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-02 PDHS 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-02 is designed to wirelessly facilitate pelvic floor muscle training (PFMT) in women and to transmit real-time performance data through a dedicated mobile application that has been downloaded to the patient's mobile device. The levo-02 is designed to be used vaginally and is intended to be used repeatedly by a single patient.
The leva-02 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 document provided is a 510(k) Summary for the Leva Pelvic Digital Health System (leva-02) and focuses on establishing its substantial equivalence to a predicate device (leva-01). As such, it details non-clinical testing performed to demonstrate this equivalence rather than presenting an exhaustive study of the device's performance against specific acceptance criteria for its intended use.

Therefore, the requested information specifically about acceptance criteria, reported device performance in a table, sample sizes for test sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be fully extracted from this document, because the document primarily refers to demonstrating safety and effectiveness compared to an existing device, not a de novo study proving efficacy to specific performance metrics for the intended use directly.

However, I can provide the information that is available and explain what is missing.

Here's an attempt to answer based on the provided text, highlighting what is implicitly or explicitly stated:

1. A table of acceptance criteria and the reported device performance

This document does not present a table of specific clinical acceptance criteria (e.g., minimum percentage improvement in pelvic floor strength, or reduction in incontinence episodes) for the device's intended use, nor does it report the device's performance against such criteria. The "acceptance criteria" mentioned in the document relate to the validation of hardware, software, usability, biocompatibility, electrical safety, and packaging against established standards and internal procedures to show equivalence to the predicate device.

For example, under "Hardware verification," it states "Hardware verification was performed in accordance with predefined test procedures and acceptance criteria and included the following assessments: Dimensional analysis […]. Hardware verification demonstrated that the subject device, leva-02, is as safe, as effective, and performs as well as the predicate device, leva-01." This is the general nature of the "reported performance" against "acceptance criteria" presented.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document largely refers to non-clinical testing:

Hardware, Software, Biocompatibility, Electrical Safety, Packaging: These involve technical tests, not patient-based test sets in the typical clinical sense. Therefore, the concept of sample size for a "test set" and "data provenance" (country/retrospective/prospective) as applies to human subjects is not relevant here.
Usability: "Usability and Human Factors testing was performed using layperson volunteers." The exact number of layperson volunteers is not specified. The provenance of these volunteers (e.g., country) is also not specified, nor whether the testing was prospective.

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)

This information is not provided as the document does not describe a clinical study that involved expert-established ground truth for performance evaluation of the device's intended use. The testing described is primarily engineering and safety-focused.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as the document does not describe a clinical study involving expert adjudication.

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

This type of study is not mentioned in the document. The device is a "Pelvic Digital Health System" working with a smartphone app, not an AI-assisted diagnostic imaging device that typically undergoes MRMC studies with human readers.

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

The device is an "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)." It "interacts with the user via smart phone technology." This inherently describes a human-in-the-loop system. The document does not describe a standalone algorithm only performance study separate from the user interaction.

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

For the non-clinical tests (hardware, software, biocompatibility, electrical safety, packaging), the "ground truth" would be compliance with specified engineering standards, design specifications, and regulatory requirements (e.g., ISO 10993 for biocompatibility). For usability, the "ground truth" was successful completion of tasks by layperson volunteers. No "clinical ground truth" (expert consensus, pathology, outcomes data) for the device's efficacy in strengthening pelvic floor muscles or treating incontinence is mentioned, as "Clinical testing was not required to support a substantial equivalence determination for the leva-02 PDHS."

8. The sample size for the training set

This document does not describe the development or optimization of an AI algorithm based on a training set. The device uses accelerometers to "provide indication of relative intensity of pelvic floor muscle contraction," which is more akin to a sensor-based measurement system than a machine learning model that would require a "training set" for classification or prediction.

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

As no training set is discussed, this information is not applicable.

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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 22, 2019

Renovia Inc. Gina Prochilo-Cawston Director of Regulatory 263 Summer St., 5th Floor Boston, MA 02210

Re: K192270 Trade/Device Name: Leva Pelvic Digital Health System Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: HIR Dated: October 28, 2019 Received: October 29, 2019

Dear Gina Prochilo-Cawston:

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. 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

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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/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 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 medical devices and radiation-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,

Angel A. Soler-García, Ph.D. Acting 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

510(k) Number (if known) K192270

Device Name leva Pelvic Digital Health System

Indications for Use (Describe) The leva Pelvic Digital 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)

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510(k) Summary

A 510(k) Summary was prepared in accordance with 21 CFR 807.92 and is provided on this page.

