(310 days)
The ENTity WiFi Video Nasopharyngoscope System is intended to be used for oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords.
The ENTity WiFi Video Nasopharyngoscope System is a complete video nasopharyngoscopy system that includes a rechargeable, battery-powered, flexible videoscope with an integral LED light source and WiFi connectivity; a video processor box that receives WiFi signals from the videoscope and provides HDMI output to a video monitor; image management and user interface software; a battery charger accessory for the videoscope; and an active touchscreen monitor accessory that can be used to view images and/or to communicate with the software user interface. Light generated by the LED light source located in the videoscope handle is transmitted through glass fiber optic bundles to the distal tip of the scope, where it illuminates the anatomy to be examined. A CMOS image sensor (camera chip) located at the distal tip of the videoscope captures still or video images in the form of electrical signals, which are wirelessly transmitted to the ENTity WiFi Video Processor. The video processor incorporates user interface and image management software. Still and/or video images may be viewed on the ENTity WiFi Active Touchscreen Monitor; the touchscreen features on the monitor can also be used to interact with the ENTity WiFi Video Processor.
The provided text describes the ENTity WiFi Video Nasopharyngoscope System and its substantial equivalence to a predicate device. However, it does not contain a specific study proving the device meets particular clinical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for identifying specific conditions). The document focuses on showing substantial equivalence based on technical characteristics, non-clinical performance data, and compliance with various engineering and safety standards.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I detail a study that proves such criteria were met, as that information is not present in the provided text.
I can, however, extract information about the non-clinical performance and testing performed to demonstrate safety and technical equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with clinical acceptance criteria (e.g., diagnostic sensitivity/specificity) and corresponding device performance data for ENTity WiFi Video Nasopharyngoscope System. Instead, it lists technical features and compliance with standards.
Here's a table based on the technical comparison and performance verification mentioned, rather than clinical acceptance criteria for diagnostic efficacy.
| Acceptance Criteria (Technical/Performance Standard) | Reported Device Performance (Compliance/Result) |
|---|---|
| Biocompatibility (ISO 10993-1, -5, -10) | Evaluation and testing performed; passed cytotoxicity, sensitization, and intracutaneous irritation tests. |
| Reprocessing Validation (FDA guidance, AAMI TIR 12, TIR 30, ASTM E1837) | Validated for manual cleaning and high-level disinfection. |
| Software Life Cycle Processes (IEC 62304) | Compliant with IEC 62304. |
| Cybersecurity Risk Management (FDA 2014 Guidance) | Risks assessed and mitigated. |
| Wireless Communication Performance (FDA 2013 Guidance, AAMI TIR69, ANSI C63.27) | WPA2 encrypted 2.4 GHz WLAN 802.11 communication; wireless coexistence testing conducted. |
| End-to-End (E2E) Latency | Comparable to predicate device + reference device; measured >160ms and |
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.