(30 days)
The Given® Diagnostic System with the PillCam™ SB Capsule is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 10 years of age and up
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas
The Given® Diagnostic System is comprised of three subsystems-PillCam™ Capsule (ESO or SB), Data Recorder Set, and RAPID® Workstation.
The modifications to the Given® Diagnostic System, which are the subject of this Special 510(k), include (1) improved PillCam™ SB capsule; and (2) labeling change, which does not affect the intended use of the device, related to the Automatic Mode of the RAPID® Software Application.
The provided text is a 510(k) summary for the Given® Diagnostic System, a medical device for visualizing the small bowel mucosa. The document focuses on regulatory approval and does not contain detailed information about acceptance criteria for device performance or a specific study proving it meets those criteria.
Therefore, I cannot provide the requested information about acceptance criteria and device performance based solely on the provided text. The document clearly states it's a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against defined acceptance criteria.
The information sought, such as detailed performance metrics (sensitivity, specificity, etc.), sample sizes for training and test sets, expert qualifications, and ground truth establishment, would typically be found in a separate clinical study report or a more comprehensive technical and clinical data submission, which is not included in this 510(k) summary.
The only performance-related statement is about the "Suspected Blood Indicator (SBI) feature" being "intended to mark frames of the video suspected of containing blood or red areas," which is an intended function, not a performance metric with acceptance criteria.
§ 876.1300 Ingestible telemetric gastrointestinal capsule imaging system.
(a)
Identification. An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.(b)
Classification. Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”