ATTACHMENT B - PRODUCT DESCRIPTION_NX EQ Image-Guided Surgical Navigation System.pdf

PRODUCT DESCRIPTION

For

NON-EXPENDABLE EQUIPMENT:

Image-Guided Surgical Navigation System

Prepared By:

Enterprise Procurement Office Department of Veterans Affairs

5202 Presidents Court, Suite 103 Frederick, MD 21703

1. SCOPE OF WORK:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Image-Guided Surgical Navigation System as a candidate for a VA-wide (otherwise referred to as “national”) single award Requirements contract.

The Image-Guided Surgical Navigation System is a stereotactic computer-aided surgical system designed to aid in the performance of minimally invasive procedures by combining medical imaging, dedicated computer software, and instrument tracking systems for guidance. The systems provide real-time, three-dimensional (3D) positioning and orientation of instruments relative to the patient’s anatomy on a video display during surgery without requiring the use of an endoscope. Image-guided surgical navigation systems work in a similar way to global positions systems (GPS) applied to the human body. They provide medical images that show the location of the instruments in real time during the procedure, and one or more imaging modalities, such as computed tomography (CT) and/or magnetic resonance imaging (MRI), may be used in the procedure. Dedicated image-guided stereotactic systems intended for particular procedures such as neurosurgery, cardiac mapping and ablation, mammographic biopsy, and cranial, spinal, orthopedic, and laryngological surgery procedures are available. Image-guided systems intended to facilitate radio surgical procedures from the exterior of the body are also available.

The Contractor must demonstrate the ability to meet all requirements for the solicitation.

The objective is to provide a complete image-guided stereotactic system to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for a base of 12-months with four 12-month option periods.

2. REQUIREMENT

This requirement will utilize Brand Name or Equal product descriptions which requires the offeror indicate that each product being offered as an “equal” product to the Medtronic Stealthstation image guided system. For each equal product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The offeror must also clearly identify the item by brand name (if any) and make/model number. Finally, the offeror must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements.

Contract Line Item#

Brand Part Number Description

0001 Medtronic 9735665 STEALTHSTATION™ S8 MAIN CART

W/MONITOR

0002 Medtronic 9735670 STEALTHSTATION™ S8 CAMERA CART

0003 Medtronic 9735943 POWER PACK 9735943 STEALTH S8 ENG

ONLY

0004 Medtronic M072707M015 STEALTHSTATION™ S8 System - New 0005 Medtronic 9735740 STEALTHSTATION™ SPINE SOFTWARE 0006 Medtronic 9736428 REF SET 9736428 SPINE REFERENCING 0007 Medtronic 9735502 UPGRADE SET 9735502 PERC PIN 0008 Medtronic 9735501 Revision Referencing Tray 0009 Medtronic 9735522 Revision Referencing Tray Upgrade

0010 Medtronic NAV2024K DRIVER NAV2024 SOLERA 4.75 STANDARD

MAS

0011 Medtronic NAV2025K DRIVER NAV2025 SOLERA 4.75 REDUCT

MAS

0012 Medtronic 9735465 CD HORIZON® SOLERA® Awl-Tip Taps 0013 Medtronic 9735469 CD HORIZON SOLERA Taps 0014 Medtronic 9734492 SOLERA DEFORMITY TAPS UPGRADE 0015 Medtronic 9735283 SOLERA 5.5/6.0 DRIVERS 0016 Medtronic 9735285 SOLERA ILIAC TAPS

0017 Medtronic 9734838 TAP KIT 9734838 SOLERA 8.5

CANNULATED

0018 Medtronic 9734494 INST SET 9734494 TACTILE PROBES 0019 Medtronic 9735173 INST KIT 9735173 2.25MM PED PROBE

0020 Medtronic 9734836 INSERTER, CAPSTONE & CLYDESDALE

SET

0021 Medtronic 9734833 NAVLOCK™ NAVIGATION INSTRUMENT

SET

0022 Medtronic 9734834 CAPSTONE TRIALS SET (TLIF/PLIF)

0023 Medtronic 9734507 STEALTHSTATION® UNIVERSAL DRILL

GUIDE

0024 Medtronic 9734835 CLYDESDALE TRIALS SET (DLIF) 0025 Medtronic 9734435 TACTILE AWL 0026 Medtronic 9735032 POWEREASE™ ADAPTER 0027 Medtronic 9735737 STEALTHSTATION™ CRANIAL SOFTWARE 0028 Medtronic 9735743 STEALTHSTATION™ 3D SOFTWARE 0029 Medtronic 9735745 STEALTHSTATION™ MERGE SOFTWARE

