clarin Regulatory Affairs Manager American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343 952-939-7072 (telephone) 952-930-5785 (fax) josh.clarin@ameircanmedicalsystems.com
Date the Summary was Prepared
September 27, 2011
Device Classification Names
Surgical Mesh, polymeric Mesh, surgical, gynecologic, for pelvic organ prolapse transvaginally placed
Device Common/Usual Name
Surgical Mesh
Device Trade/Proprietary Name
AMS Elevate PC Anterior and Apical Prolapse Repair System with IntePro Lite AMS Elevate PC Apical and Posterior Prolapse Repair System with IntePro Lite
1
K112842
P2/$
Product Codes
FTL and OTP
Classification of Device
Class II 21 CFR Part 878.3300
Predicate Device(s)
| Device Name | Submission Number | Clearance Date |
|---|---|---|
| AMS Elevate PC Anterior and Apical Prolapse Repair System | ||
| with IntePro Lite | K111118 | July 1, 2011 |
| AMS Elevate PC Apical and Posterior Prolapse Repair System | ||
| with IntePro Lite |
Device Description
The AMS Elevate PC Prolapse Repair Systems with IntePro Lite consist of a The AMO Librato F O Trelapedia opesh assembly, non-implantable needle passers, and other surgical aids that are designed to help place the mesh assembly in the pelvic floor.
The devices are identical to the predicate device AMS Elevate PC Prolapse Repair The devilous are noonidate with the following exception of the modification of the Apical Needle Passer Sheath. There are no changes to the mesh design, shape, size, material or Indications for Use.
Existing Indication for Use & Proposed Indication for Use
There are no changes to the existing indications for use. Indications for the predicate and modified devices are as follows:
Elevate PC Anterior & Apical Repair System
The Elevate PC Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.
Elevate PC Apical & Posterior Repair System
The Elevate PC Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.
2
Summary of the Technological Characteristics to the Predicate Device(s)
The modifications to the predicate devices are deemed equivalent and there are no The modifications to the predications, device indications for use/intended use and/or device functional scientific technology.
The subject devices use the same surgical approach and mesh placement procedures as the predicate devices.
Summary of Non-Clinical Testing
The components of the AMS Elevate PC Anterior and Apical Prolapse Repair Systems The Components of the AMO Elevate PC Apical and AMS Elevate PC Apical and Posterior with Inter IO Lite (Elevate TO Alikonor) and Pillo Clevate PC Posterior) have best results r rolupor Repair Oyotene minitiation, and packaging. The test results for design vehiloation, olooompans.ity, equivalent to the predicate device.
Substantial Equivalence
The modified Elevate PC Anterior and Elevate PC Posterior devices use the same surgical approach and mesh placement procedures as the predicate device.
The proposed Elevate PC Anterior and Elevate PC Posterior devices have identical indications for usefintended use, identical implant materials, identical sterilization methods; and similar delivery tool materials/characteristics as the predicate.
The proposed Elevate PC Anterior and Elevate PC Posterior device performance and fundamental scientific technology remains unchanged. The differences between the proposed device and the predicate device does not have any negative effect on the safety and effectiveness of the device.
Conclusion
AMS considers the modified Elevate PC Anterior and Elevate PC Posterior devices to be substantially equivalent to the predicate devices.
Manufacturing Facility
American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343
Establishment Registration Number: 2183959
3
Sterilization Facility
Sterigenics US, Inc.
7775 S Quincy St.
Willowbrook, IL 60527
Establishment Registration Number: 1450293
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Matthew D. Stepanek Senior Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West MINNETONKA MN 55343
SEP 2 8 2012
Re: K112842
Trade/Device Name: AMS Elevate® PC Anterior and Apical Prolapse Repair System with IntePro® Lite AMS Elevate® PC Apical and Posterior Prolapse Repair System with IntePro® Lite Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: September 28, 2011 Received: September 29, 2011
Dear Mr. Stepanek:
This letter corrects our substantially equivalent letter of October 25, 2011.
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
5
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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
6
with
Statement of Indications for Use
| Section 5 | Statement of Indications for |
|---|---|
| ----------- | ------------------------------ |
| 510(k) Number: | K112842 |
|---|---|
| Device Name: | AMS Elevate® PC Anterior and Apical Prolapse Repair System with IntePro® Lite AMS Elevate® PC Apical and Posterior Prolapse Repair System with |
Indications for Use:
IntePro® Lite
AMS Elevate PC Anterior and Apical Prolapse Repair System with IntePro Lite The Elevate PC Anterior & Apical Repair System is a surgical mesh kit intended for The Elevate FC Antenor & Apical Repair System is a cargeall prolapse and vaginal transvaginal surgiour treatment to october instrumentation for transvaginal placement.
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Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112842
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