(270 days)
No
The device description and performance studies focus on a physical pessary and its clinical efficacy, with no mention of AI or ML components.
Yes
The device is intended for the temporary management of urine leakage caused by stress urinary incontinence, which is a medical condition, and it achieves this by applying pressure to support the bladder and urethra, thereby providing a therapeutic effect.
No
The device is intended for the temporary management of urine leakage caused by stress urinary incontinence, not for diagnosing a condition.
No
The device description explicitly states it is a vaginal pessary made of injection molded silicone, which is a physical hardware device.
Based on the provided information, the Yoni.Fit® Bladder Support is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the management of urine leakage caused by stress urinary incontinence (SUI). This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device is a physical pessary that provides mechanical support to the bladder and urethra. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any components or processes typical of IVD devices, such as reagents, calibrators, controls, or analytical procedures performed on biological samples.
In summary, the Yoni.Fit® Bladder Support is a medical device used for the physical management of a condition, not for diagnosing it.
N/A
Intended Use / Indications for Use
The Yoni.Fit® Bladder Support is intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.
Product codes (comma separated list FDA assigned to the subject device)
HHW
Device Description
The Yoni.Fit® Bladder Support is a vaginal pessary prescribed by a physician for single patient use for the temporary management of stress urinary incontinence. The device is intended for a single 30-day duration per patient. It can be worn for up to 12 hours in a 24-hour period and is reusable after washing with warm water and mild. oil-free soap. The device is a single-patient. multi-use medical device that will be provided non-sterile and requires reprocessing prior its first and subsequent uses. The rim of the Yōni.Fit® Bladder Support applies pressure aqainst the urethra and bladder neck to support the bladder and urethra. The Yōni.Fit® Bladder Support is available in each of the following sizes: 34mm (Size 2), 42mm (Size 3), 42mm (Size 3), 45mm (Size 3.5), 48mm (Size 4), and 52mm (Size 5). The Yoni.Fit® Bladder Support is made of injection molded silicone (non-latex rubber) with no color additives.
Each package of the Yoni.Fit® Bladder Support comes with the following:
- 3 reusable Yōni.Fit® Bladder Supports for sizing .
- . Cleaning brush
- Storage case ●
- Instructions for Use ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vagina, Urethra, Bladder neck
Indicated Patient Age Range
18 years and older
Intended User / Care Setting
Prescribed by a physician
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical study type: Randomized, Comparator-controlled, Single Blinded, Multicenter Study
Sample size: 58 participants (31 Yōni.Fit® and 27 control) were enrolled and randomized.
Key results: The primary effectiveness endpoint was a responder rate, defined as >50% reduction in mean 12-hour pad weights during the efficacy evaluation period compared to the baseline period. A statistically significantly higher percentage of participants experiencing more than a 50% reduction in their average 12-hour pad weights was observed with the Yoni.Fit® device compared to the control device. Of the participants randomized to use the Yoni.Fit®, 51.6% had a >50% reduction in 12-hour pad weight compared to 25.9% in the control group. The two-sided 95% confidence interval for the difference in the percentage of participants experiencing more than a 50% reduction in 12-hour pad weights between the control groups was 0.0235 to 0.504.
The primary safety endpoint was the incidence and nature of adverse events. The adverse event rate was 54.8% for participants with the Yoni.Fit® Bladder Support and 29.6% for Control participants. The most common adverse event was vaginal discomfort in 9 (29.0%) Yoni.Fit® Bladder Support participants compared to 5 (18.5%) Control participants. Among study participants experiencing adverse events, the severity was mild or moderate and there were no device-related serious adverse events. Vaginal bleeding was noted among 8 participants (4 postmenopausal participants) who wore the Yōni.Fit® Bladder Support and 1 in the control arm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Responder rate: 51.6% for Yoni.Fit® vs 25.9% for control, defined as >50% reduction in mean 12-hour pad weights.
Adverse event rate: 54.8% for Yoni.Fit® vs 29.6% for control.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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May 16, 2024
Watkins-Conti Products Inc. % Adrienne Lenz Principal Medical Device Regulatiory Expert Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington, District of Columbia 20005
Re: K232525
Trade/Device Name: Yoni.Fit Bladder Support Regulation Number: 21 CFR 884.3575 Regulation Name: Vaginal Pessary Regulatory Class: Class II Product Code: HHW Dated: April 16, 2024 Received: April 16, 2024
Dear Adrienne Lenz:
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.
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"
1
(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 OS 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).
2
Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/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
for
Jessica K. Nguyen, Ph.D. Assistant 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
510(k) Number (if known) K232525
Device Name Yōni.Fit® Bladder Support
Indications for Use (Describe)
The Yoni.Fit® Bladder Support is intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Watkins-Conti Products
510(k) for Yōni.Fit® Bladder Support
K232525
510(k) SUMMARY
Submitter/Sponsor:
Watkins-Conti Products Inc. 3841 East Danforth Rd., Suite 109 Edmond, OK 73034
Contact Person:
Allison L. Watkins, CEO Watkins-Conti Products, Inc. 3841 East Danforth Rd., Suite 109 Edmond, OK 73034 Office: 1-405-330-3550
Date Prepared:
May 16, 2024
General Device Information:
Generic Device Name
Pessary, Vaginal
Tradename
Yōni.Fit® Bladder Support
Product Classification Codes
- Product Code HHW (pessary, vaginal) .
