The Maxxi Flow sensor is a respiratory sensor. It is placed under the patient's and produce a signal that is directly proportional to the temperature changes of air inhaled and exhaled during respiration. Maxxi Flow sensors generate a small analog electrical signal that provides a clear, reliable indication of respiration airflow. 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 FLOW SENSOR Thermocouple based sensors detect change of breath temperature between ambient temperature (inhalation) and lung temperature (exhalation). A thermocouple placed in front of a nostril detects breathing as a temperature change.

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

Maxxi Flow sensor is compatible with Neurovirtual PSG devices.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Maxxi Flow Sensor, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance for Maxxi Flow Sensor (K201495)

The Neurovirtual Maxxi Flow Sensor is a respiratory thermocouple flow sensor intended for use with polysomnography devices in adult patients within sleep laboratories, clinics, or hospitals. It is designed to detect temperature changes of inhaled and exhaled air to provide a signal indicating respiration airflow.

Here's the detailed breakdown of its acceptance criteria and the study that proves its compliance:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Description	Acceptance Criteria	Reported Device Performance
Parts Dimensions	Verify if the dimensions of the thermocouple unit are within the acceptable range and equivalent to the predicate.	Allowance: +/- 10% compared to predicate.	The dimensions of the thermocouple unit are within the acceptable criteria as when compared to the predicate device.
Cable Length	Verify if the wire lead length is within the acceptable range and equivalent to the predicate.	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	Verify the visual aspects of the product and equivalency with the predicate. Cable aspects, labeling, flexibility, plastic finishing, and connector conditions.	All aspects must be substantially equivalent to the predicate device.	Maxxi Flow sensor was inspected, and the result is equivalent to the predicate device.
Sensor Resistance	Verify the resistance of the sensor using the ohmmeter in a controlled test environment where the temperature is stable.	Expected: 0-10 ohms.	The Maxxi Flow was inspected, and the resistance is between the acceptable criteria range (2.0 ohms).
Output signals Frequency and Amplitude	The sensor Maxxi Flow and the predicate Easy Flow were connected to the same PSG recorder and the acquired data was compared in frequency and amplitude.	Allowance: +/- 15%.	Both sensors acquired equivalent signals within the acceptable range.
Environment Temperature Performance	Test performance with different environment temperatures. (Specific criteria not numerically stated, but the conclusion focuses on equivalence to the predicate.)	Expected to show equivalent performance to the predicate device at different temperatures.	The results showed exact same frequency as the predicate, with minimal difference on voltage amplitude and resistance measurement values.

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

The document does not explicitly state the specific sample size of Maxxi Flow Sensors used for the non-clinical testing. However, the tests are described as comparing the Maxxi Flow sensor directly against a single predicate device (Easy Flow manufactured by S.L.P Ltd.). This suggests a comparative test design.

The provenance of this test data is non-clinical testing, performed by the manufacturer, Neurovirtual USA, Inc., implying internal validation. There is no information regarding the country of origin of the data beyond the manufacturer's location in Fort Lauderdale, Florida, USA. The testing appears to be prospective in nature, as it involves newly manufactured devices undergoing specific tests.

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

This information is not provided in the document. For this type of non-clinical, performance-based testing of a sensor, "expert ground truth" as typically understood in AI/image analysis studies (e.g., radiologist consensus) is not directly applicable. The "ground truth" for these tests is based on objective measurements against engineering specifications and comparison to a legally marketed predicate device.

4. Adjudication Method for the Test Set:

An adjudication method is not applicable for these non-clinical, objective performance tests. The criteria are quantitative (e.g., +/- 10% allowance, 0-10 ohms) or qualitative but directly observable (e.g., visual equivalency). Discrepancies would be identified through measurement, not through expert opinion requiring adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of AI algorithms on human readers' performance, typically in diagnostic imaging. The Maxxi Flow Sensor is a physical medical device (a respiratory sensor), not an AI-powered diagnostic tool, so such a study would not be applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone performance study, as typically understood for AI algorithms, was not conducted because the Maxxi Flow Sensor is a physical device, not an AI algorithm. Its performance is inherent to its physical and electronic design and is measured directly through non-clinical testing. The performance evaluated here is the device's ability to generate signals based on temperature changes.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical testing was based on:

Engineering Specifications: Pre-defined acceptable ranges for physical dimensions, cable length, and sensor resistance.
Predicate Device Performance: Direct comparison of output signals (frequency and amplitude) against a legally marketed predicate device (S.L.P. Ltd.'s Thermocouple Flow Sensor (Easy Flow)) under controlled conditions.
Visual Inspection Criteria: Equivalence to the predicate device in visual aspects.

