SOURCES SOUGHT
66 -- 2 Transconductance Amplifiers
- Notice Date
- 7/16/2009
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1059444
- Point of Contact
- William T. Lee, Phone: 3014435863, Doreen Williams ,
- E-Mail Address
-
william.lee@fda.hhs.gov, doreen.williams@fda.hhs.gov
(william.lee@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantage businesses, HUB Zone businesses; veteran-owned small businesses, and women-owned small businesses. This notice is being posted for fact finding and planning purposes only and shall not be construed as an Invitation for Bid, a Request for Proposal, Solicitation, Request for Quote, or an indication the Government will contract for the items or services herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this source sought. Any response received will not be used as a proposal. No official solicitation currently exists in connection to this Sources Sought. Also, if in the future an official solicitation is released, there is no guarantee that sources responding to this RFI will be included on the source list. **QUESTIONS WILL NOT BE ENTERTAINED AS A RESULT OF THIS NOTICE** The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking to identify sources with capabilities and prior experience to develop and build two identical Transconductance Amplifiers for the Electrophysiology Laboratiory, in the Center for Devices and Radiological Health for research purposes in order to study the electrophysiology of defibrillation waveform, duration, and shape; and evaluate these properties’ effect on efficacy of defibrillation success. This research supports premarket regulatory efforts for both implanted defibrillators and external defibrillators. The Transconductance Amplifier will be used on excised animal hearts, and will therefore need to put out sufficient voltage and current for successful defibrillation. Because a primary goal of our research is to evaluate the effect of waveform shape, the Transconductance Amplifier must accept an input control waveform in the shape of the desired output waveform and then amplify this input control waveform to the specified energy requirements (keeping the duration and shape of the waveform constant Objective: The FDA regulates the safety and effectiveness of defibrillators; including external defibrillators, automatic external defibrillators (AEDs) and implantable cardioverter defibrillators (ICDs). The Electrophysiology Laboratory, in the Center for Devices and Radiological Health (CDRH), is frequently called on to evaluate the safety and efficacy of designs for new defibrillators that incorporate unique shocking waveforms. Without the ability to replicate and test these waveforms in a laboratory setting there is no way for the FDA to independently verify claims of safety and efficacy. Additionally, the basic science involved in defibrillation is still not well understood and continues to be a factor in the regulation of defibrillators. The Electrophysiology Lab will also investigate the cellular mechanisms of defibrillation. The Transconductance Amplifier will be used to amplify an arbitrary input control waveform to a high current waveform having the same shape and duration as the original voltage control waveform. The amplified arbitrary waveform will be used on excised animal hearts, and will therefore need to be of sufficient voltage and current for successful defibrillation. See Figure 1 below. The input control waveform (±5V) will be amplified by a factor of 1 Amp per Volt to produce the output waveform. The Contractor may be required to: a. Design, build and deliver two identical Transconductance Amplifiers with the following technical specifications: 1.The gain of the Transconductance Amplifier shall be 1 Amp per Volt. 2.The Bipolar Output Terminals shall be isolated from ground with a safety disconnect implemented as an electromechanical relay or equivalent. 3.The maximum output voltage range, referenced to the negative Bipolar Output Terminal, shall be -190 Volts to +190 Volts. 4.The maximum output current shall vary with the load resistance: a.For load resistances from 0 to 38 Ohms the maximum current output shall be limited to 5 Amps. b.For load resistances greater than 38 Ohms the maximum current output shall be 190 Volts divided by the load resistance. 5.Within the specifications for maximum output current (Specification 4) the current output shall follow the voltage input with a tolerance of ± 2%. 6.Duration of output waveform at 5A: 500ms or more. 7.Minimum number of 5A, square wave pulses, output per minute into a 38 Ohm load (by duration of pulse): 500 at 10ms, 50 at 100 ms, 10 at 500ms 8.The Bandwidth of the Transconductance Amplifier shall be DC to 1 kHz, or more. 9.A BNC Analog Output for monitoring the voltage output of the Transconductance Amplifier. The monitor voltage shall be a linear representation of the voltage on the Bipolar Output Terminals: +5 Volts shall represent +190 Volts and -5 Volts shall represent -190 Volts. 10.A BNC Analog Output for monitoring the current output of the Transconductance Amplifier. The monitor voltage shall be a linear representation of the voltage on the Bipolar Output Terminals: +5 Volts shall represent +5 Amps and -5 Volts shall represent -5 Amps. 11.A BNC Digital Input connection to enable the output of device. The Bipolar Output Terminals of the device shall be disconnected from the amplifier unless this enable line goes to a TTL logic low, engaging the electromechanical relays (see specification 2) and connecting the Bipolar Output Terminals to the amplifier. 12.A BNC Analog Input connector for arbitrary control waveforms (±5V) to be amplified. The input impedance shall be ≥ 5,000 Ohms. 13.Operation from AC power 110 volts, 50/60 Hz. 14.Indicators for proper functioning of the Transconductance Amplifier. 15.One year of technical support on use and troubleshooting of the HPA via both phone and email. 16.One year warranty covering repairs for defects in parts and workmanship. The vendor agrees to accept shipment of the units for repair if necessary. Deliverables may include: User’s manual, including schematics of the Transconductance Amplifier and all accessories and cables necessary for operation (excluding PC interfacing accessories). A Firm-Fixed Price/or Labor Hour type contract may be used for this project. Part A. Training and Experience – Viable parties should submit a capability Statements describing adequate training and experience in Developing & Building Transconductance Amplifiers for Defibrillation Research. Part B. Size of Business – Please provide your business size and submit a copy of any documentation such as letters of certifications to indicate the firm status. Part C. Organizational Conflict of Interest (OCI) – If any; provide disclosure of business activities of your company, your affiliates, and your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest in the performance of the objectives listed above Part D. Cost Estimate – Please provide a cost estimate for the prospective services to be conducted for the services listed above. Cost may consist of the type of labor categories, hourly rate/days and materials. Part E. Small Business – Describe your ability to meet the requirements in accordance with 52.219.14 – Limitation of Subcontracting. Responses shall adhere to the following: 1. Reference the Sources Sought number when submitting the capability statement. 2. The capability statement shall be no more than five (5) pages in length. 3. Marketing materials shall not be included. 4. The Capability Statement shall be e-mailed to the attention of the Contract Specialist listed above. FDA makes no implied or in fact contract by issuing this Sources Sought. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA’s view of the information received. Material that requires a non-disclosure agreement or that may be business sensitive will not be accepted. Please note that responses to this notice will not be returned.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1059444/listing.html)
- Place of Performance
- Address: FDA/CDRH/OSEL/Division of Physics, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20903, United States
- Zip Code: 20903
- Zip Code: 20903
- Record
- SN01878103-W 20090718/090717000905-c39fddc5f2046d193b95b2b15e85192e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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