(103 days)
No
The summary describes data recording, transmission, and report generation based on physiological signals. It mentions "feedback control" for the automated mandibular positioner, which is a standard engineering control mechanism and does not inherently imply AI/ML. There are no mentions of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as a diagnostic and assessment tool for sleep-disordered breathing, including aiding in the diagnosis of Obstructive Sleep Apnea (OSA) and identifying suitable candidates for oral appliance therapy, rather than providing direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section states: "MATRx plus uses these recordings to produce a report for the HCP that may aid in the diagnosis and assessment of sleep disordered breathing for adult patients." This directly indicates its role as an aid in diagnosis.
No
The device description clearly outlines multiple hardware components including a respiratory pressure sensor, oximetry system, effort belt, nasal cannula, pulse oximetry module, recorder, tablet, and a mandibular positioner. While software is involved in data collection, transmission, storage, and analysis, the device is not solely software.
Based on the provided information, the MATRx plus device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The MATRx plus device records physiological data from the patient's body (airflow, snoring, oxygen saturation, pulse, effort, position) using external sensors and a nasal cannula. It does not analyze biological samples like blood, urine, or tissue.
- The device's function is to record and analyze physiological signals. Its purpose is to monitor and assess sleep-disordered breathing and aid in the management of oral appliance therapy. This is a form of physiological monitoring and diagnostic aid, not an in vitro test.
Therefore, the MATRx plus device falls under the category of a medical device that collects and analyzes physiological data, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MATRx plus is indicated for use by a lay person in the home and hospital use under the direction of a Health Care Professional (HCP).
MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep.
MATRx plus uses these recordings to produce a report for the HCP that may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.
The MATRx plus device may also be used with an automated mandibular positioner that uses feedback control to record changes in the patient's respiratory status related to repositioning of the mandible during an overnight study.
MATRx plus uses these recordings to produce a report for that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position.
The use of the device does not replace the need for follow-up testing to determine the initial and ongoing effectiveness of the therapy as recommended by clinical practice guidelines.
Product codes
MNR, QCJ
Device Description
MATRx plus is a ventilatory effort recorder and closed loop auto-titration device for oral appliances. MATRx plus is a 5-channel battery-powered respiratory pressure sensor and oximetry system. MATRx plus provides recordings of respiratory pressure, snoring, respiratory effort, pulse rate, oxygen saturation, and body position during sleep.
The 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 healthcare professional (HCP) prior to deploying the device to the patient for home use. The Tablet runs the MATRx plus application and 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.
During an auto-titration study, the patient wears temporary Titration Trays connected to a mandibular positioner. During the study, the device moves the mandible in response to respiratory events in order to determine if the patient is a suitable candidate for oral appliance therapy.
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 (when used as a ventilatory effort recorder) or to assist the HCP in the clinical management of oral appliance therapy for patients with obstructive sleep apnea.
The device is intended to be used on adult patients, upon referral from their healthcare provider.
The device is not to be used as an apnea monitor or in a life supporting or life sustaining situation and must not be used in the vicinity of an MRI device.
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
Lay person in the home and hospital use under the direction of a Health Care Professional (HCP).
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)
Non-clinical: The subject device was tested to the following standards: IEC 60601-1: 2005 3rd ed. + A1:2012, IEC 60601-1-2: 2014, IEC 60601-1-6: 2010. AMDI:2003, IEC 62366: 2007, IEC 60601-1-10: 2007, IEC 60601-1-11: 2015, IEC 62304: 2006 186 Ed. + A1:2015, IEC 80601-2-61:2011, IEC 62133, EN 62311:2008, EN 300 328/1 1.8.1, EN 301 489-1, EN 301 489-17, FCC Part 15B, FCC Part 2.1091, 15.247. Reprocessing validation was completed on the new device hardware and new, simpler reprocessing instructions. Performance bench testing was completed to demonstrate that the subject device's mandibular positioner and oximeter meet the same performance criteria as those cleared in the predicate (cleared in DEN170090). All materials in contact with the mucosal membrane were assessed and tested in accordance with ISO 10993-1 and the associated FDA guidance, Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices – Part 1 Evaluation and Testing within a Risk Management Process" issued June 16, 2016. Specifically, the following tests were performed: ISO 10993-5: 2009, IOS 10993-10: 2010.
