6525--NX EQ Ultrasound Guided Fusion Biopsy System (VA-25-00042216)

1.0 DESCRIPTION

THIS IS A SOURCES SOUGHT NOTICE ONLY. This is not a solicitation for bids, proposals, proposal abstracts, or quotations. The Department of Veterans Affairs (VA) Strategic Acquisition Center (SAC) is issuing this Sources Sought Notice in accordance with the FAR 10.002(b)(2) as a means of conducting market research to identify qualified sources with the capability and the resources to meet the Veterans Health Administration s (VHA) Non-Expendable Equipment National Program requirement for Ultrasound Guided Fusion Biopsy System.

The SAC in conjunction with VHA is seeking a qualified source to supply brand name of Philips Healthcare UroNav MR and associated equipment or equal on an agency-wide basis. VA intends to award a single Requirements Contract with Firm-Fixed Price (FFP) orders IAW FAR 16.503, Requirements Contract to a supplier of this equipment. Vendors will be required to deliver Ultrasound Guided Fusion Biopsy System to VA medical centers and facilities Nationwide including OCONUS.

The anticipated period of performance is for one 12-month base period with four 12-month option periods from the date of award. However, the Government's decision as to whether to continue with the contract, upon annual review, will be based upon successful performance during each previous year and continued need.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing and the associated size standard is 1,250 employees.

The FAR Provision found at 52.204-7(b)(1) requires that All interested Offerors must be registered in SAM prior to submitting an offer or quotation. You may access the SAM website at SAM.gov | Home. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the SBA database at: https://veterans.certify.sba.gov/#search at the time of submission.

Submissions for this sources sought shall include the Notice ID in the email subject line and be submitted by email no later than the date and time listed in this announcement to:

Alex.Beck1@va.gov

Kimberly.Lemieux@va.gov

This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This Sources Sought Notice is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government may or may not issue a solicitation as a result of this notice. There is no solicitation available at this time.

2.0 SCOPE OF WORK

The Philips Healthcare UroNav MR or equal is an Image-guided computer-aided stereotactic surgical system designed to aid in the performance of minimally invasive biopsy procedures by combining medical imaging, dedicated computer software, and surgical instrument tracking systems for guidance. The systems provide surgeons with real-time, three-dimensional (3D) positioning and orientation of surgical instruments relative to the patient s anatomy on a video display during the biopsy without the use of an endoscope. Biopsy-image guided stereotactic systems provide medical images that show the location of the instruments in real time during the biopsy. 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 breast, bronchi, and prostate biopsies are available.

The following Contract Line Items are being considered:

