(57 days)
The ELEXIR 2.0 is indicated for the acute treatment of migraine (Acute mode, frequency 100 Hz) and the prophylactic treatment of episodic migraine (Prevention mode, frequency 60 Hz) in patients 18 years of age or older.
The ELEXIR 2.0 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 nerve bilaterally. It is intended to stimulate the upper branches of the trigeminal nerve in order to reduce the frequency of migraine attack. The ELEXIR 2.0 is indicated for the acute treatment of migraine and the prophylactic treatment of episodic migraine by applying 100 Hz (Acute mode) and 60 Hz (Prevention mode), low-frequency stimulation to the forehead area percutaneously to the trigeminal nerve.
The provided text is a 510(k) summary for the ELEXIR 2.0 (ALLIVE3) device, a transcranial electrical nerve stimulator for headache treatment. The document focuses on demonstrating substantial equivalence to a predicate device (ALLIVE2 (ELEXIR)) rather than presenting a study of the device's clinical performance against specific acceptance criteria.
Therefore, the requested information regarding "acceptance criteria" for device performance, a "study that proves the device meets the acceptance criteria," "sample size," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "training set details" cannot be extracted from this document, as it describes non-clinical testing for safety and electrical performance, and equivalence to a predicate, not clinical efficacy or diagnostic accuracy.
The document lists various non-clinical tests performed, such as:
- Biocompatibility tests: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), and Intracutaneous Reactivity Test (ISO 10993-10:2010).
- Electrical Safety and EMC tests: IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2014, IEC 60601-1-11:2015, and IEC 60601-2-10:2012/A1:2016.
- Performance Tests: IEC 60601-2-10:2012/A1:2016, Technical Test (IEC 60601-2-10:2012/A1:2016), Performance Test under wireless communication (Manufacturer's own standards), and Lifetime study (Manufacturer's own standards).
- Usability V&V: IEC 60601-1-6:2010/A1:2013 and IEC 62366-1:2015.
- Software Test: IEC 62304:2006/A1:2015.
These tests are primarily aimed at establishing the safety and fundamental performance characteristics to claim substantial equivalence, rather than demonstrating specific clinical effectiveness against quantified criteria. The document states, "the safety and performance test reports support the safety and effectiveness of the subject device," which is a general conclusion based on these non-clinical evaluations and comparison to the predicate.
Without a clinical study section, the specific details for clinical performance criteria and their evaluation are not available in this 510(k) summary.
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Image /page/0/Picture/0 description: The image shows 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.
Nu Eyne Co., Ltd. Dahee Kim RA Manager #608, 28, Digital-ro 30-gil, Guro-gu Seoul. 08389 Korea. South
Re: K242719
Trade/Device Name: ELEXIR 2.0 (ALLIVE3) Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous Electrical Nerve Stimulator To Treat Headache Regulatory Class: Class II Product Code: PCC Dated: September 10, 2024 Received: September 10, 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.
November 6, 2024
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).
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2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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 Rue"). 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-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 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).
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Jitendra V. Virani -S
CDR Jitendra Virani, MS, MBA Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
K242719
Device Name
ELEXIR 2.0 (ALLIVE3)
Indications for Use (Describe)
The ELEXIR 2.0 is indicated for the acute treatment of migraine (Acute mode, frequency 100 Hz) and the prophylactic treatment of episodic migraine (Prevention mode, frequency 60 Hz) 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)
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Image /page/4/Picture/1 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 nodes, positioned above the company name. The name "Nu" is written in a dark blue, blocky font, while "Eyne" is in a lighter blue, more stylized font. Below the name, the tagline "A MEDICAL R&D COMPANY" is written in smaller, dark blue letters.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
Date: October 22, 2024
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 י Fax: +82-507-0330-8120
- י Email: dahee.kim(@nueyne.com
1.2 Contact Person
- . Name: Dahee Kim (RA Manager / 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: +82-507-0330-8120
- . E-mail: dahee.kim(@nueyne.com
2. DEVICE INFORMATION
- 2.1 Trade Name / Proprietary Name: ELEXIR 2.0 / Model: ALLIVE3
- 2.2 Common Name: Transcutaneous Electrical Nerve Stimulator To Treat Headache
- 2.3 Regulation Name: Transcutaneous Electrical Nerve Stimulator To Treat Headache
- 2.4 Product Code: PCC
- 2.5 Regulation Number: 21 CFR 882.5891
- 2.6 Regulatory Class: Class II
- 2.7 Classification Panel: Neurology
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Image /page/5/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 circles above the company name. The name "Nu" is in a dark blue, while "Eyne" is in a lighter blue, and below the name is the text "A MEDICAL R&D COMPANY" in a smaller font size.
