36C24226Q0852.docx

Special Notice Special Notice

GENERAL INFORMATION

Network Contracting Office 2 James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx NY 10468-3904

POINT OF CONTACT*

Patricia Tolini patricia.tolini@va.gov Patricia.Tolini@va.gov

ADDITIONAL INFORMATION

DESCRIPTION

This is a notice of intent to award a sole source contract and is not a request for quotes.

The Department of Veterans Affairs on behalf of NJ VA Medical Center, intend to award a Firm Fixed Price (FFP), sole source action to

The objective of this action is to provide PrO2 Health Respiratory Muscle Training Remote Data Management Devise, detailed below, for existing instrumentation needed. In accordance with FAR Part 13.106-1(b), it has been determined that only one source is reasonably available due to the requirement for compatibility and therefore limits this requirement to a brand name only procurement.

This notice of intent to sole source with justification for brand name only satisfies the public posting requirements of FAR 13.501.

Market research was conducted in accordance with FAR part 10; PrO Health, Inc. as the manufacturer and has identified themselves as the only vendor authorized to provide this specific Respiratory Muscle Training Remote Data Management Devise and has expressed interested in fulfilling this requirement.

PrO2 LED Wireless Charging The LED version of the PrO2 device with wireless charging. Pair with the mobile or PC app to measure MIP/MEP, SMIP/SMEP and perform training to improve respiratory wellness.

· iOS and Android Apps

· Bluetooth connection

· Multi-user capable

· Real-time feedback

· Cloud connected

· Online reporting

· Clinician Linkable

· Wireless charging

Veterans Health Administration prohibits the use of gray market items in their Medical Centers. Gray market items are considered to be items outside of the original equipment manufacturer’s intended distribution channels.

This notice is not a request for quotes; however, all responsible sources may submit a capability statement which shall be considered by the Government. All capability statements must be received by no later than 10:00AM Eastern Standard Time on August 10, 2026. Responses to be submitted to Patricia Tolini, Contracting Officer at patricia.tolini@va.gov. A determination by the Government not to compete this proposed contract based on responses to this notice is solely within the discretion of the Government.

STATEMENT OF WORK

Background The VA Airborne Hazards and Burn Pits Center of Excellence requires commercially available electronic inspiratory muscle strength training (IMST) devices for use in a randomized clinical trial evaluating high-intensity IMST in Veterans with exertional dyspnea. The requested system must include handheld inspiratory muscle training devices, participant mobile application access, application-based data management, remote adherence monitoring, objective performance tracking, and investigator access to participant training data throughout the intervention period. The system will be used to standardize intervention delivery, monitor protocol compliance, and collect objective training metrics for research purposes. The IMST device shall provide electronically monitored, objective verification of intervention fidelity, including breath-by-breath adherence, prescribed resistance achievement, and remote investigator oversight sufficient for use in randomized clinical trials.

Selection Criteria

· Electronic inspiratory muscle training device capable of programmable high-intensity resistance loading.

· Centralized investigator dashboard capable of monitoring multiple participants simultaneously.

· Exportable participant-level, breath-by-breath performance and adherence metrics suitable for clinical research analysis.

· Commercially supported software updates and technical support.

· Compatibility with clinical research requiring standardized intervention delivery.

· Device shall provide automated resistance progression and programmable individualized training loads based on participant inspiratory muscle performance.

· Device shall provide objective breath-by-breath measurement of inspiratory effort and training performance, rather than relying solely on participant self-report.

· Device shall automatically synchronize training data with a secure cloud platform without requiring manual data entry by participants.

· Investigator platform shall permit remote review of participant-specific training quality, including completion of prescribed breaths and achievement of prescribed resistance targets.

· Device shall support research-grade intervention fidelity through objective verification that prescribed training was performed as intended.

Deliverables or Deliver Schedule

· Specifications

· Handheld electronic inspiratory muscle training device capable of providing adjustable inspiratory resistance appropriate for high-intensity IMST.

· Compatible mobile application for participant-guiding tracking.

· Investigator dashboard for remote monitoring of participant adherence and performance.

· Objective recording of training sessions, including date/time, resistance level, number of breaths completed, and performance metrics.

· Exportable participant-level training data for research analysis.

· Commercially available product with manufacturer technical support.

· Device shall utilize electronically controlled resistance technology capable of maintaining prescribed training loads across repeated breaths while automatically adapting to participant inspiratory performance during each session.

· Device shall objectively quantify inspiratory muscle training performance using proprietary electronic sensors rather than relying solely on mechanical resistance settings.

· Device shall automatically record breath-by-breath training metrics including resistance achieved, inspiratory effort, breath completion, session duration, and training compliance.

· Device shall allow investigators to remotely modify participant training prescriptions without requiring device replacement or participant return visits.

· Options

· Optional extended manufacturer warranty (if available).

· Optional software licensing or subscription renewals beyond the initial period.

· Optional replacement handheld devices available for future procurement.

· Optional additional investigator or administrative software licenses.

· Accessories

· Rechargeable handheld inspiratory muscle training devices.

· Charging cables and/or charging dock.

· Reusable or replaceable mouthpieces.

· Carrying/storage case (if included).

· Mobile application access.

· Investigator software/dashboard access.

· User manuals and instruction materials.

· Features

· Objective electronic recording of completed training sessions verification that each prescribed breath was successfully completed.

· Automated progression of prescribed training intensity based on participant performance.

· Electronic quality-control measures that minimize participant non-compliance and protocol deviations.

· Remote monitoring of participant adherence, and remote identification of missed sessions and inadequate training effort.

· Enables standardized intervention delivery across multiple study sites.

· Supports FDA-quality audit trails by maintaining permanent electronic records of participant training history.

· Eliminates reliance on participant training logs or self-reported adherence.

· Centralized investigator dashboard for monitoring multiple participants.

Exportable adherence and performance metrics for research analysis.

· Place of Performance VANJHCS East Orange Campus, Building 1 Attn: Dr. Daniel Wilhite (11-201) 385 Tremont Ave East Orange, NJ 07018

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