Contract Line Item#

Brand

Part Number

Description

0001

Philips

784039_NCSA320

UroNav 4 Fusion Biopsy

0002

Philips

784039_NCSA431

Transperineal Stepper Biopsy

0003

Philips

784039_NCSA432

Freehand Transperineal Biopsy

0004

Philips

784039_NCSA425

UroNav 4 System Upgrade In-center

0005

Philips

784039_NCSA426

UroNav 4 System Upgrade

0006

Philips

784039_NCSA427

UroNav 4 SW Upgrade In-Center

0007

Philips

784039_NCSA428

UroNav 4 SW Upgrade

0008

Philips

784039_FCS0011

Pole Cart

0009

Philips

784040_NCSA433

UroNav 4 Add Options: Trial License

0010

Philips

784040_NCSA431

UroNav 4 Add Options: Transperineal Stepper Biopsy

0011

Philips

784040_NCSA432

UroNav 4 Add Options: Freehand Transperineal Biopsy

0012

Philips

784040_NCSA377

UroNav 4 Add Options: Stepper Floor Stand

0013

Philips

784040_NCSA378

UroNav 4 Add Options: Stepper Rail Support

0014

Philips

784040_NCSA380

Stepper, Hitachi C41L47RP

0015

Philips

784040_NCSA379

Stepper, BK 8848/E14CL4b

0016

Philips

784040_FCS0011

Pole Cart

0017

Philips

78053-NCSA025

UroNav Starter Sets: Str Set, GE, E8C/E8CS/IC5-9-D

0018

Philips

78054-NCSA026

UroNav Starter Sets: Str Set, PHC, C9-5ec

0019

Philips

78054-NCSA027

UroNav Starter Sets: Str Set, PHC, C10-4ec

0020

Philips

78054-NCSA039

UroNav Starter Sets: Str Set, BK, 8808E/8818/E14C4t

0021

Philips

78054-NCSA040

UroNav Starter Sets: Str Set, BK, 8819/E10C4

0022

Philips

78054-NCSA041

UroNav Starter Sets: Str Set, SMS, EC9-4

0023

Philips

78054-NCSA042

UroNav Starter Sets: Str Set, SMS, MC9-4

0024

Philips

78054-NCSA043

UroNav Starter Sets: Str Set, BK, 8848/E14CL4b

0025

Philips

78054-NCSA050

UroNav Starter Sets: Str Set, Hitachi, C41V

0026

Philips

78054-NCSA052

UroNav Starter Sets: Str Set, Hitachi, C41L47RP

0027

Philips

78054-NCSA434

UroNav Starter Sets: Str Set, Transperineal

0028

Philips

784014-FCS0140

UroNav Consumable Parts: Sensor, Universal (3)

0029

Philips

784014-FCS0054

UroNav Consumable Parts: Clip, GE E8C/E8CS/IC5-9-D (25)

0030

Philips

784014-FCS0105

UroNav Consumable Parts: Clip, PHC, C9-5ec (25)

0031

Philips

784014-FCS0135

UroNav Consumable Parts: Clip, BK, 8808E/8818/E14C4t (25)

0032

Philips

784014-FCS0136

UroNav Consumable Parts: Clip, BK, 8819/E10C4 (25)

0033

Philips

784014-FCS0137

UroNav Consumable Parts: Clip, BK, 8848/E14CL4b (25)

0034

Philips

784014-FCS0164

UroNav Consumable Parts: Clip, Siemens, EC9-4 (25)

0035

Philips

784014-FCS0165

UroNav Consumable Parts: Clip, Siemens, MC9-4 (25)

0036

Philips

784014-FCS0146

UroNav Consumable Parts: Clip, Hitachi, C41V (25)

0037

Philips

784014-FCS0147

UroNav Consumable Parts: Clip, Hitachi, C41L47RP (25)

0038

Philips

784043-NCSA397

UroNav DynaCAD 5 Prostate

0039

Philips

784043-NCSA398

UroNav DynaCAD 5 Breast & Prostate

0040

Philips

784045-NCSA415

UroNav DynaCAD 5 Add Prostate to Breast (if already own breast)

0041

Philips

784044-NCSA422

UroNav DynaCAD 5 for Urology

0042

Philips

784043-NCSA410

UroNav DCAD 5 Prostate Upgr - In cntr

0043

Philips

784043-NCSA411

UroNav DCAD 5 B&P Upgr - In cntr

0044

Philips

784043-NCSA413

UroNav DynaCAD 5 Prostate Upgr

0045

Philips

784043-NCSA414

UroNav DynaCAD 5 B& P Upgr

0046

Philips

784043-FCS0367

UroNav DCAD 5 Addnl Concurrent User

0047

Philips

784043-FCS0369

UroNav DynaCAD 5 Addn'l Prostate Conn

0048

Philips

784044-FCS0370

UroNav DCAD 5 Addnl Urology User

0049

Philips

784046-NCSA423

UroNav DynaCAD 5 Test License, Rad

0050

Philips

784048-FCS0366

Rack Server HW

0051

Philips

784048-FCS0365

DynaCAD Tower Server Hardware

0052

Philips

890432

Invivo Solutions Service - Gold - covering Part# 784039-NCSA421 (1 year)

- parts and factory repair labor cost for defective systems

- transport cost for receiving systems back after repair (one leg of freight cost)

- next day delivery for smart set of field replaceable parts, including related transport cost

- immediate access to remote applications & tech support (standard office hours)

- on-site technical support (time, material and travel cost)

- 1 time period of 2 days per year on-site application training (not valid for SensaVue)

- System tune-up service up to 2 times / year, on customer request

- free updates for DMS Software, which comprises enhancement of existing feature packages

- 25% discount on upgrades for DMS Software with new feature packages

0053

Philips

890434

Invivo Solutions Service - Silver - covering Part# 784039-NCSA431 (1 year)

- parts and factory repair labor cost for defective systems

- transport cost for receiving systems back after repair (one leg of freight cost)

- next day delivery for smart set of field replaceable parts, including related transport cost

- immediate access to remote applications & tech support (standard office hours)

- 1 time period of 1 day per year on-site application training (not valid for SensaVue)

