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 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.

AI/ML Overview

This document is a 510(k) summary for the PhotoFix Decellularized Bovine Pericardium. It describes the device, its indications for use, and its substantial equivalence to predicate devices based on comparative testing of biomechanical properties. However, it does not contain the specific information required to complete the table or answer the detailed questions regarding acceptance criteria and study particulars for a device performance study in the way a clinical or AI-based diagnostic device submission would.

This document focuses on biomechanical performance testing comparing the new device to existing predicate devices, not on a human-in-the-loop or standalone algorithm performance study typical for AI/ML medical devices.

Therefore, many of the requested fields cannot be filled from the provided text.

Here is the information that can be extracted or deduced:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance and Comparison
Suture Retention Strength	Performance comparable to predicate devices (XenoSure K040835 and CorMatrix K063349)	"Testing demonstrated that PhotoFix is substantially equivalent to the identified predicate devices" in Suture Retention Strength. Specific quantitative values are not provided in this summary.
Ultimate Tensile Burst Strength	Performance comparable to predicate devices (XenoSure K040835 and CorMatrix K063349)	"Testing demonstrated that PhotoFix is substantially equivalent to the identified predicate devices" in Ultimate Tensile Burst Strength. Specific quantitative values are not provided in this summary.
Tear Resistance	Performance comparable to predicate devices (XenoSure K040835 and CorMatrix K063349)	"Testing demonstrated that PhotoFix is substantially equivalent to the identified predicate devices" in Tear Resistance. Specific quantitative values are not provided in this summary.
Material	Photooxidized Bovine Pericardium characteristics (same as prior PhotoFix K162506), distinct from Glutaraldehyde-Fixed Bovine Pericardium and Porcine Small Intestinal Submucosa (SIS) ECM.	PhotoFix uses "Photooxidized Bovine Pericardium," which is technologically similar to the predicate PhotoFix (K162506) but different from the material of XenoSure (Glutaraldehyde-Fixed Bovine Pericardium) and CorMatrix (Porcine SIS ECM). The summary asserts substantial equivalence despite material differences, implying the performance attributes are comparable.
Sterilization Method	Processed using ethylene oxide; sterilized using aseptic processing techniques (same as prior PhotoFix K162506), comparable to predicates.	PhotoFix uses "Processed using ethylene oxide; sterilized using aseptic processing techniques." This is similar to the predicate PhotoFix (K162506) and evaluated for comparability to XenoSure (Liquid chemical sterilized; aseptic processing) and CorMatrix (ethylene oxide gas).

Note on Acceptance Criteria: The document states that testing demonstrated that PhotoFix is substantially equivalent to the identified predicate devices for the biomechanical properties. This implies that the implicit acceptance criterion was meeting a comparable performance standard to these predicate devices, which are already legally marketed. Quantitative acceptance criteria are not explicitly listed in this summary.

Regarding the study that proves the device meets the acceptance criteria:

The study described is a comparative biomechanical testing study.

2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary. The study involved comparative biomechanical testing of the PhotoFix device against two predicate devices (XenoSure and CorMatrix). The "test set" would refer to the number of PhotoFix samples tested for each biomechanical property.
- Data Provenance: Not explicitly stated but clinical data provenance (e.g., country of origin, retrospective/prospective) is not applicable as this was a laboratory biomechanical testing study, not a clinical study. It's an in-vitro/ex-vivo material property study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a laboratory-based biomechanical performance test, not a study requiring expert consensus for ground truth. The "ground truth" would be the measured physical properties of the materials.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This was a laboratory-based biomechanical performance test.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This type of study is for diagnostic devices, particularly AI/ML-based ones. This document describes a tissue patch for surgical repair.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this type of study would be the measured physical and mechanical properties of the PhotoFix device and the predicate devices, obtained through standardized laboratory testing (e.g., force transducers, tensile testers, etc.). It is not clinical or expert-derived ground truth.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML algorithm.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
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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. NWKennesaw, GA 30144
Phone:	770-419-3355
Fax:	770-590-3783
Contact:	Heather EmerickManager, Regulatory Affairs
Device TradeName:	PhotoFix® Decellularized Bovine Pericardium
Classification: Class II	21 CFR 870.3470- Intracardiac patch or pledget made of polypropylene, polyethyleneterephthalate, or polytetrafluoroethylene.

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

Predicate Device Information

Device Name(s)	Manufacturer(s)	510(k)Number(s)	ProductCode(s)
PhotoFix® Decellularized BovinePericardium	CryoLife, Inc.	K162506	DXZ
XenoSure® Biological Patch(formerly PeriPatch)	LaMaitre Vascular,Inc.	K040835	DXZ/FTM
CorMatrix® ECM for Cardiac Tissue Repair	CorMatrixCardiovascular,Inc.	K063349	DXZ

Device Description

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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 DecellularizedBovine Pericardium	PhotoFix DecellularizedBovine Pericardium	XenoSure Biological Patch(formerly PeriPatch)	CorMatrix ECM for Cardiac TissueRepair
510(k)Number	K172085	K162506	K040835	K063349
Indicationsfor Use	Intracardiac repair, greatvessel repair, suture linebuttressing, pericardialclosure, and vascular repairand reconstruction (forexample: the carotid, iliac,femoral, and tibial bloodvessels and arteriovenousaccess revisions).	Intracardiac repair, great vesselrepair, suture line buttressingand pericardial closure.	A surgical patch material forcardiac and vascular reconstructionand repair, soft tissue deficiencyrepair and reinforcing the sutureline during general surgicalprocedures.	An intracardiac patch or pledget fortissue repair (i.e., atrial septal defect(ASD), ventricular septal defect(VSD), etc.) and suture linebuttressing.
Material	Photooxidized BovinePericardium	Photooxidized BovinePericardium	Glutaraldehyde-Fixed BovinePericardium	Porcine Small Intestinal Submucosa(SIS) ECM
Application	Single-layer	For applications exposed topeak systolic pressure, use areinforced patch technique(i.e., minimum of doublethickness)	Single-layer	Single-layer
SterilizationMethod	Processed using ethyleneoxide; sterilized usingaseptic processingtechniques	Processed using ethyleneoxide; sterilized using asepticprocessing techniques	Liquid chemical sterilized;sterilized using aseptic processingtechniques	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).

Regulation Number and Section

§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

(a)
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.(b)
Classification. Class II (performance standards).