(90 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.
Yes
The device is indicated for the "treatment" of pediatric Attention Deficit Hyperactivity Disorder (ADHD) and is described as a "transcutaneous electrical trigeminal nerve stimulator," which suggests a direct therapeutic action.
No.
The document explicitly states that the device is "indicated for the treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD)" and is a "transcutaneous electrical trigeminal nerve stimulator." It describes its use for treatment, not diagnosis.
No
The device description explicitly states it is a "transcutaneous electrical trigeminal nerve stimulator" and uses "electrodes placed on the forehead," indicating it is a hardware device that delivers electrical stimulation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- ADDNOX Function: The ADDNOX is a device that treats a condition (ADHD) by applying electrical stimulation to the trigeminal nerve. It does not analyze any biological samples from the patient.
The description clearly states its purpose is for treatment of ADHD, not for diagnosing or analyzing biological samples.
N/A
Intended Use / Indications for Use
The ADDNOX is indicated for the 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 ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.
Product codes
QGL
Device Description
The ADDNOX is a transcutaneous electrical trigeminal nerve stimulator for Attention Deficit Hyperactivity Disorder. It is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.
The ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead (Trigeminal nerve)
Indicated Patient Age Range
7 through 12 years old
Intended User / Care Setting
Home under the supervision of a caregiver. Prescription only.
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)
No clinical testing was performed on the device.
Non-clinical data:
Safety Test:
- Biocompatibility tests were performed in accordance with ISO 10993-5:2009 (Cytotoxicity) and ISO 10993-10:2010 (Sensitization, Intracutaneous Reactivity Test).
- Electrical Safety and EMC tests were conducted in accordance with IEC 60601-1:2005/A2:2020, IEC 60601-1-2:2014/A1:2020, IEC 60601-1-11:2015/A1:2020, and IEC 60601-2-10:2012/A1:2016.
Performance Test:
- Performance Tests, wireless communication tests, and lifetime studies were performed according to manufacturer's own standards.
Software:
- Software testing was performed in accordance with IEC 62304:2006/A1:2015.
Key Results:
Although there are differences in appearance, charging method, expected service life, electrode, mobile application features, and wireless communication between the subject device and the predicate device, safety and performance tests (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, bench testing, ISO 10993 Series, EMC test, performance test under wireless communication, and cyber security risk management) demonstrated that these differences do not affect the safety and effectiveness of the subject device.
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
§ 882.5898 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.
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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.
January 16, 2025
Nu Eyne Co., Ltd. Dahee Kim RA Manager #608, 28, Digital-ro 30-gil, Guro-gu Seoul. 08389 South Korea
Re: K243289
Trade/Device Name: ADDNOX (BPSPM1) Regulation Number: 21 CFR 882.5898 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Attention Deficit Hyperactivity Disorder Regulatory Class: Class II Product Code: QGL Dated: October 18, 2024 Received: October 18, 2024
Dear Dahee 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 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
Sincerely,
ROBERT KANG -S
for Pamela Scott
Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological 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
ADDNOX (BPSPM1)
Indications for Use (Describe)
The ADDNOX is indicated for the 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 ADDNOX is intended for patient treatment by prescription only and for use at 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)
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Image /page/4/Picture/0 description: The image contains the logo for NuEyene, 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 neural networks, with two dark blue circles within the design. Below the graphic, the company name "Nu Eyne" is displayed, with "Nu" in a darker blue and "Eyne" in a lighter blue. Underneath the company name, the text "A MEDICAL R&D COMPANY" is written in a smaller, sans-serif font.
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 16, 2025
1. INFORMATION
1.1 Submitter Information
- ı Submitter Name: Nu Eyne Co., Ltd.
- י Address: #608, 28, Digital-ro 30-gil, Guro-gu, Seoul, 08389, Republic of Korea
- Telephone Number: +82-2-6953-8120 ı Fax: +82-507-0330-8120
- י Email: dahee.kim@nueyne.com
1.2 Contact Person
- Name: Dahee Kim (RA Manager / Nu Eyne Co., Ltd.) י
- י Address: #608, 28, Digital-ro 30-gil, Guro-gu, Seoul, 08389, Republic of Korea
- Telephone Number: +82-2-6953-8120 י Fax: +82-507-0330-8120
- י E-mail: dahee.kim@nueyne.com
2. DEVICE INFORMATION
- 2.1 Trade Name / Proprietary Name: ADDNOX (Models: BPSPM1)
- 2.2 Common Name: Transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder
- 2.3 Regulation Name: Transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder
- 2.4 Product Code: QGL
- 2.5 Regulation Number: 21 CFR 882.5898
- 2.6 Regulatory Class: Class II
- 2.7 Classification Panel: Neurology
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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 a stylized graphic of interconnected blue circles, resembling a network or molecular structure. Below the graphic, the company name "Nu Eyne" is written in a combination of blue and black text, with "Nu" in black and "Eyne" in blue. Underneath the company name, the tagline "A MEDICAL R&D COMPANY" is written in smaller, gray text.
