(118 days)
K163665 MATRx plus
No
The summary describes an "autoscoring algorithm" for detecting apneas and hypopneas, which is a form of automated analysis, but it does not explicitly mention or provide evidence of using AI or ML techniques. The performance study compares the algorithm to polysomnography and a predicate device, focusing on accuracy and sensitivity, which are standard metrics for algorithms, not necessarily indicative of AI/ML. There is no mention of training data, models, or other characteristics typically associated with AI/ML in the context of medical devices.
No
The device aids in the diagnosis and assessment of sleep-disordered breathing by recording physiological data, but it does not provide treatment or therapy for the condition.
Yes
The "Intended Use / Indications for Use" states that the device "may aid in the diagnosis and assessment of sleep disordered breathing for adult patients." The "Device Description" further clarifies that the device produces a report "to aid in diagnosis."
No
The device description clearly outlines multiple hardware components including a recorder, sensors (nasal cannula, pulse oximeter, respiratory effort sensor), and a tablet, in addition to the software application.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description clearly states the device records physiological data from the patient's body (nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort, body position) using external sensors (nasal cannula, pulse oximeter, effort belt). It does not analyze biological samples like blood, urine, or tissue.
- The device is a ventilatory effort recorder. This type of device falls under the category of physiological monitoring equipment, not IVDs.
- The intended use is to aid in the diagnosis and assessment of sleep disordered breathing. While this is a diagnostic purpose, it's achieved through the analysis of physiological signals, not in vitro analysis of biological samples.
Therefore, the MATRx plus device, as described, is a medical device used for physiological monitoring and diagnostic aid, but it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device is indicated for use by the Health Care Professional (HCP), where it may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.
MATRx plus records the following data: patient respiratory nasal airflow. snoring, blood oxygen saturation, pulse. respiratory effort and body position during sleep.
The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing. The device is intended for home and hospital use under the direction of an HCP.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
The MATRx plus device is a ventilatory effort recorder. The MATRx plus recorder is a 5-channel battery-powered respiratory pressure sensor and oximetry system. MATRx plus provides recordings of respiratory pressure, respiratory effort, pulse rate, oxygen saturation, snoring, and body position during sleep. The physician-prescribed device is worn on the patient's abdomen attached to a reusable effort belt, and all relevant respiratory information during sleep is collected via nasal cannula, pulse oximeter, and respiratory effort sensor. The disposable plastic nasal cannula is connected to the MATRx plus recorder and positioned at the patient's nose. The cannula is dual lumen and functions to individually sample the pressure from each naris. The oximetry sensor is fixed at the patient's finger and connects directly to the device. The Recorder receives input from the sensors and wirelessly transmits the data to a bedside Tablet during the study.
The Tablet is set up through a connection to the web portal by the Health Care Professional (HCP) prior to deploying the device to the patient for use in the home. The Tablet runs the MATRx plus application. The Tablet records and stores the data. The MATRx plus application on the Tablet is also used to guide the user through the set up and conduct of the study through a stepwise user interface. At the end of a recording the Tablet advises the patient if sufficient data for analysis were recorded during the night.
After recording, the MATRx plus must be returned to the HCP. The data are automatically uploaded to the secure Portal where they can be accessed and downloaded to the Data Viewer. The Data Viewer can generate a report with the recorded and analyzed data (respiratory pressure, respiratory effort, pulse rate, oxygen saturation) to aid in diagnosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's abdomen (for device attachment), patient's nose (for cannula), patient's finger (for oximetry sensor)
Indicated Patient Age Range
Adults
Intended User / Care Setting
Health Care Professional (HCP); home and hospital use under the direction of an HCP. Deployed from Clinics, Hospitals. Used unsupervised in the Home or Clinic. Analyzed from physician's office.
