Who is the manufacturer of MATRx plus?

Zephyr Sleep Technologies filed the 510(k) submission for MATRx plus (K200695).

What is the FDA product code for MATRx plus?

MNR. It is classified under 21 CFR 868.2375 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for MATRx plus?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MATRx plus?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MATRx plus

K200695 · Zephyr Sleep Technologies · MNR · Aug 24, 2020 · Anesthesiology

Device Facts

Record ID	K200695
Device Name	MATRx plus
Applicant	Zephyr Sleep Technologies
Product Code	MNR · Anesthesiology
Decision Date	Aug 24, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2

Intended Use

The MATRx plus is indicated for use by a lay person in a 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 the HCP that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for oral appliance therapy 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 battery-powered respiratory effort recorder and closed-loop auto-titration system. Inputs include nasal airflow (pressure), snoring, blood oxygen saturation (SpO2), pulse, respiratory effort (inductance), and body position (3D accelerometer). During auto-titration, the device uses a motorized mandibular positioner and temporary titration trays to adjust jaw position based on respiratory feedback. Data is transmitted wirelessly to a bedside tablet, which guides the user through setup and records data. Post-study, data is uploaded to a secure portal for HCP review via a data viewer. The system identifies patients suitable for oral appliance therapy and recommends a target mandibular position. Used in home or hospital settings; operated by patients under HCP direction. Benefits include prospective identification of therapy candidates and optimized oral appliance positioning.

Clinical Evidence

Clinical evidence includes a prospective, blinded single-arm study and a non-inferiority crossover study. In the single-arm study (n=mild/moderate OSA patients), the device demonstrated 97.1% sensitivity (LCL=84.7%) and 90.9% target accuracy (LCL=75.7%), exceeding established endpoints (LCL > 0.60). The crossover study demonstrated non-inferiority to the predicate device for predictive accuracy within a margin of 0.125, with a mean target accuracy difference of 0.17 mm.

Technological Characteristics

Battery-powered (rechargeable Li-Ion) recorder with 5-channel sensing. Sensors: Masimo SET 2040D pulse oximeter, nasal cannula (dual lumen), inductance effort belt, 3D accelerometer. Connectivity: Wireless transmission to tablet, cloud-based portal for data analysis. Software: Auto-titration algorithm using oxygen saturation feedback. Standards: IEC 60601-1, IEC 80601-2, IEC 60601-1-10, IEC 62133:2012. Reprocessing required for mandibular positioner; titration trays are single-patient, multi-use.

Indications for Use

Indicated for adult patients with suspected sleep disordered breathing or mild to moderate obstructive sleep apnea to aid in diagnosis and assess suitability for oral appliance therapy. Contraindicated for persons under 18, patients with loose teeth, advanced periodontal disease, full dentures, or dental implants.

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

MATRX plus (K191925)

