(118 days)
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.
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.
The provided text describes a 510(k) premarket notification for the MATRx Plus device, a ventilatory effort recorder. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (K163665 MATRx Plus) and includes modifications to the scoring algorithms.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided information:
Acceptance Criteria and Device Performance
The document doesn't explicitly list "acceptance criteria" in a table format with specific thresholds. Instead, it demonstrates performance through clinical validation and by showing the new features (3% oxygen desaturation index, 3% and 4% apnea-hypopnea index, preceding peak baseline option, and improved event scoring algorithms) produce "adequate results" and that the device has "comparable sensitivity and accuracy" to a cleared predicate.
However, we can infer the implicit acceptance criteria from the clinical validation study's goal: to demonstrate that the autoscoring algorithm for the detection of apneas and hypopneas was accurate, and that its sensitivity and accuracy are comparable to previously FDA cleared devices.
Inferred Acceptance Criteria & Reported Performance:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accuracy of Apnea and Hypopnea Detection: The autoscoring algorithm for detecting apneas and hypopneas should be accurate. | "The autoscoring algorithm for the detection of apneas and hypopneas was accurate." (This is a qualitative statement of meeting the goal rather than a specific quantitative metric like a percentage, sensitivity, or specificity). |
| Comparability to Cleared Predicates (Sensitivity & Accuracy): The device's apnea and hypopnea detection algorithms should have comparable sensitivity and accuracy to previously FDA cleared ventilatory effort recorder devices (e.g., Embletta MPR Sleep Data Recording System K122516). | "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)." (Again, a qualitative statement affirming comparability rather than providing specific comparative metrics). |
| Additional Features Performance: The new features (ODI 3% autoscoring, preceding peak baseline, event rounding, reduced erroneous scoring) perform as intended. | "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." |
Note: The document provides very high-level summaries of the testing and the results. Specific quantitative metrics (e.g., exact sensitivity/specificity values, or statistical results demonstrating "comparable" performance) are not detailed within this 510(k) summary.
Study Details:
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 27 individuals
- Data Provenance: Subjects had "confirmed or suspected sleep apnea." The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is implied to be prospective clinical validation.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document states that the performance was compared to "the gold standard, polysomnography." It does not specify the number of experts (e.g., sleep specialists, polysomnography technologists) involved in interpreting the polysomnography or establishing the ground truth, nor their specific qualifications. It is generally understood that polysomnography interpretation is performed by qualified sleep physicians or technologists.
-
Adjudication Method for the Test Set:
- The document does not describe any specific adjudication method for the ground truth of the test set beyond stating that polysomnography was the "gold standard." There is no mention of 2+1, 3+1, or other multi-reader adjudication processes.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. The study described is a comparison of the device's autoscoring algorithm against a polysomnography gold standard, not a comparative effectiveness study involving human readers with and without AI assistance. Therefore, there is no effect size reported for human readers' improvement with AI vs. without AI.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Yes. The clinical validation directly assesses the performance of the "autoscoring algorithm for the detection of apneas and hypopneas" by comparing its output to polysomnography. This is a standalone assessment of the algorithm's performance.
-
The Type of Ground Truth Used:
- Expert Consensus / Physiological Gold Standard: The ground truth used was polysomnography (PSG), which is considered the clinical gold standard for diagnosing sleep disordered breathing. While PSG involves expert interpretation, the document frames PSG itself as the "gold standard" rather than raw pathological findings or purely outcome data.
-
The Sample Size for the Training Set:
- The document does not provide any information about the sample size (or any details) of the training set used for the algorithm's development. The focus of this 510(k) summary is on the validation of the modified algorithm.
-
How the Ground Truth for the Training Set Was Established:
- This information is not provided in the document. As mentioned, the document focuses on the validation of the device's modified algorithms.
