The Mentor Aris Suprapubic Surgical Kit is indicated for the surgical treatment of all types of stress urinary incontinence (SUI), and for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

The Mentor Aris Suprapubic Surgical Kit consists of two components: the Mentor Aris Sling and a set of Introducers. The Mentor Aris Sling is an implantable, suburcthral, support tape made from knitted monofilament polypropylene fibers. Two sterile, disposable flat curved Introducers necessary for implantation of the sling are also included in the Surgical Kit. The Introducers consist of a stainless steel needle with a plastic handle.

AI/ML Overview

The Mentor Aris™ Suprapubic Surgical Kit is a medical device for the surgical treatment of stress urinary incontinence. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a standalone study report.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Aris Sling Biocompatibility: Non-toxic, non-irritant	Demonstrated to be biocompatible under 510(k) K050148 (pre-cleared).
Aris Introducers Cytotoxicity (ISO 10993-5): Non-toxic	Results demonstrate the Introducers are non-toxic.
Aris Introducers Intracutaneous Reactivity (ISO 10993-10): Non-irritant	Results demonstrate the Introducers are non-irritants.
Aris Introducers Sling Pull-Out Force from Eyelet: Meets required specifications	Results demonstrate the Aris Introducers meet the required performance characteristic specifications for the intended use of the instruments.
Aris Introducers Torque and Tensile Performance of Handle/Needle Interface: Meets required specifications	Results demonstrate the Aris Introducers meet the required performance characteristic specifications for the intended use of the instruments.
Aris Introducers Needle Flexure Characterization: Meets required specifications	Results demonstrate the Aris Introducers meet the required performance characteristic specifications for the intended use of the instruments.
Aris Introducers Needle Stiffness Characterization: Meets required specifications	Results demonstrate the Aris Introducers meet the required performance characteristic specifications for the intended use of the instruments.

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

The document does not detail specific sample sizes for the testing described for the Aris Introducers. It generally states that "testing was performed."

The data provenance is not explicitly mentioned but typically in 510(k) submissions, testing is performed by the manufacturer or contracted labs. The studies listed are laboratory-based performance and biocompatibility tests, not clinical studies with human subjects.

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

This information is not applicable. The "ground truth" here refers to established standards (e.g., ISO guidelines for biocompatibility, engineering specifications for mechanical performance), not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" are relevant for clinical studies or evaluations involving human interpretation. The testing described is objective laboratory testing against predetermined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The device is a surgical kit, not an AI software or diagnostic tool that would involve human readers or image interpretation.

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

This is not applicable. The device is a physical surgical kit, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the testing described is based on:

International Standards: Specifically, ISO 10993-5 (cytotoxicity) and ISO 10993-10 (intracutaneous reactivity) for biocompatibility.
Engineering Specifications/Performance Characteristic Specifications: For the mechanical and physical properties of the Introducers (e.g., sling pull-out force, torque, tensile performance, flexure, stiffness). These specifications are set by the manufacturer to ensure the device performs as intended.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an AI model that requires a training set.

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

This is not applicable as there is no training set for this device.

Overall Study Information:

The "study" presented in this 510(k) summary is a set of tests designed to demonstrate that the Mentor Aris Suprapubic Surgical Kit (specifically the Introducers, as the Sling was previously cleared) meets established safety and performance requirements and is substantially equivalent to predicate devices. These tests include:

Biocompatibility Testing of Aris Introducers: Cytotoxicity per ISO 10993-5 and intracutaneous reactivity per ISO 10993-10. These tests determine if the device materials are harmful to biological systems.
Performance Testing of Aris Introducers: This involved evaluating the mechanical integrity and functionality of the Introducers, including:
- Sling pull-out force from the eyelet
- Torque and tensile performance of the handle/needle interface
- Needle flexure characterization
- Needle stiffness characterization

The results of these tests confirmed the Introducers are "non-toxic and non-irritants" and "meet the required performance characteristic specifications for the intended use of the instruments," supporting the claim of substantial equivalence. The document does not provide raw data, specific numerical thresholds for "acceptance criteria," or detailed test methodologies beyond the standard names mentioned.

Summary

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K053296
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DEC 16 2005

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

Contact Person: Donna A. Crawford Director, Domestic Regulatory Submissions Mentor Corporation 201 Mentor Drive Santa Barbara, CA 93111 Telephone: 805-879-6304

FAX: 805-879-6015

Date Prepared: November 23, 2005

Device Name and Classification

Proprietary Name:	Mentor Aris™ Suprapubic Surgical Kit
Common Name:	Pubourethral Support Tape
Classification Name:	Surgical Mesh, polymeric
Class:	Class II
Product Code:	OTN
CFR #:	§878.3300

Device Description

Substantial Equivalence Claim

The Mentor Aris Suprapubic Surgical Kit is substantially equivalent in material, function, performance and design to the Mentor Aris Trans-Obturator Tape and Surgical Kit cleared under 510(k) K050148, and to American Medical Systems' SPARC Sling System cleared under 510(k)s K011251, K013355, K020663 and K021263.

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K053296$_{2/2}$

Indications for Use

Mentor Aris Suprapubic Surgical Kit is indicated for the surgical treatment of all types of stress urinary incontinence (SUI), and for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Summary of Testing

The Aris Sling was demonstrated to be biocompatible under $10(k) K050148. The following biocompatibility testing was performed on the Aris Introducers: cytotoxicity per ISO 10993-5, and intracutaeous reactivity per ISO 10993-10. The results of the tests demonstrate that the Introducers are non-toxic and non-irritants.

Performance testing of the Aris Sling was previously performed under 510(k) K050148. The following testing was performed on the Aris Introducers: sling pull-out force from the eyelet; torque and tensile performance of the handle/needle interface; needle flexure characterization, and needle stiffness charactcrization. The results demonstrate that the Aris Introducers meet the required performance characteristic specifications for the intended use of the instruments.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Ms. Donna A. Crawford Director, Domestic Regulatory Submissions Mentor Corporation 201 Mentor Drive SANTA BARBARA CA 93111

SEP 2 8 2012

K053296 Re:

Trade/Device Name: Mentor Aris Suprapubic Surgical Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: November 23, 2005 Received: November 25, 2005

Dear Ms. Crawford:

This letter corrects our substantially equivalent letter of December 15, 2005.

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 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/ReportalProblem/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.

Sincerely yours,

Benjamin R. Krebs

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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K053296

Indications for Use

510(k) Number (if known): K053296

Mentor Aris™ Suprapubic Surgical Kit Device Name:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sarlare Buchner
(Division Sign-off)

Division of General, Restorative, and Neurological Devices

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510(k) Number K053296

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.