(217 days)
No reference devices were used in this submission.
No
The description focuses on electrical stimulation and basic device control via a microcontroller, with no mention of AI/ML algorithms for data analysis, personalized treatment, or adaptive stimulation.
Yes
The device is intended to "treat chronic insomnia in adults aged 22 and older," which indicates a therapeutic purpose.
No.
Modius Sleep is a neurostimulation device designed to treat chronic insomnia, not diagnose it. While it helps improve sleep, it does not assess or identify the condition itself.
No
The device description explicitly states it consists of a battery-powered device, electrode pads, and charging accessories, which are all hardware components. While it contains embedded software, it is not solely software.
Based on the provided information, the Modius Sleep device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description of the Modius Sleep device clearly states it is a non-invasive neurostimulation device that delivers electrical energy to the skin behind the ears. It does not involve the collection or analysis of any biological specimens (like blood, urine, tissue, etc.).
- The intended use is treatment, not diagnosis. The intended use is to "treat chronic insomnia," which is a therapeutic purpose, not a diagnostic one.
- The device description focuses on electrical stimulation. The mechanism of action is described as electrical vestibular nerve stimulation (VeNS), which is a physical intervention, not a method for analyzing biological samples.
Therefore, the Modius Sleep device falls under the category of a therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Modius Sleep is a non-invasive, home-use neurostimulation device to treat chronic insomnia in adults aged 22 and older.
Product codes
QJQ
Device Description
Modius Sleep is a low-risk non-invasive transdermal neurostimulation device to treat chronic insomnia. The proposed mechanism of the device is through a technology known as electrical vestibular nerve stimulation (VeNS).
It consists of a battery-powered device designed to transcutaneously deliver low-level electrical energy (up to 1mA) to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads. These pads are placed on the skin behind each ear (mastoid area). The intensity of the electric pulse can be adjusted up or down by the user. When turned on, the device delivers a small electrical impulse which stimulates the vestibular nerve. Adjustments to the stimulation level may be made using the up and down buttons on the device, which are located just above the power button. The device can also be paused by pressing the power button twice. When finished the user removes the device and disposes of the electrode pads after each use. When the device is not being used it can be charged through a micro-USB cable. For safety reasons, it is not possible to recharge the battery while the device is in use in stimulation mode.
The key components of the Modius Sleep include the Modius Sleep device (plastic enclosure and printed circuit board assembly (PCBA), stimulation pads (K210448 and K132588), skin cleansing wipes (K121655) and charging accessories. The PCBA consists of a microcontroller, USB connector (charging only), transformer driver, IO expander and EEPROM memory. The embedded software within the device manages overall functionality of the device from Stimulation Control, Power Management, and user interaction (Indication LED and Audio tones).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin behind the ears, over the mastoid processes.
Indicated Patient Age Range
Adults aged 22 and older.
Intended User / Care Setting
Home-use, user adjusts stimulation level. Prescribed by a trained physician.
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
A 4-week pivotal randomized controlled trial with two groups 1) Modius Sleep device group and 2) Sham (placebo) control group was used to evaluate the safety and efficacy of the Modius Sleep device as a treatment for chronic insomnia.
The study was a multi-site, randomised, double blinded, sham-controlled trial conducted from May 2022 to January 2023. The study has been registered at https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT04452981). Research sites included University of Ulster, United Kingdom (UK), and Hong Kong Polytechnic University, Hong Kong (HK). The study protocol was approved at the UK site by Wales Research Ethics Committee 7 (Ref: 22/WA/0022) and at the HK site by the Human Subjects Ethics Sub-Committee, Hong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Polytechnic University (Ref: HSEARS20220320001). Informed consent was obtained from all participants.
Adults with an Insomnia Severity Index (ISI) score of 15 or higher were recruited using online platforms and randomly allocation ratio) to receive the Modius Sleep device (intervention group) or the sham device (active control group). Both groups were advised to use their allocated devices for 30 minutes per day prior to going to sleep for a four-week duration. The devices are identical in appearance and therefore neither the participant nor the clinical study team knew whether the Modius Sleep device or sham device was allocated. Primary and secondary outcomes were captured at baseline and at 4 weeks.
126 participants (aged 19-67 years) with moderate to severe insomnia assessed by the insomnia severity index (ISI) were enrolled. While the ISI is a useful screening tool for insomnia, it does not cover all components of The AASM (American Academy of Sleep Medicine) International Classification of Sleep Disorders (ICSD), and The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) that are used for diagnosis of chronic insomnia. For this reason, further information was collected by an online survey to establish that the participants had chronic insomnia at the time of enrolment as defined by ICSD and DSM-V. Specifically, information was collected regarding the duration and frequency of their sleep disturbance and associated daytime symptoms, confirmation of adequate opportunity and conditions to sleep, and confirmation of no other co-existing conditions. This further information provided confirmation that the participants had Chronic Insomnia at the time of enrolment in the Modius Sleep trial.
