MATRx Plus
Device Facts
| Record ID | K191925 |
|---|---|
| Device Name | MATRx Plus |
| Applicant | Zephyr Sleep Technologies |
| Product Code | MNR · Anesthesiology |
| Decision Date | Oct 29, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2375 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
MATRx plus is a 5-channel respiratory effort recorder and closed-loop auto-titration system for oral appliances. Inputs include nasal airflow (via dual-lumen cannula), snoring, blood oxygen saturation/pulse (via finger oximeter), respiratory effort (via inductance belt), and body position (via 3D accelerometer). During auto-titration, a motorized mandibular positioner adjusts the jaw position in response to respiratory events. Data are transmitted wirelessly to a bedside tablet, which guides the user through setup and study conduct. Post-study, data are uploaded to a secure portal for HCP review. The system generates reports to aid in sleep-disordered breathing diagnosis and to identify candidates for oral appliance therapy by recommending a target mandibular position. Used in home or hospital settings by lay persons under HCP direction. Benefits include prospective identification of suitable oral appliance therapy candidates and optimization of mandibular positioning.
Clinical Evidence
No clinical data provided; substantial equivalence supported by bench testing only.
Technological Characteristics
Battery-powered (Li-Ion) respiratory effort recorder and mandibular positioner. Materials: ABS, acetal resin, anodized stainless steel, anodized aluminum. Sensing: Inductance (effort), pressure (airflow), pulse oximetry. Connectivity: Bluetooth (recorder to tablet), web portal. Software: ARM Cortex M4-based recorder; tablet-based application. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-61, ISO 10993-1.
Indications for Use
Indicated for adult patients with suspected sleep disordered breathing or mild to moderate obstructive sleep apnea. Contraindicated for persons under 18, patients with loose teeth, advanced periodontal disease, full dentures, or dental implants (when using auto-titration mode). Not for use as an apnea monitor, in life-supporting/sustaining situations, or near MRI devices.
Regulatory Classification
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.
Predicate Devices
Reference Devices
Submission Summary (Full Text)
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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
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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
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# 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) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
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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<br>Calgary, Alberta, Canada<br>T2H-2C3 |
| Phone Number: | 587-317-1976 |
| Establishment Registration Number: | 3008960597 |
| Device Proprietary Name: | MATRx plus<br>CFR 872.5571 Closed Loop Auto Titration<br>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;<br>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,<br>Inc. | Zephyr Sleep Technologies,<br>Inc. | |
| Indications for<br>Use | The MATRx plus is indicated<br>for use by a lay person in the<br>home and hospital use under<br>the direction of a Health Care<br>Professional (HCP). | The MATRx plus is indicated<br>for use by a lay person in the<br>home and hospital use under<br>the direction of a Health Care<br>Professional (HCP). | Identical |
| | MATRx plus records the<br>following data: patient<br>respiratory nasal airflow,<br>snoring, blood oxygen<br>saturation, pulse, respiratory<br>effort and body position during<br>sleep. | MATRx plus records the<br>following data: patient<br>respiratory nasal airflow,<br>snoring, blood oxygen<br>saturation, pulse, respiratory<br>effort and body position during<br>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,<br>Inc. | Zephyr Sleep Technologies,<br>Inc. | |
| | recordings to produce a report<br>for the HCP that may aid in the<br>diagnosis of sleep disordered<br>breathing for adult patients. | recordings to produce a report<br>for the HCP that may aid in<br>the diagnosis of sleep<br>disordered breathing for adult<br>patients. | |
| | The MATRx plus device may<br>also be used with an automated<br>mandibular positioner that uses<br>feedback control to record<br>changes in the patient's<br>respiratory status related to<br>repositioning of the mandible<br>during an overnight study. | The MATRx plus device may<br>also be used with an<br>automated mandibular<br>positioner that uses feedback<br>control to record changes in<br>the patient's respiratory status<br>related to repositioning of the<br>mandible during an overnight<br>study. | |
| | MATRx plus uses these<br>recordings to produce a report<br>for the HCP that can be used to<br>prospectively identify patients<br>with mild to moderate<br>obstructive sleep apnea who<br>may be suitable for therapy<br>with an oral appliance and to<br>recommend a target<br>mandibular position.<br>The use of the device does not<br>replace the need for follow-up<br>testing to determine the initial<br>and ongoing effectiveness of<br>the therapy as recommended<br>by clinical practice guidelines. | MATRx plus uses these<br>recordings to produce a report<br>for the HCP that can be used<br>to prospectively identify<br>patients with mild to moderate<br>obstructive sleep apnea who<br>may be suitable for therapy<br>with an oral appliance and to<br>recommend a target<br>mandibular position.<br>The use of the device does not<br>replace the need for follow-up<br>testing to determine the initial<br>and ongoing effectiveness of<br>the therapy as recommended<br>by clinical practice guidelines. | |
