redacted JEFO.pdf

Last Modified: May 18, 2016 Page 1 of 6

Justification for an Exception to Fair Opportunity

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

U.S Food and Drug Administration, Office of Acquisitions and Grant Services

b. Sponsoring organization.

CDRH/OSEL

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. COR/POC: redacted

ii. Mailing address:

US Food and Drug Administration

10903 New Hampshire Avenue

WO62 RM 1104

Silver Spring, Maryland 20993

iii. E-mail address: redacted

iv. Telephone number: redacted

2. Nature and/or description of the action being approved.

A research-grade, multi-channel data acquisition (DAQ) platform specifically designed for PAI applications is required to build a high-quality PAI system

a. Acquisition purpose and objectives.

The procurement is to support regulatory science tools development for the Photoacoustic Imaging (PAI) sub-program within the Optical Diagnostics and Therapeutics Program.

b. Project background.

A multi-channel data acquisition (DAQ) platform with handheld transducer is a must-have for a high-quality PAI system. The ultrasound DAQ we used in our current PAI system was the best option in 2013, Last Modified: May 18, 2016 Page 2 of 6 but was designed for traditional ultrasound rather than photoacoustic imaging. The DAQ’s limitations in frequency response produce significant image artifacts such as the well-known “boundary-buildup” effect. These issues significantly degrade vessel detectability, reduce oximetry measurement accuracy, and complicate data processing as bad scan data must be identified and discarded, costing staff time. A new DAQ with better frequency responses will dramatically increase system image quality, save experimental time, and ensure our regulatory science program has maximal impact on devices using this emerging technology.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

This equipment will enable completion of research objectives described in OSEL’s Medical Imaging and Diagnostics program charter.

a. Project title.

OSEL’s Medical Imaging and Diagnostics program charter

b. Project Description.

The Division of Biomedical Physics, Office of Science and Engineering Laboratories (OSEL) at CDRH performs regulatory science research on novel optical imaging systems to accelerate patient access to innovative, safe, and effective medical devices. The procurement is to support regulatory science tools development for the Photoacoustic Imaging (PAI) sub-program within the Optical Diagnostics and Therapeutics Program.

Refer to statement of work for more information.

Requirement type. Check the appropriate box:

☒ Research & Development (R&D) ☐ R&D support services ☐ Support services (non-R&D) ☐ Supplies/equipment ☐ Information Technology (IT) ☐ Construction ☐ Architect-Engineer (A&E) services ☐ Design-build ☐ Other: [Specify]

Type of action.

☒ New requirement ☐ Follow-on ☐ Other: [Specify]

Proposed contract/order type.

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☒ Firm-fixed-price ☐ Other fixed-price:

☐ Cost-plus-fixed-fee ☐ Other cost reimbursement:

☐ Time and materials ☐ Indefinite delivery:

☐ Other:

☐ Completion Form ☐ Term Form

Acquisition identification number.

CDRH-OSEL-25-C-1326

c. Total estimated dollar value and performance/delivery period.

redacted

4. Identification of the exception to fair opportunity (see 16.505(b)(2)) and the supporting rationale, including a demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the exception cited. If the contracting officer uses the logical follow-on exception, the rationale shall describe why the relationship between the initial order and the follow-on is logical (e.g., in terms of scope, period of performance, or value).

Check the applicable block below based on the acquisition circumstance and provide supporting rationale immediately below the exception checked.

☐ (A) The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

☒ (B) Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

IAW 16.505(a)(4)(ii) suggests placing brand-name justifications under this exception.

☐ (C) The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

☐ (D) It is necessary to place an order to satisfy a minimum guarantee.

☐ (E) For orders exceeding the simplified acquisition threshold, a statute expressly authorizes or requires that the purchase be made from a specified source.

5. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer will conduct price analysis to determine the reasonableness of the proposed price. The Contracting Officer will request a published price list or two (2) previous invoices for similar or same supplies to determine the fair and reasonableness of the proposed price. The Contracting Officer will also request a most favorable customer statement from the vendor. The https://www.acquisition.gov/far/html/Subpart%2016_5.html https://www.acquisition.gov/far/html/Subpart%2016_5.html

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Contracting Officer will not obtain the certificate of current cost or pricing as the acquisition is under the required $2 million threshold and is commercial.

