(242 days)
Used to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon.
The modified Hercules 3 Stage Wire Guided Balloon consists of coaxial catheter with a dilation balloon mounted on the distal tip. The balloon is inflatable with fluid to three distinct and progressively larger size diameters to exert pressure on strictures and affect dilation of the stricture. It is offered in a variety of balloon diameters. Supplied sterile and Intended for Single Use. Inflation device sold separately.
The provided text is a 510(k) summary for the Cook Endoscopy Hercules 3 Stage Wire Guided Balloon, dated January 23, 2009. This document is a regulatory submission to the FDA, not a study report detailing performance data and acceptance criteria for a device that uses an algorithm or AI.
Therefore, the requested information cannot be extracted from the provided text as it does not contain:
- A table of acceptance criteria and reported device performance: The document states, "We believe risks associated with the modifications to the subject device to be adequately addressed through our Design Control Process," but provides no specific performance data or acceptance criteria.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, or standalone algorithm performance: These concepts are relevant to studies involving algorithms or AI, which are not mentioned in this 510(k) summary for a medical device.
- Type of ground truth used: Not applicable as no study involving ground truth assessment is described.
- Sample size for the training set and how ground truth for the training set was established: These relate to AI/ML model development, which is not discussed.
The document is a declaration of substantial equivalence to a predicate device (Quantum T.T.C Balloon Dilation Catheter, K935094) based on similar intended use, fundamental design, operational principle, and scientific technology. It briefly describes the device, its intended use (to dilate strictures of the gastrointestinal tract), and its comparison to a legally marketed device. It does not include performance data in the format of a clinical study with acceptance criteria.
§ 876.5365 Esophageal dilator.
(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.