3. PREDICATE DEVICE
| Predicate Device | |
|---|---|
| Manufacturer | Nu Eyne Co., Ltd. |
| Device Name (Trade Name) | SMILE |
| 510(k) Number | K213629 |
| Regulation Name | Transcutaneous electrical nerve stimulator for Attention |
| Deficit Hyperactivity Disorder | |
| Regulation Number | 21 CFR 882.5898 |
| Regulatory Class | Class II |
| Product Code | QGL |
4. SUBJECT DEVICE DESCRIPTION
The ADDNOX is a transcutaneous electrical trigeminal nerve stimulator for Attention Deficit Hyperactivity Disorder. It is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.
The ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.
4.1 Principle of Operation
The ADDNOX treatment protocol is administered each night for 7-9 hours while the patient is sleeping. 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.
The ADDNOX treatment protocol has proven efficacy in alleviating ADHD symptoms with minimum risk.
5. INTENDED USE
ADDNOX is a device that stimulates the trigeminal nerves and is intended for ADHD.
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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 a stylized graphic above the company name. The graphic consists of interconnected blue shapes resembling molecules or a network, with two prominent dark blue circles within the design. Below the graphic, the company name "Nu Eyne" is displayed, with "Nu" in a darker blue and "Eyne" in a lighter blue. Underneath the company name, the text "A MEDICAL R&D COMPANY" is written in a smaller, sans-serif font.
6. INDICATIONS FOR USE
The ADDNOX is indicated for the 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 ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.
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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, interconnected network of blue shapes resembling molecules or connections. Below the logo, the company name "Nu Eyne" is written in a modern, sans-serif font, with the words "A MEDICAL R&D COMPANY" appearing in smaller letters underneath.
7. SUBSTANTIAL EQUIVALENCE
| Items | Subject Device | Predicate Device | Comparison
Result | |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|----------------------|
| Manufacturer | Nu Eyne Co., Ltd. | Nu Eyne Co., Ltd. | Same | |
| Device | Transcutaneous electrical nerve
stimulator for Attention Deficit
Hyperactive Disorder | Transcutaneous electrical nerve
stimulator for Attention Deficit
Hyperactive Disorder | Same | |
| Trade/Device Name | ADDNOX | SMILE | Different | |
| 510(k) Number | K243289 | K213629 | Different | |
| Regulation Number | 21 CFR 882.5898 | 21 CFR 882.5898 | Same | |
| Regulation Description | Transcutaneous electrical nerve
stimulator for Attention Deficit
Hyperactivity Disorder | Transcutaneous electrical nerve
stimulator for Attention Deficit
Hyperactivity Disorder | Same | |
| Regulatory Class | Class II | Class II | Same | |
| Product Code | QGL | QGL | Same | |
| Intended Use | ADDNOX is a device that stimulates the
trigeminal nerves and is intended for
ADHD. | SMILE is the device that stimulates
nerves and is intended for ADHD. | Same | |
| Items | Subject Device | Predicate Device | Comparison
Result | |
| Definition | 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. | 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. | Same | |
| Review Panel | Neurology | Neurology | Same | |
| Physical State | Electrical stimulation unit with leads and
cutaneous electrodes. | Electrical stimulation unit with leads and
cutaneous electrodes. | Same | |
| Technical Method | Applies an electrical current through
electrodes on patient's skin. | Applies an electrical current through
electrodes on patient's skin. | Same | |
| Target Area | Trigeminal nerve | Trigeminal nerve | Same | |
| Indications for Use | The ADDNOX is indicated for the
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 ADDNOX is intended for patient
treatment by prescription only and for
use at home under the supervision of a
caregiver during periods of sleep. | 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 | Same | |
| Items | Subject Device | Predicate Device | Comparison Result | |
| | | the supervision of a caregiver during
periods of sleep. | | |
| Power Source | Rechargeable battery | Rechargeable battery | Same | |
