(146 days)
No
The document describes a biological patch made from bovine pericardium and its manufacturing process. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is indicated for medical uses such as intracardiac repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction, which directly address a health condition or perform a medical function, thus classifying it as a therapeutic device.
No
The device description and intended use indicate that PhotoFix is a cardiovascular patch used for repair and reconstruction, not for diagnosing conditions.
No
The device description clearly states that PhotoFix is a cardiovascular patch prepared from bovine pericardium, indicating it is a physical, implantable medical device, 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 all surgical procedures performed in vivo (within the body) for repair and reconstruction of tissues and blood vessels. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue samples to diagnose diseases or conditions.
- Device Description: The device is a cardiovascular patch intended for implantation. This is a medical device used directly on or in a patient, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any of the typical components or processes associated with IVD devices (e.g., reagents, calibrators, controls, analytical methods).
Therefore, PhotoFix is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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).
Product codes
PSQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac, great vessel, pericardial, vascular (carotid, iliac, femoral, and tibial blood vessels, arteriovenous access)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
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/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
1
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
2
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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3
510(k) Summary
| Date: | December 1, 2017 |
|---|---|
| Submitter: | CryoLife, Inc. |
| Address: | 1655 Roberts Blvd. NW |
| 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: PSQ- Intracardiac patch or pledget, biologically derived
Predicate Device Information
| Device Name(s) | Manufacturer(s) | 510(k)
Number(s) | Product
Code(s) |
|----------------------------------------------------|--------------------------------------|---------------------|--------------------|
| PhotoFix® Decellularized Bovine
Pericardium | CryoLife, Inc. | K162506 | DXZ |
| XenoSure® Biological Patch
(formerly PeriPatch) | LaMaitre Vascular,
Inc. | K040835 | DXZ/FTM |
| CorMatrix® ECM for Cardiac Tissue Repair | CorMatrix
Cardiovascular,
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.
4
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
Bovine Pericardium | PhotoFix Decellularized
Bovine Pericardium | XenoSure Biological Patch
(formerly PeriPatch) | CorMatrix ECM for Cardiac Tissue
Repair |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | K172085 | K162506 | K040835 | K063349 |
| Indications
for Use | 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). | Intracardiac repair, great vessel
repair, suture line buttressing
and pericardial closure. | A surgical patch material for
cardiac and vascular reconstruction
and repair, soft tissue deficiency
repair and reinforcing the suture
line during general surgical
procedures. | An intracardiac patch or pledget for
tissue repair (i.e., atrial septal defect
(ASD), ventricular septal defect
(VSD), etc.) and suture line
buttressing. |
| Material | Photooxidized Bovine
Pericardium | Photooxidized Bovine
Pericardium | Glutaraldehyde-Fixed Bovine
Pericardium | Porcine Small Intestinal Submucosa
(SIS) ECM |
| Application | Single-layer | For applications exposed to
peak systolic pressure, use a
reinforced patch technique
(i.e., minimum of double
thickness) | Single-layer | Single-layer |
| Sterilization
Method | Processed using ethylene
oxide; sterilized using
aseptic processing
techniques | Processed using ethylene
oxide; sterilized using aseptic
processing techniques | Liquid chemical sterilized;
sterilized using aseptic processing
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).