AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

K063712 · C.R. Bard, Inc. · OTP · Mar 12, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K063712
• Device Name: AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
• Applicant: C.R. Bard, Inc.
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Mar 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Avaulta™ Support System is indicated for tissue reinforcement and longlasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.

Device Story

Avaulta Support System provides permanent, sterile, single-use surgical mesh for pelvic floor reconstruction. Device consists of nonabsorbable monofilament polypropylene mesh; Avaulta Plus variant includes additional porous, acellular, crosslinked collagen sheet to serve as protective barrier between mucosal tissue and mesh. Central soft knit section provides compliant organ support; strong knit arms facilitate tension-free fixation. Used by surgeons in clinical settings for anterior or posterior vaginal wall prolapse repair. Implant provides long-term reinforcement and stabilization of fascial structures; collagen layer in Plus version promotes host tissue and capillary vessel ingrowth.

Clinical Evidence

Bench testing only; performed in accordance with FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999).

Technological Characteristics

Nonabsorbable monofilament polypropylene mesh; Avaulta Plus includes acellular crosslinked collagen sheet. Features central soft knit section and strong knit arms. Sterile, single-use implant.

Indications for Use

Indicated for tissue reinforcement and stabilization of pelvic floor fascial structures in patients with vaginal wall prolapse requiring surgical mechanical support or bridging material for fascial defects.

Regulatory Classification

Identification

Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).

Predicate Devices

• Bard CollaMend™ Implant (K052322)
• UGYTEX® Dual Knit Mesh (K051503)

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.

- A. SUBMITTER INFORMATION:
Submitter's Name:

Address:

C. R. Bard, Inc. Bard Urological Division 13183 Harland Drive Covington, GA 30014

Contact Person: John C. Knorpp Contact Person's Telephone Number: 678-342-4920 Contact Person's Fax: [phone]

- B. DEVICE NAME:

| Trade Name(s): | Avaulta ^™ Solo Support System<br>Avaulta ^™ Plus Biosynthetic Support System |
|-----------------------|---------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Surgical Mesh |
| Classification Names: | 79 - Mesh, Surgical, Polymeric (OTP, PAI) |
| CFR Reference: | 21 CFR 878.3300 |
| Classification Panel: | General and Plastic Surgery |

## C. PREDICATE DEVICE NAME:

Bard CollaMend™ Implant - K052322 Trade Names: UGYTEX® Dual Knit Mesh – K051503

- D. Device Description:
The Avaulta™ Support System includes a sterile, single use, permanent implant that provides long term reinforcement to support structures in the correction of anterior or posterior vaginal wall prolapse. The central soft knit section provides compliant organ support while the strong knit arms provide improved strength for tension free fixation of the implant.

The Avaulta™ Plus Biosynthetic Support System and Avaulta™ Solo support system both utilize a nonabsorbable monofilament, polypropylene mesh to provide long-term reinforcement for support structures. The Avaulta™ Plus Biosynthetic Support System adds a porous, acellular, ultrathin sheet of crosslinked collagen attached to the polypropylene mesh which serves to establish a protective barrier between mucosal tissue and

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K0637/D
2/D

the polypropylene mesh and contains apertures uniformly sized to allow for ingrowth of host tissue and capillary vessels.

- E. Intended Use:
The Avaulta™ Support System is indicated for tissue reinforcement and longlasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.

## F. TECHNOLOGICAL CHARACTERISTICS SUMMARY:

The subject Avaulta™ Support System has the same intended use, general design and fundamental scientific technology as the predicate devices.

- G. Performance Data Summary:
The appropriate testing to determine substantial equivalence was completed. This includes testing in accordance with Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999).

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

SEP 2 8 2012

John C. Knorpp, RAC Manager, Regulatory Affairs Bard Urological Division 13183 Harland Drive COVINGTON GA 30014

Re: K063712 Trade/Device Name: Avaulta Solo™ Support System Avaulta Plus™ Biosynthetic Support System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, PAI Dated: December 8, 2006 Received: December 14, 2006

Dear Mr. Knorpp:

This letter corrects our substantially equivalent letter of March 12, 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 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 [phone] or [phone] 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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C.R. Bard, Inc., Bard Urological Division Avaulta™ Support System Premarket Notification [510(k)]

KO 63712

1.3 Indications for Use Statement

510(k) Number (if known): __

Device Name: _ Avaulta™ Support System

ે

Indications for Use:

The Avaulta™ Support System is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.

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)

Pelo R

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

11063112 510(k) Number

(Recommended Format 11/13/2003)