SPORTMESH

K052830 · Artimplant AB · FTL · Jan 19, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K052830
• Device Name: SPORTMESH
• Applicant: Artimplant AB
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jan 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sportmesh™ is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. Sportmesh™ is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery. Sportmesh™ is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide mechanical strength for the tendon repair. Sportmesh™ reinforces soft tissue and provides a degradable scaffold that is incorporated in the patient's own tissue.

Device Story

Sportmesh™ is a knitted surgical mesh composed of ARTELON fibers; designed as a degradable scaffold for soft tissue reinforcement. Supplied in sterile sheet form; cut to size by surgeon during procedures. Used in general surgery for tissue weakness and as an adjunct in rotator cuff repair (supraspinatus). Device does not provide primary mechanical strength; that function remains with sutures and bone anchors. Mesh integrates into patient's own tissue over time. Used by surgeons in clinical settings.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including biocompatibility safety studies per ISO 10993 and mechanical testing per FDA guidance for surgical mesh.

Technological Characteristics

Knitted fabric mesh made from ARTELON fibers. Supplied in sterile, double-layer peelable packaging. Biocompatibility tested per ISO 10993. Mechanical properties validated per FDA guidance for surgical mesh.

Indications for Use

Indicated for patients requiring soft tissue reinforcement in general surgical procedures or during rotator cuff repair surgery (specifically supraspinatus) where tissue is repaired via sutures or anchors.

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

• FortaFlex™ Surgical Mesh (K042809)
• Restore® Orthobiologic Soft Tissue Implant (K031969, K001738)
• ULTRAPRO™ Mesh (033337)
• Marlex Mesh (pre-Amendments)

Reference Devices

• Permacol (K021056)

Submission Summary (Full Text)

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### JAN J 9 2006

## Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes Artimplant AB's summary for the Sportmesh™.

| SUBMITTER'S NAME: | Artimplant AB |
|---------------------|-----------------------------------------------------------|
| ADRESS: | Hulda Mellgrens gata 5, SE-421 32 Västra Frölunda, Sweden |
| CONTACT PERSON: | Ajrulla Zuta |
| TELEPHONE NUMBER: | [phone] |
| FAX NUMBER: | [phone] |
| DATE OF SUBMISSION: | October 4, 2005 |

#### l. Identification of device

Proprietary Name: Sportmesh™ Common Name: Surgical Mesh, RC Patch, Rotator cuff patch Classification Status: Class II per regulations 878 3300 Product Code: FTM

#### 2. Equivalent devices

Sportmesh™ is substantially equivalent to: Organogenesis, Inc's FortaFlex™ Surgical Mesh (K042809) DePuy, Inc's Restore® Orthobiologic Soft Tissue Implant (K031969, K001738) Ethicon, Inc's ULTRAPRO™Mesh (033337) Davol's Marlex Mesh (pre-Amendments)

#### 3. Description of the Device

Sportmesh™is a knitted fabric made from ARTELON fibers. This construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied in sheet form in sterile double layer peelable packaging.

#### 4. Intended use

Sportmesh™ is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. Sportmesh™ is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery.

Sportnesh™ is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide mechanical strength for the tendon repair. Sportmesh™ reinforces soft tissue and provides a degradable scaffold that is incorporated in the patient's own tissue.

#### ನ. Comparison to predicate device.

Sportmesh™ is equivalent to the Organogenesis, Cuffpatch™ Surgical Mesh (K042809). DePuy, Inc's Restore® Orthobiologics Soft Tissus Implant (K03)969), Ethicon (K0428)
UI TDADBOTHM - 1, (80000), 1), 1800000), Ethicon (K031969), Ethicon, Inc's ULTRAPRO™Mesh (033337), Tissue Science's Permacol (K021969), Eldiconi, Inc S
Mesh (pre-Amendments) 337), Tissue Science's Permacol (K021056) and Davol's Marlex Mesh (pre-Amendments) with respect to intended use and technological characteristics.

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#### 6. Discussion of performance testing.

A collection of tests has been conducted and successfully completed including biocompatibility safety studies (ISO 10993 standards), and mechanical testing in accordance Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance. The results demonstrate that Sportmesh™ provides appropriate mechanical properties for its use in soft tissue repair.

#### 7. Conclusion

Based on comparison to the predicate devices, the Sportmesh™ is substantially equivalent to legally-marketed devices and presents no new concerns about safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN ] 9 2006

Artimplant AB c/o Ms. Terry Sheridan Powell Regulatory Consultant M Squared Associates 719 A Street, NE Washington, District of Columbia 20002

Re: K052830

Trade/Device Name: Artimplant AB Sportmesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: December 9, 2005 Received: December 12, 2005

Dear Ms. Powell:

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 - Ms. Powell

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 [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/industry/support/index.html.

Sincerely vours

Sincerely yours,

Barbara Buehr

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): K 0528 30

Artimplant A Device Name:

Indications for Use:

Sportmesh™ is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. Sportmesh™ is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery.

Sportmesh™ is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures used to repair the full
sutures or bone anchors used to ottach the i sutures or bone anchors used to attach the tissue to the bone, provide mechanical strength for the tendon repair. Sportmesh™ reinforces soft tissue and provides a degradable scaffold that is incorporated in the patient's own tissue a

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)

K052830 (barbarabuchbinder Page 1 of 1
(Division Sign-Off) for WM

Division of General, Re-rorative, and Neurological Devices

510(k) Number_ 1505 2430