(167 days)
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct.
The CHF-V choledochoscope is a flexible video endoscope used for endoscopic diagnosis and treatment within the bile duct . The CHF-V choledochoscope is basically identical to the predicate device, CHF Type P10 OES Nephroscope/Cystoscope, in intended use, spacifications, performance. The optical system of the CHF-V Is a charge coupled device (CCD) based system, allowing endoscopic image display on a video monitor.
The provided document is a 510(k) summary for the OLYMPUS CHF-V CHOLEDOCHO VIDEOSCOPE. It establishes substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and device performance metrics. Therefore, detailed information requested in the prompt's points 1-9 is largely not available in this type of submission.
Here's an analysis based on the provided text for each requested point:
1. A table of acceptance criteria and the reported device performance
- Not Applicable (N/A). This 510(k) submission does not present specific acceptance criteria or performance metrics in a table. It asserts substantial equivalence to a predicate device based on similar intended use and technological characteristics, particularly in comparison to the OES Nephroscope / Cystoscope Fiberscope CHF-P10 (K843084). The document compares specifications in Table 15-2 but does not provide quantitative performance data against predefined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (N/A). The submission does not describe a clinical performance study with a test set. This is a premarket notification asserting substantial equivalence, not a report on a clinical trial or performance evaluation study.
3. 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)
- Not Applicable (N/A). As no test set from a clinical performance study is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable (N/A). No test set or associated adjudication method is described.
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
- Not Applicable (N/A). This document concerns a video endoscope for direct visualization, not an AI-assisted diagnostic tool. No MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A). The device is a video endoscope, which is a human-operated medical instrument. There is no "algorithm only" performance that would be applicable to this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (N/A). As there is no described clinical performance study, there's no mention of a ground truth type.
8. The sample size for the training set
- Not Applicable (N/A). This submission is for a medical device (endoscope), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable (N/A). This submission does not involve a training set as it's not a machine learning device.
Summary of the Study (as per the 510(k) submission):
The "study" presented in this document is a substantial equivalence comparison to a legally marketed predicate device, the OES Nephroscope / Cystoscope Fiberscope CHF-P10 (K843084).
- Acceptance Criteria and Device Performance: The primary "acceptance criterion" for this 510(k) is demonstrating that the CHF-V Choledocho Videoscope is substantially equivalent to the predicate device in terms of intended use, specifications, performance, and materials, and that it does not incorporate any significant changes that could affect safety or effectiveness. The device's performance is implicitly accepted by its similarity to the predicate device, which has a history of safe and effective use.
- Table of (Implied) Acceptance Criteria & Reported Performance (based on comparison to predicate):
| Feature | Predicate Device (CHF-P10) "Acceptance" | Subject Device (CHF-V) "Performance" |
|---|---|---|
| Intended Use | Endoscopic diagnosis and treatment | Endoscopic diagnosis and treatment |
| Field of View | 90° | 120° |
| Direction of View | 0° | 0° |
| Optical System | Image guide fiber bundle | Color CCD |
| Angulation (Up/Down) | 160° / 130° | 160° / 130° |
| Working Length | 330mm | 380mm |
| Inst. Channel ID | φ2.0mm | φ2.0mm |
- Conclusion: The submission concludes that "When compared to the predicate device, the CHF-V does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." The primary differences highlighted are the Field of View (120° vs 90°), Working Length (380mm vs 330mm), and the Optical System (Color CCD vs. Image guide fiber bundle). These differences are presented without specific performance metrics against a clinical standard, but rather as design differences from the predicate device that are deemed not to raise new questions of safety or effectiveness.
§ 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.