8. Sample Size for the Training Set:

This information is not applicable as the Maxxi Flow Sensor is a physical medical device, not an AI/machine learning model that requires a training set.

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

This information is not applicable as there is no training set for a physical medical device like the Maxxi Flow Sensor.

Summary

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December 14, 2020

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

Re: K201495

Trade/Device Name: Maxxi Flow Sensor Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: November 10, 2020 Received: November 12, 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

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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 (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 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 Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental 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) K201495

Device Name Maxxi Flow Sensor

Indications for Use (Describe)

Intended to be use in a sleep laboratory, clinics or hospitals.

Type of Use (Select one or both, as applicable)
X 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 in shades of orange on the left, followed by the word "NEUROVIRTUAL" in blue. The "O" in "NEUROVIRTUAL" is replaced with an orange circle.

510(k) SUMMARY

Submitter's Name: Neurovirtual USA, Inc.

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

Address: 3303 W Commercial Blvd #100 Fort Lauderdale, FL 33309 USA

Phone and Fax Numbers

Phone: (786) 693-8200 Fax: (305) 393-8429

Contact Person: Eduardo J. Faria

Preparation Date: December 11, 2020

Classification Name:

Common / Usual Name: Breathing frequency monitor Proprietary Name: Maxxi Flow Sensor Product Code: MNR Class: Class II Regulation: 21 CFR 868.2375

Device Description:

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

Maxxi Flow sensor is compatible with Neurovirtual PSG devices.

Substantial Equivalence:

The Maxxi Flow Sensor is substantial equivalent with the following products:

Primary Predicate

510(k) Number	Model	Company
K922112	Thermocouple Flow Sensor (Easy Flow)	S.L.P. Ltd.Former EPM INFORMATION SYSTEMS, INC.

Reference device:

510(k) Number	Model	Company
K981445	ULTIMA AIRFLOW SENSOR	BRAEBON MEDICAL CORP.

The reference predicate was added in order to support to demonstrate the substantial equivalence with the subject device because it has similar anatomical and technological characteristics, as well it is not powered with battery which is the same as the subject device.

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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, block letters. The "O" in Neurovirtual is replaced with an orange circle.

1. Indications for Use:

Indications for Use Comparison
Neurovirtual	S.L.P. Ltd.	Braebon
Maxxi Flow Sensor	Thermocouple Flow Sensor (Easy flow)	ULTIMA AIRFLOW SENSOR
The Maxxi Flow sensor is a respiratorysensor. It is placed under the patient'snostrils and produce a signal that isdirectly proportional to the temperaturechanges of air inhaled and exhaled duringrespiration. Maxxi Flow sensors generatea small analog electrical signal thatprovides a clear, reliable indication ofrespiration airflow. This sensor is intendedto be used with polysomnography devicesand adult patients.Intended to be use in a sleep laboratory,clinics or hospitals.	The Easy flow sensor is a respiratorysensor. It is placed under the patient'snostrils and produce a signal that isdirectly proportional to the temperaturechanges of air inhaled and exhaled duringrespiration. Easy flow sensors generate asmall analog electrical signal thatprovides a clear, reliable indication ofrespiration airflow. This sensor isintended to be used in polysomnographydevicesIntended to be use in a sleep laboratory,clinics or hospitals	A Qualitative measure of respiratoryairflow for recording onto a dataacquisition system.

