(235 days)
No
The summary does not mention AI, ML, or related terms like neural networks, deep learning, or algorithms that would typically indicate the use of such technology for data processing or analysis beyond standard signal processing for vital sign measurement. The data is transferred for "processing and storage," which doesn't inherently imply AI/ML.
No.
The device is described as a "Vital Signs Monitoring System" intended to "record, transfer, store and display" various physiological parameters for "spot checking". Its intended use is for monitoring and displaying data, not for treating or preventing a disease or condition.
No
The "Intended Use / Indications for Use" section explicitly states, "This system makes no specific diagnosis." The device is intended for monitoring and displaying vital signs and basic lung function measurements, not for making a diagnosis.
No
The device description explicitly states it is a "non-invasive, battery-powered, handheld, wireless, personalized single-user, vital sign measuring apparatus" with integrated hardware components like an SpO2 sensor, ECG electrodes, microphones, and thermistor. While it uses software for data processing and display, it is fundamentally a hardware device with embedded software.
Based on the provided information, the MouthLab Vital Signs Monitoring System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- MouthLab's Function: The MouthLab system measures physiological parameters directly from the user's body (ECG, SpO2, temperature, respiration, lung function) through non-invasive sensors and acoustic measurements. It does not analyze specimens in vitro.
- Intended Use: The intended use is to record, transfer, store, and display vital signs for spot checking. It explicitly states that it "makes no specific diagnosis." This aligns with a vital signs monitor, not an IVD.
Therefore, the MouthLab Vital Signs Monitoring System falls under the category of a vital signs monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DQA, DPS, FLL, BZQ, DXN, BZH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral (for temperature, respiration rate, respiration pattern, PEF, FEV1), no specific anatomical site for ECG, HR, HRV, SpO2, PR as the device is hand-held with integrated sensors/electrodes. Contact with user's mucosal membrane and intact skin.
Indicated Patient Age Range
Adults
Intended User / Care Setting
Home environment and in healthcare facilities; single user use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- ECG and Heart Rate Measurements: Bench testing as per IEC 60601-2-27:2012 was conducted.
- Pulse Rate Measurements: Bench agreement testing as per ISO 80601-2-61:2017 was conducted.
- Temperature Measurements: Bench agreement study as per ISO 80601-2-56:2017 was conducted.
- Peak Flow Measurements: Bench testing according to the ATS Standardization of Spirometry, 2005 Update was conducted.
Clinical Testing:
- SpO2 Measurements: 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: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Heart Rate (HR) Accuracy: ± 2 bpm or ± 2%, whichever is larger
- SpO2 Accuracy: ± 3%
- SpO2 Resolution: 1%
- Pulse Rate (PR) Range: 30 – 250 ppm
- Pulse Rate (PR) Accuracy: ± 2 ppm or ± 2%, whichever is larger
- Pulse Rate (PR) Resolution: 1 ppm
- Respiration Rate (RR) Accuracy: ± 2 breaths/min
- Temperature Accuracy: ± 0.6 °F ( ± 0.3°C)
- Peak Expiratory Flow (PEF) Accuracy: ± 0.33 L/s or 10%, whichever is larger
- PEF Resolution: 0.01 L/s
- Forced Expiratory Volume (FEV1) Accuracy: ± 0.1 L or 5%, whichever is larger
- FEV1 Resolution: 0.01 L
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
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 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
2
Indications for Use
510(k) Number (if known) K201635
Device Name MouthLab Vital Signs Monitoring System
Indications for Use (Describe)
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 (FEV ).
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.
| 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 21208 | ||
| Phone: (443) 875-6456 | ||
| Website: www.aidar.com | ||
| Contact: | Sathya Elumalai | |
| Founder & Chief Executive Officer | ||
| selumalai@aidar.com | ||
| Representative/ | ||
| Consultant: | Allison C. Komiyama, Ph.D., R.A.C. | |
| AcKnowledge Regulatory Strategies, LLC | ||
| Telephone: +1(619) 458-9547 | ||
| Email: akomiyama@acknowledge-rs.com | ||
| Website: 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).
