(87 days)
Not Found
No
The document describes a TENS device for migraine treatment and prophylaxis. There are no mentions of AI, ML, or related concepts, and the performance evaluation relies on clinical data from a predicate device, not on training or testing of an algorithm.
Yes
The device is used for the "acute treatment of migraine" and "prophylactic treatment of episodic migraine," indicating a therapeutic purpose to alleviate or prevent a medical condition.
No
The device is described as a transcutaneous electrical nerve stimulator (TENS) intended for the treatment of migraine, not for diagnosis.
No
The device description explicitly states it is a "transcutaneous electrical nerve stimulator (TENS)" and is "applied to the forehead using a self-adhesive electrode." This indicates a physical hardware component is essential to the device's function, not just software.
No, 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.
- ELEXIR Function: The ELEXIR device is a transcutaneous electrical nerve stimulator (TENS). It works by applying electrical stimulation to the forehead to treat migraines. It does not analyze any samples from the body.
- Intended Use: The intended use is for the acute and prophylactic treatment of migraine, which is a therapeutic application, not a diagnostic one.
- Device Description: The description clearly states it's a TENS device applied to the skin for electrical stimulation.
Therefore, based on the provided information, the ELEXIR device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ELEXIR is indicated for the acute treatment of migraine (program 1) and the prophylactic treatment of episodic migraine (Program 2) in patients 18 years of age or older.
Product codes
PCC
Device Description
The ELEXIR device is a transcutaneous electrical nerve stimulator (TENS) that is applied to the forehead using a self-adhesive electrode positioned over the upper branches of the trigeminal verve bilaterally. It is intended to stimulate the upper branches of the trigeminal verve in order to reduce the frequency of migraine attack.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead (over the upper branches of the trigeminal verve bilaterally)
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Not Found
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)
Although clinical performance data are required to demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population on the special control according to clause b.6) of 21CFR882.5981, we consider that the subject device (ELEXIR) is not applied with clause b.6) of 21CFR882.5981.
Although there are not the clinical performance data of the subject device, we prepare the clinical evaluation report by using the collected clinical data of the predicate device.
In this evaluation report, the subject device is safe and effective as a treatment for headache in the indicated patient population.
The clinical evaluation was performed in accordance with following standards.
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.
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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.
July 30, 2021
Nu Eyne Co., Ltd. Dong Lee Manager #608, 28, Digital-ro 30-gil, Guro-gu Seoul, 08389 Korea. South
Re: K211380
Trade/Device Name: Elexir Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous electrical nerve stimulator to treat headache Regulatory Class: Class II Product Code: PCC Dated: April 28, 2021 Received: May 4, 2021
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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,
Patrick Antkowiak Assistant Director (Acting) 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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Indications for Use | |
510 K211380
Device Name ELEXIR (MODEL: ALLIVE2)
Indications for Use (Describe)
THE ELEXIR is indicated for the acute treatment of migraine (program 1) and the prophylactic treatment of episodic migraine (Program 2) 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)
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."
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6744
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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 network of blue shapes resembling molecules or connections. Above the company name are two dark blue circles. The company name, "Nu Eyne," is written in a modern font, with "Nu" in a darker shade of blue and "Eyne" in a lighter shade. Below the name, the tagline "A MEDICAL R&D COMPANY" is written in smaller, uppercase 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: APRIL, 28, 2021
1. INFORMATION
1.1 Submitter Information
- Submitter Name: Nu Eyne Co., Ltd.
- . 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
- 트 Email: dongdeong.lee@nueyne.com
1.2 Contact Person
- . Name: Dong Seong Lee (Manager / Nu Eyne Co.,Ltd.)
- Address: #608, 28, Digital-ro 30-gil, Guro-gu, Seoul, 08389, Republic of Korea
Fax: +82-303-3447-0017
- Telephone Number: +82-2-6953-8120 ■ .
- I E-mail: dongseong.lee@nueyne.com
2. DEVICE INFORMATION
- 2.1 Trade Name / Proprietary Name: ELEXIR (Model: ALLIVE2)
- 2.2 Common Name: Transcutaneous electrical nerve stimulator to treat headache
- 2.3 Classification Name: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
- 2.4 Product Code: PCC
- 2.5 Classification Regulation: 21CFR 882.5891
- 2.6 Device Class: Class II (Special Control)
- 2.7 Classification Panel: Neurology
3. PREDICATE DEVICE
| Predicate Device | |
|---|---|
| Manufacturer | CEFALY Technology |
| Device Name (Trade Name) | CEFALY® Dual |
| 510(k) Number | K173006 |
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Image /page/4/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 above the company name. The name "Nu" is in a darker blue, while "Eyne" is in a lighter blue, creating a visual distinction. Below the name, the words "A MEDICAL R&D COMPANY" are written in smaller, gray font.
