SOURCES SOUGHT
66 -- High Frequency Ultrasound System with 3 (1-year Post-Warranty Maintenance Options) - Package #1
- Notice Date
- 2/27/2013
- 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
- 1115929
- Archive Date
- 3/21/2013
- Point of Contact
- Yolanda T. Peer, Phone: 8705437479
- E-Mail Address
-
yolanda.peer@fda.hhs.gov
(yolanda.peer@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice for a High Frequency Ultrasound System with 3 (1-year Post-Warranty Maintenance Options) MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Biologics Evaluation and Research (CBER) requirement for a High Frequency Ultrasound System with 3 (1-year Post-Warranty Maintenance Options) The FDA is seeking business sources, including total small businesses, service-disabled veteran-owned small businesses, HUBZone small businesses, 8(a) certified companies and other than small businesses. In addition, the FDA is seeking business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer. The associated North American Industry Classification System (NAICS) Code is - 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard of $500 Million. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The Government is seeking capability statements from businesses capable of providing the Equipment and performing the Maintenance for the below requirements. Specifications: High frequency transducers • At least 3 transducers should be included with frequencies ranging from 15 MHz to 55 MHz • Each transducer should have adjustable focus depths • Each high frequency transducer should be able to deliver a usable frame rate of 300-400 frames per second Integrated imaging station • Allows secure positioning of the animal on a heated handling table, which maintains the animal's physiological body temperature and overall physiological function. • Platform should be integrated with an isoflurane-based anesthesia system that can be connected to oxygen or air. Monitoring of physiological function and data • ECG, heart rate, temperature and respiration should be recorded and displayed on the monitor screen alongside the images. This information should be able to be exported and saved. M-Mode • M-Mode imaging should produce quantifiable images to characterize moving anatomy, such as a cardiac wall motion, by selecting a line of the B-Mode image and observing it over time. • Should be able to sample volume size down to 50 microns • M-Mode cine loop with a maximum length of 30 seconds. • Should allow the user to steer the sample volume to any angle they choose. Doppler Mode Capabilities • The equipment should be capable of using Color Doppler Imaging to produce an image of directional flow in blood vessels. The system should overlay colors on the image of the blood vessels to represent the speed and direction of blood flow through the vessels. • In Pulsed-wave Doppler (PW) Mode, the transducer should be able to detect motion and then show the readings on screen in a spectral display. • The sampling rate for PW Doppler should range from 1-2 kHz to 125 kHz; and be able to detect velocities from a few mm/s to approximately 6 m/s. • The sweep speed parameter should be selectable within a range from 0.25 seconds at 4000 Hz to 5.1 seconds at 200 Hz. • 3D Power Doppler Mode will collect Power Doppler data during a 3D-Mode acquisition and be able to reconstruct a 3D volume that is integrated with the surrounding B-Mode 3D volume. 3D Imaging • 3D-Mode imaging should provide tools to create and manipulate three-dimensional renderings and make volumetric measurements of objects viewed with high-resolution ultrasound. • Acquires a series of 2-dimensional "slices" (as small as 10 μm) and assembles them into a 3D data set that can then be visualized and manipulated. • 3D imaging can be used in B-Mode, Power Doppler Mode or Contrast mode imaging procedures. • 3D acquisition functionality allows for precise control of step size, range and slice thickness. This functionality can be integrated with ECG and respiration gating to suppress heart and respiratory artefacts. • Range = # of slices x step size. • Maximum number of 500 slices. • Range: min value = 0.5 mm; max value = 60 mm • Step Size: min value = 0.03175 mm; max value = 0.5 mm; Contrast Imaging • A suite of software analysis and quantification tools should be provided that enables perfusion imaging and targeted/molecular imaging research applications. • Software tools should allow quantification of relative blood volume, blood perfusion and vascular density. • Should be capable of molecular imaging studies: visualization and quantification of endothelial cell markers involved in angiogenesis and inflammation in vivo, in real-time Should be capable of detecting contrast agents such as microbubbles Post-processing tool for perfusion and targeted signal analysis • Perfusion parameters are derived from a curve fitting algorithm for both bolus kinetics and replenishment kinetics following destruction reperfusion • Perfusion parameters include a series of calculations for amplitude, time and combination of amplitude and time • Spatial rendering is available in the form of parametric maps • Data can be exported in TIFF, BMP, video files and CSV formats Portability of system • The system should be portable. 3 (1-year Post-Warranty Maintenance Options) • Provide complete coverage for parts, labor, and travel for all Ultrasound equipment including high frequency transducers. • Include travel expenses and overtime labor, if required. • Include a preventative maintenance visit for each one-year coverage period. • Provide telephone and email-based technical and application support. Place of Performance: Bethesda, MD 20892 Responses to this sources sought shall unequivocally demonstrate that respondent is regularly engaged in the manufacture and/or sale of same or substantially similar items. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: • Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; [Provide this same information again if responding to provide a product manufactured by another firm.] • Three (3) years of past performance information for the manufacture and/or sale of same or substantially similar items to include date of sale, description (should also include drawings and photos), dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent; • Descriptive literature, brochures, marketing material, etc. detailing the nature of the items the responding firm is regularly engaged in manufacturing and/or selling; • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement; • If a large business, identify the subcontracting opportunities that would exist for small business concerns; and • Though this is not a request for quote, informational pricing is encouraged. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. The Government is not responsible for locating or securing any information, not identified in the response. Interested Parties must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before March 6, 2013 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Yolanda Peer, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email yolanda.peer@fda.hhs.gov. Reference 1115803. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1115929/listing.html)
- Place of Performance
- Address: Center for Biologics Evaluation and Research, NIH Building, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02997667-W 20130301/130227234910-12f72ec5a9f74a08bb785d016348a7e5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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