For the duration of the study, participants agreed not to take prescribed or over the counter sleeping medication; not to undergo any extreme lifestyle changes that could have impacted their sleep quality; not to use sleep trackers; not to travel to different time zones and to maintain a familiar sleeping routine.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Pivotal randomized, double-blind sham-controlled clinical trial.
Sample Size: 149 eligible participants were recruited and randomized (n=75 for Modius Sleep group, n=74 for sham control group). 126 participants completed the study with available data for primary effectiveness endpoint analysis (n=61 for Modius Sleep, n=65 for sham control).
AUC: Not Found
MRMC: Not Found
Standalone performance: The Modius Sleep group demonstrated a statistically significant reduction in Insomnia Severity Index (ISI) score compared to the sham control group across various analysis models (ITT (MI), ITT (LOCF), and Complete case).
Key results:
- Primary Effectiveness Endpoint: Change in the Insomnia Severity Index (ISI) score at Week 0 and Week 4 between the Modius Sleep group and sham control group.
- Complete case analysis showed a between-group difference in mean ISI score change of -2.28 (95% CI: -3.85, -0.71; p=0.005) for Model 1, -2.49 (95% CI: -4.45, -0.53; p=0.013) for Model 2, and -2.40 (95% CI: -4.36, -0.44; p=0.017) for Model 3.
- Within-group mean change at 4 weeks for Modius Sleep: -5.80 from baseline.
- Within-group mean change at 4 weeks for Sham control: -3.52 from baseline.
- Primary Safety Endpoint: Occurrence of adverse events.
- Rate of AE reporting: 12% (9 out of 75) in the Modius Sleep group vs. 8% (6 out of 74) in the Sham group.
- Adverse events were minor, self-resolving, and included headaches, nystagmus, low mood, and mild tinnitus.
- One non-device related Serious Adverse Event (SAE) was reported (minor cerebrovascular accident), attributed to previously undiagnosed hypertension.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- ISI Score Change (Primary Outcome):
- Complete case analysis (n=126): The Modius Sleep group showed a statistically significant greater reduction in ISI score compared to the sham control group.
- Mean baseline ISI for Modius Sleep: 19.72 (SD 4.03)
- Mean 4-week ISI for Modius Sleep: 13.92 (SD 4.67)
- Mean baseline ISI for Sham control: 18.34 (SD 4.69)
- Mean 4-week ISI for Sham control: 14.82 (SD 6.30)
- Between-group difference (mean change ISI, Modius Sleep vs Sham control, Model 1): -2.28 (95% CI -3.85, -0.71), p=0.005
- Complete case analysis (n=126): The Modius Sleep group showed a statistically significant greater reduction in ISI score compared to the sham control group.
- Adverse Events (AEs):
- Modius Sleep group: 16 AEs reported (12%)
- Sham control group: 6 AEs reported (8%)
- No significant difference in AEs between groups. All AEs were minor and self-limiting. One non-device related SAE occurred.
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.
CES Ultra, K062284, Alpha-Stim® CS, K903014
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.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5800 Cranial electrotherapy stimulator.
(a)
Identification. A cranial electrotherapy stimulator is a prescription device that applies electrical current that is not intended to induce a seizure to a patient's head to treat psychiatric conditions.(b)
Classification. (1) Class II (special controls) when intended to treat insomnia and/or anxiety. The special controls for this device are:(i) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device to treat insomnia and/or anxiety.
(ii) Components of the device that come into human contact must be demonstrated to be biocompatible.
(iii) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC) in its intended use environment.
(iv) Appropriate software verification, validation, and hazard analysis must be performed.
(v) The technical parameters of the device, including waveform, output mode, pulse duration, frequency, train delivery, maximum charge, and energy, must be fully characterized and verified.
(vi) The labeling for the device must include the following:
(A) The intended use population and the intended use environment;
(B) A warning that patients should be monitored by their physician for signs of worsening;
(C) A warning that instructs patients on how to mitigate the risk of headaches, and what to do should a headache occur;
(D) A warning that instructs patients on how to mitigate the risk of dizziness, and what to do should dizziness occur;
(E) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device;
(F) Instructions for use that address where to place the electrodes, what stimulation parameters to use, and duration and frequency of treatment sessions. This information must be based on the results of clinical studies for the device;
(G) A detailed summary of the device technical parameters, including waveform, output mode, pulse duration, frequency, train delivery, and maximum charge and energy; and
(H) Information on validated methods for reprocessing any reusable components between uses.