Clinical: Clinical performance testing was not required for the changes made to the subject device.
Conclusion: The conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the legally marketed MATRx plus predicate devices cleared under DEN170090 and K181996.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MATRx plus (K181996)
Reference Device(s)
K190051 TD Clip, K182312 Zyppah
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 29, 2019
Zephyr Sleep Technologies Sabina Bruehlmann Director, Technology #102, 701 64th Ave SE Calgary, Alberta, Canada T2H-2C3
Re: K191925
Trade/Device Name: MATRx Plus Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR, QCJ Dated: August 2, 2019 Received: August 5, 2019
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
1
Page 2
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191925
Device Name MATRx Plus
Indications for Use (Describe)
The MATRx plus is indicated for use by a lay person in the home and hospital use under the direction of a Health Care Professional (HCP).
MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep.
MATRx plus uses these recordings to produce a report for the HCP that may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.
The MATRx plus device may also be used with an automated mandibular positioner that uses feedback control to record changes in the patient's respiratory status related to repositioning of the mandible during an overnight study.
MATRx plus uses these recordings to produce a report for that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position.
The use of the device does not replace the need for follow-up testing to determine the initial and ongoing effectiveness of the therapy as recommended by clinical practice guidelines.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a large, bold, sans-serif 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. Below the logo is the address "#102, 701-64th Avenue SE, Calgary, AB, T2H 2C3, Canada".
K191925 Rev. October 26, 2019
Section 5 - 510k Summary - MATRx plus
| Submission Date: | July 16, 2019 |
|---|---|
| 510(k): | K191925 |
| Manufacturer Name: | Zephyr Sleep Technologies, Inc. |
| Contact Name: | Sabina Bruehlmann, PhD |
| Title: | Director, Technology |
| Postal Address: | #102, 701 64th Ave SE |
| Calgary, Alberta, Canada | |
| T2H-2C3 | |
| Phone Number: | 587-317-1976 |
| Establishment Registration Number: | 3008960597 |
| Device Proprietary Name: | MATRx plus |
| CFR 872.5571 Closed Loop Auto Titration | |
| Device for Oral Appliances; | |
| Classification Name: | CFR 868.2375 Ventilatory Effort Recorder |
| Classification Code: | Class II |
| Product Code: | QCJ, MNR |
| Primary Predicate: | MATRx plus (K181996) |
| Reference Device: | K190051 TD Clip; |
| K182312 Zyppah |
Device Description:
MATRx plus is a ventilatory effort recorder and closed loop auto-titration device for oral appliances. MATRx plus is a 5-channel battery-powered respiratory pressure sensor and oximetry system. MATRx plus provides recordings of respiratory pressure, snoring, respiratory effort, pulse rate, oxygen saturation, and body position during sleep.
The 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
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Image /page/4/Picture/1 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the company name in a blue font, 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: #102, 701-64th Avenue SE, Calgary, AB, T2H 2C3, Canada.
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 healthcare professional (HCP) prior to deploying the device to the patient for home use. The Tablet runs the MATRx plus application and 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.
During an auto-titration study, the patient wears temporary Titration Trays connected to a mandibular positioner. During the study, the device moves the mandible in response to respiratory events in order to determine if the patient is a suitable candidate for oral appliance therapy.
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 (when used as a ventilatory effort recorder) or to assist the HCP in the clinical management of oral appliance therapy for patients with obstructive sleep apnea.
The device is intended to be used on adult patients, upon referral from their healthcare provider.
The device is not to be used as an apnea monitor or in a life supporting or life sustaining situation and must not be used in the vicinity of an MRI device.
Indications for Use:
The MATRx plus is indicated for use by a lay person in the home and hospital use under the direction of a Health Care Professional (HCP).
MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep.
MATRx plus uses these recordings to produce a report for the HCP that may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.
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Image /page/5/Picture/1 description: The image shows 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 blue graphic of curved lines and a star. Below the logo is the address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada".
The MATRx plus device may also be used with an automated mandibular positioner that uses feedback control to record changes in the patient's respiratory status related to repositioning of the mandible during an overnight study.
MATRx plus uses these recordings to produce a report for the HCP that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position.
The use of the device does not replace the need for follow-up testing to determine the initial and ongoing effectiveness of the therapy as recommended by clinical practice guidelines.
