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510(k) Data Aggregation
(112 days)
FUJIFILM Ultrasonic Endoscope EG-740UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor.
This product is not intended for use on children and infants.
FUJIFILM Ultrasonic Endoscope EG-740UT is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion contains glass fiber bundles, several channels and a charge-coupled device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged into the video processor, light source, and ultrasonic processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, ultrasonic processors, and peripheral devices such as monitor, printer, foot switch, and cart.
Here's an analysis of the acceptance criteria and study information for the FUJIFILM Ultrasonic Endoscope EG-740UT, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resolution | At 5mm of working distance: 0.08mm of line pair on the square wave chart is readable. | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Resolution") |
| At 100mm of working distance: 1.4mm of line pair on the square wave chart is readable. | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Resolution") | |
| Field of View | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: Field of view") |
| Bending Capability | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: Bending capability") |
| Rate of Air Supply | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Rate of air supply") |
| Rate of Water Supply | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Rate of water supply") |
| Rate of Balloon Water Supply | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Rate of balloon water supply") |
| Rate of Suction | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Rate of suction") |
| Rate of Balloon Suction | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Rate of balloon suction") |
| Diameter of Forceps Channel | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Diameter of forceps channel") |
| Viewing Direction | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Viewing direction") |
| LG Output | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... LG output") |
| Axial Resolution | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Axial resolution") |
| Lateral Resolution | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Lateral resolution") |
| Penetration Depth | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Penetration depth") |
| Biocompatibility | (Implied by ISO 10993 standards and FDA guidance) | Evaluated using ISO 10993-1, ISO 10993-5, ISO 10993-10, and FDA guidance. |
| Electrical Safety & EMC | (Implied by IEC 60601 standards) | Evaluated using ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, and IEC 60601-2-37. |
| Laser Safety & Photobiological Safety | (Implied by IEC 60825-1 and IEC 62471 standards) | Evaluated using IEC 60825-1 and IEC 62471. |
| Endoscope Specific Testing | (Implied by ISO 8600-1) | Conducted according to ISO 8600-1:2015. |
| Usability | (Implied by IEC 62366-1 and FDA guidance) | Conducted according to IEC 62366-1:2015 and FDA guidance. |
| Cleaning, Disinfection, and Sterilization | Validation in accordance with FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" | Validated according to FDA guidance. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify a "test set" in the context of clinical data for performance evaluation. The performance data presented are primarily from bench testing and compliance with established standards for various aspects like resolution, biocompatibility, electrical safety, etc. It does not appear to involve human patient data or a clinical study test set in the traditional sense.
Therefore, information on sample size for a test set and data provenance (country, retrospective/prospective) is not applicable or not provided in this document for evaluating device performance against clinical outcomes. The studies cited are for engineering, safety, and reprocessing validations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As there's no clinical "test set" with ground truth established by experts for diagnostic performance, this information is not applicable or not provided in this document. The evaluations are against technical specifications and regulatory standards.
4. Adjudication Method for the Test Set
Since there is no clinical "test set" requiring expert judgment for ground truth, an adjudication method is not applicable or not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned in the provided text. The document focuses on the technical performance and safety of the device itself, not on differences in human reader performance with or without AI assistance. Therefore, information on effect size for human readers is not applicable or not provided.
6. Standalone (Algorithm Only) Performance Study
No standalone algorithm performance study is mentioned. The device is an endoscope, a medical instrument, not an AI algorithm. Therefore, this is not applicable or not provided.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation in this document is established by:
- Technical specifications/measurements: For metrics like resolution, field of view, bending capability, flow rates, etc. These are objective measurements against predefined engineering targets.
- Compliance with consensus standards: For biocompatibility (ISO 10993), electrical safety (IEC 60601), laser safety (IEC 60825, IEC 62471), endoscope specifics (ISO 8600-1), usability (IEC 62366-1), and reprocessing (FDA guidance). These standards themselves define the acceptable "truth" for device characteristics and safety.
8. Sample Size for the Training Set
As this is a medical device (endoscope) undergoing 510(k) clearance, and not an AI/ML algorithm, there is no concept of a "training set" in the context of learning data. The device's design and manufacturing are based on established engineering principles and prior device models, not on a machine learning training process.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set," this information is not applicable or not provided.
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(128 days)
FUJIFILM Video Laparoscope EL-R740S is intended to be used with a video processor, light source, monitor, hand instruments, electrosurgical unit and other ancillary equipment for minimally invasive observation, diagnosis and treatment in general abdominal, gynecologic and thoracic areas.
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 monitor, 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 BL-7000 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.
Video Laparoscope EL-R740S is comprised of a rigid insertion portion, cable portion, and scope connector. An optical system, CCD image sensor and electrical circuits are located within the distal end portion of the laparoscope. The video signal lines from the CCD sensor and the light quide fiber bundles are connected to the scope connector through the laparoscope.