6. Any other facts supporting the justification.

redacted conducted Market Research in June 2025 – July 2025. A Request for Information (RFI) was posted on General Services Administration ebuy.gsa. The RFI number is RFQ1767873 and was open 7/11/2025 – 7/14/2025. No sources responded to the RFI. redacted has personal knowledge and expertise in photoacoustic imaging applications, and he used his personal knowledge and expertise to identify three (3) sources for photoacoustic imaging applications.

The three (3) identified sources are PhotoSound Technologies Inc, Verasonics, Inc., and Scintica Inc. There are few data acquisition (DAQ) platforms on the market that are suitable for use in building photoacoustic imaging systems due to differences in acoustic frequency content of photoacoustic signals as compared to signals transmitted and detected by ultrasound imaging systems.

OSEL requires a multi-channel DAQ platform with handheld transducer that meets the following requirements:

• Is capable of operating with interleaved operating modes to enable combined ultrasound imaging and photoacoustic imaging during a single acquisition procedure o For photoacoustic imaging mode, operating with input impedance greater than or equal to 2 megaohms o For ultrasound imaging mode, operating with input impedance less than or equal to 50 ohms

• Provides access to raw radiofrequency data for custom post-processing

• Minimum 128 transmit/receive data channels capable of both ultrasound and photoacoustic data acquisition

• Minimum 40 decibel gain in photoacoustic imaging mode over frequency range of 0.05 – 25 megahertz

• Adjustable gain range of 50-80 decibels for photoacoustic imaging mode

• Operating sampling rate of at least 40 megasamples per second

• Connector system compatible with various piezoelectric transducer arrays

• Data acquisition capability over acoustic frequencies from 1-15 megahertz.

• Displayed image frame rates of at least 20 frames per second

• Electronic connectors enabling triggering, synchronization, and general digital control communication with Original Equipment Manufacturer (OEM) or third-party hardware and control software

• Minimum one (1) USB3 port for high-speed data transfer

• Linear-array, 128-element transducer probe for receiving ultrasonic/photoacoustic signals.

• Includes documentation describing equipment operation, programming, and maintenance protocols.

The only product that meets all of OSEL’s requirements is the MoleculUS DAQ from PhotoSound Technologies Inc. This DAQ was developed specifically for photoacoustic imaging applications and its characteristics have been optimized to ensure high-fidelity photoacoustic signal data acquisition. The DAQ from PhotoSound Technologies Inc has the ability to rapidly switch

Last Modified: May 18, 2016 Page 5 of 6 between low impedance for photoacoustic imaging mode and high impedance for ultrasound imaging mode, which is necessary to enable real-time, interleaved photoacoustic and ultrasound imaging while avoiding undesirable photoacoustic signal processing artifacts due to limited bandwidth sensing of lower frequency content when using high impedance as is normally done in ultrasound data acquisition. This specification is required by OSEL in order to develop evidence-based regulatory science and evaluation methods for PAI devices currently under FDA review and entering the medical device market.

Another candidate’s product is the Vantage 128 from Verasonics, Inc. However, this research-grade DAQ does not meet OSEL’s requirement to have different input impedances for photoacoustic imaging and ultrasound imaging modes, and since it only operates using higher impedance, the resulting limited range of frequency response for sensing photoacoustic signals produces undesirable boundary-buildup image reconstruction artifacts and low signal to noise ratio due to insufficient bandwidth for low-frequency signals (from approximately 0.05 - 1 MHz).

Another widely used DAQ in the field of photoacoustic imaging is the Prodigy system from Scintica Inc. The Prodigy systemis a ultrasound platform and can be used for photoacoustic imaging. However, this product also does not meet OSEL’s requirement to perform imaging at high and low impedances optimized for photoacoustic vs. ultrasound imaging modes.

Market research determined that there are no known sources with the ability to provide a multi-channel DAQ platform with handheld transducer that meets OSEL’s aforementioned minimum requirements. The only known source with the capability to perform interleaved operating modes with low or high impedance optimized for photoacoustic and ultrasound imaging modes is the DAQ from PhotoSound Technologies Inc.

7. Statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition for the supplies or services is made.

NA

8. Program office certification.

Evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for an exception to fair opportunity) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

Signature redacted Requiring Activity POC

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9. Contracting Officer Certification.

The CO shall complete the information required below and sign the certification in the block provided.

(NOTE: The CO’s signed certification may serve as approval of a JEFO over $150,000 but not exceeding $700,000, FAR 16.505(b)(2)(ii)(C)(1) depending on OPDIV procedures.)

This is to certify that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

Signature:____________________________________

Contracting Officer

September 9, 2025 https://www.acquisition.gov/?q=/browse/far/16