The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR 13.501(a), Only One Responsible Source. The proposed source is Brainlab, Inc. of 5 Westbook Corporate Center, Suite 1000 Westchester, IL 60154-5766.
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 maintenance contractor for the proposed equipment/systems, 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 of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage.
The system shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. 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 notice of intent 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 email@example.com. Closing date for challenges is no later than 3:00 PM ET on 24 May 2018. No phone calls will be accepted.
Deadline: Friday, July 6, 2018
Date Published: Thursday, June 21, 2018
Date Updated: Thursday, June 21, 2018
Derek J. Bell
693 Neiman Street, FT Detrick, Maryland 21702-9203