(271 days)
The Impact balloon dilation catheter is indicated for use in adult and adolescent patients to dilate esophageal strictures due to: esophageal surgery, primary gastroespoh reflux, radiation theropy.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device (B. Braun Impact Balloon Dilatation Catheter). It determines substantial equivalence to a predicate device but does not contain any information about acceptance criteria or a study proving device performance against such criteria.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document.
The document focuses on the regulatory clearance process, specifically the FDA's determination of substantial equivalence, which is a different aspect of device approval than a specific performance study against 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.