- Classification Panel - Obstetrical/Gynecological
- Device Class 2 ●
- Regulation Number and Name 21 CFR § 884.3575 Vaginal pessary ●
Predicate Device:
Uresta™ Pessary (K083769)
Note: The predicate has not been subject to a design-related recall.
Reference Device:
Poise Impressa (K131198)
5
1. INDICATIONS FOR USE
The Yoni.Fit® Bladder Support is intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.
2. DEVICE DESCRIPTION
The Yoni.Fit® Bladder Support is a vaginal pessary prescribed by a physician for single patient use for the temporary management of stress urinary incontinence. The device is intended for a single 30-day duration per patient. It can be worn for up to 12 hours in a 24-hour period and is reusable after washing with warm water and mild. oil-free soap. The device is a single-patient. multi-use medical device that will be provided non-sterile and requires reprocessing prior its first and subsequent uses. The rim of the Yōni.Fit® Bladder Support applies pressure aqainst the urethra and bladder neck to support the bladder and urethra. The Yōni.Fit® Bladder Support is available in each of the following sizes: 34mm (Size 2), 42mm (Size 3), 42mm (Size 3), 45mm (Size 3.5), 48mm (Size 4), and 52mm (Size 5). The Yoni.Fit® Bladder Support is made of injection molded silicone (non-latex rubber) with no color additives.
Each package of the Yoni.Fit® Bladder Support comes with the following:
- 3 reusable Yōni.Fit® Bladder Supports for sizing .
- . Cleaning brush
- Storage case ●
- Instructions for Use ●
3. SUBSTANTIAL EQUIVALENCE
A comparison of the device characteristics between the Yoni.Fit® Bladder Support and the Uresta™ Pessary is shown in Table 1. The Yoni.Fit® Bladder Support and the Uresta™ Pessary have the same intended use. There are minor differences in technological characteristics between the Yoni.Fit® Bladder Support and the Uresta™ Pessary. These differences do not raise different questions of safety or effectiveness. Performance data, as discussed below, demonstrate that the Yoni.Fit® Bladder Support is as safe and effective as the Uresta™ Bladder Support. The two devices therefore are considered substantially equivalent.
| Characteristic | Uresta™ Bladder Support
(K083769) | Yōni.Fit® Bladder Support | Comparison |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for Use | For use in adult women, over 18
years of age, to prevent
involuntary urine loss with
physical activity (stress urinary
incontinence) (SUI). | The Yōni.Fit® Bladder Support is
intended for the temporary
management of urine leakage
caused by stress urinary
incontinence (SUI) in women, 18
years and older. | Similar |
| Mechanism
of Operation | Increases pressure through the
anterior wall onto the urethra. | Increases pressure through the
anterior wall onto the urethra. | Same |
| Characteristic | Uresta™ Bladder Support
(K083769) | Yōni.Fit® Bladder Support | Comparison |
| Materials of
Composition | Santoprene (non-latex
thermoplastic rubber) | Silicone (non-latex rubber) with no
color additives | Different |
| Shape
and
Structure | Bell shaped, flexible.
Tapered tip interacts with
upper more horizontal
portion of vagina and bell
shape falls into place
naturally under urethra. No folding or manipulation
of pessary required. Handle allows for easy
management. | Cone-shaped, flexible.
The rim of the Yōni.Fit®
Bladder Support applies
pressure against the urethra
and bladder neck. Collapses for insertion. Handle allows for easy
management. | Different |
| Wear Time | Up to 12-hours in a 24-hour period | Up to 12-hours in a 24-hour period | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Rx/OTC | Rx | Rx | Same |
| Use | Single patient use.
Reusable.
Removed daily. | Single patient use.
Reusable.
Removed daily. | Same |
| Sizes | Multiple sizes – 7
30 – 56 mm | Multiple sizes - 6
34 – 52 mm | Different |
| Use-life | 1-year | 30-days | Different |
| Cleaning | Use warm water and a mild, non-
perfumed soap to wash. Rinse
thoroughly with water after
washing. Dry with a towel or cloth.
Place in bottom unit of case and
leave the case open to air dry. | Wash with warm water and a mild,
scent free, oil-free liquid soap. Rinse
with warm water to make sure all soap
and material are removed. Air dry in a
clean, dry place or use the optional
Storage Case. | Similar |
Table 1: Comparison of Device Characteristics between the Yoni.Fit® Bladder Support and the Uresta™ Bladder Support (K083769)
6
7
4. DEVICE PERFORMANCE DATA
4.1. Summary of Non-Clinical Performance Tests
4.1.1. Bench Tests
Bench performance tests confirmed the device met specifications for dimensions, fold force, fold width, fold height, pull tab strength, therapy force, and maximum force. The Poise Impressa (K131198) was used as a reference device to support the therapy force requirements of the Yōni.Fit®.
