User's Manual

Indications, Contraindications, Warnings, Cautions
Accuracy of the Device—SB 11
The localization software was studied in a series of 17 healthy subjects. Multiple fluoroscopic images
(92 sets) were obtained at various times during the PillCam video capsule's passage through the small
bowel. The location was assessed in two dimensions relative to the umbilicus and then compared to the
position obtained from the localization software. When compared to the relative two-dimensional
location determined fluoroscopically, approximately 87% (80/92) of the PillCam video capsule
estimates were within 6cm (a “fist”). The mean error for PillCam video capsule localization was found
to be 3.8 cm. [2]
The Suspected Blood Indicator (SBI) feature is intended to mark frames suspected of containing fresh
blood. The feature may be activated only after labeling the first duodenal image and marks frames
contained only within the small bowel. The SBI feature should not serve as a substitute for a physician's
complete viewing of the video but rather to provide supplemental information afterwards. All events
marked by the SBI feature should be carefully reviewed by a physician. In a review of 27 patients with
at least one red or bleeding lesion found by a physician on capsule endoscopy, the SBI feature correctly
marked 439, or 88%, of the 498 individual lesions. In addition, a total of 561 false positive lesions were
marked by the feature, giving a positive predictive value (PPV) of 44%. [3]
References:
[1] Clinical report presented in K010312
[2] Clinical report presented in K020341
[3] Clinical report presented in K022980