(102 days)
The device is used to dilate the lower esophageal sphincter in patients with Achalasia. This device is indicated for adult use only.
The subject dilation balloon consists of an PET balloon attached to a 75 cm that is secured to a white Pebax Y junction with two extension lines leading with a wire guide hub and an inflation hub. The catheter has four black ink markers on the catheter.
The dilation balloon is composed of PET, with a patient contacting length of 8 cm which can be inflated to a single size of 30 mm or 35 mm in diameter. The balloon has a 1.16" long tip made of white Neuthane. Three tantalum radiopaque bands are placed underneath the balloon to assist in fluoroscopic visualization of the balloon.
The provided text describes a medical device, the Wilson-Cook Achalasia Balloon, and its substantial equivalence determination by the FDA. However, the document does not contain any information regarding acceptance criteria, device performance metrics, or a study involving AI or human readers.
Therefore, I cannot provide the requested information in the format of acceptance criteria, device performance, sample sizes, expert qualifications, or MRMC studies, as these details are completely absent from the given FDA letter and associated summary.
The document focuses on the regulatory clearance process for a traditional medical device (a balloon dilator) and its comparison to a predicate device. The information provided is primarily about:
- Device Name: Wilson-Cook Achalasia Balloon
- Intended Use: To dilate the lower esophageal sphincter in patients with Achalasia (adult use only).
- Predicate Device: Rigiflex II Single-Use Achalasia Balloon Dilator (K050232)
- Comparison: The subject device is considered "substantially equivalent" to the predicate, with minor differences outlined (materials, patient contacting length, dimensions, non-sterile packaging, and higher maximum inflation pressure). These differences are stated not to raise new questions of safety or effectiveness.
- Non-Clinical Testing: A list of performance tests conducted (e.g., Balloon Diameter and Length, Pressure Verification, Distensibility, Tensile Testing, Dimensional Verification, Functional Testing, Shelf Life Testing, Biocompatibility). These tests demonstrate that the device performs as intended, but specific acceptance criteria or quantitative results are not detailed in this summary.
In summary, the provided text describes the regulatory clearance of a physical medical device and its non-clinical testing for performance and equivalence to a predicate, not an AI/ML-driven device or study with the characteristics requested in your prompt.
§ 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.