A02 RFI for Surgical Microscope RFI-Sources-Sought - KO review.docx

RFI / Sources Sought No. HT9425-24-RFI-PDM1

Date of release: 20 JUN 2024

Request for Information (RFI) / Sources Sought for

SURGICAL MICROSCOPE

THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS

(RFQ); IT IS STRICTLY A REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT. NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI.

Disclaimer: The purpose of this RFI/Sources Sought notice is to gain market knowledge. This notice does not obligate the Government to award a contract/order or otherwise reimburse respondents for the information provided in their response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's solution and qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a synopsis and/or solicitation may or may NOT be published at a future date and time. Respondents are solely responsible for all expenses associated with responding to this RFI/Sources Sought. No evaluation letters and/or results will be issued to the respondents. Currently, no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS WILL BE ACCEPTED OR RETURNED.

In accordance with Federal Acquisition Regulation (FAR) 15.201 "Exchanges with Industry Before Receipt of Proposals" and FAR 52.215-3, "Request for Information or Solicitation for Planning Purposes" this Request for Information (RFI)/Sources Sought is for information and planning purposes only at this time and shall not be construed as a solicitation or as an obligation on the part of the Government to make a future award.

This RFI/Sources Sought is being issued by United States Army Medical Research Acquisition Activity (USAMRAA) on behalf of US Army Medical Materiel Development Activity (USAMMDA) Frederick, MD 21702 (located on Fort Detrick) and is seeking sources to provide Surgical Microscope for test article purposes. The government’s intent is to carry out environmental and operational testing. The purpose of this testing is to evaluate each device’s ability to function successfully in austere environment.

INSTRUCTION TO RESPONDENTS:

The Government appreciates responses from ALL capable and qualified sources and small businesses are encouraged to respond.

Sources interested in responding to this notice are required to submit:

1) Capability statement that includes specifications and related information, in sufficient detail that clearly demonstrates the capability to meet the minimum essential characteristics (MECs) detailed below. Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point. Vendor request for documentation and/or additional information and/or submissions that only ask questions will not be considered as an affirmative response.

2) Attachment 1 - Company Information

3) Attachment 2 - Essential Characteristics that includes column titled “Items Meets Minimum Characteristics (yes/no)” filled in

RESPONSES DUE:

DAY, 5:00pm eastern 1 July 2024 to Mr. Peter D. Mitchell via email at peter.d.mitchell8.civ@health.mil

ESSENTIAL CHARACTERISTICS

These are essential characteristics, and the device must meet the “Minimum Required” in order for the device to be considered acceptable. Desired characteristics and Additional Performance Parameters are not mandatory.

1.

If the system is a Class I medical device, it shall be registered with the FDA for human use.

Minium Required

The automatic magnification of the device shall include a 10X eyepiece capable of range from 2.2x to 14; and a 15.5x eyepiece capable of range from 2.5 to 20

The automatic magnification of the device should include a 10X eyepiece capable of range from 1x to 17; and a 15.5x eyepiece capable of range from 2.5 to 25

The surgical microscope shall support the following lighting and illumination features:

- High brightness illumination via xenon or LED light sources

- Blue and Ultraviolet blocking capabilities - Adjustable illumination intensity - Adjustable brightness - Adjustable angle of illumination In addition, the surgical microscope the vendor can include an emergency backup illumination of the same level as the primary illumination being used.

The microscope shall have an assistant view scope.

The assistant view can be through a digital display instead of binocular or monocular tubes.

The microscope shall be securely packaged with light weight foam inserts for transport in a non-expanded Army Tactical Expandable Shelter that meets MILSTD-810H and doesn’t exceed 1500 lbs, which Subject matter experts (SMEs) has determine an appropriate weight.

The microscope should be securely packaged for transport in a non-expanded Army Tactical Expandable Shelter that meets MIL-STD-810H that doesn’t exceed 1200 lbs.

Minium Required

Manuals/ Materials applicable to the system Minium Required

Minium Required

Additional Performance Parameters (APPs): These characteristics are not essential and reflect desired capabilities above and beyond the minimum threshold.

The microscope shall be compatible with an Image-guided surgery system.

The system shall have the option to allow surgery through augmented/virtual reality, or “4D”, and shall come provisioned with the necessary equipment.

The microscope components, including foot-pedal and any visual support equipment such as headgear, shall have the capacity to be wired to the microscope for power and data transmission purposes. No essential function of the microscope shall require WiFi, Bluetooth, or other connectivity.

(end of RFI/Sources Sought)