4. SUBJECT DEVICE DESCRIPTION
The ELEXIR device is a transcutaneous electrical nerve stimulator (TENS) that is applied to the forehead using a self-adhesive electrode positioned over the upper branches of the trigeminal verve bilaterally. It is intended to stimulate the upper branches of the trigeminal verve in order to reduce the frequency of migraine attack.
5. INTENDED USE
The ELEXIR is indicated for the acute treatment of migraine (program 1) and the prophylactic treatment of episodic migraine (program 2) in patients 18 years of age or older.
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Image /page/5/Picture/0 description: The image contains the logo for NuEyne, a medical R&D company. The logo features a stylized, interconnected blue design resembling a network or neural connections. Below the logo, the company name "NuEyne" is written in a dark blue, sans-serif font, with the "E" stylized to resemble an eye. Underneath the company name, the text "A MEDICAL R&D COMPANY" is written in a smaller, sans-serif font.
6. SUBSTANTIAL EQUIVALENCE
| Items | Subject Device | Predicate Device | Comparison Result | |
|---|---|---|---|---|
| Manufacturer | Nu Eyne Co., Ltd. | CEFALY Technology | Different | |
| Device | Stimulator, Nerve, Electrical, | |||
| Transcutaneous, For Migraine | Stimulator, Nerve, Electrical, | |||
| Transcutaneous, For Migraine | Same | |||
| Trade/Device Name | ELEXIR/ALLIVE2 | CEFALY® Dual | Different | |
| K Number | None | K173006 | Different | |
| Regulation Number | 21CFR 882.5891 | 21CFR 882.5891 | Same | |
| Regulation Description | Transcutaneous electrical nerve | |||
| stimulator to treat headache | Transcutaneous electrical nerve | |||
| stimulator to treat headache | Same | |||
| Regulatory Class | Class II | Class II | Same | |
| Product Code | PCC | PCC | Same | |
| Definition | Used to apply an electrical current | |||
| to a patient's cranium through | ||||
| electrodes placed on the skin. | Used to apply an electrical current | |||
| to a patient's cranium through | ||||
| electrodes placed on the skin. | 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 | Afferent cranial nerves. | Afferent cranial nerves. | Same | |
| Intended use | The indications for use of the | |||
| ELEXIR are: |
- The acute treatment of migraine
with or without aura in 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 are: - The acute treatment of migraine
with or without aura in 18 years of
age or older; - The prophylactic treatment of
episodic migraine in patients 18
years of age or older. | Same | |
| Picture | Image: Drawing of a person with a device on their forehead | Image: Photo of a person with a device on their forehead | Different | |
| Power Source | 1rechargeable Lipo 3.7 V battery | 1rechargeable Lipo 3.7 V battery | Same | |
| Channels | 1 | 1 | Same | |
| Computerized | Yes | Yes | Same | |
| S/W provided | 2 fixed program: - 1 fixed program for the acute
treatment of migraine attacks
(Program 1) | 2 fixed program: - 1 fixed program for the acute
treatment of migraine attacks
(Program 1) | Same | |
| | | - 1 fixed program for prophylactic - 1 fixed program for prophylactic
treatment of migraine (Program 2)
treatment of migraine (Program 2) | | |
| | Constant current | Yes | Yes | Same |
| Constant voltage | | No | No | Same |
| Max output current | | 16mA | 16mA | Same |
| Max output voltage (2kOhm) | | 32 Volts | 32 Volts | Same |
| Patient Override Control Method | | On/Off button | On/Off button | Same |
| Max Leakage Current | | None (battery operated) | None (battery operated) | Same |
| | Electrode | Self-adhesive | Self-adhesive | 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 | 20.71g | 12g | Different |
| Device | Dimensions | 60.00mm x 44.00mm x 17.60mm | 55mm x 35mm x 15mm | Different |
| | Expected Service Life | 2 years | 7 years | Different |
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Image /page/6/Picture/0 description: The image contains the logo for Nu Eyne, 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 "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/7/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 resembling molecules or connections. Below the graphic is the company name, "Nu Eyne," in a modern, sans-serif font, with the first letter in a slightly darker shade of blue. Underneath the company name, in smaller letters, is the tagline "A MEDICAL R&D COMPANY."