| Patient<br>Population | Adults | Adults | Identical |
| Environment of<br>Use | Deployed from clinics,<br>hospitals<br>Used unsupervised in the home<br>or clinic<br>Analyzed from physician's<br>office | Deployed from clinics,<br>hospitals<br>Used unsupervised in the<br>home or clinic<br>Analyzed from physician's<br>office | Identical |
| Outcome | 1) Data to assist in the<br>diagnosis of sleep disordered<br>breathing (K181996);<br>2) Identifying patients with<br>mild to moderate sleep apnea<br>for whom an oral appliance is | 1) Data to assist in the<br>diagnosis of sleep disordered<br>breathing;<br>2) Identifying patients with<br>mild to moderate sleep apnea | Identical |
| Trade Name | MATRx plus | Proposed MATRx plus | Discussion of<br>Differences |
| 510k Number | K181996/DEN170090 | -- | |
| Manufacturer | Zephyr Sleep Technologies,<br>Inc. | Zephyr Sleep Technologies,<br>Inc. | |
| | a suitable therapy<br>(DEN170090). | for whom an oral appliance is<br>a suitable therapy. | |
| Contra-<br>indications | The device is not to be used as<br>an apnea monitor or in a life<br>supporting or life sustaining<br>situation. | The device is not to be used as<br>an apnea monitor or in a life<br>supporting or life sustaining<br>situation. | Identical |
| | The device is not to be used by<br>persons under the age of 18. | The device is not to be used by<br>persons under the age of 18. | |
| | The MATRx plus is MR<br>unsafe. | The MATRx plus is MR<br>unsafe. | |
| | In auto-titration study mode,<br>the device is not recommended<br>for use in patients who: have<br>loose teeth or advanced<br>periodontal disease; have full<br>dentures or dental implants. | In auto-titration study mode,<br>the device is not recommended<br>for use in patients who: have<br>loose teeth or advanced<br>periodontal disease; have full<br>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<br>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<br>subject device | Discussion of<br>Differences |
| 510(k) Number | DEN170090/K181996 | | |
| Manufacturer | Zephyr Sleep<br>Technologies, Inc.<br>if the airflow signal has<br>been absent for 90 s. | Zephyr Sleep<br>Technologies, Inc.<br>if the airflow signal has<br>been absent for 120 s. | |
| Respiratory Effort | Respiratory effort<br>channel to measure the<br>respiratory effort using<br>an inductance principle.<br>Third-party belt (Sleep<br>Sense, K042253).<br>Sampling frequency of<br>25 Hz. | Respiratory effort<br>channel to measure the<br>respiratory effort using<br>an inductance principle.<br>Third-party belt (Sleep<br>Sense, K042253).<br>Sampling frequency of<br>25 Hz. | Identical |
| Position | Channel to determine<br>body position of the<br>patient during sleep by<br>3D axis accelerometer. | Channel to determine<br>body position of the<br>patient during sleep by<br>3D axis accelerometer. | Identical |
| Snoring | Nasal airflow fluctuation<br>envelope signal (between<br>10 and 70 Hz).<br>Set threshold. | Nasal airflow fluctuation<br>envelope signal (between<br>10 and 70 Hz).<br>Set threshold. | Identical |
| Mandibular<br>Positioner | Small, lightweight,<br>motorized positioner<br>attached to temporary<br>Titration Trays.<br><br>Mandibular positioner is<br>held in place by the<br>Titration Trays, which fit<br>firmly to the dentition.<br><br>The mandibular<br>positioner consists of one<br>sealed rod with a double<br>seal design. The<br>mandibular positioner is<br>made from acrylonitrile<br>butadiene styrene (ABS).<br>The actuator rod material<br>is made from acetal resin<br>or anodized stainless<br>steel.<br><br>Digital transfer of<br>mandibular position,<br>sound, and acceleration.<br><br>Powered by 14 V<br>(hardware configurable). | Small, lightweight,<br>motorized positioner<br>attached to temporary<br>Titration Trays.<br><br>Mandibular positioner is<br>held in place by the<br>Titration Trays, which fit<br>firmly to the dentition.<br><br>The mandibular<br>positioner consists of one<br>sealed rod with a double<br>seal design. The<br>mandibular positioner is<br>made from acrylonitrile<br>butadiene styrene (ABS).<br>The actuator rod material<br>is made from acetal<br>resin, anodized stainless<br>steel, or anodized<br>aluminum.<br><br>Digital transfer of<br>mandibular position,<br>sound, and acceleration.<br><br>Powered by 14 V<br>(hardware configurable). | Identical aside from<br>addition of anodized<br>aluminum actuator.<br>Mandibular positioner<br>function is not affected<br>by change to actuator<br>material. Substantially<br>equivalent. |
| Proprietary Name | MATRx plus | Proposed MATRX plus<br>subject device | Discussion of<br>Differences |
| 510(k) Number | DEN170090/K181996 | | |
| Manufacturer | Zephyr Sleep<br>Technologies, Inc. | Zephyr Sleep<br>Technologies, Inc. | |
| | Digital signal is<br>converted from analogue<br>on the MP board. | Digital signal is<br>converted from analogue<br>on the MP board. |…