- free updates for DMS Software, which includes enhancement of existing feature packages

0054

Philips

890434

Invivo Solutions Service - Silver - covering Part# 784039-NCSA432 (1 year)

- parts and factory repair labor cost for defective systems

- transport cost for receiving systems back after repair (one leg of freight cost)

- next day delivery for smart set of field replaceable parts, including related transport cost

- immediate access to remote applications & tech support (standard office hours)

- 1 time period of 1 day per year on-site application training (not valid for SensaVue)

- free updates for DMS Software, which includes enhancement of existing feature packages

0055

Philips

890436

Invivo Solutions Service - Custom - covering Part# 784039-NCSA396

Contract Type: Low (1-4 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades availiable for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

0056

Philips

890436

Invivo Solutions Service - Custom - covering Part# 784039-NCSA396

Contract Type: Medium (5-10 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades availiable for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

0057

Philips

890436

Invivo Solutions Service - Custom - covering Part# 784039-NCSA396

Contract Type: High (11-25 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades availiable for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

0058

Philips

890436

Invivo Solutions Service - Custom - covering Part# 784039-NCSA397

Contract Type: Low (1-4 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades availiable for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

0059

Philips

890436

Invivo Solutions Service - Custom - covering Part# 784039-NCSA397

Contract Type: Medium (5-10 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades availiable for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

0060

Philips

890436

Invivo Solutions Service - Custom - covering Part# 784039-NCSA397

Contract Type: High (11-25 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades availiable for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

0061

Philips

890436

Invivo Solutions Service - Custom - covering Part# 784039-NCSA398

Contract Type: Low (1-4 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades availiable for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

0062

Philips

890436

Invivo Solutions Service - Custom - covering Part# 784039-NCSA398

Contract Type: Medium (5-10 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades availiable for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

0063

Philips

890436

Invivo Solutions Service - Custom - covering Part# 784039-NCSA398

Contract Type: High (11-25 Scanner Connections)

- Immediate access (7AM to 7PM Central)to Remote Clinical and Technical support

- 1 time period of 2 Consecutive days, per year on-site application training (not valid for SensaVue)

- System SW tune-up service up to 2 times / year, on customer request.

-Free updates for DMS Software, which comprises enhancement of existing feature packages.

-Software Upgrades availiable for commercial purchase or via FCO if warranted for bug fixes.

-25% discount on upgrades for DMS Software with new feature packages.

-Software Re-Installation Fee Coverage.

The Department of Veterans Affairs (VA) is seeking vendors who can provide Philips Healthcare ultrasound Guided Fusion Biopsy System as listed above or equal commodities which meet all the following salient characteristics.

CLIN s 0001-0003, 0038-0041 apply to the following SC s

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

SC 1

Image Guided Fusion Biopsy System with real-time imaging interface

Literature Review

SC 2

Capability to use three different approaches for prostate biopsy: Transrectal, Freehand Transperineal and Stabilized Transperineal

Literature Review

SC 3

Ability to fuse pre-biopsy MR images of the prostate with live Ultrasound Images

Literature Review

SC 4

Software package and interface to allow for collaboration with radiology for a streamlined workflow to store, review and manage data.

Literature Review

SC 5

FDA 510(k) Approved

Literature Review

For each product (brand name and part number), the response must include descriptive literature demonstrating the product meets or exceeds the salient characteristics (SC) specified above.

The Government's intent is to include all ancillary items to ensure the equipment can function as designed by the OEM and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the salient characteristics. Additionally, responses can include any additional product that may be beneficial. These items must be clearly identified by brand name and part number.

Responses to this Sources Sought Notice shall include the following:

Does vendor offer an annual service plan, Yes or No?

If Yes:

What does the plan cover?

Does plan cover software updates only?

Does the plan cover parts repair or replacement only?

Does the plan cover both software and parts?

Vendor is requested to provide documentation that shows information on their service plan.

Is the service provided by the OEM or a subcontractor?

Full name and address of company

DUNS number/ CAGE Code/ SAM UIE

Business Size

Manufacturer or Distributor

If distributor provide full name, business size and address of manufacturer.

Country of Origin designation for all products

Ability to provide uninterrupted supply of products on a national scale

Technical Literature that clearly shows product(s) meet the identified salient characteristics and page numbers where each salient characteristic is met

Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified.

Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement.