(197 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.
Yes
The device is intended for the treatment of various forms of incontinence by strengthening and rehabilitating pelvic floor muscles, which are therapeutic indications.
No
The device is described as a system for strengthening and rehabilitating pelvic floor muscles and monitoring progress, not for diagnosing medical conditions.
No
The device description explicitly states it is an "intra-vaginal device" and an "intra-vaginal device designed to allow the user to rehabilitate and strengthen their pelvic floor muscles". This indicates a physical hardware component is part of the system, not just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Leva Pelvic Health System Function: The leva system is an intra-vaginal device that directly interacts with the user's body to facilitate and monitor pelvic floor muscle training. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states strengthening, rehabilitation, and training of pelvic floor muscles for the treatment of incontinence. This is a therapeutic and monitoring function, not an in vitro diagnostic function.
- Device Description: The description emphasizes the device's role in facilitating PFMT and transmitting real-time performance data, not analyzing biological samples.
Therefore, based on the provided information, the leva Pelvic Health System is a therapeutic and monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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;
-
Rehabilitation and training of weak pelvic for the first-line treatment of chronic fecal incontinence (>3month uncontrolled passage of feces) in women.
This device interacts with the user via smart phone technology.
Product codes
HIR
Device Description
The leva Pelvic Health System ("leva PHS" or "leva System") is a prescription intra-vaginal device designed to allow the user 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vaginal only
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
REN-17 Study (NCT04027335):
- Study Type: Ten (10) week, single-arm, open-label study.
- Sample Size: Thirty-one (31) participants. 26 participants for Primary Effectiveness Endpoint Analysis, 27 participants for Primary Safety Endpoint Analysis.
- Data Source: Participants meeting pre-defined screening criteria, including fecal incontinence defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last three (3) months and is bothersome enough to desire treatment.
- Key Results: Primary effectiveness endpoint met. Mean St. Mark's Score improved from 14.6 at baseline to 11.6 at ten weeks (p=0.0047). Other improvements noted in FIQoL Lifestyle, Coping, and Depression.
REN-19 Study (NCT04508153) - Subset Analysis:
- Study Type: Eight (8) week, randomized controlled trial ("RCT") with a subset analysis. Multi-arm, unblinded study with an active control.
- Sample Size: Two hundred ninety-nine (299) women for the main study. A subset of 92 participants with fecal incontinence symptoms (44 in the intervention group with leva-02, 48 in the control group without device).
- Data Source: Women with stress and stress-dominant mixed urinary incontinence, with a subset also indicating fecal incontinence symptoms.
- Key Results:
- CRADI-8 (full survey): Both groups showed statistically significant improvement at 8 weeks. Leva-02 group showed statistically significantly greater improvement at 6 months (P=0.01) compared to Kegel arm as the improvement in the Kegel arm did not continue between 8 weeks and 6 months.
- CRADI-8: Question 4 (Loss of Loose Stool): Symptom improvement specific to the control of loose stool was statistically superior within the leva-02 arm at 6 months (P=0.04).
- CRAIQ-7: Both groups showed statistically significant improvement at 8 weeks, but only leva-02 met MCID. Leva-02 group demonstrated statistically significantly greater improvement at 6 months (p=0.02) as the improvement in the Kegel arm did not continue between 8 weeks and 6 months.
Key Metrics
REN-17 Study:
- St. Mark's Score (Vaizey): Baseline 14.6 ± 4.37, Week 10 11.6 ± 5.12 (Wilcoxon signed rank test: 0.008)
- FIQoL - Lifestyle: Baseline 2.7 ± 0.85, Week 10 3.1 ± 0.84 (
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 30, 2022
Renovia Inc. % Jacqueline Schmainda Regulatory Consultant Bold Type 2100 N Alafaya Trail Orlando, FL 32826
Re: K213913
Trade/Device Name: leva Pelvic Health System Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Regulatory Class: Class II Product Code: HIR Dated: June 1, 2022 Received: June 2, 2022
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. You must comply with all the Act's
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
for
Je Hi An, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213913
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;
-
Rehabilitation and training of weak pelvic for the first-line treatment of chronic fecal incontinence (>3month uncontrolled passage of feces) in women.
