VERITAS COLLAGEN MATRIX

K030879 · Synovis Surgical Innovations · OXE · Apr 24, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030879
• Device Name: VERITAS COLLAGEN MATRIX
• Applicant: Synovis Surgical Innovations
• Product Code: OXE · General, Plastic Surgery
• Decision Date: Apr 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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, pnuemonectomy/pneumectomy, 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, inguinal, lumbar, paracolostomy, scrotal, umbilical).

Device Story

Implantable surgical patch; non-crosslinked bovine pericardium; facilitates neo-collagen formation and neovascularization; allows host tissue remodeling/replacement. Used by surgeons in OR for soft tissue repair; staple line reinforcement; hernia repair; pelvic floor reconstruction. Provides mechanical support to tissue; integrates with host biology over time.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench testing.

Technological Characteristics

Non-crosslinked bovine pericardium collagen matrix. Implantable surgical mesh. Biologic material; processed to support tissue remodeling.

Indications for Use

Indicated for patients requiring surgical repair of soft tissue deficiencies, including lung/bronchus staple line reinforcement, bariatric gastric staple line reinforcement, abdominal/thoracic wall repair, muscle flap reinforcement, rectal prolapse repair, 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)

Submission Summary (Full Text)

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K030879 Page 1/2

## 510(K) SUMMARY

Submitted by:

Synovis Surgical Innovations 2575 University Avenue West St. Paul, MN 55114-1024 Tel: [phone] Fax: [phone]

Contact Person:

Fonda Burley At address above

Device Trade Name:

Veritas Collagen Matrix

Common Name:

Surgical Mesh

Mesh, Surgical 21 CFR 878.3300

Classification Name:

Product Code:

FTM, OXE, OXB, OWV, PAJ

Veritas Collagen Matrix, K002233

Predicate devices:

Device Description:

An implantable surgical patch comprised of non-crosslinked bovine Veritas Collagen Matrix undergoes proprietary pericardium. processing that allows neo-collagen formation and neovascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.

Statement of Intended 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, pnuemonectomy/pneumectomy, 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, inguinal, lumbar, paracolostomy, scrotal, umbilical).

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K030879 Page 2/2

Technological Comparisons:

Veritas Collagen matrix is substantially equivalent to the predicate device, having the same technological characteristics and indications for use.

Technology/Device Testing:

The Veritas Collagen Matrix is substantially equivalent to the predicate device in terms of testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

January 28, 2013

Synovis Surgical Innovations % Ms. Angela Mallery Regulatory Affairs Manager 2575 University Avenue West St. Paul, Minnesota 55114

Re: K030879

Veritas® Collagen Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OXE, OXB, FTM, OWV, PAJ Dated: March 18, 2003 Received: March 20, 2003

Dear Ms. Mallery:

This letter corrects our substantially equivalent letter of April 24, 2003.

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 (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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Angela Mallery

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

## Peter D. Rumm -S

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

Enclosure

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## Indications for Use

510(k) Number (if known): K030879

Device Name: Veritas Collagen Matrix

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. blebectorny, lobectorny, bullectorny, bronchial resection. segmentectomy, pnuemonectomy/pneumectomy, 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, inguinal, lumbar, paracolostomy, scrotal, umbilical).

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)

David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K030879

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