Technology:
The MATRx plus subject device is an updated version of the predicates cleared in DEN170090 and K181996. Minor changes have been made to device hardware to make the Recorder and mandibular positioner components slightly smaller and lighter, and to software to provide the healthcare professional with additional option for test set up and study workflow. The Titration Trays used during an auto-titration study can now be used for up to 6 nights and can be fit by a trained healthcare professional.
Comparison to Predicate Devices:
The MATRx plus subject device is substantially equivalent to the MATRx plus device (K181996 and DEN170090;), 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 predicates.
| Trade Name | MATRx plus | Proposed MATRx plus | Discussion of Differences |
|---|---|---|---|
| 510k Number | K181996/DEN170090 | -- | |
| Manufacturer | Zephyr Sleep Technologies, | ||
| Inc. | Zephyr Sleep Technologies, | ||
| Inc. | |||
| Indications for | |||
| Use | The MATRx plus is indicated | ||
| for use by a lay person in the | |||
| home and hospital use under | |||
| the direction of a Health Care | |||
| Professional (HCP). | The MATRx plus is indicated | ||
| for use by a lay person in the | |||
| home and hospital use under | |||
| the direction of a Health Care | |||
| Professional (HCP). | Identical | ||
| MATRx plus records the | |||
| following data: patient | |||
| respiratory nasal airflow, | |||
| snoring, blood oxygen | |||
| saturation, pulse, respiratory | |||
| effort and body position during | |||
| sleep. | MATRx plus records the | ||
| following data: patient | |||
| respiratory nasal airflow, | |||
| snoring, blood oxygen | |||
| saturation, pulse, respiratory | |||
| effort and body position during | |||
| sleep. | |||
| MATRx plus uses these | MATRx plus uses these | ||
| Trade Name | MATRx plus | Proposed MATRx plus | Discussion of Differences |
| 510k Number | K181996/DEN170090 | -- | |
| Manufacturer | Zephyr Sleep Technologies, | ||
| Inc. | Zephyr Sleep Technologies, | ||
| Inc. | |||
| recordings to produce a report | |||
| for the HCP that may aid in the | |||
| diagnosis of sleep disordered | |||
| breathing for adult patients. | recordings to produce a report | ||
| for the HCP that may aid in | |||
| the diagnosis of sleep | |||
| disordered breathing for adult | |||
| patients. | |||
| The MATRx plus device may | |||
| also be used with an automated | |||
| mandibular positioner that uses | |||
| feedback control to record | |||
| changes in the patient's | |||
| respiratory status related to | |||
| repositioning of the mandible | |||
| during an overnight study. | The MATRx plus device may | ||
| also be used with an | |||
| automated mandibular | |||
| positioner that uses feedback | |||
| control to record changes in | |||
| the patient's respiratory status | |||
| related to repositioning of the | |||
| mandible during an overnight | |||
| study. | |||
| MATRx plus uses these | |||
| recordings to produce a report | |||
| for the HCP that can be used to | |||
| prospectively identify patients | |||
| with mild to moderate | |||
| obstructive sleep apnea who | |||
| may be suitable for therapy | |||
| with an oral appliance and to | |||
| recommend a target | |||
| mandibular position. | |||
| The use of the device does not | |||
| replace the need for follow-up | |||
| testing to determine the initial | |||
| and ongoing effectiveness of | |||
| the therapy as recommended | |||
| by clinical practice guidelines. | MATRx plus uses these | ||
| recordings to produce a report | |||
| for the HCP that can be used | |||
| to prospectively identify | |||
| patients with mild to moderate | |||
| obstructive sleep apnea who | |||
| may be suitable for therapy | |||
| with an oral appliance and to | |||
| recommend a target | |||
| mandibular position. | |||
| The use of the device does not | |||
| replace the need for follow-up | |||
| testing to determine the initial | |||
| and ongoing effectiveness of | |||
| the therapy as recommended | |||
| by clinical practice guidelines. | |||
| Patient | |||
| Population | Adults | Adults | Identical |
| Environment of | |||
| Use | Deployed from clinics, | ||
| hospitals | |||
| Used unsupervised in the home | |||
| or clinic | |||
| Analyzed from physician's | |||
| office | Deployed from clinics, | ||
| hospitals | |||
| Used unsupervised in the | |||
| home or clinic | |||
| Analyzed from physician's | |||
| office | Identical | ||
| Outcome | 1) Data to assist in the | ||
| diagnosis of sleep disordered | |||
| breathing (K181996); |
- Identifying patients with
mild to moderate sleep apnea
for whom an oral appliance is | 1) Data to assist in the
diagnosis of sleep disordered
breathing; - Identifying patients with
mild to moderate sleep apnea | Identical |
| Trade Name | MATRx plus | Proposed MATRx plus | Discussion of
Differences |
| 510k Number | K181996/DEN170090 | -- | |
