(152 days)
Not Found
No
The device description and performance studies focus on a physical, bell-shaped vaginal support and its usability, with no mention of AI or ML technology.
Yes
The device is intended to reduce stress urinary incontinence by providing physical support, which is a therapeutic effect.
No
The device description indicates that Uresta® is a "vaginal bladder support" intended to "support the urethra to help reduce leaks caused by stress urinary incontinence." Its purpose is to physically manage a condition, not to diagnose it.
No
The device description clearly states it is a "bell-shaped vaginal bladder support" molded from "non-latex thermoplastic rubber," indicating it is a physical, hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Uresta's Function: The Uresta bladder support is a physical device inserted into the vagina to provide support and reduce stress urinary incontinence. It does not perform any tests on bodily samples.
The provided information clearly describes a physical medical device for mechanical support, not a diagnostic test.
N/A
Intended Use / Indications for Use
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).
Product codes
HHW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vaginal / Urethra
Indicated Patient Age Range
adult women over 18 years of age
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A self-selection and labeling usability study was performed. 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Self-selection and labeling usability study. The results of the self-selection and usability study demonstrate that patients can self-select and use the device appropriately.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
2
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
3
Indications for Use
Submission Number (if known)
Device Name
Uresta®
Indications for Use (Describe)
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).
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 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.
5
Uresta® is molded from non-latex thermoplastic rubber and is provided non-sterile for single patient use.
V. Indications for Use
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).
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/Indications
for Use | 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). | This device is for the use in
adult women, over 18
years of age who
experience involuntary
urine loss with physical
activity (stress urinary
incontinence). | Different; slight
differences in wording
do not alter the intended
use of the subject device
when compared to the
predicate device. |
| User Population | Women, ages 18 and older | Women, ages 18 and older | Identical |
| Use | Rx and OTC | Rx | Different; performance
testing demonstrates
patients can self-select
and use the device
appropriately in an OTC
setting. |
| Design | Bell-shaped pessary | Bell-shaped pessary | Identical |
| Number of models | Sizes 2 – 6 | Sizes 1 – 7 | Different, sizes 1 and 7
have been removed from
the 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.