BWMini is an electroencephalograph, which is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

BWMini is multi-channel (up to 32 channels) system designed for Electroencephalograph (EEG), Polysomnography (PSG) and Home Sleep Testing (HST) recording application, in research, home sleep studies, ambulatory and clinical environments.

The BWMini does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

Device Description

BWMini is an electroencephalograph, which is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

The BWMini does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

The device is software based (Windows), uses a memory card for data storage, has a hard plastic external material, and is powered by batteries. It has up to 32 channels, 16 Bits AD Resolution, 50-60Hz Notch Filter, 1-500uv/mm Configurable Sensitivity Selection, 0.16 - 15Hz Configurable Low Frequency filters, 15 - 100 Hz Configurable High Frequency filters, and 2 DC Inputs. The user interface is IBM PC.

AI/ML Overview

The Neurovirtual BWMini EEG, HST, and PSG device is not an AI/ML powered device, therefore the typical acceptance criteria and study designs for such devices do not apply here. This document, K131335, is a 510(k) premarket notification for an electroencephalograph (EEG) device, which is a traditional medical device for measuring and recording electrical activity of the brain. The "acceptance criteria" and "study" described herein relate to the device's technical specifications and compliance with established medical device standards and performance testing, rather than AI model performance metrics like sensitivity, specificity, or AUC.

Here's a breakdown of the information provided, framed within the context of a traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For traditional medical devices like the BWMini, "acceptance criteria" refer to the specified technical performance parameters the device must meet, often derived from industry standards or clinical guidelines. "Reported device performance" then details how the device performed against these criteria in non-clinical testing.

Feature / Criterion	Acceptance Criteria (Target/Standard)	Reported Device Performance (BWMini)
Frequency Response	0.5Hz to 100Hz (acceptable frequency range for EEG based on "principal EEG authors").	Tested at: 0.5Hz, 1Hz, 2Hz, 3Hz, 4Hz, 5Hz, 10Hz, 15Hz, 20Hz, 25Hz, 30Hz, 40Hz, 50Hz, 70Hz, 80Hz, 90Hz, and 100Hz.
Accuracy of Frequency Response	Deviation of +/- 5% in the injected value at each tested frequency compared to a known and calibrated external source.	The conclusion states: "The BWMini meets the performance standards for perform EEG and PSG exams." This implies the +/- 5% deviation was met across all tested frequencies.
AD Resolution	Minimum resolution requirement for recording EEG according to ACNS Guideline.	16 Bits (exceeds the 12 Bits of one predicate and likely the ACNS guideline). (From Comparison Table)
Sensitivity Selection	Requirement for recording EEG according to ACNS Guideline.	1-500uv/mm Configurable (exceeds the range of predicate devices and likely the ACNS guideline). (From Comparison Table)
Low Frequency Filters	Requirement for recording EEG according to ACNS Guideline.	0.16 - 15Hz Configurable (exceeds the range of predicate devices and likely the ACNS guideline). (From Comparison Table)
Notch Filter	Standard for filtering interference.	50-60Hz (matches predicate devices). (From Comparison Table)
High Frequency Filters	Standard for filtering interference.	15 - 100 Hz Configurable (matches predicate devices). (From Comparison Table)
Compliance with Standards	IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-26, IEC 60601-1-4, EN ISO 14971, EN ISO 13485, FDA Guidance software validation version 1.1	The device is stated to be "in compliance with the applicable clauses of the following standards." (From Section I: Safety and Effectiveness)

2. Sample Size Used for the Test Set and Data Provenance

This is a non-clinical device performance test, not a clinical trial with patient data.

