The Maxxi Snore Sensor is a device intended to acquire snore bursts. It responds to snoring and other sounds in the audio range picked up through the skin and convert them to a small analog voltage that provides an indication of the presence of these sound/vibration bursts. This sensor is intended to be used with polysomnography devices and adult patients. Intended to be use in a sleep laboratory, clinics or hospitals.

Device Description

MAXXI SNORE SENSOR piezo electric based sensors detect sound and vibration of the snore through skin contact. The sensor is placed on the patient neck surface where it can easily detect the snoring bursts during the sleep study. The product is offered in 2 different length sizes, 3ft and 7ft. The sensor is compatible with any recording device with the DIN 42-802 receptacle which is the gold standard for PSG recording machines.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Maxxi Snore Sensor:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Parts Dimensions	Allowance: +/-10%	"The dimensions of the piezo electric unit are within the acceptable criteria as when compared to the predicate device."
Cable Length	Expected: 3 ft and 7 ft Allowance: +/-5%	"The cable length of the sensor is within the acceptable criteria as when compared to the predicate device."
Visual Conditions	All aspects must be substantially equivalent to the predicate device.	"Maxxi Snore sensor was inspected, and the result is equivalent to the predicate device."
Output Signals Frequency and Amplitude Tests	Allowance: +/-15%	"Both sensors acquired equivalent signals within the acceptable range." (meaning within +/-15% of each other, assuming the predicate device's output is the reference)

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

The provided text does not explicitly state the sample size used for the performance testing.
The data provenance is also not explicitly stated beyond comparing the Maxxi Snore Sensor to a predicate device. It is indicated as performance testing rather than a study on patient data.

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

This information is not provided. The performance testing appears to be a direct comparison of physical properties and signal output against a predicate device, rather than a clinical study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the tests (dimensions, cable length, visual inspection, signal comparison against a predicate), a formal adjudication method by experts is not described or implied.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

A MRMC comparative effectiveness study was not done. The device is described as a sensor that outputs analog voltage for polysomnography devices, not an AI-assisted diagnostic tool for interpretation by human readers.

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

A standalone performance study of an algorithm was not done. The device is hardware. The performance described is related to its physical characteristics and direct signal output, not algorithmic interpretation.

7. The Type of Ground Truth Used

The "ground truth" used for performance testing was the specifications and output of a legally marketed predicate device (S.L.P. Ltd.'s Snoring Sensor K941759). The Maxxi Snore Sensor's performance was evaluated against the predicate device to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable as the Maxxi Snore Sensor is a hardware device (piezoelectric sensor) that detects sounds/vibrations and converts them to an analog voltage. It does not involve machine learning or AI that requires a "training set."

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

This information is not applicable for the same reason as above; there is no training set for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 16, 2020

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

Re: K191095

Trade/Device Name: Maxxi Snore Sensor Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: December 27, 2019 Received: December 31, 2019

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

{1}------------------------------------------------

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 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 (QS) 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,

for Michael Ryan Division Director DHT1C: Division of ENT. Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K191095

Device Name Maxxi Snore 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 blue. The "O" in Neurovirtual is replaced with a solid orange circle. The waveform graphic is on the left side of the logo, and the text is on the right.

Section 5 510(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 USA
C) Phone and Fax Numbers Phone: (786) 693-8200 Fax: (305) 393-8429
D) Contact Person: Eduardo J. Faria
E) Preparation Date: December 27, 2019
F) Classification Name: Common / Usual Name: Breathing frequency monitor Proprietary Name: Maxxi Snore Sensor Product Code: MNR Class: Class II Regulation: 21 CFR 868.2375
G) Device Description:

The product is offered in 2 different length sizes, 3ft and 7ft.

The sensor is compatible with any recording device with the DIN 42-802 receptacle which is the gold standard for PSG recording machines.

H) Substantial Equivalence:

The Maxxi Snore Sensor is equivalent with the following products:

510(k) Number	Model	Company
K941759	SNORING SENSOR	S.L.P. Ltd.Former EPM INFORMATIONSYSTEMS, INC.

{4}------------------------------------------------

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 on the left, followed by the word "NEUROVIRTUAL" in blue. The "O" in "NEUROVIRTUAL" is replaced with a solid orange circle.

1. Indications for Use/Intentions for Use:

Intention for Use Comparison
Neurovirtual	S.L.P. Ltd.
Maxxi Snore Sensor	Snoring Sensor
The Maxxi Snore Sensor is a device intended toacquire snore bursts. It responds to snoring andother sounds in the audio range picked upthrough the skin and convert them to a smallanalog voltage that provides an indication ofthe presence of these sound/vibration bursts.This sensor is intended to be used withpolysomnography devices and adult patients.	The Snoring Sensor is a device intended toacquire snore bursts. It responds to snoring andother sounds in the audio range picked upthrough the skin and convert them to a smallanalog voltage that provides an indication ofthe presence of these sound/vibration bursts.This sensor is intended to be used withpolysomnography devices and adult patients.
Intended to be use in a sleep laboratory, clinicsor hospitals.	Intended to be use in a sleep laboratory, clinicsor hospitals.

