(38 days)
The Boston Scientific Corporation Rigiflex™ II Single-Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.
The Rigiflex™ II Single-Use Achalasia Balloon Dilator consists of a balloon, catheter shaft, distal tip and proximal end.
I am sorry, but based on the text provided, I cannot answer your request. The document is a 510(k) premarket notification for a medical device (Rigiflex™ II Single-Use Achalasia Balloon Dilator) and confirms its substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria, details of a study proving device performance against those criteria, sample sizes, expert qualifications, adjudication methods, or other elements you've requested.
The section "PERFORMANCE DATA" briefly mentions that "functional testing support a determination of substantial equivalence," but it does not elaborate on the data itself, the criteria it met, or the specifics of the study design. It also refers to a general FDA guidance document, not a report of specific study results for this device.
§ 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.