Requirements Document 08.21.2026.pdf

U.S. Food and Drug Administration Office of Acquisitions and Grants Services Requirements Document: 3D Particle Tracking Velocimetry System (CDRH-2026-134082)

U.S. Food and Drug Administration Requirements Document

3D Particle Tracking Velocimetry (PTV) System

1. Purpose

This document states the requirements for the acquisition of one (1) complete 3D Particle Tracking Velocimetry (PTV) system. The acquisition is for commercial supplies delivered to an FDA location.

2. Background

The Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH) within the U.S. Food and Drug Administration (FDA) requires a 3D Particle Tracking Velocimetry (PTV) system to support the "Non-clinical Performance Testing for FFR Software Devices: In-Vitro Hemodynamic Reference Measurements" research project, which will generate a standardized experimental dataset, to be published as a Regulatory Science Tool (RST), providing a benchmark for validating fractional flow reserve (FFR) software devices.

This directly supports the FDA’s public health mission by improving the consistency and quality of evidence in regulatory submissions for cardiovascular devices.

3. Scope

This acquisition is for the supply of the items identified in Section 4, in the quantity stated in Section 5, delivered and accepted per Sections 6 through 8.

This acquisition does not include on-site installation, integration, training, or maintenance. These activities will be performed by Government personnel and are outside the scope of this contract.

4. Salient Characteristics and Minimum Specifications

All items shall be new and unused. Items shall not be used, refurbished, reconditioned, remanufactured, previously opened, expired, or beyond the manufacturer's shelf-life dating at the time of delivery.

Salient characteristics and any single-source need The supplies shall meet the following salient characteristics and minimum specifications: The system shall meet the requirements of one of the two technical approaches below:

Technical Approach 1: Integrated System (Preferred) This approach requires all offered components to be fully compatible and interoperable with the Government-Furnished Equipment (GFE) listed below: LaVision Imager sCMOS (high-speed camera), LaVision PTU X (timing unit), Evergreen pulsed Nd:YAG laser, Litron continuous Nd:YLF laser, and LaVision DaVis software.

This GFE is identified solely to define the compatibility requirements for Technical Approach 1. The equipment will be integrated by Government personnel and will not be

Requirements Document: 3D Particle Tracking Velocimetry System (CDRH-2026-134082) provided to the contractor for use during contract performance. No other Government-furnished property, material, equipment, or information will be provided.

Hardware:

• A complete, manufacturer-standard 3D Particle Tracking Velocimetry system available for direct purchase without custom development, including all hardware and software components necessary for 3D flow-field measurement and analysis.

All hardware shall be brand new (never sold, installed, operated, or refurbished) and manufactured in 2025 or later, with manufacturer documentation verifying manufacturing date and new condition.

• High-Speed Camera: one (1) scientific-grade high-speed camera with performance equal to or exceeding the existing GFE camera (resolution ≥ 5 megapixels; frame rate ≥ 50 Hz; quantum efficiency ≥ 70%). Brand new, unused, manufactured in 2025 or later.

• Lenses and Optics: camera lenses suitable for a measurement volume of approximately 10 mm × 10 mm; Scheimpflug adapters (if required); laser light sheet forming optics (cylindrical and/or Powell lenses); beam steering mirrors; and all mounting hardware necessary for optical alignment and system integration.

• Calibration Target: one (1) high-precision, multi-level (two- or three-plane) calibration plate sized for the measurement volume (approximately 10 mm × 10 mm), with manufacturer certification of marker positions with documented accuracy suitable for 3D reconstruction of the coordinate space.

Software:

Integrated Control: a unified environment to control all new hardware and the existing GFE camera and timing unit, including synchronized triggering, acquisition timing, and hardware parameter configuration.

3D PTV Software/Processing Functionality, including:

• Multi-plane calibration with automated marker detection and sub-pixel position accuracy.

• Volumetric 3D particle reconstruction from multi-camera views.

• High-density particle tracking algorithms capable of resolving individual particle trajectories at particle densities of at least 0.05 particles per pixel.

• Temporal tracking with predictive algorithms to maintain trajectory continuity across sequential frames.

• Post-processing computation of instantaneous 3D velocity vectors, acceleration fields, vorticity, and turbulence statistics.

• Visualization tools for particle positions, trajectories, and derived flow quantities.

• Data export to standard non-proprietary formats (e.g., ASCII, HDF5, or equivalent).

• License Integration: new software modules shall integrate with and operate within the Government’s existing software license framework without requiring a complete system replacement.

Technical Approach 2: Standalone System (Alternative) This approach is available to vendors that cannot guarantee full compatibility with the GFE identified for Technical Approach 1.

Hardware:

Requirements Document: 3D Particle Tracking Velocimetry System (CDRH-2026-134082)

• High-Speed Cameras: two (2) matched scientific-grade high-speed cameras with synchronized triggering capability (resolution ≥ 5 MP; frame rate ≥ 50 Hz; quantum efficiency ≥ 70%). Cameras must be factory-matched for sensor alignment and optical characteristics.

