(116 days)
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No
The document describes a passive electrode for recording physiological signals and does not mention any computational or analytical capabilities that would involve AI or ML.
No.
This device is described as electrodes for recording physiological signals in studies (e.g., EEG, sleep studies), not for treating a condition or disease.
Yes
This device is a recording electrode used for electroencephalography, which is a diagnostic procedure to identify physiological signals related to brain activity.
No
The device description explicitly states it is an "electrode" and describes physical characteristics like length sizes and packaging, indicating it is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "non-invasive use as recording electrodes in studies of physiological signals." This involves measuring electrical activity from the body (like brain waves in EEG), not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces its function as a recording electrode for physiological signals.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This electrode does not fit that description.
N/A
Intended Use / Indications for Use
The MaxxiGold Electrode is intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
MAXXI GOLD Electrode is intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.
The product is offered in 3 different lenath sizes, 48", 60" or 96". The product is offered in package of 5 or 10 units, with multicolor wires.
The electrode is compatible with any recording device with the DIN 42-802 receptacle which is the gold standard for EEG and EMG recording machines.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
adult or pediatric patients
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical trial was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 11, 2017
Neurovirtual USA, Inc. Eduardo Faria CEO 2315 NW 107th Ave Suite #1M27 Doral, Florida 33172
Re: K163547
Trade/Device Name: MaxxiGold Electrode 48", MaxxiGold Electrode 60", MaxxiGold Electrode 96" Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: April 4, 2017 Received: April 7, 2017
Dear Mr. Faria:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Hoffmann -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163547
Device Name
MaxxiGold Electrode 48", MaxxiGold Electrode 60", MaxxiGold Electrode 96"
Indications for Use (Describe)
The MaxxiGold Electrode is intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.
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/3/Picture/0 description: The image shows the logo for Neurovirtual. The logo consists of a stylized waveform graphic in shades of orange, followed by the word "NEUROVIRTUAL" in a bold, dark blue font. The "O" in "NEUROVIRTUAL" is colored orange, matching the waveform graphic.
Neurovirtual USA Inc. 2315 NW 107th Ave 1M27 Doral, FL 33172 - USA Phone: (786) 693-8200 – Fax (305) 393-8429
Section 5 510(k) SUMMARY
A) Submitter's Name: Neurovirtual USA, Inc.
Owner / Operator Registration Number: 9091724 Manufacture Registration Number: 3006136239
B) Address: 2315 NW 107th Ave - Suite 1M27 Doral, FL - 33172
- C) Phone and Fax Numbers Phone: (786) 693-8200 Fax: (305) 393-8429
- D) Contact Person: Eduardo J. Faria
E) Preparation Date: April 4, 2017
F) Classification Name: Common / Usual Name: Cutaneous Electrode Proprietary Name: MaxxiGold Electrode Product Code: GXY Class: Class II Requlation: 21 CFR 882.1320
- G) Device Description
MAXXI GOLD Electrode is intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.
The product is offered in 3 different lenath sizes, 48", 60" or 96". The product is offered in package of 5 or 10 units, with multicolor wires.
The electrode is compatible with any recording device with the DIN 42-802 receptacle which is the gold standard for EEG and EMG recording machines. H) Substantial Equivalence:
The MaxxiGold Electrode is equivalent with the following products:
510(k) Number | Model | Company |
---|---|---|
KO22197 | Surface Electrode for | |
Electroencephalography | The Electrode Store, Inc. | |
K071118 | EEG Surface Electrode System | Ives EEG Solutions, Inc |
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Image /page/4/Picture/0 description: The image shows the logo for Neurovirtual. The logo consists of a stylized waveform graphic in shades of orange, followed by the word "NEUROVIRTUAL" in blue. The "O" in Neurovirtual is replaced with a solid orange circle. The logo is simple and modern, and the colors are bright and eye-catching.
Neurovirtual USA Inc. 2315 NW 107th Ave 1M27 Doral, FL 33172 - USA Phone: (786) 693-8200 – Fax (305) 393-8429
1. Intentions for Use:
The MaxxiGold Electrode is a cutaneous electrode device intended for medical purposes, such as to acquire biological signals and conduct this signal to a recoding machine.
