Elevate Anterior and Apical Prolapse Repair System The Elevate Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior wall prolapse and vaginal apical prolapse.

Elevate Apical and Posterior Prolapse Repair System The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior wall prolapse and vaginal apical prolapse.

Elevate Apical and Posterior Prolapse Repair System with InteXen® LP The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse.

Device Description

Each Elevate System consists of a permanently-implanted graft and non-implantable surgical instruments that can be used as aids to transvaginally place the graft assembly in the pelvic floor. The graft assemblies for the Elevate Anterior & Apical Prolapse Repair System and Elevate Apical & Posterior Prolapse Repair System are made from polymeric mesh (IntePro Lite), and in the case of the Elevate Apical & Posterior Prolapse Repair System with InteXen LP, the graft assembly is made from a combination of lyophilized porcine dermis and polymeric mesh (IntePro Lite).

The devices are identical to the predicate devices, AMS Elevate Prolapse Repair Systems, with the exception of the modification to the Apical Needle Passer Sheath. There are no changes to the implant graft design, shape, size, and material. The revisions to the indications for use of the modified devices are to further clarify the intended use of Elevate System as a kit for transvaginal surgical treatment.

AI/ML Overview

The provided document, K121612, is a 510(k) summary for the Elevate® Anterior and Apical Prolapse Repair System, Elevate® Apical and Posterior Prolapse Repair System, and Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP. This document states that the devices are substantially equivalent to their predicate devices and focuses on non-clinical testing for a modified sheath component. It explicitly states that no clinical testing was required. Therefore, a study demonstrating device performance against acceptance criteria in a clinical setting, including details like sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in this document.

The document primarily addresses the substantial equivalence of the modified devices to their predicates based on manufacturing process and design verification of a component (sheath).

Here's a breakdown of the available information from the document related to testing, recognizing that it does not provide the clinical study details requested:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical study demonstrating device performance against acceptance criteria is described, a direct table cannot be created as requested. The document focuses on performance of a modified sheath through non-clinical testing.

Acceptance Criteria (for modified sheath)	Reported Device Performance (Non-Clinical)
Sheath compression strength	Tested
Sheath depth stop strength	Tested
Trigger/sheath locking interface push strength	Tested
Sheath cutout shear off strength	Tested
Trigger/sheath locking interface pull strength	Tested
Sheath engagement force into lock	Tested
Biocompatibility (cytotoxicity & physiochemical testing)	Tested

Note: The document only states that these tests were performed and that the modified devices are considered substantially equivalent, implying the tests met their internal acceptance criteria for design verification. No specific numerical results or thresholds are provided in this summary.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not applicable in the context of clinical performance. For the non-clinical design verification tests of the sheath, the sample sizes are not specified.
Data Provenance: Not applicable for a clinical study. For design verification, the data would be laboratory-generated from American Medical Systems, Inc.

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 was established by experts from a clinical study for this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No clinical test set or human 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

No MRMC comparative effectiveness study was done, nor is there any mention of AI assistance.

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

This is not applicable as the device is a surgical mesh kit, not an algorithm or an AI-based system.

7. The type of ground truth used

Not applicable in the context of clinical performance. The "ground truth" for the non-clinical testing was defined by the specifications and parameters of the design verification tests for the components.

8. The sample size for the training set

Not applicable. This document describes a surgical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (and why no clinical study is presented):

The document K121612 outlines that the device (Elevate® Prolapse Repair Systems) underwent a 510(k) submission for a modification to an existing, legally marketed device. The modification was specifically to the "Apical Needle Passer Sheath" component.

The core of the submission relies on demonstrating substantial equivalence to the predicate devices (K082677, K082730, and an unnamed system). The rationale is that:

There were "no changes to the implant graft design, shape, size, and material."
There were "no modifications made to the packaging or sterilization."
There was "no change to the intended use or the implant procedure."

Therefore, the only testing required was non-clinical design verification and biocompatibility testing for the modified sheath. These tests included:

Sheath compression strength and depth stop strength.
Trigger/sheath locking interface push strength.
Sheath cutout shear off strength and trigger/sheath locking interface pull strength.
Sheath engagement force into lock.
Cytotoxicity & physiochemical testing for biocompatibility.

The document explicitly states: "no clinical testing was required to support the sheath modification" because "the Elevate Prolapse Repair Systems have equivalent clinical performance to the predicate devices." The acceptance criteria for these non-clinical tests would have been internal design specifications to ensure the modified sheath performed as intended and did not negatively impact the safety or effectiveness of the overall device compared to the predicate. The document concludes that based on these non-clinical tests and the unchanged nature of the implant and procedure, the modified devices are "substantially equivalent to the predicate devices."

