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.

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.

Device Description

The AMS Elevate PC Prolapse Repair Systems with IntePro Lite consist of a permanentlyimplanted synthetic 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 is identical to the predicate device AMS Elevate Prolapse Repair System with PC Coated IntePro Lite, with the following exceptions: (1) The anterior needle passer has been modified to add a release mechanism on the handle; and (2) as a result of the anterior needle passer modifications, the connection interface for the tissue fixation elements of the anterior center graft that correspond with the anterior needle passer also changed. The geometry of the internal diameter and the base of the tissue fixation elements changed slightly to accommodate the new shape of the anterior needle tip. There are no changes to the mesh design, shape, size, or material.

AI/ML Overview

The document provided describes a Special 510(k) Device Modification for the AMS Elevate® PC Prolapse Repair System with IntePro® Lite, seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that modifications do not raise new questions of safety or effectiveness and primarily relies on non-clinical testing to prove equivalence, rather than extensive clinical studies with human participants.

Therefore, many of the requested categories related to clinical study design, human reader performance, and ground truth establishment from patient data are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Equivalence to Predicate	Substantial equivalence to predicate device in terms of safety and effectiveness.	The test results conclude the AMS Elevate PC Prolapse Repair Systems with IntePro Lite to be substantially equivalent to the predicate device, AMS Elevate Prolapse Repair Systems with PC Coated IntePro Lite.
Design Verification	N/A (General requirement for device safety and functionality)	Performed, and included in the claim of substantial equivalence.
Biocompatibility	N/A (General requirement for implanted devices)	Performed, and included in the claim of substantial equivalence.
Sterilization	N/A (General requirement for sterile devices)	Performed, and included in the claim of substantial equivalence.
Packaging	N/A (General requirement for maintaining device integrity)	Performed, and included in the claim of substantial equivalence.
Product Performance	N/A (General requirement for device functionality)	Performed, and American Medical Systems considers the product performance to be significantly equivalent to the predicate device.

Explanation of the "N/A" for Acceptance Criteria: The document states that the components were "subjected to testing which included design verification, biocompatibility, sterilization, packaging, and product performance requirements." It does not provide specific quantitative acceptance criteria for each of these tests, but rather states that the results conclude substantial equivalence. In a 510(k) submission, the "acceptance criteria" for these non-clinical tests would typically be defined internally by the manufacturer (e.g., specific tensile strength thresholds, cytotoxicity limits) and compared against the predicate's performance or established standards. The summary statement provides the overall conclusion of meeting these criteria.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. This submission relies on non-clinical testing (design verification, biocompatibility, sterilization, packaging, product performance), not a clinical test set from patients.
Data Provenance: Not applicable. The data is generated from laboratory and bench testing of the device components.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth as typically defined in diagnostic AI/clinical studies (e.g., patient outcomes, pathology) is not relevant for this non-clinical submission. The "ground truth" for the non-clinical tests is established by industry standards, engineering specifications, and comparison to the predicate device's known performance.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" of patient data requiring adjudication in this context.

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 is a medical device modification notification focused on non-clinical equivalence, not an AI-enabled device or a comparative effectiveness study involving human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-only or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" is established by engineering specifications, material science standards, and performance characteristics of the predicate device. For instance, biocompatibility would be assessed against ISO standards, and mechanical performance against the predicate's known capabilities.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this traditional medical device submission.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no "training set" for which ground truth would be established.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a summary of non-clinical testing. This testing included:

Design Verification: To ensure the modified anterior needle passer and connection interface for tissue fixation elements function as intended and meet design specifications.
Biocompatibility: To demonstrate that the device materials are safe for implantation.
Sterilization: To validate the sterilization process ensures the device is sterile.
Packaging: To confirm the packaging protects the device and maintains sterility during shelf life.
Product Performance Requirements: To show the device performs mechanically and functionally equivalently to the predicate.

The conclusion of these non-clinical tests "substantially equivalent to the predicate device, AMS Elevate Prolapse Repair Systems with PC Coated IntePro Lite" serves as the proof that the device meets the acceptance criteria for a 510(k) modification. The key modifications were the addition of a release mechanism to the anterior needle passer handle and slight changes to the geometry of the internal diameter and base of the tissue fixation elements to accommodate the new needle tip shape. The study demonstrated that these changes did not negatively impact the safety or effectiveness, thus proving substantial equivalence to the legally marketed predicate device.

Summary

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JUL - 1 2011

5.3 510(k) Summary Statement (21 CFR 807.92)

Submitter:

Owner/Operator:

Manufacturing Sites:

Contact Person:

Alternative Contact:

June 29, 2011

Device Common Name:

Summary Preparation Date:

Device Trade Names:

)

Class II, 21 CFR Part 878.3300

Surgical Mesh, polymeric (OTP);

Surgical Mesh

AMS Elevate® PC Apical and Posterior Prolapse Repair System with IntePro® Lite AMS Elevate 9 PC Anterior and Apical Prolapse Repair System with IntePro 6 Lite

Device Classification

Classification Name:

American Medical Systems (AMS) 10700 Bren Road West Minnetonka, MN 55343

American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55434-USA

American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55434-USA FDA Establishment Registration Number: 2183959

Sterigenics US, Inc. 7775 South Quincy Street Willowbrook, IL 60527 FDA Establishment Registration Number: 1450293

Mona Inman Senior Regulatory Affairs Specialist Phone: 952.930.6204 Fax: 952.930.5785 Mona. Inman@AmericanMedicalSystems.com

Laura Moen-Ftacek Principal Regulatory Affairs Specialist Telephone: 952-930-6426 Fax: 952-939-5785 Laura. Moen-Ftacek@AmericanMedicalSystems.com

Mesh, surgical, gynecologic, for pelvic organ prolapse transvaginally placed (OTP)

AMS Elevate® PC Prolapse Repair System with IntePro® Lite Special 510(k) Device Modification

Page 15 of 54

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Predicate Device:

AMS Elevate Prolapse Repair Systems with PC Coated IntePro Lite (K090713)

Indications for Use:

The indication for use for the AMS Elevate PC Prolapse Repair System has been revised from a general indication to a more specific indication based on the intended use of each mesh kit type. There is no change to the intended use of the device.

Elevate PC Anterior & Apical Repair System

Elevate PC Apical & Posterior Repair System

General Device Description

Summary of Non-Clinical Testing / Statement of Equivalence:

The components of the AMS Elevate PC Prolapse Repair Systems with IntePro Lite have been subjected to testing which included design verification, biocompatibility, sterilization, packaging, and product performance requirements. The test results conclude the AMS Elevate PC Prolapse Repair Systems with IntePro Lite to be substantially equivalent to the predicate device, AMS Elevate Prolapse Repair Systems with PC Coated IntePro Lite.

American Medical Systems considers the product performance to be significantly equivalent to the predicate device, AMS Elevate Prolapse Repair Systems with PC Coated IntePro Lite.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Mona Inman Senior Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West MINNETONKA MN 55343

SEP 2 8 2012

K111118 Re:

Trade/Device Name: 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 Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: June 2, 2011 Received: June 3, 2011

Dear Ms. Inman:

This letter corrects our substantially equivalent letter of July 1, 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/CDRH0ffices/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. Perkins

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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INDICATIONS FOR USE

510(K) Number (if known): K111118

Device Name: AMS Elevate® PC Anterior and Apical Prolapse Repair System with IntePro® Lite

Indications for Use:

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 OF NEEDED)

Concurrence of CDEH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and Urological Devices
510(k) Number	K111118

Regulation Number and Section

§ 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.