(57 days)
This instrument has been designed to be used with an OLYMPUS video system center, light source, documentation equipment, display monitor, strobe light source specified by OLYMPUS, and ancillary equipment for endoscopic diagnosis within the nasal lumens and airway anatomy.
The subject device, the VISERA Rhino-Larvngovideoscope Olympus ENF type V is identical to the predicate device cleared in #K021073. This premarket notification is submitted to expand the intended use to add compatibility with strobe light sources specified by Olympus and change the applications from the nasal and nasopharyngeal lumens and airway and airway anatomy. Olympus specifies the Light Source Model 9100 B and 9100 C (#K921184) manufactured by Kay Elemetrics corp., for endoscopic diagnosis using the strobe light source.
The provided document describes a 510(k) submission for the "VISERA Rhino-Laryngovideoscope Olympus ENF Type V". This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed device performance data against those criteria.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be extracted from the given text.
The document states:
"When compared to the predicate device, the ENF-V does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect safety and effectiveness. Therefore clinical data is not necessary for evaluation of safety and efficacy."
This indicates that the submission relies on the established safety and effectiveness of the predicate device and does not present new performance data from a specific study designed to meet new acceptance criteria. The device's compliance is primarily demonstrated through meeting voluntary safety standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-18) and ISO 10993-1 for materials, rather than a clinical performance study with the metrics you've requested.
§ 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.