The Maxxi Position Sensor is intended for use with the BWMini polysomnograph system, to acquire the body position of adult patients during sleep studies. The Sensor produces signals for five positions: supine, prone, left and right. It is intended for use in research, home sleep studies, ambulatory, and clinical environments.

Device Description

The Maxxi Position Sensor is a sensor that attaches to either around chest or abdominal belts using velcro tapes- so no additional belts or attachment systems are needed. The sensor features a fully encapsulated active element for troublefree cleaning. The Maxxi Position Sensor produces a clear and reliable signal for five positions: Upright, supine, prone, left and right. It comes with 7ft long cable for a convenient connection with the PSG device recorder.

AI/ML Overview

The provided text describes the Neurovirtual Maxxi Position Sensor, a device intended to acquire body position data during sleep studies. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test	Acceptance Criteria (Predicate Specs)	Maxxi Position Results (Reported Performance)
Sensor Dimensions	40x29x14 mm Allowance: +-10%	Measured Value: 39x31x15 mm Pass (x) Fail ( )
Cable Dimensions	Cable length: 7ft Allowance: +-5%	Measured Value: 7ft Pass (x) Fail ( )
Cable Connectivity	Not allowed false contact, or no connectivity.	Pass (x) Fail ( )
Sensor Visual Aspects	The visual aspects of the Maxxi Position must be similar/equivalent to the predicate device Ultima Body Position Sensor.	Pass (x) Fail ( )
Sensor Signal Aspect	Qualitative signal analysis must be similar in signal type, amplitude and linearity when compared with the predicate device Ultima Body Position Sensor.	Pass (x) Fail ( )
Sensor Functional Aspect	All positions signal shown in the user manual must follow the patient body position based on the sensor axis position	Pass (x) Fail ( )
Accuracy in Simulated Use	100% accuracy (implied by "100% of accuracy between them" when compared to predicates)	100% of accuracy between devices
Latency in Simulated Use	Latency differences should be negligible/acceptable (implied by 1 second difference)	Average time to detect patient body position was 1 second of latency difference

2. Sample Size and Data Provenance for Test Set

Sample Size: N=20 volunteers were used in the simulated use study.
Data Provenance: Not explicitly stated, but the company is Neurovirtual USA, Inc., located in Fort Lauderdale, Florida, implying the study was likely conducted in the USA. The study design is prospective as it involved volunteers in a "simulated use" study.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the simulated use study. The ground truth appears to be based on direct observation of the actual body position of the volunteers.

4. Adjudication Method

Not applicable, as ground truth was established by direct observation of body position, not by expert review requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed or mentioned. The primary comparison in the simulated use study was between the Maxxi Position Sensor and predicate devices, focusing on accuracy and latency of position detection.

6. Standalone Performance Study

Yes, a standalone performance study was done for the algorithm/device. The "Performance Testing" section details tests where the Maxxi Position Sensor's characteristics (dimensions, cable integrity, visual aspects, signal aspects, functional aspects) were directly verified against acceptance criteria derived from predicate device specifications. The "Performance Testing in Simulated Use" also assessed the device's functional performance in detecting body position.

7. Type of Ground Truth Used

For the "Performance Testing in Simulated Use," the ground truth was direct observation of patient body position (as the sensor's output was compared to the actual position of volunteers). For the other "Performance Tests" (Sensor Dimensions, Cable Dimensions, Cable Connectivity, Sensor Visual Aspects, Sensor Signal Aspect, Sensor Functional Aspect), the ground truth was based on physical measurements, qualitative assessment against predicate devices, and internal functional verification according to predefined specifications.

8. Sample Size for Training Set

The document is for a 510(k) premarket notification for a hardware device (sensor) and does not describe an AI/algorithm that requires a "training set" in the typical sense for machine learning. The device uses "a combination of electronic tilt switches [that] generates different types of signals depending on the sensor position" for its core function. Therefore, there is no mention of a training set as would be relevant for a machine learning model.

9. How Ground Truth for Training Set was Established

Not applicable, as there is no mention of a training set for an AI/machine learning model. The device operates based on physical principles of tilt switches.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Neurovirtual USA, Inc. Eduardo Faria CEO 3303 W Commercial Blvd. Suite #100 Fort Lauderdale, Florida 33309

Re: K191492

Trade/Device Name: Maxxi Position Sensor Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, OLV Dated: January 28, 2020 Received: February 3, 2020

Dear Eduardo 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. 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 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

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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 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).

Sincerely,

Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic 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

510(k) Number (if known) K191492

Device Name Maxxi Position Sensor

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 and yellow, followed by the word "NEUROVIRTUAL" in blue. The "O" in "NEUROVIRTUAL" is colored orange, matching the waveform graphic.

510(k) SUMMARY

A) Submitter's Name: Neurovirtual USA, Inc.

