The MouthLab Vital Signs Monitoring System is a hand-held, wireless device intended to record, transfer, store and display single lead electrocardiography (ECG), heart rate variability (HRV), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), respiration rate (RR), respiration pattern (RP), oral temperature (TEMP) and basic lung function measurements: peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1).

This system is for spot checking and does not have continuous monitoring capability or any alarm features. The device comes in contact with the user for approximately 60 seconds at each use and the captured medical parameters shall be displayed on a mobile application.

It is intended for use by adults in the home environment and in healthcare facilities. This system makes no specific diagnosis. Respiration rate is not intended for adults with underlying or suspected medical conditions. The device is for single user use.

It is intended for use with users who are well perfused and during no motion condition. Users with implanted pacemakers and/or implanted cardioverter-defibrillators (ICDs) are not recommended to use the device.

Device Description

The MouthLab Vital Signs Monitoring System is a non-invasive, battery-powered, handheld, wireless, personalized single-user, vital sign measuring apparatus. The device is intended to intermittently monitor the user vitals through the use of an integrated SpO2 sensor, ECG electrodes, microphones and thermistor, which measures the users' functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), oral temperature (TEMP), ECG, heart rate (HR) and heart rate variability (HRV). The users' respiration rate (RR) measurements, respiration pattern (RP) and the basic lung functions (FEV1 and PEF) measurements are obtained are obtained through the acoustic measurement of air turbulence. The vital signs data are transferred to the Aidar Cloud™ Application via a cellular network for processing and storage. This processed data is then displayed on the Aidar Care™ Mobile Application.

AI/ML Overview

The provided document, a 510(k) Summary for the MouthLab Vital Signs Monitoring System (K201635), outlines the device's acceptance criteria and the studies conducted to demonstrate its performance. The device measures multiple physiological parameters, and therefore, different studies were conducted for each.

1. Table of Acceptance Criteria and Reported Device Performance:

Parameter	Acceptance Criteria (from predicate/standard)	Reported Device Performance
Heart Rate (HR) Accuracy	± 2 bpm or ± 2%, whichever is larger (IEC 60601-2-27)	± 2 bpm or ± 2%, whichever is larger (Same as criteria)
SpO2 Accuracy	± 3% (ISO 80601-2-61)	± 3% (Same as criteria)
Pulse Rate (PR) Accuracy	± 2 ppm or ± 2%, whichever is larger (ISO 80601-2-61)	± 2 ppm or ± 2%, whichever is larger (Same as criteria)
Respiration Rate (RR) Accuracy	± 2 breaths/min (from Connex Monitor K171621)	± 2 breaths/min (Same as criteria)
Temperature Accuracy	± 0.6 °F (± 0.3°C) (from ISO 80601-2-56)	± 0.6 °F (± 0.3°C) (Conforms to ISO standard requirements)
Peak Expiratory Flow (PEF) Accuracy	± 0.33 L/s or 10%, whichever is larger (ATS)	± 0.33 L/s or 10%, whichever is larger (Same as criteria)
Forced Expiratory Volume (FEV1) Accuracy	± 0.1 L or 5%, whichever is larger (ATS)	± 0.1 L or 5%, whichever is larger (Same as criteria)
ECG Input Impedance	Conforms to IEC 60601-2-27 impedance requirements	> 2.5MΩ (Conforms to IEC 60601-2-27 impedance requirements)

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

SpO2 Measurements: "a controlled desaturation study with adults." The specific sample size is not provided. The data provenance is implied to be prospective clinical testing, likely conducted in a controlled environment as it refers to a "controlled desaturation study." The country of origin is not specified.
Respiration Rate Measurements: "20 healthy adults." The data provenance is prospective clinical testing. The country of origin is not specified.
For other parameters (ECG/HR, Pulse Rate, Temperature, PEF/FEV1), bench testing was performed, meaning synthetic data or physical test equipment was used. No human subject sample size is applicable.

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

Respiration Rate Measurements: Ground truth was established by "a clinician's manually scored capnography (EtCO2) waveforms." The number of clinicians is not specified, and their specific qualifications beyond "clinician" are not detailed.
SpO2 Measurements: Ground truth was established by "reference co-oximeter analysis of arterial blood gas." This implies laboratory analysis rather than human expert interpretation of raw data. No human experts were explicitly stated to establish this ground truth in the provided text.