| Predicate Device | |
|---|---|
| Manufacturer | Nu Eyne Co., Ltd. |
| Device Name (Trade Name) | ALLIVE2 (ELEXIR) |
| 510(k) Number | K211380 |
| Regulation Name | Transcutaneous Electrical Nerve Stimulator To TreatHeadache |
| Regulation Number | 21 CFR 882.5891 |
| Regulatory Class | Class II |
| Product Code | PCC |
3. PREDICATE DEVICE
4. SUBJECT DEVICE DESCRIPTION
The ELEXIR 2.0 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 nerve bilaterally. It is intended to stimulate the upper branches of the trigeminal nerve in order to reduce the frequency of migraine attack. The ELEXIR 2.0 is indicated for the acute treatment of migraine and the prophylactic treatment of episodic migraine by applying 100 Hz (Acute mode) and 60 Hz (Prevention mode), low-frequency stimulation to the forehead area percutaneously to the trigeminal nerve.
5. INTENDED USE
The ELEXIR 2.0 is indicated for the acute treatment of migraine (Acute mode, frequency 100 Hz) and the prophylactic treatment of episodic migraine (Prevention mode, frequency 60 Hz) in patients 18 years of age or older.
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Image /page/6/Picture/1 description: The image contains the logo for Nu Eune, a medical R&D company. The logo features a stylized graphic above the company name. The graphic is a blue design with two dark blue circles connected by curved lines, resembling a network or molecular structure. Below the graphic, the company name "Nu Eune" is written in a modern, sans-serif font, with "Nu" in a darker blue and "Eune" in a lighter blue. Underneath the company name, the text "A MEDICAL R&D COMPANY" is written in smaller, uppercase letters.
6. SUBSTANTIAL EQUIVALENCE
| Items | Subject Device | Predicate Device | ComparisonResult | |
|---|---|---|---|---|
| Manufacturer | Nu Eyne Co., Ltd. | Nu Eyne Co., Ltd. | Same | |
| Trade/Device Name | ELEXIR 2.0Model: ALLIVE3 | ELEXIR/ALLIVE2 | Different | |
| 510(k) Number | K242719 | K211380 | Different | |
| Regulation Number | 21 CFR 882.5891 | 21 CFR 882.5891 | Same | |
| Regulation Description | Transcutaneous electrical nervestimulator to treat headache | Transcutaneous electrical nervestimulator to treat headache | Same | |
| Regulatory Class | Class II | Class II | Same | |
| Product Code | PCC | PCC | Same | |
| Definition | Used to apply an electrical currentto a patient's cranium throughelectrodes placed on the skin. | Used to apply an electrical currentto a patient's cranium throughelectrodes placed on the skin. | Same | |
| Review Panel | Neurology | Neurology | Same | |
| Physical State | Electrical stimulation unit withleads and cutaneous electrodes. | Electrical stimulation unit withleads and cutaneous electrodes. | Same | |
| Technical Method | Applies an electrical currentthrough electrodes on patient's skin. | Applies an electrical currentthrough electrodes on patient's skin. | Same | |
| Target Area | Afferent cranial nerves. | Afferent cranial nerves. | Same | |
| Intended Use | The indications for use of theELEXIR 2.0 are:- The acute treatment of migraine inpatients 18 years of age or older. | The indications for use of theELEXIR are:- The acute treatment of migraine inpatients 18 years of age or older. | Same | |
| Items | Subject Device | Predicate Device | Comparison Result | |
| - The prophylactic treatment of episodic migraine in patients 18 years of age or older. | - The prophylactic treatment of episodic migraine in patients 18 years of age or older. | Same | ||
