(61 days)
with PillCam™ SB Capsule
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 lor vivalies 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
with PillCam™ ESO Capsule
The Given® Diagnostic System with the PillCam™ ESO Capsule is intended for the visualization of esophageal mucosa.
The Given® Diagnostic System is comprised of three subsystems-PillCam™ Capsule (ESO or SB), Data Recorder Set, and RAPID® Workstation.
The RAPIDAccess optional accessory system, which is the subject of this Special 510(k) application, is designed to facilitate access to PillCam Capsule Endoscopy by allowing the performance of CE procedure without requiring the use of a full Given® Diagnostic System. It comes in two versions: RAPIDAccess RT (Real-Time), which is a standalone accessory that also allows monitoring the advancement of the capsule through the GI tract, and RAPID Access SW (software application).
The provided text is a 510(k) summary for the RAPIDAccess optional accessory system for the Given Diagnostic System. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
The closest relevant information from the document is:
- Performance Standards and Special Controls: "The Given® Diagnostic System complies with the requirements presented in 'Class II Special Controls Guidance Document; Telemetric Gastrointestinal Capsule Imaging System; Ingestible Final Guidance for Industry and FDA' issued on November 28, 2001." This indicates general compliance with regulatory guidance but does not provide specific acceptance criteria or an associated study for the RAPIDAccess system's performance.
- Substantial Equivalence Argument: "Given Imaging Ltd. believes that the Given® Diagnostic System with RAPIDAccess optional accessory system is substantially the equivalent to the market-cleared Given® Diagnostic System without raising any new safety and/or efficacy issue." This is a regulatory statement, not a scientific study with performance metrics.
To answer your request, I would need a different document that details performance studies, acceptance criteria, and their results for the RAPIDAccess system.
§ 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.”