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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
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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
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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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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 SECalgary, Alberta, CanadaT2H-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 DataRecording 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
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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, CanadaMATRx plus (K163665) | Proposed MATRx plus(subject device) | Discussion ofDifferences | |
|---|---|---|---|
| Classification | MNR, Ventilatory EffortRecorder | MNR, Ventilatory EffortRecorder | Identical |
| Indications forUse | The MATRx plus™ isindicated foruse by the Health CareProfessional (HCP), whereit may aid in the diagnosisand assessment of sleepdisordered breathing foradult patients.MATRx plus records thefollowing data: patientrespiratory nasal airflow,snoring, blood oxygensaturation, pulse,respiratory effort and bodyposition during sleep.The device uses theserecordings to produce areport for the HCP thatmay aid in the diagnosis ofsleep disordered breathing.The device is intended forhome and hospital useunder the direction of anHCP. | The MATRx plus™ isindicated foruse by the Health CareProfessional (HCP), whereit may aid in the diagnosisand assessment of sleepdisordered breathing foradult patients.MATRx plus records thefollowing data: patientrespiratory nasal airflow,snoring, blood oxygensaturation, pulse,respiratory effort and bodyposition during sleep.The device uses theserecordings to produce areport for the HCP thatmay aid in the diagnosis ofsleep disordered breathing.The device is intended forhome and hospital useunder the direction of anHCP. | Identical |
| PatientPopulation | Adults | Adults | Identical |
| Environmentof Use | Deployed from Clinics,Hospitals. Usedunsupervised in the Homeor Clinic. Analyzed fromphysician's office. | Deployed from Clinics,Hospitals. Usedunsupervised in the Homeor Clinic. Analyzed fromphysician's office. | Identical |
| Outcome | 1) Data to assist in thediagnosis of sleepdisordered breathing | 1) Data to assist in thediagnosis of sleepdisordered breathing | Identical |
| Contraindications | The MATRx plus systemmust not be used in thevicinity of an MRI device.This device is not to beused as an apnea monitoror in a life supporting orlife sustaining situation. | The MATRx plus systemmust not be used in thevicinity of an MRI device.This device is not to beused as an apnea monitoror in a life supporting orlife sustaining situation. | Identical |
| MATRX plus (K163665) | Changes from the predicate (K163665;MATRX plus) | Discussion of Differences | |
| Sensors | |||
| PulseOximeter | Third party oximetersensor (Masimo SET 2040)attaches to patient wornrecorder, measures degreeof oxygen saturation of theblood and pulse rate.Sampling frequency of 1Hz. | Third party oximetersensor (Masimo SET 2040)attaches to patient wornrecorder, measures degreeof oxygen saturation of theblood and pulse rate.Sampling frequency of 1Hz. | Identical |
| Airflow | Dual channel nasal cannulaattaches to patient wornrecorder; records pressureand translates to airflowand snoring. Samplingfrequency of 350 Hz. | Dual channel nasal cannulaattaches to patient wornrecorder; records pressureand translates to airflowand snoring. Samplingfrequency of 350 Hz. | Identical |
| RespiratoryEffort | Respiratory effort channelto measure the respiratoryeffort using an inductanceprinciple.Third-party belt (SleepSense, K042253).Sampling frequency of 25Hz. | Respiratory effort channelto measure the respiratoryeffort using an inductanceprinciple.Third-party belt (SleepSense, K042253).Sampling frequency of 25Hz. | Identical |
| Position | Channel to determine bodyposition of the patientduring sleep by 3D axisaccelerometer. | Channel to determine bodyposition of the patientduring sleep by 3D axisaccelerometer. | Identical |
| Snoring | Nasal airflow fluctuationenvelopesignal (between 10 and 70Hz). Set threshold. | Nasal airflow fluctuationenvelopesignal (between 10 and 70Hz). Set threshold. | Identical |
| Other channels | None | None | Identical |
