ELITONE is a non-implanted muscle stimulator designed to treat stress urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues.

Device Description

The Elitone Device provides electrical muscle stimulation (commonly called EMS or E-stim) to treat stress urinary incontinence. Stimulation is delivered to the pelvic floor muscles and surrounding structures through a disposable cutaneous electrode applied to the perineal region. One end of the thin, flexible electrode is positioned proximate the pubis and the other end is positioned proximate the ischial tuberosity. Mildly adhesive and electrically conductive hydrogel portions of each electrode attach the electrode to the perineal tissues and allow comfortable transfer of electrical stimulation through the pelvic floor. The stimulation is controlled by a battery powered, wearable control unit. The housing of the control unit is approximately 55mm x 45mm x 10mm and made of ABS plastic. It includes two pushbuttons that allow the user to increment the voltage (i.e. intensity), and to start, pause and stop device operation. The stimulation utilizes a symmetric, amplitude modulated (2000Hz), sinusoidal waveform. The output intensity operates over a range of levels (0-35) that approximately correspond to a 0-30mA RMS current. The stimulation frequency alternates between a higher frequency portion (50Hz) and a lower frequency portion (10Hz). Higher frequency stimulation is typically used to encourage muscle contraction and strengthening of the pelvic floor muscles. Lower frequency stimulation is typically used to calm detrusor muscle activity, decreasing symptoms of urgency type incontinence. Each treatment session lasts 20 minutes, after which the device turns off automatically. Women are recommended to use the device 3-5 times per week.

AI/ML Overview

The Elitone Device is a non-implanted muscle stimulator designed to treat stress urinary incontinence in women by applying stimulation to the pelvic floor muscles and surrounding tissues. The following information details its acceptance criteria and the studies conducted to demonstrate its performance.

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria for the clinical performance of the Elitone device. However, based on the Clinical Testing section, "Key findings includes clinically significant improvements in incontinence episodes, pad usage and quality of life measures." This implies that improvement in these areas was considered the acceptance criteria for efficacy. For safety, the acceptance criterion was "no adverse events that resulted in injury or required medical treatment."

Aspect	Acceptance Criteria (Implied)	Reported Device Performance
Clinical Efficacy	Clinically significant improvements in incontinence episodes, pad usage, and quality of life measures.	Clinically significant improvements in incontinence episodes, pad usage and quality of life measures.
Safety	No adverse events resulting in injury or requiring medical treatment.	There were no adverse events that resulted in injury or required medical treatment.
Usability	Participants could self-select, understand instructions, and apply treatment safely and correctly for OTC use.	Participants with diversity in age, education and familiarity with incontinence were able to self-select as appropriate users... understand the instructions... and able to apply treatment safely and correctly.
Software	Software verification and validation completed as recommended by FDA guidance.	Verification and validation testing was completed as recommended by FDA guidance pertaining to medical device software.
Electrical Safety & EMC	Compliance with IEC 60601-1, IEC 60601-2-10, and IEC 60601-1-2 standards.	Testing was completed by external labs per IEC 60601-1 and IEC 60601-2-10 standards for safety and IEC 60601-1-2 standard for EMC.
Other Performance (Electrode)	Impedance, adhesiveness, and current dispersion comparable to legally marketed EMS electrodes.	Comparisons were made to legally marketed EMS electrodes. (Passed)
Biocompatibility	Compliance with ISO 10993-1 and comparable to legally marketed electrodes.	Biocompatibility evaluation completed... materials, manufacturing processes and use application are the same as those of legally marketed electrodes. (No new testing needed)

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set:
- Clinical Testing: 20 subjects
- Usability Testing: 15 subjects
Data Provenance: The document does not explicitly state the country of origin. The studies appear to be prospective, as they involve subjects self-administering treatment and participating in usability assessments.

3. Number of Experts and Qualifications for Ground Truth

Clinical Testing: The document does not specify the number of experts used to establish ground truth or their qualifications. The study focused on subject-reported outcomes (incontinence episodes, pad usage, quality of life) and adverse events, which do not typically require external expert adjudication for ground truth beyond standard clinical trial oversight.
Usability Testing: One "qualified healthcare professional (observer)" was used to verify that participants correctly self-identified as candidates for the device based on indications for use and contraindications. Specific qualifications beyond "qualified healthcare professional" are not provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method for the clinical or usability test sets in the typical sense (e.g., 2+1 or 3+1 expert consensus for image interpretation).

