SOLICITATION NOTICE
66 -- Ultrasound-Guided Prostate Brachytherapy System for existing Nucletron MicroSelection HDR
- Notice Date
- 2/12/2009
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-90061-AV
- Archive Date
- 3/10/2009
- Point of Contact
- Ashley L. Virts,
- E-Mail Address
-
virtsa@mail.nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Cancer Center Research (CCR), Radiation Oncology Branch (ROB) plans to procure the brand name Ultrasound-Guided Prostate Brachytherapy System for the existing Nucletron MicroSelectron HDR with Nucletron Corporation; 8671 Robert Fulton Drive; Columbia MD 21046. This acquisition will be conducted under the procedures for acquiring commercial items authorized in FAR Part 12 and under the authority to use simplified procedures for commercial requirements as provided in FAR 13.5019(a)(1). The North American Industry Classification System code is 334516 and the business size standard is 500 employees. The Radiation Oncology Branch (ROB) of the Cancer Research Center (CCR) treats cancer patients with radiation according to approved clinical protocols. One of the treatment modalities employed by the ROB is brachytherapy. This employs an advanced, computer controlled device for positioning and moving a radioactive source in a controlled fashion on the government owned MicroSelectron HDR. The ROB intends to launch a new treatment initiative to treat cancer of the prostate with its MicroSelectron HDR utilizing real-time ultrasound guidance for catheter placement. Accurate placement of treatment catheters and reference markers need to be performed under ultrasound guidance so as to avoid critical anatomical structures. This placement is controlled using a system consisting of a B-mode ultrasound system, a fixation table to maintain proper patient alignment and a stepper system to control catheter insertion. The system from Nucletron utilizes proprietary hardware and control software and must to be acquired as a package, rather than as individual components. This system has passed both FDA and NRC approval for use in the clinic. While the system uses a third party ultrasound machine, it has specially constructed hardware to make it compatible with the government owned treatment planning system and has developed customized software to control and transfer the appropriate information. Since the mechanics of each ultrasound machine and mechanically controlled stepper are unique, the entire system must be verified for proper operation, as per both FDA and NRC regulations. The Nuclear Regulatory Commission (NRC), in particular, is highly specific as to the technical requirements for any ancillary device that is used with a medical radioisotope irradiator. Nucletron is the only known equipment manufacturer of this system and has passed both Food and Drug Administration (FDA) and Nuclear Regulatory Commission (NRC) clearances. Nucletron is the only provider known to the NCI that can fully meet these requirements. Salient Characteristics for the brand name Ultrasound-Guided Prostate Brachytherapy System for Nucletron MicroSelectron HDR (parts A-C): A. Prostate ProGuide Package: •110 ProGuide Sharp Needles •Prostate Stepper Template Set 6F •Stepper Holder Assembly •24 high quality re-usable tungsten alloy obturators. •Stepper Holder Set (matches your stepper B-K •Grid Face Plate Set (matches your ultra-sound, B-K •Two (2) sets 189.616 6F x 240mm OncoSmart ProGuide Sharp Needle Set •Two (2) sets 189.628 6F x 240mm OncoSmart ProGuide Obturator Set •One (1) 189.067 Prostate Stepper Template, 6F •CT Marker Set 240mm, Black •Push Fit Disconnection Tool •Transfer Tube Set for 6F, Flexibles (1-9) Transfer tubes for 6F flexible implant tubes and flexible needles (consisting of one each of the following): •111032 Transfer Tube for 6F Flexibles, No 1 •111033 Transfer Tube for 6F Flexibles, No 2 •111034 Transfer Tube for 6F Flexibles, No 3 •111035 Transfer Tube for 6F Flexibles, No 4 •111036 Transfer Tube for 6F Flexibles, No 5 •111037 Transfer Tube for 6F Flexibles, No 6 •111038 Transfer Tube for 6F Flexibles, No 7 •111039 Transfer Tube for 6F Flexibles, No 8 •111040 Transfer Tube for 6F Flexibles, No 9 •094387 Cleaning Advice Chart •090687 User Guide B. OncoSelect Stepper, Floor Mount System: •Stepping Head •Head Rotation of 360º •Stable table mount structure •Elevation of the column by quick action of a side handle •Left and Right travel Knob •Continuous in-out movement by the right- or left-side hand-wheel -Setting of zero reference plane at the base of the prostate -Five millimeter stepping mode and continues stepper (probe) movement -Stable floor fixation structure -Precision and user-friendly controls •Adapterset Oncoselect Stepper - B-K Medical (exists of adapter + probe cradle 8848A) •Grid Face Plate Set, B-K (the Grid Face Plate Set is used in combination with a Stepper Holder and a Prostate Stepper Template and indicates template grid coordinates according to the rectal ultrasound system.) C. 2202A-1 B & K Pro Focus B-Series Ultrasound System Fully Digital B/W Ultrasound System •Ergonomic Design for ease of Use •Automatic Image Adjustment •Image Storage 2D-3D •User Programmable Set-Ups •Intuitive Interface •Freeze Zoom •Personalized Menus •Easy to Handle and Maneuver •DICOM Store & DICOM Print (Optional) •Integrated 3D imaging (Optional) •HC MDL 70586 CL3 •UA2251 17’ Flat Screen for 2202 •UA2223 Mechanial Input for 2202 •8848A MFI Transrectal biplane Transducer •HC MDL 70586 CL3 •UA1215 Foot Switch for 2100 Series, •101 Merlin & 2202 Series •897UPD Sony B/W Digital Printer •HC Model 1752 CL 1 This is not a solicitation for competitive quotations. However, if any interested party believes it can meet the above requirement, they may submit a statement of capabilities. All information furnished shall be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the NCI contracting office by 1:00 PM EST on February 23, 2009. All questions must be in writing and can be faxed (301) 402-4513 or emailed to Ashley Virts, Contract Specialist at virtsa@mail.nih.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference NCI-90061-AV on all correspondence.
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