Strengthening of the pelvic floor muscles;
Rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence (including overactive bladder) in women.

This device interacts with the user via smart phone technology.

Device Description

The leva Pelvic Health System ("leva System") is a prescription intra-vaginal device designed to allow the user (or woman) to rehabilitate and strengthen their pelvic floor muscles (PFM) as well as allow them to monitor their progress during pelvic floor muscle training (PFMT). The leva system is designed to wirelessly facilitate PFMT in women and to transmit real-time performance data through a dedicated mobile application that has been downloaded onto the patient's mobile device. The leva system is designed to be used vaginally and is intended to be used repeatedly by a single patient.

The leva PHS consists of a probe, storage case, associated batteries, and the Renovia Digital Health App (App). Thermoplastic elastomer (TPE) was used as the material overlay for the electronics and six accelerometers are contained within the probe. Additional electronics are contained in the storage case to transmit data wirelessly between the device and the App.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "leva Pelvic Health System." It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (K192270, leva Pelvic Digital Health System) based on technological characteristics and non-clinical testing.

Crucially, this document does NOT contain information about a study proving the device meets specific performance acceptance criteria related to its clinical efficacy or accuracy using AI. It mainly discusses hardware, firmware, and software changes, and non-clinical testing (biocompatibility, software/firmware design verification, manufacturing testing). Therefore, I cannot fulfill most of the requested information about acceptance criteria for device performance, clinical study design, expert ground truth, or MRMC studies, as these types of details are not present in the provided 510(k) summary.

The device is a perineometer that provides an indication of the relative intensity of pelvic floor muscle contraction using accelerometers. Its intended use is for strengthening, rehabilitation, and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence.

Here's what can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity, or improvement thresholds for a specific clinical outcome). The "acceptance" discussed is related to demonstrating substantial equivalence through non-clinical testing.
- Reported Device Performance: The document states that "Biocompatibility testing demonstrated that the subject device, leva Pelvic Health System, is as safe and effective, and performs as well as the predicate device, leva Pelvic Digital Health System." It also mentions "Software and firmware design verification testing" and "Manufacturing testing protocol verification" were done to ensure the device continues to meet requirements for substantial equivalence. However, specific performance metrics or thresholds are not provided.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document focuses on non-clinical testing (biocompatibility, software verification, manufacturing testing) and does not describe a clinical test set with human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not provided. No clinical test set with ground truth established by experts is described in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No clinical test set requiring adjudication 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. This document does not describe an AI-assisted device or an MRMC study. The device provides "indication of relative intensity of pelvic floor muscle contraction using accelerometers" and transmits data to a mobile app for user monitoring and guidance. It does not appear to employ AI for diagnostic or assistive interpretation requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. The device's primary function is to measure muscle contraction and provide data to the user via an app for rehabilitation purposes, not to provide an automated diagnosis or interpretation in a "standalone" fashion as might be expected from a typical AI algorithm in medical imaging.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not specified/Not applicable to a clinical study. The "ground truth" implicitly referred to is safety and performance equivalence to the predicate device, demonstrated through non-clinical tests (biocompatibility, software/firmware design verification, manufacturing testing).
8. The sample size for the training set:
- Not applicable/Not provided. This document does not pertain to the development or validation of an AI model with a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. No AI model training set is discussed.

Summary of available information regarding the device itself:

Trade/Device Name: leva Pelvic Health System
Regulation Number: 21 CFR §884.1425
Regulation Name: Perineometer
Regulatory Class: II
Product Code: HIR
Intended Use:
1. Strengthening of the pelvic floor muscles.
2. Rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women.
Principle of Operation: Provides indication of relative intensity of pelvic floor muscle contraction using accelerometers.
Key changes from predicate (minor modifications):
- Hardware (adhesive, PCB/PCBA, battery vendor, labeling)
- Embedded software (firmware: performance improvement, communications, diagnostic, bug fixes)
- Mobile Application Software (bug fixes, content updates like educational videos)
- Manufacturing and Risk Analysis updates
Testing performed to support substantial equivalence (non-clinical):
- Biocompatibility (ISO 10993-1, -5, -10)
- Software and firmware design verification testing
- Manufacturing testing protocol verification

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 8, 2021

Renovia, Inc. % Jacqueline Schmainda Director, QA/RA Bold Type 2100 N. Alafaya Trail Orlando, FL 32826

Re: K212495

Trade/Device Name: leva Pelvic Health System Regulation Number: 21 CFR §884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: HIR Dated: August 6, 2021 Received: August 9, 2021

Dear Jacqueline Schmainda:

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 and Part 809); 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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 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 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 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,

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K212495

Device Name leva Pelvic Health System

Indications for Use (Describe)

The leva Pelvic Health System is intended for:

Strengthening of the pelvic floor muscles;
Rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence (including overactive bladder) in women.

