(269 days)
The intended use of the device is to convert regulated continuous suction to "intermittent suction" appropriate for aspiration of gastro-intestinal fluid into two separate chambers that are reversed in on/off phases. This permits gravity "refeeding" of the aspirate during the "off" phases of cach chamber's cycle, while maintaining "continuous suction" on the aspiration tube.
The proposed device interrupts externally supplied continuous suction to individually provide "intermittent suction" to one or two aspiration catheters positioned in the patient's gastrointesunal tract.
Not Found
I am sorry, but there is no information about acceptance criteria and study data for the device (MossMed Dual Intermittent Aspirator) in the provided text. The documents provided relate to the 510(k) summary and the FDA's substantial equivalence determination letter, which do not typically contain detailed performance studies or specific acceptance criteria tables.
The available information includes:
- Device Name: MossMed Dual Intermittent Aspirator
- Manufacturer: Hudson Research, Inc.
- Applicant: Moss Medical Products, Inc.
- Predicate Device: Continuous & Programmable Intermittent Aspirator - Impact Instrumentation, Inc. (K951423)
- Indications for Use: The device interrupts externally supplied continuous suction to individually provide "intermittent suction" to one or two aspiration catheters positioned in the patient's gastrointestinal tract.
- FDA Determination: Substantially equivalent to the predicate device.
To answer your request, I would need a document that specifically details performance data, study designs, acceptance criteria, and ground truth establishment for the MossMed Dual Intermittent Aspirator.
§ 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.