(255 days)
For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications.
The Flexi-Seal® SIGNAL™ Fecal Management System is comprised of a soft catheter tube assembly, a Luer Syringe, a collection bag with filter and a cinch clamp to pinch off flow in the catheter when required for medication retention. The components are contained in a snap closed tray.
The catheter main drain tube is fabricated from collapsible silicone rubber. The drain tube has a low-pressure polyurethane or silicone retention balloon at the distal end and a connector for attaching a collection bag (provided with the device and separately) at the proximal end. There is a recess under the balloon for the clinician's finger allowing the device to be positioned digitally.
Two ports are attached to the side of the catheter. One port is used to inflate the retention balloon with water or saline after the device has been inserted into the patient's rectum. This port also provides a visual and tactile signal of when the low pressure retention balloon is filled to its optimal volume. The other port is used to flush the device if needed and administer medication, if prescribed.
A syringe (provided with the device) is used to fill and evacuate the retention balloon for insertion and removal.
The device, collection bay and syringe are intended for single us, are provided nonsterile, and have no components made with animal products, natural rubber latex or DEHP.
This 510(k) concerns modifications to the indications for use, materials and design featured with the predecessor device, the ConvaTec Fecal Management System (ref. K032734).
The provided text outlines the performance summary of the Flexi-Seal® SIGNAL™ Fecal Management System. However, it does not include detailed acceptance criteria or a study design with specific metrics, sample sizes, expert qualifications, or ground truth establishment as would be typically found for AI/ML device evaluations.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. This means the device is compared against existing, legally marketed devices to show it performs similarly and is equally safe and effective.
Here's an analysis based on the provided text, addressing your questions where possible:
Acceptance Criteria and Device Performance
The document describes non-clinical testing performed to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Functional Equivalence | "device's performance has been found to be substantially equivalent to the aforementioned predicate devices both functionally..." (implies performance related to managing fecal incontinence, collecting stool, and providing medication access, similar to predicates) |
| Structural Equivalence | "...and structurally (material strength, catheter size, balloon size, etc.)" (implies device components meet comparable strength and dimensional specifications as predicates) |
| Biocompatibility | "The device has also been evaluated for biocompatibility in accordance with the US Food and Drug Administration's guidance entitled Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing', issued May 1, 1995, and has been found safe in such respect for its intended use." (implies meeting ISO 10993 standards for biological safety) |
Note: The document does not provide specific quantitative acceptance thresholds (e.g., "must collect X mL of stool per hour") or quantitative performance metrics (e.g., "collected Y mL of stool per hour"). The criteria are implicitly met by demonstrating "substantial equivalence" to predicate devices through non-clinical testing.
2. Sample size used for the test set and the data provenance
The document refers to "non-clinical testing" and states that "the device's performance has been found to be substantially equivalent." This implies laboratory or bench testing rather than clinical data from a "test set" of patient cases. Therefore, the concepts of data provenance (e.g., country of origin, retrospective/prospective) and a "test set" in the context of clinical data are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no mention of a "test set" requiring expert ground truth, as the evaluation was based on non-clinical, functional, and structural testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" or human review for this type of non-clinical evaluation.
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 fecal management system, not an AI/ML diagnostic or prognostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's evaluation is based on engineering and materials standards, functional performance specifications, and biocompatibility standards applied to the device and its predicate devices. For instance, material strength would be validated against established material properties, and biocompatibility against ISO 10993 standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical functional, structural, and biocompatibility testing. It is not an AI/ML device, and therefore, many of the typical questions related to AI/ML device evaluation (such as test set sample sizes, expert review, training data, MRMC studies) are not applicable to this submission. The "study" proving the device meets acceptance criteria is the aggregate of the described non-clinical tests that showed comparable performance to the legally marketed predicate devices.
§ 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.