(175 days)
The Bard® DigniCare Stool Management System is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients. Adult Use Only
The device is composed of a catheter which consists of a retention cuff, a trans-sphincteric zone and a drainage tube. In addition, the system contains a collection bag, a syringe, lubricating jelly, an underpad and a biological odor eliminator.
The catheter is connected to a collection bag. When the catheter is disengaged from the bag, the catheter automatically closes to prevent leakage. A plug is placed on the collection bag to contain the fecal matter within the bag.
The device is single-use and latex-frec
The provided text describes a 510(k) submission for the Bard® DigniCare Stool Management System. The submission aims to demonstrate substantial equivalence to predicate devices, rather than establishing separate acceptance criteria and proving performance through a distinct study.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The submission does not outline specific, quantitative acceptance criteria for the Bard® DigniCare Stool Management System in terms of performance metrics (e.g., success rate, leakage rate, etc.). Instead, the performance data provided focuses on demonstrating substantial equivalence to existing predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Summary from Document) |
|---|---|
| Substantial Equivalence to Predicate Devices | Functional, biocompatibility, and predicate device comparative testing have demonstrated that the subject device is as safe and effective as the predicate devices. The technological differences between the subject device and its predicate devices raise no new issues of safety or effectiveness. The device is substantially equivalent to currently marketed fecal management systems. |
Study Details
The document states that a study was conducted, but it's not a traditional clinical performance study with predefined acceptance criteria that are numerically reported. Instead, it's a comparative effectiveness assessment against predicate devices to establish substantial equivalence.
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Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a test set or any clinical study.
- It does not specify the country of origin of the data or whether it was retrospective or prospective. The term "predicate device comparative testing" suggests a comparison, but details are absent.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided in the document. The study described is not one that would typically involve expert-established ground truth in this manner (e.g., image interpretation).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable and not provided in the document.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not applicable and not provided in the document. The device is a physical medical device (stool management system), not an AI imaging or diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable and not provided in the document. The device is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document indicates that "functional, biocompatibility and predicate device comparative testing" was performed. This implies engineering and laboratory testing, and potentially some form of clinical comparison to predicate devices, but the specific "ground truth" (e.g., patient outcomes, pathology) for these tests is not detailed. The goal was to show similarity to existing devices, so the ground truth would inherently be derived from the performance profiles of the predicate devices.
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The sample size for the training set:
- This information is not applicable and not provided. The device is not an AI/ML device that requires a "training set."
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How the ground truth for the training set was established:
- This information is not applicable and not provided.
§ 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.