(103 days)
The ActiFlo Indwelling Bowel Catheter System is intended for diversion of fecal matter to minimize external contact with the patient's skin, to facilitate the collection of fecal matter for patients requiring stool management, to provide access for colonic irrigation and to administer enema/medications.
The ActiFlo Indwelling Bowel Catheter System consists of a rectal catheter and accessories (waste collection bag, irrigation bag, skin barriers, syringe and lubricating jelly). The insertion end of the catheter contains a retention cuff and an intraluminal balloon, each with its own Luer connector used for inflation and deflation. A third connector provides a way to administer medications into the rectum and provides access for colonic irrigation. The ActiFlo Indwelling Bowel Catheter System allows stool to drain directly from the rectum into a closed or drainable collection bag.
The provided text is a 510(k) summary for the ActiFlo™ Indwelling Catheter System Kit, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and validation study results in the manner requested.
Therefore, the requested information regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text.
The document primarily compares the technological characteristics and indications for use of the ActiFlo™ system to two predicate devices (K023344 and K012113). It mentions "Accessory Performance Testing Conclusions" stating that "Biocompatibility testing was performed on the additional accessories based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1 and ISO 10993 biocompatibility testing standards. Product evaluation supports acceptability of the added accessories for their intended clinical use." However, this is a general statement about biocompatibility, not a detailed study of the device's primary function against specific performance acceptance criteria.
Key takeaways from the document:
- Device: ActiFlo™ Indwelling Catheter System Kit.
- Purpose: Diversion of fecal matter, collection of fecal matter for stool management, access for colonic irrigation, and administration of enema/medications.
- Regulatory Pathway: 510(k) submission, demonstrating substantial equivalence to predicate devices.
- Predicate Devices: K023344 (Indwelling Fecal Management System- Non-Sterile) and K012113 (Indwelling Fecal Management System (IFMS)).
- Testing Mentioned: Biocompatibility testing for accessories, conforming to G95-1 and ISO 10993 standards. This confirms material safety but not the functional performance of the device in its intended clinical use.
In summary, the provided text does not contain the specific details required to answer your questions about acceptance criteria and a study proving the device meets them because the 510(k) submission primarily relies on substantial equivalence to predicate devices, not on a new clinical performance study with detailed acceptance criteria.
§ 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.