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This system is composed of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with an Olympus video system center, light source, balloon control unit, splinting tube, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopic diagnosis and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral anal insertion.

Indications for Use of the Components are as follows:

SIF-Q180 (SMALL INTESTINAL VIDEOSCOPE)

This instrument has been designed to be used with an Olympus video system center, light source, single use splinting tube, balloon control unit, documentation equipment, video monitor, endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract (including the esophagus, stomach, duodenum, colon, and small intestine) by either oral and anal insertion.

OBCU (BALLOON CONTROL UNIT)

This balloon control unit has been designed for inflating and deflating the balloon attached to the distal end of a single use splinting tube in order to assist the insertion of an Olympus -designated small intestinal endoscope.

The subject device, Small Intestinal Videoscope system, is designed for endoscopy and endoscopic surgery within the small intestine. This system is composed of Small Intestinal Videoscope, Single Use Splinting Tube, and Balloon Control Unit and its accessories. The subject system is compatible with NBI observation which utilizes narrow-band spectrum to enhance contrast of the surface structure and fine capillary patterns of the mucous membranes. Also, the subject system utilizes a balloon attached to the splinting tube to facilitate advancement of the endoscope well within the small intestine.

This 510(k) summary for the Olympus Small Intestinal Videoscope System (K071254) does not contain the information requested about acceptance criteria, device performance, statistical studies, or ground truth establishment.

The document is a premarket notification for a medical device, which primarily focuses on demonstrating substantial equivalence to a predicate device. It addresses:

• General Information: Applicant, manufacturer, official correspondent.
• Device Identification: Trade name, common name, regulation number, regulation name, regulatory class, product code.
• Predicate Device Information: Details of the device it's being compared against.
• Device Description: A brief overview of the system components and their function.
• Indications for Use: The medical conditions and procedures for which the device is intended.
• Comparison of Technological Characteristics: How the new device is similar to and different from the predicate device, highlighting features like NBI observation and balloon technology.
• Conclusion: A statement that the device does not incorporate significant changes that would affect safety and effectiveness compared to the predicate.
• FDA Correspondence: The official letter from the FDA determining substantial equivalence, including regulatory compliance reminders.

The document does NOT provide:

1. Acceptance criteria or reported device performance data: There is no table detailing specific performance metrics (e.g., image resolution, depth of field, illumination, insertion success rates, diagnostic accuracy) or acceptance thresholds for these metrics.
2. Details of any study: No information is given about sample size, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set details. This is typical for a 510(k) submission where substantial equivalence is demonstrated through technological comparison rather than efficacy or performance studies against specific criteria.
3. Type of ground truth used: Since no study is described, no ground truth information is available.

Summary of missing information:

• Acceptance Criteria & Device Performance: Not reported.
• Sample Size (Test Set) & Data Provenance: Not reported, as no study is detailed.
• Number & Qualifications of Experts: Not reported.
• Adjudication Method: Not reported.
• MRMC Comparative Effectiveness Study: Not reported.
• Standalone Performance Study: Not reported.
• Type of Ground Truth: Not reported.
• Sample Size (Training Set): Not reported.
• Ground Truth for Training Set: Not reported.

In essence, this document establishes market clearance based on substantial equivalence to a previously cleared device, focusing on its intended use, design, and technological characteristics, rather than new clinical performance data or specific acceptance criteria.

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