(175 days)
The CMOS Video Rhino-Laryngoscope SSU is intended to provide visualization of nasal lumens and airway anatomy (including nasopharynx and trachea) during diagnostic procedures.
The E-Box serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.
The CMOS Video Rhino-Laryngoscope SSU System includes three main components: (1) the CMOS Video Rhino-Laryngoscope SSU (091330-01), (2) E-Box adaptor (TP010) and (3) the CCU. CMOS Video Rhino-Laryngoscope SSU is compatible with two KARL STORZ CCUs: C-HUB and C-MAC. CMOS Video Rhino-Laryngoscope SSU is provided sterile (EtO), for single use only.
The provided text describes the submission of a new medical device, the CMOS Video Rhino-Laryngoscope SSU, for 510(k) clearance by the FDA. However, the document does not contain information about acceptance criteria, device performance metrics, or study results that would typically prove a device meets specific performance criteria.
Instead, the document focuses on regulatory compliance and demonstrating substantial equivalence to predicate devices through non-clinical testing. It states:
- "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications."
- "The conclusions drawn from the nonclinical tests demonstrate that the subject device, the CMOS Video Rhino-Laryngoscope SSU is substantially equivalent to the predicate devices, that are currently marketed for the same intended use."
Therefore, I cannot provide the requested information regarding acceptance criteria and device performance based on the input text. The information is not present within this regulatory submission summary.
§ 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.