| S/W provided | Yes | Yes | Same | |
| Patient Override Control Method | On/Off button | On/Off button | Same | |
| Indicator Display: Unit Functioning | Yes | Yes | Same | |
| Low Battery Indicator | Yes | Yes | Same | |
| Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-11
IEC 60601-2-10
IEC 62366-1
IEC 62304
ISO 10993-1
ISO 10993-5
ISO 10993-10 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-11
IEC 60601-2-10
IEC 62366-1
IEC 62304
ISO 10993-1
ISO 10993-5
ISO 10993-10 | Same | |
| Timer Setting | Yes | Yes | Same | |
| Weight | 24.6 g | 20.71 g | Different | |
| Device | Dimension | 45.00 mm x 44.00 mm x 18.80 mm | 60.00 mm x 44.00 mm x 17.60 mm | Different |
| | Expected Service Life | 3 years | 1.5 years | Different |
| Electrical Protection | Type BF | Type BF | Same | |
| | Items | Subject Device | Predicate Device | Comparison
Result |
| Battery | Battery Type | Li-ion Polymer Battery | Lithium ion Battery | Same |
| | Expected Service Life | 500 cycles of complete charge-discharge | 300 cycles of complete charge-discharge | Different |
| | Maximum Input Voltage
(Charging Method) | 5.25 Vdc
(Charging Cradle) | 5.25 Vdc
(USB Connector of the Device) | Different |
| Electrode | Dimension | 78.00 mm (W) x 32.86 mm (H) | 90.00 mm (W) x 31.90 mm (H) | Different |
| | Maximum Current Density
(uA/cm2, r.m.s.) | 1.34 | 1.41 | Different |
| | Maximum Average Power
Density (uW/cm2) | 24.06 | 25.38 | Different |
| Mobile Application | | Yes | No | Different |
| Wireless Communication | | Yes | No | Different |
| Materials | | | | |
| Device Housing Material | | Plastic ABS | Plastic ABS | Same |
| Technical specifications | | | | |
| | Waveform | Symmetrical square wave | Symmetrical square wave | Same |
| Maximum Output Current | | 10 mA | 10 mA | Same |
| | Maximum Output Voltage | 5 V | 5 V | Same |
| | Pulse Duration | 250 µS | 250 µS | Same |
| | Frequency | 120 Hz | 120 Hz | Same |
| Items | Subject Device | Predicate Device | Comparison
Result | |
| Stimulation Modulation Specifications
(Cycling, Hours of Use) | 30 Sec ON, 1 Sec Ramp Down /
30 sec OFF, 1 Sec Ramp Up
Steady 7-9 hours | 30 Sec ON, 1 Sec Ramp Down /
30 sec OFF, 1 Sec Ramp Up
Steady 8 hours | Same | |
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Image /page/8/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 molecules or a network. Below the symbol, the company name "Nu Eyne" is written in a modern, sans-serif font, with "Nu" in a darker blue and "Eyne" in a lighter shade. Underneath the name, the text "A MEDICAL R&D COMPANY" is written in smaller, uppercase letters.
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Image /page/9/Picture/0 description: The image shows the logo for NuEyne, a medical R&D company. The logo features a stylized blue symbol resembling interconnected nodes or molecules, with two dark blue circles within the design. Below the symbol, the company name "NuEyne" is written in a modern, sans-serif font, with "Nu" in a darker blue and "Eyne" in a lighter shade. Underneath the name, the text "A MEDICAL R&D COMPANY" is written in smaller, uppercase letters.
10
Image /page/10/Picture/0 description: The image shows the logo for Nu Eyne, a medical R&D company. The logo features a stylized, interconnected network of blue shapes with two dark blue circles within the network. Below the network is the company name, "Nu Eyne," with "Nu" in a darker blue and "Eyne" in a lighter blue. Underneath the company name, in smaller font, is the text "A MEDICAL R&D COMPANY."
11
Image /page/11/Picture/0 description: The image contains the logo for Nu Eyne, a medical research and development company. The logo features a stylized, interconnected network of blue shapes above the company name. The text "Nu Eyne" is written in a modern font, with "Nu" in a darker blue and "Eyne" in a lighter blue. Below the company name, the text "A MEDICAL R&D COMPANY" is written in smaller, all-caps letters.
12
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 design in blue, resembling a network or a chain of molecules. Below the symbol, the company name "Nu Eyne" is written, with "Nu" in black and "Eyne" in blue. Underneath the name, the text "A MEDICAL R&D COMPANY" is written in smaller, black font.
