(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.
§ 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.