Sample Size for Test Set: Not applicable in the traditional sense of patient data. The "test set" here refers to the device units themselves that underwent performance testing. The document states "We test the produced units for performance..." implying testing was conducted on one or more manufactured units of the BWMini. The exact number of units or test runs is not specified but is typically part of a detailed test report (which is referenced as "ATTACHMENT 7").
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable as this is hardware/software performance testing, not data collection from patients. The testing was conducted by Neurovirtual USA, Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable for this type of device performance test. The "ground truth" for these tests comes from known, calibrated external signal sources as described in Section J: Non-clinical Testing. The acceptance criteria themselves are based on established guidelines (e.g., ACNS Guideline) and widely accepted principles from "principal EEG authors" rather than expert consensus on specific cases.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. Device performance testing against calibrated sources does not involve adjudication by multiple experts. The comparison is objective: device output vs. known input from a calibrated source, with a defined acceptable deviation.

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 an acquisition system, not an AI-powered diagnostic tool that assists human readers. It records physiological signals. There is no AI component mentioned or implied in this 510(k) submission. Therefore, no MRMC study or effect size related to AI assistance would be conducted.

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

Not applicable. The BWMini is an electroencephalograph (EEG), polysomnograph (PSG), and home sleep testing (HST) recording application. It is a hardware and software system for data acquisition. The submission explicitly states: "The BWMini does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic." This confirms it is not an algorithm that performs standalone diagnoses or interpretations.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing of the frequency response, the ground truth was data from a known and calibrated external source. This means a signal generator or similar equipment was used to inject precise, known frequencies and amplitudes into the device, and the device's recorded output was compared against these known inputs.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML device and therefore does not have a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 3, 2015

Neurovirtual USA. Inc. Eduardo Faria, CEO 2315 NW 107th Avenue Suite 1M27 Doral, FL 33172

Re: K131335

Trade/Device Name: BWMini EEG (Model PV 2310), BWMini HST (Model PV 2312), BWMini PSG (Model PV 2311) Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Codes: GWQ, OLV Dated: December 29, 2014 Received: December 31, 2014

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

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device-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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,

Felipe Aquel -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

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Indications for Use

510(k) Number (if known) K131335

Device Name BWMini (EEG, HST and PSG)

Indications for Use (Describe)

BWMini is an electroencephalograph, which is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

BWMini is multi-channel (up to 32 channels) system designed for Electroencephalograph (EEG). Polysomnography (PSG) and Home Sleep Testing (HST) recording application, in research, home sleep studies, ambulatory and clinical environments.

The BWMini does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

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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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: January 26, 2015

F) Classification Name:

Common / Usual Name: Full-Montage Standard Electroencephalograph Proprietary Name: BWMini (EEG, HST, PSG) Product Code: GWQ Additional Product Codes: OLV Classification: Class II Regulation Number: 21 CFR 882.1400

G) Substantial Equivalence:

The BWMini is equivalent with the following products:

510(k) Number	Model	Company
K042150	XLTEK Trex	EXCEL TECH. LTD.
K946094	CADWELL EASY AMBULATORYEEG	CADWELL LABORATORIES,INC.

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Technological Characteristics Comparison:

The predicate devices used to establish substantial equivalence for the BWMini are outlined below. This section of this submission will provide a comparison of design, materials, energy source, functional features and technical specifications of the BWMini to each of the predicate devices stratified by functional modality.

	NeurovirtualBWMini	CADWELLEASYAMBULATORYEEG	XLTEK Trex	Analysis ofDifferences
510(k) Number	K131335	K946094	K042150	NA
Classification	GWQ	GWQ	GWQ	NA
Indication of Use	EEG, PSG andHST	EEG, PSG andHST	EEG, PSG andHST	NA
Number ofChannels	Up to 32	Up to 32	Up to 32	NA
Data Storage	Memory Card	Memory Card	Memory Card	NA
Software Based	Windows	Windows	Windows	NA
Material (External)	Hard Plastic	Hard Plastic	Hard Plastic	NA
Power Source	Batteries	Batteries	Batteries	NA
AD Resolution	16 Bits	16 Bits	12 Bits	Our product uses the mostcurrent processors that exceedthe minimum resolutionrequirement for recording EEGaccording to the ACNS(American ClinicalNeurophysiology Society)Guideline.
Notch Filter	50-60Hz	50-60Hz	50-60Hz	NA
SensitivitySelection	1-500uv/mmConfigurable	1-100uv/mmConfigurable	1-200uv/mmConfigurable	Our product exceeds thesensitive range reguirementfor recording EEG according tothe ACNS (American ClinicalNeurophysiology Society)Guideline.
Low Frequencyfilters	0.16 - 15HzConfigurable	0.02-15 HzConfigurable	0.25 - 15HzConfigurable	Our product exceeds the LowFrequency Filters requirementfor recording EEG according tothe ACNS (American ClinicalNeurophysiology Society)Guideline.
High Frequencyfilters	15 - 100 HzConfigurable	15 - 100 HzConfigurable	15 - 100HzConfigurable	NA
Auxiliary DCInputs	2 DC Inputs	1 DC Input	4 DC Inputs	DC Channels are not arequirement by the ACNSGuideline for recording EEG.
User Interface	IBM PC	IBM PC	IBM PC	NA
Software	BWAnalysis510(k)K062533	EasyWrite andEasy Reader510(k)K932507	Excel Neuroworks510(k)K980214	This is only a CommercialName for each manufacturerSoftware

