Assignment Instruction

 Write a pre-Submission meeting request to FDA for the selected medical device (as I
listed below)
 Follow the sample document (in another Word doc)
 Do not include Table of Contents and Cover Letter
 Times New Roman, Font 12
 4 pages only, do not focus on too many details
Device Information:
Device Name: LOTUS EdgeTM Valve System

Generic Name: Aortic Valve, Prosthesis, Percutaneously Delivered
Product Code: NPT
Classification: Class III
PMA number: P180029
This device is an implanted device that used to relief severe native calcified aortic stenosis in
patients with symptomatic heart disease.
Verification Testing:
Biocompatibility Testing: the tests were done to prove that the LOTUS EdgeTM Valve System’s
materials and components are biocompatible.
Design Performance Testing: the tests were done to demonstrate the design and performance
attributes of the LOTUS EdgeTM Valve System. For example, mechanical property testing,
corrosion assessment, device durability, and structural integrity assessment were included in the
design performance testing.
Sterilization: LOTUS EdgeTM Valve System are sterilized in the liquid glutaraldehyde solution
for a period of time at high temperature. The Sterility Assurance Level (SAL) was 10 -6.
Packaging and Shelf Life: The LOTUS EdgeTM Valve System are placed in a thermoformed co-
polyester tray/lid in a single barrier package. The shelf life is 9 months.
Validation Testing：
Clinical Study: The study was a prospective, multicenter, randomized controlled study to
evaluate the safety and effectiveness of the LOTUS EdgeTM Valve System. The participants were
assigned a Lotus Valve System (23 mm, 25 mm, and 27 mm valve sizes) or a commercially
available CoreValve® (26 mm, 29 mm, and 31 mm valve sizes) 2:1 ratio. The control group was
the CoreValve® Transcatheter Aortic Valve Replacement System.
In the EU, the classification of implanted heart valves is considered as the Class III medical
device. Both the US and EU would require the same data for V&V testing of a Class III medical
device.
References:
U.S. Food & Drug Administration. (2019, April 23). SUMMARY OF SAFETY AND
EFFECTIVENESS DATA
(SSED). https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180029B.pdf
U.S. Food & Drug Administration. (2020, July 13). Premarket approval
(PMA). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180029
Device Name: LOTUS EdgeTM Valve System

Generic Name: Aortic Valve, Prosthesis, Percutaneously Delivered
Product Code: NPT
Classification: Class III
This device is intended to relief severe native calcified aortic stenosis in patients with
symptomatic heart disease.
Two specific standards:

 ISO 5840-3 Heart valve substitutes implanted by transcatheter techniques
This standard outline the design and manufacture of V & V transcatheter cardiac valve
substitutes through risk management. Select appropriate verification and validation tests and
methods from risk assessment. Tests include evaluating the physical, biological and mechanical
properties of cardiac valve substitutes and their materials and components.
 ISO 5840-1 General requirements for cardiovascular implants
This standard outline the packaging and labelling of cardiac valve substitutes and provides
general requirements.
Two guidance documents:

 FDA Guidance “General Considerations for Animal Studies for Cardiovascular Devices”
This guidance document guides animal studies on cardiovascular devices, including how to
develop study protocols for animal studies, methods used, and reports that support the safety and
performance of the cardiovascular system. FDA will review the non-clinical study reports
submitted in accordance with this guidance. According to this guidance document, when
conducting non-clinical studies for the Lotus EdgeTM Valve System, sponsors can follow the
recommendations in the guidance document to prove the safety of the device.
 FDA Guidance “Design Control Guidance for Medical Device Manufacturers”
This guidance document is applicable to all medical device manufacturers, including quality
system requirements for design control. This guidance describes design input and output for
medical devices. When designing the Lotus EdgeTM Valve System, it is necessary to consider
whether its intended to use conforms to the device design.
References:
U.S. Food & Drug Administration. (2018, August 21). General considerations for animal
studies for cardiovascular devices. U.S. Food and Drug
Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/
general-considerations-animal-studies-cardiovascular-devices-guidance-industry-and-fda-staff
U.S. Food & Drug Administration. (2018, September 10). Design control guidance for medical
device manufacturers. U.S. Food and Drug Administration. https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/design-control-guidance-medical-device-
manufacturers
U.S. Food & Drug Administration. (n.d.). Product
classification. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?
id=1074

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 Write a pre-Submission meeting request to FDA for the selected medical device (as I

Device Name: LOTUS EdgeTM Valve System

Device Name: LOTUS EdgeTM Valve System

Two specific standards:

Two guidance documents:

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