WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08

K073219 · American Medical Systems, Inc. · FTM · Apr 10, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073219
• Device Name: WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08
• Applicant: American Medical Systems, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Apr 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WMT Collagen Dermal Matrix is intended to reinforce soft tissue where weakness exists, specifically, for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, and other tendons. The WMT Collagen Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear, and suture or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

Device Story

WMT Collagen Dermal Matrix is a sterile, non-perforated, processed porcine collagen dermal matrix; used as a surgical mesh for soft tissue reinforcement. Device applied by surgeons during tendon repair procedures; acts as a scaffold to reinforce tissue repaired by sutures or anchors. Does not replace native tissue or provide primary biomechanical strength; strength provided by sutures/anchors. Intended for use in clinical settings by surgeons. Benefits include reinforcement of weakened soft tissue sites.

Clinical Evidence

Bench testing only. Mechanical testing characterized suitability for orthopedic applications and compared performance against predicate devices (OrthADAPT FX and RESTORE).

Technological Characteristics

Sterile, non-perforated, processed porcine collagen dermal matrix. Form factor is a surgical mesh. No electronic components or software.

Indications for Use

Indicated for reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery (rotator cuff, patellar, Achilles, biceps, quadriceps, and other tendons) in patients requiring soft tissue reinforcement.

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

• AMS Collagen Dermal Matrix, marketed as "InteXen LP" (K050445)
• RESTORE Soft Tissue Implant (K071016)
• OrthADAPT FX (K071065)

Submission Summary (Full Text)

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

K073219
1/1

#### ನ. 510(k) Summary Statement

| Submitter: | American Medical Systems (AMS)<br>10070 Bren Road West<br>Minnetonka, MN 55343<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mona Inman<br>APR 10 200 |
| Device Common Name: | Surgical Mesh |
| Device Trade Name: | WMT Collagen Dermal Matrix |
| Device Classification Name: | Surgical Mesh (FTM) |
| Predicate Devices: | AMS Collagen Dermal Matrix, marketed as "InteXen<br>LP" (K050445),<br>RESTORE Soft Tissue Implant (K071016),<br>OrthADAPT FX (K071065) |

#### Device Description

The WMT Collagen Dermal Matrix is a sterile, non-perforated processed porcine collagen dermal matrix.

#### Indications for Use

The WMT Collagen Dermal Matrix is intended to reinforce soft tissue where weakness exists, specifically, for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, and other tendons. The WMT Collagen Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear, and suture or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

## Comparison to Predicate Devices

The three predicate devices are biological-derived surgical mesh used in tissue repair and tissue reinforcement. Mechanical testing characterized the suitability of the subject device, WMT Collagen Dermal Matrix, in orthopedic applications, and compared the test results of both OrthADAPT™ FX and RESTORE® predicate devices, surgical meshes which are currently indicated for orthopedic applications. All predicate surgical mcshes are provided sterile and are indicated for single use.

# Supporting Information

Substantial equivalency was supported by information from previously cleared devices, and new bench testing comparing predicate devices and the subject device.

WMT Collagen Dermal Matrix 510(k) Notification

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

Image /page/1/Picture/1 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" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2008

K073219 Re:

% Ms. Mona Inman 10700 Bren Road West

American Medical Systems

Minnetonka, Minnesota 55343

Trade/Device Name: WMT Collagen Dermal Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: April 1, 2008 Received: April 2, 2008

Dear Ms. Inman:

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.

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

Page 2 – Ms. Mona Inman

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 yours,

Mark N Millerson

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

Enclosure

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

KO73219

## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: WMT Collagen Dermal Matrix

Indications For Use:

The WMT Collagen Dermal Matrix is intended to reinforce soft tissue where weakness exists, specifically, for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, and other tendons. The WMT Collagen Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear, and suture or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

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

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)

Nish R.P. Qalla for nam
Sign-Off

(Division Sign Division of General, Restorative, and Neurological Devices

510(k) Number K073219

WMT Collagen Dermal Matrix 510(k) Notification

Page 16 of 76