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FBO DAILY ISSUE OF JANUARY 13, 2011 FBO #3337
SOLICITATION NOTICE

66 -- High Resolution Ultrasound Imaging System and Photoacoustic Imaging Station

Notice Date

1/11/2011
 

Notice Type

Combined Synopsis/Solicitation
 

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

1083858
 

Archive Date

2/4/2011
 

Point of Contact

Howard Nesmith, Phone: 870-543-7459
 

E-Mail Address

howard.nesmith@fda.hhs.gov
(howard.nesmith@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The government intends to issue a Purchase Order in accordance with FAR PART 13.106 for the attached requirement under Simplified Acquisition Procedures. The solicitation number is 1083858. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-38. The associated North American Industry Classification System (NAICS) Code is- 334516 - Analytical Laboratory Instrument Manufacturing; Size Standards in Number of Employees, 500. Respondents are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete proposal and any additional documents before 10:00 am (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on January 20, 2011 to howard.nesmith@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, OC/OSS/OAGS, Attention of Howard Nesmith, 3900 NCTR Road, Jefferson, AR 72079-9502. When appropriate, Respondents should consult with delivery providers to determine whether their documents will be delivered prior to the scheduled time. PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in the FOB Destination section below. For information regarding this solicitation, please contact Howard Nesmith by e-Mail at howard.nesmith@fda.hhs.gov, Phone (870) 543-7459, or FAX (870) 543-7990. The Food and Drug Administration is soliciting quotes for a High Resolution Ultrasound Imaging System and Photoacoustic Imaging Station. Any award(s) resulting from this solicitation is contingent on the availability of funds within the 2011 Fiscal Year * * WHEN PROVIDING A QUOTATION PLEASE INCLUDE ALL * * * * PART/COMPONENT NUMBERS NECESSARY FOR SYSTEM ORDER * * Item #1 High Resolution Ultrasound Imaging System • 30 micron resolution for ultrasound alone and 60 microns when combined with near infrared imaging • Frame rate of up to 1000 fps • Color and Power Doppler for blood flow quantification • Mobile platform • ECG triggering/respiration gating of imaging • Must be able to image rodents (rats and mice) • For near infrared imaging, the wavelengths must cover at least 680 - 900 nm in at least 2 run increments • Integrated isofluorane anesthesia system for rodents to aid imaging process • AC Voltage 120V/5.0A Environmental Specifications: • Temperature : 10°-40°C (50°-104°F) • Relative Humidity : 15-80% non-condensing Instrumentation Hardware: • Rolling portable cart and ultrasound unit • AC Voltage 120V/5.0A • Single Micro Scan scanhead Series Connector allowing a single Micro Scan transducer to be connected to the system for imaging • Dual "dummy" ports for holding scanhead connectors while not in use • 3-step Foot Pedal with lead cable Software: Standard B-mode • Analytic software package for B-Mode (2D) image capture and analysis • Cine Loop image review, capture and display • Software analytics for advanced measurements & annotations • ECG on-screen trace Additional Components: • 38 Mhz Micro Scan Transducer o Broadband Frequency: 18 MHz - 38 MHz o Applications: mouse cardiovascular rat abdominal rabbit eye all vascular (mouse, rat, rabbit) o Max Frame Rate: 449 fps o Image Width: 15.4mm o Image Depth: 20mm o Image Axial Resolution: 50μm • 55 Mhz Micro Scan Transducer o Broadband Frequency: 32 MHz - 55 MHz o Applications: mouse/rat embryology, mouse abdominal, reproductive, epidermal imaging, tumor imaging (up to 13 mm in diameter), mouse vascular, small rat vascular, some abdominal (kidney), ophthalmology o Shallow Focal Zone o Max Frame Rate: 557 fps o Image Width: 14.1mm o Image Depth: 15mm o Image Axial Resolution: 40μm • ECG-Triggered-Respiration Gated Analysis o Single frame gating at systole and/or diastole in all 2D Modes o Cineloop acquisition for a user-defined # of cardiac cycles • Motion Mode, single line acquisition allowing high temporal resolution for LV functional analysis • Pulsed-Wave Doppler