(27 days)
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.
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.
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.
The provided text is a 510(k) summary for the DuraGraft Vascular Conduit Solution. This document pertains to the regulatory submission for a medical device (a solution for flushing and storing vascular grafts), not a software or AI-powered device. Therefore, the questions related to AI acceptance criteria, training/test sets, expert ground truth, MRMC studies, and human-in-the-loop performance are not applicable to this document.
The core of this 510(k) summary is to demonstrate substantial equivalence to a previously cleared predicate device, specifically by updating the storage conditions and shelf life. The performance data presented focuses on stability testing of the solution itself, rather than the performance of an AI algorithm.
Here's how the provided information relates to the request, addressing points where applicable and noting others as not applicable:
1. A table of acceptance criteria and the reported device performance
The document doesn't define "acceptance criteria" in the context of an AI algorithm's performance metrics (like sensitivity, specificity, AUC). Instead, it discusses the outcomes of stability testing for the solution.
| Acceptance Criteria (Implied from testing) | Reported Device Performance (from "Performance Data" section) |
|---|---|
| Chemical stability | Testing met all specified criteria. |
| Sterility | Testing met all specified criteria. |
| Endotoxin levels | Testing met all specified criteria. |
| Container/closure integrity | Testing met all specified criteria. |
| Shipping package integrity | Testing met all specified criteria. |
| Shelf life | Long-term stability testing at 25°C supports a shelf life of 2 years. |
2. Sample sizes used for the test set and the data provenance
- Sample size: Not specified in terms of "test set" for an AI. The "Performance Data" section states "Long-term stability testing was performed at 25°C" but does not detail the number of batches or samples tested.
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective clinical data for the solution). The testing appears to be laboratory-based (stability testing).
3. 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 device requiring expert adjudication of images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI device.
5. 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. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this medical device's performance relates to the intrinsic properties of the solution (chemical composition, sterility, stability) and its ability to maintain these properties over time and specific conditions. This "ground truth" is established through standard laboratory testing methods (e.g., analytical chemistry, microbiology) against predefined specifications.
8. The sample size for the training set
Not applicable. This is not an AI device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
In summary, the provided document is a regulatory submission for a medical solution, not an AI or software device. Therefore, most of the questions regarding AI-specific acceptance criteria and study methodologies are not relevant to this content.
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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 forUse | DuraGraft Vascular Conduit Solutionis indicated for adult patientsundergoing Coronary Artery BypassGrafting Surgeries and is intended forflushing and storage of the saphenousvein grafts from harvesting throughgrafting for up to four hours | DuraGraft Vascular Conduit Solutionis indicated for adult patientsundergoing Coronary Artery BypassGrafting Surgeries and is intended forflushing and storage of the saphenousvein grafts from harvesting throughgrafting for up to four hours |
| MajorComponents | Solution ASolution B | Solution ASolution B |
| Sterilization | Aseptically Processed(SAL 10-3) | Aseptically Processed(SAL 10-3) |
| Standards withwhich theDeviceComplies | ISO 10993-12 Biological evaluation ofmedical devices - Part 12: Samplepreparation and reference materialsISO 13408-1 Second edition 2008-06-15Aseptic processing of health careproducts - Part 1: Generalrequirements [Including: Amendment1 (2013)] | ISO 10993-12 Biological evaluation ofmedical devices - Part 12: Samplepreparation and reference materialsISO 13408-1 Second edition 2008-06-15Aseptic processing of health careproducts - Part 1: Generalrequirements [Including: Amendment1 (2013)] |
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| DuraGraftSubject Device | DuraGraftPredicate Device (DEN230002) | |
|---|---|---|
| ISO 13408-2 Second edition 2018-01Aseptic processing of health careproducts - Part 2: Sterilizing filtrationISO 10993-1 Fifth edition 2018-08Biological evaluation of medicaldevices - Part 1: Evaluation andtesting within a risk managementprocess | ISO 13408-2 Second edition 2018-01Aseptic processing of health careproducts - Part 2: Sterilizing filtrationISO 10993-1 Fifth edition 2018-08Biological evaluation of medicaldevices - Part 1: Evaluation andtesting within a risk managementprocess | |
| 10993-18 Biological evaluation ofmedical devices - Part 18: Chemicalcharacterization of medical devicematerials within a risk managementprocess | 10993-18 Biological evaluation ofmedical devices - Part 18: Chemicalcharacterization of medical devicematerials within a risk managementprocess | |
| ASTM D4169-16 Standard practicefor performance testing of shippingcontainers and systems. | ASTM D4169-16 Standard practicefor performance testing of shippingcontainers and systems. | |
| StorageTemperature | 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.
N/A