(129 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 a HCP.
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.
The Zephyr Sleep Technologies MATRx plus device, a ventilatory effort recorder for aiding in the diagnosis and assessment of sleep-disordered breathing in adult patients, underwent bench testing and performance comparisons to demonstrate substantial equivalence to its predicate device, the ApneaLink Air (K143272).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for clinical performance metrics (like sensitivity, specificity for diagnosing sleep-disordered breathing). Instead, it focuses on demonstrating technological equivalence to the predicate device and satisfactory performance in bench testing.
Therefore, the table below reflects the comparison of technological characteristics between the MATRx plus and its predicate device, ApneaLink Air, as presented in the submission. The acceptance criterion is implicit: the MATRx plus should be "substantially equivalent" in its performance and features to the predicate device.
| Feature / Criterion | Acceptance Criteria (Implicit: Substantially Equivalent to ApneaLink Air K143272) | Reported Device Performance (MATRx plus) | Comments on Equivalence |
|---|---|---|---|
| Intended Use | Aid in diagnosis of sleep disordered breathing for adult patients. Records nasal airflow, snoring, SpO2, pulse, resp effort, body position. | Aid in diagnosis and assessment of sleep disordered breathing for adult patients. Records nasal airflow, snoring, SpO2, pulse, resp effort, body position. | Substantially Equivalent (MATRx plus includes "assessment" in addition to "diagnosis"). |
| Environment of Use | Deployed from Clinics, Hospitals; Used unsupervised in Home or Clinic; Analyzed from physician's office. | Deployed from Clinics, Hospitals; Used unsupervised in Home or Clinic; Analyzed from physician's office. | Equivalent. |
| Outcome | Data to aid in the diagnosis of sleep disordered breathing. | Data to aid in the diagnosis of sleep disordered breathing. | Equivalent. |
| Contraindications | Not for use near MRI. | Not for use near MRI; Not an apnea monitor or for life-supporting situations; Not for use by persons under 18. | Substantially Equivalent (MATRx plus has additional safety contraindications). |
| Oximeter Sensor | Third-party sensor (Nonin Xpod 3012 LP), 1 Hz sampling. | Third-party sensor (Masimo SET 2040), 1 Hz sampling. | Substantially Equivalent. |
| Airflow Sensor | Single channel nasal cannula, 100 Hz sampling for pressure, airflow, snoring. | Dual channel nasal cannula, 350 Hz sampling for pressure, airflow, snoring. | Substantially Equivalent - Dual channel can reduce artifact. |
| Respiratory Effort Sensor | Pneumatic principle, 10 Hz sampling. | Inductance principle (third-party belt Sleep Sense, K042253), 25 Hz sampling. | Substantially Equivalent - Both are commonly used and sensitive enough. |
| Position Sensor | 3D axis accelerometer. | 3D axis accelerometer. | Substantially Equivalent. |
| Snoring Detection | Nasal airflow fluctuation envelope (10-60 Hz), user adjustable threshold. | Nasal airflow fluctuation envelope (10-70 Hz), set threshold. | Substantially Equivalent. |
| Recorder Dimensions | Approx. 2.4" x 4" x 1.2" (predicate). | Approx. 2.48" x 3.11" x 0.83" (MATRx plus). | Substantially Equivalent - Compared to reference device (K021176) at 2.5"x4.5"x1.2". |
| Recorder Weight | 66 g (predicate). | 230 g (MATRx plus). | Substantially Equivalent - Compared to reference device (K021176) at 234g. |
| Data Collection | Sensors direct to recorder, stored on recorder, uploaded via USB post-study. | Sensors direct to recorder, wirelessly transferred (Bluetooth) to tablet, stored on tablet, wirelessly uploaded to web portal post-study. | Substantially Equivalent - Bluetooth connectivity comparable to Nox T3 (K082113). Allows earlier data review. |
| Processor | ARM Cortex M3 based LPC1853. | ARM Cortex M4 based, STM32 F4, 168 MHz; Tablet minimum requirements: 1.33 GHz, 1 GB RAM. | Substantially Equivalent - MATRx plus includes a tablet for data storage and user interaction. |
| Indicators | Via LED: Test Complete, Respiratory Flow. | Via Tablet UI: Test Started, Test Paused, Test Complete, Respiratory Flow, Oximetry Connection, Effort Sensor Connection, Battery Charge. | Substantially Equivalent - Additional feedback provided by MATRx plus (via tablet). |
| 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 (reported); > 100 hours (comment). | Substantially Equivalent. |
| Patient Set-up | On device software, transferred via USB. | On device software, transferred via internet. | Substantially Equivalent - Removal of USB port to increase cybersecurity. |
