(194 days)
The MiroCam® Capsule Endoscope System 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 GI Bleeding Indicator (SGIB) is intended to mark frames of the video suspected of containing blood or red areas.
The MroCam® Capsule Endoscope System is comprised of the following core components:
- MiroCam® Capsule: MC1200-B
- MiroCam® Receiver: MR1100
- Data Cable / Data Belt (Optional): MR1000-D / MR1000-D(S) or MR1000-D(M) or MR1000-D(L)
- MroView™ Software: MroView™ U 3.0, MiroView™ RTV, MroView™ RTV-i
The general usage workflow of the MiroCam® system is as follows, the MiroCam® capsule captures images of the Gl tract, which are sent via Human Body Communication to sensor pads which are affixed to the patient body. The sensor pads are connected to the receiver by the data cables. The image data is stored on the receiver for the duration of the patient procedure. After removing the receiver set from the patient body, the receiver is connected via USB to the Commercial PC and the image data is uploaded. Following upload, the physician (Gastroenterologist) reviews the patient image data for suspected abnormalities of the small bowel.
The provided document does not contain information about specific acceptance criteria, device performance, or a study design to prove the device meets acceptance criteria.
The document is a 510(k) summary for the MiroCam® Capsule Endoscope System, focusing on demonstrating substantial equivalence to a predicate device. It describes the device, its intended use, and states that performance testing was done for the predicate device, with some additional testing for the current device's components. However, it does not detail:
- Specific acceptance criteria: There are no defined metrics (e.g., sensitivity, specificity, accuracy, detection rates, etc.) nor thresholds presented for the device's performance.
- Reported device performance: No quantitative results from any clinical or performance study are provided for the MiroCam® Capsule Endoscope System itself, especially for its "Suspected GI Bleeding Indicator (SGIB)" feature.
- Study design details: Information regarding sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment is absent because no such study is described in this summary for the present device in relation to performance metrics.
The document states:
- "The MiroCam® Capsule Endoscope System performance testing was done for the submission of predicate device but it was not included when Sensor Bench testing, Exposure Measurement testing, Minimum MTF Measurement testing, MTF Time testing, Distinguishable Contrast Value and Depth of View testing, Geometric distortion and Illumination Uniformity testing, Field of View testing, Color Reproduction testing, LED Spectrum Measurement testing, Testing intensity change during the shelf life period and Testing optical spectra of the light source at different time points during the battery life period was done."
- "The results of this performance testing conclude that the material and technological characteristics have not diminished the safety and effectiveness of the IntroMedic Co., Ltd. MiroCam® Capsule Endoscope System device when compared to the predicate device."
This indicates that the performance testing was primarily focused on technical characteristics and comparing them to the predicate, rather than evaluating clinical performance metrics against specific acceptance criteria for the new device as a whole, especially its "Suspected GI Bleeding Indicator (SGIB)".
Therefore, I cannot populate the requested tables and information as the necessary details are not present in the provided text.
§ 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.”