Mode, acquisition for blood flow velocity and waveform measurements using advanced digital Signal Processing techniques • Color Doppler Mode Color Doppler Mode - 2D and color acquisition for blood flow velocity analysis using advanced digital Signal Processing techniques • 3D Mode - Volumetric acquisition of tumors and other structures for quantification and assessment includes the 3D Motor; necessary for volumetric imaging • Contrast Imaging Functionality - Acquisition and analysis tools using Contrast Imaging, Perfusion Analysis using destruction/reperfusion quantification, Biomarker quantification tools when using Target Ready Contrast Agents • LV Analysis with Integrated BP/PV - Provides the ability to analyze Pressure Volume (PV) Loops using an integrated Blood Pressure signal and automated LV Analysis • Workstation Software supports PC-based image analysis, measurement and annotations o Includes License Dongle and Installation CD o Requires Microsoft Windows XP or Vista with a minimum of 1GB of memory (2GB recommended) o Min. System Requirements: 2.0Ghz dual core (or faster) processor, 60GB hard drive (120GB recommended), CD/DVD reader, available USB port, video card with min. resolution of 1024x768 in 32-bit color mode • Imaging System Protective Cover breathable, extremely light weight material and offers a superior dust and pollution barrier, cover includes a heavy duty zipped entry with buckle clips and an elastic around the entire bottom of the cover • Micro Marker Kit (Quantity of 10) for Tissue Enhancement, Perfusion and Micro-Circulation Applications Includes: o Sufficient contrast agent (2 vials), sterile saline for reconstitution (pre-filled syringes), syringes and needles (for preparation and introduction of the agent) for 10 injections for a Mouse o Optimized protocols and training CD o Requires Contrast Imaging Functionality for use of acquisition and analysis tools o Reagents are stable at room temperature for 1 year • Micro Marker Tall Vein Catheter - 20 x tail vein catheters (27G ½" butterfly needle with 12cm PE20 tubing attached) • Imaging Station (Imaging Station plus Imaging Station Extension with Injection Mount), Includes: o Bench-mounted adjustable rail system custom designed for small animal handling, positioning and imaging optimization o Fully adjustable Micro Scan transducer stand and mount o Micro Scan transducer adaptor o Adjustable X, Y, and Z positioning ball joint system o Injection Mount, micro-manipulation controls and rail system extensions o Y-Axis stage adjustment o Universal Power Supply Kit (UPS 120V) o Short Ball Joint unit for easy movement and manipulation of the animal and mounting of the small animal table o Mouse Handling Table o Rat Handling Table o Physiological Monitoring Unit to monitor animal temperature, ECG, heart rate and blood pressure • Universal Power Supply Kit o 120V isolated transformer o Hospital grade female receptacles o 3 - power cords • Mouse Handling Table - for placement, warming animal and physiological monitoring and manipulation o Includes Quick-Connect to mount to ball joint • Rat Handling Table - for placement, warming animal and physiological monitoring and manipulation o Includes Quick-Connect to mount to ball joint o Includes 14mm Bain Circuit and nosepiece for rat anesthesia • Thermasonic Gel Warmer - warms 3-bottles of ultrasound gel to body temperature and maintains constant temperature • Compact Dual (Med. Air & O2) Anesthesia System (Tabletop Version) Including: o Self-contained isoflurane-based anesthesia unit for use on lab o 2-Liter small animal induction chamber o Isoflurane Vaporizer o Anesthesia scavenger filter o H-type Oxygen Regulator o H-type Medical Air Regulator o Medical air flow meter o Oxygen flow meter • "H" Type Regulator o For use with Anesthesia Systems o Used with H-Cylinder Oxygen Tanks - Height: 54", Diameter: 8.5" o Volume-Liters: 7107 o Initial Pressure: 2200 PSI o Approx. Hrs Use @ 1 LPM: 118 • "H" Type Medical Air Regulator o For use with Anesthesia Systems o Used with H-Cylinder Medical Air Tanks - Height: 54", Diameter: 8.5" o Volume-Liters: 7107 o Initial Pressure: 2200 PSI o Approx. Hrs Use @ 1 LPM: 118 System Specifications: • Monitor: 24" LCD Color Monitor with articulating arm • Network: 100Mb Ethernet