(129 days)
No
The summary describes data recording and analysis using an "Autoscoring algorithm for ODI" and comparison to a predicate device's output. There is no mention of AI, ML, or related concepts like neural networks, deep learning, or training/inference processes typically associated with AI/ML. The analysis appears to be based on predefined algorithms rather than learned patterns.
No.
The device is indicated for diagnosis and assessment of sleep disordered breathing, and it records data to produce a report to aid in diagnosis. It does not provide any therapy or treatment.
Yes
The device's intended use explicitly states it "may aid in the diagnosis and assessment of sleep disordered breathing" and "may aid in the diagnosis of sleep disordered breathing." It also produces a report for the HCP to aid in diagnosis, indicating its diagnostic function.
No
The device description clearly states it includes hardware components such as a recorder, sensors (pressure, oximetry, effort), a nasal cannula, and a tablet. While software is involved in data processing and user interface, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The MATRx plus records physiological data directly from the patient's body during sleep (respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort, body position). It does not analyze samples taken from the body.
- Intended Use: The intended use is to aid in the diagnosis and assessment of sleep disordered breathing by recording physiological signals, not by analyzing biological samples.
Therefore, the MATRx plus falls under the category of a medical device that collects physiological data from the patient, rather than an in vitro diagnostic device.
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 a HCP.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
The MATRx plus is a new ventilatory effort recorder device. 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 oximetry module and respiratory effort sensor. The disposable plastic nasal cannula is connected to the MATRx plus recorder and fixed 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 according to the selected study type, 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
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Health Care Professional (HCP), home and hospital 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 Summary:
Design and system verification testing included, among others, mechanical and environmental testing according to IEC 60601-1-11:2010, electrical safety testing according to IEC 60601-1:2005+1 and EMC testing according to IEC 60601-1-2:2007 has been performed. Reprocessing validation testing was completed. A comparison of all performance characteristics for the oximeter and other sensor inputs was completed using bench testing to substantiate equivalence. Autoscoring algorithm for ODI was compared with the Snore SAT monitor output (K002159) on data from 179 patients. Software on the device was verified and validated according to the functionality in conformity to IEC 62304:2006 for software life cycle processes. Test results confirm that the device is in accordance with its specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K002159, K082113, K053269, K021176
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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem depicting three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2017
Zephyr Sleep Technologies Sabina Bruehlmann Director, Technology 610A 70 Ave SE Calgary, Alberta T2H-2J6 Canada
Re: K163665
Trade/Device Name: Matrx Plus Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: April 5, 2017 Received: April 6, 2017
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. 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.
1
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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tina
Kiang-S
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) K163665
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 assessnt 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 a HCP.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in large, bold, teal letters, with the words "Sleep Technologies" in a smaller font underneath. To the right of the word "ZEPHYR" is a crescent moon shape with a star above it. The address "Unit A, 610-70th Avenue S.E. Calgary, AB, T2H 2J6, Canada" is printed below the logo.
510k Summarv - MATRx plus
| Manufacturer Name: | Zephyr Sleep Technologies Inc. |
|---|---|
| Contact Name: | Sabina Bruehlmann, PhD |
| Postal Address: | 610A, 70 Ave SE |
| Calgary, Alberta T2H-2J6 | |
| Canada | |
| Phone Number: | 587-332-0285 |
| Title: | Director, Technology |
| Date: | May 2, 2017 |
| Device Proprietary Name: | MATRx plus |
| Device Common or Usual Name: | Ventilatory Effort Recorder |
| Classification Name: | Breathing Frequency Monitor |
| Classification Code: | Class II |
| Product Codes: | MNR (Ventilatory Effort Recorder) |
| Regulation Number: | MNR 21 CFR 868.2375 |
Predicate Devices:
The MATRx plus is a ventilatory effort recorder. Substantial equivalence is claimed to the Apnealink Air (K143272).