4. Adjudication Method for the Test Set:

For SpO2, and Temperature, the comparison was against a reference standard (co-oximeter, calibrated thermometer) implying direct comparison, not a human adjudication process.
For Respiration Rate, the comparison was against "a clinician's manually scored capnography waveforms." This suggests a single clinician's scoring was used as ground truth, implying no adjudication method (e.g., 2+1 or 3+1) was employed for establishing this ground truth.

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:

No MRMC comparative effectiveness study was done involving human readers with and without AI assistance (the MouthLab system). The studies described are validation studies comparing the device's measurements to reference standards, not studies on human reader performance improvement.

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

Yes, the performance data provided describes the standalone performance of the MouthLab Vital Signs Monitoring System in measuring various physiological parameters. The clinical and bench tests evaluate the device's ability to accurately capture and report these values.

7. The type of ground truth used:

ECG and Heart Rate: Bench testing compliant with IEC 60601-2-27:2012. (Simulated physiological signals)
Pulse Rate: Bench testing compliant with ISO 80601-2-61:2017. (Simulated physiological signals)
Temperature: Bench agreement study as per ISO 80601-2-56:2017. (Reference temperature measurements)
Peak Flow Measurements (FEV1 and PEF): Bench testing according to the ATS Standardization of Spirometry, 2005 Update. (Reference flow/volume measurements)
SpO2 Measurements: Reference co-oximeter analysis of arterial blood gas. (Objective clinical reference standard)
Respiration Rate Measurements: Clinician's manually scored capnography (EtCO2) waveforms. (Expert interpretation of surrogate physiological data)

8. The sample size for the training set:

The document does not explicitly mention a training set sample size. The performance data section focuses on "bench testing" and "clinical testing" for validation, not on the training of machine learning models. If the device uses algorithms trained on data, that information is not detailed in this summary.

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

As the document does not mention a training set, the method for establishing its ground truth is not provided.

Summary

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February 6, 2021

MultiSensor Diagnostics (dba Aidar Health) % Allison Komiyama Principal Consultant AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 San Diego, California 92110

Re: K201635

Trade/Device Name: MouthLab Vital Signs Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DPS, FLL, BZQ, BZH, DPS Dated: December 23, 2020 Received: December 28, 2020

Dear Allison Komiyama:

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

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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 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,

for Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular 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) K201635

Device Name MouthLab Vital Signs Monitoring System

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)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

Device Common Name:	Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)
Device Trade Name:	MouthLab™ Vital Signs Monitoring System
Applicant	Multisensor Diagnostics, LLC. (DBA Aidar Health)3402 Birch Hollow Rd,Pikesville, MD 21208Phone: (443) 875-6456Website: www.aidar.com
Contact:	Sathya ElumalaiFounder & Chief Executive Officerselumalai@aidar.com
Representative/Consultant:	Allison C. Komiyama, Ph.D., R.A.C.AcKnowledge Regulatory Strategies, LLCTelephone: +1(619) 458-9547Email: akomiyama@acknowledge-rs.comWebsite: www.AcKnowledge-RS.com
Date Prepared:	February 4, 2021
Classification Regulation:	Class II
Classification Name:	870.2300: Cardiac monitor (including cardiotachometer and rate alarm)
Panel:	Cardiovascular
Primary Product Code:	MWI
Secondary Product Codes:	DQA, DPS, FLL, BZQ, DXN, BZH
Predicate Devices:	Primary:	CheckMe Pro Health Monitor (K150869)Secondary: Connex Vital Signs 6000 Monitor (K171621)Wing Smart FEV1 and Peak Flow Meter (K152276)
Reference Devices:	• Masimo Acoustic Respiration Sensor (K120984)• ReadMyHeart - Model RMHI3.0 (K050620)• Peak me (K180487)

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INDICATIONS FOR USE: 1.

The MouthLab Vital Signs Monitoring System is a hand-held, wireless device intended to record, transfer, store and display single lead electrocardiography (ECG), heart rate (HR), heart rate variability (HRV), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), respiration rate (RR), respiration pattern (RP), oral temperature (TEMP) and basic lung function measurements: peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1).

DEVICE DESCRIPTION: 2.

