(170 days)
The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.
The Single-use Flexible Cystoscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and treatment of adult bladder.
This document describes the validation of a Single-Use Flexible Cystoscope (K221580), comparing it to a predicate device, the Ambu Ascope 4 Cysto (K193095).
Based on the provided text, there is no detailed study described that proves the device meets specific acceptance criteria based on clinical outcomes or performance metrics suitable for a table of reported device performance. The document primarily focuses on non-clinical testing to demonstrate substantial equivalence to the predicate device.
Here's an analysis of the provided information relative to your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document lists numerous performance tests conducted. For each of these, acceptance criteria would have been established internally by the manufacturer, and the device's performance would have been compared against these. However, these specific acceptance criteria and the quantified reported device performance (e.g., 'Bending angle: device achieved X degrees vs. acceptance criteria Y degrees') are NOT provided in this FDA 510(k) summary. The document only states that "All evaluation acceptance criteria were met" for biocompatibility and that the system "complies" with electrical safety and EMC standards, and that various performance tests were "conducted."
Therefore, a table cannot be fully constructed with the information given. The types of performance tests conducted are:
| Performance Characteristic | Specific Test / Measurement | Reported Device Performance (Not provided in detail) | Acceptance Criteria (Not provided in detail) |
|---|---|---|---|
| Physical Dimensions | Appearance, Working length, Work channel ID, Head OD, Outer diameter of main hose, Maximum outer diameter of the insertion part, Product weight, Cable length | Stated to meet criteria | (Internal Manufacturer Spec) |
| Mechanical Performance | Bending angle, Rotating sleeve | Stated to meet criteria | (Internal Manufacturer Spec) |
| Functional Performance | Handle-based photographing function, Image display, Waterproofness, Direction of view, Lens fogging, Suction ability, Water delivery ability, Handle-based camera button reliability test, Air tightness test | Stated to meet criteria | (Internal Manufacturer Spec) |
| Imaging Performance | Image quality, Field of view test, Resolution test, Observation depth of field test, Geometric distortion test, SNR test, Dynamic tolerance test, Brightness uniformity test, Color reduction test | Stated to meet criteria | (Internal Manufacturer Spec) |
| Illumination Performance | LED illuminance test, LED color temperature test, LED temperature test | Stated to meet criteria | (Internal Manufacturer Spec) |
| Biocompatibility | Cytotoxicity, Irritation, Sensitization, Pyrogenicity, Acute systemic toxicity (evaluated per ISO 10993-1:2018 for "Surface – Mucosal Membrane" with contact |
§ 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.