The Snore SAT Recorder (K002159), Nox T3 (K082113), and Masimo SET Rad-8 pulse oximeter (K053269) and Compumedics Somte System (K021176) are used as reference devices.
Device Description:
The MATRx plus is a new ventilatory effort recorder device. 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 oximetry
4
Image /page/4/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in large, bold, teal letters, 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. Below the logo is the address "Unit A, 610-70th Avenue S.E. Calgary, AB, T2H 2J6, Canada".
module and respiratory effort sensor. The disposable plastic nasal cannula is connected to the MATRx plus recorder and fixed 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 according to the selected study type, 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, ox ygen saturation) to aid in diagnosis.
| Subject Device
| Components | Material | Use type |
|---|---|---|
| Nasal Cannula | Polyvinyl Chloride (PVC) | Single patient |
| Oximeter Sensor | 3rd party accessory (K051212, K090662, K101896) provided in finished form | Multiple patient |
| Recorder | Housing: ABS | |
| Soft grip edge: Thermoplastic Elastomer | ||
| Key pad: Autotex (polyester film) | Multiple patient | |
| Recorder Body Strap | Nylon | Multiple patient |
| Effort Belt | 3rd party accessory (K042253) provided in finished form | Multiple patient |
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 a HCP.
5
Image /page/5/Picture/0 description: The image displays the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a large, teal, sans-serif font, with the words "Sleep Technologies" in a smaller font to the right. Above and to the right of the word "ZEPHYR" is a graphic of a crescent moon with a star. Below the logo is the address "Unit A, 610-70th Avenue S.E. Calgary, AB, T2H 2J6, Canada".
Contraindications:
- This device is not to be used as an apnea monitor or in a life supporting or life sustaining situation.
- This device is not to be used by persons under the age of 18. ●
- The MATRx plus is MR Unsafe. .
Patient Population:
The device is intended to be used on adult patients, upon referral from their healthcare provider.
Technological Characteristics:
The MATRx plus is substantially equivalent to the ApneaLink Air [510(k) # K143272, Summary Exhibit 12-01], manufactured by Resmed Germany Inc. The following tables provide a detailed comparison of the MATRx plus technological characteristics in comparison of the intended use for the predicate.
| Trade Name | APNEALINK AIR | MATRX plus |
|---|---|---|
| 510k | ||
| Number | K143272 | K163665 |
| Manufacturer | Resmed Germany Inc. | Zephyr Sleep Technologies, Inc. |
| Intended Use | The ApneaLink™ Air device is | |
| indicated for use by Health Care | ||
| Professionals (HCP), where it may | ||
| aid in the diagnosis of sleep | ||
| disordered breathing for adult | ||
| patients. |
ApneaLink Air 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 or for further
clinical investigation. The device is
intended for home and hospital use
under the direction of a 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 a HCP. |
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Image /page/6/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 curved lines with a star above them. Below the logo is the address "Unit A, 610 - 70th Avenue S.E. Calgary, AB, T2H 2J6, Canada".
