Health Medical Homework Help

Project: Create a Traditional 510(k) submission for a Cardiac Catheter with Clot Prevention Coating

Predicate Device: Cardiac Catheter

Modification: Clot Prevention Coating

Description of the Predicate and Proposed Modification:

To minimize the risk of restenosis after cardiac revascularization, drug-eluting stents (DES) used in cardiac catheters include a medication that is actively delivered at the stent insertion site. However, concerns have been raised about the safety of drug-eluting stents due to the possibility of blood clots developing between 6 and 12 months after implantation increasing the risk of a sudden heart attack (Lagerqvist et al., 2007). As a result, the primary benefit of the novel Cardiac Clot-Free Catheter Device is to reduce the risk of restenosis while not increasing the chance of a blood clot by implanting new sustained-release DES with a long-lasting coating.

I am needing individual sections for the following:

• Declarations of conformity & summary report
• Proposed labeling
• Sterilization/shelf life

Please Note: Most of this information can be taken from the predicate device with minor modifications for cloth preventing coating. This is for a Class III device only

I have attached some resources and the following are some FDA links that you might find helpful when researching:

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/default.cfm

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

Additional Reference:

References:

Lagerqvist, B., James, S. K., Stenestrand, U., Lindbäck, J., Nilsson, T., Wallentin, L., & SCAAR Study Group (2007). Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. The New England journal of medicine, 356(10), 1009–1019. https://doi.org/10.1056/NEJMoa067722