Leva Pelvic Health System
Device Facts
| Record ID | K212495 |
|---|---|
| Device Name | Leva Pelvic Health System |
| Applicant | Renovia, Inc. |
| Product Code | HIR · Obstetrics/Gynecology |
| Decision Date | Sep 8, 2021 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 884.1425 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The leva Pelvic 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
Prescription intra-vaginal device for pelvic floor muscle (PFM) rehabilitation and training. Probe contains six accelerometers to measure relative intensity of PFM contractions. Device transmits real-time performance data wirelessly to a dedicated mobile application. Used by women at home for repeated sessions. App provides graphical and numeric feedback based on applied bending to guide user training; helps monitor progress. Enables patient-directed exercise; facilitates PFM strengthening to treat urinary incontinence.
Clinical Evidence
Bench testing only. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, irritation). Software/firmware design verification and manufacturing testing protocols were conducted to validate modifications.
Technological Characteristics
Intra-vaginal probe with six accelerometers; Thermoplastic Elastomer (TPE) probe material; Acrylonitrile Butadiene Styrene (ABS) battery pack. Wireless data transmission to mobile app. Clean, non-sterile. Single-patient, reusable. No muscle stimulation. Biocompatibility per ISO 10993-5 and ISO 10993-10.
Indications for Use
Indicated for women with weak pelvic floor muscles requiring strengthening or rehabilitation for stress, mixed, or 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 (K192270)
Submission Summary (Full Text)
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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:
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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This 510(k) Summary has been prepared in accordance with 21 CFR 807.92.
### 1. Submitter
| Name and Address: | Renovia Inc.<br>263 Summer Street<br>Boston, MA 02210 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Jacqueline Schmainda<br>Regulatory Consultant on behalf of Renovia<br>Renovia Inc.<br>263 Summer Street<br>Boston, MA 02210<br>Phone: 763-269-2069<br>Email: <a href="mailto:jackie@boldtype.com">jackie@boldtype.com</a> |
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
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.
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## 5. Indications for Use
The leva Pelvic 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.
### 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 of<br>Operation | Provides indication of relative<br>intensity of pelvic floor muscle<br>contraction using accelerometers | Provides indication of relative<br>intensity of pelvic floor muscle<br>contraction using accelerometers |
| Muscle Stimulation | No | No |
| Intended Anatomical<br>Location | Vagina | Vagina |
| Use Model | Single patient, reusable | Single patient, reusable |
| Sterility | Clean, non-sterile | Clean, non-sterile |
| Display Information | Graphical and numeric based on<br>applied bending, anatomical overlay | Graphical and numeric based on<br>applied bending, anatomical overlay |
| Device Materials | • Probe: Thermoplastic Elastomer<br>(TPE)<br>• Probe Battery Pack: Acrylonitrile<br>Butadiene Styrene (ABS) | • Probe: Thermoplastic Elastomer<br>(TPE)<br>• Probe Battery Pack: Acrylonitrile<br>Butadiene Styrene (ABS) |
| Patient Contact<br>(Contact Duration) | • Probe: Direct (<24 hours)<br>• Probe Battery Pack: Direct (<24<br>hours)<br>• Vaginal Probe Hub: Indirect<br>(Incidental)<br>• Battery Pack Cap: Indirect<br>(Incidental) | • Probe: Direct (<24 hours)<br>• Probe Battery Pack: Direct (<24<br>hours)<br>• Vaginal Probe Hub: Indirect<br>(Incidental)<br>• Battery Pack Cap: Indirect<br>(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.
