PhotoFix Decellularized Bovine Pericardium

K172085 · Cryolife, Inc. · PSQ · Dec 4, 2017 · Cardiovascular

Device Facts

• Record ID: K172085
• Device Name: PhotoFix Decellularized Bovine Pericardium
• Applicant: Cryolife, Inc.
• Product Code: PSQ · Cardiovascular
• Decision Date: Dec 4, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PhotoFix is indicated for the following uses: intracardiac repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels and arteriovenous access revisions).

Device Story

PhotoFix is a cardiovascular patch derived from bovine pericardium; stabilized via dye-mediated photooxidation to create tissue crosslinks; avoids aldehyde chemistry. Supplied sterile in 22% buffered ethanol solution; single-use; no rinsing required. Used by surgeons in OR settings for cardiac and vascular reconstruction, suture line reinforcement, and pericardial closure. Provides mechanical support for tissue repair; benefits patient by facilitating structural integrity in cardiovascular procedures.

Clinical Evidence

Bench testing only. Comparative biomechanical testing performed against predicates (K040835, K063349) evaluating suture retention strength, ultimate tensile burst strength, and tear resistance.

Technological Characteristics

Material: Photooxidized bovine pericardium. Crosslinking: Dye-mediated photooxidation (no aldehydes). Form factor: Single-layer patch. Sterilization: Ethylene oxide processing and aseptic techniques. Connectivity: None (implantable).

Indications for Use

Indicated for patients requiring intracardiac repair, great vessel repair, suture line buttressing, pericardial closure, and vascular repair/reconstruction (e.g., carotid, iliac, femoral, tibial vessels, and arteriovenous access revisions).

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

• PhotoFix Decellularized Bovine Pericardium (K162506)
• XenoSure Biological Patch (formerly PeriPatch) (K040835)
• CorMatrix ECM for Cardiac Tissue Repair (K063349)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

December 4, 2017

CryoLife, Inc. John Ferros Senior Director, Regulatory Affairs 1655 Roberts Blvd. NW Kennesaw. Georgia 30144

Re: K172085

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: PSQ Dated: November 2, 2017 Received: November 3, 2017

Dear John Ferros:

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

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801); medical device reporting of medical device-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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Nicole G. Ibrahim -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) K172085

Device Name

PhotoFix Decellularized Bovine Pericardium

Indications for Use (Describe)

PhotoFix is indicated for the following uses: intracardiac repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels and arteriovenous access revisions).

| 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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### 510(k) Summary

| Date: | December 1, 2017 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | CryoLife, Inc. |
| Address: | 1655 Roberts Blvd. NW<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 | 21 CFR 870.3470- Intracardiac patch or pledget made of polypropylene, polyethylene<br>terephthalate, or polytetrafluoroethylene. |

Product Code: PSQ- Intracardiac patch or pledget, biologically derived

### Predicate Device Information

| Device Name(s) | Manufacturer(s) | 510(k)<br>Number(s) | Product<br>Code(s) |
|----------------------------------------------------|--------------------------------------|---------------------|--------------------|
| PhotoFix® Decellularized Bovine<br>Pericardium | CryoLife, Inc. | K162506 | DXZ |
| XenoSure® Biological Patch<br>(formerly PeriPatch) | LaMaitre Vascular,<br>Inc. | K040835 | DXZ/FTM |
| CorMatrix® ECM for Cardiac Tissue Repair | CorMatrix<br>Cardiovascular,<br>Inc. | K063349 | DXZ |

### Device Description

The PhotoFix® Decellularized Bovine Pericardium ("PhotoFix") is a cardiovascular patch that is prepared from bovine pericardium, stabilized using dye-mediated photooxidation, 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. PhotoFix is supplied sterile in a sealed container with 22% buffered ethanol solution. Rinsing of the pericardium prior to implantation is not required.

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### Indications for Use

PhotoFix is indicated for the following uses: intracardiac repair, great vessel repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels and arteriovenous access revisions).

### Substantial Equivalence to Predicate Devices

Comparative testing was performed between PhotoFix and both XenoSure (K040835) and CorMatrix ECM for Cardiac Tissue Repair (K063349) to evaluate the following biomechanical properties: Suture Retention Strength, Ultimate Tensile Burst Strength and Tear Resistance. Testing demonstrated that PhotoFix is substantially equivalent to the identified predicate devices. The table below outlines the technological characteristics of PhotoFix Decellularized Bovine Pericardium and the predicate devices.

| | PhotoFix Decellularized<br>Bovine Pericardium | PhotoFix Decellularized<br>Bovine Pericardium | XenoSure Biological Patch<br>(formerly PeriPatch) | CorMatrix ECM for Cardiac Tissue<br>Repair |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Number | K172085 | K162506 | K040835 | K063349 |
| Indications<br>for Use | Intracardiac repair, great<br>vessel repair, suture line<br>buttressing, pericardial<br>closure, and vascular repair<br>and reconstruction (for<br>example: the carotid, iliac,<br>femoral, and tibial blood<br>vessels and arteriovenous<br>access revisions). | Intracardiac repair, great vessel<br>repair, suture line buttressing<br>and pericardial closure. | A surgical patch material for<br>cardiac and vascular reconstruction<br>and repair, soft tissue deficiency<br>repair and reinforcing the suture<br>line during general surgical<br>procedures. | An intracardiac patch or pledget for<br>tissue repair (i.e., atrial septal defect<br>(ASD), ventricular septal defect<br>(VSD), etc.) and suture line<br>buttressing. |
| Material | Photooxidized Bovine<br>Pericardium | Photooxidized Bovine<br>Pericardium | Glutaraldehyde-Fixed Bovine<br>Pericardium | Porcine Small Intestinal Submucosa<br>(SIS) ECM |
| Application | Single-layer | For applications exposed to<br>peak systolic pressure, use a<br>reinforced patch technique<br>(i.e., minimum of double<br>thickness) | Single-layer | Single-layer |
| Sterilization<br>Method | Processed using ethylene<br>oxide; sterilized using<br>aseptic processing<br>techniques | Processed using ethylene<br>oxide; sterilized using aseptic<br>processing techniques | Liquid chemical sterilized;<br>sterilized using aseptic processing<br>techniques | Sterilized using ethylene oxide gas |

### Conclusion:

PhotoFix is substantially equivalent to the predicate devices PhotoFix Decellularized Bovine Pericardium (K162506), CorMatrix ECM for Cardiac Tissue Repair (K063349), and XenoSure Biological Patch (K040835).