65--Halo Generator, Electro Surgical Units, (RF Theraphy System)

This document is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 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 proposed contract action is for supplies or services for which the Government intends to solicit competitive offers. Interested persons may submit offers, and all eligible offers received prior to September, 17th 2012 will be considered by the Government. The NAICS code is 334510 and the size standard is 500 Employees. This solicitation has been completely set-aside for small business. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-60. Only emailed requests received directly from the requester are acceptable. The list of contract line item number(s) and items, quantities and units of measure, (including option(s), if applicable). Please note, all of the line items are designated Brand Name or Equal: CLIN w/DESCRIPTION/QTY/UNIT/UNIT PRICE/TOTAL AMOUNT 0001 1.00 EA $___________________ $____________________ Brand Name or Equal Description: 1190A-115A 1 HALO generator system, includes cart, mdl. #1190A-115A. Quoted on: Manufacturer name_____________________________________ Brand________________________________________________ No.__________________________________________________ 0002 1.00 EA $___________________ $____________________ Brand Name or Equal Description: CART-100 2 Cart for holding generator and supplies Quoted on: Manufacturer name_____________________________________ Brand________________________________________________ No.__________________________________________________ GRAND TOTAL --- $_______________________ Delivery, acceptance, and FOB Destination Point: ITEMS ALL QUANTITY ALL Requested Delivery Date: 30 Days ARO SHIP TO: ATTN: TBD VAMC - Warehouse (90D) 4150 Clement St., Bldg. 203, Rm. BB21 San Francisco, CA 94121 SALIENT CHARACTERISTICS Any "Or Equal" products being offered must have the following salient characteristics: o Must be able to deliver precise, uniform, superficial ablation of the esophageal epithelium to a depth of between 500 uM and 1000 uM. o Must be approved by the FDA (Food and Drug Administration) to provide ablation in the gastrointestinal tract of bleeding and nonbleeding sites, including but not limited to: Barrett's esophagus, radiation proctitis, and gastric vascular ectasia. o For treatment of circumferential Barrett's esophagus, must be able to deliver ablation of the entire circumference of the esophagus using balloon ablation catheters of the following diameters 18 mm, 22 mm, 25 mm, 28 mm and 31 mm in size. o For short, non-circumferential segments of Barrett's esophagus, must be able to deliver focal ablation of the esophageal tissue using paddle electrodes that mount on the end of an endoscope to provide precise, directed ablation. o Must have the capability (including computer software) for automatically measuring the esophagus internal diameter at several levels of the esophagus using sizing balloons. Must have automated method for calibrating the sizing balloon. After calibration, must have automated mechanism for inflating and deflating the sizing balloon to calculate the balloon volume and diameter. Must provide information on a digital LED or LCD screen about the recommended balloon diameter to use for circumferential ablation. Must be able to control balloon inflation/deflation with foot pedal. Must have balloon inflation limit of 0.31 ATM. o For circumferential ablation using a balloon catheter, must be able to provide radiofrequency power of 300 watts at 460 kHz in a bipolar mode under power control while continuously monitoring and displaying power, energy density, and balloon inflation pressure. Must be able to provide specified energy density of 10.0-15.0 J/cm2. Must be able to control balloon catheter inflation and cautery using a foot pedal. o For treatment of short, non-circumferential Barrett's esophagus using a paddle electrode attached to the endoscope, must be able to provide radiofrequency power of 104 watts at 460 kHz in bipolar mode under power control while continuously monitoring and displaying power density and energy density. o Must have LES display on generator that shows: a. when system is armed (active) and ready to deliver energy; b. when system is delivering radiofrequency ablation; c. when the system has encountered a fault; d. the maximum power setting (Watts) that can be applied; e. the maximum energy density (in Joules/cm2) that can be applied (based upon the desired amount of energy divided by the catheter electrode area); f. the balloon diameter; g. the balloon pressure (in ATM). o Must be controlled by software that is updatable. Software must control the balloon inflation process and electrocautery application. o Must provide information at end of procedure of the number of cautery applications delivered and the amount of energy delivered. o Must weigh no more than 40 lbs. o Must be no larger than 18 inches wide, 22 inches deep, and 8 inches high. o Must be approved by the FDA to interface with the following FDA approved ablation catheters: " Barrx 360 balloon ablation catheters: #32041-18; 32041-22; 32041-25; 32041-28; and 32041-31. " Barrx focal catheters: 90-9100; 90-9300; and 90-9200 INSTRUCTIONS TO OFFERORS Only electronic offers will be accepted. Offers are due to contact@example.gov by 6:00 PM PDT September, 17th 2012. EVALUATION FACTORS Offerors will be evaluated to the extent they can provide the items (or equal) listed in the price schedule in Section B. The Government will award to the lowest priced, responsible, technically acceptable offeror. FAR 52.211-6 Brand Name or Equal (Aug 1999) (a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government's needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation. (b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must- (1) Meet the salient physical, functional, or performance characteristic specified in this solicitation; (2) Clearly identify the item by- (i) Brand name, if any; and (ii) Make or model number; (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and (4) Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification. (c) The Contracting Officer will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. (d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation. (End of provision) ADDITIONAL SOLICITATION PROVISIONS/CONTRACT CLAUSES: FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998) For the purpose of this clause, the fill-ins are http://www.acquisition.gov/far/index.html and http://www1.va.gov/oamm/oa/ars/policyreg/vaar/index.cfm, respectively. FAR 52.212-4 Contract Terms and Conditions -- Commercial Items (Feb 2012). FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items (Aug 2012) For the purposes of this clause, items (b) 4, 6, 12i, 23, 26-29, 31, 38, 40i, 42, and 48 are considered checked and apply. VAAR 852.203-70 Commercial Advertising (Jan 2008) VAAR 852.211-73 Brand Name or Equal (Jan 2008) VAAR 852.273-76 Electronic Invoice Submission (Interim - October 2008) FAR 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998) For the purpose of this provision, the fill-ins are http://www.acquisition.gov/far/index.html and http://www1.va.gov/oamm/oa/ars/policyreg/vaar/index.cfm, respectively. FAR 52.212-1 Instructions to Offerors - Commercial Items (Feb 2012). FAR 52.212-3 Offeror Representations and Certifications -- Commercial Items (Apr 2012): Offerors must return this provision with their proposal. They may either (1)complete all relevant portions of the provision or (2) complete paragraph (b) of the provision and indicate that it has completed official representations and certifications online at https://orca.bpn.gov/login.aspx FAR 52.232-38 Submission of Electronic Funds Transfer Information with Offer (May 1999) (End of Clauses)