Milieve (YPS-301BD)

K233751 · Soterix Medical, Inc. · PCC · Jun 3, 2024 · Neurology

Device Facts

• Record ID: K233751
• Device Name: Milieve (YPS-301BD)
• Applicant: Soterix Medical, Inc.
• Product Code: PCC · Neurology
• Decision Date: Jun 3, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5891
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Milieve is indicated for - The acute treatment of migraine with or without aura in patients 18 years of age or older. - The prophylactic treatment of episodic migraine in patients 18 years of age or older.

Device Story

Milieve is a transcutaneous electrical nerve stimulator (TENS) for migraine management; device placed on forehead to stimulate upper branch of trigeminal nerve. Operated by patient at home (OTC). Device comprises plastic casing, electrical components, and rechargeable 3.7V LiPo battery. Two fixed treatment programs: ACUTE (at onset of migraine) and PREVENT (daily preventative). Device delivers biphasic, symmetric, rectangular current impulses via self-adhesive electrodes connected via magnets. Output parameters include 16 mA max current, 250 µs pulse width, and fixed frequencies (100 Hz for acute, 60 Hz for prevent). Healthcare provider/patient uses device to reduce migraine frequency/severity; output affects clinical decision-making by providing non-pharmacological treatment option. Benefits include acute relief and prophylactic migraine management.

Clinical Evidence

Bench testing only. Performance parameters, software verification/validation, and risk management demonstrate substantial equivalence to the predicate. Human factors validation study confirmed the device weight and dimensions do not impact usability or safety.

Technological Characteristics

TENS device; plastic casing; rechargeable 3.7V LiPo battery. Biphasic, symmetric, rectangular current impulses; 16 mA max current; 250 µs pulse width; 100 Hz (acute) or 60 Hz (prevent) frequency. Self-adhesive electrodes with 2 conductive zones; magnetic connection. Dimensions: 44.05mm x 38.98mm x 14.5mm; Weight: 21g. Fixed program software.

Indications for Use

Indicated for acute treatment of migraine with/without aura and prophylactic treatment of episodic migraine in patients 18 years or older. Contraindications: implanted metallic/electronic devices in head, pain of unknown origin, cardiac pacemaker, or implanted/wearable defibrillator.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator to treat headache is a device used to apply an electrical current to a patient's cranium through electrodes placed on the skin.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Appropriate analysis/testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety. (3) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (µC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm 2 , r.m.s.), maximum average current (mA), maximum average power density (W/cm2 ), and the type of impedance monitoring system must be fully characterized.(4) Electrical performance, adhesive integrity, shelf life, reusability, and current distribution testing of the electrodes must be conducted. (5) Appropriate software verification, validation, and hazard analysis must be performed. (6) Clinical performance data must demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population. (7) Labeling must include the following: (i) Appropriate contraindications such as not for use in subjects with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator. (ii) Appropriate warnings such as not to apply the device on the neck or chest, not to use the device in the presence of electronic monitoring equipment, not to use in the bath or shower, not to use while sleeping, not to use while driving, not to use while operating machinery. (iii) Appropriate precautions such as the long-term effects of chronic use of the device are unknown. (iv) A summary of the expected risks and benefits of using the device. (v) A summary of the clinical performance data, including information on the patient population for which the device has and has not been demonstrated to be effective, and any adverse events and complications. (vi) Information on how the device operates and the typical sensations experienced during treatment. (vii) A detailed summary of the device technical parameters. (viii) An expiration date/shelf life for the electrodes and the number of times they can be reused. (ix) Disposal instructions.

In combination with the general controls of the Food Drug & Cosmetic Act, the Transcutaneous Electrical Nerve Stimulator to Treat Headache is subject to the following special controls:

Predicate Devices

• Cefaly Dual (K201895)

Submission Summary (Full Text)

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June 3, 2024

Soterix Medical, Inc. Abhishek Datta CEO/CTO 1480 U.S. Highway 9 North Suite 204 Woodbridge, New Jersey 07095

Re: K233751

Trade/Device Name: Milieve (YPS-301BD) Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous Electrical Nerve Stimulator To Treat Headache Regulatory Class: Class II Product Code: PCC Dated: May 3, 2024 Received: May 3, 2024

Dear Dr. Abhishek Datta:

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"

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(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).

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 OS 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 (QS) 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jitendra V. Virani
-S

CDR Jitendra Virani Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological

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and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Submission Number (if known)

K233751

Device Name

Milieve (YPS-301BD)

#### Indications for Use (Describe)

The Milieve is indicated for

- The acute treatment of migraine with or without aura in patients 18 years of age or older.

