(59 days)
Not Found
No
The description focuses on electrical muscle stimulation with fixed parameters and user-controlled intensity, with no mention of adaptive algorithms or learning capabilities.
Yes
The device is designed to treat urge urinary incontinence by applying electrical stimulation to the pelvic floor muscles, which is a therapeutic action.
No
The device is described as a non-implanted muscle stimulator designed to treat urge urinary incontinence, applying electrical muscle stimulation to the pelvic floor. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly details hardware components including a disposable cutaneous electrode, a battery-powered wearable control unit with pushbuttons, and the delivery of electrical muscle stimulation.
Based on the provided information, the ELITONE Urge device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. IVDs are designed to examine specimens like blood, urine, tissue, etc., to provide information about a person's health.
- ELITONE Urge is a therapeutic device. The description clearly states its purpose is to treat urge urinary incontinence by applying electrical stimulation to the pelvic floor muscles. It does not analyze any biological samples.
The device description and intended use focus on delivering a physical therapy (electrical stimulation) to the body, not on analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
ELITONE Urge is a non-implanted muscle stimulator designed to treat urge urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues.
Product codes (comma separated list FDA assigned to the subject device)
QAJ
Device Description
The ELITONE Urge Urinary Incontinence Device (hereafter ELITONE URGE or ELITONE UUI) provides electrical muscle stimulation (commonly called EMS or E-stim) to treat urge 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 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. 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, sinusoidal waveform. The output intensity operates over a range of levels (0-35) that approximately correspond to a 0-15mA RMS current. The stimulation frequency is 10 Hz, a frequency 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 4-5 times per week.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor muscles and surrounding tissues, perineal region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-administered, at home treatment
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)
- Software Verification and Validation Testing: The software for the device was considered to be a "moderate" level of concern. Verification and validation testing was conducted in accordance with the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
- 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.
- 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 device.
- Clinical Testing:
- Study Type: Single-arm study with the patient serving as own control (comparison to baseline).
- Sample Size:
- First cohort: 15 subjects included in analysis of the ELITONE UUI device (out of 26 enrolled).
- Second cohort: 19 subjects included in the analysis of this second cohort (out of 30 enrolled).
- Final pooled analysis: 34 subjects.
- Key Results:
- Primary efficacy endpoint (percent change in urge leaks per day): 76% of participants responded to the treatment (defined as achieving >=50% reduction).
- Secondary efficacy endpoints:
- Urgency episodes: 76% responder rate (defined as achieving >=50% reduction).
- I-QoL score: 91% responder rate (defined as achieving >=2.5 points change).
- Pad use: 32% responder rate (defined as achieving >=50% reduction).
- Primary safety endpoint (adverse events that resulted in an injury or required medical treatment): None were reported.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- For primary efficacy endpoint (percent change in urge leaks per day): 76% response rate (defined as >=50% reduction in urge leaks).
- For secondary efficacy endpoint (changes in urgency episodes): 76% response rate (defined as >=50% reduction).
- For secondary efficacy endpoint (changes in I-QoL score): 91% response rate (defined as >=2.5 points change).
- For secondary efficacy endpoint (changes in pad use): 32% response rate (defined as >=50% reduction).
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
February 24, 2023
Elidah, Inc. Gloria Kolb CEO 810 Main St., Suite C Monroe, CT 06468
Re: K223884
Trade/Device Name: ELITONE Urge Urinary Incontinence Device Regulation Number: 21 CFR§ 876.5330 Regulation Name: Transcutaneous Electrical Continence Device Regulatory Class: II Product Code: OAJ Dated: December 27, 2022 Received: December 27, 2022
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 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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/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,
Negeen Haghighi -S
for
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223884
Device Name
ELITONE Urge Urinary Incontinence Device
Indications for Use (Describe)
ELITONE Urge is a non-implanted muscle stimulator designed to treat urge 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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3
510(k) Summary
| Sponsor: | Elidah, Inc.
