(190 days)
The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System is intended to be used for endoscopic access to and examination of the lower urinary tract. This system is also indicated for the examination and therapeutic applications during endoscopic procedures in bile ducts. The Cystoscope/Choledochoscope is intended to provide visualization via video processor and can be used with endoscopic accessories.
This system is intended for use in a hospital environment or medical office environment.
The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System includes a Single Use Flexible Video Cystoscope/Choledochoscope and an HD Medical Video Endoscope Image Processor.
This system is intended to be used for endoscopic access to and examination of the lower urinary tract. This system is also indicated for the examination and therapeutic applications during endoscopic procedures in bile ducts. This Cystoscope/Choledochoscope is intended to provide visualization via video processor and can be used with endoscopic accessories. This system is intended for use in a hospital environment or medical office environment.
- The Pusen Single Use Flexible Video Cystoscope/Choledochoscope is provided sterile and has the following 4 models: PC200-AS, PC200-AR, PC200-S, and PC200-R.
- The Pusen Single Use Flexible Video Cystoscope/Choledochoscope needs to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system, and it is powered by the latter.
- The HD Medical Video Endoscope Image Processor PV300 is a reusable device, used to process the image signal from the Pusen Single Use Flexible Video Cystoscope/Choledochoscope and display the real-time video on its LCD screen, which enables visual examination of target site.
This document is a 510(k) premarket notification for the "Pusen Single Use Flexible Video Cystoscope/Choledochoscope System." It seeks to establish substantial equivalence to a predicate device for an expanded indication (examination of bile ducts) from a previously cleared device (Pusen Single Use Flexible Video Cystoscope System K222602) which only covered the lower urinary tract.
The information provided does not contain acceptance criteria for device performance measured against the indicated use for the "Pusen Single Use Flexible Video Cystoscope/Choledochoscope System," nor does it describe a study to prove its performance in meeting such criteria. Instead, it relies on non-clinical performance data (bench testing) and substantial equivalence to a predicate device.
Here's an analysis based on the provided text, highlighting the absence of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document presents a comparison of technological characteristics between the subject device, a predicate device (Flexible Video-Choledo-Cysto-Ureteroscope System, K211686), and a reference device (Pusen Single Use Flexible Video Cystoscope System, K222602). This comparison (found on pages 5 and 6) lists specifications such as field of view, depth of field, working length, etc., but these are not presented as acceptance criteria for performance related to clinical outcomes or diagnostic accuracy.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document states, "No animal study or clinical study is included in this submission." This means there was no "test set" of patient data in the context of a clinical performance study. The "non-clinical performance data" mentioned refers to bench testing, for which sample sizes of tested units are not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable/provided. Since no clinical or animal studies were conducted, there was no need for experts to establish ground truth based on patient or animal data.
4. Adjudication Method
This information is not applicable/provided. No clinical studies with expert adjudication were performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable/provided. No such study was performed, as explicitly stated by "No animal study or clinical study is included in this submission." Therefore, no effect size of human readers improving with or without AI assistance can be reported.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable/provided. The device described is an endoscope system, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.
7. Type of Ground Truth Used
This information is not applicable/provided for clinical performance. As stated, no clinical studies were performed. The "ground truth" for the non-clinical performance data would be based on engineering specifications and measurements (e.g., measuring angles of deflection, illumination intensity, image resolution in a lab setting).
8. Sample Size for the Training Set
This information is not applicable/provided. Since no AI or machine learning component is described for clinical decision-making, there is no "training set" in that context.
9. How Ground Truth for the Training Set Was Established
This information is not applicable/provided. As above, there is no training set for an AI algorithm.
Summary of what the document does provide regarding performance:
The document relies on the following points to support the substantial equivalence:
- Non-Clinical Performance Data: "The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System and reference Pusen Single Use Flexible Video Cystoscope System (K222602) share the same fundamental technology and physical characteristics except for the Direction of view and the Maximum insertion portion width, verification reports on these two performances are provided." This indicates that specific bench tests were performed to verify these two differences. The document asserts that "The other performance data described in the cleared Pusen Single Use Flexible Video Cystoscope System, K222602, is also applicable to the Pusen Single Use Flexible Video Cystoscope/Choledochoscope System." This implies that prior bench testing for the K222602 device is considered sufficient for this new expanded indication, with only the differences verified.
- Substantial Equivalence Argument: The core of the submission is that the device is substantially equivalent to existing legally marketed devices, primarily the predicate device (K211686), which already has indications for both urinary tract and bile duct examination. The subject device is a modification of a previously cleared device (K222602), with the only change being an expanded "Indications for Use" to include bile ducts, matching the predicate. "No changes were made to the device design. Only the product name, indications for use and applicable labeling were updated."
- Conclusion: "Performance testing and compliance with voluntary standards, demonstrate that the subject device is substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use."
In essence, the device's "performance" for its intended use, particularly the newly added choledochoscope indication, is justified by its similarity in design and technology to a predicate device that already holds that indication, combined with non-clinical (bench) testing to confirm that minor physical differences do not raise new questions of safety or effectiveness. No clinical studies directly demonstrating performance for the bile duct indication were submitted or required for this 510(k) clearance based on substantial equivalence.
§ 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.