(160 days)
Not Found
No
The summary describes data recording, analysis, and automated control based on respiratory events, but it does not explicitly mention or imply the use of AI or ML algorithms for these functions. The analysis and control appear to be based on predefined rules or thresholds related to respiratory status.
No.
The device is indicated for aid in diagnosis and assessment of sleep disordered breathing and to identify patients for oral appliance therapy, not for providing therapy itself.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "may aid in the diagnosis and assessment of sleep disordered breathing for adult patients." Furthermore, the "Device Description" notes that the generated report can "aid in diagnosis (when used as a ventilatory effort recorder)."
No
The device description clearly outlines multiple hardware components including a respiratory pressure sensor, oximetry system, effort belt, nasal cannula, pulse oximetry module, respiratory effort sensor, and a bedside Tablet that runs the application. While software is a critical part of the system, it is not the sole component.
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 records physiological data from the patient's body (airflow, snoring, oxygen saturation, pulse, effort, position) using external sensors (nasal cannula, oximetry sensor, effort belt). It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for aiding in the diagnosis and assessment of sleep disordered breathing and identifying suitability for oral appliance therapy. While it provides data that aids in diagnosis, it does not perform a diagnostic test on a biological sample.
- The device description focuses on sensors and data recording. The components described are sensors that measure physiological parameters, not reagents or equipment for analyzing biological samples.
Therefore, the MATRx plus falls under the category of a medical device that collects physiological data for diagnostic and therapeutic management purposes, but it is not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
QCJ, MNR
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
Adults
Intended User / Care Setting
Home and hospital use under the direction of a Health Care Professional (HCP).
Deployed from clinics, hospitals.
Used unsupervised in the home or clinic.
Analyzed from physician's office.
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)
The device was tested using both a prospective, blinded single arm design and a noninferiority cross over design to directly compare the device performance of the subject and predicate device for both the prediction of outcome (responder/non-responder) and the target protrusive position.
In the single arm study, the device performance was shown to exceed the previously established clinical endpoints used to clear the original MATRx plus device (LCL > 0.60). Specifically, the device was found to have a sensitivity of 97.1% (LCL=84.7%) in the mild/moderate patient population with a target accuracy of 90.9% (LCL = 75.7%).
In the cross over study, the predictive accuracy of the subject device was demonstrated to be not inferior to the predicate device by the clinically relevant margin of 0.125, with a negligible mean target accuracy difference of 0.17 mm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity of 97.1% (LCL=84.7%)
Target accuracy of 90.9% (LCL = 75.7%)
Predictive accuracy was not inferior to predicate device by clinically relevant margin of 0.125.
Negligible mean target accuracy difference of 0.17 mm.
Predicate Device(s)
Reference Device(s)
Not Found
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 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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the 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.
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Image /page/5/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in 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. | |
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Image /page/6/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo has the word "ZEPHYR" in large, 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.
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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. | Data are stored and accessible via database. Database is located on manufacturer's secure internet accessible server. Copies are downloaded locally for analysis. | Identical |
| Design - Data Viewer (PC Application) | | | |
| Data Display – (MNR) Ventilatory effort function | MNR function: Real time waveforms displayed for all channels; autoscored 4% or 3% oxygen desaturation and 4% or 3% apnea-hypopnea events are temporally displayed in relation to the airflow, oxygen, pulse rate, and other signals. Summary data | MNR function: Real time waveforms displayed for all channels; autoscored 4% or 3% oxygen desaturation and 4% or 3% apnea-hypopnea events are temporally displayed in relation to the airflow, oxygen, pulse rate, and other signals. Summary data | 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. | |
| Data Display -
(QCJ) Auto-
titration function | QCJ function: Real
time data displayed for::
mandibular protrusion,
autoscored 4% oxygen
desaturation events,
airflow, oxygen, pulse
rate, respiratory effort. | QCJ function: Real
time data displayed for:
mandibular protrusion,
autoscored 4% oxygen
desaturation events,
oxygen, pulse rate. | Raw airflow tracings no
longer visible in Data
Viewer display. Change
to data display reflects
the change to the
operational algorithms
by which the device
commands movement of
the mandible throughout
the study (i.e., using
oxygen saturation only).
No changes to displayed
events (only oxygen
events displayed). No
changes to device
efficacy.
Substantially equivalent. |
| Data Reporting -
(MNR) Ventilatory
effort function | 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. | 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. | Identical |
| Data Reporting -
(QCJ) Auto-
titration function | QCJ function: A report
is generated that
provides: 1) raw data of
oxygen saturation,
airflow, body position,
respiratory effort, and | QCJ function: A report
is generated that
provides: 1) raw data of
oxygen saturation, body
position, and mandibular
position collected over | Substantially Equivalent
Raw data tracing of
airflow not visible on
report. No change to any
of the reported events or
indices. |
| 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. | |
| | collected over the multi-
night test; 2) a display of
the oxygen desaturation
events detected by the
device, as calculated by
the previously-cleared
sleep recorder; 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 0.60). Specifically, the device was found to have a sensitivity of 97.1% (LCL=84.7%) in the mild/moderate patient population with a target accuracy of 90.9% (LCL = 75.7%).
In the cross over study, the predictive accuracy of the subject device was demonstrated to be not inferior to the predicate device by the clinically relevant margin of 0.125, with a negligible mean target accuracy difference of 0.17 mm.
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 K191925.