BARD 3DMAX MESH

K081010 · Davol Inc., Sub. C. R. Bard, Inc. · FTL · Oct 7, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081010
• Device Name: BARD 3DMAX MESH
• Applicant: Davol Inc., Sub. C. R. Bard, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Oct 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The modified Bard 3DMAX Mesh is a sterile, single use device indicated to reinforce soft tissue where weakness exists e.g. for repair of hernias and chest wall defects. The intended use for the modified device is exactly the same as the predicate devices, 3DMAX Mesh, Bard Mesh and Usher's Marlex Tubular Mesh.

Device Story

Bard 3DMAX Mesh is a sterile, single-use surgical mesh designed for laparoscopic inguinal hernia repair. The device features a preformed, curve-shaped, knitted polypropylene monofilament structure that conforms to inguinal anatomy; it includes an M-shaped orientation marker with an arrow to assist surgeons in correct placement. The mesh is stretchable in two directions to reinforce tissue defects. Used by surgeons in an operating room setting, the device provides a structural scaffold for tissue reinforcement. The modification involves sourcing the medial marker material (polypropylene and Phthalocyaninato(2-) copper dye) from a different vendor, which was validated through biocompatibility and laboratory testing to ensure substantial equivalence to the predicate devices.

Clinical Evidence

No clinical data. Substantial equivalence was established through biocompatibility testing and comparative laboratory testing against the predicate devices, confirming the modified device is safe and effective.

Technological Characteristics

Knitted polypropylene monofilament surgical mesh; 7.5 mm diameter filaments. Curve-shaped, preformed design with sealed edges. Includes an M-shaped orientation marker composed of polypropylene and Phthalocyaninato(2-) copper dye. Sterile, single-use device.

Indications for Use

Indicated for reinforcement of soft tissue where weakness exists, specifically for the repair of hernias and chest wall defects in patients requiring surgical intervention.

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 Mesh (Davol Inc.)
• Bard 3DMAX Mesh (Davol Inc.)
• Usher's Marlex Tubular Mesh (Davol Inc.)

Submission Summary (Full Text)

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# SECTION 7.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

#### A. Submitter Information

| Submitter's Name: | Davol Inc. |
|----------------------|------------------------------------------------------------------------------------|
| Address: | Subsidiary of C. R. Bard, Inc.<br>100 Sockanossett Crossroad<br>Cranston, RI 02920 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Stephanie Baker |
| Date of Preparation: | March 20, 2008 |

#### B. Device Name

| Trade Name: | Bard 3DMAX Mesh |
|----------------------|-----------------|
| Common/Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh |

#### C. Predicate Device Name

Trade name: Bard Mesh (Davol Inc.) Trade name: Bard 3DMAX Mesh (Davol Inc.) Trade name: Usher's Marlex Tubular Mesh (Davol Inc.)

#### D. Device Description

The modified Bard 3DMAX Mesh is anatomically designed to fit the inguinal anatomy. The device is curve shaped and preformed with sealed edges that allow for easier positioning of the device than a traditional flat sheet of mesh in a laparoscopic inguinal hernia repair. The device is constructed of knitted polypropylene monofilaments 7.5 millimeters in diameter. The knit construction allows the mesh to be stretched in both directions in order to accommodate and reinforce tissue defects. The device contains an orientation marker in an M shape with an arrow to facilitate mesh positioning and placement.

PREMARKET NOTIFICATION FOR THE BARD 3DMAX MESH

-CONFIDENTIAL-

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K081010
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#### ட். Intended Use

The modified Bard 3DMAX Mesh is a sterile, single use device indicated to reinforce soft tissue where weakness exists e.g. for repair of hernias and chest wall defects. The intended use for the modified device is exactly the same as the predicate devices, 3DMAX Mesh, Bard Mesh and Usher's Marlex Tubular Mesh.

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

The modified 3DMAX Mesh device and the currently marketed 3DMAX Mesh and Bard Mesh devices are all indicated to reinforce soft tissue where weakness exists e.g. for repair of hernias and chest wall defects. Usher's Marlex Tubular Mesh is also indicated for use in hernia repair.

In addition, all products are similar in technological characteristics and performance. The modified 3DMAX Device differs from the currently marketed 3DMAX device in medial marker material only. The medial marker material used in the modified 3DMAX device will be purchased from a different vendor. The main components of the medial marker, polypropylene and Phthalocyaninato(2-) copper dye will remain the same. However, these items will be purchased from a different vendor and extruded to form a dyed polypropylene monofilament. As a result, there may be slight variations in the medial marker material formulation used in the modified device as compared to the currently marketed 3DMAX Mesh medial marker. These slight variations were evaluated through biocompatibility testing as well as laboratory testing.

#### G. Performance Data

Biocompatibility testing was performed on the modified 3DMAX device. Testing performed to date indicates that changes made to the 3DMAX device do not impact its biocompatibility profile. In addition, laboratory testing was performed to compare the modified 3DMAX Mesh device to the currently marketed 3DMAX Mesh and Bard Mesh devices. The results show that the modified device is substantially equivalent to the currently marketed predicate devices. Therefore, based on laboratory testing and biocompatibility data, the modified 3DMAX device is safe and effective for its intended use.

## PREMARKET NOTIFICATION FOR THE BARD 3DMAX MESH

-CONFIDENTIAL-

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.

Public Health Service

OCT 0 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stephanie Baker Senior Regulatory Affairs Associate Davol Incorporated Subsidiary of C.R. Bard, Incorporated 100 Sockanossett Crossroad Cranston, Rhode Island 02920

Rc: K081010

Trade/Device Name: Bard 3DMAX Mesh Regulation Number: 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: August 6, 2008 Received: August 7, 2008

Dear Ms. Baker;

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 may 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.

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Page 2- Ms. Baker

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Scctions 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATION FOR USE STATEMENT

2081010 510(k) Number (if known): Not Know

Device Name: Bard 3DMAX Mesh

Indications for Use: The Bard 3DMAX Mesh is a sterile, single use device indicated to reinforce soft tissue where weakness exists e.g. for repair of hernias and chest wall defects.

Prescription Use X Use (Part 21 CFR 801 Subpart D) Subpart C)

AND/OR

Over-The-Counter

(21 CFR 801

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ryder Sr. mkr

(Division Sign-Off) Division of Anesthesiology, General H Infection Control, Dental Devices

sion of Ceneral, Restorative, ogled Devices and Neuro!

510(k) Number

510(k) Number:

016