Revive Reusable Bladder Support

K183468 · Rinovum Subsidiary 2, LLC · HHW · Jan 25, 2019 · Obstetrics/Gynecology

Device Facts

• Record ID: K183468
• Device Name: Revive Reusable Bladder Support
• Applicant: Rinovum Subsidiary 2, LLC
• Product Code: HHW · Obstetrics/Gynecology
• Decision Date: Jan 25, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.3575
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Revive bladder support is intended for temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.

Device Story

Revive Reusable Bladder Support is a vaginal pessary for temporary management of stress urinary incontinence (SUI). Device consists of a silicone support core, a reusable tampon-like applicator, and single-use disposable cotton removal strings. User inserts device into vaginal tract to provide tension-free, mid-urethral support, reducing bladder leaks. Designed for home use; patient self-operates without physician guidance. Device is reusable for up to 31 uses; cleaned by user after each 12-hour wear period. Output is mechanical support of the urethra; helps patient maintain continence during physical activity. Benefits include reduced leakage episodes and improved quality of life.

Clinical Evidence

Multicenter interventional study (n=not specified) evaluated safety and efficacy. Primary endpoints: pad weight gain reduction, leakage episode reduction, and quality of life. Results: 53% of participants showed >50% improvement in pad weight gain; 56.7% average reduction in daily leakage episodes. 71% of participants identified as responders (>50% reduction in leakage/pad weight). Safety: 40 adverse events reported (36 mild), primarily vaginal pain/spotting. No serious adverse events. Labeling comprehension and simulated use studies validated OTC self-selection and usability.

Technological Characteristics

Materials: Silicone (bladder support), cotton (string), low-density polyethylene (applicator). Principle: Mechanical mid-urethral support. Form factor: Single-size, tampon-like applicator system. Connectivity: None. Sterilization: Reusable/cleanable design. Biocompatibility: Tested per ISO 10993-5, -10, -11, -3, -18.

Indications for Use

Indicated for women 18 years and older experiencing stress urinary incontinence (SUI) symptoms (e.g., leakage during laughing, coughing, sneezing, exercise). Not indicated for urge incontinence.

Regulatory Classification

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.

Predicate Devices

• Proctor & Gamble Always/Tampax bladder supports (K151413)

Reference Devices

• ConTIPI Ltd. Improve Bladder Supports (K131198)

Submission Summary (Full Text)

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January 25, 2019

Rinovum Subsidiary 2, LLC Shaylee Masilunas, RAC Director of Regulatory, Clinical and Quality Affairs 300 Oxford Drive, Suite 330 Monroeville, PA 15146

Re: K183468 Trade/Device Name: Revive Reusable Bladder Support Regulation Number: 21 CFR§ 884.3575 Regulation Name: Vaginal Pessary Regulatory Class: II Product Code: HHW Dated: December 14, 2018 Received: December 14, 2018

# Dear Shaylee Masilunas:

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. 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 located 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.

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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Glenn B. Bell -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Indications for Use</b> | |
| 510(k) Number (if known) | K183468 |
| Device Name | Revive Reusable Bladder Support |
| Indications for Use (Describe) | The Revive bladder support is intended for 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) | |
| | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
| | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) SUMMARY

## Rinovum Subsidiary 2, LLC's Revive™ Reusable Bladder Support

## Submitter/Sponsor:

Rinovum Subsidiary 2, LLC 300 Oxford Drive Suite 330 Monroeville, PA 15146 Phone: [phone] Facsimile: 724-204-8141

## Contact Person:

Shaylee Masilunas, RAC Director of Regulatory, Clinical, and Quality Affairs [e-mail]

# Date Prepared:

December 14, 2018

## General Device Information

### Generic Device Name

Intra-vaginal Stress Urinary Incontinence Device

### Device Tradename

Revive Reusable Bladder Support

### Product Classification Codes:

- Device Classification Name - Pessary, Vaginal
- . Product Code - HHW
- Classification Panel Obstetrical/Gynecological .
- Device Class 2 ●
- Regulation Number - 21 CFR § 884.3575

## Predicate Device

Proctor & Gamble Always/Tampax bladder supports (K151413)

### Reference Device

ConTIPI Ltd. Improve Bladder Supports (K131198)

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## Intended Use/Indications for Use

The Revive bladder support is intended for temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.

