VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH

K002672 · ETHICON, Inc. · FTL · Nov 22, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K002672
• Device Name: VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
• Applicant: ETHICON, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Nov 22, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

VYPRO Mesh is indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Story

VYPRO Mesh is a partially absorbable synthetic surgical mesh used for hernia or fascial defect repair. It consists of a composite structure of absorbable polyglactin 910 multifilament fiber and non-absorbable polypropylene multifilament fiber. The polyglactin component provides firmness to facilitate intraoperative handling; it is absorbed within 56 to 70 days, leaving behind the permanent polypropylene mesh structure to support the abdominal wall. The device is used by surgeons in an operating room setting. The porous structure allows for incorporation into surrounding tissues. The mesh provides strength, durability, and surgical adaptability for the patient.

Clinical Evidence

Clinical study compared VYPRO Mesh to MARLEX and ATRIUM meshes. Results indicated VYPRO Mesh is acceptable regarding mechanical and clinical characteristics, with some advantages noted in bench testing and clinical trials.

Technological Characteristics

Composite mesh of polyglactin 910 (90% glycolide, 10% lactide) and polypropylene multifilament fibers. Porous structure. Evaluated for thickness, burst strength, flexural rigidity, tear strength, suture pull-out, and tensile strength. Non-absorbable polypropylene component retains strength indefinitely; absorbable polyglactin component resorbs in 56-70 days.

Indications for Use

Indicated for patients requiring repair of hernia or other fascial defects needing reinforcing or bridging material.

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

• PROLENE (Polypropylene) Mesh (K002672)
• VICRYL (Polyglactin 910) Mesh (K002672)
• MERSILENE Polyester Mesh (K002672)

Reference Devices

• MARLEX Mesh
• ATRIUM Mesh

Submission Summary (Full Text)

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K002672

# NOV 2 2 2000

### SECTION 7

# SUMMARY OF SAFETY AND EFFECTIVENESS

### 510(k) Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

### MODIFIED DEVICE NAME: VYPRO* Mesh

PREDICATE DEVICE NAME: PROLENE* (Polypropylene) Mesh and VICRYL* (Polyglactin 910) Mesh for materials and indications and MERSILENE* Polyester Mesh for Indications For Use.

### 510(k) SUMMARY

...

#### Device Description

VYPRO Mesh is constructed from approximately equal parts of absorbable polyglactin 910 multifilament fiber and non-absorbable polypropylene multifilament fiber. The purpose of the absorbable polyglactin component is to add firmness to the polypropylene structure and thus make intraoperative handling of the mesh easier. The mesh affords excellent strength, durability and surgical adaptability, with a porous structure to enable mesh incorporation into surrounding tissues. The polymer of the polypropylene fiber is identical to that used in PROLENE* Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). This material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use.

Continued on next page

VYPRO* Mesh ETHICON, Inc.

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# SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

...

### 510(k) SUMMARY, Continued

Description (continued)

Intended Use

Indications Statement

Technological Characteristics

Performance Data

The polyglactin fiber consists of a copolymer containing 90% The polygiaoun 10% lactide. This copolymer is identical in gryconde and 107at used in VICRYL* (polyglactin 910) synthetic composition to that which has been found to be nonantigenic, absorbacts batand to elicit only a mild tissue reaction during nonpyrogeme and to enortial component is absorbed within 56 to absorption. The poryglacem on polypropylene mesh structure that 70 days, leaving the physiological stresses to which the abdominal wall is subject.

This mesh is intended for the repair of hernia or other fascial 1 mo most require the addition of a reinforcing or bridging material to obtain the desired surgical result.

This mesh is used for the repair of hernia or other fascial defects 1 mis mosil is aboution of a reinforcing or bridging material to obtain the desired surgical result.

The technological characteristics that were evaluated for VYPRO Mesh include: thickness, burst strength, flexural rigidity, tear strength, suture pull-out and tensile strength. The values strongin, sutters proPRO Mesh are less than those for PROLENE Mesh, but greater than MERSILENE Mesh. VYPRO Mesh has a NICSII, but grouter than ility and thickness than PROLENE Mesh, iarger porce bize, frigher burst strength than MERSILENE Mesh.

Nonclinical laboratory testing was not performed as there is no Nonemarous the clinical intended use as compared to the predicate devices. Sufficient bench testing was conducted in accordance with devices: Suitting document ""Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."

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VYPRO* Mesh ETHICON, Inc.

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# SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

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Performance Data (continued)

The results of a clinical study compared the use of VYPRO Mesh with MARLEX and ATRIUM Meshes. This study has found WYPRO Mesh to be acceptable with regard to mechanical and v ITTC Mosil to stics including some advantages in bench testing and clinical trials.

Conclusions

Based on the 510(k) summaries and 510(k) statements (21 CFR Dasod on the orrormation provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act.

Contact

Gregory R. Jones Director, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151

Date

August 25, 2000

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 2 2000

Mr. Gregory R. Jones Director, Regulatory Affairs Ethicon, Inc. Route 22 West P.O. Box 151 Somerville, New Jersey 08876

K002672 Re:

Trade Name: VYPRO Mesh VICRYL-PROLENE Partially Absorbable Synthetic Surgical Mesh

Regulatory Class: II Product Code: FTL Dated: August 25, 2000 Received: August 28, 2000

Dear Mr. Jones:

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 requirement, 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 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.

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Page 2 - Mr. Gregory R. Jones

This letter will allow you to begin marketing your device as described in your 510(k) rins letter will anow yourse obgan finding of substantial equivalence of your device to a premaince notification. - In 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 and additionally 60911594-4595. Additionally, for questions on the promotion and Compliance at (301) vice, please contact the Office of Compliance at [phone]. advortibing or your aregulation entitled, "Misbranding by reference to premarket Also, prease flore the regal 97). Other general information on your responsibilities under the nother (21) OF IC or 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,

Sincerely yours,

/ Mark McMullan

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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K002672

## INDICATION FOR USE

510(k) Number (if known):

. , :

Device Name:

Indications for Use:

VYPRO* Mesh VICRYL*-PROLENE* Partially Absorbable Synthetic Surgical Mesh

VYPRO Mesh is indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | X |
|------------------------------------------|-----------------------------------------------------------------------------------------------|
| | OR |
| Over-The Counter Use | |
| | <i>for Mark N Millhiser</i><br>(Division Sign-Off)<br>Division of General Restorative Devices |
| 510(k) Number | K002672 (Optional Format 1-2-9G) |

VYPRO* Mesh ETHICON, Inc.