(58 days)
Not Found
No
The summary describes a standard flexible endoscope and electrode for visualization and coagulation, with no mention of AI or ML capabilities, image processing beyond direct view or video connection, or data sets for training or testing.
Yes
The device is described as being used for "therapy in connection with endoscopic accessories / auxiliary instruments" and includes a "button electrode... for tissue and vessel coagulation," which are therapeutic applications.
Yes
The "Intended Use / Indications for Use" section states: "For examination, diagnosis, and /or therapy in connection with endoscopic accessories / auxiliary instruments through the working channel of the endoscope." The explicit mention of "diagnosis" indicates that the device has a diagnostic function.
No
The device description explicitly details physical components (flexible insertion part, control part, eyepiece) and their functions, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The description clearly states the device is used for visualizing body cavities and tissue/vessel coagulation under endoscopic view. This is a direct interaction with the patient's body for examination, diagnosis, and therapy.
- No Specimen Analysis: There is no mention of the device being used to analyze specimens (blood, tissue, etc.) outside of the body.
The device described is an endoscope and related accessories used for direct visualization and intervention within the body, which falls under the category of in vivo medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The flexible nasopharyngo-laryngoscope and the flexible bronchoscope are used to visualize body cavities via natual passages.
The button electrode is used for tissue and vessel coagulation by means of high frequency current under endoscopic view.
Indication and Field of Application:
For examination, diagnosis, and /or therapy in connection with endoscopic accessories / auxiliary instruments through the working channel of the endoscope. This instruement is used in the medical discipline of ENT (e.g. naso-pharynxngeal cavity - larynx / trachea and bronchial branch by adequately trained and qualified medical personnel.
Product codes (comma separated list FDA assigned to the subject device)
77 EOB, 77 EOQ
Device Description
The flexible bronchoscopes and nasopharyngo-laryngoscopes consist of three parts: 1) flexible insertion part with or without a working channel, 2) control part for the deflection of the tip, and 3) an eyepiece for direct view or connection to a video camera.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities via natual passages, naso-pharynxngeal cavity - larynx / trachea and bronchial branch.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
adequately trained and qualified medical personnel.
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)
No performance standards are known. The fiberscopes and the button electrode were built according to the specifiecied standards IEC601-1, IEC601-2-18, and IEC601-2-2. No clinical tests performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K980401, K951196, K921707, K811053, K951199
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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