(vii) Cranial electrotherapy stimulator devices marketed prior to the effective date of this reclassification must have an amendment submitted to the previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.
(2) Class III (premarket approval) when intended to treat depression.
(c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 19, 2020, for any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 19, 2020, been found to be substantially equivalent to any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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October 27, 2023
Neurovalens Limited Jason McKeown, MD CEO 8 Carmagrim Road Portglenone. BT44 8BP United Kingdom
Re: K230826
Trade/Device Name: Modius Sleep Regulation Number: 21 CFR 882.5800 Regulation Name: Cranial electrotherapy stimulator Regulatory Class: Class II Product Code: QJQ Dated: March 21, 2023 Received: March 24, 2023
Dear Dr. McKeown:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding 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,
Pamela D. Scott -S
Pamela Scott, MS Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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3
Indications for Use
510(k) Number (if known) K230826
Device Name
Modius Sleep
Indications for Use (Describe)
Modius Sleep is a non-invasive, home-use neurostimulation device to treat chronic insomnia in adults aged 22 and older.
| 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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EUROVALENS
Modius Sleep
Traditional 510(k)
Version: 01
Page: 1 of 30
510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
Submitter l.
Neurovalens Limited 8 Carmagrim Road Portglenone County Antrim BT44 8BP
United Kingdom
Contact person/ official correspondence:
Dr Jason McKeown CEO Neurovalens Ltd. Tel: +44 (0) 7412508707 Email: Jason.mckeown@neurovalens.com
Date Prepared
27th October 2023
II. Device
Name of Device: Modius Sleep Common or usual name: Electrical Vestibular Nerve Stimulator (VeNS) Classification name: Cranial Electrotherapy Stimulator (CES) Regulatory Class: II Product Code: Requested Regulation number: 882.5800 Classification panel: Neurology Special Controls: Modius Sleep complies with the special controls as set in FDA 21 CFR 882.5800 for a Class II, Cranial Electrical Stimulation (CES) device.
5
ROVALENS
Modius Sleep
Traditional 510(k)
Page: 2 of 30
510(k) Summary
Version: 01
Predicate devices lll.
Primary predicate device CES Ultra, K062284 Secondary predicate device Alpha-Stim® CS, K903014
No reference devices were used in this submission.
Device description IV.
Modius Sleep is a low-risk non-invasive transdermal neurostimulation device to treat chronic insomnia. The proposed mechanism of the device is through a technology known as electrical vestibular nerve stimulation (VeNS).
It consists of a battery-powered device designed to transcutaneously deliver low-level electrical energy (up to 1mA) to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads. These pads are placed on the skin behind each ear (mastoid area). The intensity of the electric pulse can be adjusted up or down by the user. When turned on, the device delivers a small electrical impulse which stimulates the vestibular nerve. Adjustments to the stimulation level may be made using the up and down buttons on the device, which are located just above the power button. The device can also be paused by pressing the power button twice. When finished the user removes the device and disposes of the electrode pads after each use. When the device is not being used it can be charged through a micro-USB cable. For safety reasons, it is not possible to recharge the battery while the device is in use in stimulation mode.
6
OVALENS
Modius Sleep Traditional 510(k)
Version: 01
Page: 3 of 30
510(k) Summary
The key components of the Modius Sleep include the Modius Sleep device (plastic enclosure and printed circuit board assembly (PCBA), stimulation pads (K210448 and K132588), skin cleansing wipes (K121655) and charging accessories. The PCBA consists of a microcontroller, USB connector (charging only), transformer driver, IO expander and EEPROM memory. The embedded software within the device manages overall functionality of the device from Stimulation Control, Power Management, and user interaction (Indication LED and Audio tones).
Biocompatibility testing in accordance with the endpoints of ISO 10993-1 to be addressed for a surface medical device, with prolonged: > 24 hours less than 30 days contact duration, demonstrated good biocompatibility for all components of the Modius Sleep device.
Device Usage
Daily sessions of Modius Sleep has been shown to improve insomnia when assessed at 4 weeks.
After using Modius Sleep there are usually no physical limitations imposed so most users can resume normal activities immediately. Some users may have a response that affect their ability to perform potentially hazardous tasks, such as operating a motor vehicle or heavy machinery for up to several hours after treatment. However, no significant lasting side effects have been reported.
7
EUROVALENS
Modius Sleep
Traditional 510(k)
Version: 01
Page: 4 of 30
510(k) Summary
Indications for use V.
Modius Sleep is a non-invasive, home-use neurostimulation device that is indicated to treat chronic insomnia in adults aged 22 and older.
VI. Comparison of the technological characteristics with the predicate device
Modius Sleep is substantially equivalent with respect to indications for use, stimulation parameters (i.e., current levels, frequencies, pulse width and amplitude) and electrode placement to the predicate devices CES Ultra (cleared by K062284), and Alpha-Stim® CS (cleared by K903014).
