K221590 is an FDA 510(k) clearance for the NaviCam Small Bowel Capsule Endoscopy System. Classified as System, Imaging, Gastrointestinal, Wireless, Capsule (product code NEZ), Class II - Special Controls.
Submitted by Ankon Technologies Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on December 2, 2022 after a review of 183 days - an extended review cycle.
This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1300 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.
View all Ankon Technologies Co., Ltd. devices
NCT05086471
Completed
Interventional
Performance Evaluation of the NaviCam SB Capsule Endoscope System for the Diagnosis of Small Bowel Diseases
Performance Evaluation of the NaviCam SB Capsule Endoscope System in Comparison to the PillCam SB3 Capsule System for the Diagnosis of Small Bowel Diseases
| Condition studied |
Small Bowel Disease |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
XiaoHua Hou, MD.PhD |
| Sponsor |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
|
Started 2021-09-23
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Primary completion 2021-12-01
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Completed 2021-12-30
Primary outcome
Diagnostic agreement rate
Secondary outcome
Intestinal transit time
Study completed - no results published.
This trial concluded in 2021 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov