SOURCES SOUGHT
65 -- High Frequency Ultrasound System
- Notice Date
- 2/29/2012
- Notice Type
- Sources Sought
- NAICS
- 334510
— Electromedical and Electrotherapeutic Apparatus Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1100737
- Archive Date
- 3/22/2012
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- 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. 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. 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 small business manufacturing companies and large business may also respond that can provide a High Frequency Ultrasound System as detailed below. The vendor must also be capable of providing extended service agreement coverage for multiple years after the initial warranty has expired. The instrument shall be equivalent to the salient characteristics described herein. The High-Frequency Ultrasound System will be used to image anatomical and physiological features of small animals used as model systems for human disease and injury. The high frequency ultrasound system should enable the researcher to obtain in vivo anatomical, functional, physiological and molecular data simultaneously, in real-time and with resolution down to 30 μm. 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 (rats and mice) 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. • ECG and Respiration gating can be controlled by the user. 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 the user chooses. 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. Targets (for example, tumor growth) can be segmented and volumetric measurements made. • 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 errors. • 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 from one room or lab to another. The optional service agreement includes parts and labor: The service agreement shall include the following: • Minimum of one (1) PM visit per contract year; • Unlimited emergency repairs; • Unlimited Priority Telephone Support; • Peak performance maintenance kits; • Software updates; • All labor, travel, and parts (except consumables); • Only new OEM factory certified replacement parts to repair the system. The contractor shall perform all necessary repair service and standard preventative maintenance of the system. Contractor shall perform work related to service bulletins or other manufacturer's stipulated repairs that may occur during the contract period. The offeror may provide information on multiple types of service agreements plans available. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered instrument and components meet the technical requirements identified above. Firms believing they can meet the requirements to the above specifications are encouraged to respond electronically with no less than the following information: • Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; • Sufficient descriptive literature that unequivocally demonstrates that offered products and services meet or exceed above specifications. • At a minimum provide the following: All descriptive material necessary for the government to determine whether the product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. Indicate whether the organization is the manufacturer of the items or authorized reseller. If reseller, include the manufacturer's name, address and DUNS number. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. • Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. • If a large business, provide if subcontracting opportunities exist for small business concerns. • Though this is not a request for quote, informational pricing must be submitted. The government is not responsible for locating or securing any information, not identified in the response. The associated North American Industry Classification System (NAICS) Code is- 334510- Electromedical and Electrotherapeutic Apparatus Manufacturing; Small Business Size Standard is 500 employees. Interested Contractors 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 14, 2012 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email nick.sartain@fda.hhs.gov. Reference FDA1100737. 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 seek a SBA non-manufacturer rule waiver. 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/NCTR/FDA1100737/listing.html)
- Place of Performance
- Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN02685807-W 20120302/120229234928-4cbb1fe0e9e0a5f0f9cebe8734899c78 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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