Conclusion: As showed above the comparison shows that BWMini was developed to be substantial equivalent to the predicates, not raising any safety or effectiveness concerns.

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H) Intended Use:

BWMini is an electroencephalograph, which is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

The BWMini does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

NeurovirtualBWMini	CADWELL EASYAMBULATORY EEG	XLTEK Trex
BWMini is inteded to be usedas:	Easy Ambulatory EEG is intededto be used as:	XLTEK Trex is inteded to beused as:
-Electroencephalograph(EEG)	-Electroencephalograph(EEG)	-Electroencephalograph(EEG)
-Polysomnography (PSG)	-Polysomnography (PSG)	-Polysomnography (PSG)
-Home Sleep Testing (HST)	-Home Sleep Testing (HST)	-Home Sleep Testing (HST)
BWMini can be used in research,home sleep studies, ambulatoryand clinical environments.	Easy Ambulatory EEG can beused in research, home sleepstudies, ambulatory and clinicalenvironments.	XLTEK Trex can be used inresearch, home sleep studies,ambulatory and clinicalenvironments.

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I) Safety and Effectiveness:

The BWMini is in compliance with the applicable clauses of the following standards:

IEC 60601-1:2005, "Medical Device Equipment: General Requirements for -Safety"
-IEC 60601-1-1:2009, Medical electrical equipment - Part 1: General requirements for safety - Section 1: Collateral standard: Safety requirements for medical electrical systems
-IEC 60601-1-2:2008, "Medical Device Equipment – General Requirements for Safety, Collateral Standard: Electromagnetic Compatibility, Requirements and Test"
-IEC 60601-2-26:2002, "Medical Device Equipment – Particular requirements for the safety of electroencephalographs"
-IEC 60601-1-4:2009, "Medical Device Equipment – General Requirement for Safety, Collateral Standard: Programmable Electrical Medical Systems"
-EN ISO 14971:2007, "Medical Devices: Application of Risk Management to Medical Devices"
-EN ISO 13485:2003, "Medical Devices, Quality Management Systems: Requirements for Regulatory Purposes"
-General Principles of Software Validation: FDA Guidance software validation version 1.1 (June 09, 1997)

Conclusion:

The BWMini is an EEG, PSG and HST recording device that is safe, effective and equivalent to the predicates above.

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J) Non-clinical Testing:

The principal EEG authors speak about an acceptable frequency between 0.5Hz to 100Hz.

We test the produced units for performance of the device on the following frequencies: 0.5Hz, 1Hz, 2Hz, 3Hz, 4Hz, 5Hz, 10Hz, 15Hz, 20Hz, 25Hz, 30Hz, 40Hz, 50Hz, 70Hz, 80Hz, 90Hz, and 100Hz, comparing the results with a known and calibrated external source. A deviation of +/- 5% in the injected value in each frequency is acceptable.

The complete test report as ATTACHMENT 7.

Conclusion

The BWMini meets the performance standards for perform EEG and PSG exams.

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).