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
Clinical validation testing was performed with 27 individuals with confirmed or suspected sleep apnea in accordance with the requirements outlined in 21 CFR 812.28 to demonstrate that the autoscoring algorithm for the detection of apneas and hypopneas was accurate. This was performed by comparing the output of the MATRx plus autoscoring to that of the gold standard, polysomnography.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical:
Mechanical and environmental verification testing were conducted according to IEC 60601-1-11:2010, electrical safety testing according to IEC 60601-1:2005+1, and EMC testing according to IEC 60601-1-2:2014 for the predicate device.
Additional verification testing was performed for features changed from the predicate, including the ODI3% autoscoring method, the preceding peak baseline, event rounding, and improvements to reduce erroneous scoring. This testing was found to produce adequate results.
Clinical:
Clinical validation testing was performed with 27 individuals with confirmed or suspected sleep apnea.
The MATRx plus subject's apnea and hyponea detection algorithms have comparable sensitivity and accuracy with previously FDA cleared ventilatory effort recorder devices such as the Embletta MPR Sleep Data Recording System (K122516).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Comparable sensitivity and accuracy for apnea and hypopnea detection.
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.
K163665 MATRx plus
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.
K122516 Embletta MPR Sleep Data Recording System
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
§ 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).
0
November 21, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized depiction of a human figure, and the text reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The logo is simple and professional, and it is easily recognizable.
Zephyr Sleep Technologies Sabina Bruehlmann Director, Technology #102, 701 64th Ave SE Calgary, Alberta, Canada T2H-2C3
Re: K181996
Trade/Device Name: MATRx Plus Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: July 18, 2018 Received: July 26, 2018
Dear Sabina Bruehlmann:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely.
Amy K. Levelle - S
for
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181996
Device Name MATRx plus
Indications for Use (Describe)
The device is indicated for use by the Health Care Professional (HCP), where it may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.
MATRx plus records the following data: patient respiratory nasal airflow. snoring, blood oxygen saturation, pulse. respiratory effort and body position during sleep.
The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing. The device is intended for home and hospital use under the direction of an HCP.
| 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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3
Image /page/3/Picture/1 description: The image is a logo for Zephyr Sleep Technologies. The logo has the word "ZEPHYR" in a large, bold, blue font. Below that is the phrase "Sleep Technologies" in a smaller, but still bold, blue font. The logo also includes the address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada" in a smaller, non-bold font.
Section 5 - 510k Summary - MATRx plus
| Date: | July 18, 2018 |
|---|---|
| Manufacturer Name: | Zephyr Sleep Technologies, Inc. |
| Contact Name: | Sabina Bruehlmann, PhD |
| Title: | Director, Technology |
| Postal Address: | #102, 701 64th Ave SE |
| Calgary, Alberta, Canada | |
| T2H-2C3 | |
| Phone Number: | 587-332-0285 |
| Establishment Registration Number: | 3008960597 |
| Device Proprietary Name: | MATRx plus |
| Classification Name: | CFR 868.2375 Ventilatory Effort Recorder |
| Classification Code: | Class II |
| Product Code: | MNR |
| Predicate Device: | K163665 MATRx plus |
| Reference Device: | K122516 Embletta MPR Sleep Data |
| Recording System |
Device Description:
The MATRx plus device is a ventilatory effort recorder. The MATRx plus recorder is a 5-channel battery-powered respiratory pressure sensor and oximetry system. MATRx plus provides recordings of respiratory pressure, respiratory effort, pulse rate, oxygen saturation, snoring, and body position during sleep. The physician-prescribed device is worn on the patient's abdomen attached to a reusable effort belt, and all relevant respiratory information during sleep is collected via nasal cannula, pulse oximeter, and respiratory effort sensor. The disposable plastic nasal cannula is connected to the MATRx plus recorder and positioned at the patient's nose. The cannula is dual lumen and functions to individually sample the pressure from each naris. The oximetry sensor is fixed at the patient's finger and connects directly to the device. The Recorder receives
4
Image /page/4/Picture/0 description: The image is a logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in large, bold, blue letters, with the words "Sleep Technologies" in a smaller font underneath. To the right of the word "ZEPHYR" is a graphic of a crescent moon and a star. Below the logo is the address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada".
input from the sensors and wirelessly transmits the data to a bedside Tablet during the study.
