(277 days)
Not Found
No
The description focuses on transcutaneous nerve stimulation with fixed frequency outputs (60Hz and 100Hz) and does not mention any adaptive or learning capabilities based on patient data or other inputs. The "adjusts the output mode" refers to selecting between two predefined programs, not dynamic adjustment based on AI/ML.
Yes
The device is indicated for the acute and prophylactic treatment of migraine, which are medical conditions, and it delivers transcutaneous nerve stimulation to achieve this therapeutic effect.
No
The device description and intended use clearly state that this product is for the treatment (acute and prophylactic) of migraine, using transcutaneous nerve stimulation. It does not mention any function for identifying, analyzing, or diagnosing medical conditions.
No
The device description explicitly states it is a "small, portable product that uses the principle of transcutaneous nerve stimulation" and involves "attaching an electrode to the forehead" to transmit "electrical stimulation." This indicates the presence of hardware components (the device itself, electrodes) that deliver the therapy, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The DOOPANG(YPS-301BD) is a device that applies electrical stimulation to the skin (transcutaneous nerve stimulation) for the treatment and prevention of migraines. It does not analyze any biological samples from the patient.
- Intended Use: The intended use is for the treatment and prevention of migraines, which is a therapeutic application, not a diagnostic one based on in vitro analysis.
- Device Description: The description clearly outlines a physical device that delivers electrical current to the forehead, not a system for analyzing biological samples.
Therefore, the DOOPANG(YPS-301BD) falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DOOPANG(YPS-301BD) 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
PCC
Device Description
This product is a small, portable product that uses the principle of transcutaneous nerve stimulation. By attaching an electrode to the forehead, it transmits electrical stimulation to the upper branch of the trigeminal nerve transdermally.
The electrode surface transmits electric current to the skin to generate action potentials on the nerves and adjusts the output mode (Program 1 and Program 2) to preventative treatment of episodic migraine(60Hz) and acute treatment of migraine(100Hz). Specially designed electrode of this product allows contact with the trigeminal nerve endings associated with migraine headaches. The electrodes give nerve stimulation to the orbital upper branch (V1) inside the forehead skin and transmit it to the trigeminal nervous system. This electrical stimulation is transmitted percutaneously through a bipolar adhesive electrode located on the forehead to preventative treatment of episodic migraine(60Hz) or acute treatment of migraine(100Hz).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead (trigeminal nerve, orbital upper branch (V1))
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Home & Healthcare settings
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)
Non-Clinical Test summary:
- Electrical Safety, Electromagnetic Compatibility and Performance: The DOOPANG(YPS-301BD) complies with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Software Validation: The DOOPANG(YPS-301BD) contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated.
- Biocompatibility: ISO 10993-1 and series, Biological evaluation of medical devices
- Cybersecurity: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, on October2, 2014
- Label: CFR Part 801
- Performance: Performance Evaluation Test, Real Time Stability Test
- Usability: Usability Test (IEC 62366-1:2015+AMD1:2020 CSV)
Key results:
- There appears to be a slight difference in session duration between Program 1 and Program 2 for both the predicate device and the proposed device. However, this discrepancy is not expected to pose any significant additional risk, as the variation is within a minute or less.
- The Maximum current density (mA/cm2, r.m.s) at 500 ohms of the proposed device is 2.32, while the predicate device has a value of 2.37. Although there is a slight difference, it can be argued that the performance of the proposed device is less risky because it falls within the performance range of the predicate device.
- There are no significant differences between the DOOPANG(YPS-301BD) and the predicate device that would adversely affect the product's use according to the test results. Therefore, these differences do not raise different questions of safety and effectiveness than the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 11, 2024
Ybrain, Inc. % Jonghyun Kim CEO, GMS Consulting #612, DE Riverwork Building B, 66, Cheongcho-ro, Deogyang-gu Goyang-si, Gyeonggi-do 10543 Korea. South
Re: K232749
Trade/Device Name: Doopang Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous electrical nerve stimulator to treat headache Regulatory Class: Class II Product Code: PCC Dated: May 24, 2024 Received: May 24, 2024
Dear Jonghyun Kim:
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).
