(50 days)
Not Found
No
The device description focuses on the material properties and processing of a bovine pericardium patch, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a cardiovascular patch used for intracardiac repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction, which are all therapeutic interventions.
No
The device description and intended use indicate it is a cardiovascular patch used for repair and reconstruction, not for diagnosing medical conditions.
No
The device description clearly states that PhotoFix is a cardiovascular patch made from decellularized bovine pericardium, which is a physical material, 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 (intracardiac repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction) are all surgical procedures performed in vivo (within the living body).
- Device Description: The device is a cardiovascular patch intended for implantation into the body.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the living body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit this description.
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 (comma separated list FDA assigned to the subject device)
PSO, 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, carotid, iliac, femoral, tibial blood vessels, arteriovenous access.
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)
Non-Clinical Testing:
- Simulated Distribution testing followed by Bacterial Aerosol Challenge testing
- Accelerated Aging Shelf Life testing followed by Bacterial Aerosol Challenge testing
Conclusion: PhotoFix Decellularized Bovine Pericardium is substantially equivalent to the predicate device currently on the market (K172085).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 14, 2019
CryoLife, Inc. Heather Emerick Regulatory Affairs Manager 1655 Roberts Blvd. NW Kennesaw. Georgia 30144
Re: K183635
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: PSO Dated: February 8, 2019 Received: February 11, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,
Rachel E. Neubrander -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)
K183635
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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| Date: | February 14, 2019 |
|---|---|
| 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 |
510(k) Summary
Type of 510(k): Special 510(k)
Predicate Device Information
| Device Name | Manufacturer | 510(k) Number | Product
Code |
|------------------------------------------------|----------------|---------------|-----------------|
| PhotoFix® Decellularized Bovine
Pericardium | CryoLife, Inc. | K172085 | 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.
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).
Comparison to Predicate Device
PhotoFix Decellularized Bovine Pericardium is serving as its own predicate device. PhotoFix Decellularized Bovine Pericardium is substantially equivalent to the currently marketed device (K172085) in regards to intended use, processing method, sterilization method and technological characteristics with the exception of the 8x14cm patch configuration which is the focus of this Special 510(k) submission. The 8x14cm patch configuration will be packaged in a 250mL final packaging bottle; all other PhotoFix patch configurations are packaged in a 125mL final packaging bottle.
A risk analysis has been performed and all design verification and design validation activities have been identified and completed in conformance with design control requirements. Based on the qualification activities of the new 250mL bottle, the shelf life requirement of the 8x14cm patch configuration will be identified as a minimum of 1 year.
Non-Clinical Testing
In order to demonstrate substantial equivalence between the existing 125mL bottle and the proposed 250mL bottle, the following testing was performed:
- Simulated Distribution testing followed by Bacterial Aerosol Challenge testing
- 트 Accelerated Aging Shelf Life testing followed by Bacterial Aerosol Challenge testing
Conclusion:
PhotoFix Decellularized Bovine Pericardium is substantially equivalent to the predicate device currently on the market (K172085).