ALIGN URETHRAL SUPPORT SYSTEM

K070073 · C.R. Bard, Inc. · OTN · Mar 21, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070073
• Device Name: ALIGN URETHRAL SUPPORT SYSTEM
• Applicant: C.R. Bard, Inc.
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Mar 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Align™ Urethral Support System is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Story

The Align™ Urethral Support System is a sterile, single-use permanent implant designed to provide urethral support. The device consists of a knitted, open-porosity, monofilament polypropylene mesh strip. The mesh design features large pores to facilitate macrophage penetration and tissue ingrowth, creating permanent urethral support. The material is soft and pliable due to small fiber diameter. The system is offered in multiple configurations, including retropubic, suprapubic, and transobturator, to facilitate surgical implantation. The device is used by surgeons in a clinical setting to treat stress urinary incontinence, potentially improving patient quality of life by restoring urethral stability.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: knitted, monofilament polypropylene mesh. Design: open porosity, large pore size, small fiber diameter. Form factor: mesh strip with multiple surgical configurations (retropubic, suprapubic, transobturator).

Indications for Use

Indicated for female patients with stress urinary incontinence caused by 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

• Uretex® TO Trans-Obturator Urethral Support System (K041176)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

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

- SUBMITTER INFORMATION: A.

| Submitter's Name: | C. R. Bard, Inc.<br>Bard Urological Division |
|------------------------------------|----------------------------------------------|
| Address: | 13183 Harland Dr.<br>Covington, GA 30014 |
| Contact Person: | Julie J. Bassett |
| Contact Person's Telephone Number: | 678-342-4921 |
| Contact Person's Fax: | 770-788-5517 |
| Date of Preparation: | March 9, 2006 |

### B. DEVICE NAME:

| Trade Name(s): | Bard Align™ Urethral Support System |
|-----------------------|------------------------------------------------------------------------------------|
| Common/Usual Name: | Urethral Sling; Surgical Mesh |
| Classification Names: | 79 OTN-Mesh, Surgical, Polymeric; CFR Reference:<br>21 CFR 878.3300, Surgical mesh |

- PREDICATE DEVICE NAME: C.
- Uretex® TO Trans-Obturator Urethral Support System Trade Name(s):
- D. Device Description:

The Align™ Urethral Support System includes a sterile, single use permanent implant that provides strong, stable support for the urethra in patients with stress urinary incontinence. The mesh consists of a knitted, open porosity, monofilament, polypropylene mesh strip. The open porosity of the mesh design and large pore sizes allows for macrophage penetration and tissue ingrowth to promote the creation of a permanent support for the urethra. The knitted polypropylene mesh is made from a small fiber diameter which creates a soft and pliable material.

Several configurations of this device will be offered, including retropubic, suprapubic, and transobturator, which are used to implant the device.

The principles of operation and fundamental scientific technology have not changed from the predicate.

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### E. Intended Use:

The Align™ Urethral Support System is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The intended use has not changed from the predicate (K041176).

## TECHNOLOGICAL CHARACTERISTICS SUMMARY: F.

The subject device, the Align™ Urethral Support System, has the same intended use, general design and fundamental scientific technology as the predicate device (K041176).

#### G. PERFORMANCE DATA SUMMARY:

The appropriate testing, including guidance testing, to determine substantial equivalence of the Align™ Urethral Support System was conducted.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

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

SEP 2 8 2012

C.R. Bard, Inc. % Ms. Julie J. Bassett. RAC Regulatory Affairs Specialist 13183 Harland Drive COVINGTON GA 30014

Re: K070073 Trade/Device Name: Align™ Urethral Support System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: January 5, 2007 Received: January 8, 2007

Dear Ms. Bassett:

This letter corrects our substantially equivalent letter of March 21, 2007.

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. Fuchs

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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C.R. Bard, Inc., Bard Urological Division Align™ Urethral Support System Premarket Notification {510(k)]

1.3 Indications for Use Statement

510(k) Number (if known): _

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Align™ Urethral Support System is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

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)

(Recommended Format 11/13/2003)

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

**510(k) Number** L070073

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