(160 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-lock syringe, a collection bag with cap and a cinch clamp to pinch off flow in the catheter when required for medication retention or to stop waste flow. The components are contained in a rigid thermoformed plastic clamshell. The catheter main drain tube is fabricated from collapsible silicone rubber with the addition of an odor adsorber, which is added in order to help contain the fecal odor which often permeates through the wall of the catheter. The drain tube has a low-pressure silicone retention balloon at the distal end and a connector for attaching a collection bag (provided with the device and also available separately) at the proximal end. There is a recess (pocket) under the balloon for the clinician's finger, which allows 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. An additional sampling port is located on the side of the catheter, which allows access to clinicians for stool sample collection. A syringe (provided with the device) is used to fill and evacuate the retention balloon for insertion and removal. The device, collection bag and syringe are intended for single us, are provided non-sterile and contain no components made with animal products, natural rubber latex or DEHP.
The provided document is a 510(k) premarket notification for a medical device called the Flexi-Seal® Signal™ Fecal Management System. This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing detailed acceptance criteria and a study to prove they are met in the manner one might find for a novel device or AI/software.
However, I can extract and infer information relevant to your request based on the content available.
Here's an analysis of the acceptance criteria and the study as described in the document, framed around your specific questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in a quantitative, pass/fail table format with specific thresholds and reported performance against those thresholds like one might see for a diagnostic device's sensitivity/specificity. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to a predicate device (Flexi-Seal® SIGNAL™ Fecal Management System, K112342). The performance is reported as being "substantially equivalent" in various parameters.
| Parameter (Implied Acceptance Criteria) | Reported Device Performance (Subject Device K150350) | Comparison to Predicate (K112342) |
|---|---|---|
| Intended Use (Collect liquid to semi-liquid stool, administer medications) | Manage fecal incontinence through collection of liquid to semi-liquid stool and provide access to administer medications | Same as predicate |
| Functional Configuration (Collapsible catheter, distal end secured, proximal to collection bag) | Collapsible catheter with distal end secured in rectum and proximal end connected to a collection bag | Same as predicate |
| Retention Feature (Soft annular balloon) | Soft annular balloon | Same as predicate |
| Balloon Material (Silicone rubber) | Silicone rubber | Same as predicate |
| Inflation Management (Sealed water-filled balloon) | Sealed water-filled balloon | Same as predicate |
| Retention Balloon Inflation Material (Water/saline - 45ml) | Water/saline (45ml) | Same as predicate |
| Catheter Tube Length (1,550mm - 1,670mm) | 1,550mm - 1,670mm | Same as predicate |
| Length of Sphincter Section (>10cm) | >10cm | Same as predicate |
| Drain Channel (Large main drain tube) | Large main drain tube | Same as predicate |
| Inflation/Irrigation Port Connections (Luer) | Luer | Same as predicate |
| Inflation Lumen Diameter (Two lumens at 1.45 mm) | Two lumens at 1.45 mm | Same as predicate |
| Inflation Lines (2) | 2 | Same as predicate |
| Irrigation Lines (1) | 1 | Same as predicate |
| Sampling Port (Closable snap seal for catheter syringe access) | Closable snap seal for catheter syringe access | Same as predicate |
| Collection Bag Configuration (Disposable with gas filter) | Disposable with gas filter | Same as predicate |
| Collection Bag Size (1 liter disposable) | 1 litre disposable | Same as predicate |
| Method of Bed Connection (Hanging strap on bag connector) | Hanging strap on bag connector | Same as predicate |
| Accessory Components (Syringe and cinch clamp) | Syringe and cinch clamp | Same as predicate |
| Flow Stop Mechanism (External cinch clamp) | External cinch clamp | Same as predicate |
| Sterility Status (Non-sterile) | Non-sterile | Same as predicate |
| Packaging (Thermoformed plastic clamshell) | Thermoformed plastic clamshell | Same as predicate |
| Material Softness | Maintained/evaluated via bench testing | Substantially equivalent |
| Catheter Tube Diameter | Evaluated via bench testing | Substantially equivalent |
| Catheter Tube Hardness | Evaluated via bench testing | Substantially equivalent |
| Catheter Tube Tensile Strength | Evaluated via bench testing | Substantially equivalent |
| Balloon-Catheter Bonding | Evaluated via bench testing | Substantially equivalent |
| Biocompatibility | Tested per ISO-10993 | Found safe for intended use |
| Odor Adsorbing Properties (Added feature) | Incorporates odor adsorber to help contain fecal odor | Difference (Advantageous to patient wellbeing) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical bench testing rather than human clinical studies with a test set of patients. Therefore, specific sample sizes for a "test set" in the context of patient data are not applicable. The testing was conducted by ConvaTec Ltd. which is based in the UK. The document does not specify if the testing was done at their UK facility or elsewhere, nor does it refer to "retrospective" or "prospective" as these terms typically apply to clinical studies using patient data.
3. 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)
This question is not applicable. The device is a physical medical device, not a diagnostic algorithm requiring expert "ground truth" for interpretation. The evaluation involved bench testing of physical properties and biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when interpreting ambiguous results, often involving multiple readers. This premarket notification describes bench testing for substantial equivalence, not such a clinical study.
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
This question is not applicable. The device is a physical fecal management system, not an AI or software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical and functional parameters, the "ground truth" is established by bench testing against engineering specifications and performance standards. For biocompatibility, the "ground truth" is established by adherence to ISO-10993 standards. These are objective, measurable physical properties, not subjective interpretations or clinical outcomes in the typical sense of "ground truth".
8. The sample size for the training set
This question is not applicable. This is a physical device clearance, not an AI/ML submission that would involve a "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no "training set" for this type of device submission.
§ 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.