MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT

K050148 · Mentor Corporation · OTN · Mar 9, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050148
• Device Name: MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT
• Applicant: Mentor Corporation
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Mar 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mentor Aris Trans-obturator Surgical Kit consists of the Mentor Aris Trans-obturator Tape, an implantable, suburethral, support tape, plus introducers. The Tape and the Surgical Kit are indicated for the surgical treatment of all types of stress urinary incontinence (SUI), and for the treatment of all types of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Story

Mentor Aris Trans-obturator Surgical Kit is an implantable device for treating stress urinary incontinence. The system comprises a suburethral support tape made of knitted monofilament polypropylene fibers and a set of sterile, disposable introducer needles (one flat curved, two helical). During surgery, the physician uses the introducer needles to position the tape suburethrally to provide support. The tape's structure is designed to resist traction and facilitate tissue colonization. The device is used in a clinical/surgical setting by a physician. It provides mechanical support to the urethra to restore continence.

Clinical Evidence

Bench testing only. All mechanical, biological, and chemical testing specifications comply with established ISO, USP, EN, and/or NF standards.

Technological Characteristics

Implantable suburethral tape composed of knitted monofilament polypropylene fibers. Kit includes sterile, disposable stainless steel introducer needles (flat curved and helical). Device is non-electronic, mechanical, and provided sterile.

Indications for Use

Indicated for patients with stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Regulatory Classification

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.

Predicate Devices

• Mentor ObTape Trans-Obturator Tape and Surgical Kit (K031767)
• Mentor ObTape Trans-Obturator Tape and Surgical Kit (K042851)

Submission Summary (Full Text)

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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: | K050148 |
|--------------------------------|----------------------------------------|
| Contact Person: | Donna A. Crawford |
| | Director, Corporate Regulatory Affairs |
| | Mentor Corporation |
| | 201 Mentor Drive |
| | Santa Barbara, CA 93111 |
| Telephone: | 805-879-6304 |
| FAX: | 805-879-6015 |
| Date Prepared: | January 21, 2005 |

## Device Name and Classification

| Proprietary Name: | Mentor Aris Trans-obturator Tape and Surgical Kit |
|----------------------|---------------------------------------------------|
| Common Name: | Pubourethral Support Tape |
| Classification Name: | Surgical Mesh, polymeric |
| Class: | Class II |
| Product Code: | OTN |
| CFR #: | §878.3300 |

### Device Description

The Mentor Aris Trans-obturator Kit consists of two components: the Mentor Aris Transobturator Tape and a set of introducer needles.

The Mentor Aris Trans-obturator Tape is an implantable, suburethral, support tape made from knitted monofilament polypropylene fibers. This structure gives the Aris Tape resistance to traction, allows tissue colonization and facilitates positioning during surgery.

A set of sterile, disposable Introducer Needles (one flat curved introducer and a pair of helical introducers) necessary for implantation of the tape are also included in the Surgical Kit.

#### Substantial Equivalence Claim

The Mentor Aris Trans-obturator Tape and the Kit are substantially equivalent in material, function, performance and design to the Mentor ObTape Trans-Obturator Tape

**00013:**

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K050148 page 2

and Surgical Kit cleared under 510(k)s K031767 and K042851, respectively. It is also and Surgical K.It cleared under 310(KJs K051707 and 160 150 150 150 150 150 100 100 market...
substantially equivalent to other urethral support tape products currently on th

# Indications for Use

Mentor Aris Trans-obturator Surgical Kit consists of the Mentor Aris Trans-obturator Tape, an implantable, suburethral, support tape, plus introducers. The Tape and the I apc, an implantable, subdredizal, cappen reatment of all types of stress urinary Surgical Kit are indicated for the bargivary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

### Summary of Testing

All mechanical, biological, and chemical testing specifications comply with established ISO, USP, EN and/or NF standards.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.

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

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

SEP 2 8 2012

Re: K050148 Trade/Device Name: Mentor Aris Trans-obturator Tape and Surgical Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: January 21, 2005 Received: January 24, 2005

Dear Ms. Crawford:

This letter corrects our substantially equivalent letter of March 9, 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 (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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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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510(k) Number (if known): __ K 050148

Device Name: Mentor Aris Trans-obturator Tape and Surgical Kit

Indications for Use:

The Mentor Aris Trans-obturator Surgical Kit consists of the Mentor Aris Trans-obturator Tape, The Mentor Aris Trans-outuralor Surgion Introducers. The Tape and the Surgical Kit are
an implantable, suburethral, support tape, plus introducers. The Tapentinance (SUI), an an implanable, suburetural, support app, prac his stress urinary incontinence (SU), and for indicated for the surgical treatinent of an types or on case and or intrinsic sphincter deficiency.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per CFR 801.109) or

Over the Counter Use ____________

(Optimal Format 1-2-96)

Sin. Off

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_10050 149 000011