| Trade Name | APNEALINK AIR | MATRX plus | ||
|---|---|---|---|---|
| 510k | ||||
| Number | K143272 | K163665 | ||
| Manufacturer | Resmed Germany Inc. | Zephyr Sleep Technologies, Inc. | ||
| 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 | ||||
| Outcome | Data to aid in the diagnosis of | |||
| sleep disordered breathing | Data to aid in the diagnosis of | |||
| sleep disordered breathing | ||||
| Contra- | ||||
| indications | The ApneaLink | |||
| Air system must not be used in the | ||||
| vicinity of an MRI device. | 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. | ||||
| Proprietary Name | APNEALINK AIR | MATRx plus | Comments | |
| 510k Number | K143272 | K163665 | ||
| Manufacturer | Resmed Germany Inc. | Zephyr Sleep Technologies, Inc. | Predicate vs MATRx plus | |
| Sensors | ||||
| Finger Pulse | ||||
| Oximeter | Third party oximeter sensor (Nonin Xpod | |||
| 3012 LP) attaches to patient worn | ||||
| recorder, measure 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, measure degree of oxygen | ||||
| saturation of the blood and pulse rate. | ||||
| Sampling frequency of 1 Hz | Substantially Equivalent | |||
| Airflow | Single channel nasal cannula attaches to | |||
| patient worn recorder; records pressure | ||||
| and translates to airflow and snoring. | ||||
| Sampling frequency of 100 Hz | Dual channel nasal cannula attaches to | |||
| patient worn recorder; records pressure | ||||
| and translates to airflow and snoring. | ||||
| Sampling frequency of 350 Hz. | Substantially Equivalent - | |||
| Sampling airflow separately from each | ||||
| naris can reduce artefact with temporary | ||||
| blockages. | ||||
| Respiratory Effort | Respiratory effort channel to measure the | |||
| respiratory effort using a pneumatic | ||||
| principle. | ||||
| Sampling frequency of 10 Hz. | Respiratory effort channel to measure | |||
| the respiratory effort using an | ||||
| inductance principle. | ||||
| Third-party belt (Sleep Sense, | ||||
| K042253) | ||||
| Sampling frequency of 25 Hz. | Substantially Equivalent - | |||
| Both are commonly used and are | ||||
| sufficiently sensitive to detect breathing | ||||
| effort | ||||
| 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 | Substantially Equivalent - | |||
| Snoring | Nasal airflow fluctuation envelope signal | |||
| (between 10 and 60 Hz). | ||||
| User adjustable threshold. | Nasal airflow fluctuation envelope | |||
| signal (between 10 and 70 Hz). | ||||
| Set threshold. | Substantially Equivalent - | |||
| Other channels | none | none | Equivalent | |
| 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. | Equivalent | |||
| Proprietary Name | APNEALINK AIR | MATRx plus | Comments | |
| 510k Number | K143272 | K163665 | Predicate vs MATRx plus | |
| Manufacturer | Resmed Germany Inc. | Zephyr Sleep Technologies, Inc. | ||
| Device Design | ||||
| Sensor Connection | Sensors (airflow, oximeter, effort belt) are attached to a body worn recorder unit. | Equivalent | ||
| Recorder | ||||
| Dimensions | Recorder: 2.4" x 4" x 1.2" | |||
| Oximeter: 2.1" x 0.8" x 0.6" | Recorder: 2.48" x 3.11" x 0.83" | |||
| Oximeter: 1.9"x 0.6"x 1.3" | Substantially Equivalent | |||
| Same as reference device (K021176) | ||||
| which measures 2.5"x4.5"x1.2" | ||||
| Recorder Weight | 66 g | 230 g | Substantially Equivalent | |
| Same as reference device (K021176) | ||||
| which is body worn and weighs 234g | ||||
| Data collection | All sensors connect direct to recorder. | |||
| Study data is stored on the Recorder until | ||||
| study conclusion and then uploaded via | ||||
| USB cable upon return of the unit. | All sensors connect direct to recorder. | |||
| Study data is wirelessly transferred | ||||
| (Bluetooth) | ||||
| from recorder to tablet and stored on the | ||||
| tablet until study conclusion. Data is | ||||
| wirelessly collected via device to web | ||||
| portal at the end of the study. | Substantially Equivalent – | |||
| If desired, the MATRx plus user can | ||||
| have reviewed the data prior to the | ||||
| return of the device and contact the | ||||
| patient if the study was not successfully | ||||
| completed. | ||||
| Bluetooth connectivity substantially | ||||
| equivalent to Nox T3 (K082113). | ||||
| Processor | The microprocessor system (ARM Cortex | |||