For the clinical study, ground truth appears to be based on self-reported outcomes and adverse event monitoring.
For usability testing, verification was done by a single "qualified healthcare professional (observer)."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The study evaluates the device's effectiveness directly, not its impact on human readers' performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done in the form of the "Clinical Testing" where 20 subjects self-administered treatment with Elitone for 6 weeks. This study assessed the algorithm (device) performance directly without human-in-the-loop assistance for interpretation or decision-making.

7. Type of Ground Truth Used

Clinical Testing: The ground truth was based on patient-reported outcomes (incontinence episodes, pad usage, quality of life measures) and observed adverse events.
Usability Testing: The ground truth was based on the direct observation and verification by a qualified healthcare professional of participants' ability to self-select, understand instructions, and safely and correctly apply treatment.

8. Sample Size for the Training Set

The document does not mention any "training set" in the context of an algorithm or AI model development. The Elitone Device is an electrical muscle stimulator, and its functionality is based on predefined electrical stimulation parameters, not on machine learning that would require a separate training set.

9. How Ground Truth for Training Set Was Established

Since there is no mention of a training set for an algorithm or AI model, this question is not applicable. The device's operation is based on established principles of electrical muscle stimulation rather than data-driven machine learning.

Summary

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February 11, 2019

Elidah, Inc. Gloria Kolb CEO 810 Main St., Ste C Monroe, CT 06468

Re: K183585

Trade/Device Name: ELITONE Device Regulation Number: 21 CFR§ 876.5330 Regulation Name: Transcutaneous Electrical Continence Device Regulatory Class: II Product Code: QAJ Dated: December 20, 2018 Received: December 21, 2018

Dear Gloria Kolb:

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 mav, 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 avare 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); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Angel A. Solergarcia -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) K183585

Device Name

ELITONE Device

Indications for Use (Describe)

ELITONE is a non-implanted muscle stimulator designed to treat stress urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues.

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

Sponsor:	Elidah, Inc.
	810 Main St, Suite C.
	Monroe, CT 06468
	Contact: Gloria Kolb
	Phone: 978-435-4324
	Date Prepared: February 11, 2019
Device Name:	Trade Name: Elitone Device
	Common Name: Non-implanted electrical continence device
	Classification Name: Transcutaneous Electrical Continence Device
	Classification Product Code: QAJ
	Regulation Number: 876.5330
	Classification: Class II
Predicate Device:	Innovo (DEN170049), manufactured by Bio-Medical Research Ltd.

Device Description:

Intended Use:

ELITONE is a non-implanted muscle stimulator designed to treat stress urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues.

Comparison to the Predicate Device:

The table below provides comparisons of the Elitone Device to the predicate Innovo device. The primary difference is the application site of the electrical stimulation. The Elitone Device delivers stimulation via

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a cutaneous electrode placed on the perineal tissues whereas the predicate delivers stimulation via cutaneous electrodes placed on the buttocks and thighs. This technological difference does not raise different questions of safety or efficacy. Further, acceptable methods exist to characterize the technological differences and results from those methods demonstrated substantial equivalence of the Elitone Device.

Technological	Elitone Device	Innovo Device	Comparison and Impact
Characteristic	(New Device)	(DEN170049)	on Safety/Performance
Indication for Use	Non-implanted musclestimulator designed to treatstress urinary incontinencein women. It appliesstimulation to the pelvic floormuscles and surroundingtissues.	Transcutaneous electricalstimulator indicated for thetreatment of stress urinaryincontinence in adult females.	Substantially equivalent:Both refer to SUI inwomen.
Therapeutic modality	Electrical muscle stimulation	Electrical muscle stimulation	Identical
Rx or OTC	Rx and OTC	Rx	Suitability for OTC useverified by UsabilityTesting (see below).
Targeted tissue	Pelvic floor muscles andsurrounding structures	Pelvic floor muscles andsurrounding structures	Identical
Anatomic site ofstimulation application	Perineal region	Buttocks and thighs	Different technologicalcharacteristics. See notesabove.
Number of outputmodes	1	1	Identical
Number of outputchannels	1	2	Substantially equivalent:Both perceived as singlechannel to user.
Controls	2 buttons provide allfunctionality	7 buttons provide allfunctionality	Substantially equivalent:Both interfaces providesimple, intuitive controls.
Compliance withvoluntary standards	IEC 60601-1IEC 60601-2-10IEC 60606-1-2	IEC 60601-1IEC 60601-2-10IEC 60606-1-2	Identical

