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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.

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