(194 days)
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.
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 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.
There are two treatment programs: ACUTE and PREVENT. The ACUTE treatment program is intended for treatment during migraine attack at the onset of a migraine. The PREVENT treatment program is meant for daily preventative treatment.
The Mileve device comprises a plastic external casing and electrical components. It is operated by an internal rechargeable battery.
The provided text is a 510(k) summary for the Milieve (YPS-301BD) device, a transcutaneous electrical nerve stimulator for migraine treatment. The summary demonstrates substantial equivalence to a predicate device (Cefaly Dual).
The document does not describe a study involving an AI/algorithm where acceptance criteria are set for the performance of the AI model itself. Instead, it focuses on demonstrating the Milieve device's substantial equivalence to a predicate device through bench testing and comparison of technical specifications. The acceptance criteria and "device performance" in this context refer to the physical and electrical characteristics of the Milieve device and how they compare to those of the predicate device.
Therefore, many of the requested points from your prompt (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable to this type of submission, as the Milieve device is a hardware medical device, not an AI/algorithm-based diagnostic or therapeutic system.
However, I can extract and present the relevant information regarding the device's "performance" and how its "acceptance criteria" (understood as equivalency to the predicate) are met based on the provided text.
Acceptance Criteria and Device Performance (Demonstration of Substantial Equivalence)
The acceptance criteria for the Milieve device are implicitly based on demonstrating substantial equivalence to the predicate device, Cefaly Dual. This is achieved by showing that the technological characteristics and performance parameters are either identical or substantially equivalent, and that any differences do not raise new questions of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided table directly compares the Milieve device to the Cefaly Dual (Predicate Device). The "Comparison" column indicates whether the parameters are "Identical" or "Substantially Equivalent (SE)" with notes explaining the implications of the differences.
| Parameter | Acceptance Criteria (Predicate Device - Cefaly Dual) | Reported Device Performance (Milieve) | Comparison |
|---|---|---|---|
| Indications For Use | Acute treatment of migraine with or without aura in patients 18 years or older; Prophylactic treatment of episodic migraine in patients 18 years or older. | Identical to predicate. | Identical |
| Classification Name | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | Identical to predicate. | Identical |
| Product Code | PCC | Identical to predicate. | Identical |
| Regulatory Class | Class II | Identical to predicate. | Identical |
| Classification Number | Sec 882.5891 | Identical to predicate. | Identical |
| Contraindications For Use | Subjects with implanted metallic or electronic devices in the head; suffering from pain of unknown origin; who have a cardiac pacemaker or implanted/wearable defibrillator. | Identical to predicate. | Identical |
| Power Source | Rechargeable 3.7V LiPo Battery | Identical to predicate. | Identical |
| Software provided (Programs) | 2 fixed programs (Acute, Prophylactic) | Identical to predicate. | Identical |
| Program 1 (Acute Migraine) | |||
| Max. output current | ≤ 16 mA | 16 mA | Identical |
| Pulse width | 250 µs | 250 µs | Identical |
| Pulse frequency | fixed 100 Hz | fixed 100 Hz | Identical |
| Session duration | fixed 60 minutes | fixed 60 minutes | Identical |
| Program 2 (Prophylactic) | |||
| Max. output current | ≤ 16 mA | 16 mA | Identical |
| Pulse width | 250 µs | 250 µs | Identical |
| Pulse frequency | fixed 60 Hz | fixed 60 Hz | Identical |
| Session duration | fixed 20 minutes | fixed 20 minutes | Identical |
| Waveform | Biphasic, symmetric, rectangular current impulses with zero electrical mean | Identical to predicate. | Identical |
| Phase Duration (Pulse width) | 250 µs | 250 µs | Identical |
| Inter Phase Interval | 5 µs | 5 µs | Identical |