| Manufacturer | Zephyr Sleep Technologies,
Inc. | Zephyr Sleep Technologies,
Inc. | |
| | a suitable therapy
(DEN170090). | for whom an oral appliance is
a suitable therapy. | |
| Contra-
indications | The device is not to be used as
an apnea monitor or in a life
supporting or life sustaining
situation. | The device is not to be used as
an apnea monitor or in a life
supporting or life sustaining
situation. | Identical |
| | The device is not to be used by
persons under the age of 18. | The device is not to be used by
persons under the age of 18. | |
| | The MATRx plus is MR
unsafe. | The MATRx plus is MR
unsafe. | |
| | In auto-titration study mode,
the device is not recommended
for use in patients who: have
loose teeth or advanced
periodontal disease; have full
dentures or dental implants. | In auto-titration study mode,
the device is not recommended
for use in patients who: have
loose teeth or advanced
periodontal disease; have full
dentures or dental implants. | |
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Image /page/6/Picture/0 description: The image contains the text "K191925" and "Rev. October 26, 2019". The text is arranged in two lines, with "K191925" on the top line and "Rev. October 26, 2019" on the bottom line. The text is in a clear, sans-serif font and is easily readable.
Image /page/6/Picture/1 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a large, sans-serif 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 above it. Below the logo is the address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada".
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Image /page/7/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo is in blue and features the company name in a stylized font, with the words "Sleep Technologies" appearing below "ZEPHYR". To the right of the company name is a graphic of a crescent moon with a star. Below the logo is the address: #102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada.
| Proprietary Name | MATRx plus | Proposed MATRx plus subject device | Discussion of Differences |
|---|---|---|---|
| 510(k) Number | DEN170090/K181996 | ||
| Manufacturer | Zephyr Sleep Technologies, Inc. | Zephyr Sleep Technologies, Inc. | |
| Sensors | |||
| Pulse | |||
| Oximeter | Third party oximeter sensor (Masimo SET 2040) attaches to patient worn recorder, measures degree of oxygen saturation of the blood and pulse rate. Sampling frequency of 1 Hz. | Third party oximeter sensor (Masimo SET 2040D) attaches to patient worn recorder, measures degree of oxygen saturation of the blood and pulse rate. Sampling frequency of 1 Hz. | Functionally identical; oximeters have same technology and performance standards. Substantially equivalent. |
| Airflow | Dual channel nasal cannula attaches to patient worn recorder; records pressure and translates to airflow and snoring. Sampling frequency of 350 Hz. In auto-titration mode, an alert will notify the user | Dual channel nasal cannula attaches to patient worn recorder; records pressure and translates to airflow and snoring. Sampling frequency of 350 Hz. In auto-titration mode, an alert will notify the user | No changes to airflow collection or analysis. Change to airflow alert in auto-titration study mode has no effect on data collected or test outcome. Substantially equivalent. |
| Proprietary Name | MATRx plus | Proposed MATRx plus | |
| subject device | Discussion of | ||
| Differences | |||
| 510(k) Number | DEN170090/K181996 | ||
| Manufacturer | Zephyr Sleep | ||
| Technologies, Inc. | |||
| if the airflow signal has | |||
| been absent for 90 s. | Zephyr Sleep | ||
| Technologies, Inc. | |||
| if the airflow signal has | |||
| been absent for 120 s. | |||
| Respiratory Effort | Respiratory effort | ||
| channel to measure the | |||
| respiratory effort using | |||
| an inductance principle. | |||
| Third-party belt (Sleep | |||
| Sense, K042253). | |||
| Sampling frequency of | |||
| 25 Hz. | Respiratory effort | ||
| channel to measure the | |||
| respiratory effort using | |||
| an inductance principle. | |||
| Third-party belt (Sleep | |||
| Sense, K042253). | |||
| Sampling frequency of | |||
| 25 Hz. | Identical | ||
| Position | Channel to determine | ||
| body position of the | |||
| patient during sleep by | |||
| 3D axis accelerometer. | Channel to determine | ||
| body position of the | |||
| patient during sleep by | |||
| 3D axis accelerometer. | Identical | ||
| Snoring | Nasal airflow fluctuation | ||
| envelope signal (between | |||
| 10 and 70 Hz). | |||
| Set threshold. | Nasal airflow fluctuation | ||
| envelope signal (between | |||
| 10 and 70 Hz). | |||
| Set threshold. | Identical | ||
| Mandibular | |||
| Positioner | Small, lightweight, | ||
| motorized positioner | |||
| attached to temporary | |||
| Titration Trays. |
Mandibular positioner is
held in place by the
Titration Trays, which fit
firmly to the dentition.
