CENTER VALLEY, Pa., March 15, 2021 /PRNewswire/ -- Olympus announced today FDA 510(k) clearance of Narrow Band Imaging® (NBI) to assess the neoplastic potential of colorectal polyps. By applying the NBI International Colorectal Endoscopic (NICE) classification during a screening colonoscopy, physicians can make high-confidence predictions of histology for polyps 5mm or smaller, known as diminutive polyps. Patients and healthcare systems can benefit from implementation of NBI as a decision-making support tool.

An example of a colonic lesion, or polyp, with a most likely prediction of a NICE (NBI International Colorectal Endoscopic) Type 2 adenoma as seen in near focus under the White Light and NBI (Narrow Band Imaging) observation modes of a CF-HQ190L colonovideoscope. Physicians can make high-confidence predictions of histology for polyps 5mm or smaller, known as diminutive polyps, using NBI during a screening colonoscopy for colorectal cancer.
The data submitted to the FDA in support of the 510(k) clearance included a meta-analysis of prospective real-time clinical studies of NBI use during colonoscopy.1 The data show experienced endoscopists employing a validated classification system, such as the NICE classification, have:


Demonstrated 93% sensitivity (89-96%, 95% Confidence Interval, 59-98% range) in predicting adenomatous histology of diminutive polyps during colonoscopy when made with high confidence.
Demonstrated 85% specificity (74-92%, 95% Confidence Interval, 44-99% range) in predicting adenomatous histology of diminutive polyps during colonoscopy when made with high confidence.
Demonstrated greater than 90% Negative Predictive Value in predicting adenomatous histology of diminutive polyps during colonoscopy when made with high confidence.
Achieved greater than 90% agreement with pathological analysis in assigning post-polypectomy patient surveillance intervals following colonoscopy.
Were more likely to make high-confidence predictions of diminutive polyp histology when using Near Focus mode colonoscopes than those using standard focus colonoscopes in a randomized clinical trial.
Typically, polyps are detected and removed during colonoscopy and sent out for pathological diagnosis. Given the abundance of diminutive colorectal polyps, the American Society for Gastrointestinal Endoscopy (ASGE) recognized the importance of making real-time predictions of polyp histology. ASGE created a Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) initiative to assess technologies for the ability to aid physicians in the characterization of polyps. Of the technologies evaluated by ASGE's PIVI initiative, NBI was the only one shown to meet the performance criteria for incorporation in clinical practice.2

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