810 Main St, Suite C.
Monroe, CT 06468
Contact: Gloria Kolb
Phone: 978-435-4324
Date Prepared: 2/20/23 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Information: | Trade Name: ELITONE Urge Urinary Incontinence Device
Common Name: Non-implanted electrical continence device
Classification Name: Transcutaneous electrical continence device
Classification Product Code: QAJ
Regulation Number: 876.5330
Device Classification: Class II |
| Predicate Device: | ELITONE (K183585), manufactured by Elidah, Inc.
The predicate device has not been subject to a design-related recall. |
Device Description:
The ELITONE Urge Urinary Incontinence Device (hereafter ELITONE URGE or ELITONE UUI) provides electrical muscle stimulation (commonly called EMS or E-stim) to treat urge 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 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. 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, sinusoidal waveform. The output intensity operates over a range of levels (0-35) that approximately correspond to a 0-15mA RMS current. The stimulation frequency is 10 Hz, a frequency 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 4-5 times per week.
Intended Use:
ELITONE URGE is a non-implanted muscle stimulator designed to treat urge 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 proposed ELITONE UUI device to the predicate ELITONE device (hereafter ELITONE SUI for clarity). The difference between ELITONE UUI and the predicate is the
4
composition of the output signal. Each stimulation cycle of the predicate's output combines a 50Hz signal (understood to treat stress urinary incontinence) and a 10Hz signal (understood to treat urge urinary incontinence), whereas the proposed ELITONE UUI output is solely 10Hz. This difference is achieved through a modification to the embedded software. Product labeling has been changed to reflect the new Indication for Use. All other elements of the two products are identical. Differences in technological characteristics do not raise different questions of safety and effectiveness.
| Technological
Characteristic | ELITONE UUI Device
(New Device) | ELITONE SUI Device
(K183585) | Comparison and Impact
on Safety/Performance |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | non-implanted muscle
stimulator designed to treat
urge urinary incontinence in
women. It applies stimulation
to the pelvic floor muscles
and surrounding tissues. | non-implanted muscle
stimulator designed to treat
stress urinary incontinence
in women. It applies
stimulation to the pelvic floor
muscles and surrounding
tissues. | Substantially Equivalent.
Both have an intended
use for the treatment of
urinary incontinence in
women. |
| Therapeutic modality | Electrical muscle stimulation | Electrical muscle stimulation | Identical |
| Rx or OTX | Rx and OTC | Rx and OTC | Identical |
| Targeted tissue | Pelvic floor muscles and
surrounding structures | Pelvic floor muscles and
surrounding structures | Identical |
| Anatomic site of
stimulation application | Perineal region | Perineal region | Identical |
| Device Materials | Controller Housing - ABS
Electrode - Polyethylene,
Hydrogel, PET | Controller Housing - ABS
Electrode - Polyethylene,
Hydrogel, PET | Identical |
| Sterility Status | Non-sterile | Non-sterile | Identical |
| Shelf-Life | 2-Year shelf life on GelPads | 2-Year shelf life on GelPads | Identical |
| Number of output
modes | 1 | 1 | Identical |
| Number of output
channels | 1 | 1 | Identical |
| Controls | 2 buttons provide all
functionality | 2 buttons provide all
functionality | Identical |
| Compliance with
voluntary standards | IEC 60601-1
IEC 60601-2-10
IEC 60606-1-2 | IEC 60601-1
IEC 60601-2-10
IEC 60606-1-2 | Identical |
| Waveform | Modulated, symmetric
(250µs/phase). | Modulated, symmetric
(250µs/phase). | Identical |
| Stimulation Frequency | 10 Hz
Amplitude modulated at
2000Hz | 50 Hz, 10 Hz
Amplitude modulated at
2000Hz | Substantially equivalent:
Both utilize frequencies
known to treat UUI (10-15
Hz). |
| Time (Cycle
Duration?) | 6s at 10 Hz
6s no stimulation | 4s at 50 Hz
2s at 10 Hz
6s no stimulation | Substantially equivalent:
Both utilize contract/relax
sequencing consistent
with known treatments for
incontinence. |
| Max output voltage
(500Ω) | Vrms = 8V
Vpp = 43V | Vrms = 15V at 50Hz, 8V at
10Hz
Vpp = 43V | Identical to 10Hz portion
of predicate |
| Technological
Characteristic | ELITONE UUI Device
(New Device) | ELITONE SUI Device
(K183585) | Comparison and Impact
on Safety/Performance |
| Max output current
(500Ω) | Ipp — 97mA
Irms -11.4mA | Ipp — 97mA
Irms -28.2mA at 50Hz,
11.4mA at 10 Hz | Identical to 10Hz portion
of predicate |
| Max current density | RMS: 0.4 mA/cm²
Peak: 3.5 mA/cm² | RMS: 1.0 mA/cm² at 50Hz,
0.4mA/cm² at 10Hz
Peak: 3.5 mA/cm² | Identical to 10Hz portion
of predicate |
| Maximum Power
Density (W/cm²) | 0.0032 W/cm² | 0.015 W/cm² at 50Hz,
0.0032 W/cm² at 10Hz | Identical to 10Hz portion
of predicate |
| Maximum Phase
Charge (µC @
500Ohms) | 9.09 µC | 9.09 µC | Identical |
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Testing Summary:
The following performance testing was provided in support a substantial equivalence determination.
