(98 days)
The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to the organs, tissues, and subsystems: Nasal Passage, Pharynx, Larynx, 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, video signals, and suction. 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. The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect endoscopic image data, and a radial 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 endossope PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. 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 immersable (with the use of supplied cleaning accessories) except for the ultrasound scanner connector (as described in the endoscope operator manual cleaning instructions).
The provided document, K081518, is a 510(k) summary for the Pentax EB-1970UK Ultrasound Video Bronchoscope.
The document explicitly states: "The substantial equivalence is not based on an assessment of clinical performance data." This means that traditional acceptance criteria based on clinical outcomes or diagnostic accuracy thresholds are not applicable or provided in this submission. The device's clearance is based on its substantial equivalence to predicate devices through technical specifications and performance testing (likely bench testing, and electrical/mechanical safety) rather than clinical performance studies.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in terms of diagnostic accuracy or clinical effectiveness with human readers, cannot be fully provided from the given text.
Based on the available information:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Type Acceptance Criteria (Threshold) Reported Device Performance Substantial Equivalence To be substantially equivalent to predicate devices (Olympus BF type UC-160F, Pentax EB-1830T3, Hitachi EUB-5500) based on specifications and performance testing. The FDA determined the device is substantially equivalent to legally marketed predicate devices. Functionality Perform optical visualization, ultrasonic visualization, and therapeutic access to the pulmonary tract. The device's description indicates it is designed for these functions. Specific performance metrics (e.g., image resolution, channel diameter) are summarized as being compared to predicates. Safety (Acoustic Output) Not explicitly stated in the summary, but implicit for an ultrasound device. A post-clearance special report for acoustic output measurements based on production line devices is required. -
Sample size used for the test set and the data provenance: Not applicable. No clinical performance test set data is provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical performance test set data is provided.
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Adjudication method for the test set: Not applicable. No clinical performance test set data is provided.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document predates widespread AI in medical devices, and no clinical effectiveness study is described.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an instrument used by a human operator; it's not a standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The ground truth for proving substantial equivalence was likely based on the technical specifications and safety standards met by the predicate devices.
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The sample size for the training set: Not applicable. This device is not an AI/machine learning algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable. This device is not an AI/machine learning algorithm requiring a training set.
Conclusion from document:
The 510(k) clearance for the Pentax EB-1970UK Ultrasound Video Bronchoscope was based on its substantial equivalence to existing, legally marketed predicate devices (Olympus BF type UC-160F, Pentax EB-1830T3, and Hitachi EUB-5500). This determination was made primarily through a comparison of technical specifications and performance testing (likely bench testing, electrical, and mechanical safety, as is common for such devices) rather than clinical performance data or studies involving human readers or patient outcomes. The submission explicitly states: "The substantial equivalence is not based on an assessment of clinical performance data." A post-clearance requirement for acoustic output measurements on production units was noted, indicating ongoing safety monitoring for the ultrasound component.
§ 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.