(452 days)
The SMILE external Trigeminal Nerve Stimulation (eTNS) System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications.
The device is to be used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
Transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder. A transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.
The SMILE eTNS System treatment protocol is administered each night while the patient is sleeping, for 7-9 hours. The device is designed to provide non-invasive electrical stimulation of the trigeminal nerve.
The provided document is a 510(k) summary for the Nu Eyne Co., Ltd. SMILE device, a transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD). This document focuses on demonstrating substantial equivalence to a predicate device (Monarch eTNS System), rather than presenting a clinical study where the device performance against specific acceptance criteria is measured for an AI/algorithm-driven device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for an AI/algorithm is not available in this document.
The document details the device's technical specifications, indications for use, and a comparison to a predicate device to establish substantial equivalence. It also lists the non-clinical tests performed (electrical safety, EMC, performance, usability, and software validation according to relevant standards), which support the device's safety and effectiveness in general, but not a specific performance metric against a clinical acceptance criterion in the context of an AI/algorithm.
To directly answer your request based only on the provided text, I must state that the information is not present. This document describes a medical device clearance process focused on equivalence, not on the performance of a machine learning algorithm against a clinical endpoint with a dedicated test set and ground truth.
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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.
February 12, 2023
Nu Eyne Co., Ltd. Sung jin Jung Manager #608, 28, Digital-ro 30-gil, Guro-gu Seoul, 08389 Korea. South
Re: K213629
Trade/Device Name: Smile Regulation Number: 21 CFR 882.5898 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Attention Deficit Hyperactivity Disorder Regulatory Class: Class II Product Code: OGL Dated: January 10, 2023 Received: January 13, 2023
Dear Dong Lee:
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 (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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Pamela D. Scott -S
Pamela D. Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213629
Device Name SMILE (Model: NUEYNE P022)
Indications for Use (Describe)
The SMILE external Trigeminal Nerve Stimulation (eTNS) System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications.
The device is to be used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for NuEyene, a medical R&D company. The logo features a stylized, interconnected blue design above the company name. The name "Nu" is in a darker blue, while "Eyene" is in a lighter blue, matching the color of the design above. Below the name, the text "A MEDICAL R&D COMPANY" is written in smaller, all-caps letters.
510(k) SUMMARY
This summary of 510(k) -safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: January 10, 2023
1. INFORMATION
1.1 Submitter Information
- l Submitter Name: Nu Eyne Co., Ltd.
- l Address
- : #608, 28, Digital-ro 30-gil, Guro-gu, Seoul, 08389, Republic of Korea
- Telephone Number: +82-2-6953-8120
- -Fax: +82-303-3447-0017
- I Email: sungjin.jung(@nueyne.com
1.2 Contact Person
- I Name: Sung jin Jung (Manager / Nu Eyne Co.,Ltd.)
- I Address: #608, 28, Digital-ro 30-gil, Guro-gu, Seoul, 08389, Republic of Korea
- Telephone Number: +82-2-6953-8120 I . Fax: +82-303-3447-0017
- E-mail: sungjin.jung@nueyne.com
2. DEVICE INFORMATION
- 2.1 Trade Name / Proprietary Name: SMILE (Models: NUEYNE P022)
2.2 Common Name: Transcutaneous electrical nerve stimulator for Attention Deficit Hyperactive Disorder
2.3 Classification Name: Transcutaneous Electrical Nerve Stimulator For Attention
Deficit Hyperactivity Disorder
- 2.4 Product Code: QGL
- 2.5 Classification Regulation: 21 CFR 882.5898
- 2.6 Device Class: Class II (Special Controls)
- 2.7 Classification Panel: Neurology
| Predicate Device | |
|---|---|
| Manufacturer | NeuroSigma, Inc. |
| Device Name (Trade Name) | Monarch eTNS System |
| De Novo Number | DEN180041 |
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Image /page/4/Picture/0 description: The image contains the logo for Nu Eyne, a medical R&D company. The logo features a stylized graphic of interconnected blue shapes resembling molecules or neural networks, with two dark blue circles within the design. Below the graphic, the company name "Nu Eyne" is written in a modern, sans-serif font, with "Nu" in a darker blue and "Eyne" in a lighter blue. Underneath the company name, the tagline "A MEDICAL R&D COMPANY" is written in smaller, uppercase letters.
4. SUBJECT DEVICE DESCRIPTION
Transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder. A transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.
