SPORTMESH OR ARTELON TISSUE REINFORCEMENT

K071887 · Artimplant AB · FTL · Sep 18, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071887
• Device Name: SPORTMESH OR ARTELON TISSUE REINFORCEMENT
• Applicant: Artimplant AB
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Sep 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SportMesh™/ Artelon® Tissue Reinforcement is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. SportMesh™/ Artelon® Tissue Reinforcement is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. SportMesh™ Artelon® Tissue Reinforcement is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. 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™/ Artelon® Tissue Reinforcement reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.

Device Story

SportMesh/Artelon Tissue Reinforcement is a knitted fabric scaffold composed of Artelon fibers; supplied sterile in sheet form. Used by surgeons in general surgical procedures and tendon repairs (rotator cuff, patellar, Achilles, biceps, quadriceps). Device acts as a degradable scaffold for soft tissue reinforcement; does not provide primary mechanical strength, which is provided by sutures and bone anchors. Scaffold incorporates into patient's own tissue over time. Cut to size by clinician during surgery.

Clinical Evidence

Bench testing only. Includes biocompatibility safety studies per ISO 10993 and mechanical testing in accordance with FDA guidance for surgical mesh. Results confirm appropriate mechanical properties for soft tissue repair.

Technological Characteristics

Knitted fabric made from Artelon fibers. Supplied sterile in sheet form. Biocompatibility per ISO 10993. Mechanical properties validated for soft tissue reinforcement.

Indications for Use

Indicated for patients requiring soft tissue reinforcement in general surgical procedures where weakness exists, and for reinforcement of soft tissues during tendon repair surgery (rotator cuff, patellar, Achilles, biceps, or quadriceps tendons) when used in conjunction with sutures or bone anchors. Not intended to replace normal body structure or provide full mechanical strength for tendon repairs.

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

• CuffPatchTM, Organogenesis Inc (K042809)
• OrthADAPTM Bioimplant, Pegasus Biologics (K071065)
• Zimmer® Collagen Repair Patch, Tissue Science Laboratories (K053562)
• SportMeshTM, Artimplant AB (K052830)

Submission Summary (Full Text)

{0}------------------------------------------------

-1.12

# SECTION 5. 510(K) SUMMARY

In accordance with 21 CFR 878.3300, the following information constitutes Artimplant AB's summary for the SportMeshTM /Artelon® Tissue Reinforcement.

#### A. SUBMITTER INFORMATION

SUBMITTER'S NAME: Artimplant AB Hulda Mellgrens gata 5. SE-421 32 Västra Frölunda. Sweden ADRESS: CONTACT PERSON: Ajrulla Zuta TELEPHONE NUMBER: [phone] FAX NUMBER: [phone] DATE OF SUBMISSION: 07/06/2007 ESTABLISHMENT REGISTRATION NUMBER: 3004878714

#### B. DEVICE IDENTIFICATION

DEVICE TRADE NAME: DEVICE COMMON NAME: CLASSIFICATION NAME: CLASSIFICATION REGULATION: REGULATORY CLASS: PRODUCT CODE: ADVISORY PANEL:

SportMeshTM, Artelon® Tissue Reinforcement Surgical Mesh Surgical Mesh, Polymeric 21 CFR 878.3300 Class II FTL General and Plastic Surgery

## C. PREDICATE DEVICES

SportMesh™M Artelon® Tissue Reinforcement is substantially equivalent to:

- · K042809; CuffPatchTM, Organogenesis Inc
- · K071065; OrthADAPTM Bioimplant, Pegasus Biologics
- · K053562; Zimmer® Collagen Repair Patch, Tissue Science Laboratories
- · K052830; SportMeshTM, Artimplant AB

### D. DEVICE DESCRIPTION:

SportMesh™ / Artelon® Tissue Reinforcement is a knitted fabric made from Artelon® fibers. The construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied sterile in sheet form in double laver peelable packaging.

### E. INTENDED USE:

SportMesh™/ Artelon® Tissue Reinforcement is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

SportMesh™/ Artelon® Tissue Reinforcement is also intended for reinforcement of soft tissues that are repaired by suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons,

SportMesh™ Artelon® Tissue Reinforcement is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles,

Artimplant

ર્ભ SportMesh™/ Artelon® Tissue Reinforcement 510(k)

{1}------------------------------------------------

biceps, or quadriceps tendons. 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™/ Artelon® Tissue Reinforcement reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.

### F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

SportMesh™/ Artelon® Tissue Reinforcement is identical to the predicate Artimplant's SportMesh™ (K052830) with respect to its material composition. Each of the indications for use of the SportMesh™ Artelon® Tissue Reinforcement device are shared by one or more of the predicate devices. Performance data demonstrate that SportMesh™/ Artelon® Tissue Reinforcement is technologically equivalent to one or more of the predicate devices, and that the SportMesh™ Artelon® Tissue Reinforcement demonstrates performance characteristics that are equivalent to the predicate devices. Therefore, SportMesh™ Artelon® Tissue Reinforcement is substantially equivalent to the predicate devices for the specified indications.

#### G. PERFORMANCE DATA

A collection of tests has been conducted and successfully completed including biocompatibility safety studies (ISO 10993 standards), and mechanical testing in accordance with 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™Artelon® Tissue Reinforcement provides appropriate mechanical properties for its use in soft tissue repair.

### H. CONCLUSION

Based on comparison to the predicate devices, SportMesh™ Artelon® Tissue Reinforcement is substantially equivalent to legally marketed devices and presents no new concerns of safety and effectiveness.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three heads, representing the department's focus on health, human services, and the well-being of the population. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 8 2007

Artimplant AB % M Squared Associates, Inc. Terry Sheridan Powell 719 A Street, Northeast Washington, District of Columbia 20002

Re: K071887

Trade/Device Name: SportMesh" /Artelon® Tissue Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: July 6, 2007 Received: July 9, 2007

Dear Ms. Clark:

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.

{3}------------------------------------------------

Page 2 - Terry Sheridan Powell

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.

Mark A. Millhiser

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

Enclosure

{4}------------------------------------------------

## SECTION 4. INDICATIONS FOR USE STATEMENT

Indications for Use

510(k) Number (if known): K 5 7 887 to be assigned

Device Name: SportMesh™/ ArteIon® Tissue Reinforcement

Indications for Use:

SportMesh™ Artelon® Tissue Reinforcement is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

SportMesh™/ Artelon® Tissue Reinforcement is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.

SportMesh™ Artelon® Tissue Reinforcement is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. 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™/ Artelon® Tissue Reinforcement reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) Subpart C)

(21 CFR 807

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

Over-The-Counter Use _

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark H. Millenson

**510(k) Number**

Page 1 of __ 1_

Artimplant

SportMesh™/ Artelon® Tissue Reinforcement 510(k) 5