(181 days)
Fujinon/Fujifilm Ultrasonic Endoscopes, EG-530UR2 and EG-530UT2, are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment. The product is intended to be used with a Fujinon/Fujifilm ultrasonic processor. This product is not intended for use on children and infants.
Fuiinon/Fujifilm Ultrasonic Endoscopes EG-530UR2 and EG-530UT2 are modified versions of our previously-cleared EG-530UR and EG-530UT via K063847. The modified models are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment when used with a Fujinon/Fujifilm's ultrasonic processor, which remains the same as K063847. The modified models are used in combination with a Fujinon/Fujifilm's ultrasonic processor. video endoscope processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices. When used with a Fujinon/Fujifilm's ultrasonic processor, EG-530UR2 and EG-530UT2 model emits ultrasound wave and scans the reflected signals to provide ultrasonic images.
Here's an analysis of the provided 510(k) summary, specifically focusing on acceptance criteria and supporting studies, as per your request:
Acceptance Criteria and Device Performance
The provided 510(k) summary does not contain a specific table or detailed discussion of acceptance criteria for the performance of the Fujinon/Fujifilm Ultrasonic Endoscope (EG-530UR2 and EG-530UT2) in terms of image quality metrics (e.g., resolution, contrast, penetration depth) or diagnostic accuracy. Instead, the focus of this submission is on demonstrating substantial equivalence to previously cleared devices.
The "acceptance criteria" can be implicitly understood as compliance with relevant safety and performance standards, and the ability to reproduce the performance of the predicate devices. The device "performance" is implicitly deemed acceptable if it meets these standards and is substantially equivalent.
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with IEC 60601-1 (General safety) | Evaluated in accordance with IEC 60601-1 |
| Compliance with IEC 60601-1-1 (Safety requirements for medical electrical systems) | Evaluated in accordance with IEC 60601-1-1 | |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | Evaluated in accordance with IEC 60601-1-2 | |
| Compliance with IEC 60601-2-18 (Safety of endoscopic equipment) | Evaluated in accordance with IEC 60601-2-18 | |
| Compliance with IEC 60601-2-37 (Safety and essential performance of ultrasonic medical diagnostic and monitoring equipment) | Evaluated in accordance with IEC 60601-2-37 | |
| Compliance with ISO 10993 (Biological evaluation of medical devices) | Evaluated in accordance with ISO 10993 | |
| Reprocessing instructions validated | Reprocessing instructions updated and validated by a third-party lab | |
| Performance (Substantial Equivalence) | Ability to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. | Deemed "substantially equivalent" to predicate devices (K063847 and K111243) and conforms to applicable medical device safety and performance standards. |
| Functional equivalence to predicate devices (EG-530UR and EG-530UT; SU-7000, SU-8000). | Modified versions of previously-cleared devices, used with the same ultrasonic processor. Detailed modifications provided in the submission (but not in this summary). |
Study Details:
It's crucial to understand that this is a 510(k) submission focused on demonstrating substantial equivalence for modified versions of existing devices. Therefore, the types of studies typically associated with novel AI devices (like detailed performance studies, MRMC studies, training set details) are not present here. The document explicitly states: "No clinical test was conducted."
Here's a breakdown based on your requested information:
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A table of acceptance criteria and the reported device performance: See table above. The performance evaluation primarily relied on compliance with standards and a detailed comparison matrix (not provided in this summary) to demonstrate equivalence.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable. No clinical tests or performance validation studies using patient data (test sets) are mentioned.
- Data Provenance: Not applicable, as there's no patient data involved in the studies described.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts/Qualifications: Not applicable. No ground truth establishment for a test set is discussed, as no clinical performance study was conducted.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. No test set requiring ground truth adjudication was used.
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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:
- MRMC Study: No. This device is an ultrasonic endoscope, not an AI-powered diagnostic tool, and the submission explicitly states "No clinical test was conducted." Therefore, no MRMC study or AI-related comparative effectiveness analysis was performed or reported.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No. This device is an imaging instrument, not an algorithm. Its operation inherently involves a human operator (the endoscopist) interpreting the images.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable. No clinical performance study requiring ground truth was conducted. For the reprocessing validation, the ground truth would be chemical/microbiological testing results confirming effectiveness. For the safety standards, the "ground truth" is adherence to the specified requirements of each standard.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is hardware (an endoscope) and not an AI/machine learning algorithm that requires a training set.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. No training set was used.
Summary of the Study:
The primary "studies" conducted for this 510(k) submission were engineering verification and validation studies to ensure compliance with international safety and performance standards (IEC, ISO) and reprocessing validation by a third party. The core argument for clearance is substantial equivalence to existing, legally marketed predicate devices, meaning the new device is as safe and effective as the older ones, with documented modifications. There is no evidence of clinical studies involving patient data or evaluation of diagnostic accuracy.
§ 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.