The Uresta bladder support is indicated for use in adult women over 18 years of age who experience stress urinary incontinence (involuntary urine loss, such as a pee leak that occurs when you cough, laugh, sneeze or with some physical tasks).

Device Description

Uresta® is a bell-shaped vaginal bladder support that is intended to support the urethra to help reduce leaks caused by stress urinary incontinence. It has a tapered tip for insertion into the vaginal introitus and a handle end to enable placement and removal. It may also be used with a water-based lubricant for easier insertion. Uresta® is available in five (5) sizes, ranging from 34 mm (size 2) to 52 mm (size 6). It can be inserted in the morning and removed at bedtime every day or used just for specific activities such as exercise and removed after the activity. Uresta® is molded from non-latex thermoplastic rubber and is provided non-sterile for single patient use.

AI/ML Overview

This document is a 510(k) summary for the Uresta® vaginal pessary, seeking an Over-The-Counter (OTC) indication in addition to its existing Prescription (Rx) indication. The core of the submission revolves around demonstrating that the device can be appropriately self-selected and used by a lay user population for OTC use.

Based on the provided text, the specific details regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" are focused on the usability study conducted to support the OTC claim.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of quantitative acceptance criteria and specific numerical performance results for the usability study. Instead, it states the overall conclusion.

Acceptance Criteria (Inferred from Study Purpose)	Reported Device Performance
Self-Selection: Patients can correctly determine if they meet the criteria to be an intended user based on package labeling.	"Women who were naïve to the device reviewed the external product packaging and determined if they met the criteria to be an intended user. The self-selection was confirmed via clinical diagnosis." (Implicitly, the performance was adequate to support the OTC claim, as the conclusion states patients can appropriately self-select.)
Labeling Usability & Independent Use: Intended users can understand the Instructions for Use (IFU) and independently insert and fit the device without guidance.	"Intended users then participated in a labeling usability simulated study in which they reviewed the Instructions for Use and independently inserted and fit the device without guidance." "The results of the self-selection and usability study demonstrate that patients can self-select and use the device appropriately." (Similar to self-selection, the performance was deemed appropriate.)

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

Sample Size: The document does not explicitly state the numerical sample size for the usability study. It refers to "women who were naïve to the device" and "intended users."
Data Provenance: The document does not specify the country of origin. Given the context of a 510(k) submission to the FDA, it's highly implied to be a study relevant to the U.S. patient population. The study was prospective as it involved active participation of individuals in a simulated usability environment.

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

Number of Experts: The document mentions "clinical diagnosis" for confirming self-selection, implying healthcare professionals were involved in verifying eligibility. However, it does not specify the number of experts or their qualifications (e.g., specific medical specialties or years of experience).
Qualifications: "Clinical diagnosis" suggests a qualified medical professional, but specific qualifications are not provided.

4. Adjudication method for the test set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in the usability study. The "clinical diagnosis" for confirming self-selection suggests a direct clinical assessment rather than a multi-reader, multi-case review.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or relevant in this submission. This is a medical device (vaginal pessary), not an AI/software-as-a-medical-device (SaMD) that assists human readers in interpreting medical images or data.

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 (vaginal pessary), not an algorithm or AI system.

7. The type of ground truth used

The ground truth for the usability study essentially revolved around:

Clinical Diagnosis: To confirm whether participants met the medical criteria for stress urinary incontinence after they self-selected based on packaging information.
Observed Performance: Direct observation of participants' ability to interpret the Instructions for Use and successfully insert/fit the device independently.

8. The sample size for the training set

This question is not applicable. The "training set" concept is relevant for machine learning algorithms. This submission describes usability testing of a physical medical device, not an algorithm.

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

This question is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 3, 2024

Resilia Inc. % Roshana Ahmed President Ouaras. LLC 2101 Camino Rey Fullerton, California 92833

Re: K233548

Trade/Device Name: Uresta® Regulation Number: 21 CFR 884.3575 Regulation Name: Vaginal Pessary Regulatory Class: II Product Code: HHW Dated: February 26, 2024 Received: February 26, 2024

Dear Roshana Ahmed:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sharon M. Andrews -S

Sharon M. Andrews Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K233548

Device Name

Uresta®

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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K233548 Page 1 of 3
Resilia Inc.

510(k) Summary

I. Submitter

Resilia Inc. 644 Main Street Suite S400, P.O. Box 1368 Moncton, NB E1C 1E2 Canada

Contact Person: Sam Imbeault, Chief Operating Officer Phone: 506-874-8584 Date Prepared: February 23, 2024

II. Device

Device Proprietary Name:	Uresta®
Common or Usual Name:	Vaginal pessary
Classification Name:	Vaginal pessary
Regulation Number:	21 CFR 884.3575
Product Code:	HHW (pessary, vaginal)
Device Classification	2

III. Predicate Device

Uresta®, K081385, EastMed Inc. The predicate device has not been subject to a design-related recall.

IV. Device Description

Uresta® is available in five (5) sizes, ranging from 34 mm (size 2) to 52 mm (size 6). It can be inserted in the morning and removed at bedtime every day or used just for specific activities such as exercise and removed after the activity.

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Uresta® is molded from non-latex thermoplastic rubber and is provided non-sterile for single patient use.

V. Indications for Use

VI. Comparison of Technological Characteristics

Uresta® has the same intended use as the predicate device and is intended for use in the same user population; however, the subject device is intended for both Rx and OTC use, while the predicate device is indicated for Rx use only. With the exception of available product sizes, the subject device is identical to the predicate device with respect to material of construction and design. There have been no changes to the product since clearance under K081385.

	Uresta®Subject Device	Uresta®(K081385)	Analysis
Intended Use/Indicationsfor Use	The Uresta bladder supportis indicated for use in adultwomen over 18 years ofage who experience stressurinary incontinence(involuntary urine loss,such as a pee leak thatoccurs when you cough,laugh, sneeze or with somephysical tasks).	This device is for the use inadult women, over 18years of age whoexperience involuntaryurine loss with physicalactivity (stress urinaryincontinence).	Different; slightdifferences in wordingdo not alter the intendeduse of the subject devicewhen compared to thepredicate device.
User Population	Women, ages 18 and older	Women, ages 18 and older	Identical
Use	Rx and OTC	Rx	Different; performancetesting demonstratespatients can self-selectand use the deviceappropriately in an OTCsetting.
Design	Bell-shaped pessary	Bell-shaped pessary	Identical
Number of models	Sizes 2 – 6	Sizes 1 – 7	Different, sizes 1 and 7have been removed fromthe product offering.
Reuse	Yes	Yes	Identical
Sterile	No	No	Identical

A comparison of the subject and predicate devices is provided in the table below.

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VII. Performance Data

Non-clinical and clinical data submitted within K083185 is being leverage for the subject device.

In addition, a self-selection and labeling usability study was performed and demonstrates that the subject device can be appropriately self-selected and fit by the intended lay user population. Women who were naïve to the device reviewed the external product packaging and determined if they met the criteria to be an intended user. The self-selection was confirmed via clinical diagnosis. Intended users then participated in a labeling usability simulated study in which they reviewed the Instructions for Use and independently inserted and fit the device without guidance. Participant demographics were diverse with respect to race, ethnicity, age, educational level, and health literacy and representative of the US patient population. The results of the self-selection and usability study demonstrate that patients can self-select and use the device appropriately.

VIII. Conclusion

The information provided above supports that Uresta® is substantially equivalent to the predicate device.

Regulation Number and Section

§ 884.3575 Vaginal pessary.

(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).