(182 days)
PhotoFix Decellularized Bovine Pericardium is indicated for the following uses: intracardiac repair, suture line buttressing and pericardial closure.
PhotoFix® Decellularized Bovine Pericardium is indicated for the following uses: intracardiac repair, great vessel repair, suture line buttressing and pericardial closure.
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.
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.
The provided text is a 510(k) summary for the PhotoFix Decellularized Bovine Pericardium device. This document is a premarket notification for a medical device to demonstrate that it is substantially equivalent to a legally marketed predicate device.
Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device is not directly applicable to this document. This document describes an implantable tissue patch, not an AI/ML device.
The "Performance Testing" section describes tests related to the physical and biological characteristics of the tissue patch and its packaging, specifically:
- Chemical characterization testing
- Biocompatibility testing (cytotoxicity and hemolysis)
- Packaging shelf-life
The "Conclusion" states that the device is substantially equivalent to its predicate.
To directly answer your questions based on the provided document, in the context of this specific medical device (PhotoFix Decellularized Bovine Pericardium), rather than an AI/ML device:
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A table of acceptance criteria and the reported device performance:
The document does not provide a formal table with specific acceptance criteria and detailed performance results (e.g., numerical values for cytotoxicity, hemolysis rates, or specific shelf-life data with pass/fail criteria). It only states that "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."
Acceptance Criteria (Inferred from regulatory context):
* Biocompatibility: Non-cytotoxic, Non-hemolytic.
* Sterility: Sterile barrier maintained for shelf-life.
* Equivalence: Packaging equivalent to predicate device.
Reported Performance:
* Biocompatibility: "non-cytotoxic, non-hemolytic"
* Sterility/Packaging: "maintains a sterile barrier"
* Equivalence: "The packaging is equivalent to the predicate device." -
Sample sizes used for the test set and the data provenance: Not specified in the document.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): For biocompatibility and chemical characterization, the "ground truth" would be established by laboratory testing standards and methods (e.g., ISO standards for biocompatibility), not expert consensus in the diagnostic sense. For shelf life, it would be based on real-time or accelerated aging studies.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that features a stylized representation of three human profiles facing to the right, arranged in a stacked formation. The profiles are connected and appear to form a single, flowing shape.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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.Kennesaw, GA 30144 |
| Phone: | 770-419-3355 |
| Fax: | 770-590-3783 |
| Contact: | Heather EmerickManager, Regulatory Affairs |
| Device TradeName: | PhotoFix® Decellularized Bovine Pericardium |
| Classification: | Class II21 CFR 870.3470; Intracardiac patch or pledget made of polypropylene,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 CardioFixPericardium | SulzerCarboMedics | 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 isindicated for the following uses:• Intracardiac Repair• Ventricular Repair using a reinforcedpatch technique (i.e., minimum of doublethickness)• Atrial Repair• Great vessel repair and suture line buttressingusing a reinforced patch technique (i.e.,minimum of double thickness) for applicationsexposed to peak systolic pressure• Pericardial closure. | PhotoFix Decellularized Bovine Pericardiumis indicated for the following uses:Intracardiac repair, great vessel repair, sutureline 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.
§ 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).