(217 days)
For the fecal management of patients with little or no bowel control and for patients whose stool is semi-liquid or liquid
ConvaTec Fecal Management System
The provided text is a 510(k) Premarket Notification for the ConvaTec Fecal Management System. It primarily focuses on demonstrating substantial equivalence to a predicate device and biocompatibility testing. The document does not contain information about acceptance criteria or a study proving performance against such criteria. Therefore, I cannot extract the requested information from the provided text.
Here's a breakdown of what is and is not in the document:
What is present:
- Device Name: ConvaTec Fecal Management System
- Applicant: ConvaTec
- Intended Use/Indications: Fecal management for patients with little or no bowel control and for patients whose stool is semi-liquid or liquid.
- Predicate Device: Indwelling Fecal Management System (K012113)
- Classification: Gastrointestinal tube and accessories, 21 CFR 876.5980, Class II
- Biocompatibility Testing: States that testing was done according to ISO 10993 Part I (FDA modified matrix) and concluded the device is non-sensitizing, non-cytotoxic, and non-irritating.
- Regulatory Outcome: 510(k) clearance (substantial equivalence determination).
What is not present (and is required for your request):
- Specific acceptance criteria for device performance.
- Any study results (clinical or performance bench testing beyond biocompatibility) demonstrating the device meets performance criteria.
- Sample sizes for test sets, data provenance, ground truth establishment for a performance study.
- Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
- Standalone algorithm performance or training set details.
A 510(k) submission, especially for a device demonstrating substantial equivalence, often does not include detailed performance studies with acceptance criteria in the same way a de novo or PMA submission might. The "performance" in this context is often inferred from the predicate device and relevant bench testing (like biocompatibility and basic functional tests not detailed here).
§ 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.