LEva Pelvic Digital Health System

K192270 · Renovia, Inc. · HIR · Nov 22, 2019 · Obstetrics/Gynecology

Device Facts

• Record ID: K192270
• Device Name: LEva Pelvic Digital Health System
• Applicant: Renovia, Inc.
• Product Code: HIR · Obstetrics/Gynecology
• Decision Date: Nov 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1425
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The leva Pelvic Digital Health System is intended for: 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. This device interacts with the user via smart phone technology

Device Story

Leva-02 PDHS is a prescription, reusable, intra-vaginal device for pelvic floor muscle (PFM) training. It consists of a probe containing six accelerometers, a storage case with battery, and a mobile application. The device detects PFM contractions via accelerometers and transmits real-time performance data wirelessly to the patient's smartphone. The app provides graphical and numeric feedback to the user, allowing them to monitor progress during training. Used by patients at home to strengthen pelvic floor muscles; the healthcare provider uses the output to guide rehabilitation. The system facilitates PFM training without electrical stimulation.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence was supported by bench testing, including hardware verification, software validation (IEC 62304), usability/human factors testing, biocompatibility (ISO 10993), and electrical safety/EMC testing (IEC 60601 series).

Technological Characteristics

Intra-vaginal probe constructed of Thermoplastic Elastomer (TPE) and Acrylonitrile Butadiene Styrene (ABS). Sensing principle: six internal accelerometers to measure relative intensity of PFM contraction. Connectivity: wireless transmission to mobile app. Power: battery-operated. Software: minor level of concern. Standards: IEC 62304, ISO 10993, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62366-1.

Indications for Use

Indicated for women with weak pelvic floor muscles requiring strengthening, rehabilitation, and training for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence, including overactive bladder.

Regulatory Classification

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.

Predicate Devices

• Leva Pelvic Digital Health System (leva-01) (K180637)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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:

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.

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.<br>263 Summer Street<br>Boston, MA 02210 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Gina Prochilo-Cawston<br>Director of Regulatory<br>Renovia Inc.<br>263 Summer St.<br>Boston, MA 02210<br>Phone: [phone]<br>Email: [e-mail] |
| 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

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.

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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;
- 2) 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 Device<br><i>leva</i> Pelvic Digital Health System<br>Model: <i>leva</i> -02 | Predicate Device<br><i>leva</i> Pelvic Digital Health System<br>Model: <i>leva</i> -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 <i>leva</i> Pelvic Digital Health System is<br>intended for:<br>1) Strengthening of the pelvic floor<br>muscles;<br>2) Rehabilitation and training of weak<br>pelvic floor muscles for the<br>treatment of stress, mixed and mild<br>to moderate urgency urinary<br>incontinence in women.<br>This device interacts with the user via<br>smart phone technology. | The <i>leva</i> Pelvic Digital Health System is<br>intended for:<br>1) Strengthening of the pelvic floor<br>muscles;<br>2) Rehabilitation and training of weak<br>pelvic floor muscles for the<br>treatment of stress, mixed and mild<br>to moderate urgency urinary<br>incontinence in women.<br>This device interacts with the user via<br>smart phone technology. |
| Principle of Operation | Provides indication of relative<br>intensity of pelvic floor muscle<br>contraction using accelerometers | Provides indication of relative<br>movement of pelvic floor muscle<br>contraction 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 on<br>applied bending, anatomical overlay | Graphical and numeric based on<br>applied bending, anatomical overlay |
| Device Materials | Thermoplastic Elastomer (TPE- probe | Silicone |
| Element | Subject Device<br><i>leva</i> Pelvic Digital Health System<br>Model: <i>leva</i> -02 | Predicate Device<br><i>leva</i> Pelvic Digital Health System<br>Model: <i>leva</i> -01 |
| Direct Contact | covering material)<br>Acrylonitrile Butadiene Styrene (ABS-<br>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.