ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS

K093747 · C.R. Bard, Inc. · OTN · May 7, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093747
• Device Name: ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS
• Applicant: C.R. Bard, Inc.
• Product Code: OTN · General, Plastic Surgery
• Decision Date: May 7, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Align® Urethral Support System is a sterile, single-use permanent implant for female stress urinary incontinence. Device consists of a knitted, open-porosity, monofilament polypropylene mesh strip designed for tissue ingrowth. Mesh is encased in a removable protective sheath assembly featuring a stainless steel dilator to smooth transition during placement and facilitate sheath removal. Green polyurethane tubes at sheath ends aid visualization during cystoscopy. Device is provided in various kit configurations for retropubic, suprapubic, or transobturator surgical approaches. During implantation, surgeon places mesh to provide urethral support; sheath is subsequently removed. Device acts as an inert scaffold for tissue ingrowth, providing permanent urethral support to benefit patients by alleviating incontinence symptoms.

Clinical Evidence

No clinical data provided; substantial equivalence determined via non-clinical bench and cadaver testing.

Technological Characteristics

Materials: Polypropylene (mesh), PTFE (sheath tube), polyurethane (tubing), stainless steel (dilator). Principle: Permanent implantable mesh scaffold for tissue ingrowth. Form factor: Knitted monofilament strip with protective sheath. Sterilization: Sterile, single-use.

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

• Align® Urethral Support System (K070073)
• Align® TO Urethral Support System (K070073)

Reference Devices

• American Medical System's Monarc Sling (K051530, K081613)
• Boston Scientific's Obtryx® / Lynx® Sling (K081275)

Submission Summary (Full Text)

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Bard Medical Division C & Bad Inc 9195 Industral Blu. Councin GA 10514

# MAY - 7 2010

## 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:

Address:

Contact Person: Contact Person's Telephone Number: Contact Person's Fax:

Covington, GA 30014 John Knorpp

Bard Medical Division 8195 Industrial Blvd.

770-784-6316 770-385-4706

C. R. Bard, Inc.

Summary Prepared On:

February 17, 2010

## B. DEVICE NAME:

Align® Urethral Support System Trade Name(s): Align® TO Urethral Support System Common/Usual Name: Surgical Mesh Mesh, Surgical, Polymeric Classification Name: (21 CFR 878.3300, Product Code OTN

## C. PREDICATE DEVICE NAME:

| Trade Names: | Align ^® Urethral Support System |
|--------------|-----------------------------------------------|
| | Align ^® TO Urethral Support System |
| | K070073 |

## D. DEVICE DESCRIPTION:

The Align® Urethral Support System and Align® TO Urethral Support System (Align® System) include a sterile, single use permanent implant that provides support for the urethra in female patients with stress urinary incontinence. The mesh consists of a knitted, open porosity, monofilament, polypropylene mesh strip, which is self-anchoring. The open porosity of the mesh design and large pore sizes allow for macrophage penetration and the creation of an inert scaffold for tissue ingrowth to create a permanent support for the urethra. The knitted polypropylene mesh is made from a small diameter fiber which creates a soft and pliable material.

The mesh sling is encased in a removable, protective sheath assembly. The sheath assembly consists of a PTFE tube with a Peel-Away tab that is used to separate the two sections of the sheath for removal of the sheath assembly after the implant has

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K093747

been placed. At the ends of the sheath are flexible green polyurethane tubes to aid in placing the device and for easy visualization during cystoscopy. The sheath incorporates a stainless steel dilator that smoothes the transition from the green tubing to the protective sheath to aid in sheath removal. Push on polypropylene connectors at each end of the green tubes are used to connect the device to the introducers.

Because of the different surgical approaches that may be used to place the device, the same implant is offered in several kit configurations depending on the surgical approach (retropybic, suprapubic, or transobturator) to be used for placement of the mesh implant.

- E. INTENDED USE:
The Align® System is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. There have been no changes to the intended use or indications for use.

#### F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:

The subject device Align® System has the same design, materials and fundamental scientific technology as the predicate device (described above) with the exception of the dilator. The predicate device does not include a dilator. The subject device incorporates a stainless steel dilalor that smoothes the transition from the green lubing to the protective sheath to aid in sheath removal.

- Non-clinical Performance Data Summary: G.
The tests performed include dimensional, tensile strength and insertion force testing. A cadaver study was also performed to evaluate the ability of the sheath to easily glide through lissue during implantation and the ease of sheath removal. The results of these non-clinical tests demonstrate that the subject device met the predetermined acceptance criteria and performed as well or better than the predicate device and/or other legally marketed devices that incorporate a dilating feature (American Medical System's Monarc Sling (K051530, K081613) and Boston Scientific's Obtryx® / Lynx® Sling (K081275)).

- H. Clinical Data Summary:
Clinical data is not necessary to determine substantial equivalence.

- l, CONCLUSION:
The results from the non-clinical performance data summarized above demonstrate that the Align System is as safe, as effective, and performs as well as or better than the predicate device and/or other legally marketed devices that incorporate a dilating feature.

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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 features a stylized image of an eagle with its wings spread, oriented to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all caps and is in a simple, sans-serif font.

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

C.R. Bard, Inc. % Ms. Michelle Gudith Bard Medical Division 8195 Industrial Boulevard COVINGTON GA 30014

SEP 2 8 2012

Re: K093747 Trade/Device Name: Align® Urethral Support System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: April 8, 2010 Received: April 8, 2010

Dear Ms. Gudith:

This letter corrects our substantially equivalent letter of May 7, 2010.

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 (2) 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 100.97). 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 Four may 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. 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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C.R. Bard, Inc., Bard Medical Division Align® Urethral Support System Premarket Notification [510(k)]

1.4 Indications for Use Statement

510(k) Number (if known): _

Device Name: __ Aligny Urethral Support System

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 (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)

Daniel Krouise for MXM

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093747

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