| M3 based LPC1853) processes the | ||||
| recorder patient's data (1MB) | 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. | Substantially Equivalent – | |||
| The MATRx plus includes a Tablet to | ||||
| store the data and guide user | ||||
| interactions. | ||||
| Indicators | Via LED: | |||
| Test Complete | ||||
| Respiratory Flow | Via Tablet User interface: | |||
| Test Started | ||||
| Test Paused | Substantially Equivalent – | |||
| Proprietary Name | APNEALINK AIR | MATRx plus | Comments | |
| Predicate vs MATRx plus | ||||
| 510k Number | K143272 | K163665 | ||
| Manufacturer | Resmed Germany Inc. | |||
| Oximetry Connection | ||||
| Effort Sensor Connection | Zephyr Sleep Technologies, Inc. | |||
| Test Complete | ||||
| Respiratory Flow | ||||
| Oximetry Connection | ||||
| Effort Sensor Connection | ||||
| Battery Charge | Additional feedback provided to the | |||
| MATRx plus user to help facilitate the | ||||
| test. | ||||
| Recording Time | 4 x 12 hours | 6 x 8 hours | The total number of study hours in the | |
| MATRx plus is set by the software. | ||||
| Internal memory | 48 hours | 48 hours | Internal memory is > 100hours. | |
| Battery Cover | User accessible | Tamper-proof and locked | MATRx plus battery is recharged and is | |
| not replaceable by the user. | ||||
| Study Set up and Management | ||||
| Patient Set up | Set up on device software and transferred | |||
| to Device via USB | Set up on device software and | |||
| transferred to Device via internet | Substantially Equivalent - | |||
| Removal of USB port to increase | ||||
| cybersecurity features of the device. | ||||
| Data Storage and | ||||
| Access | Data is stored and accessible via local | |||
| database. Copies are downloaded locally | ||||
| for analysis. | Data is stored and accessible via | |||
| database. Database is located on | ||||
| manufacturer's secure internet | ||||
| accessible server. Copies are | ||||
| downloaded locally for analysis. | Substantially Equivalent - | |||
| 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. | Equivalent | |||
| 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. | Equivalent - | |||
| Proprietary Name | APNEALINK AIR | MATRx plus | Comments | |
| Predicate vs MATRx plus | ||||
| 510k Number | K143272 | K163665 | Predicate vs MATRx plus | |
| Manufacturer | Resmed Germany Inc. | Zephyr Sleep Technologies, Inc. | ||
| Data Analysis | The following indices are | |||
| generated from the ApneaLink Software: | ||||
| AHI, RI, Apnea Index (unclassified, | ||||
| central, mixed, obstructive), | ||||
| Hypopnea Index, Number of flow limited | ||||
| breaths without snoring, | ||||
| Number of flow limited breaths with | ||||
| snoring, Cheyne-Stokes Breathing, | ||||
| ODI, Average saturation, Minimum | ||||
| saturation, Maximum saturation, | ||||
| Basal saturation, Minimum Pulse Rate, | ||||
| Maximum Pulse Rate, Average | ||||
| Pulse Rate | The following indices are | |||
| generated from the MATRx plus | ||||
| Software: | ||||
| ODI, Average Saturation, minimum | ||||
| saturation, maximum saturation, min | ||||
| pulse rate, max pulse rate, average pulse | ||||
| rate. | Substantially Equivalent – | |||
| The MATRx plus does not calculate or | ||||
| report: AHI, RI, Apnea Index | ||||
| (unclassified, central, mixed, obstructive), | ||||
| Hypopnea Index, Number of flow limited | ||||
| breaths without snoring, Number of flow | ||||
| limited breaths with snoring, Cheyne- | ||||
| Stokes Breathing. | ||||
| The raw data necessary for manual | ||||
| calculation of these parameters and to | ||||
| review ODI, saturation, and pulse rate | ||||
| are available for display. | ||||
| Components in | ||||
| Patient contact | Recorder and Sensors (Nasal cannula, | |||
| finger oximeter, effort belt) | Recorder and Sensors (Nasal cannula, | |||
| finger oximeter, effort belt) | Substantially Equivalent – | |||
| Biocompatibility | Cleared under K131932 | All body contacting components | ||
| previously cleared | Substantially Equivalent – | |||
| Reprocessing | Patient contacting and indirectly | |||
| contacting components are reprocessed | Patient contacting and indirectly | |||
| contacting components are reprocessed | Substantially Equivalent – | |||
