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.

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.

AI/ML Overview

This document is a 510(k) submission for a medical device called the "MaxxiGold Electrode," a type of cutaneous electrode used for recording physiological signals (e.g., EEG, biofeedback, sleep studies, evoked potentials).

A 510(k) submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy from scratch through clinical trials. Therefore, the information provided focuses on the comparison to predicate devices and adherence to manufacturing standards, rather than extensive clinical study data as might be found for novel devices or PMAs.

Based on the provided text, here's an analysis of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics with specific thresholds that the device must meet, followed by a report of the device's performance against those thresholds. Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices based on Intended Use and Technological Characteristics.

The implicit "acceptance criteria" for a 510(k) in this context are:

Identical or highly similar Indications for Use.
Highly similar technological characteristics, or if different, that the differences do not raise new questions of safety and effectiveness.

Implicit Acceptance Criteria (for 510(k) Substantial Equivalence)

Category	Acceptance Criteria	Reported Device Performance (MaxxiGold Electrode)
Indications for Use	The device's indications for use must be substantially equivalent to, or the same as, a predicate device, specifically: "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 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." (Identical to predicates K022197 and K071118)
Technological Characteristics	The device's fundamental technological characteristics (design, materials, specifications) should be the same or highly similar to a predicate device, such that any differences do not raise new questions of safety or effectiveness. Key aspects include:Application: Cutaneous ElectrodeContact design: Metallic Disk PlateStructure: Metallic Disk Plate connected to a lead wire and terminated in a DIN touch proof connectorContact Disk Material: Gold platedWire Material: Insulated Teflon wireWire Colors: MulticolorJoint material: Heat shrink tubeConnector: Monopolar DIN 42-802 touch proofPackage: Plastic bag	The MaxxiGold Electrode aligns with all listed technological characteristics of the predicate devices (K022197 and K071118). The table explicitly shows identical specifications across all compared parameters (Application, Contact design, Structure, Contact Disk Material, Wire Material, Wire Colors, Joint material, Connector, Package). The conclusion states the comparison "shows that MaxxiGold Electrode was developed to be substantial equivalent to the predicates, not raising any safety or effectiveness concerns."
Safety and Effectiveness	While quantitative performance metrics are not given, the implicit acceptance is that the device, due to its substantial equivalence to legally marketed predicates and compliance with relevant quality standards, is considered safe and effective for its intended use without raising new questions in these areas.	The manufacturer states: "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'." The submission concludes "not raising any safety or effectiveness concerns." This suggests the demonstration of substantial equivalence is the evidence for safety and effectiveness in the context of a 510(k).

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document explicitly states: "No clinical trial was performed." This indicates that there was no "test set" in the sense of patient data collected for a performance study. The data provenance is therefore not applicable as no clinical data was generated for this 510(k) submission. The basis for the submission is a comparison of design and specifications to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable, as no clinical trial or test set requiring expert ground truthing was performed. The "ground truth" for a 510(k) is typically the established safety and effectiveness of the identified predicate device(s).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no clinical trial or test set requiring adjudication was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a passive electrode, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a passive electrode, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this 510(k) submission, the "ground truth" is the legally marketed status and established safety and effectiveness of the predicate devices. The submission argues that because the new device is fundamentally the same as these predicates in terms of intended use and technological characteristics, it can also be considered safe and effective without requiring new clinical data.

8. The sample size for the training set

Not applicable, as no algorithm or machine learning model was developed or trained. This is a hardware electrode device.

9. How the ground truth for the training set was established

Not applicable, as no algorithm or machine learning model was developed or trained.

Summary

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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

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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)

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 forElectroencephalography	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
NeurovirtualMaxxiGold Electrode	The Electrode Store, Inc.Surface Electrode forElectroencephalography	Ives EEG Solutions, IncEEG Surface Electrode System
The MaxxiGold Electrode isintended for non-invasive use asrecording electrodes in studiesof physiological signals. Thesedevices are indicated for usewith adult or pediatric patientsduring electroencephalography,including biofeedback, sleepstudies and evoked potentialrecordings.	The Surface Electrode forElectroencephalography isintended for non-invasive use asrecording electrodes in studiesof physiological signals. Thesedevices are indicated for usewith adult or pediatric patientsduring electroencephalography,including biofeedback, sleepstudies and evoked potentialrecordings.	The EEG Surface ElectrodeSystem is intended for non-invasive use as recordingelectrodes in studies ofphysiological signals. Thesedevices are indicated for usewith adult or pediatric patientsduring electroencephalography,including biofeedback, sleepstudies and evoked potentialrecordings.

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	NeurovirtualMaxxiGold Electrode	The Electrode Store, Inc.Surface Electrode forElectroencephalography	Ives EEG Solutions, IncEEG 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 connectedto a lead wire and terminatein a DIN touch proofconnector.	Metallic Disk Plateconnected to a lead wireand terminate in a DINtouch proof connector.	Metallic Disk Plateconnected to a lead wireand terminate in a DINtouch proof connector.
Contact DiskMaterial	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 42-802touch proof	Monopolar DIN 42-802touch proof	Monopolar DIN 42-802touch 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.

Regulation Number and Section

§ 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).