This device interacts with the user via smart phone technology.

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:

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This 510(k) Summary has been prepared in accordance with 21 CFR 807.92.

1. Submitter

Name and Address:	Renovia Inc.263 Summer StreetBoston, MA 02210
Primary Contact:	Jacqueline SchmaindaRegulatory Consultant on behalf of RenoviaRenovia Inc.263 Summer StreetBoston, MA 02210Phone: 763-269-2069Email: jackie@boldtype.com

Date Prepared: September 8, 2021

2. Device Information

Trade Name:	leva Pelvic Health System
Model:	leva-02
Common Name:	Perineometer
Product Code:	HIR
Regulatory Class:	Class II
Classification Number:	21 CFR 884.1425
Classification Name:	Perineometer
Review Panel:	Gastroenterology/Urology

3. Predicate Information

510(k) Number	Trade Name	Model	Submitter
K192270	leva Pelvic Digital Health System	Leva-02	Renovia Inc.

4. Device Description

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5. Indications for Use

The leva Pelvic Health System is intended for:

1. Strengthening of the pelvic floor muscles;
1. Rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence (including overactive bladder) in women.

This device interacts with the user via smart phone technology.

6. Comparison of Technological Characteristics

The following table provides a comparison of the leva Pelvic Health System to the predicate device.

Characteristic	Predicate Device	Subject Device
Regulatory Information
Device Name	leva Pelvic Digital Health System	leva Pelvic Health System
Manufacturer	Renovia Inc.	Renovia Inc.
Technological Characteristics
Principle ofOperation	Provides indication of relativeintensity of pelvic floor musclecontraction using accelerometers	Provides indication of relativeintensity of pelvic floor musclecontraction using accelerometers
Muscle Stimulation	No	No
Intended AnatomicalLocation	Vagina	Vagina
Use Model	Single patient, reusable	Single patient, reusable
Sterility	Clean, non-sterile	Clean, non-sterile
Display Information	Graphical and numeric based onapplied bending, anatomical overlay	Graphical and numeric based onapplied bending, anatomical overlay
Device Materials	• Probe: Thermoplastic Elastomer(TPE)• Probe Battery Pack: AcrylonitrileButadiene Styrene (ABS)	• Probe: Thermoplastic Elastomer(TPE)• Probe Battery Pack: AcrylonitrileButadiene Styrene (ABS)
Patient Contact(Contact Duration)	• Probe: Direct (<24 hours)• Probe Battery Pack: Direct (<24hours)• Vaginal Probe Hub: Indirect(Incidental)• Battery Pack Cap: Indirect(Incidental)	• Probe: Direct (<24 hours)• Probe Battery Pack: Direct (<24hours)• Vaginal Probe Hub: Indirect(Incidental)• Battery Pack Cap: Indirect(Incidental)

See Section 7 for discussion of modifications made to the leva Pelvic Health System.

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7. Summary of Nonclinical Testing and Risk Analysis

The following non-clinical performance testing and risk analysis was performed to support modifications to the leva Pelvic Health System:

A. Biocompatibility

Biocompatibility assessment was done, as needed, based on the changes made to the device. To ensure patientsafety, all the patient-contacting material was subjected to biocompatibility testing in compliance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, for mucosal surface for limited, less than 24 hours duration including:

Cytotoxicity (ISO 10993-5)
. Sensitization (ISO 10993-10)
Irritation (ISO 10993-10)

Biocompatibility testing demonstrated that the subject device, leva Pelvic Health System, is as safe and effective, and performs as well as the predicate device, leva Pelvic Digital Health System.

B. The sponsor reported other changes in this special 510 (k) which are stated below:

Hardware (H): Change of the adhesive on the battery case, Printed Circuit Board (PCB)/Printed Circuit . Board Assemblies (PCBA), battery vendor change, and product labeling modifications.
Embedded software (firmware) (F): Software changes related to performance improvement, communications, diagnostic and bug fix modifications.
. Mobile Application Software (RA): Updates and enhancements for bug fixes and addition/modification of general content (e.g., educational videos added) to provide additional information and clarity to improve the user experience.
Manufacturing (M) and Risk Analysis (D): Manufacturing quality control related changes and updates to the risk analysis modifications.

The following testing was done on the subject device to ensure that the device continues to meet the requirements for substantial equivalence:

Software and firmware design verification testing
Manufacturing testing protocol verification

All the changes reported above are minor and did not alter the substantial equivalence of the leva Pelvic Health System.

8. Conclusion

Based on the comparison and analysis above, Renovia has demonstrated that the leva Pelvic Health System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 884.1425 Perineometer.

(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).