1
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 (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 and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
DOOPANG (YPS-301BD)
Indications for Use (Describe)
The DOOPANG(YPS-301BD) 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
- 510(K) Summary
4
510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
May 23, 2024
2. Submitter's Information [21 CFR 807.92(a)(1)]
- Name of Manufacturer: Ybrain, Inc. ●
- Address: 228, 54, Changeop-ro, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (zip code 13449) ● Kiwon, Lee/President Contact Name:
- Telephone No.: +82-70-4190-1899
- Email Address: ra@ybrain.com
- PCC Registration No.:
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| 510(k) Number | K232749 |
|---|---|
| Trade/Device/Model Name | DOOPANG/DOOPANG/YPS-301BD |
| Product Name | Transcutaneous Electrical Nerve Stimulator to Treat |
| Headache | |
| Device Classification Name | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Regulation Number | 21 CFR 882.5891 |
| Classification Product Code | PCC |
| Device Class | Class II |
| 510(k) Review Panel | Neurology |
5
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate device within this submission is shown as follow;
Predicate Device
| 510(k) Number | K201895 |
|---|---|
| Trade/Device/Model Name | Cefaly Dual |
| Product Name | Transcutaneous Electrical Nerve Stimulator to Treat |
| Headache | |
| Device Classification Name | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Requlation Number | 21 CFR 882.5891 |
| Classification Product Code | PCC |
| Device Class | Class II |
| 510(k) Review Panel | Neurology |
These predicate devices have not been subject to a design-related recall
6
5. Description of the Device [21 CFR 807.92(a)(4)]
This product is a small, portable product that uses the principle of transcutaneous nerve stimulation. By attaching an electrode to the forehead, it transmits electrical stimulation to the upper branch of the trigeminal nerve transdermally.
The electrode surface transmits electric current to the skin to generate action potentials on the nerves and adjusts the output mode (Program 1 and Program 2) to preventative treatment of episodic migraine(60Hz) and acute treatment of migraine(100Hz). Specially designed electrode of this product allows contact with the trigeminal nerve endings associated with migraine headaches. The electrodes give nerve stimulation to the orbital upper branch (V1) inside the forehead skin and transmit it to the trigeminal nervous system. This electrical stimulation is transmitted percutaneously through a bipolar adhesive electrode located on the forehead to preventative treatment of episodic migraine(60Hz) or acute treatment of migraine(100Hz).
6. Indications for use [21 CFR 807.92(a)(5)]
The DOOPANG(YPS-301BD) 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.
7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]
There are no significant differences in the technological characteristics of these devices compared to the predicate device which adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of the DOOPANG(YPS-301BD) and the predicate device:
| Proposed Device | Predicate Device | Note | |
|---|---|---|---|
| K Number | K232749 | K201895 | - |
| Manufacturer | Ybrain, Inc. | CEFALY Technology | - |
| Trade Name(Model Name) | DOOPANG(YPS-301BD) | Cefaly Dual | - |
| Product Name | Transcutaneous Electrical | ||
| Nerve Stimulator to Treat | |||
| Headache | Transcutaneous Electrical | ||
| Nerve Stimulator to Treat | |||
| Headache | - | ||
| Product Code | PCC | PCC | Same |
| Regulation Number | 21 CFR 882.5891 | 21 CFR 882.5891 | Same |
| Regulatory Class | II | II | Same |
| Proposed Device | Predicate Device | Note | |
| 510(k) Review Panel | Neurology | Neurology | Same |
[Table 1. Comparison of Proposed Device to Predicate Devices]
7
| DOOPANG(YPS-301BD) is | The Cefaly® Dual is | ||
|---|---|---|---|
| Indications for Use | 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. | 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. | Similar |
| Intended Population | Patients 18 years of age
or older | Patients 18 years of age
or older | Same |
| Intended Use Environment | Home & Healthcare
settings | Home & Healthcare
settings | Same |
| Power Source | A rechargeable 3.7V
Lithium-Polymer Battery | 1 rechargeable LiPo
3.7 V battery | Same |
| Channels | 1 | 1 | Same |
| Software provided | 2 fixed programs: - 1 fixed program for the
acute treatment of
migraine attacks(Program
- 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 fixed program for
prophylactic treatment of
migraine(Program 2) | Same |
| Program 1: | | | |
| Max. output current | 16 mA | 16 mA | |
| Pulse width | 250 μs,
fixed 100 Hz, | 250 μs,
fixed 100 Hz, | Similar |
| Pulse frequency | fixed 61 minutes | fixed 60 minutes | |
| Session duration | | | |
| Program 2: | | | |
| Max. output current | 16 mA | 16 mA | |
| Pulse width | 250 μs,
fixed 60 Hz, | 250 μs,
fixed 60 Hz, | Similar |
| Pulse frequency | fixed 21 minutes | fixed 20 minutes | |
| Session duration | Biphasic, rectangular,
symmetrical | Biphasic, rectangular,
symmetrical | Same |
| Waveform | | | |
| Net charge (µC) per pulse | 0 | 0 | Same |
| Maximum output current (mA): | | | |
| | 16 mA | 16 mA | Same |
| | | | |
| Maximum current density (mA/cm2,
r.m.s) at 500 ohms | 2.32 | 2.37 | Similar |
| Maximum average power density
(W/cm2, r.m.s) at 500 ohms | 0.000047 | 0.000047 | Same |
It is substantially equivalent to these devices in design, function, and intended use. The proposed device, DOOPANG(YPS-301BD) has been tested about electrical safety, EMC, and performance, and the software has been validated. Differences and Risks associated with that:
- There appears to be a slight difference in session duration between Program 1 and Program . 2 for both the predicate device and the proposed device. However, this discrepancy is not
8
expected to pose any significant additional risk, as the variation is within a minute or less.
