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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the leva Pelvic Digital Health System. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting a new standalone study to prove performance against specific acceptance criteria. Therefore, much of the information typically requested for a study proving device performance (like sample size for test sets, ground truth establishment, MRMC studies, or training set details for AI) is not present or applicable in this context.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, the device leverages a previous 510(k) clearance (K133990) for the predicate device, "leva Rehabilitative Positional Device." The core technology has not changed, and the current submission primarily modifies the indications for use without requiring additional supporting performance data from user studies.

The "acceptance criteria" presented are primarily conformity to existing standards and specifications, rather than quantitative performance metrics from a new clinical study.

Acceptance Criteria Category	Specific Acceptance Criterion	Reported Device Performance (Summary from K133990 & K180637)
Hardware Verification	Device design conforms to Marketing Specification, Product Specification, and System Hazards Analysis.	- Measurement and inspection of engineering drawings and specifications: Performed - Cable and vaginal device withstand pulling for over 1,460 cycles: Tested successfully - Device cleaning for over 1,460 times: Tested successfully - Device bending (+/-20°) for over 1,460 cycles: Tested successfully
Biocompatibility	Compliance with ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-10).	Patient contacting material subjected to biocompatibility testing and found compliant.
Software Validation	Software validation performs adequately with no outstanding anomalies, in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (minor software level of concern).	Software validation performed and completed with no outstanding anomalies.
Electrical Safety & EMC	Conformity to IEC 60601-1:2005 (3rd Ed.), IEC 60601-1-2:2007, and IEC 60601-1-11.	Device tested and found to conform to these standards.
Packaging Testing	Adequately protect the device during shipping and storage, conforming to ISTA 2A-2011 "Partial Simulation Performance Test Procedure for Packaged Products 150 lb (68 kg) or Less" (Atmospheric Preconditioning, Atmospheric Conditioning, Compression, Initial Random Vibration, Impacts, Final Random Vibration).	Packaging tested according to ISTA 2A-2011 protocol and found to adequately protect the device.
Usability Testing	Lay volunteers successfully complete tasks including reading instructions, setup, correct use, performing mock Kegel, interpreting UI, cleaning, storage, and disposal.	All participants successfully completed all tests.
Clinical Performance	(Not explicitly defined for this 510(k) as the submission primarily relies on equivalence to predicate and non-clinical data inherited from K133990 for the existing technology).	Not Applicable: The document states "Summary of Clinical Testing: Not Applicable." The basis for clinical effectiveness relies on the predicate device's prior clearance and the fact that the technology fundamentally has not changed. The expanded indications ("Strengthening of the pelvic floor muscles") are considered supported by the existing technology and equivalent properties.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size:
- For hardware verification, biocompatibility, electrical safety, and packaging, the 'sample size' refers to the number of units or materials tested in labs. Specific numbers are not provided, only that "the device was subjected to testing" and "patient contacting material was subjected to biocompatibility testing."
- For Usability Testing: The document mentions "lay volunteers." The exact number is not specified.
Data Provenance: The data primarily comes from non-clinical testing (bench testing, lab testing) performed to verify conformity to specifications and standards. This is likely internal testing by Remendium Labs, LLC (the original manufacturer of the predicate) and Renovia Inc.
- The data from the predicate device (K133990) is leveraged, indicating its provenance would be similar.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This type of detail is not provided in a 510(k) summary focused on substantial equivalence and non-clinical testing. Ground truth (e.g., for diagnostic accuracy) is not established through expert consensus in this context because the device is a therapeutic/training device, not a diagnostic one that produces "diagnoses" requiring expert validation.
The closest to "expert" input would be the engineers and quality assurance personnel who designed and verified the device against engineering specifications and relevant standards.

4. Adjudication method for the test set:

Not applicable for this type of submission. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or diagnostic accuracy studies where multiple readers interpret images or data, and their interpretations need to be reconciled to establish a ground truth or resolve disagreements. Here, the testing is against predefined engineering and regulatory standards.

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:

No, an MRMC comparative effectiveness study was not done. This device is a pelvic floor muscle exerciser and training system. It's a therapeutic device for muscle rehabilitation, not an AI-assisted diagnostic tool that would be evaluated for its impact on human reader performance. Its function is to provide biofeedback and guidance for exercise, not to assist in interpreting clinical data that humans typically read.

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

This concept is not directly applicable. The device provides biofeedback on muscle contraction. It functions "stand-alone" in the sense that the user interacts directly with the device via a smartphone app to visualize their Kegel exercises. However, it's not an "algorithm" in the typical AI sense that processes data to produce a medical conclusion without human intervention. The "human-in-the-loop" is the user performing the exercises.

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

For the non-clinical testing, the "ground truth" is defined by engineering specifications, regulatory standards, and established test protocols. For example:
- For pull or bend cycles: The ground truth is the specified number of cycles the device must withstand without failure.
- For biocompatibility: The ground truth is compliance with the ISO 10993 series of standards.
- For electrical safety: The ground truth is conformity to IEC 60601 standards.
- For usability: The ground truth is the successful completion of specified tasks by lay volunteers.
No clinical "ground truth" (like pathology or clinical outcomes data from a new trial) was presented in this 510(k) summary as the current submission relies on the predicate's prior clearance and the inherent nature of the technology.

8. The sample size for the training set:

Not applicable. This device description does not involve a "training set" in the context of machine learning, AI, or diagnostic algorithm development. Its function is based on accelerometers providing biofeedback, not on a trained AI model.

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

Not applicable, as there is no "training set" for an AI model mentioned in the document.

Summary

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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);

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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

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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)

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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 hardware consists of the training device itself and an associated battery powered electronics box. The training device has a biocompatible, colored silicone covering

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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:

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.

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 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 via smartphone technology.	The leva Pelvic Floor Trainer is intended forthe purpose of rehabilitation and training ofweak pelvic floor muscles for the treatmentof stress, mixed and mild-moderate urgeincontinence in women. This device interactswith the user via smart phone technology.
Principle ofOperation	Provides indication of relative intensity ofpelvic floor muscle contraction usingaccelerometers	Provides indication of relative intensity ofpelvic floor muscle contraction usingaccelerometers
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 onapplied bending, anatomical overlay	Graphical and numeric based on appliedbending, anatomical overlay
Probe Material	Silicone	Silicone

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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

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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.

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).