Requirements Documents 09-09.docx

Generic SOW Template

Requirements Document

Background The Division of Biomedical Physics, 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. A modern, high-quality PAI system is essential to ensuring our regulatory science efforts in this space, which will include human subjects research, is relevant to the current generation of PAI devices in today’s market and going through regulatory evaluation. A research-grade, multi-channel data acquisition (DAQ) platform specifically designed for PAI applications is required to build a high-quality PAI system. This equipment will enable completion of research objectives described in OSEL’s Optical Diagnostics and Therapeutics program charter.

Objectives/Scope The objective of this procurement is to acquire a key component needed to assemble a modern Photoacoustic Imaging (PAI) System to support CDRH’s regulatory science research under the Optical Diagnostics and Therapeutics Program. The required PAI System is critical for developing evidence-based regulatory guidance and evaluation standards for PAI devices currently under FDA review and entering the medical device market. The upgraded capability will enable human subjects research that directly informs regulatory decision-making, ensuring FDA's evaluation methods remain current with rapidly advancing PAI technology A multi-channel data acquisition (DAQ) platform with integrated handheld transducer is essential for obtaining high-quality resolution photoacoustic data. The current PAI System utilizes an ultrasound DAQ that, while state-of-the-art in 2013, was designed for traditional ultrasound applications rather than photoacoustic imaging. The current DAQ’s limited frequency response characteristics produce significant image artifacts, including “boundary-buildup” effect, that compromise image quality. These imaging artifacts significantly degrade vessel detectability, reduce oximetry measurement accuracy, and complicate data processing by requiring manual identification and removal of compromised scan data, resulting in reduced research efficiency. An upgraded DAQ with improved frequency responses will dramatically enhance system image quality, reduce experimental processing time, and ensure CDRH’s regulatory science program can efficiently develop tools and data to support evaluation of emerging photoacoustic imaging technology.

Tasks The Contractor shall deliver a PAI-specific Data Acquisition System with the following technical specifications:

· Is capable of operating with interleaved operating modes to enable combined ultrasound imaging and photoacoustic imaging during a single acquisition procedure

· For photoacoustic imaging mode, operating with input impedance greater than or equal to 2 megaohms

· 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.

· Minimum of one (1) year warranty from date of installation and acceptance. The Contractor shall guarantee system replacement at no additional cost to the Government for any manufacturing defects or operational failures during normal use as defined in the user manual. Warranty coverage shall include all associated shipping costs for replacement units.

Delivery Requirements: The Contractor shall deliver the items and quantities ordered as soon as possible, but within 150 days of award.

All deliverables required under this Purchase Order shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the Purchase Order number and the Contractor’s name. The Contractor shall guarantee that all required materials shall be delivered at the Original Equipment Manufacturer (OEM) standards. The Contractor shall provide tracking information and delivery confirmation.

Delivery Address:

Attention: William Vogt US Food and Drug Administration 10903 New Hampshire Avenue

WO62 RM 1104

Silver Spring, Maryland 20993

Telephone: 240-402-4142 Email:william.vogt@fda.hhs.gov Place of Performance N/A

Period of Performance Period of performance shall be 180 days from contract award through completion of delivery and acceptance by the Government. The Contractor shall deliver the item within 150 days of award. There is a 30-day timeframe to inspect and accept delivery. The Contractor shall provide one (1) year manufacturer warranty.