(65 days)
The SPY® Fluorescent Imaging System is intended to intra-operatively enable surgeons to visually assess blood flow and related tissue perfusion during organ transplant procedures.
The Novadag® Technologies SPY® Fluorescent Imaging System used in plastic, micro, and reconstructive surgery indication consists of 2 components:
- · the SP2001 Imaging Device
- · the SPY Paq®
The SPY Pags are available in 2 configurations dependent on the intended indication for use. Each SPY Paq contains sufficient number of ICG, custom sterile drapes called Novadrape®, and diluent for 6 imaging procedures. Each configuration of SPY Pag has a unique part number assigned to it, and different Instructions for Use exist for the two types of SPY Pags. The different Instructions for Use also have unique part numbers for ease of assembly of the Pags and quidance for the end user.
The SP2000 Imaging Device consists of an imaging head containing a charge coupled device (CCD) camera, a laser light source, motion sensor, and distance sensor attached via an articulating arm to a mobile cart. The mobile cart contains a flat panel display, a computer with keyboard and optical mouse, an electronics enclosure, and a printer.
The SPY® System provides the surgeon with the capability to view, record, and replay fluorescent images of blood flow in vessels and organs. A laser light source is used to illuminate the area of interest. In order to obtain the images, ICG is injected intravenously through the central or peripheral venous line, bypass pump, cardioplegia line, or down a coronary graft. While the ICG is passing through the vessels, the absorption of laser light causes excitation of the ICG dye, followed by the emission of infrared energy. A CCD camera of the SP2000 Imaging Device captures the infrared emission, resulting in a fluorescent image of blood flow and related tissue perfusion. These images are used to evaluate the integrity of native and grafted vasculature and blood flow in the organs.
The SP2001 Imaging Device represents a modification of the SP2000 Imaging Device in the following ways:
- The maximum recording time for image sequences captured has been extended to 60 seconds from the 34 seconds of the SP2000 Imaging Device.
- An ability to move the SP2001 camera head in horizontal plane during image sequence acquisition has been implemented.
- A variable Laser Power Attenuator has been added to the device to permit laser illumination at power levels lower or equal to the laser power level of the SP2000 Imaging Device.
- New HELIOS 10 software has been developed to support the SPY System in its organ transplant surgery indication.
Here's an analysis of the provided 510(k) summary regarding the SPY® Fluorescent Imaging System (SP2001) for use in organ transplant procedures, focusing on acceptance criteria and supporting studies.
It's important to note that a 510(k) summary is a high-level overview. Detailed acceptance criteria and study designs are typically found in the full 510(k) submission, which is not provided here. Therefore, some information may be inferred or stated as "not specified" based on the available text.
Acceptance Criteria and Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to predicate devices and expanding the Indications for Use, rather than explicitly stating quantitative performance acceptance criteria in the context of a new efficacy study. The "acceptance criteria" here are largely met by demonstrating safety, effectiveness, and equivalence to existing cleared devices, particularly for the expanded indication.
Based on the document, the de-facto acceptance criteria for this 510(k) submission revolve around:
- Safety: No adverse acute or long-term cellular, renal, or hepatic effects from device use, and exposure levels below maximum permissible limits.
- Effectiveness/Utility: Ability to acquire high-quality, reproducible fluorescent images of blood flow and tissue perfusion, enabling surgeons to visually assess these parameters.
- Equivalence: The modified SP2001 device for organ transplant procedures is as safe and effective as the predicate SP2000 device and other legally marketed devices, with enhanced functionality.
