STATEMENT OF WORK Page 1 of 4 This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. If you have any questions or concerns, please provide them in writing to
[email protected]. Services required: Tissue Removal Transaction number: 644-18-3-201-0894 Please provide the following information clearly and precisely. The Phoenix VA Health Care System is looking to procure tissue removal. The applicable NAICS code is 339112 Surgical and Medical Instrument Manufacturing. The size standard for this NAICS code is $18M. The resulting contract will be a firm fixed price order. It is anticipated that a Request for Quotes will be issued August 17, 2018. Award of a firm fixed price contract is contemplated by September 30, 2018. This notice is published to conduct market research to determine if there are a sufficient number of certified Service Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), Small Businesses (SB), or Large Businesses capable of performing the requirements to warrant a socio-economic set-aside. Interested parties responding to this sources sought request shall submit the following information at a minimum: (1) company name and address, point of contact with phone number, and DUNS number; (2) FSS contract number and expiration date, if available; (3) VA Vetbiz (CVE) SDVOSB/VOSB verification. Responses to this Sources Sought notice shall be received at
[email protected] no later than 5 PM PST, August 15, 2018 for consideration. The Contractor shall furnish all necessary equipment and supplies. Supplier shall provide all labor, material, tools, parts, equipment, operating and/or Technical/maintenance manuals, training, delivery, and accessories necessary. Description of what the equipment being requested is: The Hysteroscopic Tissue Removal System integrates high-speed radio frequency resection (one device per case) with a self-contained fluid management system and internal intrauterine pressure monitor into a single console. The system limits fluid overload, monitors pressure from within the uterine cavity, adjusts flow rates to help prevent cavity collapse, and efficiently and effectively resects and evacuates tissue specimens that can be sent for further pathology evaluation. VA will save money by not having to send Veterans out unnecessarily. Description of how the equipment being requested operates: The Hysteroscopic Tissue Removal System uses bipolar radiofrequency for resecting and coagulation. Fluid management is via a'closed-loop' filtration system. The Hysteroscopic Tissue Removal System has two distinct modes: diagnostic and resection mode. In Diagnostic Mode, the Hysteroscopic Tissue Removal System provides distension of the uterus for diagnostic hysteroscopy. Bipolar radiofrequency energy is NOT active in this mode (i.e. no resection and/or coagulation). A footswitch allows the surgeon to aspirate and re-circulate the saline. In Resection Mode, bipolar radiofrequency energy is active (i.e. bipolar resecting and/or coagulation). Aspiration is also active in Resection Mode resection device is bladeless and disposable and for single patient use. This procedure can be performed with no anesthesia or with local anesthesia only. Technical Specifications: The Controller provides bipolar radiofrequency outputs (resection and coagulation) and fluid management through the use of two integrated peristaltic pumps. The Resecting Device is a disposable, hand held bipolar radiofrequency device configured for the resection and aspiration of uterine pathology. Fluid infusion and aspiration of the uterine cavity are controlled by the Controller s peristaltic pumps, in conjunction with the disposable Fluid Management Accessories; these components form a closed loop re-circulating system. The Controller with Integrated Fluid Management System has two distinct modes; diagnostic mode and resection mode. The Controller with the integrated closed loop recirculating Fluid Management System provides distension of the uterus during diagnostic hysteroscopy. Bipolar radiofrequency energy is NOT active in this mode (no resection and coagulation). A footswitch allows the surgeon to aspirate and re-circulate the saline. In Resection mode, bipolar radiofrequency energy is active (bipolar resection and coagulation). Aspiration is also active in Resection Mode. The Symphion System is for use with the Symphion Endoscope Refer to Endoscope Instructions. The Symphion System is intended to distend the uterus by filling it with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and provide fluid management through the closed loop recirculation of filtered distension fluid. It is also intended for resection and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device. Ordering Information: SYMPHION Controller-PART NUMBER FG-0612-BRAND NAME OR EQUAL (Quantity -1)- All necessary components-pole, footswitch, power cord, controller SYMPHION Endoscope 6.3 -PART NUMBER FG-0703-BRAND NAME OR EQUAL (Quantity - 2) Endoscopes along with both light post adapter and cleaning brushes Input 100-240VAC, 50-60Hz, 700VA Dimensions without Pump Heads and Saline Pole 6 ¾ (H) x 16 (W) x 21 (D) (17.1 x 41.0 x 53.7 cm) Packaged Weight 39 lbs (17.7kg) Output (Resect): 275W ±20%, 275VMAX, 148 kHz, 200 load Output (Coag): 110W ±20%,, 200VMAX, 148 kHz, 200 load Fuses 5x20mm Type T 6.3A /250V slow blow (Qty. 2; Littelfuse or equivalent) Unites breakthrough fluid management, direct intrauterine pressure monitoring and bladeless resection to work together in perfect harmony. The Hysteroscopic Tissue Removal System includes a compact controller with built-in fluid management system, a 6.3mm OD hysteroscope, a molecular filtration system and a 3.6mm RF bipolar tissue resection device. Compact Controller works with the system to directly monitor the pressure inside the uterus and to automatically adjust fluid flow and prevent cavity collapse. The controller provides RF plasma energy for resection and spot-coagulation Fluid Management System puts you in control of fluid flow through the procedure and allows for accurate absorption monitoring in real time. The system ingeniously uses a single 3-liter saline bag to collect, filter and continuously recirculate fresh saline throughout the procedure. At a glance, you always know how much fluid is in use. The maximum amount of fluid that can intravasate is 2.5 liters.* Foot Pedal conveniently enables resection, spot coagulation and on-demand aspiration to quickly clear the visual field 3.6mm Resecting Device features innovative high-speed RF plasma technology and smooth, rounded edges with a side resection window. B-Flow Imaging Uses non-Doppler technology to display true hemodynamics and 6.3mm Hysteroscope has four separate channels to address the common challenges of surgery: visibility, cavity collapse, inadequate aspiration and the ability to directly monitor uterine pressure.