(30 days)
Diversion of fecal matter to minimize external contact with the patient, to facilitate the collection of fecal matter for patients requiring stool management, and to provide access for colonic irrigation to trigger a defecatory response, and administration of enemas/medications.
IFMS Catheter (Bowel Mgt Sys) K012113
This document is a 510(k) summary for the "Indwelling Fecal Management System - Non-Sterile" (IFMS) manufactured by Bowel Management Systems, LLC. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the typical sense for a medical device with an AI component.
Therefore, much of the requested information regarding acceptance criteria, performance metrics, and study details for an AI-powered device is not applicable or available in this specific 510(k) submission.
Here's a breakdown of the information that can be extracted and where the document falls short for an AI-focused request:
1. Table of Acceptance Criteria and Reported Device Performance
- Not Applicable in the traditional sense for an AI device. This 510(k) is for a basic medical device (rectal irrigation tube) and does not involve AI or software performance metrics like sensitivity, specificity, or accuracy.
- The "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to predicate devices by matching or favorably comparing features, indications for use, and materials.
| Feature/Function | Predicate Device (Example: IFMS Catheter K012113) | This Device (IFMS - Non Sterile) |
|---|---|---|
| Intended Use/Indications for Use: | Diversion of fecal matter to minimize external contact with the patient, to facilitate the collection of fecal matter for patients requiring stool management, and to provide access for colonic irrigation to trigger a defecatory response, and administration of enema/medications. | Diversion of fecal matter to minimize external contact with the patient, to facilitate the collection of fecal matter for patients requiring stool management, and to provide access for colonic irrigation to trigger a defecatory response, and administration of enema/medications. |
| Material: | Silicone | Silicone |
| Bowel Retention Mechanism: | External balloon | External balloon |
| Bowel Irrigation Feature: | Silicone Lumen with flared capped port termination | Silicone Lumen with flared capped port termination |
| Enema/Medication Administration Feature: | Silicone Lumen with flared capped port termination | Silicone Lumen with flared capped port termination |
| Port Access for Sampling/Fluid Administration: | Sampling/fluid administration | Sampling/fluid administration |
| Sterility: | No | No |
| Conclusion of Equivalence (FDA determination): | "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." (This is the "reported device performance" in the context of a 510(k) for this type of device). | Substantially Equivalent |
2. Sample size used for the test set and the data provenance
- Not applicable. This document describes a physical medical device, not an AI algorithm. There is no "test set" in the context of evaluating algorithm performance. The "testing" would have focused on biocompatibility, integrity, and functional aspects through engineering tests, not data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth generation by experts is relevant for AI model training and validation. This device is not an AI model.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
5. 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. This device is a physical tube, not an AI software. MRMC studies are for evaluating human-AI interaction in diagnostic or interpretative tasks.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is hardware; there is no standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. There is no "ground truth" in the context of an AI algorithm's performance for this submission. The "ground truth" for a physical device would relate to its physical properties and functionality meeting design specifications and safety standards, typically assessed through engineering tests and material evaluations.
8. The sample size for the training set
- Not applicable. There is no AI model, therefore no training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary:
This 510(k) submission is for a conventional, non-AI medical device (Rectal Irrigation Tube). The document focuses on demonstrating substantial equivalence to pre-existing devices by comparing physical characteristics, materials, and intended uses. It does not contain any information related to AI acceptance criteria, study methodologies for AI performance, or data sets for AI training/testing. The "study" here refers to the process of demonstrating substantial equivalence to predicate devices, which primarily involves comparing features and functions as presented in the table 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.