The mandibular
positioner consists of one
sealed rod with a double
seal design. The
mandibular positioner is
made from acrylonitrile
butadiene styrene (ABS).
The actuator rod material
is made from acetal resin
or anodized stainless
steel.
Digital transfer of
mandibular position,
sound, and acceleration.
Powered by 14 V
(hardware configurable). | Small, lightweight,
motorized positioner
attached to temporary
Titration Trays.
Mandibular positioner is
held in place by the
Titration Trays, which fit
firmly to the dentition.
The mandibular
positioner consists of one
sealed rod with a double
seal design. The
mandibular positioner is
made from acrylonitrile
butadiene styrene (ABS).
The actuator rod material
is made from acetal
resin, anodized stainless
steel, or anodized
aluminum.
Digital transfer of
mandibular position,
sound, and acceleration.
Powered by 14 V
(hardware configurable). | Identical aside from
addition of anodized
aluminum actuator.
Mandibular positioner
function is not affected
by change to actuator
material. Substantially
equivalent. |
| Proprietary Name | MATRx plus | Proposed MATRX plus
subject device | Discussion of
Differences |
| 510(k) Number | DEN170090/K181996 | | |
| Manufacturer | Zephyr Sleep
Technologies, Inc. | Zephyr Sleep
Technologies, Inc. | |
| | Digital signal is
converted from analogue
on the MP board. | Digital signal is
converted from analogue
on the MP board. | |
| | Mandibular positioning
is constrained to the
anterior/posterior
direction and uses a
protrusive step size of
0.2 to 0.3 mm. A 5 s
delay is imposed by the
software. | Mandibular positioning
is constrained to the
anterior/posterior
direction and uses a
protrusive step size of
0.2 to 0.3 mm. A 5 s
delay is imposed by the
software. | |
| | The maximum force that
the mandibular
positioner can apply is
70 N. The position is
held by the linear
actuator and measured
by the software. | The maximum force that
the mandibular
positioner can apply is
70 N. The position is
held by the linear
actuator and measured
by the software. | |
| | The mandibular
positioner requires
reprocessing between
patients. | The mandibular
positioner requires
reprocessing between
patients. | |
| Titration Trays | Maxillary and
mandibular U-shaped
trays with two walls to
receive impression
material. Full arch that
encapsulates the incisors
and canines, narrower at
the front and lower wall
height on inner surface.
The trays have slits in
the tray base to promote
flexibility. The trays are
available in 2 sizes to
accommodate the incisor
region, medium and
large. | Maxillary and
mandibular U-shaped
trays with two walls to
receive impression
material. Full arch that
encapsulates the incisors
and canines, narrower at
the front and lower wall
height on inner surface.
The trays have slits in
the tray base to promote
flexibility. The trays are
available in 2 sizes to
accommodate the incisor
region, medium and
large. | The Titration Trays used
in the subject device are
unchanged from those
used in the predicate
device.
Additional
biocompatibility and
performance testing were
demonstrated for the
identical Titration Trays
in a reference device
(K190051). Therefore,
the allowed test duration
has been increased to
that allowed by the
device software (6
nights). As the trays
themselves are
unchanged, the devices
are substantially |
| Proprietary Name | MATRx plus | Proposed MATRx plus subject device | Discussion of Differences |
| 510(k) Number | DEN170090/K181996 | | |
| Manufacturer | Zephyr Sleep
Technologies, Inc. | Zephyr Sleep
Technologies, Inc. | |
| | 14 mm (20 mm range).
