36C25719Q0818-000.docx

FedBizOpps Combined Synopsis/Solicitation Notice

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* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 NTX CAAS 8.1 Software 78229 36C25719Q0818 05-30-2019 N 541519 Department of Veterans Affairs VISN17 Network Contracting Activity 7400 Merton Minter Blvd. (10N17/90C) San Antonio TX 78229 rolando.pasayan@va.gov

VA NORTH TX HCS

DALLAS VA MEDICAL CENTER

4500 S. LANCASTER RD

DALLAS, TX

75216

USA

rolando.pasayan@va.gov rolando.pasayan@va.gov rolando.pasayan@va.gov rolando.pasayan@va.gov The Network Contracting Office 17 intends to award a firm-fixed price contract in accordance with FAR Part 12, Acquisition of Commercial Items for the purchase of CAAS Workstation (See description below). This is a Combined Synopsis/Solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Quotes are being requested and a written solicitation will not be issued. The solicitation number is 36C25719Q0818. This acquisition is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-02TA May 6, 2019. The associated North American Industrial Classification System Code (NAICS) for this procurement is 541519 with a Small Business (SB) standard of 1000 employees. This acquisition is solicited as a set aside for SB.

“This procurement is for new Equipment ONLY; no remanufactured or "gray market" items. All Equipment must be covered by the manufacturer's warranty.”

***Brand-name or equal items accepted. However, similar items must meet or exceed selected technical capabilities of the listed equipment. *** Responses to the solicitation are due by 31 May 2019 @ 0800 AM Central Time (CT) via e-mail: rolando.pasayan@va.gov

ITEM NO. DESCRIPTION QUANTITY UNIT ESTIMATED

OR STOCK NO. UNIT COST

PIE000 1 CAAS 8.1 BASE MODULE

CAAS Workstation is a dedicated analysis program for the quantification of coronary and peripheral arteries, analysis of left and right ventricle of the heart, and enhanced visualization of stent deployment regions. The flexible GUI layout enables analysis in both Cath lab and workstation settings. Multiple analyses can be performed simultaneously and side by side. The different workflows are: CAAS QCA, CAAS QCA3D, CAAS QVA, CAAS LVA, CAAS

RVA, CAAS IV-LINQ and CAAS Stent Enhancer. 1 EA

PIE010 2 CAAS 8.1 QCA

CAAS QCA (Quantitative Coronary Analysis) is the worldwide accepted standard for the assessment of coronary artery dimensions. The QCA workflow can assist in the selection of the optimal size of balloon and stent. QCA features single vessel and bifurcation analysis including calibration, automatic contour detection, and quantification of the severity of stenosis. Resulting measurements:

Minimum luminal diameter Reference diameter Percentage diameter stenosis Length stenotic segment Bifurcation angles 1 EA

PIE011 3 CAAS 8.1 OPTION 3D QCA

CAAS QCA can be extended to CAAS QCA3D which allows 3D analysis of single and bifurcated coronary arteries based on two angiographic projections. These projections are used to calculate the true geometric shape in 3D space and create an interactive rendered view of the artery of interest. The key product features of CAAS QCA3D are:

Quantification of lesion length and percentage stenosis in a 3D reconstruction Elimination of foreshortening and out-of-plane magnification errors Interactive 3D rendered view for assessment of shape Full automatic calibration: this eliminates the need for manual input Resulting measurements:

3D bifurcation angles Minimum luminal diameter Reference diameter Percentage diameter stenosis Length stenotic segment 1 EA

PIE070 4 CAAS vFFR ANALYSIS

Pie Medical Imaging developed a new non-invasive analysis called vFFR (vessel FFR). The new workflow is available in CAAS Workstation 8.0.

CAAS vFFR calculates the pressure drop and vFFR value in coronary vessels, this will expand the cardiologists tooling for patient diagnostics. vFFR can be performed online during the patient procedure without the need for a pressure wire and hyperaemic agent.

The vFFR analysis builds a 3D coronary reconstruction using two angiograms and assesses pressure drop, resulting in a vFFR value. Furthermore, with the 3D reconstruction anatomical lesion information can be calculated, like percentage stenosis. Pressure drop and vFFR calculation based on 3D vessel reconstruction:

Simple and fast workflow X-Ray system independent Additional stenosis measurements 510(k) Cleared, CE Marked and PMDA Compliant Key Results:

Pressure drop in coronary artery vFFR value Quantification of percentage stenosis and lesion length 1 EA

PIE030 5 CAAS 8.1 QVA

The CAAS QVA (Quantitative Vascular Analysis) workflow offers fast and intuitive peripheral vessel analysis, including the abdominal aorta and the carotid, renal, iliac and femoral arteries. The QVA workflow features single vessel analysis including calibration, contour detection and quantification of the severity of stenosis. Resulting measurements:

Minimum luminal diameter Reference diameter Percentage diameter stenosis Length stenotic segment Area at minimum luminal diameter 1 EA

PIE010FL 6 FLOATING LICENSE FOR CAAS QCA 2 EA

PIE012FL 7 FLOATING LICENSE FOR CAAS QCA

RESEARCH 2 EA

PIE070FL 8 FLOATING LICENSE FOR CAAS vFFR

ANALYSIS

The floating license allows many users to share the Pie Medical / 3mensio analysis software across a facilities network. It enables the application(s) to be loaded on as many workstations as desired. It is only limited by the number of concurrent user connections purchased; i.e.: single user only one person can be using the application at any given time. 2 users, 2 people can be using the application at the same time, etc. Floating licensing is provided as either a software license or hardcoded to a USB dongle and needs to be located on the network, VLAN, or VPN of the client systems. The Floating license, single user, reduces the cost of purchasing a second standalone license by 75%. 2 EA

TOTAL COST:

See attached document: 36C25719Q0818.