(89 days)
The VITALA™ Continence Control Device is a single-use device intended to prevent the release of stool from an end colostomy while allowing any flatus from the stoma to be deodorized and released.
To be used only with a 1 ¾ in. (45 mm) or 2 ¼ in. (57 mm) ConvaTec NATURA® skin barrier. Not intended for use with ConvaTec Moldable Technology™ skin barriers.
The Vitala™ Continence Control Device is a pouchless ostomy device consisting of a self-inflating Air Seal which contacts a stoma and is held against the stoma with a low pressure, allowing flatus to be deodorized and vented while retaining stool. The Air Seal contains a soft foam insert that expands to fill the Air Seal, causing the Air Seal to expand with it. As it expands, the Air Seal gently contacts the stoma and conforms to the shape of the stoma, and is held against the stoma with a low pressure. The Air Seal will re-inflate to remain in contact with the stoma if the stoma retracts or moves away from the Air Seal.
The Vitala™ Continence Control Device also includes an expandable container to collect stool during removal of the device. This single use device is designed to be used only with a 1 ½" (45mm) or 2 ¼" (57mm) ConvaTec Natura® skin barrier, and will accommodate a range of stoma diameters.
The Vitala™ Continence Control Device is indicated for individuals with end colostomies. The device is not intended for use until the abdomen and peristomal area have fully healed from bowel surgery (typically 6-12 weeks post surgery), or for use with a stoma protrusion greater than 2 cm (when lying down). The device should also not be used in individuals with end colostomies with a history of chronic liquid stool. ConvaTec Moldable Technology™ skin barriers should not be used with the Vitala™ device.
This 510(k) notification concerns modification of the labeling for the Vitala™ Continence Control Device to allow an expanded wear time of up to 12 hours per day for the device as well as expanded compatibility with ConvaTec Natura® convex products. Otherwise, the design, materials, and manufacture of the device remain unchanged from its description in 510(k) Premarket Notification K083785, except that its deflation shield is now made from polypropylene.
The provided document describes two clinical studies conducted to demonstrate the safety and effectiveness of the Vitala™ Continence Control Device for an extended wear time of up to 12 hours per day and its compatibility with ConvaTec Natura® convex products.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on safety and effectiveness, rather than specific acceptance criteria thresholds. However, we can infer the primary objectives of the studies served as the de facto acceptance criteria.
| Acceptance Criteria (Inferred from Study Objectives) | Reported Device Performance |
|---|---|
| Safety: | |
| * Frequency of adverse events (AEs) related to stoma, GI, and surrounding skin. | Study #1: Overall AE rate: 0.01 per patient per day. Most AEs were mild/moderate; 27 severe/very severe AEs, of which 2 were possibly device-related. |
| Study #2: Overall AE rate during Vitala™ Stage: 0.02 per patient per day. Most AEs were mild/moderate; 1 very severe AE, not device-related. | |
| * Microbiology profile (no harmful changes to normal flora). | Study #1: No obvious or harmful changes to normal flora noted. No aberrant flora in GI event samples. |
| Study #2: Not discussed for this study. | |
| * Stoma vascularity (no significant difference in oxygen saturation, no hypoxic regions). | Study #1: No significant difference in mean oxygen saturation (SO2). No evidence of systematic development of hypoxic regions. |
| Study #2: No evidence of changes in stoma/peristomal skin SO2 or development of hypoxic/hyperoxic regions. | |
| * No device-related serious adverse events (SAEs). | Study #1: 2 severe/very severe AEs "possibly related" out of 27. |
| Study #2: No Vitala™ device related SAEs. | |
| Effectiveness: | |
| * Ability to restore continence (general patient rating). | Study #1: 86.9% of subjects rated the device "good" or "very good" in its ability to restore continence. |
| Study #2: 64% of subjects rated the device "good" or "very good" in its ability to restore continence. | |
| * Compatibility with ConvaTec Natura® convex products. | Study #2: Device was found safe and effective when worn with convex products. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Study #1:
- Sample Size: 78 subjects enrolled; 66 subjects wore the Vitala™ device.
- Data Provenance: Multi-national (USA and Europe), Prospective, Open-label.
- Study #2:
- Sample Size: 27 subjects enrolled.
- Data Provenance: USA, Prospective, Open-label.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
The document does not mention the involvement of "experts" in establishing a ground truth in the traditional sense (e.g., for image analysis). The studies are clinical trials where patient outcomes, adverse events, microbiology, and vascularity measurements directly constitute the data. Clinical investigators would interpret these findings. No specific number or qualifications of "experts" are provided to establish a separate "ground truth" for the test set beyond the clinical evaluation itself.
4. Adjudication Method for the Test Set:
The document does not describe a formal "adjudication method" in the context of resolving discrepancies in expert interpretations, as would be common in diagnostic studies. The clinical studies collected safety and effectiveness data directly from subjects and medical assessments. Adverse events would likely be classified and reviewed by study investigators and reported, but no specific adjudication process (like 2+1 or 3+1) is detailed.
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 device is a physical medical device (continence control device), not an AI/diagnostic software. Therefore, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This device is a physical medical device and does not involve an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. The Type of Ground Truth Used:
The "ground truth" for these studies is based on:
- Self-reported patient outcomes: Continence perception, adverse events.
- Clinical assessments: Severity of adverse events, stoma and skin condition.
- Objective measurements: Microbiology results, stoma vascularity (oxygen saturation).
Essentially, a combination of patient-reported outcomes and clinical/physiological data served as the basis for evaluating safety and effectiveness.
8. The Sample Size for the Training Set:
This device is a physical medical device and does not involve AI or machine learning algorithms that require a "training set." Therefore, no training set was used.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set.
§ 876.5900 Ostomy pouch and accessories.
(a)
Identification. An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.