DuraGraft Vascular Conduit Solution
Device Facts
| Record ID | K240925 |
|---|---|
| Device Name | DuraGraft Vascular Conduit Solution |
| Applicant | Marizyme |
| Product Code | QEJ · Gastroenterology, Urology |
| Decision Date | May 1, 2024 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 876.4100 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
DuraGraft Vascular Conduit Solution is a solution indicated for adult patients undergoing Coronary Artery Bypass Grafting Surgeries and is intended for flushing and storage of the saphenous vein grafts from harvesting through grafting for up to 4 hours.
Device Story
DuraGraft is a single-use, non-pyrogenic solution for flushing and storing saphenous vein grafts during CABG surgery. Provided as two components (Solution A in PETG bottles; Solution B in glass vials) mixed at point-of-use. Solution maintains ionic balance, isotonicity, and provides a non-oxidizing environment to prevent ischemic injury to vascular conduits. Used by surgical staff in clinical settings. Benefits include preservation of graft integrity during the interval between harvesting and grafting. Stability testing supports storage at controlled room temperature (20-25°C).
Clinical Evidence
No new clinical data provided. Bench testing included chemical stability, sterility, endotoxin levels, and container/closure/shipping integrity testing to support the updated storage temperature and shelf life. Previous clinical data from DEN230002 remain applicable.
Technological Characteristics
Aqueous-based solution; components are GRAS and USP/NF compliant. Osmolality ~305 Osmol/kg; pH 7.4. Aseptically processed (SAL 10^-3). Complies with ISO 10993-1, -12, -18; ISO 13408-1, -2; ASTM D4169-16. Single-use, non-electronic.
Indications for Use
Indicated for adult patients undergoing Coronary Artery Bypass Grafting (CABG) surgeries; intended for flushing and storage of saphenous vein grafts from harvesting through grafting for up to 4 hours.
Regulatory Classification
Identification
A flushing and storage solution for vascular autografts at room temperature is a device that is used for flushing or short-term storage of vascular grafts. This generic type of device is intended to maintain cell viability and structural integrity of vascular grafts during short-term storage at room temperature during the surgical procedure. The DuraGraft Vascular Conduit Solution is specifically indicated for adult patients undergoing Coronary Artery Bypass Grafting (CABG) surgeries and is intended for flushing and storage of the saphenous vein grafts from harvesting through grafting for up to 4 hours.
Special Controls
In combination with the general controls of the FD&C Act, the flushing and storage solution for vascular autografts at room temperature is subject to the following special controls:
Predicate Devices
- DuraGraft Vascular Conduit Solution (DEN230002)
Submission Summary (Full Text)
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May 1, 2024
Marizyme % John J. Smith, MD, J.D., Partner Hogan Lovells US LLP 555 13th Street NW Washington, DC 20004
Re: K240925
Trade/Device Name: DuraGraft Vascular Conduit Solution Regulation Number: 21 CFR§ 876.4100 Regulation Name: Flushing and Storage Solution for Vascular Autografts at Room Temperature During Coronary Artery Bypass Graft Surgeries Regulatory Class: II Product Code: QEJ Dated: April 4, 2024 Received: April 4, 2024
Dear John J. Smith:
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Maura Rooney -S
Maura Rooney Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
Submission Number (if known)
K24925
Device Name
DuraGraft Vascular Conduit Solution
Indications for Use (Describe)
DuraGraft Vascular Conduit Solution is a solution indicated for adult patients undergoing Coronary Artery Bypass Graffing Surgeries and is intended for flushing and storage of the saphenous vein grafts from harvesting through grafting for up to 4 hours.
Type of Use (Select one or both, as applicable)
( Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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## 510(k) Summary
## Marizyme, Inc.'s DuraGraft Vascular Conduit Solution
## K240925
#### Submitter
Marizyme, Inc 555 Heritage Dr. Suite 205 Jupiter, FL 33458 Phone: 215-896-4403
Contact Person: Dr. Catherine J. Pachuk
Date Prepared: April 4, 2024
Trade Name of Device: DuraGraft Vascular Conduit Solution
Common Name of Device: Vascular Conduit Solution
Classification Name: Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
Regulatory Class: Class II
Regulation: 21 CFR 876.4100
Product Code: QEJ
Predicate Device: DuraGraft Vascular Conduit Solution (DEN230002)
#### Device Description
DuraGraft Vascular Conduit Solution is a single-use, clear, colorless to slightly yellow, non-pyrogenic solution used as a flushing and storage solution during the harvesting and grafting interval in Coronary Artery Bypass Grafting (CABG surgeries). All ingredients are Generally Recognized as Safe (GRAS) and comply with United States Pharmacopoeia (USP) or National Formulary (NF) specifications. No components are of animal or blood origin. The product is aseptically processed using aseptic filling procedures. Stability testing at 25℃ supports a shelf life of 2 years at a storage temperature of 20-25°C (controlled room temperature).
