Salient Characteristics.docx
DOCX document 3 MB Posted
- Attached to
- 6515--3D Prostate Cartography and Biopsy System
- Solicitation number
- 36C26126Q0951
About this file
This is a Brand Name or Equal Worksheet (Salient Characteristics) document for a 3D Prostate Cartography and Biopsy System procurement by the Department of Veterans Affairs (VA) San Francisco Health Care System. The brand name item specified is the Koelis Trinity Prostate Biopsy system, model KURO-3000-3-FULL TRINITY with full configuration. The salient characteristics that establish equivalency requirements include MRI/US fusion prostate biopsy, PET/US fusion prostate biopsy, ultrasound-guided prostate biopsy, rectal spacer placement, fiducial marker insertion, ablative therapy planning and guidance for prostate cancer, and diagnostic transrectal, abdominal, and small parts ultrasound capabilities.
The required equipment configuration includes the Trinity V4 system with 3D Prostate Cartography and Biopsy capability, Steady Pro Arm, probe holders, TP and TR probes, ProMap Lite Software Module for one workstation, single-use grid needles (full and mini configurations with 25 units each), and two days of on-site training. The manufacturer is Koelis. The certifying official has confirmed that the listed salient characteristics are essential to government requirements and that these restrictions will not limit acquisition to a single manufacturer, allowing for equivalent alternative products to be considered in the associated Sources Sought notice (Solicitation Number 36C26126Q0951) under NAICS code 334510 for Electromedical and Electrotherapeutic Apparatus Manufacturing.
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Other files
| File | Type | Posted |
|---|---|---|
| 36C26126Q0951_Items.xlsx | XLSX spreadsheet | |
| 36C26126Q0951.docx | DOCX document |
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Text version
Brand Name or Equal Worksheet (“Salient Characteristics”) v 2.0
Brand Name Item: Koelis Trinity Prostate Biopsy
1) Essential/significant physical, functional, or performance characteristics.
Salient characteristics are those characteristics that make an item equal to the brand name item we specify. Specifically, salient characteristics are those characteristic of the brand name item that the VA needs.
| Prostate Biopsy Equipment must have: |
| • MRI/US fusion prostate biopsy |
• PET/US fusion prostate biopsy
• Ultrasound guided prostate biopsy
• Rectal spacer placement
• Fiducial marker insertion
• Ablative therapy planning and guidance for prostate cancer
• Diagnostic transrectal, abdominal, and small parts ultrasound
2) Complete generic identification – Prostate Biopsy
2) Applicable model/make/catalog number –
| KURO-3000-3-FULL |
| TRINITY - FULL CONFIGURATION (TR & TP) TRINITY V4 - 3D |
Prostate Cartography and Biopsy system
| KSP.Arm |
| Steady Pro Arm |
| KSP.SUPP.TP |
| Steady Pro TP Probe Holders (x5 units) |
| K3DEL00 |
| TP Probe |
| K3DEC00-2 |
| TR Probe |
| KSOF-2602-Li-ONEAH |
| ProMap Lite Software Module - 1 Workstation |
| KSU.EL4.18-25 |
| TP Single Use FULL Grid 18G (x25 units) |
| KSOF-2602-GR |
| Promap-GR software |
| KSU.EL1.18-25 |
| TP Single Use MINI Grid (x25 units) |
| KMNT-3000-F |
| On-Site Training (2 Days) |
3) Manufacturer name – Koelis
Per VAAR 811.104 and 811.105, I certify the following regarding the above information:
· The salient characteristics listed above are essential to the Government’s requirements.
· To my knowledge, the restrictions listed above will not limit the acquisition to an item peculiar to one manufacture.
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File details come from the government source that posted it. Updated .