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.

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.

AI/ML Overview

The information provided describes a 510(k) premarket notification for a design modification of the VITALA™ Continence Control Device, primarily focusing on its compatibility with ConvaTec Moldable Technology™ skin barriers. The document outlines a clinical study and some bench testing.

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative, pre-defined manner typical of clinical trial endpoints. Instead, it describes outcomes and draws conclusions based on those outcomes. We can infer performance against safety and effectiveness observations.

Acceptance Criteria (Inferred from Study Goals)	Reported Device Performance (Summary)
Safety:
Absence of serious adverse events	No serious adverse events reported.
Minimal non-serious adverse events	Overall AE rate during Vitala™ Stage: 0.014 per patient per day. Most common AEs: influenza and erythema (2 subjects, 7.4%). 3 subjects (11.1%) had moderate AEs during Vitala™ wear. 2 subjects (7.4%) had AEs (erythema) related to the Vitala™ device.
No detrimental changes to stoma vascularity	No evidence of changes in stoma oxygen saturation (SO2) or development of hypoxic/hyperoxic regions in the stoma due to wearing the Vitala™ device with moldable skin barriers.
No stoma-related or GI-related AEs	No stoma-related or gastrointestinal-related AEs reported that were related to the Vitala™ device.
Effectiveness:
Continence during 12-hour wear	Demonstrated continence during 12-hour wear based on both objective and subjective measurements when worn with moldable products.
Low leakage rates	Leakage rates during the Vitala™ Stage were low and identical to the Moldable Stage (pre-Vitala™).
User preference and satisfaction	91% of subject responses rated use as "good" or "very good" for restoring continence (54% "very good"). 76% preferred the Vitala™ device for ostomy management. Subjects found the device easy to use with moldable skin barriers. Odor prevention and stoma noise prevention improved in the Vitala™ Stage. Only 8% rated it "poor" and 1% "very poor" for restoring continence.
Compatibility with Moldable Technology™ skin barriers	The study specifically assessed and concluded on the safety and effectiveness of the modified device "when used with ConvaTec Moldable Technology™ skin barriers."

2. Sample size used for the test set and the data provenance

Sample Size (Clinical Study):
- Enrolled: 28 subjects.
- Completed: 24 subjects (85.7%).
- Wore device: 27 subjects (total who wore the Vitala™ device).
Data Provenance: USA (multi-center clinical study). The study was initiated on September 17, 2010, and completed on November 11, 2010, making it a prospective study for the purpose of this notification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number of experts for ground truth or their qualifications. The study was "non-randomized, open-label," and included "investigator" determination for subject needs. Safety and effectiveness were assessed via AE reporting and "objective and subjective measurements," but the specific roles and qualifications of those evaluating these measures (e.g., clinicians, nurses, specialists) are not detailed as explicitly "expert" ground truth adjudicators in the medical imaging sense.

4. Adjudication method for the test set

The document does not describe an adjudication method in the context of multiple readers/experts reaching consensus on a particular finding, which is typically found in imaging studies. The assessment of safety and effectiveness appears to be primarily based on reported adverse events, subject feedback, and clinical observations (e.g., stoma vascularity results).

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

There was no MRMC comparative effectiveness study and no mention of AI assistance. This device is a physical medical device, not an AI/software-as-a-medical-device (SaMD).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical medical device, not an algorithm. However, its "standalone" performance as a device was evaluated in the clinical study, with human users ("human-in-the-loop" in the sense of operating it), but without a pre-existing "without AI assistance" baseline for improvement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical study was established through a combination of:

Clinical observation and assessment: By investigators for adverse events and stoma health (e.g., stoma vascularity, SO2).
Subjective feedback/Patient-reported outcomes: Subject responses regarding continence restoration, ease of use, preference, odor prevention, and stoma noise prevention.
Objective measurements: While not explicitly detailed, "objective measurements" were mentioned for continence during 12-hour wear, presumably including direct observation or measurement of leakage.

8. The sample size for the training set

The document describes a clinical study and bench tests for this specific 510(k) submission. It does not mention a training set in the context of machine learning. The clinical study described in detail here is effectively the "test set" for validating the modified device.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for an AI model.

Summary

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<111365

AUG 1 9 2011

510(k) SUMMARY

Subject Device:	VITALA™ Continence Control Device
Date Prepared:	May 12, 2011
Applicant:	ConvaTec Inc.200 Headquarters Park DriveSkillman, New Jersey 08558
Contact:	Charles RyanAssociate Director, US Regulatory AffairsTel: 908-904-2500Fax: 908-904-2235
Device Trade Name:	Vitala™ Continence Control Device
Classification Name:	Ostomy Pouch and Accessory (ref. 21 CFR 876.5900; Product Code EZQ)
Device Class:	Class I
Predicate Device Trade Name:	Vitala™ Continence Control Device
Classification Name:	Ostomy Pouch and Accessory (ref. 21 CFR 876.5900; Product Code EZQ)
Device Class:	Class I
510(k) Substantial Equivalence:	K102536 - determined substantially equivalent onDecember 1, 2010K083785 - determined substantially equivalent onApril 2, 2010

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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 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 (until 6 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.

This 510(k) notification concerns a design modification for the Vitala™ Continence Control Device to allow its use with ConvaTec Moldable Technology™ skin barriers.

ConvaTec has performed additional non-clinical, bench testing to assess the safety and effectiveness of the design modification (the addition of the air seal cap), which allows expanded compatibility of the Vitala™ Continence Control Device when used with ConvaTec Moldable Technology™ skin barriers. Such testing included the following:

. Air Bag Leak Rate
Air Flow ●
Inflation Time .
Foam Pressure

ConvaTec has performed a clinical study to assess the safety and effectiveness of the modified design of the Vitala™ Continence Control Device and its compatibility with ConvaTec Moldable Technology™ skin barriers.

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.

Ciur world in what we make on it

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K111365
page 3 of 4

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

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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.

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.

Overall Conclusions

There are no significant differences in the intended use between the subject and predicate Vitala™ Continence Control Devices. The Vitala™ device is non-invasive to the stoma, and has demonstrated substantial equivalence as well as safety and effectiveness through use in clinical studies and vascularity testing of the stoma.

Based on the evidence provided, we propose that the modified Vitala™ Continence Control Device can be used safely and effectively for individuals with end colostomies to prevent the release of stool from an end colostomy, when used with ConvaTec Moldable TechnologyTM skin barriers.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Mark R. Jakubowski Manager, Regulatory Affairs ConvaTec Inc. 200 Headquarters Park Drive SKILLMAN NJ 08558

AUG 1 9 2011

Re: K111365

Trade/Device Name: VITALATM Continence Control Device Regulation Number: 21 CFR& 876.5900 Regulation Name: Ostomy pouch and accessories Regulatory Class: 1 Product Code: EZQ Dated: August 12, 2011 Received: August 15, 2011

Dear Mr. Jakubowski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Lehman MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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Traditional 510(k) Premarket Notification VITALA Continence Control Device

Indications For Use

KIII 365 510(k) Number (if known): Not Yet Assigned

Device Name: VITALA™ Continence Control Device

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 % in. (45 mm) or 2 ¼ in. (57 mm) ConvaTec NATURA® skin , barrier.

Prescription Use (21 CFR 801 Subpart D) AND/OR

Over the Counter Use XX (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulel Remen

e, Gastro-Re

Page 1 of 1

ConvaTec Inc.

Regulation Number and Section

§ 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.