The salts in DuraGraft are intended for buffering (to maintain both ionic balance and isotonicity with respect to vascular conduits. The organic components are intended to provide a non-oxidizing environment for vascular conduits and to maintain additional buffering capability and osmolality. The organic components are all normal constituents of blood and are included for their roles in maintaining the extracellular environment of vascular conduits to prevent ischemic injury.
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DuraGraft Vascular Conduit Solution is provided in two aseptically processed containers; Solution A and Solution B. Solution A is an aqueous based solution provided in sterile PETG bottles with white HDPE closures. Solution B is an aqueous based solution provided in sterile Type I borosilicate glass vials with bromobutyl rubber stoppers with aluminum crimps. Solution B are mixed at the point of use to generate DuraGraft Vascular Conduit Solution which is the graft storage and flushing solution.
The mixed solution is used at room temperature and has an osmolality of about 305 Osmol/kg, viscosity of 1.06 cST, a sodium concentration of 155-160 mEq/L (sodium concentration is expressed as a range due to the use of Sodium bicarbonate for pH adjustment of Solution A and is based on review of several (10+) manufacturing batch records), and a potassium concentration of 5.8 mEq/L, and a pH of 7.4 at room temperature.
## Indications for Use
DuraGraft Vascular Conduit Solution is a solution indicated for adult patients undergoing Coronary Artery Bypass Grafting Surgeries and is intended for flushing and storage of the saphenous vein grafts from harvesting through grafting for up to 4 hours.
## Substantial Equivalence
The purpose of this Special 510(k) submission was to update the storage condition and shelf life to 20-25°C (controlled room temperature) for 2 years. All other technological characteristics of the subject and predicate DuraGraft are identical. A comparison chart between the predicate and subject devices is presented below.
| | DuraGraft | DuraGraft |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device (DEN230002) |
| Indications for<br>Use | DuraGraft Vascular Conduit Solution<br>is indicated for adult patients<br>undergoing Coronary Artery Bypass<br>Grafting Surgeries and is intended for<br>flushing and storage of the saphenous<br>vein grafts from harvesting through<br>grafting for up to four hours | DuraGraft Vascular Conduit Solution<br>is indicated for adult patients<br>undergoing Coronary Artery Bypass<br>Grafting Surgeries and is intended for<br>flushing and storage of the saphenous<br>vein grafts from harvesting through<br>grafting for up to four hours |
| Major<br>Components | Solution A<br>Solution B | Solution A<br>Solution B |
| Sterilization | Aseptically Processed<br>(SAL 10-3) | Aseptically Processed<br>(SAL 10-3) |
| Standards with<br>which the<br>Device<br>Complies | ISO 10993-12 Biological evaluation of<br>medical devices - Part 12: Sample<br>preparation and reference materials<br><br>ISO 13408-1 Second edition 2008-06-<br>15<br>Aseptic processing of health care<br>products - Part 1: General<br>requirements [Including: Amendment<br>1 (2013)] | ISO 10993-12 Biological evaluation of<br>medical devices - Part 12: Sample<br>preparation and reference materials<br><br>ISO 13408-1 Second edition 2008-06-<br>15<br>Aseptic processing of health care<br>products - Part 1: General<br>requirements [Including: Amendment<br>1 (2013)] |
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| | DuraGraft<br>Subject Device | DuraGraft<br>Predicate Device (DEN230002) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ISO 13408-2 Second edition 2018-01<br>Aseptic processing of health care<br>products - Part 2: Sterilizing filtration<br><br>ISO 10993-1 Fifth edition 2018-08<br>Biological evaluation of medical<br>devices - Part 1: Evaluation and<br>testing within a risk management<br>process | ISO 13408-2 Second edition 2018-01<br>Aseptic processing of health care<br>products - Part 2: Sterilizing filtration<br><br>ISO 10993-1 Fifth edition 2018-08<br>Biological evaluation of medical<br>devices - Part 1: Evaluation and<br>testing within a risk management<br>process |
| | 10993-18 Biological evaluation of<br>medical devices - Part 18: Chemical<br>characterization of medical device<br>materials within a risk management<br>process | 10993-18 Biological evaluation of<br>medical devices - Part 18: Chemical<br>characterization of medical device<br>materials within a risk management<br>process |
| | ASTM D4169-16 Standard practice<br>for performance testing of shipping<br>containers and systems. | ASTM D4169-16 Standard practice<br>for performance testing of shipping<br>containers and systems. |
| Storage<br>Temperature | 20-25°C | 2-8°C |
| Shelf Life | 2 years | 3 years |
## Performance Data
Long-term stability testing was performed at 25°C to support the updated storage temperature and shelf life. Testing included evaluation of chemical stability, sterility endotoxin levels, and container/closure integrity and shipping package integrity. Testing met all specified criteria. Previously performed non-clinical and clinical data from DEN230002 remain applicable to the subject device.
## Conclusions
DuraGraft (subject device) has the same indications for use as DuraGraft (predicate device). The composition, technological characteristics, and principles of operation are identical between DuraGraft and its predicate. Thus, the DuraGraft is substantially equivalent.
