FDA-FY22-SS-1255500.pdf

FDA- FY22-SS-1255500

High Intensity Focused Ultrasound Array

The U.S. Food and Drug Administration (FDA) hereby issue this notice of intent to award a sole source firm fixed price purchase order to Sonic Concepts, 181916 North Creek Parkway, Suite 115, Bothell, WA 98011 for a High Intensity Focused Ultrasound Array.

This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1(b)(1) to use simplified procedures for commercial acquisitions. The North American Industry Classification System Code is 334516 - Analytical Laboratory Instrument Manufacturing.

Only one award will be made as a result of this notice. This will be a firm fixed price type purchase order. Period of performance shall be one (1) year from date of award.

THIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS; no solicitation document is available and telephone request will not be accepted. The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under authority of FAR 13.106-1(b) (1). Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all proposals received within 7 days after date of publication of this notice will be considered by the government. The capability statement must be received via email by on or before 10:00 AM, ET on August 2, 2022. All questions must be submitted in writing and can be emailed to Linda Troutman, Contract Specialist at Linda.Troutman@fda.hhs.gov, in the subject line of the email please reference (FDA-FY22-SS- 1255500). A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose, of determining whether to conduct a competitive procurement.

mailto:Linda.Troutman@fda.hhs.gov

Statement of Work

The FDA is seeking to purchase two state-of-the-art transducers and accompanying components to extend the capabilities of their high intensity ultrasound system that can be applied to generate high pressure fields that is required for histotripsy procedure. The required technical specifications for the transducers are listed below:

For the Overall System

• All required components, including connectors, housings, electronics, and cables, shall be compatible with FDA’s existing Verasonics Vantage 256 HIFU Driving System.

• All required components shall be designed, built, and ready for installation within the delivery timeframe.

One 2D Array Transducer

• Shall have center frequency of 0.7 ± 0.05 MHz

• Shall have a focused geometry, with minimum aperture size of 60.0 mm outer diameter x

35.0 mm radius of curvature

• Shall have at least 128 individual equal-area elements over surface area

• Individual array elements Shall be rated for a minimum sustained continuous power of 8

W of acoustic power per channel with all elements operational

• All components Shall be water-proof and submergible for a minimum period of 24 continuous hours

• Shall have a Matching Network to connect the power output to the transducer (with at least 128 elements) that is tuned to 0.7 MHz

• Shall be capable of producing a sustained continuous wave acoustical output power of at least 100 W without damaging the array’s surface, electrical bonds, piezoelectric radiators, backing materials, or any other aspects of the entire system

One Cavitation Detection Hydrophone for the 2D Array Transducer

• Shall have a focused hydrophone (10 kHz to 15 MHz bandwidth)

• The hydrophone Shall be calibrated over the operating frequency range and the calibration chart Shall be provided with the associated error (with less than 10% pressure measurement uncertainty)

• Shall have a mean sensitivity ≤ 50 mV/MPa. The frequency response and sensitivity analysis Shall be provided over the entire range of operating frequencies.

• The electrical impedance (magnitude and phase) analysis as a function of frequency shall be included

One Single Element Transducer

• Shall have center frequency of 1.5 MHz

• Shall generate up to 80 MPa focal pressure

• Shall have a minimum central opening of 20 mm (to attach a cavitation detection hydrophone) and a minimum radius of curvature of 45 mm

• Shall have 3rd harmonic impedance matching network so that the transducer can be operated at both fundamental and third harmonic frequencies

• Shall have MRI compatible coupling cone with acoustic transparent membrane assembly and water ports to fill the cone with degassed water (as a transition medium between the transducer surface and the target location)

• All components shall be water-proof and submergible for a minimum period of 24 continuous hours.

Power Output for the Single Element Transducer

• Shall have a minimum of 2 output channels (so that the power output can be adjusted between channels).

• Shall be able to generate up to 2,000 W.

• Shall have frequency of 1.5 -5 MHz (to cover the transducer operation at both fundamental and third harmonic frequencies).

• Shall have transmitter agility: frequency, phase, pulse mode, burst mode, continuous mode, complex mode, amplitude

• Shall include a Breakout Board to connect the output channels (must stand up to 2000 W)

• The transducer and the power output system shall be calibrated together, and the calibration charts shall be provided (with an efficiency of at least 70% at center frequency)

One Cavitation Detection Hydrophone for the Single Element Transducer

• Shall have a high intensity hydrophone (2.0 MHz to 4.0 MHz bandwidth) that can be integrated in the central opening of transducer for real time cavitation detection

• The hydrophone Shall be calibrated over the operating frequency range and the calibration chart Shall be provided with the associated error (with less than 10% pressure measurement uncertainty)

• Shall have a mean sensitivity ≤ 300 mV/MPa. The frequency response and sensitivity analysis shall be provided over the entire range of operating frequencies.

• The electrical impedance (magnitude and phase) analysis as a function of frequency Shall be included