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Modius Sleep
Traditional 510(k)
Page: 5 of 30
510(k) Summary
Version: 01
Table 1. Summary of substantial equivalence
| Property | Proposed Device | Primary Predicate | Secondary Predicate | Comment |
|---|---|---|---|---|
| Device | Modius Sleep | CES Ultra | Alpha-Stim® CS | |
| Indications for Use | Modius Sleep is a non-invasive, home-use neurostimulation device that is indicated to treat chronic insomnia in adults aged 22 and older. | The CES Ultra is indicated for the treatment of insomnia, depression or anxiety | The Alpha-Stim® 100 is a precision medical instrument used for the management of pain, anxiety, depression, and/or insomnia. | All devices are indicated for the treatment of insomnia. |
| Target Population | Adults 22 and older | Adults | Adults, and children under adult supervision | N/A |
| Environment | Home | Home | Home | N/A |
| Waveform | Symmetrical Biphasic Rectangular Wave | Symmetrical Biphasic Rectangular Wave | Symmetrical Biphasic Rectangular Wave | Identical |
| Current Intensity Range | $0\u03bc$ A - 1000 $\u03bc$ A | $0\u03bc$ A - 1500 $\u03bc$ A continually adjustable | $0\u03bc$ A - 500 $\u03bc$ A | Modius Sleep and the CES Ultra have near identical current intensity ranges |
| Pulse Width Range | 1s | 2ms | 250ms - 1s | Pulse width varies depending on frequency range |
| Number of electrodes | Two | Two | Two | Identical |
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Modius Sleep
Traditional 510(k)
Page: 6 of 30
510(k) Summary
Version: 01
| Property | Proposed Device | Primary Predicate | Secondary Predicate | Comment |
|---|---|---|---|---|
| Electrode placement | Mastoid | Mastoid or earlobes | Head - earlobes | The Modius Sleep electrodes are placed on |
| mastoids. CES Ultra also supports mastoid only | ||||
| electrode placement. | ||||
| Power Source | 3.75 Lithium Polymer | |||
| Battery | 9V Alkaline Battery | 2 x AAA NiMH | ||
| Frequency | 0.25Hz | 100Hz | 0.5Hz, 1.5Hz, 100Hz | |
| Treatment Range | 30 min | 30min, 60min or | ||
| continuous | 10min, 20min, 60 min or | |||
| continuous | Modius Sleep maximum treatment time is within | |||
| the range of the predicates | ||||
| Unit Controls | Built into the device | Built into the device | Built into the device | Identical |
| Dimensions | 16.5cm x 15.1cm x | |||
| 6.6cm | 13.5cm x 6.4cm x | |||
| 3.3cm | 9.8cm x 6.3cm x 2cm | Modius Sleep is larger than the predicate | ||
| devices | ||||
| Enclosure | Plastic | Plastic | Plastic | Identical |
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Table 2. Safety Information Comparison
| Property | Proposed Device | Primary Predicate | Secondary Predicate | Comment | |
|---|---|---|---|---|---|
| Modius Sleep | CES Ultra | Alpha-Stim® CS | |||
| Electrical Safety | Complies with IEC | ||||
| 60601-1 | Complies with IEC | ||||
| 60601 | Complies with | ||||
| IEC 60601 | The proposed device and predicate devices are | ||||
| identical | |||||
| EMC | Complies with IEC | ||||
| 60601-1-2 | Complies with IEC | ||||
| 60601-1-2 | Complies with IEC | ||||
| 60601-1-2 | The proposed device and predicate devices are | ||||
| identical | |||||
| Software | Level of | ||||
| Concern | Moderate | Moderate | Moderate | The proposed device and predicate devices are | |
| identical | |||||
| Verification & | |||||
| Validation | Complies with | ||||
| FDA Guidance | |||||