The Tablet is set up through a connection to the web portal by the Health Care Professional (HCP) prior to deploying the device to the patient for use in the home. The Tablet runs the MATRx plus application. The Tablet records and stores the data. The MATRx plus application on the Tablet is also used to guide the user through the set up and conduct of the study through a stepwise user interface. At the end of a recording the Tablet advises the patient if sufficient data for analysis were recorded during the night.
After recording, the MATRx plus must be returned to the HCP. The data are automatically uploaded to the secure Portal where they can be accessed and downloaded to the Data Viewer. The Data Viewer can generate a report with the recorded and analyzed data (respiratory pressure, respiratory effort, pulse rate, oxygen saturation) to aid in diagnosis.
Intended Use:
The device is indicated for use by the HCP, where it may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.
MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort, and body position during sleep.
The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing. The device is intended for home and hospital use under the direction of an HCP.
Technology:
The MATRx plus subject device is an update to the predicate MATRx plus (K163665) and includes the following changes:
- Expansion of the oxygen desaturation index to include 3% desaturation -
- Addition of an apnea-hypopnea index for both 3 and 4% desaturation -
- Addition of option to toggle between a moving average baseline (previously cleared) and a preceding peak baseline (new)
- -Modifications to the event scoring algorithms
Comparison to Predicate Device:
The MATRx plus subject device is substantially equivalent to the MATRx plus device [K163665 Summary, Exhibit 12-01], manufactured by Zephyr Sleep Technologies, Inc. The following tables provide a detailed comparison of the MATRx plus technological characteristics in comparison of the intended use for the predicate.
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Image /page/5/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a large, bold, teal font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the text is a graphic of a crescent moon with a star.
| | #102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada
MATRx plus (K163665) | Proposed MATRx plus
(subject device) | Discussion of
Differences |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | MNR, Ventilatory Effort
Recorder | MNR, Ventilatory Effort
Recorder | Identical |
| Indications for
Use | The MATRx plus™ is
indicated for
use by the Health Care
Professional (HCP), where
it may aid in the diagnosis
and assessment of sleep
disordered breathing for
adult patients.
MATRx plus records the
following data: patient
respiratory nasal airflow,
snoring, blood oxygen
saturation, pulse,
respiratory effort and body
position during sleep.
The device uses these
recordings to produce a
report for the HCP that
may aid in the diagnosis of
sleep disordered breathing.
The device is intended for
home and hospital use
under the direction of an
HCP. | The MATRx plus™ is
indicated for
use by the Health Care
Professional (HCP), where
it may aid in the diagnosis
and assessment of sleep
disordered breathing for
adult patients.
MATRx plus records the
following data: patient
respiratory nasal airflow,
snoring, blood oxygen
saturation, pulse,
respiratory effort and body
position during sleep.
The device uses these
recordings to produce a
report for the HCP that
may aid in the diagnosis of
sleep disordered breathing.
The device is intended for
home and hospital use
under the direction of an
HCP. | Identical |
| Patient
Population | Adults | Adults | Identical |
| Environment
of Use | Deployed from Clinics,
Hospitals. Used
unsupervised in the Home
or Clinic. Analyzed from
physician's office. | Deployed from Clinics,
Hospitals. Used
unsupervised in the Home
or Clinic. Analyzed from
physician's office. | Identical |
| Outcome | 1) Data to assist in the
diagnosis of sleep
disordered breathing | 1) Data to assist in the
diagnosis of sleep
disordered breathing | Identical |
| Contraindications | The MATRx plus system
must not be used in the
vicinity of an MRI device.
This device is not to be
used as an apnea monitor
or in a life supporting or
life sustaining situation. | The MATRx plus system
must not be used in the
vicinity of an MRI device.
