(121 days)
The BARD® DigniShield™ Stool Management System is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients.
The BARD® DigniShield™ Stool Management System is sold as a tray (kit). The catheter portion of the system consists of a retention cuff, a trans-sphincteric zone and a drainage tube which are constructed from a Styrenic-based Thermoplastic Elastomer (TPE) material. The system includes a collection bag which is also manufactured from the same TPE material. Additionally, the tray (kit) contains stand alone finished components, a syringe, lubricating jelly, and an odor eliminator. The collection bag interfaces with the catheter and allows for the collection of the fecal matter. The syringe is used to facilitate the inflation of the retention cuff portion of the catheter. The lubricating jelly is provided to minimize patient discomfort and irritation of the rectum while the device is being inserted into the rectal vault. The catheter is connected to a collection bag. When the catheter is disconnected from the collection bag, the self-sealing mechanisms of both the catheter and collection bag are engaged. This minimizes the leakage of fecal matter from either the catheter or the collection bag. The device is single-use, non-sterile, and has no components made of natural rubber latex.
Here's an analysis of the provided text regarding the BARD® DigniShield™ Stool Management System, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria (e.g., a certain percentage of successful insertions, a specific rate of leakage reduction) are not explicitly stated. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through functional and structural integrity testing.
| Acceptance Criteria (Implied) | Reported (Demonstrated) Device Performance |
|---|---|
| Functional and Structural Integrity | "Functional and structural integrity testing characteristic of devices of this type (e.g., tensile strength, dimensional, cuff inflation, etc.,}, including biocompatibility testing in accordance with ISO 10993 has been performed on the subject device demonstrating that it is as safe and effective, and is substantial equivalent to legally marketed predicate device(s)." |
| Material Compatibility (Biocompatibility) | Biocompatibility testing performed in accordance with ISO 10993. |
| Equivalent Safety and Effectiveness to Predicate Devices | The device "is as safe and effective, and is substantial equivalent to legally marketed predicate device(s)." The only technological difference (TPE material vs. silicone/LPDE) "does not raise any new issues of safety or effectiveness." |
| Intended Use Compatibility | "The BARD® DigniShield™ Stool Management System is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients." The device is deemed substantially equivalent for this intended use. |
| Minimization of Fecal Leakage (during disconnection) | "When the catheter is disconnected from the collection bag, the self-sealing mechanisms of both the catheter and collection bag are engaged. This minimizes the leakage of fecal matter from either the catheter or the collection bag." (This is a design feature claimed, but not explicitly measured with performance criteria in the provided text). |
| Patient Comfort/Irritation (during insertion) | "The lubricating jelly is provided to minimize patient discomfort and irritation of the rectum while the device is being inserted into the rectal vault." (A design provision, not a measured performance metric in the text). |
Summary of Study Information:
The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical trial with specific performance endpoints. Therefore, many of the requested details about a clinical study are not present in this submission.
2. Sample Size Used for the Test Set and Data Provenance
The document only states that "Functional and structural integrity testing... has been performed." It does not specify:
- The sample size of devices used for this testing.
- The data provenance (e.g., country of origin, retrospective or prospective). This testing appears to be bench testing or in-vitro performance evaluation, not human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The study described is functional and structural integrity testing (bench testing, biocompatibility), not a clinical study requiring expert assessment of patient data.
4. Adjudication Method for the Test Set
Not applicable. There's no indication of a clinical test set or subjective assessments that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document makes no mention of a multi-reader multi-case comparative effectiveness study or human readers improving with or without AI assistance. This device is a physical medical device, not an AI software.
6. Standalone (Algorithm Only) Performance Study
No. This is a physical device, not an algorithm.
7. Type of Ground Truth Used
For the functional and structural integrity testing, the "ground truth" would be established engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and performance benchmarks derived from the predicate devices. For biocompatibility, the ground truth is defined by the ISO 10993 standards for biological evaluation of medical devices.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
§ 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.