(151 days)
The CapsoCam® Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
CapsoCam Plus (SV-3) capsule is a single-use, ingestible video capsule that acquires and stores video images in on-board memory while moving through the gastrointestinal tract, propelled by natural peristalsis. The patient retrieves the capsule using the provided retrieval kit and returns it to the physician who downloads and reviews the images on a computer. The capsule is typically excreted within 3 to 30 hours after swallowing.
CapsoCam Plus (SV-3) capsule endoscope is a single-use ingestible capsule system for diagnostic visualization of the adult small bowel. The overall system consists of an ingestible Capsule CapsoCam (SV-3), the CapsoRetrieve® (CVR1) Capsule Retrieval Kit, the CapsoAccess® Capsule Data Access System (CDAS) and the CapsoView® (CVV) software. The capsule contains a panoramic color digital video camera, two silver-oxide watch batteries, white-LED light sources, a laser diode for data download and system-control and nonvolatile flash-memory data-storage electronics.
The provided text is a 510(k) summary for the CapsoCam Plus (SV-3) video capsule system. This document outlines the device's indications for use, its description, and its substantial equivalence to a previously cleared predicate device. It also briefly mentions non-clinical and clinical testing performed.
However, the document does not contain specific acceptance criteria, study details demonstrating performance against criteria, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or information about AI assistance or standalone algorithm performance.
The clinical summary states that the testing demonstrated:
- Images are captured throughout an entire small bowel exam, with complete small bowel exam defined as the ability of the capsule to reach the cecum while still recording images.
- Images are correctly downloaded using the CapsoAccess® capsule data access system (CDAS3).
- Small bowel images of diagnostic quality are able to be reviewed using the CapsoView® CVV Software and determined to be effective for diagnostic purposes by the study investigator.
It concludes that "the results of this clinical testing demonstrate that it meets the primary endpoints per the study protocol and the performance of the CapsoCam Plus (SV-3) Capsule Endoscope System does not raise new issues of safety or effectiveness when compared to the predicate device (K161773)."
The purpose of this 510(k) submission appears to be related to minor changes or reaffirmation of substantial equivalence to an already cleared device (K161773). Therefore, the detailed performance study information, including specific acceptance criteria and quantitative results, would have been part of the original K161773 submission, not this K183192 summary.
Therefore, based solely on the provided text, I cannot provide the requested information in detail because it is not present. The document focuses on showing substantial equivalence rather than detailing a de novo performance study with specific metrics and acceptance criteria.
§ 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.”