| Method ofconnection tothe patient | Plastic tubing and cannulafor pressure sensing; beltsfor respiratory effort;probes or Flexi Wrap foroximetry; touch proofelectrode cables; belts forattaching of device and clipstraps to secure position ofdevice. The device is wornon the patient's chest. | Plastic tubing and cannulafor pressure sensing; beltsfor respiratory effort;probes or Flexi Wrap foroximetry; touch proofelectrode cables; belts forattaching of device and clipstraps to secure position ofdevice. The device is wornon 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 StartedTest Paused | Via Tablet User interface:Test StartedTest Paused | Identical |
| Oximetry ConnectionEffort 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 | |
| Internalmemory | 48 hours | 48 hours | Identical |
| Battery Cover | Tamper-proof and locked.MATRX plus battery isrecharged and is notreplaceable by the user. | Tamper-proof and locked.MATRX plus battery isrecharged and is notreplaceable by the user. | Identical |
| Study Set up and Management | |||
| Patient Set up | Set up on device softwareand transferred to Devicevia internet. | Set up on device softwareand transferred to Devicevia internet. | Identical |
| Data StorageandAccess | Data are stored andaccessible via database.Database is located onmanufacturer's secureinternet accessible server.Copies are downloadedlocally for analysis. | Data are stored andaccessible via database.Database is located onmanufacturer's secureinternet accessible server.Copies are downloadedlocally for analysis. | Identical |
| Design - Data Viewer (PC Application) | |||
| Data Display | Real time waveformsdisplayed for all channels;Autoscored oxygendesaturation events aretemporally displayed inrelation to the airflow,oxygen, pulse rate andother signals. Summarydata is calculated. | Real time waveformsdisplayed for all channels;Autoscored 4% or 3%oxygen desaturation and4% or 3% apnea-hypopneaevents are temporallydisplayed in relation to theairflow, oxygen, pulse rateand other signals.Summary data arecalculated. | Addition of3% oxygendesaturationindex, 4% and3% apnea-hypopneaindex. Optionfor HCP toselect movingaveragebaseline (usedin predicate)or precedingpeak baseline. |
| Data Reporting | Data related to patientrespiratory nasal airflow,snoring, blood oxygensaturation, pulse,respiratory effort and bodyposition can beanalyzed/displayed bySoftware and a report canbe generated automatically. | Data related to patientrespiratory nasal airflow,snoring, blood oxygensaturation, pulse,respiratory effort and bodyposition can beanalyzed/displayed bySoftware and a report canbe generated automatically. | Addition ofODI 3% andAHIparametersautomaticallygenerated onreport. |
| Data Analysis | The following indices aregenerated from theMATRx plus software:ODI, average saturation, | The following indices aregenerated from theMATRx plus software:ODI (4% and 3%), AHI | Addition ofcalculation of:ODI 3%, AHI(3% and 4%) |
| MATRX plus (K163665) | Changes from the predicate (K163665; MATRX plus) | Discussion of Differences | |
| minimum saturation,maximum saturation, minpulse rate, max pulse rate,average pulse rate. | (4% and 3%), AI (4% and3%), average saturation,minimum saturation,maximum saturation,minimum pulse rate,maximum pulse rate,average pulse rate. | AI (3% and4%). | |
| Components inPatient contact | Recorder and Sensors(Nasal cannula, fingeroximeter, effort belt). | Recorder and Sensors(Nasal cannula, fingeroximeter, effort belt). | Identical |
| Biocompatibility | All body contactingcomponents previouslycleared. | All body contactingcomponents previouslycleared. | Identical |
| Reprocessing | Patient contacting andindirectly contactingcomponents arereprocessed. | Patient contacting andindirectly contactingcomponents arereprocessed. | Identical |
| Safety Testing | Tested to IEC 60601-1-11:2010; Tested to IEC60601-1-2:2007; Tested toIEC 60601-1:2005. | Tested to the new IEC60601-1-2:2014 standard. | Testingupdated tonew standard(60601-1-2:2014) |
| Patient isolation | Device has no galvanicconnections to mains as itis a battery-operateddevice. Not possible toconnect auxiliary devicesto the device. | Device has no galvanicconnections to mains as itis a battery-operateddevice. Not possible toconnect auxiliary devicesto the device. | Identical |
| BatteryPowered | Internally powered: singlecell rechargeable Li-Ionbattery (3.7 V).The battery is notreplaceable by the user.The battery is charged by a5V - 2A medical grade(double insulated) wallpower supply connectedwith a standard barrelpower jack. The batterywas safety tested forcompliance to IEC62133:2012 | Internally powered: singlecell rechargeable Li-Ionbattery (3.7 V).The battery is notreplaceable by the user.The battery is charged by a5V - 2A medical grade(double insulated) wallpower supply connectedwith a standard barrelpower jack. The batterywas safety tested forcompliance to IEC62133:2012 | 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.
§ 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).