Related Devices

K191925 — MATRx Plus · Zephyr Sleep Technologies · Oct 29, 2019
K163665 — MATRx plus · Zephyr Sleep Technologies · May 5, 2017
K181996 — MATRx Plus · Zephyr Sleep Technologies · Nov 21, 2018
DEN170090 — MATRx plus · Zephyr Sleep Technologies · Aug 23, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. August 24, 2020 Zephyr Sleep Technologies Sabina Bruehlmann Director, Technology 102, 701 64 Ave SE Calgary, Alberta T2H-2C3 Canada Re: K200695 Trade/Device Name: MATRx plus Regulation Number: 21 CFR 872.5571 Regulation Name: Auto Titration Device For Oral Appliances Regulatory Class: Class II Product Code: QCJ, MNR Dated: July 21, 2020 Received: July 31, 2020 Dear Sabina Bruehlmann: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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 (OS) 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 mediation-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, Srinivas Nandkumar, Ph.D. 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) K200695 Device Name MATRx plus #### Indications for Use (Describe) The MATRx plus is indicated for use by a lay person in a 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 the HCP that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for oral appliance therapy 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) | <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> <path d="M2,2 L14,14 M14,2 L2,14" stroke="black" stroke-width="2"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features 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. The address "#102, 701-64th Avenue SE, Calgary, AB, T2H 2C3, Canada" is printed below the company name. # K200695 - 510k Summary - MATRx plus | Date: | August 24, 2020 | |------------------------------------|--------------------------------------------------------------------------------| | 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 (K191925) | ## 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 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a bold, sans-serif font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the text is a crescent moon design with a star above it. Below the logo is the address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada". 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. 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. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in large, bold, sans-serif font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the word "ZEPHYR" is a crescent moon design with a star above it. The address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada" is printed below the logo. 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 predicate cleared in K191925. The auto-titration study has been revised to rely only on the oxygen saturation signal to guide the positioning of the mandible during sleep and to establish the prediction of therapeutic response to an oral appliance. There is no change to the information provided to the user, no change to the hardware and no change that impacts the use of the device as a ventilatory effort recorder. ## Comparison to Predicate Devices: The MATRx plus subject device is substantially equivalent to the MATRx plus device (K191925), 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 - Predicate | MATRX plus - Subject | Discussion of Differences | |----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | 510k Number | K191925 | K200695- | | | 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 recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing for adult patients. | MATRx plus uses these 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. | | | Trade Name | MATRx plus - Predicate | MATRx plus - Subject | Discussion of Differences | | 510k Number | K191925 | K200695- | | | Manufacturer | Zephyr Sleep Technologies, Inc. | Zephyr Sleep Technologies, Inc. | | | | 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; 2) Identifying patients with mild to moderate sleep apnea for whom an oral appliance is a suitable therapy. | 1) Data to assist in the diagnosis of sleep disordered breathing; 2) Identifying patients with mild to moderate sleep apnea for whom an oral appliance is a suitable therapy. | Identical | | 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 by persons under the age of 18. The MATRx plus is MR unsafe. In auto-titration study mode, the device is not recommended | 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 by persons under the age of 18. The MATRx plus is MR unsafe. In auto-titration study mode, the device is not recommended | Identical | | #102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada | | | | | Trade Name | MATRx plus - Predicate | MATRx plus - Subject | Discussion of Differences | | 510k Number | K191925 | K200695 | | | Manufacturer | Zephyr Sleep Technologies, Inc. | Zephyr Sleep Technologies, Inc. | | | | loose teeth or advanced periodontal disease; have full dentures or dental implants. | loose teeth or advanced periodontal disease; have full dentures or dental implants. | | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo has the word "ZEPHYR" in large, bold letters, with the words "Sleep Technologies" underneath in a smaller font. To the right of the word "ZEPHYR" is a crescent moon shape with a star above it. The address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada" is printed below the logo. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a bold, sans-serif font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the word "ZEPHYR" is a graphic of a crescent moon with a star above it. The address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada" is printed below the logo. | Proprietary Name | MATRx plus | Proposed MATRx plus subject device | Discussion of Differences | |----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K191925 | K200695 | | | Manufacturer | Zephyr Sleep Technologies, Inc. | Zephyr Sleep Technologies, Inc. | | | Sensors | | | | | Pulse Oximeter | 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. | 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. | Identical | | Airflow | Dual channel nasal cannula attaches to patient worn recorder; records pressure and translates to airflow and snoring. | Dual channel nasal cannula attaches to patient worn recorder; records pressure and translates to airflow and snoring Not required for use in the auto-titration device. | No changes to nasal cannula or collection of airflow data for basic study type. Removal of airflow from auto-titration study does not affect device efficacy. | | Respiratory Effort | Respiratory effort channel to measure the respiratory effort using an inductance principle. | Respiratory effort channel to measure the respiratory effort using an inductance principle. | Substantially equivalent. | | | | | 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 | Nasal airflow fluctuation envelope signal | No changes to snoring data for basic study type. | | Proprietary Name | MATRx plus | Proposed MATRx plus subject device | Discussion of Differences | | 510(k) Number | K191925 | K200695 | | | Manufacturer | Zephyr Sleep Technologies, Inc. | Zephyr Sleep Technologies, Inc. | Removal of airflow-based snoring from auto-titration study does not affect device efficacy. Substantially equivalent. | | 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 requires reprocessing between patients. | 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 requires reprocessing between patients. | Identical | | 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 Titration Trays are single patient, multi-use and are not reprocessed. 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 trained healthcare professional. | 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 Titration Trays are single patient, multi-use and are not reprocessed. 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 trained healthcare professional. | Identical | | Other channels | None | None | Identical | | Device Design Recording Time | 6 x 8 hours. The total number of study hours in | 6 x 8 hours. The total number of study hours in | Identical | | Proprietary Name | MATRx plus | Proposed MATRx plus subject device | Discussion of Differences | | 510(k) Number | K191925 | K200695 | | | Manufacturer | Zephyr Sleep Technologies, Inc. | Zephyr Sleep Technologies, Inc. | | | | the MATRx plus is set by the software. Internal memory is > 100 hours. | the MATRx plus is set by the software. Internal memory is > 100 hours. | | | 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. 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). | 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). | Identical | | Data Storage and Access | Data are stored and accessible via database. Database is located on manufacturer's secure internet accessible server. Copies are downloaded locally for analysis.…