This device is not to be
used as an apnea monitor
or in a life supporting or
life sustaining situation. | Identical |
| | MATRX plus (K163665) | Changes from the predicate (K163665;
MATRX plus) | Discussion of Differences |
| Sensors | | | |
| Pulse
Oximeter | Third party oximeter
sensor (Masimo SET 2040)
attaches to patient worn
recorder, measures degree
of oxygen saturation of the
blood and pulse rate.
Sampling frequency of 1
Hz. | Third party oximeter
sensor (Masimo SET 2040)
attaches to patient worn
recorder, measures degree
of oxygen saturation of the
blood and pulse rate.
Sampling frequency of 1
Hz. | Identical |
| Airflow | Dual channel nasal cannula
attaches to patient worn
recorder; records pressure
and translates to airflow
and snoring. Sampling
frequency of 350 Hz. | Dual channel nasal cannula
attaches to patient worn
recorder; records pressure
and translates to airflow
and snoring. Sampling
frequency of 350 Hz. | Identical |
| Respiratory
Effort | Respiratory effort channel
to measure the respiratory
effort using an inductance
principle.
Third-party belt (Sleep
Sense, K042253).
Sampling frequency of 25
Hz. | Respiratory effort channel
to measure the respiratory
effort using an inductance
principle.
Third-party belt (Sleep
Sense, K042253).
Sampling frequency of 25
Hz. | Identical |
| Position | Channel to determine body
position of the patient
during sleep by 3D axis
accelerometer. | Channel to determine body
position of the patient
during sleep by 3D axis
accelerometer. | Identical |
| Snoring | Nasal airflow fluctuation
envelope
signal (between 10 and 70
Hz). Set threshold. | Nasal airflow fluctuation
envelope
signal (between 10 and 70
Hz). Set threshold. | Identical |
| Other channels | None | None | Identical |
| Method of
connection to
the patient | Plastic tubing and cannula
for pressure sensing; belts
for respiratory effort;
probes or Flexi Wrap for
oximetry; touch proof
electrode cables; belts for
attaching of device and clip
straps to secure position of
device. The device is worn
on the patient's chest. | Plastic tubing and cannula
for pressure sensing; belts
for respiratory effort;
probes or Flexi Wrap for
oximetry; touch proof
electrode cables; belts for
attaching of device and clip
straps to secure position of
device. The device is worn
on the patient's chest. | Identical |
| Device Design | | | |
| #102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada | | | |
| | MATRX plus (K163665) | Changes from the predicate (K163665; MATRX plus) | Discussion of Differences |
| Sensor Connection | Sensors (airflow, oximeter, effort belt) are attached to a body worn recorder unit. | Sensors (airflow, oximeter, effort belt) are attached to a body worn recorder unit. | Identical |
| Recorder Dimensions | Recorder: 2.48" x 3.11" x 0.83"
Oximeter: 1.9"x 0.6"x 1.3" | Recorder: 2.48" x 3.11" x 0.83"
Oximeter: 1.9"x 0.6"x 1.3" | Identical |
| Recorder Weight | 230 g | 230 g | Identical |
| Data collection | All sensors connect direct to recorder.
Study data are wirelessly transferred (Bluetooth) from recorder to tablet and stored on the tablet until study conclusion. Data are wirelessly collected via device to web portal at the end of the study. | All sensors connect direct to recorder.
Study data are wirelessly transferred (Bluetooth) from recorder to tablet and stored on the tablet until study conclusion. Data are wirelessly collected via device to web portal at the end of the study. | Identical |
| Processor | Recorder microprocessor system (ARM Cortex M4 based, STM32 F4, 168 MHz) processes the patient's data (1MB).
Tablet minimum requirements: 1.33 GHz processor, 1 GB RAM.
The MATRx plus includes a Tablet to store the data and guide user interactions. | Recorder microprocessor system (ARM Cortex M4 based, STM32 F4, 168 MHz) processes the patient's data (1MB).