| Data Storage and Access | Stored and accessible via local database. Copies downloaded locally. | Stored and accessible via manufacturer's secure internet-accessible server. Copies downloaded locally. | Substantially Equivalent. |
| Data Analysis (Indices) | AHI, RI, Apnea Index (various), Hypopnea Index, flow limited breaths, Cheyne-Stokes, ODI, various saturations, various pulse rates. | ODI, Average Saturation, minimum saturation, maximum saturation, min pulse rate, max pulse rate, average pulse rate. (Does NOT calculate AHI, RI, Apnea Index, Hypopnea Index, flow limited breaths, Cheyne-Stokes). | Substantially Equivalent - Raw data available for manual calculation of uncalculated parameters. |
| Biocompatibility | Cleared under K131932. | All body contacting components previously cleared (Nasal Cannula K151506; Oximeter sensor K051212, K090662, K101896). | Substantially Equivalent. |
| Safety Testing | IEC 60601-1-11: 2010; IEC 60601-1-2:2007; IEC 60601-1:2005. | (Implied equivalent; states "Design and system verification testing included... 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.") Rechargeable battery tested to IEC 62133:2012. | Equivalent. |
2. Sample size used for the test set and the data provenance
The document mentions validation of the "Autoscoring algorithm for ODI" (Oxygen Desaturation Index) by comparing its output with the Snore SAT monitor (K002159).
- Test Set Sample Size: 179 patients.
- Data Provenance: Not explicitly stated (e.g., country of origin). It's mentioned as "data from 179 patients" when comparing the autoscoring algorithm. The study appears to be retrospective, using existing data for comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states: "Autoscoring algorithm for ODI was compared with the Snore SAT monitor output (K002159) on data from 179 patients."
- This implies that the "ground truth" for the ODI autoscoring comparison was the output of the Snore SAT monitor (K002159).
- The document does not specify the number of human experts, their qualifications, or their role in establishing this ground truth for the test set. It relies on the predicate device's (or reference device's) established output as the comparative standard.
4. Adjudication method for the test set
Not applicable. The ground truth for the ODI autoscoring was based on the output of a previously cleared device (Snore SAT monitor), not on human consensus or adjudication in this specific context.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study is mentioned for the MATRx plus. The submission focuses on demonstrating substantial equivalence to a predicate device through technological comparison and bench testing, not on assessing human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was done for the Autoscoring algorithm for ODI.
- "Autoscoring algorithm for ODI was compared with the Snore SAT monitor output (K002159) on data from 179 patients."
- This suggests the MATRx plus's algorithm-driven ODI calculation was directly compared to the output of a reference device without human interpretation as part of this specific comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the ODI autoscoring algorithm validation, the ground truth was the output of a legally marketed predicate/reference device, the Snore SAT monitor (K002159). This is a form of "reference device data" ground truth, not pathology, expert consensus, or outcomes data in this specific study.
8. The sample size for the training set
The document does not provide information on the sample size used for training any algorithms within the MATRx plus device. The focus of this 510(k) summary is on demonstrating equivalence, not on detailing algorithm development and training.
9. How the ground truth for the training set was established
Not provided in the document. As no information on the training set is included, the method for establishing its ground truth is also absent.
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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.
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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
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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 SECalgary, Alberta T2H-2J6Canada |
| 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
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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 DeviceComponents | 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: ABSSoft grip edge: Thermoplastic ElastomerKey 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.
