(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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.