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510(k) Data Aggregation
(191 days)
Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
Processor VP-7000:
The VP-7000 unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope).
This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and light source together with montor, recorder and various peripheral devices. BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy. BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis.
The Image Processing Unit EX-0 is an optional module intended for use as an adjunctive monitor of the hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in patients at risk for ischemic states.
This product may be used on all patients requiring endoscopic examination when using a Fujinon/FUJIFILM medical endoscope, video processor and light source together with monitor, recorder and various peripheral devices.
The prospective clinical value of measurements made with OXEI has not been demonstrated in disease states.
Light Source BL-7000X:
The BL-700X Light Source is used for endoscopic observation, diagnosis, treatment, and image recording, It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination.
This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and video processor together with monitor, recorder and various peripheral devices.
Processor VP-7000 relays the image from the endoscope to a video monitor. Projection can be either analog or digital at the user's preference. VP-7000 also incorporates internal digital storage capacity. VP-7000 controls the light projected to the body cavity. VP-7000 provides for optional structural enhancement through user modes FICE (Flexible spectral-Imaging Color Enhancement), BLI (Blue Light Imaging), BLI-brt (Blue Light Imaging-Bright) and LCI (Linked Color Imaging) at the user's option. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 120V/60Hz, 0.8A. VP-7000 is housed in a steel-polycarbonate case measuring 390x485x110mm. Optional Image Processing Unit EX-0 receives image data from the VP-7000, and displays an OXEI image on a LCD monitor. The OXEI image is a color-coded digital image showing tissue oxygen saturation (StO2). EX-0 incorporates an internal digital storage capacity. The device is AC-operated at a power setting of 120V/60Hz, 1.0A. EX-0 is housed in a steel-polycarbonate case measuring 320x165x340 mm.
The Fujifilm endoscopes employ fiber bundles to transmit light from Light Source BL-7000X and subsequently to the body cavity. BL-7000X employs five LED lamps. Brightness control is performed by the user. The device is AC operated at a power setting of 120V / 60Hz 1.2A. BL-7000X is housed in a steel polycarbonate case measuring 395x485x155mm.
Processor VP-7000, Light Source BL-7000X, and Image Processing Unit EX-0 are used as a system in conjunction with a compatible video laparoscope or endoscope for visualization of tissue oxygen saturation (StO2) levels.
The provided document describes the Fujifilm Processor VP-7000, Light Source BL-7000X, and Image Processing Unit EX-0. The Image Processing Unit EX-0 is an optional module intended for use as an adjunctive monitor of hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in patients at risk for ischemic states.
Based on the provided information, the acceptance criteria and the study proving the device meets them can be summarized as follows:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Software | Compliance with IEC 62304:2015 and FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)". | Evaluated according to IEC 62304:2015 and the FDA quidance mentioned. |
| Cybersecurity | Compliance with FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2, 2014)". | Developed according to the FDA guidance mentioned. |
| Electrical Safety/EMC | Compliance with ANSI/AAMI ES 60601-1: 2005/(R)2012 and A1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-2-18:2009, and IEC 60825-1:2007. | Electrical safety, electromagnetic compatibility, and laser safety were evaluated using these standards. (Implicitly met as no issues stated). |
| Photobiological Safety | Compliance with IEC 62471:2006, ensuring no realistic optical hazard and meeting exposure limits. | Evaluated according to IEC 62471:2006. The subject device met all exposure limits and was found to not pose a realistic optical hazard. |
| StO2 Measurement Performance (Bench) | Subject device performs comparably to the reference device (T-Stat K081233) with a dissolved oxygen meter as a gold standard, using 7 different blood-based phantoms. | Results demonstrated that the subject device performs comparably to the reference device, T-Stat (K081233), with respect to monitoring StO2 levels when compared against a dissolved oxygen meter as a gold standard using 7 blood-based phantoms. |
| StO2 Measurement Performance (Animal - Laparoscopic Visualization) | Adequate images showing visualization of the device and StO2 overlay. Acknowledge variability in StO2 measurements (up to ~29.8% between subject and reference devices) while demonstrating adequate visualization. | Study 1 showed variability between subject and reference devices of approximately 29.8%, potentially due to StO2 variability within observed tissues. However, adequate images were provided to show visualization of the device, as well as the StO2 overlay, which were considered acceptable. |
