SMALL BARD VENTRALEX PATCH

K024008 · C.R. Bard, Inc. · FTL · Feb 20, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K024008
• Device Name: SMALL BARD VENTRALEX PATCH
• Applicant: C.R. Bard, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Feb 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bard Ventralex Hernia Patch is intended for use in all forms of hernia repair requiring reinforcement with a nonabsorbable support material. The small Bard Ventralex Patch (REF 0010301) is also intended to repair soft tissue deficiencies including deficiencies caused by trocars.

Device Story

Self-expanding, three-layer surgical patch; two layers polypropylene mesh; one layer expanded polytetrafluoroethylene (ePTFE). Features monofilament PET polymer ring for stability; positioning strap and pocket for placement/fixation; strap removed post-fixation. Used in surgical hernia repair and soft tissue deficiency repair. Operated by surgeons in clinical/OR settings. Provides nonabsorbable reinforcement to tissue; facilitates placement via integrated positioning features.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Three-layer surgical mesh; polypropylene mesh layers; ePTFE layer; monofilament PET polymer ring. Heat-sealed edges; interlocking PTFE stitch pattern. Dimensions: small form factor. Non-absorbable. Sterile.

Indications for Use

Indicated for patients requiring hernia repair or repair of soft tissue deficiencies, including those caused by trocars, where reinforcement with nonabsorbable support material is necessary.

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

• Bard Ventralex Hernia Patch (K021736)

Submission Summary (Full Text)

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K024008

# FEB 2 0 2003

## SECTION 6.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE VENTRALEX PATCH

#### Submitter Information A.

| Submitter's Name: | Davol, Inc. |
|----------------------|--------------------------------|
| Address: | Subsidiary of C. R. Bard, Inc. |
| | 100 Sockanossett Crossroad |
| | Cranston, RI 02920 |
| Telephone: | 401-463-7000 ext. 2263 |
| Fax: | 401-463-3845 |
| Contact Person: | Brian A. Kanerviko |
| Date of Preparation: | December 3, 2002 |

#### B. Device Name

Small Bard Ventralex Patch

#### C. Predicate Device Name

Trade name: Bard Ventralex Hernia Patch (K021736)

#### D. Device Description

The proposed Ventralex Patch is a self-expanding, three layer device. Two layers consist of polypropylene mesh. The top layer of polypropylene mesh forms a positioning strap and pocket. The purpose of the strap and pocket is to facilitate placement, positioning and fixation of the device. After the device has been properly placed and attached, the positioning strap must be removed and properly discarded. The monofilament PET polymer "ring" is captured between the two layers of polypropylene mesh and adds stability to the device enabling greater simplicity and assurance in the proper placement. The third layer of the device is a single laver of expanded polytetrafluoroethylene (ePTFE) that is attached to the polypropylene mesh with an interlocking PTFE stitch pattern. The peripheral edge of the polypropylene mesh is heat sealed to the ePTFE layer.

#### E. Intended Use

The Bard Ventralex Hernia Patch is intended for use in all forms of hernia repair requiring reinforcement with a nonabsorbable support material. The small Bard Ventralex Patch is also intended to repair soft tissue deficiencies, including deficiencies caused by trocars.

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### Summary of Similarities and Differences in Technological F. Characteristics, Performance and Intended Use

The small Ventralex Patch has same technological and performance characteristics as the predicate Ventralex Patch.

The predicate Ventralex Patch is intended for use in all forms of hernia repair requiring reinforcement with nonabsorbable support material.

The Bard Ventralex Hernia Patch is intended for use in all forms of hernia repair requiring reinforcement with a nonabsorbable support material. The small Bard Ventralex Patch is also intended to repair soft tissue deficiencies caused by trocars.

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Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2003

C. R. Bard, Inc. c/o Davol, Inc. Brian A. Kanerviko Regulatory and Clinical Affairs Associate 100 Sockanossett Crossroad P. O. Box 8500 Cranston, Rhode Island 02920

Re: K024008

Trade/Device Name: Small Bard Ventralex Patch Regulation Number: 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: December 3, 2002 Received: December 4, 2002

Dear Mr.Kanerviko:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 - Mr. Brian A. Kanerviko

(21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely vours.

Muriam' C. Provost

(or Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

... . . . . . . .

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Ventralex Patch

Indications for Use: The Bard Ventralex Hernia Patch is intended for use in all forms of hernia repair requiring reinforcement with a nonabsorbable support material. The small Bard Ventralex Patch (REF 0010301) is also intended to repair soft tissue deficiencies including deficiencies caused by trocars.

(Please do not write below this line -- Continue on another page if needed)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Section

**OR**

Over-the Counter Use ____________

iriam C. Provost
(Optional Format 1-2-96)

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

510(k) Number_KO24008