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Image /page/8/Picture/0 description: The image contains a logo for a medical research and development company. The logo features a stylized, interconnected blue design resembling a network or neural connections above the company name. The company name, "Nu Eyne," is written in a modern, sans-serif font, with the first letter in uppercase and the rest in lowercase. Below the company name, the text "A MEDICAL R&D COMPANY" is written in smaller, uppercase letters.
| IP Classification | IP22 | IP22 | Same | |||||
|---|---|---|---|---|---|---|---|---|
| Electrical Protection | Type BF | Type BF | Same | |||||
| Battery Type | Lithium ion Battery | Lithium ion Battery | Same | |||||
| Battery | Expected Service Life | 2 years (75Cycles of complete | ||||||
| discharge) | 7 years (300Cylces of complete | |||||||
| discharge) | Different | |||||||
| Maximum input voltage | ||||||||
| (USB connector) | 5.25 Vdc | 5.25 Vdc | Same | |||||
| Electrode | Dimensions | 90mm (W) x 31.9mm (H) | 94mm (W) x 30mm (H) | Different | ||||
| Expected Service Life | 20 times | 20 times | Same | |||||
| Special Requirement b.3) in accordance with 21CFR 882.5891 | ||||||||
| Waveform | Biphasic | Biphasic | Same | |||||
| Maximum output voltage | ||||||||
| (V) | 500 ohms | 8 | 8 | Same | ||||
| 2,000 ohms | 32 | 32 | Same | |||||
| 10,000 ohms | 65 | 60 | Same | |||||
| Maximum output current | ||||||||
| (mA) | 500 ohms | 16 | 16 | Same | ||||
| 2,000 ohms | 16 | 16 | Same | |||||
| 10,000 ohms | 6.5 | 6 | Same | |||||
| Pulse duration (µS) | 505 | 505 | Same | |||||
| Frequency | Program 1 | 100Hz fixed | Program 1 | 100Hz fixed | Same | |||
| Program 2 | 60Hz fixed | Program 2 | 60Hz fixed | |||||
| Net charge (µC) per pulse | 0 | 0 | Same | |||||
| Duration of the primary (depolarizing) phase | 250 | 250 | Same |
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Image /page/9/Picture/0 description: The image shows the logo for NuEyene, a medical R&D company. The logo features a stylized blue symbol resembling interconnected nodes, possibly representing neural connections or networks. Below the symbol, the company name "NuEyene" is written in a modern font, with the "N" in a darker blue and the rest of the name in a lighter shade. Underneath the name, the tagline "A MEDICAL R&D COMPANY" is written in smaller, uppercase letters.
| (µS) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Standby duration between the two phase (µS) | 5 | 5 | Same | |||||||
| Maximum current density | ||||||||||
| (mA/cm2, r.m.s.) | 500 ohms | |||||||||
| 2.37 | 2.37 | Same | ||||||||
| Maximum average power density | ||||||||||
| (W/cm2) | 500 ohms | |||||||||
| 0.000017 | 0.000017 | Same | ||||||||
| Maximum average current | ||||||||||
| (Average absolute value, mA) | 500 ohms | |||||||||
| 0.48 | 0.48 | Same | ||||||||
| Other Technical Item | ||||||||||
| Wave Shape | Rectangular | |||||||||
| Full compensated | ||||||||||
| Symmetrical | Rectangular | |||||||||
| Full compensated | ||||||||||
| Symmetrical | Same | |||||||||
| Method | Same charge quantity on positive | |||||||||
| and negative impulse | Same charge quantity on positive | |||||||||
| and negative impulse | Same | |||||||||
| Max phase amplitude | 16mA with a load of a 4.7 µF | |||||||||
| capacitor parallel with 2.2K ohms | ||||||||||
| resistance | 16mA with a load of a 4.7 µF | |||||||||
| capacitor parallel with 2.2K ohms | ||||||||||
| resistance | Same | |||||||||
| Phase rise time | 2 µS | 2 µS | Same | |||||||
| Phase decay time | 2 µS | 2 µS | Same | |||||||
| Interphase interval | nil | nil | Same | |||||||
| Burst mode | No | No | Same | |||||||
| Maximum Phase Charge (µS) at 500 ohms | 4 | 4 | Same | |||||||
| Amplitude | 0 to 16 mA Fixed | Same | ||||||||
| Modulation option | Frequency | |||||||||
| Program 1 100 Hz fixed Program 2 60Hz fixed | Program 1 100 Hz fixed Program 2 60Hz fixed |
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Image /page/10/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. Below the name, the text "A MEDICAL R&D COMPANY" is written in smaller, capitalized letters.
