(210 days)
Single Use Guide Sheath Kit K-401, K-402
These instruments have been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree and collect tissue, specimens, or cells bronchoscopically. This kit and its components are intended for adult patients only.
- Indications for use of each component
Single Use Guide Sheath SG-400C
The single use guide sheath has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and for ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree.
Single Use Biopsy Forceps FB-433D
The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible bronchoscope within the tracheobronchial tree.
Single Use Cytology Brush BC-205D
The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with the bronchoscope within the tracheobronchial tree.
Single Use Guiding Device CC-220DR
This instrument has been designed to be used with an Olympus endoscope and guide sheath to the respiratory organs and to collect specimens within the respiratory organs. This device is intended for adult patients only.
Single Use Guide Sheath Kit K-401/K-402
The kit has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree and collect tissue, specimens, or cells bronchoscopically.
The compatible bronchoscope for the subject Single Use Guide Sheath Kit needs to have the working length 600mm or less (exclude the ultrasonic bronchoscope) and a working channel inner diameter that is no less than 2.0mm.
The guide sheath kit consists of the following components: Guide Sheath, Biopsy Forceps, with/without Cytology Brush. EU stoppers and US Stopper are also included in the kit as accessories. Each component and the accessory stoppers are sterile and packaged in individual package. All of them are collected into one carton box as one final kit product.
The single use guide sheath has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree.
This guide sheath is designed to function as an extended working channel. The function of the subject guide sheath is to facilitate obtaining multiple biopsy specimens by leaving the guide sheath in place after localization of the target tissue.
This instrument consists of an insertion portion and a handle portion. The insertion portion is composed of tube and X-ray tip.
The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible bronchoscope. The subject device is allowed to insert into the channel of a bronchoscope with the subject device guide sheath, and then collect tissue with the pair of forceps which is equipped at the distal end of the subject device. Finally, users withdraw the subject device biopsy forceps from the bronchoscope to collect the samples.
The single use cytology brush BC-205D has been designed to collect specimens or cells endoscopically for cytology examination in conjunction with bronchoscopes. The subject device is allowed to insert into the channel of a bronchoscope with the subject device guide sheath, and then collect specimens or cells with the brush which is affixed in the distal end of the subject device. Finally, users withdraw the subject device cytology brush from the bronchoscope to collect the samples.
The ET stopper and US stopper are included in the guide sheath kit as accessory. They are used to fasten the sampling devices (EndoTherapy accessories) or ultrasonic probe to the guide sheath, which serve as a mark to keep the sampling devices or ultrasonic probe in relative position to the guide sheath. The ET stopper are made of silicone rubber outside, molded with stainless steel plate inside.
Single Use Guiding Device CC-220DR
The Single Use Guiding Device has been designed to be used with an Olympus endoscope and guide sheath to guide the guide sheath to the respiratory organs and to collect specimens within the respiratory organs.
The compatible bronchoscope for the subject Single Use Guiding Device CC-220DR needs to have the working length 600mm or less (exclude the ultrasonic bronchoscope) and a working channel inner diameter that is no less than 2.0mm.
The subject device consists of a handle section and an insertion. The distal end in the insertion portion consists of a double-joint curette which bends by operating the handle section. The rotation grip in handle section also allows for rotation of the curette in the distal end. The subject device inserts into an endoscope with the guide sheath, and enables the guide sheath to be directed to the target area following the direction the curette in distal end to the target area. The curette can also collect the specimen by scraping the tissue.
Although this device is used together with the subject device guide sheath in Single Use Guide Sheath Kit, it is marketed independently as a single product.
The provided document is a 510(k) summary for medical devices (bronchoscope accessories) and does not describe acceptance criteria or a study proving device performance in the context of an AI/ML algorithm. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various performance tests, sterilization/shelf-life testing, and biocompatibility testing for medical hardware.
Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria and studies from this document. The document lists different types of engineering and biological performance tests for the physical medical devices, but not for an AI/ML model's performance.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.