Tablet minimum requirements: 1.33 GHz processor, 1 GB RAM.
The MATRx plus includes a Tablet to store the data and guide user interactions. | Identical |
| Indicators | Via Tablet User interface:
Test Started
Test Paused | Via Tablet User interface:
Test Started
Test Paused | Identical |
| Oximetry Connection
Effort Sensor Connection | Additional feedback provided to the MATRx plus user to help facilitate the test. | Additional feedback provided to the MATRx plus user to help facilitate the test. | Identical |
| Recording Time | 6 x 8 hours. The total number of study hours in the MATRx plus is set by the software. Internal memory is > 100 hours | 6 x 8 hours. The total number of study hours in the MATRx plus is set by the software. Internal memory is > 100 hours | Identical |
| #102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada | | | |
| | MATRX plus (K163665) | Changes from the predicate (K163665; MATRx plus) | Discussion of Differences |
| Internal
memory | 48 hours | 48 hours | Identical |
| Battery Cover | Tamper-proof and locked.
MATRX plus battery is
recharged and is not
replaceable by the user. | Tamper-proof and locked.
MATRX plus battery is
recharged and is not
replaceable by the user. | Identical |
| Study Set up and Management | | | |
| Patient Set up | Set up on device software
and transferred to Device
via internet. | Set up on device software
and transferred to Device
via internet. | Identical |
| Data Storage
and
Access | Data are stored and
accessible via database.
Database is located on
manufacturer's secure
internet accessible server.
Copies are downloaded
locally for analysis. | Data are stored and
accessible via database.
Database is located on
manufacturer's secure
internet accessible server.
Copies are downloaded
locally for analysis. | Identical |
| Design - Data Viewer (PC Application) | | | |
| Data Display | Real time waveforms
displayed for all channels;
Autoscored oxygen
desaturation events are
temporally displayed in
relation to the airflow,
oxygen, pulse rate and
other signals. Summary
data is calculated. | Real time waveforms
displayed for all channels;
Autoscored 4% or 3%
oxygen desaturation and
4% or 3% apnea-hypopnea
events are temporally
displayed in relation to the
airflow, oxygen, pulse rate
and other signals.
Summary data are
calculated. | Addition of
3% oxygen
desaturation
index, 4% and
3% apnea-
hypopnea
index. Option
for HCP to
select moving
average
baseline (used
in predicate)
or preceding
peak baseline. |
| Data Reporting | Data related to patient
respiratory nasal airflow,
snoring, blood oxygen
saturation, pulse,
respiratory effort and body
position can be
analyzed/displayed by
Software and a report can
be generated automatically. | Data related to patient
respiratory nasal airflow,
snoring, blood oxygen
saturation, pulse,
respiratory effort and body
position can be
analyzed/displayed by
Software and a report can
be generated automatically. | Addition of
ODI 3% and
AHI
parameters
automatically
generated on
report. |
| Data Analysis | The following indices are
generated from the
MATRx plus software:
ODI, average saturation, | The following indices are
generated from the
MATRx plus software:
ODI (4% and 3%), AHI | Addition of
calculation of:
ODI 3%, AHI
(3% and 4%) |
| | MATRX plus (K163665) | Changes from the predicate (K163665; MATRX plus) | Discussion of Differences |
| | minimum saturation,
maximum saturation, min
pulse rate, max pulse rate,
average pulse rate. | (4% and 3%), AI (4% and
3%), average saturation,
minimum saturation,
maximum saturation,
minimum pulse rate,
maximum pulse rate,
average pulse rate. | AI (3% and
4%). |
| Components in
Patient contact | Recorder and Sensors
(Nasal cannula, finger
oximeter, effort belt). | Recorder and Sensors
(Nasal cannula, finger
oximeter, effort belt). | Identical |
| Biocompatibility | All body contacting
components previously
cleared. | All body contacting
components previously
cleared. | Identical |
| Reprocessing | Patient contacting and
indirectly contacting
components are
reprocessed. | Patient contacting and
indirectly contacting
components are
reprocessed. | Identical |
| Safety Testing | Tested to IEC 60601-1-11:
2010; Tested to IEC
60601-1-2:2007; Tested to
IEC 60601-1:2005. | Tested to the new IEC
60601-1-2:2014 standard. | Testing
updated to
new standard
(60601-1-
2:2014) |
| Patient isolation | Device has no galvanic
connections to mains as it
is a battery-operated
device. Not possible to
connect auxiliary devices
to the device. | Device has no galvanic
connections to mains as it
is a battery-operated
device. Not possible to
connect auxiliary devices
to the device. | Identical |
| Battery
Powered | Internally powered: single
cell rechargeable Li-Ion
battery (3.7 V).