Owner / Operator Registration Number: 9091724 Manufacture Registration Number: 3006125362

B) Address: 3303 W Commercial Blvd #100 Fort Lauderdale, FL - 33309
C) Phone and Fax Numbers Phone: (786) 693-8200 Fax: (305) 393-8429
D) Contact Person: Eduardo J. Faria
E) Revision Date: March 24, 2020
F) Classification Name: Common / Usual Name: Body Position Sensor Proprietary Name: Maxxi Position Sensor Product code: GWQ, OLV Class: Class II Regulation: 21 CFR 882.1400

G) Device Description

The Maxxi Position Sensor produces a clear and reliable signal for five positions: Upright, supine, prone, left and right.

It comes with 7ft long cable for a convenient connection with the PSG device recorder.

H) Substantial Equivalence:

The Maxxi Position Sensor is equivalent with the following products:

510(k) Number	Model	Company
K131335	BWMINI	NEUROVIRTUAL USA INC.
K981969	ULTIMA BODY POSITION SENSOR	BRAEBON MEDICAL CORP.

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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, sans-serif font. The "O" in "NEUROVIRTUAL" is replaced with a solid orange circle.

1. Indications for Use:

Indications for Use Comparison
NeurovirtualMaxxi Position Sensor	BRAEBON MEDICAL CORP.Ultima Body Position Sensor	NeurovirtualBWMini
The Maxxi PositionSensor is intended foruse with the BWMinipolysomnograph system,to acquire the bodyposition of adult patientsduring sleep studies. TheSensor produces signalsfor five positions:standing/sitting, supine,prone, left and right. It isintended for use inresearch, home sleepstudies, ambulatory, andclinical environments.	The BRAEBON MEDICALCORPORATION Ultima BodyPosition Sensor™ is intended foruse during sleep disorder studiesas an indicator of body position.The sensor uses a three-voltlithium battery and plugs directlyinto either a DC amplifier ormultiplexer.The target population of theUltima Body Position Sensor is allchildren and adult patients whoare screened during sleepdisorder studies. The majority ofthe screenings occur at a sleeplaboratory although the sensorcan also be used in homestudies.The Ultima Body Position Sensoris intended for use only by or onthe order of a physician.	BWMini is an electroencephalograph,which is a device used to measure andrecord the electrical activity of thepatient's brain obtained by placing twoor more electrodes on the head.BWMini is multi-channel (up to 32channels) system designed forElectroencephalograph (EEG),Polysomnography (PSG) and HomeSleep Testing (HST) recordingapplication, in research, home sleepstudies, ambulatory and clinicalenvironments.The BWMini does not make anyjudgment of normality or abnormalityof the displayed signals or the resultsof an analysis. In no way are any ofthe functions represented as being inand of themselves diagnostic.

2. Technological Characteristics Comparison:

The predicate devices used to establish substantial equivalence for the Maxxi Position Sensor is outlined below. This section of this submission will provide a comparison of design, materials, and technical specifications of the Maxxi Position Sensor to each of the predicate devices stratified by functional modality.

Specifications Comparison
Device Brandand CommonName	NeurovirtualMaxxi PositionSensor	NeurovirtualBWMini	BRAEBONMEDICAL CORP.Ultima BodyPosition Sensor	Comments
510(k)Number	K191492	K131335	K923033	NA
Classification	GWQ, OLV	GWQ, OLV	LEL	The predicate BWMiniis classified as GWQ
Regulation #	21 CFR 882.1400	21 CFR 882.1400	21 CFR 882.5050	is classified as GWQ
ClassificationName	Electroencephalograph used forpolysomnographyor sleep studies	Electroencephalograph used forpolysomnographyor sleep studies	Device, SleepAssessment	because it is a fullpolysomnographrecording device thatincludes an internalbody position sensorwith same
				technologicalcharacteristics as thesubject device. Thisinformation may notpublicly available.
PatientPopulation	Adult patient	Adult patient	Adult patient	Identical
IndentedEnvironment	The intendedenvironments areresearch, homesleep studies,ambulatory, andclinicalenvironments. Itis intended foradult patients.	The intendedenvironments areresearch, homesleep studies,ambulatory, andclinicalenvironments. It isintended for adultpatients.	The intendedenvironments areresearch, homesleep studies,ambulatory, andclinicalenvironments. It isintended for adultpatients.	Identical
PrescriptionUse	YES	YES	YES	Identical
SensorMaterial	Plastic ABSenclosureElectroniccomponentsPrinted Circuitboard	Plastic ABSenclosureElectroniccomponentsPrinted Circuitboard	Plastic ABSenclosureElectroniccomponentsPrinted Circuitboard	Equivalent
CablesMaterial	ABS - plasticinjection	ABS - plasticinjection	ABS - wire jacket	Equivalent
Interfacewith Patient	Around theabdomen orthorax beltsusing velcrotapes	Around theabdomen or thoraxbelts using velcrotapes	Around theabdomen or thoraxbelts using velcrotapes	Identical
Type ofEquipment toBe Connectedto	Polysomnographyrecorder	NA	Polysomnographyrecorder	Identical
ConnectorType	Monopolar DIN42-802 touchproof	NA	Monopolar DIN 42-802 touch proof	Identical
Signalsoutput	Body position:upright, supine,prone, left andright0 to 1 VDCoutput	Body position:upright, supine,prone, left andright0 to 1 VDC output	Body position:upright, supine,prone, left andright0 to 1 VDC output	Identical
PositionDetectionTechnology	Combination ofelectronic tiltswitchesgeneratesdifferent types ofsignalsdepending on thesensor position.	Combination ofelectronic tiltswitches generatesdifferent types ofsignals dependingon the sensorposition.	Combination ofelectronic tiltswitches generatesdifferent types ofsignals dependingon the sensorposition.	Identical

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Image /page/5/Picture/0 description: The image shows the logo for Neurovirtual. The logo features a stylized waveform graphic in shades of orange on the left. To the right of the waveform is the company name "NEUROVIRTUAL" in blue, with the "O" in Neurovirtual being a solid orange circle.