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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 |
|---|---|---|
| 510kNumber | K143272 | K163665 |
| Manufacturer | Resmed Germany Inc. | Zephyr Sleep Technologies, Inc. |
| Intended Use | The ApneaLink™ Air device isindicated for use by Health CareProfessionals (HCP), where it mayaid in the diagnosis of sleepdisordered breathing for adultpatients.ApneaLink Air records the followingdata: patient respiratory nasalairflow, snoring, blood oxygensaturation, pulse, respiratory effortand body position during sleep.The device uses these recordings toproduce a report for the HCP thatmay aid in the diagnosis of sleepdisordered breathing or for furtherclinical investigation. The device isintended for home and hospital useunder the direction of a HCP. | The MATRx plus™ is indicated foruse by the Health Care Professional(HCP), where it may aid in thediagnosis and assessment of sleepdisordered breathing for adultpatients.MATRx plus records the followingdata: patient respiratory nasalairflow, snoring, blood oxygensaturation, pulse, respiratory effortand body position during sleep.The device uses these recordings toproduce a report for the HCP thatmay aid in the diagnosis of sleepdisordered breathing. The device isintended for home and hospital useunder 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 | ||
|---|---|---|---|---|
| 510kNumber | K143272 | K163665 | ||
| Manufacturer | Resmed Germany Inc. | Zephyr Sleep Technologies, Inc. | ||
| Environmentof Use | Deployed from Clinics, HospitalsUsed unsupervised in the Home orClinicAnalyzed from physician's office | Deployed from Clinics, HospitalsUsed unsupervised in the Home orClinicAnalyzed from physician's office | ||
| Outcome | Data to aid in the diagnosis ofsleep disordered breathing | Data to aid in the diagnosis ofsleep disordered breathing | ||
| Contra-indications | The ApneaLinkAir system must not be used in thevicinity of an MRI device. | The MATRxplus system must not be used in thevicinity of an MRI device.This device is not to be used as anapnea monitor or in a life supportingor 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 PulseOximeter | Third party oximeter sensor (Nonin Xpod3012 LP) attaches to patient wornrecorder, measure degree of oxygensaturation of the blood and pulse rate.Sampling frequency of 1 Hz | Third party oximeter sensor (MasimoSET 2040) attaches to patient wornrecorder, measure degree of oxygensaturation of the blood and pulse rate.Sampling frequency of 1 Hz | Substantially Equivalent | |
| Airflow | Single channel nasal cannula attaches topatient worn recorder; records pressureand translates to airflow and snoring.Sampling frequency of 100 Hz | Dual channel nasal cannula attaches topatient worn recorder; records pressureand translates to airflow and snoring.Sampling frequency of 350 Hz. | Substantially Equivalent -Sampling airflow separately from eachnaris can reduce artefact with temporaryblockages. | |
| Respiratory Effort | Respiratory effort channel to measure therespiratory effort using a pneumaticprinciple.Sampling frequency of 10 Hz. | Respiratory effort channel to measurethe respiratory effort using aninductance principle.Third-party belt (Sleep Sense,K042253)Sampling frequency of 25 Hz. | Substantially Equivalent -Both are commonly used and aresufficiently sensitive to detect breathingeffort | |
| Position | Channel to determine body position ofthe patient during sleep by 3D axisaccelerometer | Channel to determine body position ofthe patient during sleep by 3D axisaccelerometer | Substantially Equivalent - | |
| Snoring | Nasal airflow fluctuation envelope signal(between 10 and 60 Hz).User adjustable threshold. | Nasal airflow fluctuation envelopesignal (between 10 and 70 Hz).Set threshold. | Substantially Equivalent - | |
| Other channels | none | none | Equivalent | |
| Method ofconnection to thepatient | Plastic tubing and cannula for pressure sensing; belts for respiratory effort; probes orFlexi Wrap for oximetry; touch proof electrode cables; belts for attaching of deviceand 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 | ||
| RecorderDimensions | 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 EquivalentSame as reference device (K021176)which measures 2.5"x4.5"x1.2" | |
| Recorder Weight | 66 g | 230 g | Substantially EquivalentSame 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 untilstudy conclusion and then uploaded viaUSB 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 thetablet until study conclusion. Data iswirelessly collected via device to webportal at the end of the study. | Substantially Equivalent –If desired, the MATRx plus user canhave reviewed the data prior to thereturn of the device and contact thepatient if the study was not successfullycompleted.Bluetooth connectivity substantiallyequivalent to Nox T3 (K082113). | |