| Requirement | Complies with FDA | ||||
| Guidance Requirement | Complies with FDA | ||||
| Guidance Requirement | |||||
| Biocompatibility | Complies with ISO | ||||
| 10993 | Complies with ISO | ||||
| 10993 | Complies with | ||||
| ISO 10993 | The proposed device and predicate devices are | ||||
| identical |
Modius Sleep
Traditional 510(k)
Page: 7 of 30
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| NEUROVALENS | Modius Sleep |
|---|---|
| Traditional 510(k) | |
| Version: 01 | Page: 8 of 30 |
| 510(k) Summary |
Table 3. Technical Information for Modius Sleep Output Parameters
| Modius Sleep | CES Ultra | Alpha-Stim CS | ||
|---|---|---|---|---|
| 510(k) Number | K230826 | K062284 | K903014 | |
| Device Name | Modius Sleep | CES ultra | Alpha-Stim CS | |
| Manufacturer | Neurovalens Ltd | Neuro-Fitness LLC | Electromedical Products Inc. | |
| Power Source† | 3.75 Lithium Polymer | |||
| Battery | 9V Alkaline Battery | 2 x AAA NiMH | ||
| -Method of Line Current Isolation | DC:DC transformer | N/A Non Rechargeable | N/A Non-Rechargeable | |
| - Patient Leakage Current (as per ANSI/AAMI 60601-1) | 0μΑ | Unknown | Unknown | |
| -Normal Condition (μΑ) | 0-1000μΑ | 0-1500μΑ | 0-500μΑ | |
| -Single Fault Condition (μΑ) | 2.3μA | Unknown | 1.3mA | |
| Average DC current through the electrodes when the device is on but no pulses are being delivered (µA) | 0μΑ | Unknown | Unknown | |
| Number of output channels | 1 | 1 | 1 | |
| -If more than one channel, is the stimulus delivered to each channel synchronous or alternating between each channel? | N/A | N/A | N/A | |
| -If more than one channel, describe method of channel isolation | N/A | N/A | N/A | |
| Software/Firmware/Microprocessor Control | Yes | Yes | Yes | |
| Automatic Overload Trip? | No | No | No | |
| Automatic Shut Off? | Yes | Yes | Yes | |
| Modius Sleep | CES Ultra | Alpha-Stim CS | ||
| User Override Control? | Yes | Yes | Yes | |
| Mode or Program Name | Stimulation mode | Stimulation mode | Stimulation/Treatment Mode | |
| Waveform (e.g., pulsed monophasic, biphasic) | Biphasic | Biphasic | Biphasic | |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Rectangular | Rectangular | Rectangular | |
| Maximum Output Voltage (volts) (+/-1%) | 500mV @500 Ω | Unknown | @500 Ω | |
| 2 V @ 2 kΩ | Unknown | @ 2 kΩ | ||
| 10V @10 kΩ | Unknown | @10 kΩ | ||
| Maximum Output Current (specify units) (+/-2%) | 1000μA @500 Ω | Unknown | 500μA @ 500 Ω | |
| 1000μA @ 2 kΩ | 1.5mA @ 2kΩ | 500μA @ 2 kΩ | ||
| 1000μA @10 kΩ | Unknown | 500μA @10 kΩ | ||
| Duration of primary (depolarizing) phase† (msec) | 4000 | |||
| (4 seconds) | 10ms | 2000ms, 1000ms, 10ms | ||
| Pulse Duration†† (msec) | 2000 | |||
| (2 second) | 5ms | 1000ms, 500ms, 5ms | ||
| Frequency†† (Hz) [or Rate†† (pps)] | 0.25Hz | 100Hz | 0.5Hz, 1Hz, 100Hz | |
| For interferential modes only: Beat Frequency† (Hz) | ||||
| For multiphasic waveforms Symmetrical phases? only: | ||||
| Phase Duration† (include units), | ||||
| (state range, if applicable), (both phases, if asymmetrical) | Not Applicable for these devices | |||
| Modius Sleep | CES Ultra | Alpha-Stim CS | ||
| Net Charge (microcoulombs (mC) per pulse) (If zero, state method of achieving zero net charge.) | 1000 μC @2kΩ | 0.75μC @500 Ω | 300μC, 150 μC, 1.5 µC | |
| Maximum Phase Charge, (μC) | 1000μC @2kΩ | 0.75μC@ 2 kΩ | 500µC @ 500Ω | |