Incisor edge-to-edge is
marked by the zero
position on the tray
scale. | 14 mm (20 mm range).
Incisor edge-to-edge is
marked by the zero
position on the tray
scale. | The change to the fitting
of the Titration Trays is
supported by reference
devices such as the
Zyppah (K182312),
which is an over-the-
counter oral appliance
(LRK) that is fitted by
the patient - an untrained
individual. Since the
creation and use of a
custom oral appliance by
a patient without
direction from an HCP
has been cleared as safe
and effective for
applying a protrusive
repositioning during
sleep, the subject
device's Titration Trays
can similarly be fitted by
a non-healthcare
professional. The subject
device is substantially
equivalent in this manner
to the reference device. |
| | The mounting bracket is
integral with the trays,
manufactured from a
single mold design. The
trays are vertically
constrained by
interconnection between
the two mounting
brackets. | The mounting bracket is
integral with the trays,
manufactured from a
single mold design. The
trays are vertically
constrained by
interconnection between
the two mounting
brackets. | |
| | The Titration Trays are
single patient, multi-use
and are not reprocessed. | The Titration Trays are
single patient, multi-use
and are not reprocessed. | |
| | Titration Trays can be
used for 24 hours. | Titration Trays can be
used for 6 nights, i.e., the
maximum duration
allowed by the Tablet
software. | |
| | The Titration Trays are
fit by a qualified dentist
or dental professional. | The Titration Trays are
fit by a trained healthcare
professional. | |
| Other channels | None | None | Identical |
| Method of
connection to the
patient | Plastic tubing and
cannula for pressure
sensing; belts for
respiratory effort; probes
or
Flexi Wrap for oximetry;
touch proof electrode
cables; belts for
attaching of device and
clip straps to secure
position of device.
The device is worn on
the patient's chest. | Plastic tubing and
cannula for pressure
sensing; belts for
respiratory effort; probes
or
Flexi Wrap for oximetry;
touch proof electrode
cables; belts for
attaching of device and
clip straps to secure
position of device.
The device is worn on
the patient's chest. | Identical |
| Device Design | | | |
| Sensor Connection | Sensors (airflow,
oximeter, effort belt,
mandibular positioner | Sensors (airflow,
oximeter, effort belt,
mandibular positioner | Identical |
| Proprietary Name | MATRx plus | Proposed MATRx plus
subject device | Discussion of
Differences |
| 510(k) Number | DEN170090/K181996 | | |
| Manufacturer | Zephyr Sleep
Technologies, Inc.
(during auto-titration
study) are attached to a
body worn recorder unit. | Zephyr Sleep
Technologies, Inc.
(during auto-titration
study) are attached to a
body worn recorder unit. | |
| Recorder
Dimensions/Weight | 6.30 x 7.90 x 6.60 cm
230 g | 11.0 x 8.0 x 3.5 cm
166 g | Subject device is smaller
and lighter than
predicate. Substantially
equivalent. |
| Mandibular
Positioner
Dimensions/Weight | 5.2 x 5.7 x 2.8 cm
80 g | 5.2 x 5.5 x 2.6 cm
80 g | Subject device is slightly
smaller than predicate
and the same weight.
New design has been
tested to ensure it meets
the same performance
criteria as predicate
device. Substantially
equivalent. |
| 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, STM32F407,
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, STM32F407,
168 MHz) processes the
patient's data (1MB).
Tablet minimum
requirements: 1.33 GHz
processor, 1 GB RAM.
The MATRx plus
includes a Tablet to store
the data and guide user
interactions. | Identical |
| Indicators | Via Tablet User
interface:
Test Started
Test Paused | Via Tablet User
interface:
Test Started
Test Paused | Identical |
| Oximetry
Connection
Effort Sensor | Additional feedback
provided to the MATRx
plus user to help | Additional feedback
provided to the MATRx
plus user to help | Identical |
| Proprietary Name | MATRx plus | Proposed MATRx plus
subject device | Discussion of
Differences |
| 510(k) Number | DEN170090/K181996 | | |
| Manufacturer | Zephyr Sleep
Technologies, Inc. | Zephyr Sleep
Technologies, Inc. | |
| 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 |
| Internal memory | 48 hours | 48 hours | Identical |
| Battery Cover | Tamper-proof and
locked. MATRx plus
battery is recharged and
is not replaceable by the
user. | Tamper-proof and
locked. MATRx plus
battery is recharged and
is not replaceable by the
user. | Identical |
| Study Set up and Management | | | |
| Patient Set up | Set up on device
software and transferred
to Device via internet | Set up on device
software and transferred
to Device via internet.