Intention of Use Comparison | ||
---|---|---|
Neurovirtual | ||
MaxxiGold Electrode | The Electrode Store, Inc. | |
Surface Electrode for | ||
Electroencephalography | Ives EEG Solutions, Inc | |
EEG Surface Electrode System | ||
The MaxxiGold Electrode is | ||
intended for non-invasive use as | ||
recording electrodes in studies | ||
of physiological signals. These | ||
devices are indicated for use | ||
with adult or pediatric patients | ||
during electroencephalography, | ||
including biofeedback, sleep | ||
studies and evoked potential | ||
recordings. | The Surface Electrode for | |
Electroencephalography is | ||
intended for non-invasive use as | ||
recording electrodes in studies | ||
of physiological signals. These | ||
devices are indicated for use | ||
with adult or pediatric patients | ||
during electroencephalography, | ||
including biofeedback, sleep | ||
studies and evoked potential | ||
recordings. | The EEG Surface Electrode | |
System is intended for non- | ||
invasive use as recording | ||
electrodes in studies of | ||
physiological signals. These | ||
devices are indicated for use | ||
with adult or pediatric patients | ||
during electroencephalography, | ||
including biofeedback, sleep | ||
studies and evoked potential | ||
recordings. |
2. Technological Characteristics Comparison:
The predicate devices used to establish substantial equivalence for the MaxxiGold Electrode are outlined below. - This section of this submission will provide a comparison of design, materials, and technical specifications of the MaxxiGold Electrode to each of the predicate devices stratified by functional modality.
Specifications Comparison | |||
---|---|---|---|
Device | Neurovirtual | ||
MaxxiGold Electrode | The Electrode Store, Inc. | ||
Surface Electrode for | |||
Electroencephalography | Ives EEG Solutions, Inc | ||
EEG Surface Electrode System | |||
510(k) Number | K163547 | KO22197 | K071118 |
Classification | GXY | GXY | GXY |
Application | Electrode cutaneous | Electrode cutaneous | Electrode cutaneous |
Contact design | Metallic Disk Plate | Metallic Disk Plate | Metallic Disk Plate |
Structure | Metallic Disk Plate connected | ||
to a lead wire and terminate | |||
in a DIN touch proof | |||
connector. | Metallic Disk Plate | ||
connected to a lead wire | |||
and terminate in a DIN | |||
touch proof connector. | Metallic Disk Plate | ||
connected to a lead wire | |||
and terminate in a DIN | |||
touch proof connector. | |||
Contact Disk | |||
Material | Gold plated | Gold plated | Gold plated |
Wire Material | Insulated Teflon wire | Insulated Teflon wire | Insulated Teflon wire |
Wire Colors | Multicolor | Multicolor | Multicolor |
Joint material | Heat shrink tube | Heat shrink tube | Heat shrink tube |
Connector | Monopolar DIN 42-802 | ||
touch proof | Monopolar DIN 42-802 | ||
touch proof | Monopolar DIN 42-802 | ||
touch proof | |||
Package | Plastic bag | Plastic bag | Plastic bag |
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Image /page/5/Picture/0 description: The image shows the logo for Neurovirtual. The logo consists of a stylized brainwave graphic in shades of orange, followed by the word "NEUROVIRTUAL" in blue. The "O" in Neurovirtual is orange. A thin, light orange line extends from the brainwave graphic to above the word "NEUROVIRTUAL".
Neurovirtual USA Inc. 2315 NW 107th Ave 1M27 Doral, FL 33172 - USA Phone: (786) 693-8200 – Fax (305) 393-8429
Conclusion: As showed above the comparison shows that MaxxiGold Electrode was developed to be substantial equivalent to the predicates, not raising any safety or effectiveness concerns.
I) Safety and Effectiveness:
In order to reach high quality and effectiveness the MaxxiGold Electrode is produced in compliance with the quality management standard ISO 13485:2003, "Medical Devices, Quality Management Systems: Requirements for Regulatory Purposes" and FDA GMP "Good Manufacturing Practices".
J) Non-clinical Testing:
No clinical trial was performed.