(67 days)
Not Found
No
The description focuses on the device's function as a TENS device and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated for the prophylactic treatment of episodic migraine, which is a medical condition, making it a therapeutic device.
No
The device is indicated for the prophylactic treatment of episodic migraine, and its description as a transcutaneous electrical nerve stimulator (TENS) also points to a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a transcutaneous electrical nerve stimulator (TENS) that is applied to the forehead using a self-adhesive electrode, indicating it is a hardware device that delivers electrical stimulation.
Based on the provided information, the Allive device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "prophylactic treatment of episodic migraine." This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as a "transcutaneous electrical nerve stimulator (TENS)" that stimulates nerves. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis, which are key characteristics of IVDs.
Therefore, the Allive device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Allive is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
Product codes (comma separated list FDA assigned to the subject device)
PCC
Device Description
The Allive 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 (Allive) is not applied with clause b.6) of 21CFR882.5891.
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. 1, Items: Clinical Evaluation, Standards: MEDDEV 2.7.1. rev.4
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2019
Nu Eyne Co., Ltd % Dongha Lee Regulatory Affairs Consultant KMC, Inc. Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul, 08375 Kr
Re: K192773
Trade/Device Name: Allive Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous Electrical Nerve Stimulator To Treat Headache Regulatory Class: Class II Product Code: PCC, Dated: September 26, 2019 Received: September 30, 2019
Dear Dongha 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,
Timothy Marjenin 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
2
Indications for Use
510(k) Number (if known) K192773
Device Name
ALLIVE (MODEL: ALLIVE01, AD-01)
Indications for Use (Describe)
The Allive is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Nu Eyne. The logo features a stylized eye with the letters "NE" inside the pupil. Below the eye, the words "Nu Eyne" are written in a sans-serif font. Underneath the company name is the tagline "Advanced Vision Care, New Life."
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: SEPTEMBER 26, 2019
1. INFORMATION
1.1 Submitter Information
- 트 Submitter Name: Nu Eyne Co., Ltd.
- . Address
- : #403, Seoul Biohub, 117-3 Hoegi-ro, Dongdaemun-gu, Seoul, 02455, Korea
- . . Telephone Number: +82-2-6953-8120 Fax: +82-303-347-0017
- I Email: dongseong.lee@nueyne.com
1.2 Contact Person
- . Name: DongHa Lee (Consultant / KMC, Inc.)
- . Address: Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu, Seoul, 08375, Korea
- Telephone Number: +82-70-8965-5554 ■ Fax: +82-2-2672-0579
- . E-mail: dhlee@kmcerti.com
2. DEVICE INFORMATION
- 2.1 Trade Name / Proprietary Name: ALLIVE (Model: ALLIVE01, AL-2HP)
- 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
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Image /page/4/Picture/0 description: The image shows the logo for Nu Eyne. The logo features a stylized eye with a blue iris and a white pupil. Inside the pupil is a stylized "N" and "E". Below the eye is the text "Nu Eyne" in a sans-serif font. Below that is the text "RESTORING SIGHT WITH LIGHT THERAPY" in a smaller font.
3. PREDICATE DEVICE
| Predicate Device | |
|---|---|
| Manufacturer | CEFALY Technology |
| Device Name (Trade Name) | CEFALY® |
| 510(k) Number | K160237 |
4. SUBJECT DEVICE DESCRIPTION
The Allive 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 Allive is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
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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 | Allive | CEFALY® | Different | |
| K Number | None | K160237 | 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 Allive is indicated for the | |||
| prophylactic treatment of episodic | ||||
| migraine in patients 18 years of | ||||
| age or older. | The Cefaly® device is indicated for | |||
| the prophylactic treatment of | ||||
| episodic migraine in patients 18 | ||||
| years of age or older. | Same | |||
| Picture | Image: Allive device | Image: Cefaly device | 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 | 1 fixed program | 1 fixed program | Same | |
| 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 | |
| Device | Weight | 110.2g | 12g | Different |
| Dimensions | 160mm x 66.5mm x 55mm | 55mm x 35mm x 15mm | Different | |
| Expected Service Life | 5 years | 7 years | ||
| IP Classification | IP22 | IP22 | ||
| Electrical Protection | Type BF | Type BF | ||
| Battery Type | Lithium ion Battery | Lithium ion Battery | Same | |
| Battery | Expected Service Life | 7 years (300Cycles of complete | ||
| discharge) | 7 years (300Cylces of complete | |||
| discharge) | Same | |||
| Maximum input voltage | ||||
| (USB connector) | 5.25 Vdc | 5.25 Vdc | ||
| Dimensions | 94mm (W) x 30mm (H) | 94mm (W) x 30mm (H) | Same | |
| Electrode | 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 Range | 60Hz fixed | 60Hz fixed | Same | |
| Net charge (µC) per pulse | 0 | 0 | Same | |
| Duration of the primary (depolarizing) phase | ||||
| (µS) | 250 | 250 | Same | |
| 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 | |||
| Phase rise time | 2 µS | 2 µS | Same | |
| Phase decay time | 2 µS | 2 µS | Same | |
| Maximum Phase Charge (µS) at 500 ohms | 4 | 4 | Same | |
| Modulation option | Amplitude | 0 to 16 mA Fixed | 0 to 16 mA Fixed | Same |
| Frequency | 60Hz fixed | 60Hz Fixed | Same | |
| Duration | 250 µS | 250 µS | Same | |
| Ramp Modulation | Ramp up | 14min | 14min. | Same |
| Ramp down | 45s | 45s | Same | |
| Steady time | 6min | 6min | Same | |
| Session Duration | 20min 45s | 20min 45s. | Same | |
| 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 | Uv curable dielectric ink | x | Different | |
| Central pin | N/A | N/A | Same | |
| Metallic parts for magnetic attraction | Tinplate | Tinplate | Same |
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Image /page/6/Picture/0 description: The image shows a logo for Nu Eyne. The logo features a stylized eye with a blue outline and a white fill. Inside the eye is the letter "N" in a stylized font. Below the eye is the text "NU Eyne" in a sans-serif font, with the word "NU" in a larger font size than "Eyne".
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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/11/Picture/0 description: The image shows the logo for Nu Eyne Advanced Spine and Joint Labs. The logo features a stylized eye with the letters "NE" inside the pupil. The text "Nu Eyne" is written below the eye, and the words "Advanced Spine and Joint Labs" are written in a smaller font below "Nu Eyne."
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 | Manufacturer's SOP |
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 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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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 (Allive) 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. | Items | Standards |
|---|---|---|
| 1 | Clinical Evaluation | • MEDDEV 2.7.1. rev.4 |
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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.