3. BIOCOMPATIBILITY:

The MouthLab Vital Signs Monitoring System is a surface device that includes components that have prolonged contact duration (> 24h and less than 30 days) with the

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user's mucosal membrane and intact skin. Testing was performed in accordance with ISO 10993-1.

4. PERFORMANCE DATA:

4.1. Bench Testing:

The following bench testing was provided to support the substantial equivalence of the MouthLab Vital Signs Monitoring System:

. ECG and Heart Rate Measurements: To validate the ability of the MouthLab Vital Signs Monitoring System to capture ECG waveforms and heart rate measurements, bench testing as per IEC 60601-2-27:2012 was conducted.
Pulse Rate Measurements: To validate the ability of the MouthLab Vital Signs Monitoring System to capture pulse rate measurements, bench agreement testing as per ISO 80601-2-61:2017 was conducted.
Temperature Measurements: To validate the ability of the MouthLab Vital Signs Monitoring System to calculate temperature measurements, a bench agreement study was conducted, as per ISO 80601-2-56:2017.
Peak Flow Measurements: To validate the ability of the MouthLab Vital Signs ● Monitoring System to measure the basic lung functions (FEV1 and PEF), bench testing according to the ATS Standardization of Spirometry, 2005 Update was conducted.

4.2. Clinical Testing:

The following clinical testing was provided to support the substantial equivalence of the MouthLab Vital Signs Monitoring System:

. SpO2 Measurements: To validate the ability of the MouthLab Vital Signs Monitoring System to make pulse oximetry measurements, a clinical agreement study as per ISO 80601-2-61:2017 was conducted. MouthLab SpO2 measurements were validated in a controlled desaturation study with adults and compared to reference co-oximeter analysis of arterial blood gas.
Respiration Rate Measurements: To validate the ability of the MouthLab Vital Signs Monitoring System to calculate respiration rate, a clinical agreement study was conducted with 20 healthy adults and MouthLab respiration rate measurements were compared against a clinician's manually scored capnography (EtCO2) waveforms.

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5. SOFTWARE DOCUMENTATION:

Software documentation for a Moderate Level of Concern device was provided in support of the MouthLab Vital Signs Monitoring System as recommended by FDA's Guidance, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005 and IEC 62304:2006 + A1:2015.

6. ELECTRICAL SAFETY TESTING:

The MouthLab Vital Signs Monitoring System was found to be compliant with the following standards:

IEC 60601-1:2005 + A1:2012 .
IEC 60601-1-6:2010 + A1:2013 o
IEC 60601-1-11:2015 ●

7. ELECTROMAGNETIC COMPATIBILITY TESTING:

The MouthLab Vital Signs Monitoring System was found to be compliant with IEC 60601-1-2:2014 standard.

HUMAN FACTORS/USABILITY TESTING: 8.

Human factors/usability testing was conducted to evaluate the ability of lay people to read and understand the MouthLab Vital Signs Monitoring System instructions for use, and subsequently simulate normal use of the MouthLab Vital Signs Monitoring System with limited training. The MouthLab Vital Signs Monitoring System was also tested as per IEC 60601-1-11:2015, for suitability of the system in a home environment.

SUBSTANTIAL EQUIVALENCE DISCUSSION: 9.

The MouthLab Vital Signs Monitoring System is substantially equivalent to the predicate devices based on the information summarized here.

The subject device has the same intended use and similar technological characteristics as the predicate devices cleared in K150869, K171621, and K152276. The primary predicate, CheckMe Pro Health Monitor (K150869) is also a handheld device for monitoring physiological parameters in the home or healthcare environment. The subject device has seven primary medical device functions and each of them have been compared to predicate devices. There are no differences in the technological characteristics for SpO2, Pulse Rate, Heart Rate, ECG, Temperature, Respiration Rate, Respiration Pattern, PEF and FEV1. The subject device also measures the heart rate variability (HRV) in R-R interval, which is a mathematical analysis of the variation in the

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heart rate and is not intended to produce any interpretation of those measurements or be used for any kind of diagnosis.

The similar indications for use, technological characteristics, and performance characteristics for the proposed MouthLab Vital Signs Monitoring System are assessed to be substantially equivalent to the predicate devices. A comparison of the technological characteristics between the subject device and the predicate devices is provided in the tables below.