4.1 Device Identification
| Component | Description |
|---|---|
| Instruction Manual | Instruction for Use |
| SMILE Device | Main Body |
| Cable | Charging Cable |
4.2 Device Characteristics
| Trade Name | SMILE (Models: NUEYNE P022) |
|---|---|
| Classification Name | Transcutaneous electrical nerve stimulator for Attention DeficitHyperactivity Disorder |
| Common Name | Transcutaneous Electrical Nerve Stimulator For ADHD |
| Classification Regulation | 21 CFR 882.5898 |
| Regulation Description | Transcutaneous electrical nerve stimulator for Attention DeficitHyperactive Disorder |
| Device Class | Class II (Special Control) |
| Panel | Neurology |
| Product Code | QGL |
| Definition | A transcutaneous electrical nerve stimulator for AttentionDeficit Hyperactivity Disorder (ADHD) is a prescription devicethat stimulates transcutaneously or percutaneously throughelectrodes placed on the forehead. |
| Physical State | Electrical stimulation unit with leads and cutaneous electrodes |
| Technical Method | Applies an electrical current through electrodes on patient's skin |
| Target Area | Trigeminal nerve |
| Software | Software Name: Nueyne_SMILESoftware Version: 1.00Level-of Concern: Class B (Moderate Level) |
The SMILE is not related to biologics, drugs, coatings, additives, single-use, and sterile.
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Image /page/5/Picture/0 description: The image shows the logo for Nu Eyne, a medical R&D company. The logo features the company name in two lines, with "Nu" in a dark blue, and "Eyne" in a lighter blue. Above the name is a stylized graphic of interconnected circles and lines, also in the lighter blue color, suggesting a network or molecular structure.
4.3 Environment of Use
The device is to be used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
4.4 Description of the Device
(1) Explanation of how the device works/principle of operation
The SMILE eTNS System treatment protocol is administered each night while the patient is sleeping, for 7-9 hours. The device is designed to provide non-invasive electrical stimulation of the trigeminal nerve. The trigeminal nerve is the largest cranial nerve and has three major sensory divisions of the face, all of which are bilateral.
The trigeminal nerve provides a direct connection to multiple brain structures implicated in ADHD and other neurologic and neuropsychiatric disorders.
Image /page/5/Figure/7 description: This image shows a diagram of a device contained in a plastic enclosure. The diagram includes a rechargeable 3.7V battery connected to a main board. A power switch and control switch are connected to the main board, and an electrode pad is also connected to the main board. The diagram also includes labels A, B, and C, which may indicate different connections or pathways within the device.
(2) Mechanism of action
(3) Any necessary feature to determine SE or device performance
The SMILE external Trigeminal Nerve Stimulation (eTNS) System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications.
4.5 Materials of Use
The device is manufactured using the materials listed below. The device does not contain Phthalates and not incorporate medicinal substances, tissues, or blood products.
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Image /page/6/Picture/0 description: The image shows the logo for Nu Eyne, a medical R&D company. The logo features the company name in a stylized font, with "Nu" in a darker blue and "Eyne" in a lighter blue. Above the name is a graphic element consisting of interconnected circles, also in blue, resembling a network or molecular structure. Below the name, the tagline "A MEDICAL R&D COMPANY" is written in smaller, uppercase letters.
| Product | Part | Technical data | Manufacturer |
|---|---|---|---|
| SMILEDevice | Battery | TW342431-240mAh | SHENZENTAIWOOBATTERY CO.,LTD |
| PCB | FR4, V-0 | JDM CO LTD | |
| LED plastic | LUPOY PC, V-2 | LG Chem | |
| Enclosure | ABS, V-0 | LG Chem |
We design the enclosure material of SMILE with Acrylonitrile butadiene styrene (ABS).
4.6 Key Performance Specifications/Characteristics of the Device
| (1) SMILE device (TPD-PS02) | ||
|---|---|---|
| -- | -- | ----------------------------- |
| Classification | Protection against electric shock: Internally powered ME EquipmentApplied part: Type BF |
|---|---|
| Dimensions (WxHxD) | 60.00mm x 44.00mm x 17.60mm |
| Weight | 20.71g |
| Power source | Rechargeable battery |
| Maximum output current | 10mA |
| Lifetime | 1.5 years |
| Operating condition | Temperature: 10°C ~ 40°CRelative humidity: 5% ~ 85 %Pressure: 700hPa ~ 1060hPa |
| Storage condition | Temperature: -10°C ~ 45°CRelative humidity: 5% ~ 85 %Pressure: 500hPa ~ 1060hPa |
(2) Cable (CB-02)
| Dimensions (Length) | 1000mm |
|---|---|
| Current Rating | 2A |
| Voltage Rating | 250V |
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Image /page/7/Picture/0 description: The image contains the logo for Nu Eyne, a medical R&D company. The logo features a stylized graphic of interconnected blue circles above the company name. The name "Nu" is in a dark blue, modern font, while "Eyne" is in a lighter blue, futuristic font. Below the name, the tagline "A MEDICAL R&D COMPANY" is written in smaller, uppercase letters.
