(26 days)
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.
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 System 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.
The provided text describes a 510(k) premarket notification for a medical device, the "AMS Elevate® PC Anterior and Apical Prolapse Repair System with IntePro® Lite" and "AMS Elevate® PC Apical and Posterior Prolapse Repair System with IntePro® Lite". This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria for performance.
Therefore, many of the requested details about acceptance criteria, efficacy studies, sample sizes, expert involvement, and ground truth establishment are not applicable or not found in this type of submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This submission is for a modification to a previously cleared device. The focus is on demonstrating that the modifications do not negatively impact safety and effectiveness compared to the predicate device, rather than meeting new, specific quantitative performance acceptance criteria.
The submission states:
- "The test results for design verification, biocompatibility, sterilization, and packaging are virtually equivalent to the predicate device." (Section 2)
- "The proposed Elevate PC Anterior and Elevate PC Posterior device performance and fundamental scientific technology remains unchanged." (Section 2)
2. Sample size used for the test set and the data provenance
Not applicable. No specific 'test set' in the context of an efficacy study is described. The document refers to "test results for design verification, biocompatibility, sterilization, and packaging" (Section 2), implying engineering and materials testing, but does not provide details on sample sizes or data provenance for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a test set in the context of device performance or efficacy is described.
4. Adjudication method for the test set
Not applicable. No adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a surgical mesh system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical mesh system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth, in the context of an efficacy study, is not described as this is a substantial equivalence submission for a surgical device modification.
8. The sample size for the training set
Not applicable. No training set for an algorithm is described.
9. How the ground truth for the training set was established
Not applicable. No ground truth for a training set is described.
Summary of Device and Rationale for Substantial Equivalence (as provided in the document):
The submission details a change to the AMS Elevate PC Anterior and Apical Prolapse Repair System with IntePro Lite and the AMS Elevate PC Apical and Posterior Prolapse Repair System with IntePro Lite.
The modification is solely to the Apical Needle Passer Sheath (a non-implantable surgical aid). There are no changes to the mesh design, shape, size, material, or Indications for Use.
The rationale for substantial equivalence is based on the following points:
- The devices are identical to the predicate device with the single exception of the Apical Needle Passer Sheath modification.
- There are no changes to the existing indications for use.
- The modifications are deemed equivalent, with no changes to the 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.
- Components underwent design verification, biocompatibility, sterilization, and packaging tests, with results "virtually equivalent" to the predicate device.
- The proposed devices have identical indications for use/intended use, identical implant materials, identical sterilization methods, and similar delivery tool materials/characteristics as the predicate.
- The proposed device performance and fundamental scientific technology remain unchanged.
- The differences between the proposed device and the predicate device do not have any negative effect on the safety and effectiveness of the device.
Therefore, the submission asserts that the modified devices are substantially equivalent to their predicate devices, implying that their safety and effectiveness are maintained despite the minor modification. No new clinical or performance studies demonstrating effectiveness against specific acceptance criteria are presented because the modification is considered minor and does not alter the fundamental performance or intended use of the device.
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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
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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 Systemwith IntePro Lite | K111118 | July 1, 2011 |
| AMS Elevate PC Apical and Posterior Prolapse Repair Systemwith 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.
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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
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Sterilization Facility
Sterigenics US, Inc.
7775 S Quincy St.
Willowbrook, IL 60527
Establishment Registration Number: 1450293
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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
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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 (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
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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
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(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
Page 11 of 55
§ 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.