BARD COMPOSITE PROSTHESIS

K971745 · Davol Inc., Sub. C. R. Bard, Inc. · FTL · Aug 6, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971745
• Device Name: BARD COMPOSITE PROSTHESIS
• Applicant: Davol Inc., Sub. C. R. Bard, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Aug 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Composite Mesh is intended for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.

Device Story

Bard Composite Prosthesis is a surgical mesh for soft tissue reconstruction; used in hernia and chest wall defect repairs. Device consists of a double layer of knitted polypropylene monofilament (6 mil diameter) heat-bonded to a single layer of expanded polytetrafluoroethylene (e-PTFE). Polypropylene side facilitates tissue ingrowth via large pores; e-PTFE side limits ingrowth via small pores. Device is sterile and for single use. Surgeons implant the mesh to reinforce weakened tissue. Clinical benefit derived from structural support provided by the mesh layers and biocompatible interface. Performance assessed via physical, chemical, and in-vivo testing to ensure equivalence to predicate meshes.

Clinical Evidence

No human clinical trials. Evidence based on bench testing and in-vivo animal studies. Bench testing included pore size, surface roughness, suture retention, burst strength, FTIR, and DSC. In-vivo testing evaluated organ adhesion, tissue ingrowth, and overall performance in simulated clinical conditions. Biocompatibility testing conducted per ISO-10993, Part 1, confirming the device is non-toxic and non-sensitizing.

Technological Characteristics

Knitted polypropylene monofilament (6 mil diameter) bonded to expanded polytetrafluoroethylene (e-PTFE). Double-layer polypropylene mesh structure. Sterile, single-use implant. Biocompatibility testing per ISO-10993. Characterization via scanning electron microscopy, FTIR, and DSC.

Indications for Use

Indicated for reconstruction of soft tissue deficiencies, including repair of hernias and chest wall defects.

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 Marlex Mesh (Davol Inc.)
• GORE-TEX Dual Mesh (W. L. Gore & Associates, Inc.)

Submission Summary (Full Text)

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Javol Inc. Subsidiary of C. R. Bard, Inc. 100 Sockanossett Crossroad P.O. Box 8500 Cranston, RI 02920 401 463-7000

K971745

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Bard® Composite Prosthesis

AUG - 6 1097

## Section VII

# 510(k) Summary of Safety and Effectiveness Information

#### A. Submitter Information

| Submitter's Name: | Jeannette G. Cloutier |
|----------------------|----------------------------|
| Address | Davol Inc. |
| | 100 Soekanossett Crossroad |
| | Cranston, RI 02920 |
| Telephone No. | 401-463-7000, Ext. 2728 |
| Fax No. | 401-463-3845 |
| Contact Person: | Jeannette G. Cloutier |
| Date of Preparation: | May 9, 1997 |

#### B. Device Name

| Trade Name: | Bard Composite Prosthesis |
|----------------------|---------------------------|
| Common/Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh, Polymeric |

#### Predicate Devices Name ட்

| Trade Name: | Bard Marlex Mesh (Davol Inc.) |
|-------------|----------------------------------------------------|
| | GORE-TEX Dual Mesh (W. L. Gore & Associates, Inc.) |

#### D. Device Description

The proposed Composite Mesh is manufactured from knitted polypropylene monofilament with a diameter of 6 mil. The unique knitting process for the Composite Mesh produces a flat double layer of mesh. This double layer of mesh is knitted and interconnected simultaneously during the knitting process. One side of one layer of mesh is heat bonded to a single layer of expanded polytetrafluoroethylene (e-PTFF).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jeannette G. Cloutier Sr. Regulatory Affairs Administrator Davol. Inc. 100 Sockanossett Crossroad PO Box 8500 Cranston, Rhode Island 02920

AUG - 6 1997

K971745 Trade Name: Bard® Composite Prosthesis Regulatory Class: II Product Code: FTL Dated: May 9, 1997 Received: May 12, 1997

Dear Ms. Cloutier:

Re:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Ms. Jeannette G. Cloutier

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Hollyfa

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

Enclosure

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Section I - D

510(K) Number:

Device Name: BARD® COMPOSITE PROSTHESIS

K921745

Indications for Use:

Reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.

(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)

Or

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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#### E. Intended Use of the Device

The Composite Mesh is intended for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.

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

The 510(k) Substantial Equivalence Decision-Making Process (Detailed) decision tree (ODE guidance memo #K86-3) was utilized to make a determination of substantial equivalence. The answers to the following questions from this decision tree lead to a determination of substantial equivalence.