| Maximum Current Density,††† (mA/cm², r.m.s.) | 0.5mA /cm² | |||
| @500 Ω | 1.91mA/cm² | |||
| @500 Ω | ~1.2mA/cm² @ 500Ω | |||
| Maximum Average Current (average absolute value), mA | 1mA @2kΩ | 3.07mA/cm² @ | ||
| 2 kΩ | Unknown | |||
| Maximum Average Power Density,††† (W/cm²), (using smallest electrode conductive surface area) | 0.99mW/cm² @2 kΩ | 9.19mW/cm² @2 kΩ | Unknown | |
| Burst Mode†††† (i.e., pulse trains): | (a) Pulses per burst | 2 | 2 | 2, 2, 2 |
| (b) Bursts per second | 0.25 | 100 | 0.5, 1, 100 | |
| (c) Burst duration (seconds) | 4 | 0.01 (10ms) | 2, 1, 0.01s | |
| (d) Duty Cycle: Line (b) x Line (c) | 0.5 (50%) | 0.2(20%) | 0.5 (50%) | |
| ON Time (seconds) | 2 sec | 10ms | 1sec, 0.5sec, 10ms | |
| OFF Time (seconds) | 2 sec | 40ms | 1sec, 0.5sec, 10ms |
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Table 4. Comparison of Device Outputs
| Output value | Modius Sleep | CES Ultra | Alpha Stim CS |
|---|---|---|---|
| Output value at | Provide for all load conditions. | Provide for all load conditions. | Provide for all load conditions. |
| 500Ω, 2kΩ and 10kΩ | 1mA at all loads | 1.5mA at all loads | 0.5mA at all loads |
| Load conditions | 0.25Hz | 100Hz | 0.5Hz |
| Electrode | |||
| surface | Conductive Area (16mm diameter) | Ear clips | 1.5cm Diameter |
| area in cm2 | 2.0cm² | Diameter 7.9mm | |
| 0.5cm² Area | 1.77cm² | ||
| Current density | 500Ω | ||
| 0.5mA/cm², | 500Ω | ||
| 1.91mA/cm² | 500Ω | ||
| 1.2mA/cm² | |||
| 2kΩ | |||
| 0.5mA/cm² | 2kΩ | ||
| 3.07mA/cm² | 2kΩ | ||
| Unknown | |||
| 10kΩ | |||
| 0.5mA/cm² | 10kΩ | ||
| Unknown | 10kΩ | ||
| Unknown | |||
| Charge density | 500Ω | ||
| 497.63µC/cm² – Per Pulse | 500Ω | ||
| Unknown | 500Ω | ||
| Max 500uC | |||
| 2kΩ | |||
| 497.63µC/cm² – Per Pulse | 2kΩ | ||
| Unknown | 2kΩ | ||
| Max 500uC | |||
| 10kΩ | |||
| 497.63µC/cm² – Per Pulse | 10kΩ | ||
| Unknown | 10kΩ | ||
| Max 500uC | |||
| Power density | 500Ω, | ||
| 0.25mW/cm² | |||
| 2KΩ | |||
| 0.99mW/cm² | |||
| 10KΩ | |||
| 4.97mW/cm² | 500Ω, | ||
| Unknown | |||
| 2KΩ | |||
| 9.19ma/cm² | |||
| 10KΩ | |||
| Unknown | 500Ω, | ||
| Unknown | |||
| 2KΩ | |||
| Unknown | |||
| 10KΩ | |||
| Unknown | |||
| Max phase charge | |||
| (pulse width x peak | |||
| current) | 500Ω, | ||
| 1000 μC – Per Pulse | |||
| 2KΩ | |||
| 1000 μC – Per Pulse | |||
| 10KΩ | |||
| 1000 μC – Per Pulse | 500Ω, | ||
| Unknown | |||
| 2KΩ | |||
| 0.75 μC | |||
| 10KΩ | |||
| Unknown | 500Ω, | ||
| 500 μC | |||
| 2KΩ | |||
| Unknown | |||
| 10KΩ | |||
| Unknown | |||
| Max phase charge | |||
| density (pulse width | |||
| x peak current) / | |||
| electrode surface | |||
| area | 500Ω | ||
| 497.63μC/cm² – Per Pulse | |||
| 2KΩ | |||
| 497.63μC/cm² – Per Pulse | |||
| 10KΩ | |||
| 497.63μC/cm² – Per Pulse | 500Ω | ||
| Unknown | |||
| 2KΩ | |||
| Unknown | |||
| 10KΩ | |||
| Unknown | 500Ω | ||
| Unknown | |||
| 2KΩ | |||
| Unknown | |||
| 10KΩ | |||
| Unknown | |||
| Max average power | |||
| density (Duty cycle x | |||
| peak current)^2 x | 500Ω, | ||
| 0.12mW/cm² | 500Ω, | ||
| Unknown | 500Ω, | ||
| Unknown | |||
| (load Ω) ÷ electrode | |||
| surface area) | 2kΩ | ||
| 0.5mW/cm² | |||
| 10kΩ | |||
| 2.49mW/cm² | 2kΩ | ||
| 9.19mW/cm² | |||
| 10kΩ | |||
| Unknown | 2kΩ | ||
| Unknown | |||
| 10kΩ | |||
| Unknown | |||
| Electrode number | 2 Electrodes | 2 Electrodes | 2 Electrodes |
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Performance Data VII.
