(145 days)
The Flexible Video-Choledo-Cysto-Ureteroscope System is indicated for endoscopic examination in the urinary tract and can be used percutaneously to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. The Flexible Video-Choledo-Cysto-Ureteroscope System is also indicated for the examination of bile ducts surgically, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
Imaging Processor System (Including Light Source) is composed of lighting system, image processing board. The lighting system provides the light source for the endoscope probe at the back end. The image processing board receives electronic signals from the front-end camera module and processes them, and finally transmits them to the display through the video interface. Flexible Video-Choledo-Cysto-Ureteroscope is a kind of medical electronic optical instrument, also known as optical camera, which can enter into the human bladder, ureter, biliary and pancreatic duct for observation and diagnosis. The operator delivers the optical camera system to the site of diagnosis and treatment by means of a mechanical part with a flexible insertion tube and a system of bends. The product is equipped with tiny size digital imaging parts -- photoelectric sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light signals into electrical signals. The electrical signal will be transferred to Imaging Processor System (Including Light Source) and display images on it's monitor output for doctor observation and diagnosis.
This document is a 510(k) premarket notification for a new medical device, the Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100). This type of submission relies on demonstrating "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already legally marketed. Therefore, the "study" referred to is primarily a non-clinical performance evaluation comparing the proposed device to a predicate device, rather than a clinical trial or AI-specific validation study typically associated with AI/ML devices.
Here's an analysis of the provided information concerning acceptance criteria and the "study":
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comparative table between the proposed device (PL-2100) and its primary predicate device (Flexible Video-Choledo-Cysto-Ureteroscope System, K211686, Model: PL-1000). The "acceptance criteria" are implied by the predicate device's characteristics, and the "reported device performance" are the proposed device's characteristics. The goal is to show they are "Same" or "Similar" in ways that don't raise new questions of safety or effectiveness.
| Item | Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) | Comment |
|---|---|---|---|
| Imaging Processor System | Model: PL-1000 | Model: PL-2100 | |
| Indication for Use | Signals from the endoscope are converted to the image and displayed on an inspection monitor. | Signals from the endoscope are converted to the image and displayed on an inspection monitor. | Same |
| Target patients | Patients who are considered suitable for the application of this product by the physician | Patients who are considered suitable for the application of this product by the physician | Same |
| User qualifications | Physicians (experts approved by endoscopic medical safety administrator at each medical facility, or as defined by government/academic society). Specific training is not required. | Physicians (experts approved by endoscopic medical safety administrator at each medical facility, or as defined by government/academic society). Specific training is not required. | Same |
| Place of use | Medical facility | Medical facility | Same |
| Power input | 100-240V~50/60Hz45VA | 100-240V~50/60Hz48VA | Similar |
| Imaging output | HDMI | CVBS&DVI&S-VIDEO | Different |
| Light Source | LED 2W | LED 2W | Same |
| Lamp Life | 30,000 hrs | 30,000 hrs | Same |
| Screen | N/A (implied external display) | 10.1 inches | Different |
| USB Flash Memory | USB 2.0 (Max:128G; FAT32) | USB 2.0 (Max:128G; FAT32) | Same |
| illumination | ≥2000LUX | ≥2000LUX | Same |
| Resolution | d = 10mm, MTF50 value of SFR at center not lower than 200lw/pH, MTF50 value at 70% FOV not lower than 80% of center position. | d = 10mm, MTF50 value of SFR at center not lower than 200lw/pH, MTF50 value at 70% FOV not lower than 80% of center position. | Same |
| Field of View | 110°±10% | 110°±10% | Same |
| Observe the depth of field | 5-50mm, MTF50 ≥ 200 (LW/PH) | 5-50mm, MTF50 ≥ 200 (LW/PH) | Same |
| Direction of View | 0°±2° | 0°±2° | Same |
| TV distortion |
§ 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.