| StO2 Measurement Performance (Animal - Endoscopic Monitoring) | Subject device can monitor/measure StO2 levels in a clinically relevant setting (e.g., in a large animal model under controlled conditions of decreasing arterial oxygen saturation). Correlation of results with the reference device should be demonstrated. | Study 2 demonstrated that the subject device could monitor/measure StO2 levels in a clinically relevant setting (endoscopically in 4 minipigs with SpO2 decreased from 100% to 60%). A correlation of results with the reference device was compared for performance evaluation (results implicitly acceptable as the conclusion states the device monitors StO2 comparably). |
| StO2 Measurement Performance (Animal - Open Surgery Comparability) | Subject device measures/monitors StO2 comparably to the reference device under controlled conditions (e.g., in an open surgery setting with minimized tissue movement), with acceptable differences in StO2 readings. Maximum difference in StO2 readings should be within an acceptable range (e.g., up to ~11.4%). | Study 3 demonstrated that the subject device measures/monitors the StO2 comparably to the reference device, with differences in StO2 readings up to 11.4%. This finding was similar to the bench testing results, establishing that EX-0 may be used as an adjunctive monitor of hemoglobin oxygenation. |
2. Sample size used for the test set and the data provenance:
- Bench Testing: 7 different blood-based phantoms. Data provenance is not explicitly stated but implies laboratory (benchtop) testing.
- Animal Testing:
- Study 1 (Laparoscopic): Number of animals not specified, but involved "a visualization study."
- Study 2 (Endoscopic): 4 female Göttingen minipigs.
- Study 3 (Open Surgery): 3 swine.
- Data Provenance (Animal Studies): Live animal studies, likely conducted in a controlled laboratory environment. No specific country of origin is mentioned for the animal studies, but the entire submission is to the U.S. FDA. The details provided (e.g., "female Göttingen minipigs at 11 months of age") suggest prospective data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Bench Testing: A "dissolved oxygen meter" was used as the "gold standard" for StO2 measurements. This is an objective measurement tool, not human experts.
- Animal Testing: The document does not specify the use of human experts to establish ground truth for the StO2 measurements. The reference device (T-Stat 303 Microvascular Tissue Oximeter) served as a comparator, and the study focused on the comparability of the subject device's measurements to the reference device and, implicitly, to the physiological changes induced (e.g., decreased arterial oxygen saturation).
4. Adjudication method for the test set:
Not applicable. The ground truth for StO2 measurement was established by an objective "gold standard" (dissolved oxygen meter in bench testing) or by comparison to a legally marketed predicate/reference device and physiological changes in animal models. No human adjudication is mentioned for the StO2 measurements.
5. 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 device (Image Processing Unit EX-0) acts as an "adjunctive monitor" of StO2. The studies described focus on the device's ability to measure StO2 accurately and comparably to a reference device, not on improving human reader performance in interpreting images with AI assistance versus without it. This device itself is an "adjunctive tool," not specifically an AI assisting human interpretation of images for diagnosis, but rather providing a quantifiable physiological parameter (StO2).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the performance testing of the StO2 measurement function appears to be a standalone evaluation of the device's capability to measure and display StO2 levels. The bench testing directly compared the device's output to a gold standard, and the animal studies evaluated the device's measurements against a reference device's measurements and induced physiological states. The language suggests the device outputs StO2 values or color-coded images autonomously, without direct human intervention in the measurement process itself, though a human interprets the displayed information.
7. The type of ground truth used:
- Bench Testing: Dissolved oxygen meter (objective measurement, considered a "gold standard").
- Animal Testing:
- Comparison to a legally marketed reference device (T-Stat 303 Microvascular Tissue Oximeter).
- Induced physiological states (e.g., decreasing arterial oxygen saturation (SpO2) to simulate ischemic states). These physiological changes and the measurements from the reference device serve as the de-facto ground truth for evaluating the subject device's performance in a living system.
8. The sample size for the training set:
Not applicable. The document describes performance testing for a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device. This typically involves verification and validation testing, not the development and training of an AI algorithm from a training set. The Image Processing Unit EX-0 processes existing endoscopic image data to display StO2; it is not presented as a machine learning or AI-driven diagnostic tool that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
Not applicable, as no training set is described for this device in the provided document.
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