Non-clinical tests
The Modius Sleep was evaluated for its safety and effectiveness based on the following testing:
Table 5: Non-clinical tests
| Test Name | Test Description | Results |
|---|---|---|
| Device Ship/Transport | ||
| Testing | Ensure device, enclosed in the selected shipping container, | |
| meets ASTM D4169 specifications. | Passed | |
| Biocompatibility Testing | Testing and analysis of the Modius Sleep device has | |
| demonstrated compliance to ISO 10993-1: Biological | ||
| evaluation of medical devices - Guidance | Passed | |
| Electrical Safety | The Modius Sleep device was tested to confirm that it met | |
| the applicable standards for electrical safety (IEC 60601-1) | Passed | |
| EMC | The Modius Sleep device was tested to confirm that it met | |
| the applicable standards for electromagnetic compatibility | ||
| (EMC) (IEC 60601-1-2) | Passed | |
| Usability Testing | Modius Sleep was assessed with regards to usability for | |
| compliance with IEC 62366 - Medical devices - Application | ||
| of usability engineering to medical devices | Passed | |
| Maximum Current & | ||
| Phase Charge Testing | The Maximum Current & Phase Charge Testing was to detail | |
| the Max Current / Power output of the system under different | ||
| load conditions and determine the Max Phase Charge, Max | ||
| Current Density and Max Power Density of the Modius Sleep | ||
| device. | Passed | |
| System Verification and | ||
| Validation Testing | The system verification and validation testing was performed | |
| to verify the hardware and firmware of the Modius Sleep | ||
| Device | Passed |
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Labeling
The labeling for the device included the intended use population and the intended use environment; warning that patients should be monitored by their physician for signs of worsening; A warning that instructs patients on how to mitigate the risk of headaches, and what to do should a headache occur; a warning that instructs patients on how to mitigate the risk of dizziness, and what to do should dizziness occur; a detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device; Instructions for use that address where to place the electrodes, what stimulation parameters to use, and duration and frequency of treatment sessions based on the results of clinical studies for the device; A detailed summary of the device technical parameters, including waveform, output mode, pulse duration, frequency, train delivery, and maximum charge and energy; and Information on validated methods for reprocessing any reusable components between uses.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
The software for this device was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Animal Studies
No animal studies were conducted as part of submission to prove substantial equivalence.
Clinical Studies
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CES devices collectively demonstrate a class effect of CES for treating anxiety and/or insomnia. However, it cannot be concluded, based on available information alone, that specific CES devices or stimulation parameters are effective for treating anxiety and/or insomnia. As such, individuals using this device should work with the prescribing medical provider to determine the best treatment settings to use. As such, please see below for a general summary of pertinent clinical literature that has been published using various combinations of CES devices, stimulation settings, and electrode positions.
General CES Summary (January 1, 1970 to November 8, 2022)
As of November 2022, there were a total of 23 studies that evaluated the effectiveness of CES on insomnia. Of the 11 randomized control trials (RCT), some reported greater reduction in insomnia symptoms in the CES group compared to placebo12345, while others reported no significant differences in measures of insomnia symptoms between the 2 groups®73,9;10;11 .Among the 8 observational studies, CES treatment was associated with less frequent12 and less intense13 sleep disturbances, improved soundness of sleep14, less difficulty falling asleep14;15;16 and feeling more rested15 or improved mood14 in the morning. Several observational studies reported no impact of CES on insomnia1718 or reported an effect that did not persist after the first week19. A meta-analysis of 14 RCTs indicated that CES versus sham treatment had no impact on insomnia20. Lastly, 3 reviews evaluated the effectiveness of CES on insomnia. One review found 23 studies, 6 of which were RCTs of which only 2 studied participants with insomnia21. Of these two RCTs, only 1 showed improved patient-reported sleep latency and objective changes in sleep, while the other did not show any change21. The other 2 reviews concluded that studies evaluating the effectiveness of CES on insomnia were inconclusive22 or inconsistent²3. In studies that reported improvement in insomnia with use of CES, the reported stimulation parameters, electrode placement, and treatment schedule varied widely and were only evaluated in a small number of combinations.
Please note that not all combinations of parameters provided below have been studied for safety and effectiveness; therefore, individuals using this device should work with the prescribing medical provider to determine the best treatment settings to use and should not apply electrodes to locations that are not indicated in the specific product's labeling. Please
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also note that not all CES devices are capable of providing the same stimulation parameters or combination of stimulation parameters.
Please see information below on the 23 studies (January 1, 1970 to November 8, 2022) noted above that evaluated the effectiveness of CES on insomnia:
Electrode placement:
- . Over orbits and mastoids
- Over eyelid and mastoids .
- Over orbits and occiput .
- . Earlobes
Waveform:
- . Square
- Rectangular, monophasic .
Frequency:
- . 100 Hz
- 350 Hz
- 0.5 Hz ●
- 14 Hz ●
Pulse Width:
- 0.7 ms .
- 1 ms
- 2 ms .
Maximum current:
-
0.01-1.9mA
Treatment schedule: -
30 minutes, 5 times a week for 1-2 weeks ●
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- 30-minute sessions twice a day ●
- single 20-30 minute session
- . 15 minutes daily for 24 days
- 30 minutes for 1-7 days .