## Device Description

The Revive bladder support reduces bladder leaks in women who are suffering from SUI by preventing or reducing unwanted urinary leakage. Use of the device is applicable for women who experience leakage when laughing, coughing, exercising, sneezing, etc. The device is not intended to treat women with urge incontinence. The shape of the Revive bladder support is designed to fit in the vaginal tract, and there is no sizing required. The device fits most users. The device can be worn daily for up to 12 hours. The Revive bladder support can be reused (and cleaned) for up to 31 times. Each packaged Revive bladder support device comes with the following:

- · 1 Reusable Bladder Support
- · 1 Reusable Applicator
- · 1 Month Strings Supply
- · Travel Case
- · Instructions for Use

## Technological Characteristics

The Revive Reusable Bladder Support is a reusable and cleanable system that includes a silicone bladder support and a tampon-like reloadable applicator. A single-use disposable cotton string is assembled to the bladder support for easy, tampon-like removal from the vaginal cavity. The package will also include a set of 30 replacement strings, detailed Instructions for Use, and a device storage case. The bladder support and applicator components are to be cleaned after each use. The device is available in only one size and is sold over the counter.

## Performance Data

### Summary of non-clinical tests

### Removal string to pessary retention force

This method determines the force required to separate the string from the pessary. The product is confirmed to meet specification.

### Pessary from applicator extraction force

This method determines the force required to extract the pessary from the applicator. The product is confirmed to meet specification.

### Tensile strength of string

This method determines the force required to break the withdrawal removal string. The product is confirmed to meet specification.

### Retraction force of pessary removal

This method determines the force required to remove the pessary, using the withdrawal removal string, from the vaginal cavity. The product is confirmed to meet specification.

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Revive™ Reusable Bladder Support

# Dimension verification

Specified product dimensions are confirmed to meet finished product specifications.

### Biocompatibility Assessment

| Revive<br>Component | ISO<br>Standard | Test | Results |
|---------------------------------|-----------------|----------------------------------------------------|-------------------------------------------|
| Pessary<br>String<br>Applicator | 10993-5 | Cytotoxicity Study Using the ISO<br>Elution Method | Non-cytotoxic |
| Pessary<br>String<br>Applicator | 10993-10 | ISO Guinea Pig Maximization<br>Sensitization Test | Non-sensitizer |
| Pessary<br>String<br>Applicator | 10993-10 | ISO Vaginal Irritation Study in<br>Rabbits | Non-irritant |
| Pessary<br>String | 10993-11 | Material Mediated Pyrogenicity in<br>Rabbits | Non-pyrogenic |
| Pessary<br>String | 10993-3 | Genotoxicity: Bacterial Reverse<br>Mutation Study | Non-mutagenic |
| Pessary<br>String | 10993-3 | Genotoxicity: Mouse Lymphoma<br>Assay | Non-mutagenic |
| Pessary<br>String | 10993-18 | Chemical Characterization | Outlined in Biological Risk<br>Assessment |

A biological risk assessment was completed and indicated that the likelihood of a toxic effect is neqligible and that the Revive™ device can be considered safe for use as intended. No further testing was recommended.

## Evaluation of Toxic Shock Syndrome Risk

The device was evaluated to determine that is does not enhance the growth of Staphylococcus aureus and does not increase the production of Toxic Syndrome Toxin-1 (TSST-1). Under the test conditions, the Revive bladder support did not promote or enhance the bacterial growth or toxin production.

## Summary of Clinical Testing

A safety and efficacy study of the Revive Bladder Support was conducted. This clinical study was conducted as a non-IDE, Non-Significant Risk study, and was registered with clinicaltrials gov. In this interventional, multicenter study, women underwent a baseline phase, as well as a treatment phase where they wore the investigational product. Device efficacy was evaluated through pad weight gain reduction, leakage reduction, and improvement in quality of life analysis. Safety was assessed by an evaluation of adverse events and other safety outcomes, such as vaginal swab and urinalysis results.

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This study showed that the Revive bladder support was effective, well tolerated, and safe for use with no serious adverse events reported. During the clinical study, there was a total of 40 adverse events reported. Thirty-six were classified as mild. The most common adverse events that participants experienced throughout this study was vaginal pain and vaginal spotting. All adverse events were reviewed by a third-party adjudicator for consistent reporting and classification using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Vaginal swabs and urinalyses were also performed to evaluate if the product caused any significant negative changes in the vaqinal microflora or urinary tract health, respectively. Only one participant tested positive for yeast cells after the treatment phase and was asymptomatic and not treated. Two participants screened positive in the urinalysis at final visit, however both participants were asymptomatic.

Statistically significant improvement in leakage volume and number of leakage episodes while wearing the Revive device was observed. 53% of the participants showed a >50% improvement in pad weight gain compared to baseline phase. Additionally, participants experienced an average 56.7% reduction in the number of leakage episodes per day. Compared to baseline, women reported a significant improvement in their quality of life. The study also showed that women were able to appropriately identify symptoms of SUI and determine in the device was a proper fit.

A responder analysis was performed, where a responder was defined as achieving >50% reduction in pad weight gain and/or >50% reduction in leakage episodes. Results indicated that 71% of participants achieved a clinically meaningful reduction in leakage episodes, pad weight gain, or both. The percentage of responders is greater as compared to the predicate device.