| Maximum Current Intensity | @500 Ω: 16 mA; @2000 Ω: 16 mA; @10000 Ω: 6 mA | @500 Ω: 16 mA; @2000 Ω: 16 mA; @10000 Ω: 6 mA | Identical |
| Maximum average current @500 Ω | 0.48 mA | 0.48 mA | Identical |
| Maximum output voltage | @500Ω: 8 V; @2000Ω: 32 V; @10000Ω: 60 V | @500Ω: 8 V; @2000Ω: 32 V; @10000Ω: 60 V | Identical |
| Ramp up Time | 14 min | 14 min | Identical |
| Steady Time | 6 min | 6 min | Identical |
| Ramp down Time | 45 s | 60 s | SE (Note 1) |
| Maximum Phase Charge @500 Ω | 4 µC | 4 µC | Identical |
| Net Charge per Pulse | 0 | 0 | Identical |
| Maximum Current Density @500 Ω | 2.37 mA/cm2 | 2.37 mA/cm2 | Identical |
| Maximum Average Power Dens @500 Ω | 0.000047 W/cm2 | 0.000047 W/cm2 | Identical |
| Dimensions | 55 mm x 40 mm x 15 mm | 44.05 mm x 38.98 mm x 14.5 mm | SE (Note 2) |
| Weight | 12 g | 21 g | SE (Note 3) |
| Electrode | Self-adhesive with 2 conductive zones | Identical to predicate. | Identical |
| Device output ports | 2 magnets for connection with electrode | Identical to predicate. | Identical |
Notes on Substantial Equivalence:
- Note 1 (Ramp down Time): "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 (Dimensions): "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."
- Note 3 (Weight): "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."
Regarding the AI/Algorithm-specific questions (which are not applicable to this submission):
- 2. Sample size used for the test set and the data provenance: Not applicable. The study was bench testing of a hardware device.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth was established by direct measurement against engineering specifications and comparison to the predicate device.
- 4. Adjudication method for the test set: Not applicable. Performance was assessed via bench testing.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a hardware medical device, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a TENS unit, not an algorithm, and its use is intended for direct patient application (OTC).
- 7. The type of ground truth used: For the technical specifications, the ground truth is the performance parameters of the predicate device and established engineering standards. For the human factors validation (mentioned for weight), the ground truth is likely defined by user feedback and ability to use the device as intended.
- 8. The sample size for the training set: Not applicable. No AI model was trained.
- 9. How the ground truth for the training set was established: Not applicable. No AI model was trained.
Summary of the Study Proving Acceptance Criteria:
The study involved bench testing to demonstrate that the Milieve device's performance parameters are "substantially equivalent" to those of the predicate device (Cefaly Dual). Additionally, software verification and validation and risk management were conducted to support this equivalence. A human factors validation study was also mentioned regarding the device's weight, indicating that the slightly increased weight did not negatively impact usability.
The overarching "acceptance criteria" here is the demonstration of substantial equivalence to a legally marketed predicate device, as per 510(k) requirements. The study successfully met these criteria by showing identical or non-concerning, explained differences in all critical parameters.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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: 888-990-8327 | |
| Fax: 212-315-3232 | |
| 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 ACUTEtreatment program is intended for treatment during migraine attack at theonset of a migraine. The PREVENT treatment program is meant for dailypreventative treatment. | |
| The Mileve device comprises a plastic external casing and electricalcomponents. It is operated by an internal rechargeable battery. | |
| IntendedUse/Indications: | The indications for use of the Mileve device for over-the-counter useare:- The acute treatment of migraine with or without aura in patients18 years of age or older.- The prophylactic treatment of episodic migraine in patients 18years of age or older. |
| TechnologicalComparison: | The Mileve uses the same technological principle as the predicate deviceto accomplish its intended use, namely the stimulation of the upper branchof the trigeminal nerve to treat and prevent migraine. In conjunction withthe Cefaly Dual approved for the treatment and prevention of migraineMileve's intended use is similar to that of the predicate. All outputspecifications of the subject device are either identical or substantiallyequivalent 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:
