(65 days)
The 5 Star Medical bronchoscope is intended for use in the direct visualization and diagnosis in the trachea and lungs.
A description of the Bronchoscope's components is as follows: Optical Catheters, Optical Handle, Fiber Optic Cables, Adapters and Light Sources.
This document, K960876, is a 510(k) summary for a Bronchoscope. It primarily focuses on demonstrating substantial equivalence to a predicate device (Microvasive Visicath) based on technological characteristics and intended use. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
Therefore, I cannot populate the table or answer the questions related to acceptance criteria, device performance, sample sizes, ground truth, or study methodologies. The provided text is a regulatory submission for pre-market notification, not a clinical or performance evaluation report.
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XIII.
510 (k) Summary for 5 Star Medical, Inc.
MAY - 8 1996
DEVICE NAME
Bronchoscope
NAME OF PREDICATE OR LEGALLY MARKETED DEVICE
Microvasive Visicath
DESCRIPTION OF DEVICE
A description of the Bronchoscope's components is as follows:
Optical Catheters
The deflecting tip optical catheters are available in various lengths (30 to100 cm) and outer diameters (1.6 to 2.7mm) for visualization of the trachea and lungs. They are available with a working chunnel, fiber optic cable connection and device for deflection. Manipulation at the proximal end of the flexible scope activates the deflection of the distal tip.
Optical Handle
The optical handle consists of an eye piece, a barrel and an optical connection. The handle incorporates magnifying optics which can be adjusted for focus with the focusing ring.
Fiber Optic Cables, Adapters and Light Sources
The fiber optic cables consist of a bundle of non-coherent glass fibers. The fiber optic bundle is sheathed. The light source end of the cable is configured to fit various light sources currently available in distribution (e.g. Wolf, Olympus, Storz and ACMI). The instrument end of the cable is finished with a female ACMI type connector. Light sources which are in common use are compatible with the Bronchoscope. Diagnostic and photo light sources are effective and safe to use with this system. The adapters which are included with the fiber optic cable provide for connection to light sources built by Wolf, Olympus, Storz and ACMI.
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STATEMENT OF INTENDED USE
44.2017
The 5 Star Medical bronchoscope is intended for use in the direct visualization and diagnosis in the trachea and lungs.
STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES
The Microvasive Visicath is intended for use in the direct visualization and diagnosis in the trachea and lungs.
STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON
The 5 Star Medical Bronchoscope has substantially equivalent technological characteristics compared to the predicate Microvasive Visicath device. The devices' field of view, focusing capability, focal lengths, design configuration (i.e. the body, working channels and imaging/light fiber configuration) are similar and comparable. The biocompatibility of the materials of both devices are similar and comparable. In addition, the mode of operation of both devices are similar and comparable.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The 5 Star Medical Bronchoscope is substantially equivalent to the Microvasive Visicath. Both devices are intended for direct visualization and diagnosis of the trachea and lungs. The technological characteristics of the Bronchoscope and predicate device (design, materials, and mode of operation) are comparable and determined to be substantially equivalent.
§ 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.