7.1 Differences between Subject Device and Predicated Device
-
Although the appearance and the charging method of the device differ between the subject device and the predicate device, the safety and performance tests according to IEC 60601-1 and IEC 60601-1-2 have demonstrated that this difference does not affect the safety and effectiveness of the subject device.
-
Although the expected service life differs between the subject device and the predicate device, the lifetime study activity has demonstrated that this difference does not affect the safety and effectiveness of the subject device.
-
Although the electrode differs between the subject device and the predicate device, the safety and performance tests according to IEC 60601-1, IEC 60601-2-10, bench testing standards, and ISO 10993 Series have demonstrated that this difference does not affect the safety and effectiveness of the subject device.
-
Although the features of the mobile application and wireless communication differ between subject device and the predicate device, the EMC test, the performance test under wireless communication, and the cyber security risk management activity have demonstrated that this difference does not affect the safety and effectiveness of the subject device.
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Image /page/13/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 neural connections. Below the symbol, the company name "Nu Eyne" is written in a modern font, with "Nu" in a darker blue and "Eyne" in a lighter shade. Underneath the name, the tagline "A MEDICAL R&D COMPANY" is written in smaller, capitalized letters.
8. NON-CLINICAL DATA
8.1 Safety Test
- Biocompatibility
The biocompatibility tests were performed to protect patients from undue risks arising from biological hazards associated with the materials of manufacture and the final device. These tests were conducted in accordance with the following standards and FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
| No. | Test Items | Standards |
|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5:2009 |
| 2 | Sensitization | ISO 10993-10:2010 |
| 3 | Intracutaneous Reactivity Test | ISO 10993-10:2010 |
2) Electrical Safety and EMC
The electrical safety tests were performed to protect patients from undue risks arising from any hazards associated with the final device. These tests were conducted in accordance with the following standards.
| No. | Test Items | Standards |
|---|---|---|
| 1 | General requirement for basic safety and | |
| essential performance | - IEC 60601-1:2005/A2:2020 | |
| (ANSI/AAMI ES60601-1:2005+A2:2021) | ||
| 2 | General requirement for safety - | |
| Electromagnetic disturbances | - IEC 60601-1-2:2014/A1:2020 | |
| 3 | General requirement for safety - Medical | |
| electrical equipment used in the home | ||
| healthcare environment | - IEC 60601-1-11:2015/A1:2020 and |
- FDA Guidance ("Design Considerations for
Devices Intended for Home Use") |
| 4 | Particular requirement for safety - Nerve
and muscle stimulators | - IEC 60601-2-10:2012/A1:2016 |
8.2 Performance Test
The following tests were performed to assess the effectiveness of the device's performance. These tests were conducted in accordance with the following standards.
| No. | Test Items | Standards |
|---|---|---|
| 1 | Performance Test | - Manufacturer's own standards |
| 2 | wireless communication test | - Manufacturer's own standards |
| 3 | Lifetime study | - Manufacturer's own standards |
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Image /page/14/Picture/0 description: The image shows the logo for Nu Eyne, a medical R&D company. The logo features a stylized graphic of interconnected nodes in blue, resembling a network or molecular structure. Below the graphic, the company name "Nu Eyne" is written, with "Nu" in a darker blue and "Eyne" in a lighter blue. Underneath the name, the tagline "A MEDICAL R&D COMPANY" is written in smaller, uppercase letters.
8.3 Software
The following test was performed to assess the effectiveness of the device's software. The test was performed in accordance with the following standards.
| No. | Test Items | Standards |
|---|---|---|
| 1 | General requirement for safety - | |
| Programmable electrical medical systems | ||
| (PEMS) | - IEC 62304:2006/A1:2015 |
- FDA Guidance ("Content of Premarket
Submissions for Device Software Functions") |
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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 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 connected nodes, also in the lighter blue color. Below the name, in smaller font, is the text "A MEDICAL R&D COMPANY".
9. CLINICAL TESTING
No clinical testing was performed on the device.
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Image /page/16/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 and lines, resembling a network or molecular structure. Below the graphic, the company name "Nu Eyne" is written, with "Nu" in a darker blue and "Eyne" in a lighter blue. Underneath the name, the text "A MEDICAL R&D COMPANY" is written in a smaller font size.
10. CONCLUSION
When comparing substantial equivalence between the subject device and the predicate device, similarities exist in various aspects, including general information, technical details, and material details. Although some differences exist, the safety and performance test reports support the safety and effectiveness of the subject device. Therefore, we conclude that the subject device is substantially equivalent to the predicate device.