(69 days)
PROCEED Surgical Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh deigned for the repair of hernias and other fascial deficiencies. The mesh product is comprised of an oxidized regenerated cellulose (ORC) fabric, and PROLENE* Soft Mesh, a nonabsorbable polypropylene mesh, which is encapsulated by a polydioxanone polymer. The polypropylene mesh side of the product allows for tissue ingrowth while the ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh. The polydioxanone provides a bond to the ORC layer.
This document is a 510(k) summary for the PROCEED Surgical Mesh, comparing it to a predicate device. It confirms substantial equivalence based on technological characteristics and intended use, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The document discusses:
- Submitter and contact information
- Trade Name, Common Name, Classification Name, and Product Code
- Predicate Device: PROCEED Trilaminate Surgical Mesh
- Device Description: A sterile, thin, flexible laminate mesh for hernia repair, comprised of oxidized regenerated cellulose (ORC) fabric and PROLENE* Soft Mesh, encapsulated by polydioxanone polymer. The polypropylene mesh side allows for tissue ingrowth, while the ORC side provides a bioresorbable layer to minimize tissue attachment.
- Intended Use: For the repair of hernias and other fascial deficiencies requiring reinforcing or bridging material.
- Technological Characteristics: Stated as "identical to the predicate device, PROCEED SURGICAL Mesh."
- Conclusions: "The descriptive information provided about PROCEED Surgical Mesh demonstrates substantial equivalence to the predicate device."
- FDA Clearance Letter: Confirming substantial equivalence.
- Indications for Use Statement: Reiterating the intended use.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth, or MRMC studies, as none of this information is present in the provided text.
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MAY 2 5 2006
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SECTION 5 – 510(K) SUMMARY
| 510(k) Summary | |
|---|---|
| Submitter | Ethicon Inc., a Johnson and Johnson Company |
| Contact Information | Sergio J. Gadaleta, Ph.D.Director, Worldwide Regulatory AffairsEthicon Inc., a Johnson & Johnson CompanyP.O. Box 151Route 22 WestSomerville, NJ 08876Telephone: 908-218-3102Facsimile: 908-218-2595e-mail: sgadale@ethus.jnj.com |
| Date | March 10, 2006 |
| Trade Name | PROCEED Surgical Mesh |
| Common Name | Surgical Mesh |
| Classification Name | Surgical MeshRegulation Number: 878.3300Product Code: FTL |
| Predicate Device | PROCEED Trilaminate Surgical Mesh |
| Device Description | PROCEED Surgical Mesh is a sterile, thin,flexible laminate mesh deigned for the repairof hernias and other fascial deficiencies. Themesh product is comprised of an oxidizedregenerated cellulose (ORC) fabric, andPROLENE* Soft Mesh, a nonabsorbablepolypropylene mesh, which is encapsulated bya polydioxanone polymer. The polypropylene |
| KO607132 of 2 | |
| mesh side of the product allows for tissueingrowth while the ORC side provides abioresorbable layer that physically separates thepolypropylene mesh from underlying tissueand organ surfaces during the wound-healingperiod to minimize tissue attachment to themesh. The polydioxanone provides a bond tothe ORC layer. | |
| Intended Use | PROCEED Mesh may be used for the repairof hernias and other fascial deficiencies thatrequire the addition of a reinforcing orbridging material to obtain the desired surgicalresult. |
| Technological Characteristics | The technological characteristics ofPROCEED Surgical Mesh are identical to thepredicate device, PROCEED SURGICALMesh. |
| Conclusions | The descriptive information provided aboutPROCEED Surgical Mesh demonstratessubstantial equivalence to the predicate device. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2006
Ethicon Inc., a Johnson & Johnson Co. % Sergio J. Gadaleta, Ph.D. Director, Worldwide Regulatory Affairs Route 22 West, P.O. Box 151 Somerville, NJ 08876
Re: K060713
Trade/Device Name: PROCEED Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: May 10, 2006 Received: May 11, 2006
Dear Dr. Gadaleta:
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
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Page 2 - Sergio J. Gadaleta, Ph.D.
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mike A Millhurn
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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SECTION 4 – INDICATIONS FOR USE STATEMENT
5071
510(k) Number (if known): _ Device Name: PROCEED Surgical Mesh Indications for Use:
PROCEED Surgical Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desiréd surgical result.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
---------Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Mark A. Millican
ision Sign-Division of General. Restorative and Neurological Devices
Number: K060713
6
§ 878.3300 Surgical mesh.
(a)
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.(b)
Classification. Class II.