Summary

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K121612

Page 1 of 5

AMS

an oracle health solution

JUL 20 2012

Section 5

510(k) Summary

Submitter's Name and Address

Ngoc Linh Pham Latchman Sr. Regulatory Affairs Specialist American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343 952-939-7056 (telephone) 952-930-5785 (fax) Linh PhamLatchman@AmericanMedicalSystems.com

Alternate Contact Name and Information

Josh Clarin Manager, Regulatory Affairs American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343 952-939-7072 (telephone) 952-930-5785 (fax) Josh. Clarin@AmericanMedicalSystems.com

Date the Summary was Prepared

July 20, 2012

Device Classification Name

Mesh, surgical, gynecologic, for pelvic organ prolapse, transvaginally placed (OTP) Mesh, surgical, non-synthetic; urogynecologic, for pelvic organ prolapse, transvaginally placed (PAI)

Device Common/Usual Name

Surgical Mesh

Device Trade/Proprietary Name

Elevate® Anterior and Apical Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP

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510(k) Summary

Device Trade/Proprietary Name

Elevate® Anterior and Apical Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP

Product Code

OTP & PAI :

Classification of Device

Class II / 21 CFR § 878.3300

Predicate Device(s)

Device Name	Submission Number
AMS Elevate Anterior and Apical Prolapse Repair System withIntePro Lite	K082677
AMS Elevate Apical and Posterior Prolapse Repair System withIntePro Lite	K082730
AMS Elevate Apical and Posterior Prolapse Repair System withInteXen LP

Device Description

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510(k) Summary

Existing Intended Use & Proposed Indication for Use

Existing indications for use

Elevate Anterior and Apical Prolapse Repair System The Elevate Anterior & Apical Repair System is intended for the treatment of anterior and/or apical vaginal prolapse.

Elevate Apical and Posterior Prolapse Repair System The Elevate Apical & Posterior Repair System is intended for the treatment of apical and/or posterior vaginal prolapse.

Proposed indications for use

The following are revisions to the indications for use to further clarify that the Elevate System Repair Systems are intended for transvaginal surgical treatment.

Elevate Anterior and Apical Prolapse Repair System

The Elevate Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior wall prolapse and vaginal apical prolapse.

Elevate Apical and Posterior Prolapse Repair System

The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior wall prolapse and vaginal apical prolapse.

Summary of the Technological Characteristics to the Predicate Device(s)

The modification to the Elevate Prolapse Repair Systems are deemed equivalent to the current device and there are no changes to the device intended use and/or device functional scientific technology.

The subject devices use the same surgical approach and implant placement procedures as the predicate devices.

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510(k) Summary

11121617

Bage 4 of 5

Summary of Non-Clinical & Clinical Testing

The modified sheath of the Elevate Anterior and Apical Prolapse Repair System, Elevate Apical & Posterior Prolapse Repair System, and Elevate Apical & Posterior Prolapse Repair System with InteXen LP has been tested for design verification and biocompatibility (cytotoxicity & physiochemical testing). Design verification testing of the sheath included the following tests:

sheath compression strength and depth stop strength, .
trigger/sheath locking interface push strength, ●
sheath cutout shear off strength and trigger/sheath locking interface pull . strenath
sheath engagement force into lock .

There were no modifications made to the packaging or sterilization of the devices as a result of the change; thus, no additional testing was required. There was no change to the intended use or the implant procedure as a result of the change: thus the Elevate Prolapse Repair Systems have equivalent clinical performance to the predicate devices and no clinical testing was required to support the sheath modification

American Medical Systems considers the Elevate Anterior & Elevate Posterior devices' product performance to be substantially equivalent to the predicate devices.

Substantial Equivalence

The modified Elevate Anterior and Elevate Posterior devices use the same surgical approach and implant placement procedures as the predicate devices, Elevate Anterior & Elevate Posterior.

The modified Elevate Anterior and Elevate Posterior devices have identical intended use, identical implant materials, identical sterilization methods; and similar delivery tool materials/characteristics as the predicate.

The proposed Elevate Anterior and Elevate Posterior device performance and fundamental scientific technology remains unchanged. The differences between the proposed device and the predicate device do not negatively affect the safety and effectiveness of the device.

Conclusion

AMS considers the modified Elevate Anterior and Elevate Posterior devices to be substantially equivalent to the predicate devices.

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11121612 se Sof 5

510(k) Summary

Manufacturing Facility

American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343

Establishment Registration Number: 2183959

Sterilization Facility

Sterigenics US, Inc. 7775 S Quincy St. Willowbrook, IL 60527

Establishment Registration Number: 1450293

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three stylized lines forming the body and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

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

Ms. Ngoc Linh Pham Latchman Senior Regulatory Affairs Specialist American Medical Systems, Inc. 10700 Bren Road West MINNETONKA MN 55343

JUL 20 2012

Re: K121612

Trade/Device Name: Elevate® Anterior and Apical Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP

Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OTP, PAI Dated: May 31, 2012 Received: June 28, 2012

Dear Ms. Latchman:

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

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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" (21CFR 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.

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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Statement of Indications for Use

Section 6

510(k) Number: K121612

Device Name: Elevate® Anterior and Apical Prolapse Repair System

Indications for Use:

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)
--------------------------------------------------------

	7/20/12
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, andUrological Devices
510(k) Number	K121612

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Section 6

510(k) Number: K121612

Elevate® Apical and Posterior Prolapse Repair System Device Name:

Indications for Use:

Prescription Use __ X (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 !F NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division/Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K121612

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Section 6 Statement of Indications for Use,

510(k) Number: K121612

Device Name: Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP

Indications for Use:

Prescription Use _ X (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)

Beutun R. Fuch 20 July 2012

vision Sign-Off of Reproductiv

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.