- The prophylactic treatment of episodic migraine in patients 18 years of age or older.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# K233751

# 510(k) SUMMARY

| Submission Date: | November 17th, 2023 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Information: | |
| Company Name: | Soterix Medical, Inc. |
| | 1480 US Highway 9 North |
| | Suite 204 |
| | Woodbridge, NJ 07095 |
| Contact Person(s) : | Danielle Dadona (Regulatory Affairs Specialist) |
| | Abhishek Datta (CEO / CTO) |
| | Phone: [phone] |
| | Fax: [phone] |
| Device Information: | |
| Trade Name: | Milieve (YPS-301BD) |
| Common Name: | Milieve |
| Classification Name: | PCC - Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| | (21 CFR 882.5891) |
| Device Class: | Class II |
| Predicate Device: | Cefaly Dual (K201895) |
| | CEFALY Technology |
| | Class II |
| Device Description: | The Milieve device is a transcutaneous electrical nerve stimulator (TENS) developed for the acute treatment of migraine and the prophylactic treatment of episodic migraine. The device is placed on the patient's |
| | There are two treatment programs: ACUTE and PREVENT. The ACUTE<br>treatment program is intended for treatment during migraine attack at the<br>onset of a migraine. The PREVENT treatment program is meant for daily<br>preventative treatment. |
| | The Mileve device comprises a plastic external casing and electrical<br>components. It is operated by an internal rechargeable battery. |
| Intended<br>Use/Indications: | The indications for use of the Mileve device for over-the-counter use<br>are:<br>- The acute treatment of migraine with or without aura in patients<br>18 years of age or older.<br>- The prophylactic treatment of episodic migraine in patients 18<br>years of age or older. |
| Technological<br>Comparison: | The Mileve uses the same technological principle as the predicate device<br>to accomplish its intended use, namely the stimulation of the upper branch<br>of the trigeminal nerve to treat and prevent migraine. In conjunction with<br>the Cefaly Dual approved for the treatment and prevention of migraine<br>Mileve's intended use is similar to that of the predicate. All output<br>specifications of the subject device are either identical or substantially<br>equivalent to the predicate device. |

forehead to stimulate the upper branch of the trigeminal nerve. It is harmless to the human body. The Milieve device is indicated for OTC use.

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#### Basis for Equivalence:

| - <b>Performance Testing:</b> | Bench testing demonstrated that the performance parameters of the Milieve device are substantially equivalent to that of the predicate device. The subject device is compliant to the same international standards as the legally marketed predicate device. Further, software verification and validation and risk management demonstrate that Milieve is substantially equivalent to the predicate device. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

- The labeling of the Milieve device is substantially equivalent to that of the -Labeling: predicate device.
- The Milieve device is substantially equivalent to the predicate device. The Conclusions from Testing: Milieve device is identical to its predicate device in intended use. Bench testing supports the conclusion that the performance parameters of the Milieve device is substantially equivalent to the predicate devices, and any differences between the devices do not pose new questions of safety and effectiveness.

