6515--ENDOSCOPES ENDOFLIP 300 SYSTEM

Form / Attachment / Pricing Sheet

This document outlines the "Salient Characteristics" for the EndoFlip 300 system, detailing the essential technical and functional requirements for a medical device intended for assessing esophageal and sphincter distensibility and compliance.

• Clinical Function: Measures and displays intraluminal dimensions and pressure for assessing esophagus, pylorus, and anal sphincter distensibility and compliance in adult and pediatric patients (≥5 years).
• Measurement Capabilities: Provides real-time impedance planimetry-based estimates of luminal diameter and cross-sectional area. Allows controlled inflation/deflation of balloon catheters.
• Display Requirements: Continuously displays estimated balloon diameter, pressure, volume, and calculated distensibility/compliance values. Includes "topography-style" visualization of luminal geometry.
• Data Capture: Supports patient/study identifier entry and storage. Allows saving of still images/data snapshots. Supports continuous recording of procedure data (≥6 hours).
• System Configuration: Includes a pump/drive unit for automated syringe movement, an integrated/dedicated display unit, and compatibility with a mobile cart.
• Physical/Environmental: Manageable size/weight for procedure room carts. Operates within 20–40 °C ambient temperature and 15–95% non-condensing humidity. Suitable for transport/storage between −30–60 °C.
• Electrical/Safety/EMC: Operates on 100–240 VAC, 50/60 Hz. Meets medical electrical safety and EMC requirements (IEC/EN 60601‑1‑2 Class A). Includes audible/visual alarms.
• Performance: Reliable operation with prompt response to user commands. Designed to prevent unsafe autonomous operation during electromagnetic interference.
• Workflow/Compatibility: Compatible with single-use balloon catheters for impedance planimetry. Intended for use in endoscopy/GI suites.
• Infection Control: Supports routine cleaning/disinfection. Patient-contact components (catheters, syringes) must be single-use.

This attachment defines the critical technical specifications and performance requirements for the EndoFlip 300 system. Bidders must ensure their proposed solutions meet or exceed these salient characteristics to be considered compliant with the solicitation's technical requirements.

Request for Information (RFI)

This RFI is issued by the Department of Veterans Affairs (VA), Network Contracting Office 22, for planning and information purposes only. It seeks to identify potential qualified sources capable of providing an Endoscope System, specifically the Endoflip 300 System, for the VA San Diego Healthcare System. This RFI does not constitute a solicitation, and responses will not be considered offers.

• The primary requirement is for an Endoscope System that meets the salient characteristics detailed in "Attachment A – Salient Characteristics – Endoscope." Interested sources must demonstrate their capability to provide supplies/services fulfilling these specifications.

• Interested and capable sources are requested to provide specific information, including:

  • Company name, address, and point of contact.
  • Business size status and representations (e.g., SDVOSB, VOSB, Hubzone, WOSB, Large Business) relative to NAICS code 339112 (size standard 1,000 employees).
  • Whether the company is a manufacturer or distributor, and country of origin.
  • For distributors, details on any alterations, assembly, or modifications made to the items.
  • Information on existing federal contracts (FSS, NASA SEWP, etc.) and availability of referenced items.
  • General pricing for market research purposes.
  • Capabilities regarding salient characteristics and "equal to" items, with compelling evidence for equivalency.
  • Unique Entity ID (UEI) number.

• Responses must be submitted via email to Samuel.Han@va.gov.

• Response Date/Time: May 14, 2026, 1:00 PM Pacific Time, Los Angeles, USA.

• This RFI is for market research to inform future acquisition decisions. A solicitation may be published later.

• Responses are not a request to be added to a prospective bidders list or to receive a solicitation copy.

• Responders are responsible for all associated costs.