Pulse Duplicator Data Acquistion Control System and pump head assembly

Sources Sought Synopsis Notice to Small Businesses The purpose of this notice is to obtain information regarding the availability and capability of qualified small business concerns; 8(a), Woman-Owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone), Small Businesses, and Service-Disabled Veteran-owned Small Businesses (SDVOSB). The Food and Drug Administration intends to provide maximum practicable opportunities in its acquisitions to small businesses. Background The Food and Drug Administration (FDA) is conducting a market survey to assess the availability of small business firms as defined by NAICS code 334516 to provide a pulse duplicator data acquisition control system and pump head assembly. This notification is for market research purposes and does not constitute a commitment, implied or otherwise, that a procurement will be accomplished. FDA welcomes responses from all interested parties. FDA does not intend to make a selection decision or award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this sources sought with any interested parties. However, FDA reserves the right to contact vendors if additional information is required. Requirement The potential requirement is to procure a pulse duplicator data acquisition control system and pump head assembly that adheres to the following minimum salient characteristics: Pulse Duplicator Data Acquisition Control System - Flow control: The DAQ and control system should have the ability to simulate a variety of flow conditions including arrhythmias, normal, hypo and hypertensive states for adult and pediatric populations over a range of cardiac outputs and frequencies (beat rates). - Hardware Compatibility: The system is able to control piston motion of a Vivitro AR series SuperPump. - Pressure Waveforms: The unit should be able to create, modify, control and replicate arterial blood pressure waveforms. - Input Signals: System is capable of creating and storing a wide range of arterial pressure waveforms. It must also be able to accept externally generated waveforms (5.0 V signals). The maximum piston pump velocity is ~ 60 mm/s. - Data Acquisition: System is capable of simultaneously acquiring at least 4 channels of pressure, piston position, and flow signals (5 V signals). Connectors should be compatible with BNC cables. - Software: Software is designed for monitoring, acquisition, and analysis of in vitro data. Software is able to superimpose collected signals on a single time plot. Pump Head - Pumping Behavior: The pump head should contain inflow and outflow valves to represent a left ventricle and generate reproducible physiological cardiac flows. - Hardware Compatibility: The pump head must be able to attach directly to a ViVitro AR series SuperPump. - Valves: The pump head should be compatible with commercially available mechanical and tissue heart valves for generating physiological flow and pressure waveforms. - Biocompatibility: The ventricle unit should connect directly to biocompatible Tygon tubing. All fluid-contacting surfaces of the pump head should be compatible with blood analogs. - Material Properties: The pump head should contain a left ventricular chamber to simulate physiological arterial blood flow and pressure. It should have a compliant membrane to interface between the piston pump section and the mock circulatory flow loop. - Visualization: The ventricle should be transparent to visualize heart valve dynamics. - Flow Rate: The pump head should assist in generating flow ? 8 L/min. - Beat Rate Range: The pump should be able to create a heart rate range of at least 40 - 150 beats per minute. - Resistance and Compliance: The unit contains or is compatible with peripheral resistance and characteristic compliances to simulate arterial flow and pressure in an arm phantom. - Stroke Volume: The pump head must have a stroke (displacement) volume range of at least 10 - 100mL/stroke when used in combination with a Vivitro AR series SuperPump. - LaserJet printer or equivalent with cables for connection to computer system. Delivery Location Davis, CA 95616 General Instructions Contractors that believe they possess the ability to provide the required equipment must submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement should include the organization name, type of business, DUNS number, point of contact name/telephone number/email address, and applicable NAICS code. Capability statements that do not provide sufficient information for assessment will be considered non-responsive. Simply stating that Contractor can provide the equipment will be considered non-responsive. Contractors must demonstrate that they are capable of providing the equipment and that the equipment can adhere to each minimum salient characteristic. When submitting the information, please reference the solicitation number FDA-14-1132964-SS. Responses should be submitted via email to Tania Gates at Tania.Gates@fda.hhs.gov by 12:00 noon on July 11, 2014.