ULTRAPRO MESH

K033337 · ETHICON, Inc. · FTL · Apr 1, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033337
• Device Name: ULTRAPRO MESH
• Applicant: ETHICON, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Apr 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ULTRAPRO Mesh may be used for the repair of hernias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Story

ULTRAPRO Mesh is a sterile, partially absorbable composite surgical mesh. It is constructed from approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non-absorbable polypropylene monofilament fiber. The device is intended for use by surgeons in clinical settings to reinforce or bridge abdominal fascial deficiencies during hernia repair. By providing a structural scaffold, the mesh supports tissue ingrowth and abdominal wall integrity. The absorbable component allows for a reduction in foreign material over time while the polypropylene component provides long-term reinforcement.

Clinical Evidence

Bench testing only. Non-clinical laboratory testing demonstrated physical property comparability to standard surgical meshes. Animal testing demonstrated the device achieves good tissue ingrowth.

Technological Characteristics

Partially absorbable composite mesh; materials: poliglecaprone-25 monofilament fiber and polypropylene monofilament fiber. Properties: thickness, burst strength, flexural rigidity, tear strength, tensile strength, porosity, suture pull-out strength. Sterile.

Indications for Use

Indicated for repair of hernias and abdominal fascial deficiencies requiring 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

• VYPRO Mesh
• PROLENE Polypropylene Mesh
• MERSILENE Mesh

Submission Summary (Full Text)

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K03337

# SECTION 8

# 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.<br><br>NEW DEVICE NAME: ULTRAPRO* Mesh<br><br>PREDICATE DEVICES NAME: VYPRO Mesh, PROLENE Polypropylene Mesh, MERSILENE Mesh | |
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| Device Description | ULTRAPRO* Mesh is a sterile partially absorbable composite mesh designed for the repair of hernias and other abdominal fascia deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.<br><br>ULTRAPRO Mesh is manufactured from approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non absorbable polypropylene monofilament fiber. | |
| Intended Use | ULTRAPRO Mesh may be used for the repair of hernias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result. | |
| Indications Statement | ULTRAPRO Mesh may be used for the repair of hernias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result. | |
| Technological<br>Characteristics | | ULTRAPRO has similar technological characteristics as the<br>predicate devices. The characteristics evaluated include thickness,<br>burst strength, flexural rigidity, tear strength, tensile strength,<br>porosity, and suture pull-out strength. Comparison to other<br>commercialized surgical meshes indicates equivalency in clinical<br>performance. |
| Performance Data | | Non-clinical laboratory testing was performed demonstrating that<br>the device is comparable to standard surgical mesh devices that are<br>indicated for hernia repair and other fascial deficiencies that<br>require the addition of a reinforcing or bridging material to obtain<br>that desired surgical result. Additionally, animal testing<br>demonstrated that ULTRAPRO would achieve good tissue<br>ingrowth. |
| Conclusions | | Based on the 510(k) summaries and 510(k) statements (21 CFR<br>807) and the information provided herein, we conclude that the<br>modified device is substantially equivalent to the Predicate Devices<br>under the Federal Food, Drug, and Cosmetic Act. |
| Contact | | Rey Librojo<br>Senior Project Manager, Regulatory Affairs<br>ETHICON Products<br>ETHICON, Inc.<br>Rt. #22, West<br>Somerville, NJ 08876-0151 |
| Date | | October 14, 2003 |

Trademark ULTRAPRO Mesh ETHICON, Inc.

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* Trademark ULTRAPRO Mesh ETHICON, Inc.

K03337

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 1 2004

Mr. Ray Librojo Senior Project Manager Ethicon. Inc. Rt. #22, West Somerville, New Jersey 08876-0151

Re: K033337

Trade/Device Name: ULTRAPRO Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: January 8, 2004 Received: January 13, 2004

Dear Mr. Librojo:

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 (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.

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### Page 2 - Mr. Ray Librojo

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 vour 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). 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

(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): K033337

### Device Name: ULTRAPRO Mesh

Indications For Use. Is for the "repair of hemias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result."

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

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510(k) Number_K633337