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: 2.
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.
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
5
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
7
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 | Substantial
Equivalence to
Predicate Device |
|-----------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| 510(k) Number | K201635 | K150869 | NA |
| Applicant | Multisensor
Diagnostics, LLC | Viatom Technology Co.
Ltd. | NA |
| Device Name | MouthLab Vital Signs
Monitoring System | CheckMe Pro Health
Monitor | NA |
| Classification
Regulation | 870.2300 -
Physiological Patient
Monitor | 870.2300 -
Physiological Patient
Monitor | Same |
| Device Class | Class II | Class II | Same |
| Physiological
Parameters
Monitored | ECG, HR, HRV, SpO2,
PR, RR, RP,
TEMP, PEF, FEV1 | ECG, HR, SpO2, PR,
TEMP | Similar |
| Location | Home and Healthcare
facilities | Home and Hospital | Same |
| Rx or OTC | Rx | Rx | Same |
| Power Supply | 2000mAh rechargeable
lithium-polymer battery | 560mAh rechargeable
lithium-ion polymer
battery | Similar |
| User
Population | Adults | Adults and Pediatric | Subject device only
supports adult
users |
| Alarm | No Alarms | No Alarms | Same |
| Data
Collection | Minimum of 10,000
measurements storage | 100 measurements
storage | Similar |
| Memory | | | |
| | Subject Device | Primary Predicate | Substantial
Equivalence to
Predicate Device |
| Operating
Modes | Spot-Check | Continuous Recording
and Spot-Check | Subject device only
supports spot-
check |
| | Comparison of ECG and Heart Rate Measurements | | |
| Measured
ECG
Parameters | ECG Waveform, Heart
Rate (HR), Heart Rate
Variability (HRV) | ECG Waveform, Heart
Rate (HR) | Similar |
| ECG Rhythm
Classification | Not Included | Not Included | Same |
| ECG Lead
Type | Single Lead, 2 Contacts | External
ECG Cable
and
Electrodes | Similar |
| Input
Impedance | > 2.5MΩ | > 10MΩ | Conforms to IEC
60601-2-27
impedance
requirements |
| Input Dynamic
Range | ± 2mV | ± 3mV | Subject device
supports this range |
| Bandwidth | 0.5 - 50 Hz | 0.05 - 40
Hz | Similar |
| A/D
Conversion | 24 bit | 16 bit | Similar |
| Sampling Rate | 1000 Hz | 500 Hz | Similar |
| Measurement
Time | ≤ 60 seconds | 30 seconds | Similar |
| Display | Mobile Application | 400*240 Dot-matrix
LCD Display | Subject device only
supports mobile
application. |
| Input | Dry Conductive
Electrodes | Dry Conductive
Electrodes and/or
External Auxiliary
Electrodes | Similar |
| Heart Rate
(HR) Range | 30 - 200 bpm | 30 - 250 bpm | Conforms to the
requirements of the
IEC 60601-2-27
heart rate
measurements |
| | Subject Device | Primary Predicate | Substantial
Equivalence to
Predicate 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 Data
Mode | SpO2, Pulse Rate (PR)
Spot-Check | SpO2, Pulse Rate (PR)
Continuous Recording
and Spot-Check | Same
Subject device only
supports spot-
check |
| Sensor Types | Integrated | Integrated and External | Subject device only
supports integrated
sensors |
| SpO2 Range | 70 – 100% | 70 – 100% | Same |
| SpO2
Accuracy | $\pm$ 3% | Integrated: $\pm$ 3% | Same |
| SpO2
Resolution | 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
8
9
Table 2: Technological Comparison – MouthLab System vs Connex Monitor
| Comparison of Respiration Rate Measurement | |||
|---|---|---|---|
| Subject Device | Secondary | ||
| Predicate | Substantial | ||
| Equivalence to | |||
| Predicate Device | |||
| 510(k) Number | K201635 | K171621 | NA |
| Applicant | Multisensor | ||
