(15 days)
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 the Olympus Video System Center, light source, endoscope balloon controller, splinting tube, balloons, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral or anal insertion.
The subject device, Small I surgery within the small intrisune. The subject device utilizes senuential geolovment of two bailouns, one attached to an gastrointestinal . ment of the endoscope well within the small intestine. The suppor over can access inrough the small intestine via either oral or anal introduction.
The provided 510(k) summary (K051551) for the "SMALL INTESTINAL VIDEOSCOPE SYSTEM" does not include a detailed study with acceptance criteria and reported device performance in the way a modern AI/ML device submission would. This document is from 2005, and the device in question is a medical endoscope system, not an AI-powered diagnostic tool. Therefore, the traditional acceptance criteria and study design elements typically associated with AI/ML device evaluations (like sensitivity, specificity, AUC, sample sizes for training/test sets, ground truth establishment by experts, MRMC studies, etc.) are not present in this submission.
Instead, this 510(k) submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, intended use, and materials.
Here's an attempt to answer the questions based on the available information, noting where no direct information is provided due to the nature of the device and submission type:
1. A table of acceptance criteria and the reported device performance
No explicit "acceptance criteria" or "reported device performance" in terms of quantitative metrics (e.g., sensitivity, specificity, accuracy) are presented in this 510(k) summary. The acceptance criteria for this type of device and submission are implicitly met by demonstrating substantial equivalence to predicate devices, meaning the device performs as safely and effectively as a legally marketed predicate device. The performance is summarized by comparing physical specifications and material commonalities.
| Area of Comparison | Acceptance Criteria (Implicit) | Reported Device Performance (as presented) |
|---|---|---|
| Technological Characteristics | No significant differences that would raise new questions of safety or effectiveness compared to predicates. | XSIF-160DB vs. K001241 (PCF-160AL/I) & K031256 (XSIF-1TQ140A): |
- Field of View: 140° (same as predicates)
- Depth of Field: 3~100 mm (same as predicates)
- Direction of View: 0° Forward Viewing (same as predicates)
- Outer Diameter of Distal End: φ 9.2 mm (smaller than predicates)
- Outer Diameter of Insertion Tube: φ 9.2 mm (smaller than predicates)
- Working Length: 2000 mm (different, but within typical variations for endoscopes)
- Inner Diameter of Instrument Channel: φ 2.8 mm (smaller than XSIF-1TQ140A, larger than PCF-160AL/I)
XSIF-160DB vs. K040048 (EN-450P5/20): - Field of View: 140° (larger than predicate's 120°)
- Depth of Field: 3
100 mm (predicate 5100 mm) - Direction of View: 0° Forward Viewing (same as predicate)
- Outer Diameter of Distal End: φ 9.2 mm (larger than predicate's φ 8.5 mm)
- Outer Diameter of Insertion Tube: φ 9.2 mm (larger than predicate's φ 8.5 mm)
- Inner Diameter of Instrument Channel: φ 2.8 mm (larger than predicate's φ 2.2 mm) |
| Intended Use | Identical or highly similar to predicate devices. | "Designed to be used with the Olympus Video System Center, light source, endoscope balloon controller, splinting tube, balloons, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral or anal insertion." (Essentially identical to general endoscope intended uses). |
| Materials | Patient contact materials are identical to those in legally marketed predicate Olympus devices. | "All the patient contact materials used in the SMALL INTESTINAL VIDEOSCOPE SYSTEM are identical to those used in the legally marketed Olympus devices." |
| Safety and Effectiveness | No new questions of safety or effectiveness are raised compared to predicate devices. Non-clinical tests support this. | "When compared to the predicate devices, SMALL INTESTINAL VIDEOSCOPE SYSTEM do not the safety and offectiveness, In intended use, method of operation, material, or design that could affect the safety and effectiveness. In addition, the provided of operation, or design that could and efficacy of the subject system." (This statement is slightly garbled in the scan but suggests no new safety/effectiveness concerns). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for a physical medical device (endoscope), not a software/AI device that requires a test set of data for performance evaluation. The "study" here is a comparison of specifications and intended use against existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment by experts for a test set is part of this type of submission for a physical endoscope.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set adjudication method is relevant for this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no ground truth concept in the context of this 510(k) submission as it's not evaluating diagnostic or interpretation performance.
8. The sample size for the training set
Not applicable. This is not a software/AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set or associated ground truth.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.