SOLICITATION NOTICE
66 -- Analog Controller
- Notice Date
- 5/7/2010
- 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
- 1073401
- Point of Contact
- WIKIKI HENTON, Phone: 4042531252
- E-Mail Address
-
wikiki.henton@fda.hhs.gov
(wikiki.henton@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 13 - Simplified Acquisition Procedures. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. The North American Industrial Classification Code System (NAICS) for this procurement is 334516 with a business size standard of 500 employees. Background: The Center for Device and Radiological Health (CDRH) of the Food and Drug Administration promotes and protects the health of the public by ensuring the safety and effectiveness of medical devices and the safety of radiological products. Objective: CDRH requires a replacement analog controller to solve challenging engineering issues associated with percutaneous heart valve development for patient safety. Line Item 0001: Quantity one (1) each Analog Controller meeting or exceeding all of the following minimum specifications: Performance Requirements Replace obsolete analog controller with advanced signal conditioning module compatible with FDA/DSFM-owned M6 Heart Valve accelerated wear tester. System should include the following which is compatible with FDA-owned M6 Heart Valve accelerated wear tester. All replacement electronics and data acquisition system/software shall fit within the existing FDA-owned M6 Heart Valve accelerated wear tester. All replacement electronics shall function seamlessly with existing FDA-owned M6 Heart Valve accelerated wear tester. All cabling will be compatible with existing FDA-owned M6 Heart Valve accelerated wear tester electronics, and instrument controller computer. The system should meet Dynatek's electronics and safety standards for the accelerated wear testing. It should provide advanced signal conditioning that improves data accuracy, is more reliable than the current system, is easy for staff to use, and is expandable in future if required. The system shall provide digital control of the system. The system shall also include the following features and capabilities: • Integrated digital closed loop control and data acquisition electronics shall acquire data from the critical components to control the desired mechanical capabilities of speed, temperature, pressure, systemic pressure, and cycle time (including their limits and bandwidths). Some of the features available in the DC7000 series controller are: o Drive motor (in from valve tester) speed adjust 100-2000 rpms o Power driven 115 VAC 50/60 Hz AC in from valve tester o Digital speed/cycle count readout o Temperature and pressure sensor (10-32 tapped for miniature Endevco transducers [available for purchase, included in the total]) ports for sensor attachments o Use 3 different types of throttle valves based on the application - a 3/4" bypass hole is supplied for tissue valves; a 1/2" bypass hole is supplied for mechanical valves; and a 5/16" bypass hole is supplied for biomaterial test sections ([available for purchase with Test sections for Bioprosthetic Valves, included in the total]) o Temperature adjust, usually at 37 degreeC factory set to +1 degreeC o Pressure and temperature readout o Capacitance tank level to adjust systemic pressure, usually 130-160mmHg o Self-contained pressure pump to maintain the correct head pressure in the capacitance tank o Automatic shutoff of the machine if any of the above parameters fall outside their set limits • All data acquisition shall be synchronous across all channels (pressure, temperature, speed, etc). • All measurement and setting control channels shall be compatible with the FDA-owned M6 Heart Valve accelerated wear tester and include a software interface. • English language labels, headings, etc. on all components/software. • Valve diagnostics (with related service port) and user-friendly status indicators. • Computer interface shall include an Ethernet frame interface and necessary cables. • The host computer shall include compatible software to operate the DC7000 controller settings. Some features of this software include: o monitoring cycle rate, cycle count, systemic pressure, and system temperature and recording this data with each data acquisition o using the Controller Functions window, the user can input the following control parameters or items: load count to the counter, zero the counter, shutdown count, maximum rate limit, systemic pressure, systemic pressure limits, temperature set point, and record comments o all the above actions will be recorded in an event log which is stored in both the host PC and the DC7000 controller internal memory • All new mounting hardware, controller assembly, and cables. • 12-month minimum factory warranty for all manufacturer-supplied components. • Installation of replacement controller and associated components including computer, including integration and/or verification of the controller and components to the existing FDA-owned M6 Heart Valve accelerated wear tester. Line Item 0002: Quantity one (1) each Training. On-site training is required. Delivery: Delivery shall be FOB Destination. FDA shall not be responsible for any transit liability. Final Acceptance: Final Acceptance shall be provided and payment in full shall be made upon receipt and acceptance of all Line Items. Evaluation Criteria and Basis for Award: Award will be made on technically-acceptable, lowest-price basis. Technically -acceptable refers to meeting or exceeding the technical specifications delineated in this Solicitation and acceptable to the End User. Price shall not be evaluated on quotes that are determined not to be technically-acceptable. Place of Performance: U.S. Food and Drug Administration 10903 New Hampshire Avenue White Oak Campus, Building 62 Silver Spring, MD 20993 PROVISIONS AND CLAUSES The full text of a FAR provision or clause may be accessed electronically at www.acqnet.gov/far. The following provisions apply to this acquisition: 52.212-1 - Instructions to Offerors - Commercial; and 52.212-3 - Offeror Representations and Certifications - Commercial Items. In accordance with FAR 52.212-3 Offeror Representations and Certifications - Commercial Items, offerors must complete annual representations and certifications on-line at http://orca.bpn.gov. If paragraph (j) of the provision applies, a written submission is required; The following clauses apply to this acquisition: 1) 52.212-4 - Contract Terms and Conditions (Commercial Items); 2) 52.212-5 - Contract Terms and Conditions Required to Implement Statutes or Executive Orders (Commercial Items including subparagraphs); 3) 52.222-3 - Convict Labor; 4) 52.222-19 - Child Labor (Cooperation with Authorities and Remedies); 5) 52.222-21 - Prohibition of Segregated Facilities; 6) 52.222-26 - Equal Opportunity; 7) 52.222-36 - Affirmative Action for Workers with Disabilities; 8) 52.225-1 - Buy American Act-Supplies; 9) 52.225-13 - Restriction on Certain Foreign Purchases (E.O. 12722, 12724, 13059, 13067, 13121, and 13129); 10) 52.232-33 - Payment by Electronic Funds Transfer (Central Contractor Registration); and
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