0030 Medtronic 9735739 STEALTHSTATION™ STEREOTAXY

SOFTWARE

0031 Medtronic 9735738 STEALTHSTATION™ DBS SOFTWARE

0032 Medtronic 9735921 STEALTHSTATION™ DBS + STEREOTAXY

SOFTWARE

0033 Medtronic 9735747 SCHALTENBRAND WHAREN ATLAS 0034 Medtronic 9736423 SW KIT 9736423 S8 2.0 TRACTOG

0035 Medtronic 9733935 CRANIAL INSTRUMENT SET - PASSIVE

0036 Medtronic 9730092 INST HNDL 9730092 PASS CATHETER

INTROD

0037 Medtronic 9731965 TOUCH-N-GO KIT 9731965 0038 Medtronic 9733157 PROBE, 9733157, NAVIGUS 0039 Medtronic 9730269 MICROSCOPE PROBE 0040 Medtronic 9733936 VERTEK PASSIVE BIOPSY KIT 0041 Medtronic 961-337 INST REF FRAME 961-337 SM PASSIVE CR 0042 Medtronic 960-556 PASSIVE PLANAR BLUNT PROBE 0043 Medtronic 961-574 INSTRUMENT SET - SURETRAK II PASSIVE 0044 Medtronic 9734252 ARM 9734252 VERTEK II

0045 Medtronic 9735955 STEALTHSTATION™ EM KIT S8 CRANIAL

ACCESSORIES

0046 Medtronic 9736149 ZEISS KINEVO INTERFACE KIT 0047 Medtronic 9736150 S8 DIGITAL HUD UPGRADE KIT

0048 Medtronic KINEVOS8

UPGRADE

KINEVO KIT W/ S8 UPGRADE HARDWARE

0049 Medtronic 9736023 INTF KIT 9736023 ZEISS PENTERO HUD S8 0050 Medtronic 9736042 SCOPE KIT 9736042 S8 ZEISS UPG 0051 Medtronic 9736027 INTF KIT 9736027 LEICA HUD S8 0052 Medtronic 9736028 INTF KIT 9736028 LEICA PTR ONLY S8

0053 Medtronic 9735959 STEALTHSTATION™ EM KIT S8 FLAT

EMITTER

0054 Medtronic 9735736 STEALTHSTATION™ ENT SOFTWARE 0055 Medtronic 9735742 SFW 9735742 STEALTH 3D ENT 0056 Medtronic 9733452XOM ENT NAVIGATION INSTRUMENT SET 0057 Medtronic 9736325 Monitor Cover 9736325 Stealth S8 SVC 0058 Medtronic 9736326 Camera Cover 9736326 Stealth S8 SVC