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Image /page/6/Picture/0 description: The image shows the logo for Neurovirtual. The logo consists of a stylized waveform in shades of yellow and orange, followed by the word "NEUROVIRTUAL" in blue. The "O" in "NEUROVIRTUAL" is colored orange, matching the waveform.

Power Source	3VDC coinbattery	AA batteries	3VDC coin battery	Similar
ApplicableStandards	IEC 60601-1IEC 60601-1-2	IEC 60601-1IEC 60601-1-2	IEC 60601-1IEC 60601-1-2	Identical
Packing	Plastic bag	Cartoon box	Plastic bag	Equivalent
SensorDimensions	39x31x15 mm	NA	40x29x14 mm	Equivalent
DevicePicture	Image: Device with black strap and white wires	Image: BW device	Image: Device with black strap	Equivalent

Substantial Equivalency Discussion: The Maxxi Position and the predicate devices BWMini and Ultima Body Position Sensor are substantially equivalent in technology, function, and intended use: the devices are intended to provide body position signals for sleep disordered studies; the devices use the same method of action; the devices use equivalent material and also provide identical output signals.

I) Performance Testing Summary:

1. Electrical Safety and Effectiveness Testing

The Maxxi Position was submitted to standard IEC 60601-1 test which resulted in full compliance as reported in the test reports.

2. EMC Testing

The Maxxi Position was submitted to electromagnetic compatibility test, standard IEC 60601-1-2 which resulted in full compliance as reported in the test reports.

3. Signal Quality and Comparison Testing:

Signal integrity tests were conducted for the Maxxi Position Sensor with focus on signal to noise ratio, signal range, bandwidth and linearity and the test results compared to the signal integrity test conducted for the predicate Ultima Body Position Sensor.

4. Performance Testing:

The performance test was conducted in order to verify technological and functional performance characteristics when compared with the predicate. The summary of the results is listed below.

PerformanceTest	Description	Acceptance Criteria(Predicate Specs)	Maxxi PositionResults
SensorDimensions	Verify if the dimensions of thesensor are within the acceptablerange in accordance with theproduct specifications.	40x29x14 mmAllowance: +-10%	Measured Value:39x31x15 mmPass ( x ) Fail ( )

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Image /page/7/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 an orange circle. The logo is simple and modern, and it is likely used to represent a company or organization that is involved in neuroscience or virtual reality.

CableDimensions	Verify if the cable length is withinthe acceptable range.	Cable length: 7ftAllowance: +-5%	Measured Value: 7ftPass ( x ) Fail ( )
CableConnectivity	Using a multimeter in continuityscale, check if the internal beltwiring has connectivity.	Not allowed falsecontact, or noconnectivity.	Pass ( x ) Fail ( )
SensorVisualAspects	Verify the visual aspects of theproduct including, labeling,mechanism of action, method ofconnection, application,interaction with the user andcable specifications.	The visual aspects ofthe Maxxi Positionmust besimilar/equivalent tothe predicate deviceUltima Body PositionSensor.	Pass ( x ) Fail ( )
SensorSignalAspect	Signal integrity tests wereconducted for the Maxxi PositionSensor with focus on signal tonoise ratio, signal range,bandwidth and linearity and thetest results compared to thesignal integrity test conductedfor the predicate Ultima BodyPosition Sensor.	Qualitative signalanalysis must besimilar in signal type,amplitude andlinearity whencompared with thepredicate deviceUltima Body PositionSensor.	Pass ( x ) Fail ( )
SensorFunctionalAspect	Verify if the PSG systemidentifies the sensor's positionSupine, Prone, Left, Right andStand accordingly with therespective sensor output signals.	All positions signalshown in the usermanual must followthe patient bodyposition based on thesensor axis position	Pass ( x ) Fail ( )

5. Performance Testing in Simulated Use:

A comparative test in simulated use was performed in N=20 volunteers in a simulated use study between the subject device and predicates in order to compare the accuracy and latency to detect the patient's body position in a PSG system.

The results showed the average time to detect the patient body position was 1 second of latency difference between the devices and 100% of accuracy between them. This result demonstrated substantially equivalence between the subject device and the predicates.

Based on the substantial equivalence comparison, and nonclinical Conclusion: performance tests applied to the Maxxi Position Sensor and the predicates, we conclude that the devices have similar indications for use, technological characteristics and method of action, additionally the nonclinical performance testing demonstrate that the subject device is safe and effectively as well substantially equivalency to the predicates.

J) Clinical Testing:

No clinical trial was performed.

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).