The battery is not
replaceable by the user.
The battery is charged by a
5V - 2A medical grade
(double insulated) wall
power supply connected
with a standard barrel
power jack. The battery
was safety tested for
compliance to IEC
62133:2012 | Internally powered: single
cell rechargeable Li-Ion
battery (3.7 V).
The battery is not
replaceable by the user.
The battery is charged by a
5V - 2A medical grade
(double insulated) wall
power supply connected
with a standard barrel
power jack. The battery
was safety tested for
compliance to IEC
62133:2012 | Identical |
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Image /page/6/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo has the word "ZEPHYR" in large blue font on the top line, and the words "Sleep Technologies" in a smaller blue font on the second line. To the right of the words is a blue graphic of a crescent moon and a star. The address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada" is printed in a small font below the logo.
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Image /page/7/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo consists of the word "ZEPHYR" in a large, bold, blue font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the word "ZEPHYR" is a graphic of a crescent moon with a star. The address "#102, 701-64th Avenue SE, Calgary, AB, T2H 2C3, Canada" is printed below the company name.
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Image /page/8/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in large, blue, sans-serif font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the company name is a blue graphic of curved lines and a star. The address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada" is printed below the company name.
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Image /page/9/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo consists of the word "ZEPHYR" in a large, bold, blue font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the word "ZEPHYR" is a graphic of a crescent moon with a star. The address "#102, 701-64th Avenue SE, Calgary, AB, T2H 2C3, Canada" is printed below the company name.
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Image /page/10/Picture/0 description: The image displays the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a large, bold, blue font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the text is a stylized image of a crescent moon with a star above it. The address "#102, 701-64th Avenue SE, Calgary, AB, T2H 2C3, Canada" is printed below the logo.
Testing Summary: Non-clinical:
Mechanical and environmental verification testing were conducted according to IEC 60601-1-11:2010, electrical safety testing according to IEC 60601-1:2005+1, and EMC testing according to IEC 60601-1-2:2014 for the predicate device. As no changes have been made to the subject device that would affect such testing, this testing was not repeated. Similarly, reprocessing validation was not repeated for the subject device as no relevant changes have been made to the subject device that could affect reprocessing.
All features that were changed from the predicate devices are covered by additional verification testing to ensure the intended performance and was found to produce adequate results. Performance bench testing was performed to validate the addition of the ODI3% autoscoring method, the preceding peak baseline, event rounding, and the improvements to reduce erroneous scoring.
Clinical:
Clinical validation testing was performed with 27 individuals with confirmed or suspected sleep apnea in accordance with the requirements outlined in 21 CFR 812.28 to demonstrate that the autoscoring algorithm for the detection of apneas and hypopneas was accurate. This was performed by comparing the output of the MATRx plus autoscoring to that of the gold standard, polysomnography. The results of this testing demonstrate that the MATRx plus subject's apnea and hyponea detection algorithms have comparable sensitivity and accuracy with previously FDA cleared ventilatory effort recorder devices such as the Embletta MPR Sleep Data Recording System (K122516).
Conclusion:
The conclusions drawn from the non-clinical and clinical tests demonstrate that the device is as safe and effective and performs as well as or better than the legally marketed MATRx plus predicate device cleared under K163665.