0059 Medtronic AUTOGUIDE_

SYSTEM

Stealth Autoguide System

0060 Medtronic 9736464 Stealth Autoguide Instrument Set

0061 Medtronic AUTOGUIDE_

REG_KIT

Stealth Autoguide Non-sterile Registration Kit

0062 Medtronic 9736189 Stealth Autoguide Visualase Instrument Set

0063 Medtronic 9736377 Stealth Autoguide STERILIZATION TRAY

9736377 AUTOGUIDE II

0064 Medtronic 9736382 Stealth Autoguide STERILE TRAY 9736382

AUTOGUIDE AND MR8

0065 Medtronic BI70002000 O-ARM O2 BASE

0066 Medtronic BI75000027 CONFIG BI75000027 O2 SYSTEM

NAVIGATION INTERFACE

0067 Medtronic BI75000034 CONFIG BI75000034 O2 MULTIPLE FIELD

OF VIEW

0068 Medtronic BI75000030 CONFIG BI75000030 O2 ADVANCED

VIEWING

0069 Medtronic BI75000031 CONFIG BI75000031 O2 ISO-WAG™

ROTATION

0070 Medtronic BI75000032 CONFIG BI75000032 O2 COLLIMATED

AXIAL 3D

0071 Medtronic BI75000029 CONFIG BI75000029 O2 HIGH DEFINITION

3D – HD3D

0072 Medtronic BI75000045 O-ARM O2 2D LONG FILM - NEW SYSTEM

0073 Medtronic BI71000875 O-ARM O2 2D LONG FILM UPGRADE -

EXISTING SYSTEM

0074 Medtronic BI75000046 O-arm O2 Medtronic Implant Resolution (MIR) 0075 Medtronic BI75000047 O-arm O2 Spine Smart Dose (SSD) 0076 Medtronic BI75000048 O-arm O2 3D Long Scan (3DLS)

0077 Medtronic BI75000050 O-arm O2 4.3.0, MIR, SSD and 3DLS - Active Service Agreement Customer

Medtronic BI75000049 O-arm O2 4.3.0, MIR, SSD and 3DLS, and

Computer for Non -Service Agreement Customer

Medtronic BI75000051 O-arm O2 4.3.0, MIR, SSD and 3DLS, without computer for Non -Service Agreement Customer

The Department of Veterans Affairs (VA) is seeking vendors who can provide a Medtronic Stealthstation or equal image-guided surgical navigation systems as listed above which meet all the salient characteristics listed below. Vendors may quote any product solution or configuration so long as they meet the salient characteristics.

Products quoted in the technical volume must be captured on the Vendor’s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may quote any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor’s pricing volume with a quantity of zero.

Offerors must propose a complete solution including associated accessories, as required for the system’s full functionality.

SC # SALIENT CHARACTERISTICS METHOD OF

EVALUATION

Page # where SC Met

SC 1 Must have a minimum of 27” high resolution touchscreen monitor

Literature Review

SC 2 Must have Real-time navigation of images with the ability to fuse 3D preoperative images for advanced planning

Literature Review

SC 3 Must be capable of interfacing with all of the following intraoperative imaging systems: MRI, CT, and 3D Ultrasound.

Literature Review

SC 4 Must have the ability to integrate with external devices for streamlined visualization workflows.

Literature Review

SC 5 Must be able to perform navigation for cranial neurosurgery and spine applications.

SC 6 Must have optical and EM tracking capabilities

Literature Review

SC 8 Must be FDA 510(k) Approved Literature Review SC 9 Must provide a minimum one-year

Manufacturer Warranty Literature Review

SC 10 Interoperability with the VA Electronic Health Record System

Evaluation Sub-factors

1. Safety Safety features and functions of the offered equipment will be evaluated. Areas may include but are not limited to the following:

a) System security

b) Maintenance reminders

c) Emergency alarms

2. Design

Design features and functions of the equipment offered will be evaluated. Areas may include but are not limited to the following:

a) Touchscreen user interface and ease of use

b) Image display quality and resolution

c) Data storage and RAM memory

d) Patient data management

e) External device and instrument compatibility

f) System footprint and weight

g) Power and environmental requirements

h) Optical and EM tracking capabilities

i) Optical tracking volume

j) Different types of Intraoperative imaging systems capable of interfacing with

k) Ergonomics

3. Diagnostic Tools and Imaging Techniques

Diagnostic tools and imaging techniques of the offered equipment will be evaluated. Areas may include but are not limited to the following:

a) Patient registration

b) Surgical navigation

c) Tool tracking

d) Image merging

e) Procedure specific software applications

f) Pre and intraoperative planning

4. Quality/Construction

Aspects of the construction and quality of material of the equipment will be evaluated and may include but not limited to the following:

a) Life span

b) Warranty terms and conditions

c) Maintenance requirements

d) Service plans terms and conditions

e) Training options