(199 days)
The Bard® DigniShield® Stool Management System with odor barrier properties is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients and to provide access for the administration of medications. Adult use only.
The Bard® DigniShield® Stool Management System is sold as a tray (kit) including a catheter, collection bag and stand alone components. The catheter consists of a retention cuff, transsphincteric zone, drainage tubing, inflation arm, irrigation arm, flush arm and piston valve connector. The retention cuff and trans-sphincteric zone are constructed from silicone and the drainage tubing is constructed from a Thermoplastic Elastomer (TPE) material. The system includes a collection bag which is manufactured from the same TPE material as the drainage tubing. The collection bag interfaces with the catheter and allows for the collection of fecal matter. Additionally, the kit includes a syringe, lubricating jelly and odor eliminator. The tube clamp is used to retain medication during administration and the syringe is used to facilitate inflation of the catheter cuff.
The provided text describes the Bard® DigniShield® Stool Management System. This is a medical device, and the submission is a Traditional 510(k) for premarket notification, indicating it is a Class II device. The document focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving a novel performance claim through a clinical study. Therefore, the information requested for acceptance criteria, device performance, and study details like sample size, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not directly applicable or provided in this type of submission.
The section titled "Summary of Performance (Nonclinical)" states that "The subject device as substantially equivalent to the predicate device for all functions and relevant testing for performance testing and biocompatibility has been performed." This implies that the device was evaluated against established standards or predicate device performance, but specific quantitative acceptance criteria and detailed study results are not elaborated in the summary.
Here's a breakdown of the available information in relation to your request:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantitative metrics in this summary. The submission aims to demonstrate substantial equivalence to predicate devices, meaning it must meet the same safety and effectiveness profiles. This would typically involve non-clinical performance testing (e.g., fluid dynamics, strength, material compatibility) and biocompatibility, but specific numerical targets are not provided here.
- Reported Device Performance: The summary states that "The subject device as substantially equivalent to the predicate device for all functions and relevant testing for performance testing and biocompatibility has been performed." This indicates successful performance against relevant benchmarks, but specific data points or results are not included in this document.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This 510(k) summary does not describe a clinical study with a test set of patient data. The evaluation would have been based on non-clinical (benchtop) testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided, as there is no clinical test set requiring expert ground truth establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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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
- Not applicable/Not provided. This device is a stool management system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. The "ground truth" for this device would relate to engineering specifications, material properties, and functionality standards, not clinical outcomes in the context of expert diagnosis or pathology.
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The sample size for the training set
- Not applicable/Not provided, as this is not an AI/machine learning device.
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How the ground truth for the training set was established
- Not applicable/Not provided.
In summary, this 510(k) submission is for a physical medical device (stool management system) and relies on demonstrating substantial equivalence through non-clinical performance and biocompatibility testing, rather than clinical studies requiring patient data, expert review, or AI model training/testing. Therefore, most of the detailed information requested regarding clinical study design and performance metrics is not found in this type of regulatory document.
§ 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.