(90 days)
The Given® Diagnostic System is intended for visualization of the small bowel mucosa. It may be used as an adjunctive tool in the detection of abnormalities of the small bowel
The Given® Diagnostic System is comprised of three subsystems M2ATM Capsule, Data Recorder Set, and Rapid™ Workstation. The M2A™ Capsule is a wireless, disposable capsule designed to glide smoothly through the digestive system by the peristaltic activity of the intestinal muscles and is excreted naturally. During its passage, the capsule transmits digital data that is captured by receiving antennas attached to the patient's body. The images are stored in the Data Recorder that is connected to the receiving antennas and is worn on a belt around the waist of the patient. When the test is over, the antennas and recorder are removed from the patient's body. The images from the recorder are downloaded to the Rapid™ Workstation for processing and viewing by the physician.
The provided text is a 510(k) summary for the Given® Diagnostic System. It does not contain information about specific acceptance criteria, device performance, study details, or ground truth establishment. Therefore, I cannot generate the requested information based on the input provided.
This document mainly outlines:
- The applicant and contact information.
- Trade and classification names of the device.
- Intended use and contraindications.
- Device description.
- A statement of substantial equivalence to a predicate device.
- The FDA's decision letter for clearance.
To answer your request, a document detailing the performance study, clinical trials, or validation reports would be necessary.
§ 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.”