Submitter

Name and Address:	Renovia Inc.263 Summer StreetBoston, MA 02210
Primary Contact:	Gina Prochilo-CawstonDirector of RegulatoryRenovia Inc.263 Summer St.Boston, MA 02210Phone: (857) 324-3089Email: gcawston@renoviainc.com
Date Prepared:	November 18, 2019
Device Information
Device Trade Name:	leva Pelvic Digital Health System
Device Model #:	leva-02
Common Name:	Pelvic Muscle Exerciser
Classification Name:	Perineometer
Product Code:	HIR
Classification Number:	884.1425

884.1425 Regulatory Class: Class II GU - Gastroenterology/Urology Review Panel: Medical Specialty: OB - Obstetrics/Gynecology

Predicate Device Information

510(k) Number:	K180637
Device Trade Name:	Leva Pelvic Digital Health System
Device Model #:	leva-01
Common Name:	Pelvic Muscle Exerciser
Classification Name:	Perineometer
Product Code:	HIR
Classification Number:	884.1425
Regulatory Class:	Class II
Review Panel:	GU - Gastroenterology/Urology
Medical Specialty:	OB - Obstetrics/Gynecology
Manufacturer:	Renovia Inc.

l. Device Description

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The leva-02 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.

II. Indications for Use

The /eva Pelvic Digital 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 in women.

This device interacts with the user via smart phone technology.

III. Comparison of Technological Characteristics

The following table compares the leva Pelvic Digital Health System (leva-02) to the predicate device (leva-01) with respect to the indications for use and primary technological characteristics:

Element	Subject Deviceleva Pelvic Digital Health SystemModel: leva -02	Predicate Deviceleva Pelvic Digital Health SystemModel: leva -01
510(k)Number	This submission	K180637
Manufacturer	Renovia Inc.	Renovia Inc.
Common/Usual Name	Perineometer	Perineometer
Classification Number	884.1425	884.1425
Device Class	Class II	Class II
Product Code	HIR	HIR
Intended Use	The leva Pelvic Digital Health System isintended for:1) Strengthening of the pelvic floormuscles;2) Rehabilitation and training of weakpelvic floor muscles for thetreatment of stress, mixed and mildto moderate urgency urinaryincontinence in women.This device interacts with the user viasmart phone technology.	The leva Pelvic Digital Health System isintended for:1) Strengthening of the pelvic floormuscles;2) Rehabilitation and training of weakpelvic floor muscles for thetreatment of stress, mixed and mildto moderate urgency urinaryincontinence in women.This device interacts with the user viasmart phone technology.
Principle of Operation	Provides indication of relativeintensity of pelvic floor musclecontraction using accelerometers	Provides indication of relativemovement of pelvic floor musclecontraction using accelerometers
Muscle Stimulation	No	No
Intended Anatomical Location	Vagina	Vagina
Single Patient Device	Yes	Yes
Reusable	Yes	Yes
Sterile	Clean, Non-sterile	Clean, Non-sterile
Information Display	Graphical and numeric based onapplied bending, anatomical overlay	Graphical and numeric based onapplied bending, anatomical overlay
Device Materials	Thermoplastic Elastomer (TPE- probe	Silicone
Element	Subject Deviceleva Pelvic Digital Health SystemModel: leva -02	Predicate Deviceleva Pelvic Digital Health SystemModel: leva -01
Direct Contact	covering material)Acrylonitrile Butadiene Styrene (ABS-probe battery pack)

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IV. Summary of Non-Clinical Testing and Risk Analysis

The following non-clinical performance testing and risk analysis was performed to support the leva-02 PDHS:

A. Hardware

Hardware verification was performed in accordance with predefined test procedures and acceptance criteria and included the following assessments:

. Dimensional analysis
. Accelerometer performance
. Device integrity (e.g., pull force, bend, material) under repeated motion
. Wireless communications
. Component connections (i.e., probe, battery pack)
. Cleanability

Hardware verification demonstrated that the subject device, leva-02, is as safe, as effective, and performs as well as the predicate device, leva-01.