- Software Verification and Validation Testing - The software for the device was considered to be a "moderate" level of concern. Verification and validation testing was conducted in accordance with the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
- . 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.
- 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 device.
- Clinical Testing – Clinical testing was conducted on women with urge urinary incontinence in the US. The study design was a single-arm study with the patient serving as own control (i.e., comparison to baseline). Subjects self-administered treatment for 6-weeks. The pre-specified primary efficacy endpoint was the percent change in urge leaks per day, determined by comparing 7-day baseline data with data from the 6th week of treatment. Responders were defined as achieving ≥50% reduction in urge leaks. Pre-specified secondary efficacy endpoints included: changes in urgency episodes (i.e., combined number of urge leaks and urgency events that did not result in a leak) with responders defined as achieving ≥50% reduction, changes in pad use with responders defined as achieving ≥50% reduction, and changes in I-QoL score with responders defined as achieving ≥2.5 points change. Subjects with urge incontinence symptoms predominant to stress incontinence symptoms (if present) were randomly assigned to treat with one of two
6
devices, one of which was the subject ELITONE UUI device. 15 subjects were included in analysis of the ELITONE UUI device. Clinical testing was later expanded (under a second IRB-approved protocol) to include a cohort of women with urge urinary incontinence without stress incontinence symptoms. These subjects self-administered treatment for 6-weeks with the ELITONE UUI device according to the same protocol as the first cohort. Pre-specified primary and secondary endpoints aligned with those from the first cohort of subjects. 19 subjects were included in the analysis of this second cohort. The protocol detailing the expanded data collection specifies intent to pool data from the two testing periods. Accordingly, 34 subjects were included in the final analysis. For the primary efficacy endpoint, 76% of participants responded to the treatment. Responder rates for the secondary endpoints were: 76% for urgency episodes, 91% for I-QoL, and 32% for pad use. The primary safety endpoint was defined as adverse events that resulted in an injury or required medical treatment. None were reported. The self-administered, at home treatment limited the opportunity for direct oversight by study personnel, making it relatively easy for subjects to enroll and then subsequently opt-out of participation before initiating treatment. In the first cohort, 26 subjects were shipped the ELITONE UUI device (i.e., enrollment), 15 returned the study device demonstrating at least one treatment session (i.e., treatment), and 15 were found to have completed the study protocol (i.e., analysis). Enrollment, treatment, and analysis values for the second cohort were 30, 23, and 19 respectively.
Risk Management Summary:
ELITONE UUI has been designed according to Elidah's internal procedures with traceability between the design inputs, design outputs, verification and validation activities. ELITONE UUI has been evaluated for risks according to Elidah's internal procedures based on ISO 14971. The risks associated with ELITONE UUI were individually and collectively assessed, and the risk/benefit analysis was acceptable.
Conclusion:
The non-clinical data demonstrate that ELITONE UUI is as safe as the predicate. The software verification and validation demonstrate that ELITONE UUI performs as intended in the specified use conditions. The clinical literature evaluation supports the use of transcutaneous electrical stimulation as an effective treatment of urge urinary incontinence in women. The clinical study data demonstrates that ELITONE UUI is as safe and effective as the predicate device. Collectively, performance testing supports a Substantial Equivalence determination.