| Power Source | 1 rechargeable Lipo 3.7 V battery | 1 rechargeable Lipo 3.7 V battery | Same | |
| Channels | 1 | 1 | Same | |
| S/W provided | 2 fixed programs:- 1 fixed program for the acute treatment of migraine (Acute mode)- 1 fixed program for prophylactic treatment of episodic migraine (Prevention mode) | 2 fixed programs:- 1 fixed program for the acute treatment of migraine attacks (Program 1)- 1 fixed program for prophylactic treatment of migraine (Program 2) | 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 | |
| Timer Setting | Yes | Yes | Same | |
| Device | Weight | 20.71 g | 20.71 g | Same |
| Dimensions | 60.00 mm x 44.00 mm x 17.60 mm | 60.00 mm x 44.00 mm x 17.60 mm | Same | |
| Expected Service Life | 8 years | 2 years | Different | |
| Battery | Battery Type | Li-ion Polymer Battery | Lithium ion Battery | Same |
| Expected Service Life | 8 years | 2 years | Different | |
| Maximum Input Voltage (USB connector) | 5.25 Vdc | 5.25 Vdc | Same | |
| Items | Subject Device | Predicate Device | Comparison Result | |
| Electrode | Electrode Type | Self-adhesive | Self-adhesive | Same |
| Dimensions | 78.00 mm (W) x 32.86 mm (H) | 90 mm (W) x 31.9 mm (H) | Different | |
| Expected Service Life | 20 times | 20 times | Same | |
| Mobile Application | Yes | No | Different | |
| Wireless Communication | Yes | No | Different | |
| Special Requirement b.3) in accordance with 21 CFR 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 | 65 | Same | |
| Maximum Output Current (mA) | 500 ohms | 16 | 16 | Same |
| 2,000 ohms | 16 | 16 | Same | |
| 10,000 ohms | 6.5 | 6.5 | Same | |
| Pulse Duration (µS) | 505 | 505 | Same | |
| Duration of the Primary (depolarizing) Phase (µS) | 250 | 250 | Same | |
| Standby Duration between the Two Phases (µS) | 5 | 5 | Same | |
| Net Charge (µC) per Pulse | 0 | 0 | Same | |
| Maximum Current Density (mA/cm2, r.m.s.) | 500 ohms | 2.37 | 2.37 | Same |
| Items | Subject Device | Predicate Device | ComparisonResult | |
| Maximum Average PowerDensity (W/cm2) | 500 ohms | 0.000017 | 0.000017 | Same |
| Maximum Average Current(Average absolute value, mA) | 500 ohms | 0.48 | 0.48 | Same |
| Wave Shape | RectangularFull compensatedSymmetrical | RectangularFull compensatedSymmetrical | Same | |
| Modulation Option | Amplitude | 0 to 16 mA Fixed | 0 to 16 mA Fixed | Same |
| Frequency | Acute mode 100 Hz fixedPrevention mode 60 Hz fixed | Program 1 100 Hz fixedProgram 2 60 Hz fixed | Same | |
| Duration | 250 µs | 250 µs | Same | |
| Ramp Modulation | Ramp Up | 14 min. | 14 min. | Same |
| Ramp Down | 1 min. | 1 min. | Same | |
| Steady Time | Acute mode 45 min.Prevention mode 5 min. | Program 1 45 min.Program 2 5 min. | Same | |
| Session Duration | Acute mode 60 min.Prevention mode 20 min. | Program 1 60 min.Program 2 20 min. | ||
| Amplitude Modulation | Amplitude is adjusted by the user. | Amplitude is adjusted by the user. | ||
| Material | ||||
| Device Housing Materials | Plastic ABS | Plastic ABS | Same | |
| Electrode Gel used | Hydrogel | Hydrogel | Same |
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Image /page/7/Picture/1 description: The image shows the logo for Nu Eyne, a medical R&D company. The logo features a stylized graphic of interconnected circles in shades of blue, 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 company name, the text "A MEDICAL R&D COMPANY" is written in smaller, sans-serif font.
