Indications For Use; Device Description - CapsoVision CapsoCam Plus Mode D'emploi

Indications for Use

The CapsoCam Plus® capsule system is intended for
visualization of the small bowel mucosa in patients ages
2 and above. It may be used as a tool in the detection of
abnormalities of the small bowel.
Indications for Pediatric Use
Based upon review of the published literature and available
guidelines published to date, indications for Capsule
Endoscopy (CE) in pediatric patients are as follows:
• Diagnosis of Inflammatory Bowel Disease (IBD), including
the evaluation of suspected Crohn' s Disease (CD) and the
ongoing diagnostic surveillance of pediatric patients
with established CD.
• A normal CE study has a high specificity for excluding
small bowel CD.
• CE should be recommended in suspected cases of CD when
conventional endoscopy and imaging tools are not feasible
or have been non-diagnostic and no bowel obstructive
symptoms are present.
• The possibility of capsule retention should be carefully
considered in patients at risk for intestinal stenosis, mainly
those with a previous abdominal surgery and those with
suspected or established Crohn' s disease.
2
Document Number: IFU-2320 Rev: H Revision Date: 8/28/2019
• Diagnosis of Occult Gastrointestinal Bleeding (OGIB) and/or
Chronic Anemia—as an alternative diagnostic methodology
and as a tool for management of OGIB in pediatric patients.
• Diagnosis of Polyposis Syndromes—providing safe, accurate
detection of small-bowel polyps in pediatric patients.
Specifically, CE may be a useful tool in the screening and
surveillance of patients with Peutz-Jeghers syndrome (PJS).
• CE may be useful as an alternative diagnostic modality
for other diseases affecting the pediatric population such as:
celiac disease and malabsorption syndromes,
lymphangiectasia, graft-versus-host disease, chronic
abdominal pain, and failure to thrive.

Device Description

CapsoCam Plus is a single-use, ingestible capsule that acquires
and stores endoscopy examination 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 being swallowed.
Ratings
IP68
Type BF applied part
3.1V DC battery-powered
10mA
Class IIa