5. INTENDED USE
SMILE is a prescription device that stimulates nerves transcutaneously through electrodes placed on the forehead and is intended for pediatric ADHD.
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Image /page/8/Picture/0 description: The image shows the logo for NuEyene, a medical R&D company. The logo features a stylized blue symbol resembling interconnected molecules or cells. Below the symbol is the company name, "NuEyene," in a simple, sans-serif font, with the tagline "A MEDICAL R&D COMPANY" underneath in smaller letters.
6. SUBSTANTIAL EQUIVALENCE
| Items | Subject Device | Predicate Device | ComparisonResult |
|---|---|---|---|
| Manufacturer | Nu Eyne Co., Ltd. | NeuroSigma, Inc. | Different |
| Device | Transcutaneous electrical nervestimulator for Attention DeficitHyperactive Disorder | Transcutaneous electrical nervestimulator for Attention DeficitHyperactive Disorder | Same |
| Trade/Device Name | SMILE | Monarch eTNS System | Different |
| 510(k)/Denovo Number | K213629 | DEN180041 | Different |
| Regulation Number | 21 CFR 882.5898 | 21 CFR 882.5898 | Same |
| Regulation Description | Transcutaneous electrical nervestimulator for Attention DeficitHyperactive Disorder | Transcutaneous electrical nervestimulator for Attention DeficitHyperactive Disorder | Same |
| Regulatory Class | Class II | Class II | Same |
| Product Code | OGL | QGL | Same |
| Intended Use | SMILE is the device that stimulatesnerves and is intended for ADHD | Monarch eTNS System isTranscutaneous electrical nervestimulator for Attention DeficitHyperactivity Disorder. | Same |
| Definition | A transcutaneous electrical nervestimulator for Attention DeficitHyperactivity Disorder (ADHD) is aprescription device that stimulatestranscutaneously or percutaneously | A transcutaneous electrical nervestimulator for Attention DeficitHyperactivity Disorder (ADHD) is aprescription device that stimulatestranscutaneously or percutaneously | Same |
| through electrodes placed on theforehead. | through electrodes placed on theforehead. | ||
| Review Panel | Neurology | Neurology | Same |
| Physical State | Electrical stimulation unit with leadsand cutaneous electrodes. | Electrical stimulation unit with leadsand cutaneous electrodes. | Same |
| Technical Method | Applies an electrical current throughelectrodes on patient's skin. | Applies an electrical current throughelectrodes on patient's skin. | Same |
| Target Area | Trigeminal nerve | Trigeminal nerve | Same |
| Indications for Use | The SMILE external Trigeminal NerveStimulation (eTNS) System is indicatedfor treatment of pediatric AttentionDeficit Hyperactivity Disorder (ADHD)as a monotherapy in patients ages 7through 12 years old who are notcurrently taking prescription ADHDmedications.The device is to be used for patienttreatment by prescription only and isintended to be used in the home underthe supervision of a caregiver duringperiods of sleep. | The Monarch external TrigeminalNerve Stimulation (eTNS) System isindicated for treatment ofpediatric Attention DeficitHyperactivity Disorder (ADHD) as amonotherapy in patients ages 7through 12 years old who are notcurrently taking prescription ADHDmedications.The device is to be used for patienttreatment by prescription only and isintended to be used inthe home under the supervision of acaregiver during periods of sleep. | Same |
| Picture | Different | ||
| Power Source | Rechargeable battery | Rechargeable battery | Same |
| Computerized | Yes | Yes | Same |
| S/W provided | MODERATE level of concern | MODERATE level of concern | Same |
| Max output current | 10mA | 10mA | Same |
| Patient Override Control Method | On/Off button | On/Off button | Same |
| Max Leakage Current | None (battery operated) | None (battery operated) | Same |
| Indicator display: Unit functioning | Yes | Yes | Same |
| Low battery indicator | Yes | Yes | Same |
| Standards | IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-11IEC 60601-2-10IEC 62366-1IEC 62304ISO 10993-1ISO 10993-5ISO 10993-10 | IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-11IEC 60601-2-10IEC 62366-1IEC 62304ISO 10993-1 | Same |
| ISO 10993-5ISO 10993-10 | |||
| Picture | Image: head with device on forehead | Image: person putting device on another person's head | Different |
| Power Source | Rechargeable battery | Rechargeable battery | Same |
| Computerized | Yes | Yes | Same |
| S/W provided | MODERATE level of concern | MODERATE level of concern | Same |
| Max output current | 10mA | 10mA | Same |
| Patient Override Control Method | On/Off button | On/Off button | Same |
| Max Leakage Current | None (battery operated) | None (battery operated) | Same |
| Indicator display: Unit functioning | Yes | Yes | Same |
| Low battery indicator | Yes | Yes | Same |
| Standards | IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-11IEC 60601-2-10IEC 62366-1IEC 62304 | IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-11IEC 60601-2-10IEC 62366-1IEC 62304 | Same |
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Image /page/9/Picture/0 description: The image contains the logo for Nu Eyne, a medical R&D company. The logo features a stylized, interconnected network of blue shapes resembling a neural network or molecular structure. Below the symbol, the company name "Nu Eyne" is written in a modern, sans-serif font, with the tagline "A MEDICAL R&D COMPANY" appearing in smaller letters underneath.
