(287 days)
Choledochoscope System is intended to be used by physicians through percutaneous insertion to access, visualize, and perform procedures in the pancreaticobiliary system including the hepatic ducts and the common bile duct.
The image processor provides illumination for the choledochoscope, and is also used to receive the signal from the endoscope, convert it into an image and display it on the examination monitor.
The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
The Choledochoscope System consists of a single-use choledochoscope to provide illumination and intuitive images in endoscopic surgery of the pancreatic ductal system and serves as a guide to diagnosis and management with accessories and an image processor for clinical image processing.
The single-use choledochoscope is a sterile single-use flexible choledochoscope and has the following 4 models: CH-M50, CH-M52, CH-M40, CH-M32. The four models are the same except for the difference in the characteristics of the insertion tube, including diameter of the insertion tube, maximum insertion portion width and minimum insertion channel width.
The image processor is a reusable monitor.
The single-use choledochoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image processor processes the images from the choledochoscope and outputs video signals to a display.
The provided text describes the regulatory clearance of a medical device, the "Choledochoscope System," and highlights the tests performed to demonstrate its substantial equivalence to a predicate device. However, it does not include the detailed information needed to answer many of the questions regarding acceptance criteria and the study proving the device meets those criteria, particularly for performance metrics related to AI or image analysis beyond general optical performance.
Specifically, the document states: "No clinical study is included in this submission" which is critical. This means the device's performance was primarily demonstrated through bench testing and compliance with standards, not through clinical trials or comparative effectiveness studies with human readers.
Therefore, for many of the requested points, the answer will be that the information is "Not available in the provided text" or "Not applicable as no clinical or AI-based performance study was conducted."
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document mentions several performance tests and compliance with standards, but does not provide a table with specific acceptance criteria (e.g., minimum resolution, specific SNR values) and reported performance values for each. It generally states "Comply with" or "evaluated in accordance with."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: In accordance with ISO 10993-1, ISO 10993-7, ISO 10993-10, ISO 10993-11. | Complied with listed ISO standards. No cytotoxicity, not an irritant, not a sensitizer, no acute systemic toxicity, no temperature rise. |
| Sterilization: Validation in accordance with ISO 11135:2014. | Validated in accordance with ISO 11135:2014. |
| EO/ECH Residuals: According to ISO 10993-7:2008. | Performed according to ISO 10993-7:2008. |
| Shelf Life: Determined based on optical testing and product performance testing after accelerated aging test according to ASTM F1980-16. | Determined to be 3 years. |
| Package Validation: According to ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1886/F1886M-16, ASTM F88/F88M-15, ASTM F 1929-15. | Conducted according to listed ASTM and ISO standards. |
| Electrical Safety: Compliance with IEC 60601-1 and IEC60601-2-18. | Complied with IEC 60601-1 and IEC60601-2-18. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2. | Complied with IEC 60601-1-2. |
| Software Verification and Validation (V&V): According to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | Software V&V conducted, documentation provided, considered "moderate" level of concern. |
| Optical Performance: According to ISO 8600 series. | Performed according to ISO 8600 series. |
| Color performance, geometric distortion, optical performance (resolution, depth of field and image intensity uniformity), SNR, dynamic range, image frame frequency, system delay: Compared with the predicate device. | Testing performed; stated as comparative to predicate device, implying acceptable performance relative to it. No specific numerical results are provided. |
| Mechanical Testing: Working Channel Flow Rate, bending, Insertion Portion Leak testing. | Testing performed. No specific numerical results are provided, but implies acceptable performance. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not applicable for human-data based test sets, as "No clinical study is included in this submission." For bench tests (e.g., optical, mechanical), the sample sizes are not specified in the document.
- Data Provenance: Not applicable for clinical data. For manufacturing and testing, the company is based in Shenzhen, Guangdong, China. The testing appears to be primarily bench-top and engineering performance testing rather than human clinical data.
- Retrospective/Prospective: Not applicable, as no clinical studies were conducted using human data.
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)
- Number of experts: Not applicable. No clinical expert-driven ground truth was established, as no clinical study was conducted.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. No clinical test set requiring expert adjudication was used.
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
- MRMC study: No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission."
- Effect size: Not applicable, as no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This device is an endoscope system (hardware and image processor), not an AI algorithm analyzing medical images. Its performance is related to its ability to capture and display images, not interpret them. The document refers to "Software Verification and Validation Testing" but treats the software as a "moderate" level of concern, indicating it's mainly for control and image processing, not diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: For the engineering and performance tests (optical, mechanical, electrical, biocompatibility), the "ground truth" would be established physical measurements, engineering standards, chemical analyses, and standardized test methodologies. There is no biological/clinical "ground truth" in the form of expert consensus or pathology within this submission.
8. The sample size for the training set
- Sample size (Training Set): Not applicable. This submission is for a medical device (endoscope system), not an AI/ML model for which a training set would be described in this context. The software mentioned is for device operation and image display, not for learning from data.
9. How the ground truth for the training set was established
- Ground truth (Training Set): Not applicable, as this device does not involve a machine learning training set with biological or clinical ground truth.
In summary, the provided document focuses on demonstrating the substantial equivalence of the Choledochoscope System to a predicate device through adherence to established regulatory standards for medical device safety and performance (biocompatibility, sterilization, electrical safety, mechanical, and optical bench tests), rather than clinical efficacy or AI-driven performance.
§ 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.