Table 1: Technological

	Subject Device	Primary Predicate	SubstantialEquivalence toPredicate Device
510(k) Number	K201635	K150869	NA
Applicant	MultisensorDiagnostics, LLC	Viatom Technology Co.Ltd.	NA
Device Name	MouthLab Vital SignsMonitoring System	CheckMe Pro HealthMonitor	NA
ClassificationRegulation	870.2300 -Physiological PatientMonitor	870.2300 -Physiological PatientMonitor	Same
Device Class	Class II	Class II	Same
PhysiologicalParametersMonitored	ECG, HR, HRV, SpO2,PR, RR, RP,TEMP, PEF, FEV1	ECG, HR, SpO2, PR,TEMP	Similar
Location	Home and Healthcarefacilities	Home and Hospital	Same
Rx or OTC	Rx	Rx	Same
Power Supply	2000mAh rechargeablelithium-polymer battery	560mAh rechargeablelithium-ion polymerbattery	Similar
UserPopulation	Adults	Adults and Pediatric	Subject device onlysupports adultusers
Alarm	No Alarms	No Alarms	Same
DataCollection	Minimum of 10,000measurements storage	100 measurementsstorage	Similar
Memory
	Subject Device	Primary Predicate	SubstantialEquivalence toPredicate Device
OperatingModes	Spot-Check	Continuous Recordingand Spot-Check	Subject device onlysupports spot-check
	Comparison of ECG and Heart Rate Measurements
MeasuredECGParameters	ECG Waveform, HeartRate (HR), Heart RateVariability (HRV)	ECG Waveform, HeartRate (HR)	Similar
ECG RhythmClassification	Not Included	Not Included	Same
ECG LeadType	Single Lead, 2 Contacts	ExternalECG CableandElectrodes	Similar
InputImpedance	> 2.5MΩ	> 10MΩ	Conforms to IEC60601-2-27impedancerequirements
Input DynamicRange	± 2mV	± 3mV	Subject devicesupports this range
Bandwidth	0.5 - 50 Hz	0.05 - 40Hz	Similar
A/DConversion	24 bit	16 bit	Similar
Sampling Rate	1000 Hz	500 Hz	Similar
MeasurementTime	≤ 60 seconds	30 seconds	Similar
Display	Mobile Application	400*240 Dot-matrixLCD Display	Subject device onlysupports mobileapplication.
Input	Dry ConductiveElectrodes	Dry ConductiveElectrodes and/orExternal AuxiliaryElectrodes	Similar
Heart Rate(HR) Range	30 - 200 bpm	30 - 250 bpm	Conforms to therequirements of theIEC 60601-2-27heart ratemeasurements
	Subject Device	Primary Predicate	SubstantialEquivalence toPredicate Device
Heart Rate(HR) Accuracy	$\pm$ 2 bpm or $\pm$ 2%,whichever is larger	$\pm$ 2 bpm or $\pm$ 2%,whichever is larger	Same
Comparison of Blood Oxygen Saturation (SpO2) Measurements
Display DataMode	SpO2, Pulse Rate (PR)Spot-Check	SpO2, Pulse Rate (PR)Continuous Recordingand Spot-Check	SameSubject device onlysupports spot-check
Sensor Types	Integrated	Integrated and External	Subject device onlysupports integratedsensors
SpO2 Range	70 – 100%	70 – 100%	Same
SpO2Accuracy	$\pm$ 3%	Integrated: $\pm$ 3%	Same
SpO2Resolution	1%	1%	Same
Pulse Rate(PR) Range	30 – 250 ppm	30 – 250 ppm	Same
Pulse Rate(PR) Accuracy	$\pm$ 2 ppm or $\pm$ 2%,whichever is larger	$\pm$ 2 ppm or $\pm$ 2%,whichever is larger	Same
Pulse Rate(PR)Resolution	1 ppm	1 ppm	Same

Comparison – MouthLab System vs CheckMe Pro

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Table 2: Technological Comparison – MouthLab System vs Connex Monitor

Comparison of Respiration Rate Measurement
	Subject Device	SecondaryPredicate	SubstantialEquivalence toPredicate Device
510(k) Number	K201635	K171621	NA
Applicant	MultisensorDiagnostics, LLC	Welch Allyn, Inc	NA
Device Name	MouthLab VitalSigns MonitoringSystem	Connex Vital SignsMonitor	NA
ClassificationRegulation	870.2300 -	870.2300 -	Same