#### 1. Does New Device Have Same Indication Statements?

Yes. The proposed Composite Mesh and the Predicate GORE-TEX have identical intended use. Both devices are intended for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernia and chest wall defects.

The proposed Composite Mesh and the Predicate Marlex have similar intended use. The Predicate Marlex is indicated for use to Teinforce soft tissue where weakness exists, e.g., for repair of hernia and chest wall defects.

### Does New Device Have the Same Technological Characteristics, e.g., Design, Materials, 2. etc.?

No. The proposed Composite Mesh and the predicate devices are similar in that the devices are provided sterile, single use for the repair of hernias and chest wall defects. The proposed Composite Mesh and the Predicate GORE-TEX are manufactured to provide one side containing large pores for tissue ingrowth and an opposite side with small pores to limit ingrowth. The e-PTFE side of the Composite Mesh and the smooth side of Predicate GORE-TEX have similar surface morphology. Additionally, the proposed Composite Mesh is manufactured from knitted polypropylene monofilament with a diameter of approximately 6 mil, which is identical to the material used to knit the currently marketed Predicate Marlex. Also, the knit structure of the proposed Composite Mesh is similar to the knit structure of the Predicate Marlex.

However, the entire construction of the Composite Mesh includes two layers of polypropylene mesh and one layer of e-PTFE, while the Predicate GORE-TEX is manufactured from two layers of e-PTFE and the Predicate Marlex is manufactured from one layer of polypropylene mesh.

#### Could the New Characteristics Affect Safety or Effectiveness? 3.

Yes. The single layer of e-PTFE bonded to a double layer of polypropylene which comprises

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the Composite Mesh as compared to the two layers of e-PTFE for the Predicate GORE-TEX and the one layer of polypropylene for the Predicate Marlex could affect both safety and effectiveness.

#### Do the New Characteristics Raise New Types of Safety or Effectiveness Questions? 4.

No. Surgical meshes, such as the proposed Composite Mesh and the predicate devices, are generally intended for use in the reconstruction of soft tissue deficiencies. The safety and effectiveness questions are not new and include questions such as pore size, surface roughness, mesh strength, biocompatibility, and suture retention. Additionally, there are a variety of other meshes currently on the market with different characteristics compared to the proposed Composite Mesh or the predicate devices.

#### Do Accepted Scientific Methods Exist for Assessing Effects of the new Characteristics? ನ.

Yes. The assessment of the effects of the characteristics of the proposed Composite Mesh can be determined by performing common measures utilized for surgical implant fabrics in the industry. The assessments to characterize the effects include pore size, surface roughness, suture retention strength, burst strength and in-vivo testing.

#### Are Performance Data Available to Assess Effects of New Characteristics? 6.

Yes. Laboratory testing was performed to assess the effects of the new characteristics of the proposed Composite Mesh. These tests compared Composite Mesh against the predicate devices, where applicable. These tests include:

- the physical characteristics in terms of pore size, surface roughness, and surface (1) morphology (scanning electron micrographs);
- (2) performance in terms of suture retention and burst strength testing were performed;
- (3) the chemical characteristics of the e-PTFE of both the proposed Composite Mesh and the Predicate GORE-TEX by testing utilizing the Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC); and,
- in-vivo testing for a quantitative measure of organ adhesion characteristics of the e-(4) PTTE layer, a qualitative assessment of tissue ingrowin characteristics, and overall performance in a simulated clinical situation.

In addition, biocompatibility testing, performed in accordance with ODE memorandum #G95-1 (International Standard ISO-10993, Part 1), has been conducted on the proposed Composite Mesh.

#### 7. Does Performance Data Demonstrate Equivalence?

Yes. Based on the results of the laboratory testing provided in Section VI of this submission,

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the physical and chemical characteristics of the proposed Composite Mesh are comparable to that of the currently marketed predicate devices. Additionally, the results from the in-vivo testing indicate that the adhesion response for the proposed Composite Mesh is comparable to the Predicate GORE-TEX and the gross tissue ingrowth is comparable to both predicate devices. Results from the biocompatibility tests have shown that the proposed Composite Mesh is non-toxic and non-sensitizing.

Conclusion:

Based on the FDA's decision tree, the subject device, the proposed Composite Mesh, is substantially equivalent to the predicate devices.

Contact Person:

Jeanette G. Cloutier

Sr. Regulatory Affairs Administrator Dated:

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