(182 days)
Not Found
No
The device description focuses on the biological material and processing techniques, with no mention of AI or ML.
Yes.
The device is used for intracardiac repair, great vessel repair, suture line buttressing, and pericardial closure, which are therapeutic interventions.
No
Explanation: The device is a cardiovascular patch used for repair and buttressing of tissues, not for diagnosing medical conditions.
No
The device description clearly states it is a cardiovascular patch prepared from bovine pericardium, which is a physical tissue product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are for surgical repair and closure within the body (intracardiac, great vessel, pericardial). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description details a tissue patch for implantation, not a reagent, instrument, or system used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
This device is a surgical implant used for structural repair.
N/A
Intended Use / Indications for Use
PhotoFix Decellularized Bovine Pericardium is indicated for the following uses: intracardiac repair, great vessel repair, suture line buttressing and pericardial closure.
Product codes
DXZ
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac, great vessel, pericardial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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 Emerick |
Manager, Regulatory Affairs | |
Device Trade | |
Name: | PhotoFix® Decellularized Bovine Pericardium |
Classification: | Class II |
21 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 CardioFix | |||
Pericardium | Sulzer | ||
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.
4
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 | |
indicated for the following uses: | |
• Intracardiac Repair | |
• Ventricular Repair using a reinforced | |
patch technique (i.e., minimum of double | |
thickness) | |
• Atrial Repair | |
• Great vessel repair and suture line buttressing | |
using a reinforced patch technique (i.e., | |
minimum of double thickness) for applications | |
exposed to peak systolic pressure | |
• Pericardial closure. | PhotoFix Decellularized Bovine Pericardium |
is indicated for the following uses: | |
Intracardiac repair, great vessel repair, suture | |
line buttressing and pericardial closure. |
5
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.