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	Subject Device	SecondaryPredicate	SubstantialEquivalence toPredicate Device
	PhysiologicalPatientMonitor	PhysiologicalPatient Monitor
Device Class	Class II	Class II	Same
Location	Home andHealthcareFacilities	Hospital	Similar
MeasurementTechniques	AcousticMeasurements	AcousticMeasurements	Same
Display Range	6 – 50 breaths/min	4 – 70 breaths/min	Subject device supportsthis range
MeasurementRange	6 – 50 breaths/min	4 – 70 breaths/min	Subject device supportsthis range
Respiration Rate(RR) Accuracy	$\pm$ 2 breaths/min	$\pm$ 1 breath/min	Subject device supportsthis accuracy
Comparison of Temperature Measurement
MeasurementTechnique	Thermo-resistiveSensor	Thermo-resistiveSensor	Same
Measurement Site	Oral	Oral, Axillary,Rectal	Subject device onlysupports oralmeasurements
Mode	Direct Mode	Direct or PredictiveMode	Subject device onlysupports direct mode
Unit	°F or °C	°F or °C	Same
Measuring Range	93.2°F – 109.4°F(34°C – 43.0°C)	80°F – 110°F(26.7°C – 43.3°C)	Conforms to the ISOstandard requirements
Accuracy	$\pm$ 0.6 °F( $\pm$ 0.3°C)	$\pm$ 0.2°F( $\pm$ 0.1°C)	Conforms to the ISOstandard requirements

Table 3: Technological Comparison – MouthLab System vs Wing

Comparison of Lung Function Measurements
510(k) Number	Subject Device	SecondaryPredicate	SubstantialEquivalence
K201635	K152276	NA
	Subject Device	SecondaryPredicate	SubstantialEquivalence
Applicant	MultisensorDiagnostics, LLC	Sparo Labs	NA
Device Name	MouthLab VitalSigns MonitoringSystem	Wing Smart FEV1and Peak FlowMeter	NA
ClassificationRegulation	870.1860 – PeakFlow Meter forSpirometry	870.1860 – PeakFlow Meter forSpirometry	Same
Device Class	Class II	Class II	Same
PhysiologicalParametersMonitored	FEV1, PEF	FEV1, PEF	Same
Location	Home and Hospital	Home	Similar
User Interface	Mobile Application	Mobile Application	Same
Rx or OTC	Rx	OTC	Subject device is onlyapplicable forprescription use basedon other parameters itmeasures
Use Population	Adults	Adults and pediatricusers above 5years of age	Subject device is foradult users
Operating Modes	Spot-Check	Spot-Check	Same
MeasurementTechnique	AcousticMeasurement usingMicrophones	AcousticMeasurement usingMicrophones	Same
Peak ExpiratoryFlow (PEF) Range	2 – 15 L/s	50 – 900 L/min	Subject devicesupports this range
Peak ExpiratoryFlow (PEF)Accuracy	± 0.33 L/s or 10%,whichever is larger	±20 L/min or 10%,whichever is larger	Same
PEF Resolution	0.01 L/s	1 L/min	Same
Forced ExpiratoryVolume (FEV1)Range	1.00 – 7.50 L	0.01 – 9.99 L	Subject devicesupports this range
Forced ExpiratoryVolume (FEV1)Accuracy	± 0.1 L or 5%,whichever is larger	± 0.1 L or 5%,whichever is larger	Same
	Subject Device	SecondaryPredicate	SubstantialEquivalence
FEV1 Resolution	0.01 L	0.01 L	Same

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10. CONCLUSION:

Based on the information provided in this 510(k) premarket notification, the MouthLab Vital Signs Monitoring System is considered to be substantially equivalent (safe and effective) to its predicate devices: CheckMe Pro Health Monitor (K150869), the Welch Allyn Monitor (K171621), and Wing Smart FEV1 and Peak Flow Meter (K152276). The MouthLab Vital Signs Monitoring System has the same intended uses, similar indications, technological characteristics and principles of operation as its predicate devices. Through the performance and clinical testing conducted as mentioned herein, the minor technological differences between MouthLab Vital Signs Monitoring System and its predicate devices raise no new issues of safety and effectiveness. Hence, the MouthLab Vital Signs Monitoring System is substantially equivalent to its predicate devices.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).