| Safety Testing | Tested to IEC 60601-1-11: 2010; Tested to IEC 60601-1-2:2007; Tested to IEC | |||
| 60601-1:2005 | Equivalent | |||
| 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 | Equivalent - | |||
| Battery Powered | Internally powered: 2 x batteries: LR03 / | |||
| Micro / AAA / 1.5V | ||||
| / at least 1.0 Ah | ||||
| or | ||||
| 2 x NiMh accumulators: HR03 / Micro / | ||||
| AAA / 1.2 V / at least 1.0 Ah | Internally powered: single cell | |||
| rechargeable Li-Ion battery | ||||
| (3.7V). | ||||
| 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. | Substantially Equivalent – | |||
| The battery was safety tested for | ||||
| compliance to IEC 62133:2012. |
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Image /page/7/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo includes the company name in a stylized font, with the word "ZEPHYR" in large, bold letters and "Sleep Technologies" in smaller letters underneath. To the right of the company name is a graphic of a crescent moon with a star. Below the logo is the company's address: Unit A, 610 - 70th Avenue S.E. Calgary, AB, T2H 2J6, Canada.
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Image /page/8/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the company name in a teal color, with the word "ZEPHYR" in a larger font size than "Sleep Technologies." To the right of the company name is a graphic of three curved lines with a star above them. Below the logo is the company's address: Unit A, 610 - 70th Avenue S.E. Calgary, AB, T2H 2J6, Canada.
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Image /page/9/Picture/0 description: The image contains a logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a bold, teal font, with "Sleep Technologies" written in a smaller font underneath. To the right of the text is a graphic of a crescent moon with a star. The address "Unit A, 610 - 70th Avenue S.E. Calgary, AB, T2H 2J6, Canada" is printed below the logo.
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Image /page/10/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the company name in a teal color, with the word "ZEPHYR" in a larger, bolder font than "Sleep Technologies." To the right of the company name is a graphic of a crescent moon with a star. Below the logo is the company's address: Unit A, 610 - 70th Avenue S.E. Calgary, AB, T2H 2J6, Canada.
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Image /page/11/Picture/1 description: The image displays the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a bold, sans-serif font, with "Sleep Technologies" written in a smaller font underneath. The address "Unit A, 610 - 70th Avenue S.E. Calgary, AB, T2H 2J6, Canada" is printed below the company name.
Bench Testing Summary:
Design and system verification testing included, among others, mechanical and environmental testing according to IEC 60601-1-11:2010, electrical safety testing according to IEC 60601-1:2005+1 and EMC testing according to IEC 60601-1-2:2007 has been performed. Reprocessing validation testing was completed. A comparison of all performance characteristics for the oximeter and other sensor inputs was completed using bench testing to substantiate equivalence. Autoscoring algorithm for ODI was compared with the Snore SAT monitor output (K002159) on data from 179 patients. Software on the device was verified and validated according to the functionality in conformity to IEC 62304:2006 for software life cycle processes. Test results confirm that the device is in accordance with its specifications.
Biocompatibility:
All body contacting components have been cleared in previous 510K devices.
| Patient contacting
Components | Contact Type | Contact Duration | 510K
Clearance |
|----------------------------------|-----------------------------------------------------|-----------------------------|-------------------------------|
| Nasal Cannula | Externally
Communicating –
Tissue/Bone/Dentin | ≤24 hr, cumulative exposure | K151506 |
| Oximeter sensor | Skin contact | ≤24 hr, cumulative exposure | K051212
K090662
K101896 |
Conclusion:
Based on the results of the performance testing for MATRx plus and the substantial equivalence comparison with the predicate devices, MATRx plus is substantially equivalent to the predicate device, the Apnealink Air (K143272).