36C26118Q9530-001.pdf

Brand Name or Equal Worksheet (“Salient Characteristics”) v 2.0

Brand Name Item: Boston Scientific- SpyGlass DS System

1) Essential/significant physical, functional, or performance characteristics.

SpyGlass DS System:

• Must be able to determine if patient has cancer of the bowel ducts, pancreatic cancer, or gallstones

• Must be able to help drain cysts, remove bowel duct stones, pancreatic duct stones, and diagnose strictures

• Must fit on a standard endoscopy cart

• Must have an integrated digital sensor

• Single use scope with tapered catheter tip

• Same unit for camera and light source

• Set-up time under 5 minutes

• Must have a fixed imager for consistent steering

• Generator:

o Automatic power range regulation to prevent overload to the probe o Automatic probe monitoring and alerts for when to replace the probe o Touch screen controls to make it easy to use and understand

• Probe:

o 1.9 Fr., 375 cm

• Digital Controller:

o Automatic light control and LED illumination o Dedicated irrigation and aspiration channels o Automatic white balance and focus

• Forceps:

o 1 mm outer diameter o 4.1 mm biopsy cup opening o Central spike to help secure samples

2) Complete generic identification – Bipolar Electrohydraulic Lithotripsy System

3) Applicable model/make/catalog number – M005466800 Autolith Touch EHL Generator M00546650 SpyGlass™ DS - Digital Controller M00546600 SpyScope Digital Access and DeliveryCath M00546620 Autolithtouch EHL Probe SpyGlass DS M00546270 Spybite Biopsy Forceps

4) Manufacturer name – Boston Scientific

Per VAAR 811.104 and 811.105, I certify the following regarding the above information:

Attachment 1

Brand Name or Equal Worksheet (“Salient Characteristics”) v 2.0

• 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.

Name, Date: Jason Lee

Madison Pallante

6/13/18