### Self-Selection, Labeling Comprehension, and Simulated Use

As mentioned above, the clinical safety and efficacy study was conducted to support an OTC indication for use, as well as contribute to labeling comprehension. Self-selection was evaluated through the completion of a "Fit Test" during the screening process, in which the participants independently inserted a device using the Instructions for Use without physician quidance. Self-selection was also evaluated by participants' ability to identify with SUI symptoms without a formal diagnosis prior to enrolling in the study. Additionally, this study contributed to labeling comprehension as participants used the Instructions for Use throughout the duration of the treatment phase.

Multiple rounds of summative testing were completed in the form of Labeling Comprehension, Selection and Simulated Use studies. This testing was performed to evaluate the appropriateness of the Instructions for Use and package labeling to support an OTC indication for use. The last round of summative testing was also used to validate the usability of the reusable device design. A diverse population of women in race, ethnicity age, and literacy rates participated.

## Substantial Equivalence

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The Revive Reusable Bladder Support has the following similarities to the previously cleared predicate device Always/Tampax bladder supports (K151413) and reference device Improve Bladder Support (K131198):

- Same general intended use ●
- . Similar indications for use
- Same operating principle ●
- Similar materials ●
- . Similar performance characteristics

The following modifications have been made to the Revive Reusable Bladder Support compared to the predicate device:

- . The Revive bladder support and applicator are designed and validated to be reusable.
- . The Revive bladder support does not include a fabric or mesh overwrap.

| | PREDICATE DEVICE: | REFERENCE DEVICE: | SUBJECT DEVICE: |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison Element | Tampax/Always Bladder<br>Supports K151413 | Improve Bladder Support<br>(Poise Impressa) K131198 | Revive Bladder Support<br>Stress Incontinence<br>Device |
| INTENDED<br>USE/INDICATIONS FOR<br>USE STATEMENT | For the temporary<br>management of stress-<br>urinary incontinence in<br>women. | The IMPROVE BLADDER<br>SUPPORT is an over-the-<br>counter device intended for<br>the temporary management<br>of stress urinary<br>incontinence (SUI) in<br>women. | The Revive bladder support<br>is intended for temporary<br>management of urine<br>leakage caused by stress<br>urinary incontinence (SUI)<br>in women, 18 years and<br>older.<br>(Unchanged from K151413<br>and K131198) |
| PATIENT POPULATION | Women ≥18 with SUI<br>symptoms | Women ≥21 with SUI | Women ≥18 with SUI<br>symptoms (Unchanged from<br>K151413) |
| INTENDED ENVIRONMENT<br>FOR USE | Home Use | Home Use | Unchanged from K151413<br>and K131198 |
| SINGLE USE? | Yes | Yes | No. The Revive Bladder<br>Support is reusable for 31<br>days. |
| WEAR TIME | Up to 12-hours in a 24-hour<br>period | Up to 8-hours in a 24-hour<br>period | Up to 12-hours in a 24-hour<br>period (Unchanged from<br>K151413) |
| DEVICE DESIGN | The Tampax/Always Bladder<br>Support consists of a<br>shaped high-density<br>polyethylene core covered<br>by a non-woven wrap with a<br>tampon-like withdrawal cord,<br>loaded into an applicator. | The Improve Bladder<br>Support consists of a flexible<br>silicone rubber core covered<br>with mesh with a removal<br>string, loaded into an<br>applicator. | The Revive™ system<br>consists of a reusable<br>silicone bladder support<br>(does not include an<br>overwrap), with a removal<br>string and a reusable,<br>tampon-like applicator. The<br>string is single-use<br>disposable. Replacement<br>strings are provided. |

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| | PREDICATE DEVICE: | REFERENCE DEVICE: | SUBJECT DEVICE: |
|---------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Comparison Element | Tampax/Always Bladder Supports K151413 | Improve Bladder Support (Poise Impressa) K131198 | Revive Bladder Support Stress Incontinence Device |
| MECHANISM OF ACTION | Increases pressure through the anterior wall onto the urethra. | Tension free, mid-urethral support for the temporary management of stress urinary incontinence (SUI). | Tension-free, mid-urethral support for the temporary management of stress urinary incontinence (SUI). |
| SIZES | 1 size | 3 size | 1 size (Unchanged from K151413) |
| MATERIAL | Bladder support - High-density polyethylene core with a non-woven overwrap<br>String - cotton-like<br>Applicator - plastic | Bladder support - Silicone rubber core covered with a non-woven mesh<br>String - cotton-like<br>Applicator - plastic | Bladder support - Silicone rubber<br>String - Cotton<br>Applicator - low-density polyethylene |

# Conclusion

The performance and technological characteristics of the Revive Reusable Bladder Support are substantially equivalent to the predicate device Always/Tampax bladder supports (K151413) and reference device Improve Bladder Support (K131198). The differences described above do not raise new issues of safety or effectiveness.