(147 days)
The EB-1970UK. Ultrasound Video Bronchoscope. is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
The EB-1970UK, Ultrasound Video Bronchoscope, must be used with a Pentax Video Processor (a software-controlled device) and must be used with an Ultrasound Scanner (a software-controlled device). The endoscope has a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE connector will be attached to the Video Processor and has connections for illumination and video signals. The ultrasound umbilical connector will be attached to the ultrasound scanner unit. The control body includes controls for up/down angulation, suction control, video processor remote control buttons, and ports for manual balloon insufflation/ evacuation and accessory inlet. A sterile, single use disposable natural rubber latex balloon is fitted over the convex array ultrasound transducer prior to the procedure. It is designed to be inflated with a specific volume of water during the procedure so that the effective transport of ultrasonic pulses from the ultrasound transducer to the target anatomical site and back to the ultrasound transducer can take place. The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect endoscopic image data, and a convex array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced. The video processor contains a lamp that provides white light focused at the endoscope PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data and other screen display information are formatted and presented to the video outputs of the video processor for display. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and the signals are passed to the ultrasound scanner for processing and display. The instrument is immersible (with the use of supplied cleaning accessories).
The provided text is a 510(k) summary for the PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the detailed performance of an AI/ML algorithm through specific acceptance criteria and a human reader study.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance for an AI/ML algorithm.
- Sample size and data provenance for a test set for an AI/ML algorithm.
- Number and qualifications of experts for AI/ML ground truth.
- Adjudication method for an AI/ML test set.
- MRI multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
- Standalone (algorithm-only) performance of an AI/ML algorithm.
- Type of ground truth used for an AI/ML algorithm.
- Sample size for an AI/ML training set.
- How ground truth for the training set was established for an AI/ML algorithm.
Explanation:
The core of this 510(k) summary is to demonstrate that the new device (PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope when used with specific new compatible processors/scanners: EPK-i7010 video processor and NOBLUS Ultrasound scanner) is substantially equivalent to a previously cleared predicate device (PENTAX Ultrasound Video Bronchoscope EB-1970UK + HI VISION Preirus). The changes are primarily the addition of compatible hardware components (newer video processor and ultrasound scanner).
The "Non-Clinical Performance Data" section mentions:
- "Software verification and validation testing were conducted..." and software is classified as CLASS A with "Moderate" level of concern. This indicates standard software development practices, not necessarily AI/ML performance testing as typically understood in the context of an AI device.
- "Cybersecurity risks have been assessed and mitigated."
- "EMC and Electrical Safety" testing against recognized standards.
These are standard non-clinical tests for medical devices, ensuring basic functionality, safety, and compatibility with new components. They are not the specific performance metrics or studies associated with demonstrating the clinical utility or accuracy of an AI/ML-driven diagnostic or therapeutic aid.
To summarize, this document is for a hardware device clearance based on substantial equivalence, not an AI/ML software clearance that would require the specific performance study details you've outlined.
§ 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.