(232 days)
This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is also used as a suction catheter that establishes a conduit used for irrigation of kidney stones and stone dust during ureteral lithotripsy.
The Pusen Single Use Flexible Video Ureteroscope (Model: PU3033H, PU3033AH) and Pusen Single Use Suction Access Ureteroscope (Model: PU400A, PU411A) have been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is also used as a suction catheter that establishes a conduit used for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy. This product is for use in a hospital or qualified medical institution.
- Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope are provided sterile with the following model differences:
| Product name | Single Use
Ureteroscope | Suction Access | Single Use
Ureteroscope | Flexible Video |
|----------------|----------------------------|----------------|----------------------------|----------------|
| Model | PU400A | PU411A | PU3033H | PU3033AH |
| Suction access | Yes | Yes | Yes | Yes |
| Buttons | Yes | Yes | No | Yes | - . The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope have two LEDs and CMOS imaging sensor at its distal tip. The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope need to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system. The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope are powered by the HD Medical Video Endoscope Image Processor PV300.
- The HD Medical Video Endoscope Image Processor PV300 was cleared under 510(k) number K222602.
The provided text describes a submission to the FDA for a medical device (Single Use Suction Access Ureteroscope and Single Use Flexible Video Ureteroscope) and its comparison to a predicate device. However, it does not contain information related to software AI performance or studies specifically designed to establish AI acceptance criteria.
The document focuses on the safety and effectiveness of the physical ureteroscope devices, including aspects like:
- Biocompatibility
- Electrical safety and electromagnetic compatibility (EMC)
- Software verification and validation (for the device's operational software, not AI)
- Mechanical and optical performance
- Image quality (of the physical device's optics, not AI-enhanced image analysis)
- Photobiological safety
- Luer taper
- Sterilization and shelf life
Therefore, I cannot provide the requested information about acceptance criteria and studies related to an AI component, as it is not present in the given text.
The closest relevant section is "Software Verification and Validation Testing," which states:
"Software verification and validation testing were conducted, and relevant software documentations were provided as recommended by FDA's Guidance for Industry and FDA staff, "Guidance for the Content of Premarket Submissions for Device Software Function" (issued on June 14, 2023)."
This refers to the software controlling the device's basic functions, not an AI component for medical diagnosis or image interpretation. Without specific details on AI functionality, performance metrics, or clinical studies involving AI, the requested table and study details cannot be generated from this document.
§ 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.