OPHIRA MINI SLING SYSTEM

K110420 · Promedon S.A · PAH · May 8, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K110420
• Device Name: OPHIRA MINI SLING SYSTEM
• Applicant: Promedon S.A
• Product Code: PAH · General, Plastic Surgery
• Decision Date: May 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ophira™ Mini Sling is intended to be used for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Device Story

Ophira™ Mini Sling System is a surgical implant for female stress urinary incontinence. Device consists of a sterile monofilament polypropylene mesh sling with two polypropylene fixation arms and a retractable insertion guide. Fixation arms feature multiple points for self-anchoring into the internus transobturator muscle, eliminating the need for sutures. A center mark on the mesh assists in symmetrical placement. Temporary adjustment sutures are included on fixation arms to allow tension modification during implantation, then removed. Used by surgeons in a clinical setting to provide suburethral support. Benefits include minimally invasive placement and adjustable tensioning for optimal patient outcomes.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Monofilament polypropylene mesh and polypropylene fixation arms. Principle: Self-anchoring surgical mesh for suburethral support. Form factor: Sling with retractable insertion guide. Sterilization: Sterile. No software or electronic components.

Indications for Use

Indicated for female patients with stress urinary incontinence caused by urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

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

• MiniArc Precise™ Single-Incision Sling (K100807)

Submission Summary (Full Text)

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## MAY - 8 2012

## 510(K) SUMMARY

## Ophira™ Mini Sling System

## Submitter's name and address:

Promedon S.A.

Av Gral Manuel Savio s/n

Lote 3 - Manzana 3 - Parque Industrial Ferreyra

- X5925XAD
Cordoba, Argentina

## Contact person and telephone number:

Sofia Olivero

Quality Assurance and Regulatory Affairs Manager Telephone: [phone] Fax: [phone]

## Date Summary was prepared:

February 11, 2011

#### Name of the device:

Proprietary Name: Common Name: Classification Name: Product Code:

OphiraTM Mini Sling System Mesh, Surgical (21 CFR 878.3300) OTN

#### Substantial Equivalence:

Ophira™ Mini Sling System is substantially equivalent in function and intended use to MiniArc Precise™ Single-Incision Sling, which has been cleared under K100807.

## Device Description:

Ophira™ Mini Sling System consists of a sterile polypropylene sling and a sterile retractable insertion guide for sling placement. The sling is composed of monofilament polypropylene mesh between two polypropylene fixation arms; the fixation arms have multiple fixation points along the arms, which is the basis of the autofixing system, i.e., the two fixation arms are self anchored to the internus transobturator muscle and, therefore, the sling needs no sutures. An easily identifiable mark in the center of the mesh sling helps to achieve a symmetrically centered location for the proper placement of the sling. The sling has a suture inserted onto each fixation arm to provide the ability to adjust tension, if necessary, during the procedure for optimum suburethral support. These sutures are removed once the implantation procedure is completed.

## Intended Use:

Ophira™ Mini Sling is intended to be used for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

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Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine.

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

Promedon S.A. % Ms. Stephanie D. Rais Consultant SDRS LLC 221 Ellis Parkway PISCATAWAY NJ 08854

MAY - 8 2012

Re: K110420

> Trade/Device Name: Ophira™ Mini Sling System Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: April 25, 2012 Received: April 26, 2012

Dear Ms. Rais:

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

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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 [phone] or [phone] 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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# Indications for Use Form

## Indications for Use

510(k) Number (if known): Jaknown

K110420

Device Name:

Ophira™ Mini Sling System

Indications for Use:

Ophira™ Mini Sling System is intended to be used for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

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 CDRH, Office of Device Evaluation (ODE)

thomashwhan

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(Division 'Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110420