B. Software

Software validation was performed in accordance with IEC 62304 and completed with no outstanding anomalies. Software documentation was provided in accordance with FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (2005) for a minor software level of concern. The leva-02 PDHS was tested and found to conform to the requirements of the following standards:

IEC 62304:2006 (First Edition) + A1:2015, Medical device software life cycle processes
Software verification demonstrated that the subject device, leva-02, is as safe, as effective, and performs as well as the predicate device, leva-01.

C. Usability

Usability and Human Factors testing was performed using layperson volunteers. Testing included:

Reading Instructions for Use and Quick Start Guide .
. Setting up the system
. Using system correctly
. Cleaning, storage, disposal

All participants successfully completed all testing demonstrated that the subject device, levice, levice, levice, leva-02, is as safe, as effective, and performs as well as the predicate device, leva-01.

D. Biocompatibility

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 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-02, is as safe, as effective, and performs as well as the predicate device, leva-01.

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Electrical Safety and Electromagnetic Compatibility E.

The leva-02 PDHS was tested and found to conform to the requirements of the following standards:

. IEC 60601-1:2005 + A1: 2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
. IEC 60601-1-6:2010, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
. IEC 60601-1-11, General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
. IEC 60601-1-2 ed 4.0 (2014-02), Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
. IEC 61000, Electromagnetic Compatibility

Electrical Safety and Electromagnetic Compatibility testing demonstrated that the subject device, leva-02, is as safe, as effective, and performs as well as the predicate device, leva-01.

F. Additional Testing

The leva-02 PDHS was found to conform to the following additional standards and requirements:

0 IEC 62366-1:2015, Medical Devices -- Part 1: Application of Usability Engineering to Medical Devices
. CISPR 11:2016+A2:2019, Industrial, scientific and medical equipment - Radiofrequency disturbance characteristics - Limits and methods of measurement
. 47CFR15.247 Subpart C: 02/2019, Federal Communications Commission, Radio Frequency Devices, Intentional Radiators
. 47CFR15.247 Subpart B: 02/2019, Federal Communications Commission, Radio Frequency Devices, Unintentional Radiators
. RSS-247 Issue 2 February 2017, Canada Radio Equipment Standards Specifications, Digital Transmission Systems (DTSs), Frequency Hopping Systems (FHSs) and License-Exempt Local Area Network (LE-LAN) Devices
. ICES-003 Issue 6 Published: January 2016, updated April 2017, Canada Interference Causing Equipment Standards, Information Technology Equipment (Including Digital Apparatus) — Limits and Methods of Measurement
. RSS-Gen Issue 5 April 2018, Canada Radio Equipment Standards, Radio Standards Specifications, General Requirements for Compliance of Radio Apparatus
. RSS-102 Issue 5 March 2015, Canada Radio Equipment Standards Specifications, Radio Frequency (RF) Exposure Compliance of Radiocommunication Apparatus (All Frequency Bands)
. CISPR 25 Ed 3:2008. Vehicles, boats and internal combustion engines. Radio disturbance characteristics -limitsandmethods ofmeasurement for the protection for on-board receivers.
. EN 50121-3-2:2015. Railway Applications - Electromagnetic Capability.
. RTCA DO-160G; Section 21.4 RF Radiated Emission; Published: December 8, 2010. Environmental Conditions and Test Procedures for Airborne Equipment.

The additional testing demonstrated that the subject device, leva-02, is as safe and as effective and performs as well as the predicate device, leva-01.

G. Packaging

The leva-02 PDHS packaging system will be subjected to ISTA 2A-2011 "Partial Simulation Performance Test Procedure for Packaged Products 150 lb. (68 kg) or Less" testing, prior to commercial launch. To ensure the packaging adequately protects the device during shipping and storage this testing will include:

. Atmospheric Preconditioning
. Compression
. Initial Random Vibration

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. Impact
Final Random Vibration

H. Risk Analysis

In addition to non-clinical performance testing, a risk analysis was performed in accordance with ISO 14971:2012 to identify potential hazards and hazardous situate and evaluate the potential risks, and implement risk control measures to mitigate the potential risks of the device, where possible.

The risk analysis demonstrated that the subject device, leva-02, is as safe, as effective, and performs as well as the predicate device, leva-01.

V. Clinical Testing

Clinical testing was not required to support a substantial equivalence determination for the leva-02 PDHS.

VI. Conclusion

Based on the comparison and analysis above, Renovia has demonstrated that the leva-02 PDHS 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).