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

AI/ML Overview

The provided document describes the Revive™ Reusable Bladder Support, intended for temporary management of urine leakage caused by stress urinary incontinence (SUI) in women aged 18 and older. While the document details the device's characteristics, non-clinical tests, and a clinical study, it does not explicitly state quantified acceptance criteria for device performance. Instead, it reports observed performance outcomes from a clinical study and states that the device was effective, well-tolerated, and safe.

Therefore, for the acceptance criteria table, I will use clinically meaningful improvements reported in the study as the "acceptance criteria" based on the reported "met" performance.

Here's the information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from reported study outcomes)	Reported Device Performance (from Clinical Study)	Met?
Efficacy:
>50% improvement in pad weight gain	53% of participants showed >50% improvement	Yes
>50% reduction in leakage episodes	Average 56.7% reduction in leakage episodes	Yes
Clinically meaningful reduction in leakage episodes, pad weight gain, or both	71% of participants achieved this	Yes
Safety:
Low incidence of serious adverse events	No serious adverse events reported	Yes
Minimal significant negative changes in vaginal microflora	Only one participant had yeast cells (asymptomatic)	Yes
Minimal significant negative changes in urinary tract health	Two participants screened positive in urinalysis (asymptomatic)	Yes
Non-cytotoxic	Non-cytotoxic	Yes
Non-sensitizer	Non-sensitizer	Yes
Non-irritant (vaginal)	Non-irritant	Yes
Non-pyrogenic	Non-pyrogenic	Yes
Non-mutagenic	Non-mutagenic	Yes
Does not enhance growth of Staphylococcus aureus	Did not promote or enhance bacterial growth	Yes
Does not increase production of TSST-1	Did not promote or enhance toxin production	Yes
Functional:
Meets specified dimensions	Product dimensions confirmed to meet specifications	Yes
String retention force within specifications	Confirmed to meet specification	Yes
Pessary extraction force within specifications	Confirmed to meet specification	Yes
String tensile strength within specifications	Confirmed to meet specification	Yes
Pessary removal retraction force within specifications	Confirmed to meet specification	Yes

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

Test Set (Clinical Study): The exact number of participants is not explicitly stated, but it refers to "participants" throughout the clinical study summary. Based on the percentages provided for efficacy results (53% of participants, 71% of participants), an N value for the clinical study is not given.
Data Provenance: The study was a "multicenter study," implying data from multiple locations, but specific countries are not mentioned. It was an "interventional" study, indicating a prospective design where participants underwent a baseline phase and a treatment phase with the investigational product.

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

The document states that "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."
The number and qualifications of this "third-party adjudicator" or any other experts establishing ground truth for efficacy measures are not specified in the provided text.

4. Adjudication method for the test set

For adverse events, a "third-party adjudicator" reviewed events for consistent reporting and classification. No specific adjudication method like "2+1" or "3+1" is mentioned, just that a single (implied) third-party individual or entity performed the review.
For efficacy outcomes (pad weight gain, leakage episodes, quality of life), no adjudication method is described.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned. The device is a physical medical device (bladder support), not an AI algorithm. The closest comparison is the statement: "The percentage of responders is greater as compared to the predicate device," but this is a direct comparison of the device's performance against historical data/reports of a predicate device, not an MRMC study.

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

Not applicable. This device is a physical medical device, not an algorithm.

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

Clinical Outcomes Data: The ground truth for efficacy was based on direct clinical measurements and patient-reported outcomes from the intervention:
- Pad weight gain reduction (quantitative measure).
- Leakage reduction (number of leakage episodes per day, quantitative measure).
- Improvement in quality of life analysis (patient-reported outcome).
Safety Data: Adverse events, vaginal swabs, and urinalysis results served as ground truth for safety.
Laboratory Testing: Biocompatibility data (cytotoxicity, sensitization, irritation, pyrogenicity, genotoxicity, chemical characterization) and Staphylococcus aureus growth/TSST-1 production tests provided ground truth for material safety.
Engineering/Mechanical Test Data: Removal string retention, pessary extraction, string tensile strength, and pessary removal retraction forces provided ground truth for physical performance.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not an AI/machine learning algorithm that requires a training set. The clinical study was for evaluation of the device as a whole.

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

Not applicable. As above, there was no "training set" in the context of an AI/ML algorithm.

Summary

{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 features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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.

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
Indications for Use
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)
	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)	Page 1 of 1
	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.

{3}------------------------------------------------

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: 412-200-7996 Facsimile: 724-204-8141

Contact Person:

Shaylee Masilunas, RAC Director of Regulatory, Clinical, and Quality Affairs smasilunas@rinovum.com

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)

{4}------------------------------------------------

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

· 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.

{5}------------------------------------------------

Revive™ Reusable Bladder Support

Dimension verification

Specified product dimensions are confirmed to meet finished product specifications.

Biocompatibility Assessment

ReviveComponent	ISOStandard	Test	Results
PessaryStringApplicator	10993-5	Cytotoxicity Study Using the ISOElution Method	Non-cytotoxic
PessaryStringApplicator	10993-10	ISO Guinea Pig MaximizationSensitization Test	Non-sensitizer
PessaryStringApplicator	10993-10	ISO Vaginal Irritation Study inRabbits	Non-irritant
PessaryString	10993-11	Material Mediated Pyrogenicity inRabbits	Non-pyrogenic
PessaryString	10993-3	Genotoxicity: Bacterial ReverseMutation Study	Non-mutagenic
PessaryString	10993-3	Genotoxicity: Mouse LymphomaAssay	Non-mutagenic
PessaryString	10993-18	Chemical Characterization	Outlined in Biological RiskAssessment

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.

{6}------------------------------------------------

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

{7}------------------------------------------------

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 BladderSupports K151413	Improve Bladder Support(Poise Impressa) K131198	Revive Bladder SupportStress IncontinenceDevice
INTENDEDUSE/INDICATIONS FORUSE STATEMENT	For the temporarymanagement of stress-urinary incontinence inwomen.	The IMPROVE BLADDERSUPPORT is an over-the-counter device intended forthe temporary managementof stress urinaryincontinence (SUI) inwomen.	The Revive bladder supportis intended for temporarymanagement of urineleakage caused by stressurinary incontinence (SUI)in women, 18 years andolder.(Unchanged from K151413and K131198)
PATIENT POPULATION	Women ≥18 with SUIsymptoms	Women ≥21 with SUI	Women ≥18 with SUIsymptoms (Unchanged fromK151413)
INTENDED ENVIRONMENTFOR USE	Home Use	Home Use	Unchanged from K151413and K131198
SINGLE USE?	Yes	Yes	No. The Revive BladderSupport is reusable for 31days.
WEAR TIME	Up to 12-hours in a 24-hourperiod	Up to 8-hours in a 24-hourperiod	Up to 12-hours in a 24-hourperiod (Unchanged fromK151413)
DEVICE DESIGN	The Tampax/Always BladderSupport consists of ashaped high-densitypolyethylene core coveredby a non-woven wrap with atampon-like withdrawal cord,loaded into an applicator.	The Improve BladderSupport consists of a flexiblesilicone rubber core coveredwith mesh with a removalstring, loaded into anapplicator.	The Revive™ systemconsists of a reusablesilicone bladder support(does not include anoverwrap), with a removalstring and a reusable,tampon-like applicator. Thestring is single-usedisposable. Replacementstrings are provided.

{8}------------------------------------------------

	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 overwrapString - cotton-likeApplicator - plastic	Bladder support - Silicone rubber core covered with a non-woven meshString - cotton-likeApplicator - plastic	Bladder support - Silicone rubberString - CottonApplicator - 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.

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).