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Image /page/10/Picture/0 description: The image shows the logo for Nu Eyne, a medical R&D company. The logo features a stylized blue symbol resembling interconnected nodes or a network. Below the symbol, the company name "Nu Eyne" is written in a modern, sans-serif font, with "Nu" in a darker shade of blue. Underneath the name, the tagline "A MEDICAL R&D COMPANY" is written in smaller, uppercase letters.
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Image /page/11/Picture/0 description: The image contains a logo for a company called Nu Eyne, which is described as "A MEDICAL R&D COMPANY". The logo features a stylized, interconnected design in blue, resembling a network or a chain of molecules. The company name "Nu Eyne" is written in a modern, sans-serif font, with "Nu" in a slightly larger size and a darker shade of blue compared to "Eyne".
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Image /page/12/Picture/0 description: The image shows the logo for Nu Eyne, a medical R&D company. The logo features a stylized, interconnected blue design above the company name. The company name, "Nu Eyne," is written in a modern font, with "Nu" in a darker blue and "Eyne" in a lighter blue. Below the name, the tagline "A MEDICAL R&D COMPANY" is written in smaller, uppercase letters.
| ISO 10993-1ISO 10993-5ISO 10993-10 | ISO 10993-1ISO 10993-5ISO 10993-10 | ||||
|---|---|---|---|---|---|
| Timer Setting | Yes | Yes | Same | ||
| Device | Weight | 20.71g | 145 g (without battery) | Different | |
| Dimensions | 60.00mm x 44.00mm x 17.60mm | 69mm x 115mm x 27mm | Different | ||
| Expected Service Life | 1.5 years | 5 years | Different | ||
| Electrical Protection | Type BF | Type BF | Same | ||
| Battery | Battery Type | Lithium ion Battery | Lithium ion Battery | Same | |
| Expected Service Life | 300 cycles of complete charge-discharge | 300 charges per battery(10 months each) | Same | ||
| Maximum input voltage(USB connector) | 5.25 Vdc | 5.36 Vdc | Different | ||
| Material | |||||
| Device housing materials | Plastic ABS | Plastic ABS | Same | ||
| Stimulation Characteristics | |||||
| Maximum charge per phase | 2.5 uC (Max 10 mA) | 2.5 uC | Same | ||
| Net Charge per pulse | 0 | 0 | Same | ||
| Peak and peak-to-peak currentPeak voltage | ± 10 mA | ± 10 mA | Same | ||
| Phase duration | 250 us | 250 us | Same |
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Image /page/13/Picture/0 description: The image features the logo for "Nu Eyne, A MEDICAL R&D COMPANY". The logo consists of a stylized, interconnected blue design above the company name. The design appears to be a network of connected nodes, suggesting a focus on research and development. The company name is written in a simple, modern font, with "Nu Eyne" in a larger font size than "A MEDICAL R&D COMPANY".
| Maximum average power density | 20 uW/cm^2 | 7.5 mW/cm^2 | Different Largersurface areamakespower density smaller |
|---|---|---|---|
| Maximum average current density | 66.6 uA/cm^2 | 1.4 mA.cm^2 | Different Largersurface area makescurrent densitysmaller |
| Skin contact surface area of the stimulatingelectrode | 9 cm^2 | 7.1 cm^2 | Different |
| And include the stimulation modulationspecifications (Ramp up, Ramp down, on, andoff and times for ramp up, ramp down, on, andoff. | 30 Sec ON, 1 Sec Ramp Down / 30 sec OFF,1 Sec Ramp UpSteady 8 hours | 30 Sec ON: 1 Sec Ramp Down: 30 SecOFF: 1 Sec Ramp UpSteady 7-9 hours | Samet |
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Image /page/14/Picture/0 description: The image features the logo for "Nu Eyne, A MEDICAL R&D COMPANY". The logo consists of a stylized graphic above the company name. The graphic is a blue, interconnected network-like design with two prominent circular nodes. The text "Nu Eyne" is in a bold, dark blue font, and below it, in a smaller font, is the phrase "A MEDICAL R&D COMPANY".