Testing Summary:

The following performance testing was provided in support a substantial equivalence determination. The Elitone Device passed all testing.

Software Verification and Validation Testing The software for the device was considered to be a ● "moderate" level of concern. Verification and validation testing was completed as recommended by FDA guidance pertaining to medical device software.
. Electrical Safety and Electromagnetic Compatibility (EMC) Testing – Testing was completed by external labs per IEC 60601-1 and IEC 60601-2-10 standards for safety and IEC 60601-1-2 standard for EMC.

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Other Performance Testing - Performance of the electrode component was assessed by measuring its impedance, its adhesiveness and its current dispersion. Comparisons were made to legally marketed EMS electrodes.
Biocompatibility Assessment – A biocompatibility evaluation was completed in accordance with the ISO 10993-1 standard. The electrode is considered tissue contacting for a duration of less than 24 hours. The materials, manufacturing processes and use application are the same as those of legally marketed electrodes. Accordingly, no new biocompatibility testing was needed to demonstrate safety and efficacy.
. Clinical Literature Evaluation – A literature review was conducted to demonstrate the safety and efficacy of perineal-applied EMS in the treatment of female urinary incontinence. Articles were reviewed to assess their relevance to the performance and safety of the Elitone device.
. Clinical Testing – Results from a 20 subject study were submitted. Subjects were with mild-moderate predominant stress incontinence who self-administered treatment with Elitone for 6-weeks. Key findings includes clinically significant improvements in incontinence episodes, pad usage and quality of life measures. There were no adverse events that resulted in injury or required medical treatment.
. Usability Testing – 15 subjects participated in a human factors / usability study to assess the device's suitability for safe over-the-counter use. Key finds included: (1) participants with diversity in age, education and familiarity with incontinence were able to self-select as appropriate users of the Elitone device based on the package label, (2) participants were able to understand the instructions for use and a qualified healthcare professional (observer) verified that they correctly self-identified as candidates based on the indications for use and contraindications, and (3) participants were able to apply treatment safely and correctly.

Risk Management Summary:

The Elitone Device has been designed according to Elidah's internal procedures with traceability between the design inputs, design outputs, verification and validation activities. The Elitone Device has been evaluated for risks according to Elidah's internal procedures based on ISO 14971. The risks associated with the Elitone Device were individually and collectively assessed, and the risk/benefit analysis was acceptable.

Conclusion:

The non-clinical data support the safety of the device, and the software verification and validation demonstrates that Elitone performs as intended in the specified use conditions. The clinical literature evaluation, as well as the technological comparison to the predicate device, supports the use of transcutaneous electrical stimulation as an effective treatment of stress urinary incontinence in women. The clinical study supports the effectiveness of the device and confirms the low-risk nature of EMS devices. The usability study was designed to ensure that potential users could self-identify as having stress urinary incontinence (allowing for the use of the product) while also self-identify as not having urge urinary incontinence (excluding them from use). The verbiage used in the product labeling was found to be appropriate for this kind of self-identification in a general population of women. The data included within this submission supports Elitone as a safe and OTC treatment for stress urinary incontinence in women.

Regulation Number and Section

§ 876.5330 Transcutaneous electrical continence device.

(a)
Identification. A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must characterize the electrical stimulation, including the following: Waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.
(2) The patient-contacting materials must be demonstrated to be biocompatible.
(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, thermal safety, and mechanical safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) Instructions for use, including specific instructions regarding the proper placement of electrodes;
(ii) A summary of electrical stimulation parameters; and
(iii) Cleaning instructions and reuse information.