ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH

K093932 · Ethicon GmbH · FTL · Apr 9, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093932
• Device Name: ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH
• Applicant: Ethicon GmbH
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Apr 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ETHICON PHYSIOMESH™ 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.

Device Story

ETHICON PHYSIOMESH™ is a sterile, low-profile, flexible composite mesh for hernia and fascial deficiency repair. Device consists of a nonabsorbable, macroporous polypropylene mesh laminated between two undyed polyglecaprone-25 films, bonded with an undyed polydioxanone film. A dyed polydioxanone film marker is included for orientation. Used by surgeons in clinical settings to provide reinforcement or bridging at the surgical site. Device provides mechanical support to fascial tissues, facilitating surgical repair and patient recovery.

Clinical Evidence

Bench and animal testing only. Bench testing evaluated device thickness, pore size, burst strength, weight, tensile strength, stiffness, suture pullout strength, and tear resistance. In-vitro and in-vivo testing demonstrated the device performed as intended.

Technological Characteristics

Composite mesh composed of macroporous polypropylene mesh laminated between polyglecaprone-25 films, bonded with polydioxanone film. Includes dyed polydioxanone orientation marker. Sterile, low-profile, flexible form factor.

Indications for Use

Indicated for patients requiring surgical repair of hernias and fascial deficiencies 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

• PROCEED Mesh (K031925 & K060713)
• ULTRAPRO Hernia System (K071249)
• ULTRAPRO Mesh (K033337)

Submission Summary (Full Text)

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K093932
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# 510(K) SUMMARY

APR - 9 2010

#### Submitter Name: 1.

ETHICON, INC. P.O. Box 151 Route 22 West Somerville, J.J. 08876 Phone: + 1.908.218.3323 FAX: + 1.908.218.2595

#### 2. Date:

March 18, 2010

#### Contact Information: 3.

Neelu Medhekar Director, Regulatory Affairs ETHICON, INC. Phone: + 1.908.218.3323 FAX: [phone]

#### 4. Substantially Equivalent To:

The ETHICON PHYSIOMESH™ is substantially equivalent to:

| PROCEED Mesh (K031925 &<br>K060713) | For Indications for Use and technological characteristics |
|-------------------------------------|------------------------------------------------------------------------------------------------------|
| ULTRAPRO Hernia System<br>(K071249) | For technological characteristics related to the<br>poligelcaprone 25 Film |
| ULTRAPRO Mesh (K033337) | For technological characteristics related to the mesh<br>materials poliglecaprone 25 & polypropylene |

#### Description of the Device Subject: ડ.

ETHICON PHYSIOMESH™, Flexible Composite Mesh, is a sterile, low profile, flexible composite mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is composed of a nonabsorbable, macroporous polypropylene mesh laminated between two undyed polyglecaprone-25 films. An undyed polydioxanone film provides the bond between the polyglecaprone-25 film and polypropylene mesh. The polypropylene component is constructed of knitted filaments of extruded polypropylene. An additional dyed polydioxanone film marker has been added for orientation purposes.

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#### Indications for Use: 6.

11

ETHICON PHYSIOMESH™ 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.

#### 7. Performance Data:

ETHICON PHYSIOMESH™, Flexible Composite Mesh underwent a comprehensive bench, and animal testing program and passed all intended criteria in accordance with appropriate test protocols and standards. During bench testing the device was subject to testing such as device thickness, pore size, burst strength, device weight, tensile strength, device stiffness, suture pullout strength, burst strength and tear resistance. Additionally, invitro and in-vivo testing was provided showing that the device performed as intended.

#### Overall Performance Conclusion: 8.

ETHICON PHYSIOMESHTM, Flexible Composite Mesh met all testing criteria, demonstrated substantial equivalence to its predicate devices and did not raise any new questions of safety or effectiveness.

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Image /page/2/Picture/0 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" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, suggesting themes of protection and service.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

APR - 9 2010

Ethicon, Inc. % Neelu Medhekar Director, Regulatory Affairs P.O. Box 151, Route 22 West Somerville, New Jersey 08876

Re: K093932

Trade/Device Name: Ethicon Physiomesh™, Flexible Composite Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: March 19, 2010 Received: March 22, 2010

Dear Neelu Medhekar:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Neelu Medhekar

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## IV.INDICATIONS FOR USE

510(k) No (if known):

Device Name: ETHICON PHYSIOMESH™, Flexible Composite Mesh

### Indications for Use:

ETHICON PHYSIOMESH™ 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.

Prescription Use ﯾﮯ (Part 21 CFR 801 Subpart D)

រ

- AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Daniel Krone for MXM
(Division Sign Off)

(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number k093932