Who is the manufacturer of FIVE STAR BRONCHOSCOPE?

Five Star Medical, Inc. filed the 510(k) submission for FIVE STAR BRONCHOSCOPE (K960876).

What is the FDA product code for FIVE STAR BRONCHOSCOPE?

EOB. It is classified under 21 CFR 874.4760 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for FIVE STAR BRONCHOSCOPE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like FIVE STAR BRONCHOSCOPE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FIVE STAR BRONCHOSCOPE

K960876 · Five Star Medical, Inc. · EOB · May 8, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K960876
Device Name	FIVE STAR BRONCHOSCOPE
Applicant	Five Star Medical, Inc.
Product Code	EOB · Ear, Nose, Throat
Decision Date	May 8, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4760
Device Class	Class 2

Intended Use

The 5 Star Medical bronchoscope is intended for use in the direct visualization and diagnosis in the trachea and lungs.

Device Story

Flexible bronchoscope for visualization of trachea and lungs; consists of deflecting tip optical catheters (1.6-2.7mm OD, 30-100cm length) with working channels; optical handle with adjustable magnifying eyepiece; fiber optic cables for illumination. Operated by clinicians in clinical settings. Proximal manipulation controls distal tip deflection. Fiber optic bundles connect to standard external light sources (Wolf, Olympus, Storz, ACMI) via adapters. Provides direct optical visualization to assist in diagnosis; aids clinical decision-making by enabling visual inspection of pulmonary anatomy.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design comparison.

Technological Characteristics

Flexible fiber optic bronchoscope; non-coherent glass fiber bundles; optical handle with magnifying optics; distal tip deflection mechanism. Compatible with standard external light sources (Wolf, Olympus, Storz, ACMI) via female ACMI connectors. Materials biocompatible. No electronic or software components.

Indications for Use

Indicated for direct visualization and diagnosis of the trachea and lungs in patients requiring bronchoscopic examination.

Regulatory Classification

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.

Predicate Devices

Microvasive Visicath

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Submission Summary (Full Text)

{0} K960876 XIII. MAY - 8 1996 510 (k) Summary for 5 Star Medical, Inc. 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 to 100 cm) and outer diameters (1.6 to 2.7mm) for visualization of the trachea and lungs. They are available with a working channel, 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. {1} 11. # STATEMENT OF INTENDED USE 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.