This device interacts with the user via smart phone technology.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/2 description: The image shows the word "Renovia" in a stylized font. The word is in a purple color. Above the right side of the word are three curved lines.
This 510(k) Summary has been prepared in accordance with 21 CFR 807.92.
1. Submitter
| Name and Address: | Renovia Inc.
263 Summer Street
Boston, MA 02210 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Jacqueline Schmainda
Regulatory Consultant on behalf of Renovia
Renovia Inc.
263 Summer Street
Boston, MA 02210
Phone: 763-269-2069
Email: jackie@boldtype.com |
| Date Prepared: | June 27, 2022 |
2. Device Information
| Trade Name: | leva® Pelvic Health System |
|---|---|
| Model: | leva-02 |
| Common Name: | Perineometer |
| Product Code: | HIR |
| Regulatory Class | Class II |
| Regulation Number: | 21 CFR 884.1425 |
| FDA Panel: | Obstetrics / Gynecology |
3. Predicate Information
| 510(k) Number | Trade Name | Applicant |
|---|---|---|
| K212495 | leva Pelvic Health System | Renovia Inc. |
4. Device Description
The leva Pelvic Health System ("leva PHS" or "leva System") is a prescription intra-vaginal device designed to allow the user 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.
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5. Indications for Use
The /eva 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 2) to moderate urgency urinary incontinence (including overactive bladder) in women;
-
- Rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence (≥3-month uncontrolled passage of feces) 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 | Subject Device | Predicate Device |
|---|---|---|
| leva PHS | leva PHS | |
| This Submission | K212495 | |
| Regulatory Information | ||
| Brand Name | leva Pelvic Health System | leva Pelvic Health System |
| Manufacturer | Renovia Inc. | Renovia Inc. |
| Model Number | leva-02 | leva-02 |
| Common or Usual | ||
| Name | Perineometer | Perineometer |
| Regulation | 21 CFR 884.1425 | 21 CFR 884.1425 |
| Class | Class II | Class II |
| Product Code | HIR | HIR |
| Intended Use / Indications for Use | ||
| Intended Use | Strengthen pelvic floor muscles for the | |
| treatment of urinary incontinence and fecal | ||
| incontinence | Strengthen pelvic floor muscles for the | |
| treatment of urinary incontinence | ||
| Indications for Use | ||
| Statement | 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; - Rehabilitation and training of weak pelvic
floor muscles for the first-line treatment of
chronic fecal incontinence (>3-month
uncontrolled passage of feces) in women.
This device interacts with the user via smart
phone technology. | 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. |
| | Subject Device | Predicate Device |
| Characteristic | leva PHS | leva PHS |
| | This Submission | K212495 |
| Technological Characteristics | | |
| Principle of Operation | Provides indication of relative position of
pelvic floor muscle contraction using
accelerometers | Provides indication of relative position of
pelvic floor muscle contraction using
accelerometers |
| Mechanism of Action | Lift and Squeeze for pelvic floor muscle
strengthening. The leva sensor hardware
(probe) transmits biofeedback to leva App
which is displayed to user. | Lift and Squeeze for pelvic floor muscle
strengthening. The leva sensor hardware
(probe) transmits biofeedback to leva App
which is displayed to user. |
| Electrical Stimulation | No | No |
| Parameter | Relative position of device | Relative position of device |
| Anatomical Use | Vaginal only | Vaginal only |
| Single Patient Device | Yes | Yes |
| Reusable | Yes | Yes |
| Sterility | Non-sterile, clean | Non-sterile, clean |
| Information Display | Graphical and numeric based on implied
bending, anatomical overlay | Graphical and numeric based on implied
bending, anatomical overlay |
| Patient Contact
(Contact Duration) | • Probe: Direct (leva -02) | Control Group (Active) |
| Treatment | 44 participants | 48 participants |
| Primary Effectiveness Endpoint Analysis | 44 participants | 48 participants |
| Primary Safety Endpoint Analysis | 44 participants | 48 participants |
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Safety:
There were no treatment-related severe adverse events in either arm of the Ren-19 Study. Looking at only those 92 participants within the Fl subset analysis, there were two (2) urinary tract infections in the control (Kegel) group, neither of which were deemed to be intervention related, and none in the intervention (leva-02) group. There was one (1) adverse event, vaginal spotting, in one subject which was reported as "possibly" intervention related occurring in the intervention (leva-02) arm. This resolved before the end of the study and the participant resumed use of the device without complication through the study endpoint at 8 weeks.