Connection • Storage: 250GB HD • DVD-Reader/Writer Standard Outputs: • USB 2.0 (3) • S-Video • DVSI • Ethernet • Firewire • 3D Motor • Physio Data • TX Trig • Trig in • Trig Out Successfully Tested According to the Following Specifications: • CISPR 11:1997/EN 55011:1988, CLASS A, GROUP 1 - Limits and methods of measurements or radio disturbance characteristics of industrial, scientific and medical (ISM) radio-frequency equipment • EN 61326:1997 + A1:1998 + A2:2001 (IEC 61326:2002) - Electrical equipment for measurement, control and laboratory use - electromagnetic compatibility IEC 61010-1; Ed 1:90 + A1:92 and A2:95; CAN/CSA C22.2 No. 1010.1:92; 1010.1B:97; UL 3101-1:93 Quantity System Total: 1 (One) Total System Price: __________________ Item #2 High Resolution Ultrasound Imaging System 2-Day On-Site Micro Marker Training Includes: • Overview of the handling, preparation and application of Micro Marker Contrast Agents and Contrast Imaging Functionality • 2 consecutive days of in vivo user training • Travel and associated expenses • Application or technique-specific training is available upon request Unit Price: __________________ Item #3 High Resolution Ultrasound Imaging System Introductory 2-Day On-Site User Training Includes: • Overview of the system's functionality, care & maintenance and hands-on imaging techniques • 2 consecutive days of user training • Travel and associated expenses • Additional application or technique-specific training is available upon request Unit Price: __________________ Item #4 High Resolution Ultrasound Imaging System Installation Includes: • On-site setup and installation of the system and all purchased accessories • Travel and accommodation expenses • For installations within Continental USA Unit Price: __________________ Item #5 High Resolution Ultrasound Imaging System Shipping Includes: • Cost for freight shipment of complete system and component parts within Continental USA • Costing based on 1-week in-transit shipping schedule Unit Price: __________________ Item #6 Photoacoustic Imaging System - (TO BE USED ON ABOVE SYSTEM) Enables the Above Imaging System to acquire high sensitivity photoacoustic images inherently registered with high resolution ultrasound images Environmental Specifications: • Temperature: 10°-40°C (50°-104°F) Relative Humidity: 15-80% non-condensing Supported AC line voltages, rated at 50/60Hz frequency, 120V Photoacoustics Performance: • System Dynamic Range (DR): 70 dB Signal to Noise Ratio (Photoacoustic signal) SNR: 20dB +/- 10dB Data acquisition time: o 2D : 0.2 seconds* o 3D : 74 seconds (10 mm)* *full field of view (14-23 mm wide) • Photoacoustic Penetration Depth: 1 cm • Contrast Sensitivity: 521 nM of Methylene Blue Electrical Specifications (Laser): • Tunable Laser o Flashlamp pumped Q-switched Nd:YAG laser with optical parametric oscillator (OPO) and second harmonic generator o Frequency: 20 Hz o Wavelength: 680-970 nm o Step size: 1 nm o Pulse duration: 4-6 ns o Peak Energy*: 45 mJ +/-5 mJ (at 20Hz) o Spot size: 24 mm2 (1 mm x 24 mm) Standard Software: • Photoacoustic mode: PA-mode o Analytic software package for photoacoustic mode (3D) image capture and analysis o PA (photoacoustic) mode for 2D detection and analysis o Cineloop image capture, display and review o Measurements/calculations & annotations  Hemoglobin content and quantification  Oxygen saturation calculation and quantification o Integrated physiological trace, which includes:  Display of ECG, Respiration Waveform and body temperature • B-Mode: o Analytic software package for B-Mode (2D) image capture and analysis o Cine Loop image review, capture and display o Software analytics for advanced measurements & annotations o ECG on-screen trace Data Management and Export Standard Outputs: • USB 2.0 (3) • S-Video • DVSI • Ethernet • Firewire • 3D Motor • Physio Data • TX Trig • The following formats are support for data, image and video exports: o Data formats: CSV, TXT o Image formats: TIFF, BITMAP, DICOM o Video formats: AVI, GIFF, DICOM System Specifications • 22" LCD Color Monitor with articulating arm • Network: 100 Mb Ethernet Connection • Storage: 250 GB HD • DVD-Reader/Writer Imaging Station Laser sealed enclosure with a viewing window that allows the user to visually monitor the