(65 days)
Not Found
No
The summary describes a standard bronchoscope with optical components and light sources, and explicitly states that AI, DNN, or ML are "Not Found".
No
The intended use explicitly states "diagnosis," which indicates a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in the direct visualization and diagnosis in the trachea and lungs," indicating a diagnostic purpose.
No
The device description explicitly lists hardware components such as Optical Catheters, Optical Handle, Fiber Optic Cables, Adapters, and Light Sources.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "direct visualization and diagnosis in the trachea and lungs." This describes a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The components listed (Optical Catheters, Optical Handle, Fiber Optic Cables, Adapters, Light Sources) are consistent with a device used for direct visualization within the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on such samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This bronchoscope is a medical device used for direct observation within the body.
N/A
Intended Use / Indications for Use
The 5 Star Medical bronchoscope is intended for use in the direct visualization and diagnosis in the trachea and lungs.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea and lungs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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.