Video 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. The Processor incorporates internal digital storage capacity. VP-7000 also controls the light projected to the body cavity. VP-7000 provides for optional structural enhancement through user modes FICE, BLI-bright and LCI. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 100-240V/50-60Hz/0.8-0.5A. VP-7000 is housed in a steel polycarbonate case measuring 390x110x485mm.
The Fujinon/FUJIFILM endoscope employs fiber bundles to transmit light from Light Source BL-7000 to the body cavity. BL-7000 employs 4 LED lamps with a total power of 79.2W. Brightness control is performed by the user. The device is AC operated at a power setting of 100-240V/50-60Hz/1.2- 0.7A. BL-7000 is housed in a steel polycarbonate case measuring 390x155x485mm.
This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided FDA 510(k) summary for the FUJIFILM Video Laparoscope EL-R740S, Video Processor VP-7000, and Light Source BL-7000.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies typical for novel AI/ML devices. Therefore, much of the requested information regarding "AI performance," "human readers," "effect size," "standalone performance," "training set," and "adjudication methods" is not applicable as this submission is for a medical device (laparoscope, video processor, and light source) that relies on established technological principles rather than artificial intelligence/machine learning for its primary function. The "Performance Data" section details engineering and safety tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from regulatory standards and equivalence claims) | Reported Device Performance (Summary from provided text) |
|---|---|---|
| Electrical, Laser, and Photobiological Safety | Compliance with established safety standards (e.g., ANSI/AAMI ES60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-2-18:2009, IEC 60825-1:2007, IEC 62471:2006) | Evaluated using specified standards; deemed compliant. |
| Biocompatibility | Compliance with established biocompatibility standards (e.g., ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017) and FDA guidance. | Biocompatibility testing performed and found compliant. |
| Endoscope Specific Performance | Compliance with endoscope-specific standards (e.g., ISO 8600-1:2015). | Conducted according to ISO 8600-1:2015. |
| Cleaning and Sterilization Validation | Validation of reprocessing instructions according to FDA guidance. | Validation performed for EL-R740S cleaning and sterilization instructions in accordance with FDA guidance. |
| Software Validation | Compliance with software lifecycle process standards (e.g., ANSI/AAMI/IEC 62304:2006) and FDA guidance for premarket submissions. | Software testing conducted according to specified standard and FDA guidance. |
| Cybersecurity | Implementation of cybersecurity controls according to FDA guidance. | Cybersecurity controls developed according to FDA guidance. |
| Color Reproduction | Comparability to predicate device. | Demonstrated substantial equivalence to the predicate device. |
| Image Resolution | Comparability to predicate device. | Demonstrated substantial equivalence to the predicate device. |
| Intended Use | Same intended use as predicate device. | Shared "same mode of operation and intended use" as predicate device. |
| Technological Characteristics & Materials | Differences do not raise new issues of safety or effectiveness. | Bench testing demonstrates selected differences raise "no new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes engineering and bench testing, not clinical studies involving human patients as "test sets" in the context of an AI/ML algorithm.
- Sample Size for Test Set: Not applicable in the context of human patient data for an AI/ML device. The performance data refers to testing of the physical device components and software functionality.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not applicable for the type of testing described (bench testing, safety standards compliance). The data is generated from testing the device prototypes/production samples in laboratory settings.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or outcomes. The tests performed here are for device safety, functionality, and equivalence, which are typically assessed against engineering specifications and regulatory standards rather than clinical expert consensus on diagnostic accuracy.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert opinions for ground truth establishment. This document details engineering and compliance testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a traditional medical instrument (laparoscope, video processor, light source) and not an AI-assisted diagnostic tool that would typically undergo such a study to evaluate human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device does not feature a standalone "algorithm only" component in the sense of an AI/ML diagnostic or predictive algorithm. Its software functions involve image processing (BLI, LCI, FICE as adjunctive tools) and device control, which are integral to the system's operation but not designed to operate independently as a diagnostic algorithm. The software testing mentioned evaluates the integrity and functionality of these embedded software components.
7. The Type of Ground Truth Used
The "ground truth" for the various performance evaluations were:
- Safety Standards: Established international and national medical device safety standards (e.g., IEC 60601 series, ISO 10993 series, ISO 8600-1).
- Regulatory Guidance: FDA guidance documents for biocompatibility, reprocessing, software, and cybersecurity.
- Predicate Device Performance: The performance characteristics (color reproduction, image resolution) of the legally marketed predicate devices against which substantial equivalence was sought.
8. The Sample Size for the Training Set
Not applicable. This device and its software are not described as using machine learning models that require a "training set" of data. The software functionality (e.g., BLI, LCI, FICE modes) is based on deterministic algorithms for image enhancement, not learned patterns from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a machine learning "training set." The image enhancement features (BLI, LCI, FICE) are described as "proprietary software" using spectral and structural enhancements, implying pre-defined algorithms rather than algorithms trained on labeled ground truth data.
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