| Processor | The microprocessor system (ARM CortexM3 based LPC1853) processes therecorder patient's data (1MB) | Recorder microprocessor system (ARMCortex M4 based, STM32 F4, 168MHz) processes the patient's data(1MB).Tablet minimum requirements: 1.33GHz processor, 1 GB RAM. | Substantially Equivalent –The MATRx plus includes a Tablet tostore the data and guide userinteractions. | |
| Indicators | Via LED:Test CompleteRespiratory Flow | Via Tablet User interface:Test StartedTest Paused | Substantially Equivalent – | |
| Proprietary Name | APNEALINK AIR | MATRx plus | CommentsPredicate vs MATRx plus | |
| 510k Number | K143272 | K163665 | ||
| Manufacturer | Resmed Germany Inc.Oximetry ConnectionEffort Sensor Connection | Zephyr Sleep Technologies, Inc.Test CompleteRespiratory FlowOximetry ConnectionEffort Sensor ConnectionBattery Charge | Additional feedback provided to theMATRx plus user to help facilitate thetest. | |
| Recording Time | 4 x 12 hours | 6 x 8 hours | The total number of study hours in theMATRx 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 isnot replaceable by the user. | |
| Study Set up and Management | ||||
| Patient Set up | Set up on device software and transferredto Device via USB | Set up on device software andtransferred to Device via internet | Substantially Equivalent -Removal of USB port to increasecybersecurity features of the device. | |
| Data Storage andAccess | Data is stored and accessible via localdatabase. Copies are downloaded locallyfor analysis. | Data is stored and accessible viadatabase. Database is located onmanufacturer's secure internetaccessible server. Copies aredownloaded locally for analysis. | Substantially Equivalent - | |
| Design - Data Viewer (PC Application) | ||||
| Data Display | Real time waveforms displayed for all channels; Autoscored oxygendesaturation 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 Softwareand a report can be generated automatically. | Equivalent - | ||
| Proprietary Name | APNEALINK AIR | MATRx plus | CommentsPredicate vs MATRx plus | |
| 510k Number | K143272 | K163665 | Predicate vs MATRx plus | |
| Manufacturer | Resmed Germany Inc. | Zephyr Sleep Technologies, Inc. | ||
| Data Analysis | The following indices aregenerated from the ApneaLink Software:AHI, RI, Apnea Index (unclassified,central, mixed, obstructive),Hypopnea Index, Number of flow limitedbreaths without snoring,Number of flow limited breaths withsnoring, Cheyne-Stokes Breathing,ODI, Average saturation, Minimumsaturation, Maximum saturation,Basal saturation, Minimum Pulse Rate,Maximum Pulse Rate, AveragePulse Rate | The following indices aregenerated from the MATRx plusSoftware:ODI, Average Saturation, minimumsaturation, maximum saturation, minpulse rate, max pulse rate, average pulserate. | Substantially Equivalent –The MATRx plus does not calculate orreport: AHI, RI, Apnea Index(unclassified, central, mixed, obstructive),Hypopnea Index, Number of flow limitedbreaths without snoring, Number of flowlimited breaths with snoring, Cheyne-Stokes Breathing.The raw data necessary for manualcalculation of these parameters and toreview ODI, saturation, and pulse rateare available for display. | |
| Components inPatient 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 componentspreviously cleared | Substantially Equivalent – | |
| Reprocessing | Patient contacting and indirectlycontacting components are reprocessed | Patient contacting and indirectlycontacting components are reprocessed | Substantially Equivalent – | |
| Safety Testing | Tested to IEC 60601-1-11: 2010; Tested to IEC 60601-1-2:2007; Tested to IEC60601-1:2005 | Equivalent | ||
| Patient isolation | Device has no galvanic connections to mains as it is a battery-operated device. Notpossible to connect auxiliary devices to the device | Equivalent - | ||
| Battery Powered | Internally powered: 2 x batteries: LR03 /Micro / AAA / 1.5V/ at least 1.0 Ahor2 x NiMh accumulators: HR03 / Micro /AAA / 1.2 V / at least 1.0 Ah | Internally powered: single cellrechargeable Li-Ion battery(3.7V).The battery is not replaceable by theuser.The battery is charged by a 5V - 2Amedical grade (double insulated) wallpower supply connected with a standardbarrel power jack. | Substantially Equivalent –The battery was safety tested forcompliance 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 contactingComponents | Contact Type | Contact Duration | 510KClearance |
|---|---|---|---|
| Nasal Cannula | ExternallyCommunicating –Tissue/Bone/Dentin | ≤24 hr, cumulative exposure | K151506 |
| Oximeter sensor | Skin contact | ≤24 hr, cumulative exposure | K051212K090662K101896 |
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).
§ 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).