The IntePro® Y-Mesh is intended for use in vaginal prolapse repair via abdominal sacrocolpopexy procedures, including but not limited to open, laparoscopic, and robotically assisted surgical approaches.

Device Description

The IntePro® Y-Mesh is constructed of polypropylene suture (fibers) knitted together to form a mesh. The mesh has bi-directional elasticity and resists unraveling. The mesh is provided as a sterile, single use device in a pre-formed Y-shape for sacrocolpopexy procedures.

AI/ML Overview

This document describes a 510(k) submission for the IntePro® Y-Mesh. The key information is that the device is identical in all technical characteristics (design, materials, manufacturing, intended use) to its predicate device, the IntePro® AMS Large Pore Polypropylene Mesh (K040521).

Therefore, the submission does not include a study to prove the device meets acceptance criteria in the way you've outlined. This is because the regulatory pathway chosen, a 510(k) for substantial equivalence, relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. When a device is identical to its predicate, no new performance studies are typically required to establish new acceptance criteria.

The FDA's letter explicitly states: "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...". This determination is based on the claim of identity to the predicate.

Therefore, many of the requested fields are not applicable to this 510(k) submission. I will indicate "Not Applicable" or explain why the information isn't present based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Applicable (see explanation below)	Not Applicable (see explanation below)

Explanation: The 510(k) summary states, "All technical characteristics of the proposed device are identical to those of the predicate, including device design, materials of construction, manufacturing process and intended use." Because the device is claimed to be identical to a previously cleared predicate device (IntePro® AMS Large Pore Polypropylene Mesh, K040521), specific new acceptance criteria and a study to prove performance against new criteria are not presented in this summary. The substantial equivalence argument relies on the predicate device's established safety and effectiveness.

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

Not Applicable. No new performance testing in a "test set" for clinical data is described for this specific device in the provided summary, as it relies on substantial equivalence to an identical predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No new clinical performance testing requiring expert ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No new clinical performance testing requiring adjudication for a test set 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 is a surgical mesh device, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

Not Applicable. This is a surgical mesh device, not an algorithm or AI system.

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

Not Applicable. No new clinical performance testing requiring ground truth for this device is described. The basis for clearance is identity to a predicate device.

8. The sample size for the training set

Not Applicable. This is a surgical mesh device, not an algorithm requiring a training set.

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

Not Applicable. This is a surgical mesh device, not an algorithm requiring a training set and associated ground truth.

Summary

{0}------------------------------------------------

PAGE 1 of 2

510(k) Summary As required by 21CFR 807.92

510(k) Number:	K121805	OCT 16 2012
Date Prepared:	August 29, 2012
Submitter's Name/Address:	American Medical Systems10700 Bren Road W.Minnetonka, MN 55343
Contact Person:	Laura Moen-FtacekPrincipal Regulatory Affairs SpecialistTel: 952-930-6426Fax: 952-930-5785Laura.Moen-Ftacek@AmericanMedicalSystems.com
Alternate Contact:	Melanie HessDirector, Regulatory AffairsTel: 952-939-6094Fax: 952-930-5785Melanie.Hess@AmericanMedicalSystems.com
Device Information:
Trade Name:Common Name:Classification Name:	IntePro® Y-MeshSurgical MeshMesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed

Predicate Device:

IntePro® AMS Large Pore Polypropylene Mesh (K040521)

Product Code:

Device Description:

ото

Indications for Use:

Summary of the Technical Characteristics to the Predicate Device(s):

All technical characteristics of the proposed device are identical to those of the predicate, including device design, materials of construction, manufacturing process and intended use.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.

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

OCT 16 2012

Ms. Renee Mellum Senior Regulatory Affairs Associate American Medical Systems 10700 Bren Road West MINNETONKA MN 55343

Re: K121805

Trade/Device Name: IntePro® Y-Mesh Regulation Number: 21 CFR& 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: October 1, 2012 Received: October 3, 2012

Dear Ms. Mellum:

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 (reporting of medical

{2}------------------------------------------------

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 K. Firkle

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

{3}------------------------------------------------

Indications for Use

510(k) Number (if known): K121805

Device Name: IntePro® Y-Mesh

Indications for Use: The IntePro® Y-Mesh is intended for use in vaginal prolapse repair via abdominal sacrocolpopexy procedures, including but not limited to open, laparoscopic, and robotically assisted surgical approaches.

X 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)

Jopph K. Khaz

(Division Sign-Off) ( vision of Reproductive, Gastro-Renal, an Urological Devices 510(k) Number =

Page 1 of 1

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.