(81 days)
Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the SPY-PH System is used with SPY AGENT GREEN to perform intraoperative fluorescence angiography. The SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older.
The SPY-PHI System is indicated for fluorescence imaging of blood flow and tissue perfusion before, and after. vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.
Upon interstitial administration of SPY AGENT GREEN, the SPY-PHI System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon intradermal administration of SPY AGENT GREEN, the SPY-PHI System is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with breast cancer for which this procedure is a component of intraoperative management.
The SPY-PHI System is a real-time white-light and near-infrared illumination/ fluorescence imaging system used during open-field surgical procedures. Near-infrared illumination is used for fluorescence imaging using SPY AGENT® GREEN for the visual assessment of blood flow, tissue perfusion and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. It consists of the SPY Portable Handheld Imager/ imaging head with an integrated light guide and camera cable and the Video Processor/ Illuminator. Additionally, SPY-QP Fluorescence Assessment Software is provided as an optional upgrade to the SPY-PHI System that enables relative quantification of NIR fluorescence.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance |
|---|---|---|
| Optical Imaging - Dynamic Range | The user shall be able to visualize SPY AGENT GREEN in physiology applications. The response on the system monitor to the minimum clinically relevant concentration of SPY AGENT GREEN shall be at least 6.9 (ΔE), and the system response to the maximum clinically relevant concentration shall be at least twice that at low concentrations. | PASS (Stated in "Performance Testing - Bench": "In accordance with design input specifications including optical imaging performance specifications") |
| Optical Imaging - Localization | The user shall be able to visualize SPY AGENT GREEN in anatomy applications. The response on the system monitor shall be at least 10.35 (ΔΕ) under clinically relevant conditions. | PASS (Stated in "Performance Testing - Bench": "In accordance with design input specifications including optical imaging performance specifications") |
| Electromagnetic Compatibility (EMC) | In accordance with IEC 60601-1-2:2014, Medical electrical equipment... Electromagnetic compatibility - Requirements and tests. | PASS |
| Electrical Safety | In accordance with IEC 60601-1:2005+A1:2012 (Medical electrical equipment, Part 1) and IEC 60601-1-6:2020-07 (Medical electrical equipment - Part 1-6). | PASS |
| Laser Safety | In accordance with IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements. | PASS |
| Usability | In accordance with IEC 62366-1:2015, Medical devices -- Part 1: Application of usability engineering to medical devices. | PASS |
| Software | In accordance with IEC 62304:2006, Medical device software - Software life cycle processes. | PASS |
| Clinical Effectiveness (Primary Endpoint) | SPY AGENT GREEN and SPY-PHI should demonstrate a statistically significant and greater proportion of lymph nodes identified compared to Tc99m / gamma probe. (Implicit: showing superiority or non-inferiority to a specified degree). | 89% of confirmed LNs identified by SPY AGENT GREEN and SPY-PHI vs. 66% identified by Tc99m / gamma probe, a difference of 23% [95% CI 3.67% to 9.48%]; p |
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.