• Timing Unit: one (1) master timing unit capable of synchronizing camera acquisition with illumination source triggering at the required camera frame rates specified above.

• Illumination Source: one (1) pulsed laser source suitable for PTV applications with pulse duration, repetition rate, and energy output appropriate for the measurement volume (approximately 10 mm × 10 mm) and required temporal framerate resolution specified above.

• Lenses and Optics: camera lenses suitable for a measurement volume of approximately 10 mm × 10 mm; Scheimpflug adapters (if required); laser light sheet forming optics (cylindrical and/or Powell lenses); beam steering mirrors; and all mounting hardware necessary for optical alignment and system integration.

• Calibration Target: one (1) high-precision, multi-level (two- or three-plane) calibration plate sized for the measurement volume (approximately 10 mm × 10 mm), with manufacturer certification of marker positions with documented accuracy suitable for 3D reconstruction of the coordinate space.

• Equipment Condition: all hardware must be brand new (never sold, installed, operated, or refurbished) and manufactured in 2025 or later, with manufacturer documentation verifying manufacturing date and new condition.

Software:

A complete, integrated solution including:

• Hardware Control: unified control interface for all system hardware including cameras, timing unit, and illumination source, with synchronized triggering, acquisition timing, and hardware parameter configuration.

• Multi-plane calibration with automated marker detection and sub-pixel position accuracy.

• Volumetric 3D particle reconstruction from multi-camera views.

• High-density particle tracking algorithms capable of resolving individual particle trajectories at particle densities of at least 0.05 particles per pixel.

• Temporal tracking with predictive algorithms to maintain trajectory continuity across sequential frames.

• Post-processing computation of instantaneous 3D velocity vectors, acceleration fields, vorticity, and turbulence statistics.

• Visualization tools for particle positions, trajectories, and derived flow quantities.

• Data export to standard non-proprietary formats (e.g., ASCII, HDF5, or equivalent).

Not Applicable. This requirement is not brand-name restricted. Technical Approach 2 (Standalone System) is expressly offered as an alternative for vendors that cannot guarantee full compatibility with the Government-Furnished Equipment referenced in Technical Approach 1, preserving competition among sources.

5. Quantity and Deliverables

Requirements Document: 3D Particle Tracking Velocimetry System (CDRH-2026-134082)

The contractor shall furnish the following supplies in the quantities shown:

Item description Unit of issue

Quantity Delivery location Delivery frequency

Complete 3D Particle Tracking Velocimetry (PTV) system, including all hardware, software, licenses, accessories, interfaces, cabling, calibration components, and documentation required by the offered technical approach

Each 1 FDA White Oak Campus, Attn: Ian Carr, 10903 New Hampshire Ave, Silver Spring, MD 20993

One-time

Quantity basis: One-time purchase; total quantity is one (1) complete 3D PTV system.

6. Delivery Schedule and Delivery Terms

FOB point: Destination.

Delivery location(s): FDA White Oak Campus, Attn: Ian Carr, 10903 New Hampshire Ave, Silver Spring, MD 20993.

Delivery schedule: one shipment, delivered within 90 days of contract award.

Delivery dates are firm. The contractor shall not extend a delivery date without prior written approval of the Contracting Officer.

7. Packaging, Marking, and Shipping

Supplies shall be packaged in accordance with standard commercial practice, sufficient to ensure arrival at destination undamaged and in usable condition. Each shipment shall be marked with the contract or order number, item description, quantity, and destination.

8. Inspection and Acceptance

Inspection and acceptance shall be at destination. Consistent with RFO 46.202-1, the Government will rely on the contractor's existing quality assurance system for commercial products. Final acceptance is based on receipt of the correct items, in the correct quantity, conforming to the specifications in Section 4, in undamaged and usable condition.

Acceptance additionally requires manufacturer documentation verifying that all hardware is new (never sold, installed, operated, or refurbished) and manufactured in 2025 or later, consistent with the hardware requirements.

9. Information Technology and Accessibility

Requirements Document: 3D Particle Tracking Velocimetry System (CDRH-2026-134082)

State whether the item includes embedded or companion software, connects to an FDA network, or stores or transmits data: Yes, the system includes control and data-processing software (see Section 4). Per source SOW: no unique security requirements are associated with this contract; the contractor will not require access to government facilities, systems, or data. No special passes, security clearances, or escort requirements apply.

10. Period of Performance

The period of performance begins upon award. For a one-time acquisition, it continues through final delivery and acceptance of all items. For a recurring-delivery acquisition, it continues through the base period stated in the resulting contract, plus any option periods exercised.

Not Applicable. This is a one-time acquisition, not a recurring-delivery acquisition. Per source SOW, the period of performance is from the date of contract award through 90 days after contract award, concluding upon successful delivery of all items. No option periods apply.

11. Points of Contact See contract for points of contact.