2. Technological Characteristics Comparison:

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

Specifications Comparison
Device	NeurovirtualMaxxi Flow Sensor	S.L.P. Ltd.Thermocouple Flow Sensor (Easyflow)	BraebonULTIMA AIRFLOW SENSOR
510(k) Number	K201495	K922112	K981445
Regulation	21 CFR 868.2375	21 CFR 868.2375	21 CFR 868.2375
Classification	MNR	BZQ	BZQ
Target population	Adults	All Ages	All Ages
Environment	sleep laboratory, clinics orhospitals	sleep laboratory, clinics orhospitals	sleep laboratory, clinics orhospitals
Application	Respiratory thermocouple flowsensor	Respiratory thermocouple flowsensor	Respiratory thermocouple flowsensor
Mechanical application	Sensor is placed under thepatient's nostrils	Sensor is placed under thepatient's nostrils	Sensor is placed under thepatient's nostrils
Structure	Thermocouple elementscovered by TPC plasticinjection with a wire toconnect to the PSG amplifier.	Thermocouple elements coveredby TPC plastic injection with a wireto connect to the PSG amplifier.	Thermocouple elementscovered by TPC plastic injectionwith a wire to connect to thePSG amplifier.
Contact Material	Thermoplastic elastomers(TPC-ETs)	Thermoplastic elastomers (TPC-ETs)	Thermoplastic elastomers (TPC-ETs)
Wire Material	Insulated Teflon wire	Insulated Teflon wire	Insulated Teflon wire
Wire Colors	White	White	White
Connector	DIN 42-802touch proof	DIN 42-802touch proof	DIN 42-802touch proof
Signal output	AC signal	AC signal	AC signal
Signal Frequency range	0-30 HZ	0-30 HZ	0-30 HZ

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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, with the darker orange portion resembling an EKG. To the right of the waveform is the company name, "NEUROVIRTUAL," in bold, dark blue letters. The "O" in "NEUROVIRTUAL" is a lighter orange circle.

Sensor Resistance	<10Ω	<10Ω	Not disclosed by manufacturer
Sensor Dimensions	.032 x 1.36 x 0.23 (in)	0.30 x 1.3 x 0.22 (in)	0.30 x 1.3 x 0.22 (in)
Single-Use	No	No	No
Cable length	3ft and 7ft	3ft and 7ft	3ft and 7ft
Package	Plastic bag	Plastic bag	Plastic bag
Pictures	Image: sensor with wires	Image: sensor with wires	Image: sensor with wires

Discussion: The Maxxi Flow and the predicate devices, are substantially equivalent in technology, function, and intended use, all sensors are indicated to provide respiratory airflow signal for a polysomnography device; all devices use the same method of action; all devices use equivalent material and all devices provide equivalent output signals.

I) Applied Standards:

In order to reach high guality and effectiveness the Maxxi Flow Sensor is produced in compliance with the following standards:

ISO 13485:2003, "Medical Devices, Quality Management Systems: Requirements for Regulatory -Purposes" and FDA GMP "Good Manufacturing Practices".
-ISO10993-1:2009, "Biological Evaluation of Medical Devices"
-60601-1 3a edition - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
-60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

J) Non-clinical Testing:

The test performance comparing the Maxxi Flow and the predicate device Easy Flow manufactured by S.L.P Ltd was performed and the summary results are show in the summary below.

Test	Description	Criteria	Results
Parts Dimensions	Verify if the dimensions of thethermocouple unit are within theacceptable range and equivalent to thepredicate	Allowance: +-10%	The dimensions of the thermocouple unit arewithin the acceptable criteria as whencompared to the predicate device.
Cable Length	Verify if the wire lead length is within theacceptable range and equivalent to thepredicate	Expected: 3 ft and 7 ftAllowance: +-5%	The cable length of the sensor is within theacceptable criteria as when compared to thepredicate device.
Visual Conditions	Verify the visual aspects of the product andequivalency with the predicate. Cableaspects, labeling, flexibility, plastic finishing,and connector conditions.	All aspects must be substantiallyequivalent to the predicatedevice.	Maxxi Flow sensor was inspected, and the resultis equivalent to the predicate device.
Sensor Resistance	Verify the resistance of the sensor using theohmmeter in a controlled test environmentwhere the temperature is stable.	Expected: 0-10 ohms	The Maxxi Flow was inspected, and theresistance is between the acceptable criteriarange. (2.0 ohms)

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

Output signalsFrequency and AmplitudeTests	The sensor Maxxi Flow and the predicateEasy Flow were connected to the same PSGrecorder and the acquired data wascompared in frequency and amplitude.	Allowance: +-15%	Both sensors acquired equivalent signals withinthe acceptable range.
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Additionally, the test performance with different environment temperatures was performed. The results showed exact same frequency as the predicate, with minimal difference on voltage amplitude and resistance measurement values.

Conclusion: The Maxxi Flow and the predicate device Easy Flow manufactured by S.L.P Ltd., are substantially equivalent in technology, function, and intended use.

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).