The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.501(a)). The proposed source is Brainlab Inc., 3 Westbrook Corporate Center Suite 400, Westchester, IL 60154. NMC Portsmouth has a requirement for an upgrade to their installed image-guided stereotactic surgical navigation system from Brainlab, Inc. for use in neurosurgical procedures. The software shall be upgraded to include the following capabilities: image fusion from multiple imaging modalities with surgical navigation data, 3D image rendering from CT, MR, PET and SPECT datasets, and updates to the surface matching algorithm. The upgraded software capabilities shall not require reintegration with existing imaging modalities (i.e. ultrasound or mobile radiographic/fluoroscopic units) or with the existing surgical microscope. The upgraded software capabilities shall not require the purchase of additional software licenses. The system shall include a dual display navigation station to run the upgraded software. The system shall be DICOM compatible and shall allow for viewing of DICOM images. The upgraded system shall be compatible with the current Brainlab accessory sets, which include instruments and sterilization trays for cranial surgery, open spine surgery, and drilling. An additional accessory set for minimally invasive spine surgery shall be included. At least one day of training on the upgraded cranial and spine software shall be included.

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.

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.

If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Brian Miller at [email protected]. In addition, challenges can be faxed to 301-619-1132 Attn: Brian Miller, reference solicitation number N6264514RCES035. Email challenges are preferred. Closing date for challenges is no later than 2:00pm. ET on 23 May 2014. No phone calls will be accepted.

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