(194 days)
Not Found
No
The document describes a standard TENS device with pre-set programs and does not mention any AI/ML components or capabilities.
Yes
The device is indicated for the acute treatment and prophylactic treatment of migraine, which are medical conditions, and states that it is a transcutaneous electrical nerve stimulator (TENS) for these purposes.
No
The device is a transcutaneous electrical nerve stimulator (TENS) intended for the treatment (acute and prophylactic) of migraine, not for diagnosis.
No
The device description explicitly states that the Milieve device comprises a plastic external casing and electrical components, indicating it is a hardware device.
Based on the provided information, the Milieve device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Milieve's Function: The Milieve device is a transcutaneous electrical nerve stimulator (TENS) that applies electrical stimulation to the forehead. It does not analyze any biological samples from the patient.
- Intended Use: The intended use is for the treatment and prevention of migraine, which is a therapeutic application, not a diagnostic one based on analyzing biological samples.
Therefore, the Milieve device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
PCC
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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"
1
(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
2
and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
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 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. | |
| Intended | |
| Use/Indications: | The indications for use of the Mileve device for over-the-counter use |
| are: |
- 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. |
| Technological
Comparison: | The Mileve uses the same technological principle as the predicate device
to accomplish its intended use, namely the stimulation of the upper branch
of the trigeminal nerve to treat and prevent migraine. In conjunction with
the Cefaly Dual approved for the treatment and prevention of migraine
Mileve's intended use is similar to that of the predicate. All output
specifications of the subject device are either identical or substantially
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.
5
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.
6
| Parameter | Milieve | Cefaly Dual
(Predicate Device) | Comparison |
|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 510(k) | Proposed Device | K201895 | -- |
| Device Name and
Model | Milieve (YPS-301BD) | Cefaly Dual | -- |
| Manufacturer | Ybrain Inc. | CEFALY Technology | -- |
| Indications
For Use | The indications for use of the
Milieve for an over-the-counter
use are:
- 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 indications for use of the
Cefaly Dual for an over-the-
counter use are: - 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. | Identical |
| Classification
Name | 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 |
| Classification
Number | Sec 882.5891 | Sec 882.5891 | Identical |
| Contraindications
For Use | Subjects with implanted metallic
or electronic devices in the head.
Subjects suffering from pain of
unknown origin.
Subjects who have a cardiac
pacemaker or implanted or
wearable defibrillator. This
may cause interference with
pacing, electric shock, or death. | Subjects with implanted
metallic or electronic devices
in the head.
Subjects suffering from pain
of unknown origin. Subjects
who have a cardiac
pacemaker or implanted or
wearable defibrillator. This
may cause interference with
pacing, electric shock, or
death. | 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 current
Pulse width
Pulse frequency
Session duration | 16 mA
250 $\mu$ s
fixed 100 Hz
fixed 60 minutes | 16 mA
250 $\mu$ s
fixed 100 Hz
fixed 60 minutes | Identical |
| Program 2:
Max. output current
Pulse width
Pulse frequency
Session duration | 16 mA
250 $\mu$ s
fixed 60 Hz
fixed 20 minutes | 16 mA
250 $\mu$ s
fixed 60 Hz
fixed 20 minutes | Identical |
| Waveform | Biphasic, symmetric,
rectangular current impulses
with zero electrical mean | Biphasic, symmetric,
rectangular current impulses
with zero electrical mean | Identical |
| Phase Duration (or
Pulse width) | 250 $\mu$ s | 250 $\mu$ s | Identical |
| Inter Phase Interval | 5 $\mu$ s | 5 $\mu$ s | Identical |
| Maximum Current
Intensity (±10%)
@500 $\Omega$
@2000 $\Omega$
@10000 $\Omega$ | 16 mA
16 mA
6 mA | 16 mA
16 mA
6 mA | Identical |
| Maximum average
current @500 $\Omega$ | 0.48 mA | 0.48 mA | Identical |
| Maximum output
voltage (±10%) | | | Identical |
| Parameter | Milieve | Cefaly Dual
(Predicate Device) | Comparison |
| @500Ω
@2000Ω
@10000Ω | 8 V
32 V
60 V | 8 V
32 V
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
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 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 | SE
Note 2 |
| Weight | 21 g | 12 g | SE
Note 3 |
| Electrode | Self-adhesive with 2 conductive
zones | Self-adhesive with 2
conductive zones | Identical |
| Device output ports | 2 magnets for connection with
electrode | 2 magnets for connection with
electrode | Identical |
7
8
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.
9
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.