INCLOSE SURGICAL MESH SYSTEM

K050969 · Anulex Technologies, Inc. · FTL · Aug 18, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050969
• Device Name: INCLOSE SURGICAL MESH SYSTEM
• Applicant: Anulex Technologies, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Aug 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The mesh may be used to support soft tissue where weakness exists, or for the repair of hernias requiring the addition of a reinforcing, or bridging material, such as the repair of groin hernias.

Device Story

Inclose Surgical Mesh System consists of expandable braided polyethylene terephthalate (PET) mesh patch and two suture assemblies (Anchor Bands); provided sterile and preloaded on disposable delivery instruments. Device inserted through tissue defect aperture; affixed to surrounding soft tissue via Anchor Bands; standard surgical sutures may also be used for fixation. Two platinum/iridium markers on monofilament fibers facilitate post-surgical identification. Used in operating room by surgeons for hernia repair and soft tissue reinforcement. Benefits include structural support for weakened tissue.

Clinical Evidence

Bench testing only. Biocompatibility and bench testing completed to support safety and effectiveness.

Technological Characteristics

Materials: Polyethylene terephthalate (PET) mesh; platinum/iridium markers. Design: Expandable braided patch with integrated suture assemblies (Anchor Bands). Delivery: Preloaded on disposable instruments. Sterilization: Sterile. Connectivity: None.

Indications for Use

Indicated for patients requiring soft tissue support or hernia repair, including groin hernias, where reinforcing or bridging material is necessary.

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® Mesh PerFix® Plug (K922916)
• Ethicon Mersilene Polyester Fiber Mesh (K851086)

Submission Summary (Full Text)

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K050969 1/2

# SECTION 2

### AUG 1 8 2005

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Submitter: | Anulex Technologies, Inc.<br>5600 Rowland Road, Suite 280<br>Minnetonka, MN 55343 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tim Miller<br>Vice President, Regulatory and Clinical Affairs<br>Anulex Technologies, Inc.<br>5600 Rowland Road, Suite 280<br>Minnetonka, MN 55343<br>Direct: 952-224-4003<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | April 15, 2005 |
| Trade Name: | Inclose ^™ Surgical Mesh System |
| Classification Name:<br>and Number: | Surgical mesh, polymeric; 21CFR 878.3300 |
| Product Code: | FTL |
| Predicate Device(s): | The Inclose ^™ Surgical Mesh System is substantially<br>equivalent to: |
| | Bard® Mesh PerFix® Plug<br>(K922916 - Decision Date: 8/24/1992) |
| | Ethicon Mersilene Polyester Fiber Mesh<br>(K851086 -- Decision Date: 5/21/1985) |
| Device Description: | The Inclose ^™ Surgical Mesh System is comprised of a<br>Mesh Implant and two suture assembles (Anchor Bands).<br>The implanted components are provided sterile and<br>preloaded on their respective disposable delivery<br>instruments. The Mesh Implant is an expandable braided<br>patch that is inserted through the aperture of the tissue<br>defect and affixed to surrounding soft tissue with the<br>Anchor Bands. Materials utilized in the construct of the |

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| | implanted components consist of polyethylene<br>terephthalate (PET). In addition, two platinum/iridium<br>markers are placed on monofilament fibers and positioned<br>toward the proximal end of the mesh. These two markers<br>are located 180° from each other and are intended to<br>facilitate identification of the Inclose™ Mesh Implant<br>following surgery. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Standard operating room sutures may also be utilized for<br>fixation of the device. |
| Intended Use: | The mesh may be used to support soft tissue where<br>weakness exists, or for the repair of hernias requiring the<br>addition of a reinforcing, or bridging material, such as the<br>repair of groin hernias. |
| Functional and<br>Safety Testing: | Biocompatibility and bench testing have been completed<br>and support the safety and effectiveness of the Inclose™<br>Surgical Mesh System. |
| Conclusion: | The Inclose™ Surgical Mesh System is substantially<br>equivalent in intended use, scientific technology, materials<br>and design to predicate devices in interstate commerce. |

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AUG 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tim Miller VP, Regulatory and Clinical Affairs Anulex Technologies, Inc. 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 55343

Re: K050969

Trade/Device Name: Inclose™ Surgical Mesh System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: July 28, 2005 Received: July 29, 2005

Dear Mr. Miller:

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.

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" written around it. The logo is simple and recognizable, conveying the department's mission and purpose.

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This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter will and in yourse FDA finding of substantial equivalence of your device to a legally promation hotification. "Theesults 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 [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 other general 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

lane buch MD
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Inclose™ Surgical Mesh System

Indications For Use:

The mesh may be used to support soft tissue where weakness exists, or for the repair of hernias requiring the addition of a reinforcing, or bridging material, such as the repair of groin hernias.

Prescription Use X (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)

Sauberc Bneeldfon Mulkerson

Division of General, Restorative, and Neurological Devices

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510(k) Number K050961