(95 days)
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No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML algorithms for data processing, decision making, or adaptation.
Yes.
The device is intended to prevent the release of stool from an end colostomy, which is a therapeutic function addressing a medical condition.
No
Explanation: The VITALA™ Continence Control Device is described as a "single-use device intended to prevent the release of stool from an end colostomy," which is a therapeutic rather than a diagnostic function. It is designed to manage output, not to diagnose a condition.
No
The device description clearly outlines a physical device with components like an "Air Seal," "soft foam insert," and an "expandable container." The 510(k) is for a modification to allow use with different physical skin barriers. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "prevent the release of stool from an end colostomy while allowing any flatus from the stoma to be deodorized and released." This describes a device that physically manages bodily waste externally.
- Device Description: The description details a mechanical device with an "Air Seal" and an "expandable container" for collecting stool. It functions by physically interacting with the stoma.
- Lack of Diagnostic Function: There is no mention of the device being used to test or analyze samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for health issues.
- Clinical Study Focus: The clinical study focuses on the safety and performance of the device in preventing stool leakage and managing flatus, not on diagnostic accuracy or the analysis of biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
EZQ
Device Description
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 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 ¾" (45mm) or 2 ¼" (57mm) ConvaTec Natura® skin barrier, and will accommodate a range of stoma diameters.
This 510(k) notification concerns a design modification for the Vitala™ Continence Control Device to allow its use with ConvaTec Moldable Technology™ skin barriers.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
stoma, end colostomies
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Clinical Study Summary:
A non-randomized, open-label, multi-center clinical study was conducted in the USA. The study was initiated on September 17, 2010 and completed on November 11, 2010, with a primary objective to assess the safety of the VitalaTM Continence Control Device when used with currently marketed ConvaTec Natura® moldable skin barriers featuring Stomahesive® or Durahesive® technologies in flange sizes of 45mm and 57mm, depending on the needs of the subject as determined by the investigator, during 12 hours of daily wear.
The planned methodology was to enroll 25 subjects with an end colostomy of at least 12 weeks duration with formed or semi-formed effluent who had a stoma that protruded no more than 2cm at rest (supine/lying down on the back), a willingness to wear a moldable skin barrier and an ability to complete self-care.
A total of 28 subjects were enrolled in this study across four study centers in the USA. Eight subjects who were moldable skin barrier users at baseline and 20 subjects who were non-moldable users at baseline were enrolled into the study. Twenty-four subjects (85.7%) completed the study while four subjects (14.3%) discontinued from the study. Overall, 27 subjects wore the Vitala™ device.
In general, 91% of subject responses rated their use of the Vitala™ device as either "good" or "very good" in its ability to restore continence. The majority of subject responses (54%) rated the Vitala™ device as "very good" in restoring continence. There were only six subject responses (8%) that rated it "poor" and only one subject response (1%) rated it "very poor." Additionally, the majority of subject responses (76%) stated that the Vitala™ device was their preferred method of ostomy management.
Overall, the rate of adverse events (AEs) during the Moldable Stage (where subjects used ConvaTec Natura® moldable skin barrier products prior to use of the Vitala™ device) was 0.003 and during the Vitala™ Stage it was identified at 0.014 per patient per day. Influenza and erythema were the most commonly reported AEs (two subjects, 7.4%). Three subjects (11.1%) had AEs that were considered moderate in severity during the Vitala™ wear period. One subject (3.7%) in the Moldable Stage had an AE (hypersensitivity) that was considered related to the skin barrier while two subjects (7.4%) in the Vitala™ Stage had AEs (erythema) that were related to the study device.
Stoma vascularity results provided no evidence of any changes in stoma oxygen saturation (SO2) or the development of hypoxic regions in the stoma and hyperoxic regions in the stoma as a result of wearing the Vitala™ device with ConvaTec Moldable Technology™ skin barrier products.
In conclusion, safety results therefore showed no serious adverse events and no abnormal findings during the Vitala™ Stage. No stoma related or gastrointestinal related AEs were reported that were related to the Vitala™ device. Stoma vascularity results provided no evidence of any changes in stoma SO2 or the development of hypoxic regions in the stoma as a result of wearing the Vitala™ device. The Vitala™ device demonstrated continence during 12 hour wear based on both objective and subjective measurements when worn with moldable products. Any leakage rates were low during the Vitala™ Stage and identical to the Moldable Stage. Subject responses showed that subjects found the VitalaTM device easy to use with moldable skin barriers. Odor prevention and stoma noise prevention also improved in the Vitala™ Stage as compared to the Moldable Stage. The majority of subjects also stated that the Vitala™ device was the preferred method of ostomy management.
Overall, results from this study indicate that the Vitala™ device with its new modifications is safe and performs as expected when worn up to 12 hours daily with ConvaTec Moldable Technology™ skin barrier products.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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