75F40124Q00367_SSN.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR

ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO

THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the Center for Devices and Radiological Health (CDRH), Cardiovascular Program within the Division of Applied Mechanics (DAM), Office of Science and Engineering Laboratories (OSEL) in order to determine if there are existing small business sources capable of providing one (1) Heart Valve Pulse Duplicator Test System.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Yolanda.rankin@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background: The FDA/CDRH/Cardiovascular Program within the Division of Applied Mechanics (DAM), Cardiovascular Program within the DAM/OSEL has need for one (1) Heart Valve Pulse Duplicator Test System. This test system will be directly used in regulatory science research projects carried out by the Cardiac Device Flow Laboratory to develop and standardize non-clinical test methods that can be used to effectively evaluate the hemodynamic performance of peripheral and cardiac valve devices. Characterization of the functional/hemodynamic performance of valvular devices in a non-clinical benchtop setting is a pre-market regulatory test requirement and is critical to ensure that such devices perform safely and effectively when used in animal studies and human subject trials.

Minimum Technical Requirements for one (1) Heart Valve Pulse Duplicator Test System:

• The system components shall include an integrated fluid reservoir with directional flow valve(s), compliance chambers, resistance element, and one (1) test valve fixture with pressure transducer ports on either side of valve.

• The system includes one (1) high-speed video camera for integrated high-speed video capture of valve outflow with synchronization to the pressure and flow data.

• The system includes necessary software and hardware for integrated pressure, flow, and video data collection and analysis in accordance with the ISO 5840 heart valve standard requirements.

• The system shall be able to accommodate up to three (3) pressure transducers and one (1) flow probe for instantaneous hemodynamics monitoring.

• The system is capable of testing cardiac and peripheral valves: mitral, tricuspid, aortic, pulmonary, venous.

• The system is capable of generating physiologic, pulsatile cardiac and peripheral vascular (e.g., venous) hemodynamics at the test valve.

• The system can accommodate surgical and transcatheter valves.

• Test valve size: Up to 40 mm.

• The system integrates with a customizable (based on test valve size, e.g., 9 to 12 mm) test valve fixture that is designed and fabricated by the vendor. The computer-aided design file of the test valve fixture is transferrable to the FDA.

• The system shall be able to enable flow visualization (e.g., dye washout) across the test valve.

• Flow rate: 0 to 10 L/min.

• Flow rate resolution: ≤ 0.1 L/min.

• Heart rate range: 10 to 240 BPM.

• The system shall be compatible with the following test fluids: water, saline, blood analog fluid (40% glycerin/60% water).

• The following components do not need to be included with the system: Pulsatile Pump, Heart Function Emulator (HFE), Pressure Transducers, and Flow Probe.

• Shall include shipping, handling and customer fees.

• Shall be compatible and directly integrate with the PD-1100 Pulsatile Pump (BDC Laboratories).

Installation, Training and Warranty Requirements:

• The system and its associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and trouble shooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy and/or electronic format.

• The Contractor shall provide remote (online-based) training for five (5) end users on the system operation and system maintenance

• Offered systems shall be a turn-key solution i.e., the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need.

• The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

• The Contractor shall provide access to the Original Equipment Manufacturer (OEM)’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures

• The Contractor shall provide all labor, travel, kits and tools, etc, to install the equipment at the address provided below.

• System shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates; unlimited telephone/e-mail support for questions regarding operation, onsite visits for diagnosis of problems and repairs inclusive of all parts, labor, and travel expenses at no additional cost to the FDA.

Estimated Delivery Date: 90 days after award

Delivery Location:

Food and Drug Administration Center for Devices and Radiological Health 10903 New Hampshire Ave White Oak Building 62, Room 4215 Silver Spring, MD 20993

Service Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA Technical Representative and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Though the target audience is small business vendors or small businesses capable of supplying a U.S.

service of a small business vendor or producer all interested parties may respond. At a minimum, responses shall include the following:

• Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address.

Provide this same information again if responding to provide a service offered by another firm.

• Past Performance information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments to include date of sale, description, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include UEI number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/or selling.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered services meet the technical requirements identified above.

• The offeror shall advise if the product and/or service is on a Best-in-Class contract.

• If applicable, the offeror shall clearly identify where the offered product is made.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

• If a large business, provide if subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

• The Government is not responsible for locating or securing any information, not identified in the response.

• Informational pricing is desired.

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before July 8, 2024, by 13:00 hours (Central Time in Dallas, Texas) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Yolanda Rankin, email yolanda.rankin@fda.hhs.gov. Reference: 75F40124Q00367.

Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in 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 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 pre‐solicitation synopsis and solicitation may be published in sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response.

The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.