| Duration | |||||||
|---|---|---|---|---|---|---|---|
| 250 µS | 250 µS | Same | |||||
| Ramp Modulation | Ramp up | 14 min | 14 min. | Same | |||
| Ramp down | 1 min | 1 min | Same | ||||
| Steady time | Program 1 | 45 min | Program 1 | 45 min | Same | ||
| Program 2 | 5 min | Program 2 | 5 min | ||||
| Session Duration | Program 1 | 60 min | Program 1 | 60 min | Same | ||
| Program 2 | 20 min | Program 2 | 20 min. | ||||
| Amplitude modulation | Amplitude is adjusted by the user | Amplitude is adjusted by the user | Same | ||||
| Material | |||||||
| Device housing materials | Plastic ABS | Plastic ABS | Same | ||||
| Electrode top layer | Polyethylene terephthalate | Polyurethane | Different | ||||
| Electrode intermediate layer | Conductive silver carbon ink | Carbon with silver coating | Different | ||||
| Electrode bottom layer | x | x | Same | ||||
| Central pin | N/A | N/A | Same | ||||
| Metallic parts for magnetic attraction | Tinplate | Tinplate | Same |
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Image /page/11/Picture/0 description: The image shows the logo for Nu Eyne, a medical R&D company. The logo features a stylized graphic of interconnected circles in a light blue color, resembling a network or molecular structure. Below the graphic, the company name "Nu Eyne" is written in a modern font, 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 smaller, sans-serif font.
7. NON-CLINICAL DATA
7.1 Safety Test
- Biocompatibility
The biocompatibility tests were performed to protect patients from undue risks arise from biological hazards associated with materials of manufacture and final device. The tests were performed 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 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 and | |
| essential 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 - Medical | |
| electrical equipment used in the home | ||
| healthcare environment | - IEC 60601-1-11:2015 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/Amd1:2016 |
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Image /page/12/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, positioned above the company name. The text "Nu" is in a dark blue, blocky font, while "Eyne" is in a lighter blue, more stylized font. Below the company name, in smaller font, is the text "A MEDICAL R&D COMPANY".
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 - Nerve | |
| and 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 device. The test was performed in accordance with following standards.
| No. | Test Items | Standards |
|---|---|---|
| 1 | General requirement for safety – Usability | - IEC 60601-1-6:2013 |
- IEC 62366-1:2015 and
- FDA Guidance (“Applying Human Factors and
Usability Engineering to Medical Devices”) |
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 |
|---|---|---|
| 1 | General requirement for safety - | |
| Programmable electrical medical systems | ||
| (PEMS) | - IEC 62304:2006/Amd1:2015 |
- FDA Guidance ("Guidance for the Content of
Premarket Submissions for Software Contained in
Medical Devices") |
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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 the company name in two lines, with "Nu" in a darker blue and "Eyne" in a lighter blue. Above the name is a stylized graphic of interconnected circles, also in the lighter blue color. Below the name, in smaller font, is the text "A MEDICAL R&D COMPANY".
8. CLINICAL DATA
Although clinical performance data are required to demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population on the special control according to clause b.6) of 21CFR882.5981, we consider that the subject device (ELEXIR) is not applied with clause b.6) of 21CFR882.5981.
Although there are not the clinical performance data of the subject device, we prepare the clinical evaluation report by using the collected clinical data of the predicate device.
In this evaluation report, the subject device is safe and effective as a treatment for headache in the indicated patient population.
The clinical evaluation was performed in accordance with following standards.
| No. | Test Items | Standards |
|---|---|---|
| 1 | Clinical Evaluation | - MEDDEV 2.7.1. rev.4 |
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Image /page/14/Picture/0 description: The image contains the logo for "Nu Eyne, A Medical R&D Company". The logo features a stylized blue graphic above the company name. The graphic appears to be a network of connected nodes, possibly representing a biological or technological network. The text "Nu Eyne" is in a modern sans-serif font, with "Nu" in a darker shade of blue and "Eyne" in a lighter shade. Below the company name, the text "A MEDICAL R&D COMPANY" is printed in a smaller, simpler font.
9. 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.