(28 days)
The Pusen Single Use Flexible Video Cystem is intended to be used for endoscopic access to and examination of the lower urinary tract. The Pusen Single Video Cystoscope 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 System includes a Single Use Flexible Video Cystoscope and an HD Medical Video Endoscope Image Processor. The Pusen Single Use Flexible Video Cystoscope 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 has two LEDs and CMOS imaging sensor at its distal tip. The Pusen Single Use Flexible Video Cystoscope needs to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system. The Pusen Single Use Flexible Video Cystoscope is powered by the HD Medical Video Endoscope Image Processor PV300. 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 and display the real-time video on its LCD screen, which enables visual examination of the lower urinary tract (the urethra and the bladder).
The provided FDA 510(k) summary for the Pusen Single Use Flexible Video Cystoscope System does not describe specific acceptance criteria in quantitative terms nor does it detail a study that proves the device meets such criteria in the format requested. The document outlines general categories of performance data that were used to demonstrate substantial equivalence to a predicate device.
Here's an attempt to extract and present the information based on the provided text, acknowledging where specific details are missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for the performance tests, nor does it provide specific numerical results for the device performance beyond stating that tests were "passed" or "complies with." The table below summarizes the listed performance tests and the general outcome.
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Passed |
| Intracutaneous Irritation | Passed |
| Sensitization | Passed |
| Overall compliance with ISO 10993-1 | Complies |
| Electrical Safety & EMC: | |
| Compliance with IEC 60601-1 | Complies |
| Compliance with IEC 60601-2-18 | Complies |
| Compliance with IEC 60601-1-2 (EMC) | Complies |
| Software Verification & Validation: | |
| Compliance with FDA Guidance | Relevant documentation provided |
| Bench Performance Testing: | |
| Mechanical & Optical Performance (ISO 8600) | Complies |
| Image Quality: | |
| Color Performance Testing | Performed (for substantial equivalence) |
| Optical Performance Testing | Performed (for substantial equivalence) |
| Photobiological Safety: | |
| Compliance with IEC 62471:2006 | Tested (implies compliance) |
| Luer Taper: | |
| Compliance with ISO 80369-7:2021 | Tested (implies compliance) |
| Sterilization & Shelf Life: | |
| Shelf Life (3 years) validation | Supported |
| EO sterilization validation to ISO 11135:2014 | Validated |
| Reprocessing validation (HD Medical Video Endoscope Image Processor) | Validated |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the described performance tests (e.g., how many cystoscopes were tested for mechanical performance, how many individuals for biocompatibility, etc.). It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, though the nature of these tests (bench, lab-based) inherently implies prospective testing within a controlled environment.
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)
The document does not mention the involvement of experts for establishing ground truth, as the performance data is primarily technical and bench-test based (e.g., biocompatibility passes, electrical safety compliance). No clinical studies or expert consensus for interpretation were conducted as part of this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The reported data relates to bench testing, not clinical interpretation that would require an adjudication method.
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
No such study was conducted or reported. The device is a "Single Use Flexible Video Cystoscope System," not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the device is a medical instrument (cystoscope system), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests described would be derived from:
- Compliance with international standards: For biocompatibility, electrical safety, EMC, photobiological safety, Luer taper, and sterilization validation (e.g., ISO 10993-1, IEC 60601 series, IEC 62471, ISO 80369-7, ISO 11135).
- Engineering specifications/measurements: For mechanical and optical performance (e.g., working length, channel diameter, angle of deflection, field of view, depth of field, flow rates, tensile strength, resolution, color reproduction, distortion).
- Accelerated aging and package integrity testing: For shelf life validation.
8. The sample size for the training set
Not applicable, as this is a medical device approval, not an AI/machine learning algorithm submission that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no "training set."
§ 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.