Amendment_0002_RPP_W91CRB_QA.pdf

Amendment #0002 | RPP W91CRB-26-AWSP

Amendment #0002 to RPP W91CRB-26-AWSP

Official Questions and Answers (Q&A) Clarification Document

Document Type: Solicitation Amendment Q&A

Solicitation Number: RPP W91CRB-26-AWSP

Amendment Number: 0002

Date of Issue: September 30, 2026

Table of Contents

1. Gas Supply Characterization (CODS-3)

2. Gas-Supply Pressure Display (CODS-4)

3. Transport Case & 510(k) Timing

4. Weight vs. Portability Objective (§ 3.1 / APA-4)

5. O2-Concentrator Clearance Timing

6. Environment of Use — Fit to Field Deployment

1. Gas Supply Characterization (CODS-3)

Question: To characterize our device's system response with the proposed CODS-3 supply (≤ 50 psi / ≤

30 LPM), we need either the pressure-flow characteristic of that supply or the name / model of the proposed gas source (e.g., the specific O2 concentrator). Are you able to supply that?

Government Response:

Per Section 3.1 Operational Objectives: “Operate seamlessly with external Army Oxygen Generation

Systems (operating pressure no more than 50 psi, and no more than 30 liters per minute), if the proposed solution does not include its own oxygen source/concentrator.” This is known as the Portable

Oxygen Generation System and can included historical or future versions. Also found in APA #7.

2. Gas-Supply Pressure Display (CODS-4)

Question: Is it acceptable that the gas-supply pressure is measured and displayed electronically (on the screen) rather than by a mechanical gauge?

Government Response:

This question was previously answered with the following response: “Yes, this is acceptable. Measuring and displaying gas-supply pressure electronically (e.g., via digital pressure transducers and display screens) meets the intent of CODS-4.”

However, in accordance with CODS-4 and CODS-6:

1. The electronic pressure monitoring capability must be supported by the system's battery backup power (minimum 1 hour per CODS-10); and

2. If electronic gas delivery or flow control is utilized, the system must retain a physical mechanical backup to ensure the clinician can verify gas flow and deliver manual ventilation during a complete loss of electrical power.

Respondents should describe their pressure display architecture and power-loss contingency mechanisms in Volume II (Technical Approach).

3. Transport Case & 510(k) Timing

Question: Do you expect the reusable transport case to be delivered within the same 45-60 days after award, or may it be delivered later during the program? And if we add a software feature to improve use with an O2 concentrator, by when do you expect an FDA 510(k) clearance for that specific feature?

Government Response:

This question was previously answered with the following response: “The Government would like prototype delivery 45-60 days after award; however, if minimal modifications, such as a transport case, needs to be created, then 120-180 days after award is the latest the Government would like to accept the prototypes.”

Per Section 2.5 Prototype Scope Overview: “This is a commercial-derivative technology prototype effort.

Proposed solutions shall be Food and Drug Administration (FDA) cleared for human use as well as Trade

Agreements Act (TAA) Compliant.”

4. Weight vs. Portability Objective (§ 3.1 / APA-4)

Question: A non-OR only minimally modified Atlan will weigh roughly 135 kg plus packaging. Will this be acceptable, even though it conflicts with the Operational Objective in section 3.1 and with APA-4

“Portable Design” in section 5.2?

Government Response:

Please refer to section 8.0 Evaluation Approach to determine how the Government will be evaluating proposals.

5. O2-Concentrator Clearance Timing

Question: Use with an O2 concentrator is currently only technically demonstrated and not yet FDA-cleared in the US. When is clearance expected — already at prototype delivery, or within the 12-month period of performance?

Government Response:

Per Section 2.5 Prototype Scope Overview: “This is a commercial-derivative technology prototype effort.

Proposed solutions shall be Food and Drug Administration (FDA) cleared for human use as well as Trade

Agreements Act (TAA) Compliant.”

6. Environment of Use — Fit to Field Deployment

Question: The Atlan IFU currently clears use only in “rooms … in health-care facilities with a class A electromagnetic environment” and lists as “Do not use” environments — among others “Outside buildings”, “During patient transport”, “In vehicles, airplanes, helicopters, and on ships” and “areas where oxygen concentrations above 25 Vol% … can occur”. Does the intended military field-hospital use stay within this cleared envelope, or which of these excluded environments must be added to the environment of use?

Government Response:

Please refer to section 2.4 Mission Need/Problem Statement and section 2.5 Prototype Scope Overview to determine the intent of the Government requiring a Commercial-Off-The-Shelf or Non-

Developmental Item anesthesia workstation system.