VERITAS COLLAGEN MATRIX

K062915 · Synovis Surgical Innovations · FTM · Dec 6, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062915
• Device Name: VERITAS COLLAGEN MATRIX
• Applicant: Synovis Surgical Innovations
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Dec 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies, this includes but is not limited to the following: Buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy / pneumectomy, pneumoreduction) and other incisions and excision of the lung and bronchus. Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. Abdominal and thoracic wall repair, muscle flap reinforcement, rectal and vaginal prolapse repair, urinary incontinence treatment, reconstruction of the pelvic floor, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical). Veritas Collagen Matrix minimizes tissue attachment to the device in case of direct contact with viscera.

Device Story

Implantable surgical patch; comprised of non-crosslinked bovine pericardium. Proprietary processing allows neo-collagen formation and neo-vascularization; facilitates host tissue replacement or remodeling. Minimizes tissue attachment to viscera. Used in surgical settings (OR) by surgeons for soft tissue repair and staple line reinforcement. Output is physical barrier/reinforcement material; aids in healing and structural integrity of repaired tissue.

Clinical Evidence

Animal study conducted to evaluate tissue attachment. Results demonstrated that Veritas Collagen Matrix exhibits minimal tissue attachment to viscera when compared to a named predicate device.

Technological Characteristics

Implantable surgical patch; material is non-crosslinked bovine pericardium. Proprietary processing for remodeling and neo-vascularization. No electronic, software, or mechanical sensing components.

Indications for Use

Indicated for patients requiring surgical repair of soft tissue deficiencies, including lung staple line reinforcement, bariatric gastric staple line reinforcement, abdominal/thoracic wall repair, muscle flap reinforcement, rectal/vaginal prolapse repair, urinary incontinence treatment, pelvic floor reconstruction, and hernia repair.

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

• Veritas® Collagen Matrix (K002233, K030879, K040119)
• PARIETEX® COMPOSITE Mesh (K002699, K040998, K050187)
• MacroPore Surgi-Wrap MAST Bioresorbable Sheet (K031955)
• GORE-TEX® Dualmesh® Biomaterial (K992189)
• Genzyme Serpramesh™ IP (K040868)

Submission Summary (Full Text)

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

Page 1/2

Veritas® Collagen Matrix

# 3.0 SUMMARY OF SAFETY AND EFFECTIVENESS

| Submitted by | Synovis Surgical Innovations<br>2575 University Ave. W.<br>St. Paul, MN 55114<br>Tel: [phone]<br>Fax: [phone] | DEC - 6 2006 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person | Cynthia Lamarucciola<br>At address above | |
| Device Trade Name: | Veritas® Collagen Matrix | |
| Common Name | Surgical Mesh | |
| Classification Name | Mesh, Surgical<br>878.3300 | |
| Predicate devices | Veritas® Collagen Matrix K002233, K030879 and K040119<br>Synovis Surgical Innovations (Acting as its own predicate.)<br>PARIETEX® COMPOSITE Mesh, K002699, K040998, K050187<br>MacroPore Surgi-Wrap MAST Bioresorbable Sheet, K031955<br>GORE-TEX® Dualmesh® Biomaterial, K992189<br>Genzyme Serpramesh™ IP, K040868 | |
| Device Description | An implantable surgical patch comprised of non-crosslinked<br>bovine pericardium. Veritas® Collagen Matrix undergoes<br>proprietary processing that allows neo-collagen formation and neo-<br>vascularization of the implanted device and permits replacement<br>of the device with host tissue, or remodeling. | |

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

| Statement of<br>Intended use | Veritas Collagen Matrix is intended for use as an implant for the<br>surgical repair of soft tissue deficiencies, this includes but is not<br>limited to the following: |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Buttressing and reinforcing staple lines during lung<br>resection (e.g., wedge resection, blebectomy, lobectomy,<br>bullectomy, bronchial resection, segmentectomy,<br>pneumonectomy / pneumectomy, pneumoreduction) and<br>other incisions and excision of the lung and bronchus. |
| | Reinforcement of the gastric staple line during the bariatric<br>surgical procedures of gastric bypass and gastric banding. |
| | Abdominal and thoracic wall repair, muscle flap<br>reinforcement, rectal and vaginal prolapse repair, urinary<br>incontinence treatment, reconstruction of the pelvic floor,<br>and repair of hernias (e.g., diaphragmatic, femoral,<br>incisional, inguinal, lumbar, paracolostomy, scrotal,<br>umbilical). |
| | Veritas Collagen Matrix minimizes tissue attachment to<br>the device in case of direct contact with viscera. |
| Technological<br>Comparisons | Veritas Collagen Matrix is acting as its own predicate and is<br>therefore substantially equivalent, having the same technological<br>characteristics and intended use with the exception of the<br>additional intended use, which is the subject of this submission. |
| Technology/Device<br>Testing | Veritas Collagen Matrix is acting as its own predicate and is<br>therefore substantially equivalent in terms of testing. |
| Indication Testing | An animal study was conducted, specific to the subject of this<br>submission. The study concluded that Veritas ® Collagen Matrix<br>demonstrates minimal tissue attachment to the viscera when<br>compared to a named predicate. |

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

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines and two stylized feet.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Synovis Surgical Innovations % Ms. Cynthia Lamarucciola Regulatory Affairs Manager 2575 University Avenue, West St. Paul, Minnesota 55114-1024

May 2, 2013

Re: K062915

Trade/Device Name: Veritas® Collagen Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXE, OXB, PAJ Dated: October 31, 2006 Received: November 2, 2006

Dear Ms. Lamarucciola:

This letter corrects our substantially equivalent letter of December 6, 2006.

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.

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

Page 2 - Ms. Cynthia Lamarucciola

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact 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. 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 yours, FOR

# Peter D. Rumm -S

Mark Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

K062915 510(k) Number (if known):

Device Name:

Veritas Collagen Matrix

Indications For Use:

Vertas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies: this includes but is not limited to the following:

Buttressing and reinforcing staple lines during lung resection (e.g., wedge lobectomy, bullectomy, bronchial resection, blebectomy, resection, segmentectorny, pnuemonectorny, pneumoreduction) and other incision and excision of the lung and bronchus.

Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.

Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional. inquinal. lumbar, paracolostomy, scrotal, umbilical).

Veritas Collagen Matrix minimizes tissue attachment to the device in case of direct contact with viscera.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of

510(k) Number K962915