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Image /page/8/Picture/1 description: The image contains the logo for Nu Eyne, a medical research and development company. The logo features the company's name in two lines, with "Nu" in a dark blue font and "Eyne" in a lighter blue font. Above the name is a stylized graphic of two interconnected circles in the same light blue color, and below the name is the text "A MEDICAL R&D COMPANY" in a smaller, dark blue font.
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Image /page/9/Picture/0 description: The image contains the logo for Nu Eyne, a medical research and development company. The logo features the company name in a stylized font, with "Nu" in a darker color and "Eyne" in a lighter, complementary color. Above the name is a graphic element consisting of interconnected circles and lines, resembling a network or a stylized representation of molecules, which likely symbolizes the company's focus on medical research and innovation.
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Image /page/10/Picture/1 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 blue, resembling a network or molecular structure. Below the name, the tagline "A MEDICAL R&D COMPANY" is written in smaller, all-caps letters.
6.1 Differences between Subject Device and Predicate Device
I) Although the expected service life differs between the predicate device, the lifelime study activity has demonstrated the expected service life of the subject device, ensuring that this difference does not affectiveness of the subject device.
-
Although the dimension of the electrode differs between the predicate device, the safety and performance tests according to IEC 60601-1 and IEC 60601-2-10 have demonstrated the electrode feature of the subject device, ensuring that this safety and effectiveness of the subject device.
-
Although the features of the mobile application differ between subject device and the predicate device, the EMC test, the performance test under wireless communication and the ever activity have demonstrated the use of mobile application and wireless communication, ensuring that this difference does not affectiveness of the subject device.
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Image /page/11/Picture/1 description: The image shows the logo for NuEyene, a medical R&D company. The logo features the company name in two different fonts and colors. The word "Nu" is in a larger, bolder, dark blue font, while "Eyene" is in a lighter blue, sans-serif font. Above the name is a stylized graphic of interconnected circles, also in light blue, resembling a network or molecular structure. Below the name, in smaller letters, is the tagline "A MEDICAL R&D COMPANY".
7. NON-CLINICAL DATA
7.1 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 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/A1:2016 |
7.2 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 | Particular requirement for safety – Nerveand muscle stimulators | - IEC 60601-2-10:2012/A1:2016 |
| 2 | Technical Test | - IEC 60601-2-10:2012/A1:2016 |
| 3 | Performance Test under wirelesscommunication | - Manufacturer's own standards |
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Image /page/12/Picture/1 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 with two dark blue circles, resembling a network or molecular structure. Below the graphic, the company name "Nu Eyne" is displayed in a sans-serif font, with "Nu" in a darker shade than "Eyne". Underneath the company name, the text "A MEDICAL R&D COMPANY" is written in smaller, uppercase letters.
| No. | Test Items | Standards |
|---|---|---|
| 4 | Lifetime study | - Manufacturer's own standards |
7.3 Usability V&V
The following test was performed to assess the effectiveness of the device's usability. The test was performed in accordance with the following standards.
| No. | Test Items | Standards |
|---|---|---|
| 1 | General requirement for safety –Usability | - IEC 60601-1-6:2010/A1:2013- IEC 62366-1:2015 and- FDA Guidance (“Applying Human Factors andUsability Engineering to Medical Devices”) |
7.4 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 PremarketSubmissions for Device Software Functions") |
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Image /page/13/Picture/1 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 molecular structure. 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 tagline "A MEDICAL R&D COMPANY" is printed in smaller, uppercase letters.
8. 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.
§ 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.