- The Maximum current density (mA/cm2, r.m.s) at 500 ohms of the proposed device is 2.32, . while the predicate device has a value of 2.37. Although there is a slight difference, it can be arqued that the performance of the proposed device is less risky because it falls within the performance range of the predicate device.
There are no significant differences between the DOOPANG(YPS-301BD) and the predicate device that would adversely affect the product's use according to the test results. Therefore, these differences do not raise different questions of safety and effectiveness than the predicate.
8. Non-Clinical Test summary
The DOOPANG(YPS-301BD) complies with voluntary standards for electrical safety,
electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:
- Electrical Safety, Electromagnetic Compatibility and Performance:
The DOOPANG(YPS-301BD) complies with the electrical safety and electromagnetic compatibility requirements established by the standards.
| Standards
No. | Standards
Organization | Standard Title | Version | Publication
Year |
|------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------|
| 60601-1 | AAMI/IEC | Medical Electrical Equipment - Part 1: General
Requirements for Basic Safety and Essential
Performance (IEC 60601-1:2005, MOD) | ES60601-1:
2005(R)201
2 and
A1:2012 | 2014 |
| 60601-1-2 | IEC | Medical Electrical Equipment - Part 1-2: General
Requirements for Safety – Collateral Standard:
Electromagnetic Compatibility - Requirements
and Tests | 60601-1-2
Edition 4.0
2014-02 | 2016 |
| 60601-1-6 | IEC | Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability | 60601-1-6
Edition 3.0
2012-07 | 2012 |
| 60601-1-
11 | IEC | Medical electrical equipment - Part 1-11: General
requirements for basic safety and essential
performance - Collateral Standard: Requirements
for medical electrical equipment and medical
electrical systems used in the home healthcare
environment | 60601-1-11
Edition 2.0
2015-01 | 2016 |
| 60601-2-
10 | IEC | Medical electrical equipment - Part 2-10:
Particular requirements for the basic safety and
essential performance of nerve and muscle
stimulators | 60601-2-10
Edition 2.1
2016-04 | 2018 |
| 62366-1 | IEC | Medical devices - Part 1: Application of usability
engineering to medical devices | 62366-1
Edition 1.1
2020-06
CONSOLIDA
TED
VERSION | 2020 |
9
2) Software Validation
The DOOPANG(YPS-301BD) contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA guidance:
- The content of premarket submissions for software contained in medical devices, on May 11, ● 2005
-
- Biocompatibility
- ISO 10993-1 and series, Biological evaluation of medical devices
-
- Cybersecurity
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, on October2, 2014
-
- Label
- CFR Part 801
-
- Performance
- Performance Evaluation Test
- Real Time Stability Test
-
- Usability
- . Usability Test (IEC 62366-1:2015+AMD1:2020 CSV)
9. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
There are no significant differences between the proposed device and the predicate device, K201895 that would adversely affect the use of the product. It is substantially equivalent to these devices in indications for use and technology characteristics.
10. Conclusion [21 CFR 807.92(b)(3)]
In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, concludes that the DOOPANG(YPS-301BD) is substantially equivalent in safety and effectiveness to the predicate device as described herein.