(126 days)
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine mucosa.
- It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy.
- It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy.
- It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia(IDA) not detected by upper and lower endoscopy.
The Red Color Detection Function is intended to mark frames of the video suspected of containing blood or red areas.
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM may be used as a tool in the detection of abnormalities of the small intestine and is intended for use in adults only.
The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is a capsule imaging system used for visualization of the small intestine mucosa. This system consists of capsule endoscopes which capture images and transmit the data, an antenna unit and a recorder which are secured around the patient and receive data from the capsule, and workstation software which downloads the image data from the recorder and processes images for visualization. After the visualization, the diagnostic review (also known as reading) of images would start with user selectable OMNI mode feature. OMNI mode is an algorithm that assists the physician in reviewing the Capsule Endoscopy(CE) case data.
The provided text describes the OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM and its performance. However, it does not explicitly define specific "acceptance criteria" in a quantitative table or directly state that the device meets pre-defined acceptance criteria in all aspects. The document focuses on demonstrating substantial equivalence to a predicate device and presenting the results of a clinical study for the OMNI mode.
Based on the provided text, here's an attempt to answer your request, highlighting where information is directly available and where it's inferred or not explicitly stated:
1. Table of acceptance criteria and the reported device performance
The provided text does not contain a specific table of quantitative acceptance criteria for the entire device or the OMNI mode, nor does it explicitly state that the device "meets" acceptance criteria in a comparative table.
However, the clinical study's outcome regarding reading efficiency can be considered a performance metric and, implicitly, a criterion for the OMNI mode's improvement claim.
| Criterion Type (Inferred) | Acceptance Criteria (Not explicitly stated in a quantitative manner) | Reported Device Performance (OMNI Mode) |
|---|---|---|
| Reading Efficiency (for OMNI mode) | Claims for "improvement of capsule reading efficiency and the reduction of redundant images" (implicit acceptance criteria is significant improvement) | OMNI mode required, on average, 27.3 minutes for review, while Normal mode required 75.1 minutes, on average (p |
§ 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.”