(23 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like algorithms that learn or adapt. The device description focuses on hardware, software for visualization, and standard performance testing.
Yes
The device is described as facilitating "pelvic floor exercise training to strengthen pelvic floor muscles and for the treatment of stress, mixed and mild to moderate urgency urinary incontinence in women," which falls under the definition of a therapeutic device.
No
The device is intended for "strengthening of the pelvic floor muscles" and "rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence in women." Its purpose is to facilitate exercise and training, not to diagnose a condition.
No
The device description explicitly states that the hardware consists of a training device and an associated battery-powered electronics box, and the performance studies include hardware verification testing, biocompatibility testing, electrical safety and electromagnetic compatibility testing, and packaging testing, all of which relate to physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for strengthening and rehabilitation of pelvic floor muscles and treatment of urinary incontinence. This is a therapeutic and training purpose, not a diagnostic one.
- Device Description: The device is described as a training device used vaginally to facilitate pelvic floor exercise. It interacts with the user via a smartphone app to visualize exercises. This aligns with a therapeutic/training device, not a device that analyzes biological samples for diagnostic information.
- Lack of Diagnostic Activity: There is no mention of the device analyzing biological samples (like urine, blood, tissue, etc.) or providing any diagnostic information about a patient's condition. Its function is to help the user perform exercises and visualize their progress.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such function.
N/A
Intended Use / Indications for Use
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 in women.
This device interacts with the user via smart phone technology.
Product codes (comma separated list FDA assigned to the subject device)
HIR
Device Description
The leva Pelvic Digital Health System (leva PDHS) is specifically designed to facilitate pelvic floor exercise training to strengthen pelvic floor muscles and for the treatment of stress, mixed and mild to moderate urgency urinary incontinence in women. The leva PDHS is intended to be used repeatedly by a single patient. The device is designed to be used vaginally.
The hardware consists of the training device itself and an associated battery powered electronics box. The training device has a biocompatible, colored silicone covering which isolates the motion electronics from the environment. The leva PDHS uses an app to connect via smart phone. This enables the user to visualize the Kegel exercise she is being trained on.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing provided in the predicate submission (K133990) was leveraged in the current submission as the device technology has not changed since the prior clearance and the only change in this submission was a modification to the indication for use that did not require additional supporting performance data. A summary of the performance testing used to support the current submission is provided below:
- A. Hardware Verification Testing: The device was subjected to testing to ensure that the device design conforms to the requirements of the Marketing Specification. Product Specification and System Hazards Analysis. Specific device testing included: measurement and inspection of engineering drawings and specifications, testing of the ability of the cable and vaginal device to withstand pulling for over 1,460 cycles (expected lifetime of the device), cleaning of the device over 1,460 times (expected lifetime of the device), and +/-20° bending of the device for over 1.460 cycles (expected lifetime of the device).
- B. 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, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-10).
- C. Software: Software validation was performed and completed with no outstanding anomalies. Software documentation was provided in accordance with FDA quidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005 for a minor software level of concern.
- D. Electrical Safety and Electromagnetic Compatibility: The subject device was tested and found to conform to the requirements of the following:
- i. IEC 60601-1:2005 (3rd Edition), Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- ii. IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- iii. 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
- E. Packaging Testing: Device packaging was subjected to ISTA 2A-2011 "Partial Simulation Performance Test Procedure for Packaged Products 150 lb (68 kg) or Less" testing, which included: Atmospheric Preconditioning, Atmospheric Conditioning, Compression, Initial Random Vibration, Impacts, Final Random Vibration. The packaging was found to adequately protect the device during shipping and storage.
- F. Usability Testing: Usability testing was performed using lay volunteers and comprised: reading the Instructions for Use and Quick Start Guide, setting up the system, using the system correctly, performing a mock Kegel, interpreting the user interface, cleaning, storage, and disposal. All participants successfully completed all tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 4, 2018
Renovia Inc. Gina Prochillo-Cawston Director, Business Integrity, Compliance and Quality 263 Summer St., 5th Floor Boston, Massachusetts 02210
Re: K180637 Trade/Device Name: leva Pelvic Digital Health System Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Regulatory Class: Class II Product Code: HIR Dated: March 9, 2018 Received: March 12, 2018
Dear Gina Prochillo-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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180637
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 in women.
This device interacts with the user via smart phone technology.
X 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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary K180637
Submitter's name and address:
Contact person:
Renovia Inc. 263 Summer St. Boston, MA 02210
Gina Prochillo-Cawston Director of Business Integrity, Compliance & Quality Renovia Inc. 263 Summer St. Boston, MA 02210 Phone: +1-866-735-8424 ext. 1024 e-mail: qcawston@renoviainc.com
Date summary was prepared:
Device Information
Trade/Proprietary Name: Common/Usual Name: Classification Name: Requlation Number: Device Classification: Product Code: Review Panel:
March 26, 2018
leva Pelvic Digital Health System Pelvic Floor Muscle Exerciser Perineometer 21 CFR 884.1425 Class II HIR (perineometer) Obstetrics/Gynecology
Predicate Device Identification
510(k) Number: Device Name: Manufacturer:
K133990 leva Rehabilitative Positional Device Remendium Labs, LLC (Renovia Inc, is the current holder of the 510(k))
The predicate device has not been subject to a design-related recall.
