NaviCam Small Bowel Capsule Endoscopy System

The NaviCam Small Bowel Capsule Endoscopy System extends ANKON’s capsule platform to full small intestine visualization. Cleared through the FDA 510(k) pathway based on demonstrated substantial equivalence to established predicate devices, the system provides clinicians with an effective non-invasive method for detecting small bowel abnormalities.

Product Overview

Small bowel evaluation presents unique diagnostic challenges due to the organ’s length (typically 5-6 meters) and inaccessibility to conventional endoscopy. While standard gastroscopy reaches the proximal duodenum and colonoscopy examines the terminal ileum, the intervening jejunum and mid-ileum remain beyond the reach of traditional instruments.

The NaviCam SB system addresses this diagnostic gap through a wireless, swallowable capsule that traverses the entire small intestine, capturing images throughout its natural passage. Unlike the magnetically controlled gastric system, small bowel capsules operate passively, propelled by peristalsis while continuously recording mucosal images.

Key Features

Designed for small bowel visualization, the NaviCam SB capsule records continuous high-resolution images during passive peristaltic transit through the jejunum and mid-ileum.

• Continuous Image Capture: High-resolution cameras document the entire small bowel transit
• Wireless Data Transmission: Images transmit to external data recorder worn by patient
• Extended Battery Life: Operating time sufficient for complete small bowel passage
• ESView Software Platform: Dedicated image review software with navigation and annotation tools
• ProScan AI Integration: Optional AI-assisted lesion detection module

Technical Specifications

Designed for FDA 510(k)-cleared small bowel examination, NaviCam SB uses capsule models AKES-11SW and AKES-11SI with optional ProScan AI for accelerated lesion review.

Clinical Applications

The primary indication targets patients with suspected small bowel bleeding who have undergone negative bidirectional endoscopy (gastroscopy and colonoscopy). Presenting symptoms typically include iron deficiency anemia with or without melena or hematochezia.

Diagnostic Yield: A prospective multi-center European study (14 centers, 133 patients) demonstrated that the NaviCam SB system with ProScan AI assistance achieved non-inferior diagnostic performance to standard reading for detecting potentially bleeding P1 and P2 lesions per the Saurin classification.

Efficiency Gains: AI-assisted reading significantly reduced mean review time while maintaining diagnostic accuracy, addressing the historically time-intensive nature of capsule endoscopy interpretation.

Additional clinical applications include:

• Crohn’s disease assessment and monitoring
• Small bowel tumor surveillance
• Celiac disease evaluation
• Vascular malformation detection
• NSAID-induced enteropathy assessment

Regulatory Status

The FDA 510(k) clearance (K221590) established substantial equivalence to the PillCam SB3 Capsule Endoscopy System as primary predicate device and the NaviCam Stomach System as reference device. Clinical data supporting the submission demonstrated diagnostic overall percent agreement of 89.66% between NaviCam SB and PillCam SB3, with Kappa coefficient of 0.6652 indicating substantial agreement.

Safety evaluation documented a 1.15% adverse event incidence, with one case of dual capsule retention. No abdominal pain, distention, nausea, vomiting, headache, obstruction, or other adverse events occurred during the clinical study.

Frequently Asked Questions

How does NaviCam SB differ from the magnetically controlled gastric system?

The NaviCam SB system operates passively without magnetic guidance, as small bowel examination relies on natural peristalsis to propel the capsule. The gastric system’s magnetic control is necessary for systematic stomach examination but not required for the tubular small intestine where peristalsis naturally advances the capsule.

What is the ProScan AI feature?

ProScan is a deep neural network-based software module that automatically screens capsule images for potentially significant findings. The AI pre-selects images likely to contain lesions, allowing physicians to focus review time on relevant frames rather than reviewing thousands of images sequentially.

How long does small bowel capsule examination take?

Patient preparation and capsule ingestion require minimal time. The capsule then transits the small bowel over 3-8 hours while the patient continues normal activities wearing the data recorder. Image review by the physician occurs subsequently using ESView software.