SYNOVIS COLLAGEN MATRIX (TBD)

K122306 · Synovis Surgical Innovations · DXZ · Mar 8, 2013 · Cardiovascular

Device Facts

• Record ID: K122306
• Device Name: SYNOVIS COLLAGEN MATRIX (TBD)
• Applicant: Synovis Surgical Innovations
• Product Code: DXZ · Cardiovascular
• Decision Date: Mar 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synovis Collagen Matrix is intended for the reconstruction and repair of the pericardium.

Device Story

Synovis Collagen Matrix is an implantable biologic patch composed of non-crosslinked bovine pericardium. It is used by surgeons for the reconstruction and repair of the pericardium. The device acts as a scaffold that integrates into host tissue, undergoing extensive remodeling to form connective tissue indistinguishable from adjacent host tissue. It is provided as a sterile patch. Clinical benefit includes effective tissue repair with minimal inflammation, foreign body response, or fibrosis, and minimal tissue attachment to viscera.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing and animal studies. Bench testing included suture retention, thickness, amine index, tensile strength, burst pressure, sterilization validation, and biocompatibility (ISO 10993-1). Animal studies (swine and canine models) demonstrated no systemic or site-specific toxicity, minimal inflammation/fibrosis, and successful remodeling/integration into host tissue. Rat model confirmed minimal tissue attachment to viscera.

Technological Characteristics

Implantable biologic patch; non-crosslinked bovine pericardium. Evaluated for suture retention, thickness, amine index, tensile strength, and burst pressure. Biocompatibility per ISO 10993-1. Sterilized.

Indications for Use

Indicated for patients requiring reconstruction and repair of the pericardium.

Regulatory Classification

Identification

An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

Predicate Devices

• Veritas® Collagen Matrix (K002233, K030879, K062915)
• Supple Pericard® Pericardium with APEX Processing (K921895, K923657, K961810, K983162)
• Peri-Guard® Pericardium with APEX Processing (K821532, K833021, K842066, K961811, K971726, K983162)
• CorMatrix® ECM™ for Pericardial Closure (K051405)

Submission Summary (Full Text)

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# 510(K) SUMMARY

Applicant:

MAR 8 2013

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

#### Contact Person:

Jodi Jorgenson Regulatory Affairs Manager At address above

#### Date Prepared:

July 31, 2012

#### Device Trade Name: ·

Synovis Collagen Matrix (TBD)

#### Common Name:

Pericardial Patch

#### Classification Name:

21 CFR 870.3470: Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate or polytetrafluoroethylene Product Code: DXZ

#### Predicate Devices:

- Synovis Surgical Innovations, Veritas® Collagen Matrix: . K002233, K030879, K062915
- . Synovis Surgical Innovations, Supple Pericard® Pericardium with APEX Processing: K921895, K923657, K961810, K983162
- . Synovis Surgical Innovations, Peri-Guard® Pericardium with APEX Processing: K821532, K833021, K842066, K961811, K971726, K983162
- . CorMatrix Cardiovascular Inc, CorMatrix® ECM™ for Pericardial Closure: K051405

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#### Device Description:

Synovis Collagen Matrix is an implantable biologic patch comprised of non-crosslinked bovine pericardium.

### Statement of Intended Use:

Synovis Collagen Matrix is intended for the reconstruction and repair of the pericardium.

#### Substantial Equivalence:

The indications for use for Synovis Collagen Matrix for reconstruction and repair of the pericardium are substantially equivalent to the indications for use of the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Therefore, Synovis Collagen Matrix for reconstruction and repair of the pericardium is substantially equivalent to the predicate devices.

#### Summary/Comparison of Technological Characteristics:

The safety and performance of Synovis Collagen Matrix was evaluated through nonclinical testing.

The non-clinical testing assessed the following aspects of the device:

- Suture retention .
- Thickness .
- Amine index �
- Tensile �
- Burst ●
- . Sterilization validation
- . Packaging and shelf-life
- . Biocompatibility
- . Animal studies

Bench testing results support the performance requirements for Synovis Collagen Matrix. Biocompatibility testing was performed in accordance to ISO 10993-1 (Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process).

Various animal studies were conducted to support the safety and efficacy of Synovis Collagen Matrix. Systemic toxicology was evaluated in a swine model, and the results indicated that at all time points, there was no detectable systemic or site-specific toxicity. Histological examination revealed the device was readily remodeled and integrated into the adjacent host connective tissue.

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Synovis Collagen Matrix was also used to repair the tissue "stump" remaining after pneumonectomy and defects in the chest wall in a canine model. Results indicated no systemic or implant site specific toxicity, elicits minimal inflammation, minimal foreign body response or fibrosis, complete healing of the bronchial stump with no air leaks and repaired chest wall defects with sufficient mechanical integrity that remained hernia free throughout the 90 day post-implant period. Histological analysis demonstrated that Synovis Collagen Matrix undergoes extensive remodeling through host tissue integration of the implant and leads to formation of connective tissue that is indistinguishable from adjacent host tissue.

Adhesion formation was evaluated in a rat model, and the results confirmed that Synovis Collagen Matrix demonstrates minimal tissue attachment to the device in case of direct contact with viscera. These animal studies indicate that the device is safe and confirms product functionality.

#### Conclusions:

Synovis Collagen Matrix for reconstruction and repair of the pericardium is substantially equivalent to the predicate devices.

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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

March 8, 2013

Synovis Surgical Innovations C/O Jodi Jorgenson, Regulatory Affairs Manager 2575 University Avenue West St. Paul, MN 55114-1024

Re: K122306

Trade/Device Name: Synovis Collagen Matrix Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate or polytetrafluoroethylene Regulatory Class: Class II Product Code: DXZ Dated: February 20, 2013 Received: February 22, 2013

Dear Ms. Jorgenson:

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.

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

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## Page 2 - Ms. Jodi Jorgenson

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

OwenPFaris-S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):_ K122306

Device Name: Synovis Collagen Matrix

Indications For Use:

Synovis Collagen Matrix is intended for the reconstruction and repair of the pericardium.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Owen P. Faris -S
2013.03.08
15:17:13 -05'00'

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