(210 days)
SB Indications for Use:
The Given PillCam® Platform with the PillCam® SB Capsules 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 two years of age.
The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.
AGILE Indications for Use:
The Given® AGILE Patency System is an accessory to the PillCam video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam video capsule in patients with known or suspected strictures in adults and children from two years of age.
The Given PillCam® Platform is comprised of three main subsystems; (1) the ingestible PillCam capsule, (2) the RAPID® software, and (3) the Given® Workstation and Hardware.
- Ingestible PillCam Capsule
The disposable, ingestible PillCam Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via a RF communication channel to the DataRecorder located outside the body.
- RAPID Software
The RAPID Software is a software application that is utilized to process, analyze, store, and view the acquired images collected from the DataRecorder to create a RAPID video of the images. The software also includes a reporting function to create detailed clinical reports, in-service training videos, and patient instruction forms.
- Given Workstation and Hardware
The Workstation is a modified standard personal computer that is the operational platform for the RAPID software. The DataRecorder is an external receiving/recording unit that receives acquired images from the capsule. The SensorArray receives data from the PillCam capsule and transfers the data to the DataRecorder. The RAPID Real Time is a handheld device that allows for real-time viewing of acquired images through the GI tract. Other accessories include a flat panel LCD monitor, a high-capacity mass storage device, and a high-capacity USB portable storage device.
The Given Agile Patency System is designed to determine which patients with known or suspected intestinal strictures can safely ingest a PillCam video capsule. The system consists of an ingestible and dissolvable capsule that is the same size as the PillCam SB capsule, and an external scanner.
The provided text is a 510(k) summary for the Given® AGILE Patency System and Given PillCam® Platform with PillCam® SB Capsules. While it mentions that "Clinical data has been summarized to show safety and effectiveness for the proposed indications for use" and that "The devices meet the guidance entitled 'Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA dated November 28, 2001," it does not include any specific performance data, acceptance criteria, or details of a study that proves the device meets acceptance criteria.
Therefore, I cannot provide the requested information, including the table of acceptance criteria and reported device performance, sample size, ground truth details, or information about MRMC studies. The document states that the technological characteristics are "exactly the same as the predicate devices," suggesting the approval is based on substantial equivalence rather than a new performance study.
§ 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.”