PhotoFix Decellularized Bovine Pericardium

K162506 · Cryolife, Inc. · DXZ · Mar 9, 2017 · Cardiovascular

Device Facts

• Record ID: K162506
• Device Name: PhotoFix Decellularized Bovine Pericardium
• Applicant: Cryolife, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Mar 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PhotoFix Decellularized Bovine Pericardium is indicated for the following uses: intracardiac repair, great vessel repair, suture line buttressing and pericardial closure.

Device Story

PhotoFix is a cardiovascular patch derived from bovine pericardium; stabilized via dye-mediated photooxidation to create tissue crosslinks; processed without aldehyde chemistry; ethylene oxide sterilized; supplied in 22% buffered ethanol solution. Intended for single-use in surgical settings; implanted by cardiovascular surgeons during intracardiac or great vessel procedures. Patch serves as a structural scaffold for tissue repair, reinforcement of suture lines, or pericardial closure. Benefits include biocompatible tissue support for cardiac and vascular defects. Device is provided in various sizes to accommodate specific surgical needs; requires no rinsing prior to implantation.

Clinical Evidence

Bench testing only. Testing included chemical characterization, biocompatibility (cytotoxicity and hemolysis), and packaging shelf-life validation. Results confirmed the device and new polymer packaging are non-cytotoxic, non-hemolytic, and maintain a sterile barrier equivalent to the predicate.

Technological Characteristics

Bovine pericardium tissue; dye-mediated photooxidation crosslinking; no aldehyde chemistry used. Supplied in 22% buffered ethanol solution. Polymer storage container. Ethylene oxide sterilization. Single-use, non-resterilizable.

Indications for Use

Indicated for intracardiac repair, great vessel repair, suture line buttressing, and pericardial closure in patients requiring cardiovascular surgical intervention.

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

• Sulzer CarboMedics CardioFix Pericardium (K993288)

Submission Summary (Full Text)

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

March 09, 2017

CryoLife, Inc. Heather Emerick Manager, Regulatory Affairs 1655 Roberts Blvd., N.W. Kennesaw, Georgia 30144

Re: K162506

Trade/Device Name: PhotoFix Decellularized Bovine Pericardium 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 3, 2017 Received: February 6, 2017

Dear Ms. Emerick:

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 device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

M.A. Hillebrand

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) K162506

Device Name

PhotoFix Decellularized Bovine Pericardium

Indications for Use (Describe)

PhotoFix Decellularized Bovine Pericardium is indicated for the following uses: intracardiac repair, suture line buttressing and pericardial closure.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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| Date: | March 9, 2016 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | CryoLife, Inc. |
| Address: | 1655 Roberts Blvd., N.W.<br>Kennesaw, GA 30144 |
| Phone: | 770-419-3355 |
| Fax: | 770-590-3783 |
| Contact: | Heather Emerick<br>Manager, Regulatory Affairs |
| Device Trade<br>Name: | PhotoFix® Decellularized Bovine Pericardium |
| Classification: | Class II<br>21 CFR 870.3470; Intracardiac patch or pledget made of polypropylene,<br>polyethylene terephthalate, or polytetrafluoroethylene. |
| Product Code: | DXZ - Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene |

510(k) Summary

## Predicate Device Information:

| Device Name | Company | 510(k) Clearance | Product Code |
|---------------------------------------------|-----------------------|------------------|--------------|
| Sulzer CarboMedics CardioFix<br>Pericardium | Sulzer<br>CarboMedics | K993288 | DXZ |

Sulzer CarboMedics CardioFix Pericardium was originally cleared under K993288 in 1999. Subsequently, the device name changed to PhotoFix Decellularized Bovine Pericardium.

## Device Description

The PhotoFix® Decellularized Bovine Pericardium ("PhotoFix") is a cardiovascular patch prepared from bovine pericardium which is stabilized using a dye-mediated photooxidation process, processed using ethylene oxide and sterilized using aseptic processing techniques. The photooxidation process creates crosslinks in the bovine tissue. No aldehyde chemistry is used during any phase of manufacturing including the tissue fixation or sterilization processes.

PhotoFix is intended for single use only and cannot be resterilized.

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PhotoFix is supplied sterile in a sealed plastic container with 22% buffered ethanol solution. The package is designed to facilitate convenient aseptic transfer of the pericardium into the sterile field. Rinsing of the pericardium prior to implantation is not required.

| Catalog Number(s) | Size(s) (cm) |
|-------------------|--------------|
| PFP 1x1 | 1cm x 1cm |
| PFP 4x4 | 4cm x 4cm |
| PFP 6x8 | 6cm x 8cm |
| PFP 8x14 | 8cm x 14cm |
| PFP 10x16 | 10cm x 16cm |
| PFP 14x16 | 14cm x 16cm |

## Model Numbers and Configurations:

#### Indications for Use:

PhotoFix® Decellularized Bovine Pericardium is indicated for the following uses: intracardiac repair, great vessel repair, suture line buttressing and pericardial closure.

## Substantial Equivalence to Predicate/ Technological Characteristics:

Following to the clearance of K993288, the CardioFix Pericardium name changed to PhotoFix Decellularized Bovine Pericardium. PhotoFix Decellularized Bovine Pericardium is substantially equivalent to the identified predicate, CardioFix Pericardium (K993288), in regards to material, processing method, sterilization method, packaging solution, and storage. The table below provides a summary of the differences between the CardioFix and PhotoFix indications for use. The differences in the Indications for Use statement between PhotoFix Decellularized Bovine Pericardium and the originally cleared device, the predicate, do not affect the safety and effectiveness of the device when used as labeled.

| K993288 | K162506 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sulzer Carbomedics CardioFix Pericardium is<br>indicated for the following uses:<br>• Intracardiac Repair<br>• Ventricular Repair using a reinforced<br>patch technique (i.e., minimum of double<br>thickness)<br>• Atrial Repair<br>• Great vessel repair and suture line buttressing<br>using a reinforced patch technique (i.e.,<br>minimum of double thickness) for applications<br>exposed to peak systolic pressure<br>• Pericardial closure. | PhotoFix Decellularized Bovine Pericardium<br>is indicated for the following uses:<br>Intracardiac repair, great vessel repair, suture<br>line buttressing and pericardial closure. |

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In addition, the packaging material of the storage jar changed from glass to a polymer.

# Performance Testing

The following performance tests were conducted to support the change:

- Chemical characterization testing .
- Biocompatibility testing (cytotoxicity and hemolysis) .
- Packaging shelf-life ●

The results of the testing demonstrated that the packaging is non-cytotoxic, non-hemolytic, and maintains a sterile barrier. The packaging is equivalent to the predicate device.

## Conclusion:

PhotoFix is substantially equivalent to the respective predicate device, CardioFix Pericardium.