Device Description
The leva Pelvic Digital Health System (leva PDHS) is specifically designed to facilitate pelvic floor exercise training to strengthen pelvic floor muscles and for the treatment of stress, mixed and mild to moderate urgency urinary incontinence in women. The leva PDHS is intended to be used repeatedly by a single patient. The device is designed to be used vaginally.
The hardware consists of the training device itself and an associated battery powered electronics box. The training device has a biocompatible, colored silicone covering
4
which isolates the motion electronics from the environment. The leva PDHS uses an app to connect via smart phone. This enables the user to visualize the Kegel exercise she is being trained on.
Indications for Use
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 in women.
This device interacts with the user via smart phone technology.
Predicate Comparison
The following table compares the leva Pelvic Digital Health System to the predicate device with respect to the indications for use and technological characteristics:
| Device | Subject Device | Predicate Device |
|---|---|---|
| leva Pelvic Digital Health System | leva Rehabilitative Positional Device | |
| 510(k)Number | K180637 | K133990 |
| Manufacturer | Renovia Inc | Remendium Labs, LLC |
| Common/Usual Name | Perineometer | Perineometer |
| Regulation Number | 884.1425 | 884.1425 |
| Device Class | Class II | Class II |
| Product Code | HIR | HIR |
| Intended Use | 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 in women.
This device interacts with the user via smart
phone technology. | The leva Pelvic Floor Trainer is intended for
the purpose of rehabilitation and training of
weak pelvic floor muscles for the treatment
of stress, mixed and mild-moderate urge
incontinence in women. This device interacts
with the user via smart phone technology. |
| Principle of
Operation | Provides indication of relative intensity of
pelvic floor muscle contraction using
accelerometers | Provides indication of relative intensity of
pelvic floor muscle contraction using
accelerometers |
| Muscle Stimulation | No | No |
| Parameter | Relative position of device | Relative position of device |
| Anatomical Site | Vagina | Vagina |
| Single Patient Device | Yes | Yes |
| Reusable | Yes | Yes |
| Sterile | Non-sterile | Non-sterile |
| Information Display | Graphical and numeric based on
applied bending, anatomical overlay | Graphical and numeric based on applied
bending, anatomical overlay |
| Probe Material | Silicone | Silicone |
5
The leva Pelvic Digital Health System has the same intended use and technological characteristics compared to the predicate device. The are no different questions of safety and effectiveness.
Summary of Non-Clinical Testing
Non-clinical testing provided in the predicate submission (K133990) was leveraged in the current submission as the device technology has not changed since the prior clearance and the only change in this submission was a modification to the indication for use that did not require additional supporting performance data. A summary of the performance testing used to support the current submission is provided below:
- A. Hardware Verification Testing: The device was subjected to testing to ensure that the device design conforms to the requirements of the Marketing Specification. Product Specification and System Hazards Analysis. Specific device testing included: measurement and inspection of engineering drawings and specifications, testing of the ability of the cable and vaginal device to withstand pulling for over 1,460 cycles (expected lifetime of the device), cleaning of the device over 1,460 times (expected lifetime of the device), and +/-20° bending of the device for over 1.460 cycles (expected lifetime of the device).
- B. 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, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-10).
- C. Software: Software validation was performed and completed with no outstanding anomalies. Software documentation was provided in accordance with FDA quidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005 for a minor software level of concern.
- D. Electrical Safety and Electromagnetic Compatibility: The subject device was tested and found to conform to the requirements of the following:
- i. IEC 60601-1:2005 (3rd Edition), Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- ii. IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- iii. IEC 60601-1-11 General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical
6
equipment and medical electrical systems used in the home healthcare environment
- E. Packaging Testing: Device packaging was subjected to ISTA 2A-2011 "Partial Simulation Performance Test Procedure for Packaged Products 150 lb (68 kg) or Less" testing, which included: Atmospheric Preconditioning, Atmospheric Conditioning, Compression, Initial Random Vibration, Impacts, Final Random Vibration. The packaging was found to adequately protect the device during shipping and storage.
- F. Usability Testing: Usability testing was performed using lay volunteers and comprised: reading the Instructions for Use and Quick Start Guide, setting up the system, using the system correctly, performing a mock Kegel, interpreting the user interface, cleaning, storage, and disposal. All participants successfully completed all tests.
Summary of Clinical Testing
Not Applicable
Conclusion
Based on the comparison and analysis above, the leva Pelvic Digital Health System is substantially equivalent to the predicate device.