| - Performance Testing: | 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(Predicate Device) | Comparison |
|---|---|---|---|
| 510(k) | Proposed Device | K201895 | -- |
| Device Name andModel | Milieve (YPS-301BD) | Cefaly Dual | -- |
| Manufacturer | Ybrain Inc. | CEFALY Technology | -- |
| IndicationsFor Use | The indications for use of theMilieve for an over-the-counteruse are:- The acute treatment ofmigraine with or without aura inpatients 18 years of age or older.- The prophylactic treatment ofepisodic migraine in patients 18years of age or older. | The indications for use of theCefaly Dual for an over-the-counter use are:- The acute treatment ofmigraine with or without aurain patients 18 years of age orolder.- The prophylactic treatmentof episodic migraine inpatients 18 years of age orolder. | Identical |
| ClassificationName | Stimulator, Nerve, Electrical,Transcutaneous, For Migraine | Stimulator, Nerve,Electrical, Transcutaneous,For Migraine | Identical |
| Product Code | PCC | PCC | Identical |
| Regulatory Class | Class II | Class II | Identical |
| ClassificationNumber | Sec 882.5891 | Sec 882.5891 | Identical |
| ContraindicationsFor Use | Subjects with implanted metallicor electronic devices in the head.Subjects suffering from pain ofunknown origin.Subjects who have a cardiacpacemaker or implanted orwearable defibrillator. Thismay cause interference withpacing, electric shock, or death. | Subjects with implantedmetallic or electronic devicesin the head.Subjects suffering from painof unknown origin. Subjectswho have a cardiacpacemaker or implanted orwearable defibrillator. Thismay cause interference withpacing, electric shock, ordeath. | Identical |
| Parameter | Milieve | Cefaly Dual(Predicate Device) | Comparison |
| Power Source | Rechargeable 3.7V LiPo Battery | Rechargeable 3.7V LiPo Battery | Identical |
| Software provided | 2 fixed programs:- 1 fixed program for the acute treatment of migraine attacks (Program 1)- 1 fixed program for prophylactic treatment of migraine (Program 2) | 2 fixed programs:- 1 fixed program for the acute treatment of migraine attacks (Program 1)- 1 fixed program for prophylactic treatment of migraine (Program 2) | Identical |
| Program 1:Max. output currentPulse widthPulse frequencySession duration | 16 mA250 $\mu$ sfixed 100 Hzfixed 60 minutes | 16 mA250 $\mu$ sfixed 100 Hzfixed 60 minutes | Identical |
| Program 2:Max. output currentPulse widthPulse frequencySession duration | 16 mA250 $\mu$ sfixed 60 Hzfixed 20 minutes | 16 mA250 $\mu$ sfixed 60 Hzfixed 20 minutes | Identical |
| Waveform | Biphasic, symmetric,rectangular current impulseswith zero electrical mean | Biphasic, symmetric,rectangular current impulseswith zero electrical mean | Identical |
| Phase Duration (orPulse width) | 250 $\mu$ s | 250 $\mu$ s | Identical |
| Inter Phase Interval | 5 $\mu$ s | 5 $\mu$ s | Identical |
| Maximum CurrentIntensity (±10%)@500 $\Omega$@2000 $\Omega$@10000 $\Omega$ | 16 mA16 mA6 mA | 16 mA16 mA6 mA | Identical |
| Maximum averagecurrent @500 $\Omega$ | 0.48 mA | 0.48 mA | Identical |
| Maximum outputvoltage (±10%) | Identical | ||
| Parameter | Milieve | Cefaly Dual(Predicate Device) | Comparison |
| @500Ω@2000Ω@10000Ω | 8 V32 V60 V | 8 V32 V60 V | |
| Ramp up Time | 14 min | 14 min | Identical |
| Steady Time | 6 min | 6 min | Identical |
| Ramp down Time | 60 s | 45 s | SENote 1 |
| Maximum PhaseCharge @500 Ω | 4 µC | 4 µC | Identical |
| Net Charge perPulse | 0 | 0 | Identical |
| Maximum CurrentDensity @500 Ω | 2.37 mA/cm2 | 2.37 mA/cm2 | Identical |
| Maximum AveragePower Density@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 | SENote 2 |
| Weight | 21 g | 12 g | SENote 3 |
| Electrode | Self-adhesive with 2 conductivezones | Self-adhesive with 2conductive zones | Identical |
| Device output ports | 2 magnets for connection withelectrode | 2 magnets for connection withelectrode | 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.
§ 882.5891 Transcutaneous electrical nerve stimulator to treat headache.
(a)
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.(b)
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.