| Diagnostics, LLC | Welch Allyn, Inc | NA | |
| Device Name | MouthLab Vital | ||
| Signs Monitoring | |||
| System | Connex Vital Signs | ||
| Monitor | NA | ||
| Classification | |||
| Regulation | 870.2300 - | 870.2300 - | Same |
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| | Subject Device | Secondary
Predicate | Substantial
Equivalence to
Predicate Device |
|---------------------------------------|--------------------------------------|-----------------------------------|------------------------------------------------------|
| | Physiological
Patient
Monitor | Physiological
Patient Monitor | |
| Device Class | Class II | Class II | Same |
| Location | Home and
Healthcare
Facilities | Hospital | Similar |
| Measurement
Techniques | Acoustic
Measurements | Acoustic
Measurements | Same |
| Display Range | 6 – 50 breaths/min | 4 – 70 breaths/min | Subject device supports
this range |
| Measurement
Range | 6 – 50 breaths/min | 4 – 70 breaths/min | Subject device supports
this range |
| Respiration Rate
(RR) Accuracy | $\pm$ 2 breaths/min | $\pm$ 1 breath/min | Subject device supports
this accuracy |
| Comparison of Temperature Measurement | | | |
| Measurement
Technique | Thermo-resistive
Sensor | Thermo-resistive
Sensor | Same |
| Measurement Site | Oral | Oral, Axillary,
Rectal | Subject device only
supports oral
measurements |
| Mode | Direct Mode | Direct or Predictive
Mode | Subject device only
supports 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 ISO
standard requirements |
| Accuracy | $\pm$ 0.6 °F
( $\pm$ 0.3°C) | $\pm$ 0.2°F
( $\pm$ 0.1°C) | Conforms to the ISO
standard requirements |
Table 3: Technological Comparison – MouthLab System vs Wing
| Comparison of Lung Function Measurements | |||
|---|---|---|---|
| 510(k) Number | Subject Device | Secondary | |
| Predicate | Substantial | ||
| Equivalence | |||
| K201635 | K152276 | NA | |
| Subject Device | Secondary | ||
| Predicate | Substantial | ||
| Equivalence | |||
| Applicant | Multisensor | ||
| Diagnostics, LLC | Sparo Labs | NA | |
| Device Name | MouthLab Vital | ||
| Signs Monitoring | |||
| System | Wing Smart FEV1 | ||
| and Peak Flow | |||
| Meter | NA | ||
| Classification | |||
| Regulation | 870.1860 – Peak | ||
| Flow Meter for | |||
| Spirometry | 870.1860 – Peak | ||
| Flow Meter for | |||
| Spirometry | Same | ||
| Device Class | Class II | Class II | Same |
| Physiological | |||
| Parameters | |||
| Monitored | 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 only |
| applicable for | |||
| prescription use based | |||
| on other parameters it | |||
| measures | |||
| Use Population | Adults | Adults and pediatric | |
| users above 5 | |||
| years of age | Subject device is for | ||
| adult users | |||
| Operating Modes | Spot-Check | Spot-Check | Same |
| Measurement | |||
| Technique | Acoustic | ||
| Measurement using | |||
| Microphones | Acoustic | ||
| Measurement using | |||
| Microphones | Same | ||
| Peak Expiratory | |||
| Flow (PEF) Range | 2 – 15 L/s | 50 – 900 L/min | Subject device |
| supports this range | |||
| Peak Expiratory | |||
| Flow (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 Expiratory | |||
| Volume (FEV1) | |||
| Range | 1.00 – 7.50 L | 0.01 – 9.99 L | Subject device |
| supports this range | |||
| Forced Expiratory | |||
| Volume (FEV1) | |||
| Accuracy | ± 0.1 L or 5%, | ||
| whichever is larger | ± 0.1 L or 5%, | ||
| whichever is larger | Same | ||
| Subject Device | Secondary | ||
| Predicate | Substantial | ||
| Equivalence | |||
| 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.