Stereotactic System

Added: Jun 14, 2018 9:52 am The requirement is for one (1) stereotactic system, image-guided, surgical, multi-procedure [27-302] and one (1) scanning system, computed tomography, spiral [18-443]. The surgical image-guided system shall be capable of real-time navigation of instrumentation used in spinal, cranial, and trauma surgeries. The surgical image-guided system shall be capable of integrating a 3D C-arm, navigation instrumentation, and microscope instrumentation. The surgical image-guided stereotactic system shall include a mobile cart with dual-displays and infrared tracking cameras for intuitive positioning, alignment assistance, real-time instrument tracking, and volume detection. The surgical image-guided system shall provide real-time surgical and navigation updates during surgery. The surgical image-guided stereotactic system shall display a minimum of four (4) instruments simultaneously. The surgical image-guided system shall include software for 3D-reconstruction and screw placement planning, as well as surgical workflow planning software for clinicians to conduct pre-operative planning. The surgical image-guided system shall include needle guides, screws, bone fixators, drill guides, drill bits, probes, reflective markers, disposables, and all necessary software and hardware for spinal, cranial, and trauma surgeries.

An intraoperative computed tomography (iCT) system capable of integration with the surgical image-guided stereotactic system shall be provided. The mobile iCT shall be a high-resolution intraoperative helical CT scanner for total spine and cranial imaging. The iCT system shall include a patient table for imaging in cranial and spinal cases, in prone, supine, lateral, and sitting positions. The surgical image-guided system and iCT shall directly exchange images and patient data. The surgical image-guided system and iCT system shall be capable of operation with the existing Siemens Arcadis Orbic 3D C-Arm and Zeiss Surgical Microscopes at NMCSD. The systems shall include clinician training and biomedical technician service training. The power requirement is 110 VAC, 60 Hz.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

Upon delivery, the vendor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage.

The system, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with OSHA requirements.

There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 339112. This RFI is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on 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.
If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Derek Bell at derek.j.bell.civ@mail.mil. Closing date for information is no later than 3:00 PM ET on 19 June 2018. No phone calls will be accepted.