HCP may start a new
study for a patient
previously created in the
web Portal.
HCP may opt to set up a
study containing both
study types (i.e., basic
sleep study preceding or
following auto-titration
study). | HCP may continue to set
up the study in the web
Portal and load on Tablet
or can alternatively start
the study directly on the
Tablet. No new
functionality introduced
(just change of function
location).
Addition of option for
HCP to set up multiple
studies for one patient
removes the need for the
device to be returned to
the HCP between
studies. Study types
remain the same.
Addition of risk that is
mitigated by Tablet
software.
Substantially equivalent. |
| Data Storage and | Data are stored and | Data are stored and | Identical |
| Access | accessible via database.
Database is located on
manufacturer's secure
internet accessible
server. Copies are
downloaded locally for
analysis. | accessible via database.
Database is located on
manufacturer's secure
internet accessible
server. Copies are
downloaded locally for
analysis. | |
| Design - Data Viewer (PC Application) | | | |
| Data Display | MNR function: Real
time waveforms
displayed for all
channels; autoscored 4%
| MNR function: Real
time waveforms
displayed for all
channels; autoscored 4%
| Identical |
| Proprietary Name | MATRx plus | Proposed MATRx plus subject device | Discussion of Differences |
| 510(k) Number | DEN170090/K181996 | | |
| Manufacturer | Zephyr Sleep
Technologies, Inc. | Zephyr Sleep
Technologies, Inc. | |
| | desaturation and 4% or
3% apnea-hypopnea
events are temporally
displayed in relation to
the airflow, oxygen,
pulse rate, and other
signals. Summary data
are calculated.
QCJ function: Real
time data displayed for
all channels: mandibular
protrusion, autoscored
4% oxygen desaturation
events, airflow, oxygen,
pulse rate, respiratory
effort. | desaturation and 4% or
3% apnea-hypopnea
events are temporally
displayed in relation to
the airflow, oxygen,
pulse rate, and other
signals. Summary data
are calculated.
QCJ function: Real
time data displayed for
all channels: mandibular
protrusion, autoscored
4% oxygen desaturation
events, airflow, oxygen,
pulse rate, respiratory
effort. | |
| Data
Reporting/Analysis | MNR function: 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. The
following indices are
generated from the
MATRX plus software:
ODI (4% and 3%), AHI
(4% and 3%), AI (4%
and 3%), average
saturation, minimum
saturation, maximum
saturation, minimum
pulse rate, maximum
pulse rate, average pulse
rate.
QCJ function: A report
is generated that
provides: 1) raw data of
oxygen saturation,
airflow, body position,
respiratory effort, and
mandibular position | MNR function: 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. The
following indices are
generated from the
MATRX plus software:
ODI (4% and 3%), AHI
(4% and 3%), AI (4%
and 3%), average
saturation, minimum
saturation, maximum
saturation, minimum
pulse rate, maximum
pulse rate, average pulse
rate.
QCJ function: A report
is generated that
provides: 1) raw data of
oxygen saturation,
airflow, body position,
respiratory effort, and
mandibular position | Identical |
| Proprietary Name | MATRx plus | Proposed MATRx plus
subject device | Discussion of
Differences |
| 510(k) Number | DEN170090/K181996 | | |
| Manufacturer | Zephyr Sleep
Technologies, Inc.
night test; 2) a display of
the oxygen desaturation
events detected by the
device, as calculated by
the previously-cleared
sleep recorder
(K181996); an
assessment of whether
the patient is predicted to
achieve an oxygen
desaturation index (ODI)
of less than 10 per hour
with a third-party custom
oral appliance; 4) a
protrusive position that is
predicted to be
efficacious to achieve the
desired therapeutic
success criterion (ODI