7. NON-CLINICAL DATA
7.1 Electrical Safety and EMC Test
The electrical safety tests were performed to protect patients from undue risks arise from any hazards associated with final device. The tests were performed in accordance with the following standards.
| No. | Test Items | Standards |
|---|---|---|
| 1 | General requirement for basic safety andessential performance | - IEC 60601-1:2005/A1: 2012(AAMI/ANSI ES 60601-1: 2005/A1: 2012) |
| 2 | General requirement for safety -Electromagnetic disturbances | - IEC 60601-1-2:2014 |
| 3 | General requirement for safety - Medicalelectrical equipment used in the homehealthcare environment | - IEC 60601-1-11:2015 and- FDA Guidance ("Design Considerations forDevices Intended for Home Use") |
| 4 | Particular requirement for safety - Nerveand muscle stimulators | - IEC 60601-2-10:2012/Amd1:2016 |
7.2 Performance Test
The following tests were performed to assess effectiveness of performance of the device. The tests were performed in accordance with following standards.
| No. | Test Items | Standards |
|---|---|---|
| 1 | Particular requirement for safety – Nerveand muscle stimulators | - IEC 60601-2-10:2012/Amd1:2016 |
| 2 | Technical Test | - IEC 60601-2-10:2012/Amd1:2016 |
7.3 Usability V&V
The following tests were performed to assess effectiveness of usability of the test was performed in accordance with following standards.
| No. | Test Items | Standards and FDA Guidance documents |
|---|---|---|
| 1 | General requirement for safety – Usability | - IEC 60601-1-6:2013 |
| - IEC 62366-1:2015 and | ||
| - FDA Guidance ("Applying Human Factors andUsability Engineering to Medical Devices") |
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Image /page/15/Picture/0 description: The image shows the logo for Nu Eyne, a medical R&D company. The logo features a stylized graphic above the company name. The graphic consists of interconnected blue shapes resembling molecules or a network. The company name, "Nu Eyne," is written in a modern font, with "Nu" in a darker blue and "Eyne" in a lighter blue. Below the name, the tagline "A MEDICAL R&D COMPANY" is written in smaller, uppercase letters.
7.4 Software
The following tests were performed to assess effectiveness of software of the device. The test was performed in accordance with following standards.
| No. | Test Items | Standards and FDA Guidance Documents |
|---|---|---|
| 1 | General requirement for safety -Programmable electrical medical systems(PEMS) | - IEC 62304:2006/AMD1:2015- FDA Guidance (“Guidance for the Content ofPremarket Submissions for Software Contained inMedical Devices”) |
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Image /page/16/Picture/0 description: The image shows the logo for Nu Eyne, a medical R&D company. The logo features a stylized, interconnected blue design resembling a network or a chain of molecules. Below the graphic is the company name, "Nu Eyne," in a simple, sans-serif font, with the tagline "A MEDICAL R&D COMPANY" underneath in smaller letters.
8. CONCLUSION
Under the comparing substantial equivalence between the subject device and the predicate device, there are the same points such as general information, some technical and material information. Although there are some differences, the safety and performance test reports are supported to the safety and effectiveness of the subject device.
In this regard, we conclude that the subject device is substantially equivalent to the predicate device.
§ 882.5898 Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.
(a)
Identification. A transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.(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) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be performed:
(i) Electrical performance testing must validate electrical output and duration of stimulation;
(ii) Battery performance testing must be performed; and
(iii) Adhesive integrity testing of the electrodes must be conducted.
(4) The technical parameters of the device including waveform, maximum output current and voltage, pulse duration, frequency, net charge per pulse, maximum current density, maximum average current, and maximum average power density must be fully characterized.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Shelf life testing of the electrodes must be performed to demonstrate continued package integrity and component functionality over the labeled shelf life.
(7) Labeling must include the following:
(i) A contraindication for patients with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator;
(ii) A warning that the device is only for use on clean, intact skin;
(iii) Information on how the device operates and the typical sensations experienced during treatment;
(iv) A detailed summary of the device technical parameters;
(v) A shelf life for the electrodes;
(vi) Instructions for use, including placement of the device on the patient; and
(vii) Cleaning instructions.