| Acceptance Criteria (Inferred from 510(k) Goal) | Reported Device Performance |
|---|---|
| Safety: | |
| a) No adverse effects (acute/long-term cellular, renal, hepatic) | "no reports of adverse acute or long-term cellular, renal or hepatic effects" (from >7000 vascular procedures with SPY System in general). |
| "no intra-operatively observed renal or hepatic effects of using the SPY System" (specific to 49 organ transplant cases). | |
| b) Laser exposure below Maximum Permissible Exposure (MPE) | Exposure at 30 cm distance is 31.2 mW/cm², which is "far below the maximum permissible exposure (MPE) of 326 mW/cm² established by ANSI" (specific to SP2001). |
| c) No increase in myocardial tissue temperature (relevant for cardiac aspects) | "It was possible to acquire images with no increase in myocardial tissue temperature" (from original pig studies for cardiac use). |
| Effectiveness/Utility: | |
| a) Ability to acquire high-quality, reproducible images of blood flow/perfusion. | "demonstrated the clinical utility of the device in producing high quality and resolution images of the entire vascular bed of the area of interest." |
| "It was possible to acquire high quality images in a simple and reproducible manner" (from original pig studies). | |
| b) Enable surgeons to visually assess blood flow and tissue perfusion. | "The SPY System enabled surgeons to assess blood flow" (specific to 49 organ transplant cases). |
| c) Identify issues (e.g., poor graft patency for CABG indication) | "able to non-invasively, quickly and safely identify 17 conduits in 311 patients that required revision during the surgical procedures" (for CABG indication). |
| Equivalence: | |
| a) Functional equivalence of SP2001 to SP2000 for expanded use | Modifications to SP2001 (increased recording time, camera head movement, variable laser power, new software) introduced for "increased functionality for using the SPY System in the organ transplant surgery" while demonstrating "no significant changes or modifications" for safety. |
| b) Meets relevant safety and performance standards. | "Testing of the SPY System was completed in conformance with the following standards... The SPY System successfully met all of the requirements for these standards." (IEC 60601-1, IEC 60601-1-2, 21 CFR 1040, ANSI Z136.3, ANSI Z136.1). |
Study Proving Device Meets Acceptance Criteria:
The current 510(k) relies on a combination of previous clearances, existing clinical experience, and minimal new data specifically for the organ transplant indication.
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Sample size used for the test set and data provenance:
- Test Set for Organ Transplant Indication: "31 cases in the United States and 18 reported in the literature from Japan" (total 49 cases) of human clinical experience. This data is retrospective from real-world use.
- Previous Indications (CABG, etc.): "over 7000 vascular procedures in humans" (global, retrospective/real-world), and "six pig studies" (prospective, animal). Data provenance for the 7000 human procedures is unspecified beyond being "in the United States of America, Japan, Europe, and Canada."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly specified for the 49 organ transplant cases. The assessment of blood flow and tissue perfusion appears to be a direct visual assessment by the attending surgeons during the procedures. The document refers to "surgeons" being able to assess blood flow, implying their intra-operative judgment serves as a form of ground truth.
- For the CABG data, the ground truth of "lack of patency" was identified by the surgeon, leading to revision.
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Adjudication method for the test set:
- Not specified. Given the nature of intra-operative visual assessment by the operating surgeon, it's unlikely a formal adjudication process involving multiple independent experts was performed for each case in the real-world usage described. The surgeon's decision to revise a graft, for instance, implies their assessment/ground truth.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The SPY System is an imaging device, and this submission is for an expanded indication for use, not for an AI/CAD product or an assessment of human reader performance improvement with AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The SPY System is a device that provides visual information to the surgeon for assessment; it is not a standalone algorithm making diagnostic or decision-making outputs. The human (surgeon) is inherently "in-the-loop."
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The type of ground truth used:
- Surgeon's Intra-operative Visual Assessment/Clinical Judgment/Outcomes Data (for revisions): For the human cases, the ground truth is derived from the surgeon's observation and their subsequent actions (e.g., revising a graft). For the organ transplant cases, the ground truth is stated as the system enabling "surgeons to visually assess blood flow." In the CABG context, instances requiring "revision" clearly indicate identifying a clinical issue, which serves as a form of outcome-based ground truth related to the system's utility.
- Physiological measurements in animal studies: For the pig studies, ground truth included the ability to acquire high-quality images, lack of detrimental effects on heart function/coronary flow, and no increase in myocardial tissue temperature.
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The sample size for the training set:
- Not applicable in the traditional sense. The 510(k) process for this device relies on prior clearances, general clinical experience (over 7000 procedures), and a smaller set of clinical experience for the new indication (49 organ transplant cases) for validation, not for training a new algorithm. The "HELIOS 10 software" mentioned as new was based on a "cleared DaqPac software" and focused on interface and reporting, not on a machine learning model that would require a dedicated training set.
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How the ground truth for the training set was established:
- Not applicable. As there isn't a "training set" in the context of a machine learning algorithm, the concept of establishing ground truth for it does not apply to this submission. The development of the device and its various software iterations would have relied on engineering verification and validation, as well as clinical feedback, but not a formally labeled "training set" for a learning algorithm.
§ 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.