Inactive

1. Background These data should then be reconstructed into 3D volumes that can be manipulated to visualize what parts of the lung are covered by the ultrasound beam and to calculate the percentage of ... 1. Background These data should then be reconstructed into 3D volumes that can be manipulated to visualize what parts of the lung are covered by the ultrasound beam and to calculate the percentage of the lung volume covered by the ultrasound beam. 2. Scope The FDA requires that the vendor, in consultation with the FDA research team, work out the details of the visualization and user interface with the project principal investigator based on the research team’s initial experience with current fusion imaging capabilities. The processing and visualization could happen on the current Sequoia ultrasound system or some of the visualization could be performed on an off-line workstation. The scan procedures and additional components required to perform the fusion, 3D visualization, and volume ratio computations would be developed in collaboration with the FDA research team and it should be possible to provide other researchers with the needed information to duplicate and extend the visualization to other organs. 3. Requirements 3.1 The visualization solution shall lead the Government to produce the following end results: Allowing visualization and manipulating a 3D imaging containing both the chest computed tomography (CT) scan and the ultrasound scan volume within the CT volume. Manipulation includes but is not limited to reslicing in multiple planes of the operator’s choosing, rotation of the 3D image, maximum and minimum intensity projections of the 3D volume. Computation of lung volume after automated or manual segementation of the 3D volume. Computation of the volume swept out by the ultrasound beam after automated or manual segmentation. Calculation of the resultant CT-US volume ratio. The solution shall provide 3D visualization and manipulation of the fused CT and ultrasound beam information to allow a user to determine which portions of the lung are covered by the ultrasound beam. The volume of the CT covered by the ultrasound shall be labeled (tinted) in one or more colors to allow easy distinction from the CT image. The transparency of the US volume shall be variable to ease visualization of the extent of lung coverage by the US beam. The solution shall be able to create appropriate volume images created by either arc movement of the transducer or translation of the transducer across the skin of the patient or surface of the phantom. The solution shall have user interface functionality to provide a user-friendly method for editing of the boundaries of organ volumes used for computation of the volume ratios in a manner to be developed in collaboration with the FDA research team. The solution shall provide configuration instructions and parameters. 3.2 Technical Support Requirements: The Contract shall provide access to its development team for consultation and visualization modifications for the project duration as needed to meet the project goals. The Contractor shall ensure compatibility with future versions of Sequoia system and/or provide a modification path should incompatibilities arise. The Contractor shall begin collaborative development work within 30 days of contract award. The Contractor shall provide updated instructions and imaging examples reflecting the latest collaborative ideas and desired capabilities throughout the project period. The Contractor shall provide support via the collaboration between the contractor team and the FDA research team. 3.3 Compatibility Requirements: The solution shall be compatible with the Siemens transducers that can be used with the current FDA Siemens Sequoia system. he solution shall be usable and fully compatible with the current FDA Sequoia US system, model #1114875 software revision VA11F or higher, including the 3D positioning system & data (Ascension Technology) already procured from Siemens as an option for the Sequoia. If an off line workstation is required for the visualization solution, that workstation should be a PC compatible workstation running Linux or Windows 10 available at the FDA. 4. Instruction to Qutoers. This solicitation is issued under FAR Part 12 and 13.5 procedures. This is an unrestricted procurement. The NAICS code is 541519. Quoters responding to this RFQ must be registered with an Active status in the System for Award Management (SAM): www.sam.gov. Quoters shall certify their quotes to be valid for at least 30 days. Quotes shall be in an unsecured format. Quotes shall include a technical approach with sufficient details to explain how to meet the requirements specified in Section 3. The following categorical descriptions shall be used to derive an evaluation of the Quoter’s technical proposal: Acceptable: The proposed technical approach is clear, comprehensive, and feasible. The technical approach meets the Government’s requirements as provided in this solicitation using standard industry practices, technologies, methodologies, and processes. The quoter's proposed approaches/solutions, when implemented, are expected to produce the results specified in Section 3.1 of this RFQ. Unacceptable: The proposed technical approach is not clear, comprehensive, nor feasible. The technical approach does not meet the Government’s requirements as provided in this solicitation using standard industry practices, technologies, methodologies, and processes. The quoter's proposed approaches/solutions, when implemented, are will likely not produce the results specified in Section 3.1 of this RFQ. The Quotes shall represent the Quoter’s best pricing. The Government will not research items to determine compatibility; all information regarding compatibility must be contained within the quotation. Quoters shall submit a complete pricing and clearly state the overall cost to the Government. Partial quotes will not be considered. Incomplete pricing or pricing with omissions may not be considered for award. Quotations shall meet all the requirements of this solicitation in order to be considered technically acceptable. Please submit questions to Min Jie (Terry) Zeng via email at minjie.zeng@fda.hhs.gov by 5PM ET on September 15, 2020. Please submit quotes to Min Jie (Terry) Zeng via email at minjie.zeng@fda.hhs.gov by 12PM ET on September 18, 2020. 5. Evaluation Criteria The Government will award a contract resulting from this solicitation to the responsible quoter as a fixed?price contract on the lowest price technically acceptable (LPTA) evaluation method. Award will be made on the basis of the lowest evaluated price meeting or exceeding the non?cost factor (technical conformance to the requirements of the solicitation). The Quoter’s initial quotation should contain the Quoter’s best terms from a price standpoint. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award.