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| Parameter | Milieve | Cefaly Dual<br>(Predicate Device) | Comparison |
|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 510(k) | Proposed Device | K201895 | -- |
| Device Name and<br>Model | Milieve (YPS-301BD) | Cefaly Dual | -- |
| Manufacturer | Ybrain Inc. | CEFALY Technology | -- |
| Indications<br>For Use | The indications for use of the<br>Milieve for an over-the-counter<br>use are:<br>- The acute treatment of<br>migraine with or without aura in<br>patients 18 years of age or older.<br>- The prophylactic treatment of<br>episodic migraine in patients 18<br>years of age or older. | The indications for use of the<br>Cefaly Dual for an over-the-<br>counter use are:<br>- The acute treatment of<br>migraine with or without aura<br>in patients 18 years of age or<br>older.<br>- The prophylactic treatment<br>of episodic migraine in<br>patients 18 years of age or<br>older. | Identical |
| Classification<br>Name | Stimulator, Nerve, Electrical,<br>Transcutaneous, For Migraine | Stimulator, Nerve,<br>Electrical, Transcutaneous,<br>For Migraine | Identical |
| Product Code | PCC | PCC | Identical |
| Regulatory Class | Class II | Class II | Identical |
| Classification<br>Number | Sec 882.5891 | Sec 882.5891 | Identical |
| Contraindications<br>For Use | Subjects with implanted metallic<br>or electronic devices in the head.<br>Subjects suffering from pain of<br>unknown origin.<br>Subjects who have a cardiac<br>pacemaker or implanted or<br>wearable defibrillator. This<br>may cause interference with<br>pacing, electric shock, or death. | Subjects with implanted<br>metallic or electronic devices<br>in the head.<br>Subjects suffering from pain<br>of unknown origin. Subjects<br>who have a cardiac<br>pacemaker or implanted or<br>wearable defibrillator. This<br>may cause interference with<br>pacing, electric shock, or<br>death. | Identical |
| Parameter | Milieve | Cefaly Dual<br>(Predicate Device) | Comparison |
| Power Source | Rechargeable 3.7V LiPo Battery | Rechargeable 3.7V LiPo Battery | Identical |
| Software provided | 2 fixed programs:<br>- 1 fixed program for the acute treatment of migraine attacks (Program 1)<br>- 1 fixed program for prophylactic treatment of migraine (Program 2) | 2 fixed programs:<br>- 1 fixed program for the acute treatment of migraine attacks (Program 1)<br>- 1 fixed program for prophylactic treatment of migraine (Program 2) | Identical |
| Program 1:<br>Max. output current<br>Pulse width<br>Pulse frequency<br>Session duration | 16 mA<br>250 $\mu$ s<br>fixed 100 Hz<br>fixed 60 minutes | 16 mA<br>250 $\mu$ s<br>fixed 100 Hz<br>fixed 60 minutes | Identical |
| Program 2:<br>Max. output current<br>Pulse width<br>Pulse frequency<br>Session duration | 16 mA<br>250 $\mu$ s<br>fixed 60 Hz<br>fixed 20 minutes | 16 mA<br>250 $\mu$ s<br>fixed 60 Hz<br>fixed 20 minutes | Identical |
| Waveform | Biphasic, symmetric,<br>rectangular current impulses<br>with zero electrical mean | Biphasic, symmetric,<br>rectangular current impulses<br>with zero electrical mean | Identical |
| Phase Duration (or<br>Pulse width) | 250 $\mu$ s | 250 $\mu$ s | Identical |
| Inter Phase Interval | 5 $\mu$ s | 5 $\mu$ s | Identical |
| Maximum Current<br>Intensity (±10%)<br>@500 $\Omega$<br>@2000 $\Omega$<br>@10000 $\Omega$ | 16 mA<br>16 mA<br>6 mA | 16 mA<br>16 mA<br>6 mA | Identical |
| Maximum average<br>current @500 $\Omega$ | 0.48 mA | 0.48 mA | Identical |
| Maximum output<br>voltage (±10%) | | | Identical |
| Parameter | Milieve | Cefaly Dual<br>(Predicate Device) | Comparison |
| @500Ω<br>@2000Ω<br>@10000Ω | 8 V<br>32 V<br>60 V | 8 V<br>32 V<br>60 V | |
| Ramp up Time | 14 min | 14 min | Identical |
| Steady Time | 6 min | 6 min | Identical |
| Ramp down Time | 60 s | 45 s | SE<br>Note 1 |
| Maximum Phase<br>Charge @500 Ω | 4 µC | 4 µC | Identical |
| Net Charge per<br>Pulse | 0 | 0 | Identical |
| Maximum Current<br>Density @500 Ω | 2.37 mA/cm2 | 2.37 mA/cm2 | Identical |
| Maximum Average<br>Power Density<br>@500 Ω | 0.000047 W/cm2 | 0.000047 W/cm2 | Identical |
| Dimensions | 44.05 mm x 38.98 mm x 14.5 mm | 55 mm x 40 mm x 15 mm | SE<br>Note 2 |
| Weight | 21 g | 12 g | SE<br>Note 3 |
| Electrode | Self-adhesive with 2 conductive<br>zones | Self-adhesive with 2<br>conductive zones | Identical |
| Device output ports | 2 magnets for connection with<br>electrode | 2 magnets for connection with<br>electrode | Identical |

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Note 1:

The subject device has a slightly longer ramp down time. This longer ramp time helps with subject comfort. This difference will not raise new questions of efficacy as the therapeutic session times (20 min and 60 min) are identical.

### Note 2:

The dimension of the subject device is slightly different from the predicate device. This minor difference will however not raise any new safety and effectiveness issues.

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Note 3:

The weight of the subject device is slightly more than the predicate device. This minor weight increase has not impacted the ability to hold device and electrode reliably on the forehead in the in-house tests conducted and the human factors validation study. It is therefore expected to not raise any new safety and effectiveness issues.