Hologic Hysteroscopy Set and Accessories Statement of Need Background: The Myosure Omni Hysteroscope and Tissue Device is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. The Fluent Fluid Management System and Disposable Pack is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus while providing drive, control and suction for hysteroscopic morcellators. The Novasure RF Controller Model 10 and Novasure V5, has Smart-Depth Technology and continuously monitors and measures tissue impedance to ensure a customized, reliable, and reproducible depth of ablation for every patient. Scope of Work: The Lebanon VA Medical Center (LVAMC) has a Brand Name only requirement for a Hologic Hysteroscopy System Set. The set includes two (2) Myosure Omni Hysteroscopy Standard Set and Tray, one (1) Fluent System and one (1) Novasure RF Controller Model 10. This shall include training of all equipment. Salient Characteristics of the brand name required Hologic Myosure Omni Hysteroscopy Standard Set, Tray and Tissue removal device: The Omni Hysteroscope and tissue removal device is intended for use in visualizing the uterine cavity and performing operative hysteroscopy procedures including use with the MyoSure Tissue Removal Device. The Omni Hysteroscope system includes a base scope with compatible sheaths of varying working channel size. The removable outflow channels are intended to be used to provide a fluid outflow lumen for use with Omni 5.5mm and 6mm Operative Sheaths. The removable outflow channel includes a sealed entry port to permit the introduction of instrumentation. The reusable rod lens hysteroscope utilizes rod lenses for visualization and fibers for illumination. The hysteroscope includes Omni 5.5mm and 6mm Operative Sheaths to accommodate the respective MyoSure Tissue Removal Device. The operative hysteroscopy system can be combined with a hysteroscopic fluid management system to provide continuous flow hysteroscopy capability. 60-201 Omni 3.7mm Diagnostic Sheath 60-200 Omni Hysteroscope 60-202 Omni 5.5mm Operative Sheath 40-201 Omni 5.5mm Outflow Channel 50-201XL Omni 6mm Outflow Channel 60-203 Omni 6mm Operative Sheath 40-904 Outflow Channel End Cap x 3 40-900 Storz Light Guide Adapter 40-901 Wolf Light Guide Adapter 30-403 - LITE MYOSURE LITE TISSUE REMOVAL DEVICE (3-PACK) 50-503XL - MYOSURE XL TISSUE REMOVAL DEVICE (3-PACK) 10-403FC - MYOSURE REACH TISSUE REMOVAL DEVICE (3-PACK) Salient Characteristics of the brand name required Hologic Fluent System: Dual peristaltic pump technology with integrated suction Deficit accuracy within +/- 50mL Preset deficits per AAGL guidelines System won t leave setup screen until all components are in place System starts warning users at 75% of set deficit limit System warns users when supply bag is low and waste bag is full Can hang a bag while the system is running Deficit set from 100ml-2,500Ml in 50ml increments Pressure can be set from 40-120mmHg in 5mmHg increments Fluent Disposable Pack (6-Pack) Salient Characteristics of the brand name required Hologic Novasure RF Controller Model 10 Advanced touchscreen interface has responsiveness set to react to user intent and is optimized for use with or without surgical gloves. Ablation timer and summary screen display cumulative running ablation time and total ablation time at the end of the procedure, as well as length, width and power level. The prior procedure data is also recoverable if the controller is powered on and off. With IFU procedural instructions on the interface, the RFC10 walks a physician through corrective actions when an error message is encountered. Volume-controlled and mutable alarms are perfect for in-office procedures where a patient can be easily startled. RFC10 controller is compatible with all generations of NovaSure devices. RF controller is a constant power output generator with a nominal maximum power delivery capability of 180 watts. Controller automatically calculates the power output based on the uterine cavity Length and width measurements that the user key-enters the controller Monitoring tissue impedance during the ablation process automatically Controls the depth of endo-myometrial ablation Novasure V5 Delivery: Delivery shall be within thirty (30) days from the time of award. The Myosure Omni Hysteroscopy Standard Set and Tray, one (1) Fluent System and one (1) Novasure RF Controller Model 10 and accessories shall be delivered to the Lebanon VAMC located at 1700 S. Lincoln Ave., Lebanon, PA 17042; Attn; Warehouse. Biomedical Engineering will need to perform a safety check and enter the equipment into the system for annual Preventive Maintenance (PM) checks. Placement in the LVAMC clinic shall be coordinated through the Contracting Officer Representative. Please contact the Contracting Officer Representative with any questions or concerns. Nominated COR: Beverly Miller Phone: (717) 272-6621 x 4120 Email:
[email protected] Instructions The information identified above is intended to be descriptive, of the Brand Name only Hologic Hysteroscopy Set and Accessories, to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above. Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, DUNS Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 339112. Please answer the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? (2) Is your company considered small under the NAICS code identified under this RFI? (3) Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? (4) If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). (5) Describe how your small business takes ownership of the equipment in the manufacturing, assembly, or delivery process. (6) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (7) If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work and completion of job. (8) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number. (9) If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? (10) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. (11) Please submit your capabilities in regard to the brand name equipment. (12) Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 8. Responses must be received via e-mail to
[email protected] no later than, 4 PM Eastern Standard Time (EST) on August 17, 2022. This notice will help the VA in determining available potential sources only. Reference 36C24422Q1068 in the subject of the email response. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Specialist, David Santiago. All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award. If a solicitation is issued, information will be posted on the beta.Sam website for all qualified interested parties at a later date and interested parties must respond to this Sources Sought Notice to be considered for a set-aside. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information (RFI). Information will only be accepted in writing by e-mail to Contract Specialist at
[email protected] DISCLAIMER 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. 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.