Endpoints:
The Ren-19 subset analysis compared participants' overall CRADI-8 scores and the two individual questions within the CRADI-8 specifically addressing Fl, and participants' condition-specific quality of life assessment using the Colorectal-Anal Impact Questionnaire Short Form (the "CRAIQ-7") – each at baseline, 8-weeks, and 6-months.
The results of the FI subset analysis demonstrate that FI symptom improvement of those in the leva-02 arm was statistically superior to that of participants in the Kegel arm, as summarized in the Results table below.
CRADI-8 Results:
On the CRADI-8, both the Kegel arm and the leva-02 arm demonstrated statistically significant improvement that met the minimum clinical important difference ("MCID") (-4.68) for the CRADI-8 at 8 weeks. Jelovsek, Chen et. al. found in their 2014 publication, Minimum Important Differences for Scales Assessing Symptom Severity and Quality of Life in Patients with Fecal Incontinence (available at doi: 10.1097/SPV.00000000000000078), that the MCID for the CRADI-8 is a reduction of 4.68.
While the improvement in the leva-02 arm was greater, there was not a statistically significant difference between the groups at 8 weeks (P=.54). However, the CRADI-8 symptom improvement of the leva-02 group was statistically significantly greater at 6 months. This difference at 6 months was driven by the fact that the CRADI-8 results of participants in the Kegel arm did not continue to improve between 8 weeks and 6 months. In the leva-02 arm, however, the CRADI-8 results continued to improve between 8 weeks and 6 months.
This result of stronger continued improvement in Fl symptoms through 6 months within the leva-02 arm is also evident in the results of the questions 3 and 4 of CRADI-8, which are the two questions within the survey that specifically address loss of stool.2 As shown in Table 4 below, the symptom improvement specific to the control of loose stool was statistically superior within the leva-02 arm at 6 months.
CRAIQ-7 Results:
In the CRAIQ-7 assessing participants' condition-specific quality of life, both the Kegel arm and the leva-02 arm demonstrated statistically significant improvement at 8 weeks. However, only participants in the leva-02 arm reported results that met the MCID (-8.01) for the CRAIQ-7 at 8 weeks (see Jelovsek, Chen et. dl. for MCID on CRAIQ-7).
While the CRAIQ-7 improvement in the leva-02 arm was greater, there was not a statistically significant difference between the groups at 8 weeks (P=.39). However, the CRAIQ-7 improvement of the leva-02 group demonstrated improvement that was statistically significantly greater at 6 months (p=0.02). This difference at 6 months was driven by the fact that the CRAIQ-7 results of participants in the Kegel arm did not continue
1 Question 3 of the CRADI-8 asks: Do you usually lose stool beyond your control if your stool is well formed? Question 4 of the CRADI-8 asks: Do you usually lose stool beyond your control if your stool is loose?
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to improve between 8 weeks and 6 months. In the leva-02 arm, however, the CRAIQ-7 results continued to improve between 8 weeks and 6 months.
| REN-19 Subset Analysis – Results | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to 8 weeks | Baseline to 6 months | ||||||||||
| Baseline | 8 | ||||||||||
| Weeks | Abs Mean | ||||||||||
| Difference | Paired | ||||||||||
| t-test | Students | ||||||||||
| t-test | Baseline | 6 | |||||||||
| Months | Abs Mean | ||||||||||
| Difference | Paired | ||||||||||
| t-test | Students | ||||||||||
| t-test | |||||||||||
| CRADI-8 (full survey) | |||||||||||
| Kegel arm | 40.9 | ||||||||||
| (±19.9) | 29.2 | ||||||||||
| (±22.4) | -5.3 | ||||||||||
| (±14.3) |