Cleaning validation studies were performed in accordance with FDA's 2015 guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, AAMI TIR12:2020, AAMI ST98:2022, and with ISO 10993-5 to validate the device cleaning procedures listed in the Instructions for Use.
Laboratory studies were performed to evaluate the impact of the device on Staphylococcus aureus growth and TSST-1 production, following FDA guidance for Menstrual Tampons and Pads: Information for Premarket Notification Submissions. These studies demonstrated that the Yōni.Fit® does not enhance TSST-1 production above the no product controls or marketed tampons and does not alter the growth of vaginal microflora, including TSST-1 producing S. aureus, as compared to no product controls.
4.1.2. Biocompatibility
The Yoni.Fit® Bladder Support has undergone biocompatibility evaluation and testing in conformance with ISO 10993-1:2018 and FDA's quidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The Yōni.Fit® Bladder Support is categorized as a surface device in contact with mucosal membrane for prolonged (>24 hours up to 30 days) contact duration. Cytotoxicity, sensitization, vaqinal irritation, acute systemic toxicity, material-mediated pyrogenicity, and subchronic systemic toxicity tests were performed, and the results of the biocompatibility testing were acceptable.
4.2. Summary of Clinical Performance Tests
4.2.1. Summary of Clinical Testing
The clinical study, "Randomized, Comparator-controlled, Single Blinded, Multicenter Study Evaluating the Efficacy and Safety of Yōni. Fit® in Women with Stress Urinary Incontinence (SUI)." was conducted to evaluate the safety and effectiveness of the Yoni.Fit® Bladder Support in temporary management of SUI in women in comparison to a sham comparator device. This was a randomized, comparator-controlled, single blinded, multicenter crossover study in which participants from three US sites with SUI were enrolled in the study. Study participants included females 18 years of age or older diagnosed with SUI by both a cough supine test and ≥ 3 month history of experiencing SUI. Clinical study participants were randomized to either the Yōni.Fit® or a control device (Ring type pessary). After a brief training and fitting with the appropriate size of the device, each participant wore a study device for 12 hours per day. Participants wore incontinence pads
8
to measure any potential leakage, recorded voiding (urination) in diaries, and provided responses to questionnaires. At baseline (1-week post-randomization with no device), fitting (1 week after baseline), and efficacy evaluation (1 week after fitting), 12-hour pad weights, and participant questionnaires were collected. After completion of the fitting and treatment period, the Yōni.Fit® subjects and comparator device subjects wishing to cross-over to the Yōni.Fit® entered a 4-week open-label follow-up phase of daily tvpical use.
A total of 58 participants (31 Yōni.Fit® and 27 control) were enrolled and randomized. Participants were between the ages of 30 – 71 years old in the treatment arm and 36 – 73 years old in the control-comparator arm. Of these, 5 postmenopausal participants were randomized in the treatment arm and 12 in the control-comparator arm, but a total of 7 postmenopausal participants were exposed to Yōni.Fit®. Other demographics of total study subjects included 2.2% (1) American Indian/Alaskan Native, 13.3% (6) Asian, 20% (9) Black/African American, 2.2% (1) Native Hawaiian/Pacific Islander, 55.6% (25) White/Caucasian and 6.6% (3) Not disclosed/Other. Fifty-six (56) participants completed the treatment phase and 54 continued to the open label phase. Forty-two (42) participants completed 30 days of safety follow-up and 38 participants completed 6 weeks of safety follow-up. There were four participants (2 Yōni.Fit®, 2 control) who had completely missing data for the efficacy evaluation phase. Participants with completely missing data for the efficacy evaluation phase were considered non- responders in the analyses and assumed to have less than a 50% reduction in their average 12-hour pad weights during the efficacy evaluation phase.
The primary effectiveness endpoint was a responder rate, defined as >50% reduction in mean 12-hour pad weights during the efficacy evaluation period compared to the baseline period. A statistically significantly higher percentage of participants experiencing more than a 50% reduction in their average 12-hour pad weights was observed with the Yoni.Fit® device compared to the control device. Of the participants randomized to use the Yoni.Fit®, 51.6% had a >50% reduction in 12-hour pad weight compared to 25.9% in the control group. The two-sided 95% confidence interval for the difference in the percentage of participants experiencing more than a 50% reduction in 12-hour pad weights between the control groups was 0.0235 to 0.504.
The primary safety endpoint was the incidence and nature of adverse events. The adverse event rate was 54.8% for participants with the Yoni.Fit® Bladder Support and 29.6% for Control participants. The most common adverse event was vaginal discomfort in 9 (29.0%) Yoni.Fit® Bladder Support participants compared to 5 (18.5%) Control participants. Among study participants experiencing adverse events, the severity was mild or moderate and there were no device-related serious adverse events. Vaginal bleeding was noted among 8 participants (4 postmenopausal participants) who wore the Yōni.Fit® Bladder Support and 1 in the control arm.
5. CONCLUSION
The results of the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device for the intended 30 days use of which clinical and non-clinical testing was performed. Therefore, the Yoni.Fit® Bladder Support and the Uresta™ Pessary are determined to be substantially equivalent.