Clinical Testing of Modius Sleep
Clinical testing of Modius Sleep included a pivotal randomized, double blind sham controlled clinical trial to evaluate the safety and efficacy of the Modius Sleep Electrical Vestibular Stimulation (VeNS) device, for the treatment of chronic insomnia.
Study design
A 4-week pivotal randomized controlled trial with two groups 1) Modius Sleep device group and 2) Sham (placebo) control group was used to evaluate the safety and efficacy of the Modius Sleep device as a treatment for chronic insomnia.
The study was a multi-site, randomised, double blinded, sham-controlled trial conducted from May 2022 to January 2023. The study has been registered at https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT04452981). Research sites included University of Ulster, United Kingdom (UK), and Hong Kong Polytechnic University, Hong Kong (HK). The study protocol was approved at the UK site by Wales Research Ethics Committee 7 (Ref: 22/WA/0022) and at the HK site by the Human Subjects Ethics Sub-Committee, Hong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Kong Polytechnic University (Ref: HSEARS20220320001). Informed consent was obtained from all participants.
Adults with an Insomnia Severity Index (ISI) score of 15 or higher were recruited using online platforms and randomly allocation ratio) to receive the Modius Sleep device (intervention group) or the sham device (active control group). Both groups were advised to use their allocated devices for 30 minutes per day prior to going to sleep for a four-week duration. The devices are identical in appearance and therefore neither the participant nor the clinical study team knew whether the Modius Sleep device or sham device was allocated. Primary and secondary outcomes were captured at baseline and at 4 weeks.
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126 participants (aged 19-67 years) with moderate to severe insomnia assessed by the insomnia severity index (ISI) were enrolled. While the ISI is a useful screening tool for insomnia, it does not cover all components of The AASM (American Academy of Sleep Medicine) International Classification of Sleep Disorders (ICSD), and The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) that are used for diagnosis of chronic insomnia. For this reason, further information was collected by an online survey to establish that the participants had chronic insomnia at the time of enrolment as defined by ICSD and DSM-V. Specifically, information was collected regarding the duration and frequency of their sleep disturbance and associated daytime symptoms, confirmation of adequate opportunity and conditions to sleep, and confirmation of no other co-existing conditions. This further information provided confirmation that the participants had Chronic Insomnia at the time of enrolment in the Modius Sleep trial.
For the duration of the study, participants agreed not to take prescribed or over the counter sleeping medication; not to undergo any extreme lifestyle changes that could have impacted their sleep quality; not to use sleep trackers; not to travel to different time zones and to maintain a familiar sleeping routine.
Primary Effectiveness Endpoint
The efficacy of the Modius Sleep device was quantified by change in the Insomnia Severity Index (ISI) score24 at Week 0 and Week 4 between the Modius Sleep group and sham control group.
Primary Safety Endpoint
An evaluation of the safety of the Modius Sleep device was quantified by the occurrence in adverse events between the Modius Sleep group and sham control group.
Results
A total of 149 eligible participants were recruited and randomised to the Modius Sleep group (n=75) or the sham control group (n=74). Twenty-three participants withdrew from the study
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before the 4-week visit. A complete case analysis was undertaken on all participants (n=126) with available data at baseline and at the 4-week visit. The mean age of the sample (67% female) was 41 years (age range: 19 to 67 years).
Table 6: Participant accountability
| Stage | Modius Sleep Device | Sham control device | Total |
|---|---|---|---|
| Enrollment | 75 | 74 | 149 |
| Treatment | 75 | 74 | 149 |
| Primary safety endpoint | |||
| analysis | 75 | 74 | 149 |
| Primary effectiveness | |||
| endpoint analysis | 61 | 65 | 126 |
| Secondary endpoint | |||
| analysis | 61 | 65 | 126 |
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Table 7: The effect of Modius Sleep on Insomnia Severity Index (Primary outcome all participants)
| | Modius Sleep | Sham control | Between-group difference mean (95% CI);
P valueb | | |
|---------------------------------------------------|-----------------------------------|-----------------------------------|-----------------------------------------------------|----------------------------------|----------------------------------|
| | Mean (SD) | Mean (SD) | Model 1 | Model 2 | Model 3 |
| ITT (MI) | | | | | |
| Baseline | 19.77 (0.48)c | 18.36 (0.52)c | | | |
| 4 weeks | 13.99 (0.65)c | 14.67 (0.78)c | -2.08
(-3.93, -0.24)
0.028 | -2.13
(-4.34, 0.07)
0.058 | -1.93
(-4.02, 0.16)
0.070 |
| Within-group
mean change
(95% CI); P valuea | -5.78
(-6.93, -4.63)