experiment and contains: • Animal handling platform • Physiological monitoring capabilities • LED lights with dimmer switch • Ventilation system • Integrated anesthesia system • Detachable front • Interior electrical outlet The animal handling platform is comprised of the following components: • Bench-mounted adjustable rail system custom designed for small animal handling, positioning and imaging optimization • Fully adjustable Laser transducer stand and mount • Laser transducer adaptor. • Adjustable X,Y, and Z positioning system for Ball Joint • Injection Mount, micro-manipulation controls and rail system extensions • Y-Axis stage adjustment • Universal Power Supply Kit (UPS 120V) • Short Imaging Ball Joint unit for easy movement and manipulation of the animal and mounting of the small animal table • Mouse Handling Table • Rat Handling Table • Physiological Monitoring Unit to monitor animal temperature, ECG, heart rate and blood pressure Transducers Integrated fiberoptic linear array transducer: • 256 elements for detection, enabling fast, real-time acquisition • Broadband Frequency: 13 MHz - 24 MHz; • Image Width: 23mm • Image Depth: 30mm • Image Axial Resolution: 75μm Quantity System Total: 1 (One) Total System Price: __________________ Item #7 Photoacoustic Imaging System Introductory 2-Day On-Site User Training Includes: • Overview of the system's functionality, care & maintenance and hands-on imaging techniques • 2 consecutive days of user training • Travel and associated expenses • Additional application or technique-specific training is available upon request Unit Price: __________________ Item #8 Photoacoustic Imaging System Installation Includes: • On-site setup and installation of the system and all purchased accessories • Travel and accommodation expenses • For installations within Continental USA Unit Price: __________________ Item #9 Photoacoustic Imaging System Shipping Includes: • Cost for freight shipment of complete system and component parts within Continental USA • Costing based on 1-week in-transit shipping schedule Unit Price: __________________ FOB Destination - U.S. Food & Drug Administration, National Center for Toxicological Research (NCTR), 3900 NCTR Rd., Jefferson, AR USA 72079 Contract Type - Commercial Item - Firm fixed price. Simplified procurement procedures will be utilized. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. CCR REQUIREMENT - Company must be registered on Central Contractor Registration (CCR) before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items applies to this solicitation. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows: The government will award the purchase order to the lowest price technically acceptable quote. Technical acceptability will be determined by review of information submitted by the quoter which must provide a description in sufficient detail to show that the product/service quoted meets the Government's requirement. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the service meets the technical requirements. Quotes shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror. The Provision at FAR 52.212-3, Offerors Representations and Certifications-Commercial Items, applies to this acquisition. An offeror shall complete only paragraph (b) of the provision if the offeror has completed the annual representations and certification electronically at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been attached to the clause: None. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.225-3, 52.225-13, and 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.arnet.gov. CCR Requirement - Company must be registered on Central Contractor Registration (CCR) before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. A standard commercial warranty on parts and workmanship is required. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1083858/listing.html)
 

Place of Performance

Address: U.S. Food & Drug Administration, National Center for Toxicological Research (NCTR), 3900 NCTR Rd, Jefferson, Arkansas, 72079, United States

Zip Code: 72079
 

Record

SN02358324-W 20110113/110111234429-9f591151e8574de51a861ac2cbe6442b (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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