§ 876.1330 Colon capsule endoscopy system.

(a) Identification. A prescription, single-use ingestible capsule designed to acquire video images during natural propulsion through the digestive system. It is specifically designed to visualize the colon for the detection of polyps. It is intended for use only in patients who had an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The capsule must be demonstrated to be biocompatible.

(2) Non-clinical testing data must demonstrate the mechanical and functional integrity of the device under physically stressed conditions. The following performance characteristics must be tested and detailed protocols must be provided for each test:

(i) Bite test to ensure that the capsule can withstand extreme cases of biting.

(ii) pH resistance test to evaluate integrity of the capsule when exposed to a range of pH values.

(iii) Battery life test to demonstrate that the capsule's operating time is not constrained by the battery capacity.

(iv) Shelf-life testing to demonstrate that the device performs as intended at the proposed shelf-life date.

(v) Optical testing to evaluate fundamental image quality characteristics such as resolution, field of view, depth of field, distortion, signal-to-noise ratio, uniformity, and image artifacts. A test must be performed to evaluate the potential of scratches, caused by travelling through the gastrointestinal tract, on the transparent window of the capsule and their impact on the optical and color performance.

(vi) An optical safety analysis must be performed based on maximum (worst-case) light exposure to internal gastrointestinal mucosa, and covering ultraviolet, visible, and near-infrared ranges, as appropriate. A mitigation analysis must be provided.

(vii) A color performance test must be provided to compare the color differences between the input scene and output image.

(viii) The video viewer must clearly present the temporal or spatial relationship between any two frames as a real-time lapse or a travel distance. The video viewer must alert the user when the specific video interval is captured at a frame rate lower than the nominal one due to communication errors.

(ix) A performance test evaluating the latency caused by any adaptive algorithm such as adjustable frame rate must be provided.

(x) If the capsule includes a localization module, a localization performance test must be performed to verify the accuracy and precision of locating the capsule position within the colon.

(xi) A data transmission test must be performed to verify the robustness of the data transmission between the capsule and the recorder. Controlled signal attenuation should be included for simulating a non-ideal environment.

(xii) Software validation, verification, and hazards analysis must be provided.

(xiii) Electrical equipment safety, including thermal and mechanical safety and electromagnetic compatibility (EMC) testing must be performed. If the environments of intended use include locations outside of hospitals and clinics, appropriate higher immunity test levels must be used. Labeling must include appropriate EMC information.

(xiv) Information demonstrating immunity from wireless hazards.

(3) The clinical performance characteristics of the device for the detection of colon polyps must be established. Demonstration of the performance characteristics must include assessment of positive percent agreement and negative percent agreement compared to a clinically acceptable alternative structural imaging method.

(4) Clinician labeling must include:

(i) Specific instructions and the clinical and technical expertise needed for the safe use of the device.

(ii) A detailed summary of the clinical testing pertinent to use of the device, including the percentage of patients in which a polyp was correctly identified by capsule endoscopy, but also the percent of patients in which the capsule either missed or falsely identified a polyp with respect to the clinically acceptable alternative structural imaging method.

(iii) The colon cleansing procedure.

(iv) A detailed summary of the device technical parameters.

(v) A detailed summary of the device- and procedure-related complications pertinent to use of the device.

(vi) An expiration date/shelf life.

(5) Patient labeling must include:

(i) An explanation of the device and the mechanism of operation.

(ii) Patient preparation procedure.

(iii) A brief summary of the clinical study. The summary should not only include the percentage of patients in which a polyp was correctly identified by capsule endoscopy, but also the percent of patients in which the capsule either missed or falsely identified a polyp with respect to the clinically acceptable alternative structural imaging method.

(iv) A summary of the device- and procedure-related complications pertinent to use of the device.

[79 FR 28403, May 16, 2014]