2. Technological Characteristics Comparison:

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

Technological Characteristics Comparison
Device	NeurovirtualMaxxi Snore Sensor	S.L.P. Ltd.Snoring Sensor
510(k) Number	K191095	K941759
Classification	BZQ	BZQ
Target population	Adults	Adults
Environment	sleep laboratory, clinics or hospitals	sleep laboratory, clinics or hospitals
Principle of operation	The mechanism of snoring isvibration of anatomical structures inthe pharyngeal airway. The sensor isplaced on the side of the patient neckin order to capture the movement orvibration during the snore's events.Crystalline materials produce smallamounts of electricity when a force isapplied that changes their shape insome way. These are calledpiezoelectric materials. When thesmall amounts of vibration applied tothe Maxxi Snore crystal, a smallvoltage is produced for a PSG deviceamplify and display the signal in thesleep study.The signal output for snoring is calledsnore bursts.Based on the snore signals during the	The mechanism of snoring is vibrationof anatomical structures in thepharyngeal airway. The sensor isplaced on the side of the patient neckin order to capture the movement orvibration during the snore's events.Crystalline materials produce smallamounts of electricity when a force isapplied that changes their shape insome way. These are calledpiezoelectric materials. When thesmall amounts of vibration applied tothe Maxxi Snore crystal, a smallvoltage is produced for a PSG deviceamplify and display the signal in thesleep study.The signal output for snoring is calledsnore bursts.Based on the snore signals during the

{5}------------------------------------------------

Image /page/5/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 dark blue. The "O" in "NEUROVIRTUAL" is replaced by a solid orange circle. The waveform graphic is positioned to the left of the text, with a horizontal line extending from the waveform to the beginning of the word "NEUROVIRTUAL".

	sleep study the physician will qualify,quantify and along with the othersleep parameters determine thediagnose of the sleep disorder.	sleep study the physician will qualify,quantify and along with the othersleep parameters determine thediagnose of the sleep disorder.
Parent device	To work in conjunction with apolysomnography device.	To work in conjunction with apolysomnography device.
Mechanical application	Sensor is placed on patient's neck	Sensor is placed on patient's neck
Structure	Piezo-electric element covered byTPC plastic injection with a wire toconnect to the PSG amplifier.	Piezo-electric element covered by TPCplastic injection with a wire to connectto the PSG amplifier.
Contact Material	Thermoplastic elastomers (TPC-ETs)	Thermoplastic elastomers (TPC-ETs)
Wire Material	Insulated Teflon wire	Insulated Teflon wire
Wire Colors	White	White
Connector	DIN 42-802touch proof	DIN 42-802touch proof
Signal output	AC signal	AC signal
Signal Frequency range	0-500 HZ	0-500 HZ
Amplitude sensitivityrange	0-500uV	0-500uV
Sensor diameter	18mm	18mm
Cable length	3ft and 7ft	3ft and 7ft
Package	Plastic bag	Plastic bag
Image	Image: sensor	Image: sensor

Discussion: The Maxxi Snore and the predicate device Snoring Sensor manufactured by S.L.P Ltd., are substantially equivalent in technology, function, and intended use: both sensors are indicated to provide snoring signal for sleep disordered breathing; both devices use the same method of action; both devices use equivalent material and both devices provide equivalent output signals.

I) Applied Standards:

In order to reach high quality and effectiveness the Maxxi Snore Sensor is produced in compliance with the quality management standard ISO 13485:2003, "Medical Devices, Quality Management Systems: Requirements for Requlatory Purposes" and FDA GMP "Good Manufacturing Practices".

ISO 10993 for Cytotoxicity, Skin Sensitization and Irritation Studies

IEC 60601-1, IEC 60601-1-1

J) Performance Testing:

The test performance comparing the Maxxi Snore and the predicate device Snoring Sensor manufactured by S.L.P Ltd was performed and the summary results are show below.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Neurovirtual. The logo consists of a stylized waveform in shades of orange on the left, followed by the word "NEUROVIRTUAL" in blue. The "O" in "NEUROVIRTUAL" is replaced by a solid orange circle.

Test	Description	Criteria	Results
PartsDimensions	Verify if the dimensions of thePiezo electric unit are withinthe acceptable range andequivalent to the predicate	Allowance: +-10%	The dimensions of the piezoelectric unit are within theacceptable criteria as whencompared to the predicatedevice.
Cable Length	Verify if the cable length iswithin the acceptable rangeand equivalent to the predicate	Expected: 3 ft and 7 ftAllowance: +-5%	The cable length of the sensor iswithin the acceptable criteria aswhen compared to the predicatedevice.
Visual Conditions	Verify the visual aspects of theproduct and equivalency withthe predicate. Cable aspects,labeling, flexibility, plasticfinishing, and connectorconditions.	All aspects must besubstantiallyequivalent to thepredicate device.	Maxxi Snore sensor wasinspected, and the result isequivalent to the predicatedevice.
Output signalsFrequency andAmplitude Tests	The sensor Maxxi Snore andthe predicate Snoring Sensorwere connected to the samePSG recorder and the acquireddata was compared infrequency and amplitude.	Allowance: +-15%	Both sensors acquired equivalentsignals within the acceptablerange.

Discussion: The Maxxi Snore and the predicate device Snoring Sensor manufactured by S.L.P Ltd., are substantially equivalent in technology, function, and intended use: both sensors are indicated to provide respiratory signal for sleep disordered breathing; both devices use the same method of action; both devices use equivalent material and both devices provide equivalent output signals.

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).