(117 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 through a percutaneous route and/or intraoperatively.
The CHF-Y0003 choledochoscope is a flexible video endoscope used for endoscopic diagnosis and treatment within the bile duct through a percutaneous route and/or intraoperatively, utilized with the EVIS EXERA II 180 System. The CHF-Y0003 choledochoscope is basically identical to the predicate device, CHF Type V, in specifications, performance, and optical system.
The differences of the subject CHF-Y0003 from the predicate device CHF-V are as follows:
- The material of the bending rubber in the bending section is different.
- Indication for use has been changed to include a percutaneous route and/or intraoperatively use to specify the applied part.
Acceptance Criteria and Study for CHF-Y0003 CHOLEDOCHO VIDEOSCOPE
Based on the provided 510(k) summary, the CHF-Y0003 CHOLEDOCHO VIDEOSCOPE is deemed substantially equivalent to its predicate device, the CHF-V. This submission focuses on demonstrating substantial equivalence rather than fulfilling specific performance acceptance criteria for a novel device. The primary "study" presented is a comparison between the new device and the predicate device, supported by clinical literature and biocompatibility testing for a material change.
Key takeaway: This 510(k) relies on the substantial equivalence pathway, meaning it aims to show the new device is as safe and effective as a legally marketed predicate, rather than meeting novel performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission demonstrating substantial equivalence to a predicate device, specific quantitative "acceptance criteria" in the traditional sense (e.g., minimum sensitivity/specificity for an AI algorithm) are not explicitly stated or met. Instead, the "acceptance criteria" are implied to be "identical in specifications except for material, and comparable in intended use, method of operation, and design, such that safety and effectiveness are maintained."
The "reported device performance" is essentially the evidence presented to support this substantial equivalence.
| Aspect of Comparison | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Evidence Presented) |
|---|---|---|
| Intended Use | Comparable to predicate device. | Changed to include "percutaneous route and/or intraoperatively use" – supported by clinical literature. Remainder identical. |
| Specifications | Identical to predicate device. | "Basically identical" in specifications, performance, and optical system. |
| Optical System | Identical to predicate device. | "Basically identical". |
| Performance | Identical to predicate device. | "Basically identical". |
| Material | Safety and effectiveness maintained despite changes. | Material of bending rubber in bending section is different. Supported by biocompatibility testing. |
| Method of Operation | No significant changes that affect safety/effectiveness. | No significant changes mentioned. |
| Design | No significant changes that affect safety/effectiveness. | No significant changes mentioned. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary. There is no discreet "test set" of patient data used to evaluate the device's diagnostic or therapeutic performance in a quantified manner. The evaluation is based on a comparison to the predicate device and specific tests for the changed component.
- Data Provenance:
- Clinical Literature: Used to support the new indications for use (percutaneous route and/or intraoperatively). The summary does not specify the country of origin or whether these were retrospective or prospective studies, only that "clinical literatures provided in this submission supports the safety and efficacy of the choledochoscope used in a percutaneous route and/or intraoperatively."
- Biocompatibility Testing: Performed on the new material for the bending rubber. This is typically pre-clinical (in vitro or in vivo animal) testing, not human patient data. The summary does not specify the provenance of this testing data beyond "Test data...provided in this submission supports the safety and efficacy of the new material."
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This device is a medical instrument (videoscope), not an AI-powered diagnostic system requiring expert consensus for ground truth on a specific image or patient outcome. The evaluation is based on engineering specifications, material safety, and comparison to an existing device.
4. Adjudication Method for the Test Set
- Not applicable. As there is no "test set" of patient cases requiring interpretation or diagnosis, no adjudication method was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is a medical device, not an AI or imaging diagnostic software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable to this submission.
6. Standalone (Algorithm Only) Performance Study
- No. This is a medical device (a videoscope), not an algorithm or software. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
- Engineering Specifications: The primary "ground truth" for showing substantial equivalence relies on comparing the new device's physical and functional specifications to those of the predicate device (CHF-V).
- Material Biocompatibility Standards: The "ground truth" for the new bending rubber material is its compliance with recognized biocompatibility standards and test results proving it is safe for patient contact.
- Clinical Evidence (Literature Review): For the expanded indications for use, the "ground truth" is established through existing clinical literature supporting the safe and effective use of choledochoscopes in percutaneous and intraoperative settings.
8. Sample Size for the Training Set
- Not applicable. This is a medical instrument, not an AI or machine learning model. Therefore, no training set was used.
9. How Ground Truth for the Training Set Was Established
- Not applicable. As no training set was used for an algorithm, no ground truth was established for one.
§ 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.