Search Results
Found 3 results
510(k) Data Aggregation
(160 days)
Calgary, Alberta T2H-2C3 Canada
Re: K200695
Trade/Device Name: MATRx plus Regulation Number: 21 CFR 872.5571
|
| Device Proprietary Name: | MATRX plus CFR 872.5571
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.
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.
The MATRx plus device underwent non-clinical and clinical testing to demonstrate its substantial equivalence to its predicate device (K191925).
Here's an breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Single Arm Study (Prediction of Outcome for Mild/Moderate Sleep Apnea Patients) | |
| Sensitivity (LCL) > 0.60 (against established clinical endpoints for responder/non-responder prediction) | Sensitivity = 97.1% (LCL = 84.7%) |
| Target Accuracy (LCL) > 0.60 | Target Accuracy = 90.9% (LCL = 75.7%) |
| Cross-over Study (Non-inferiority in Predictive Accuracy compared to Predicate Device) | |
| Predictive accuracy non-inferiority margin: 0.125 (compared to predicate device) | Predictive accuracy demonstrated to be non-inferior to the predicate device with a negligible mean target accuracy difference of 0.17 mm. ("meaning the difference was less than 0.125, but not explicitly stated what percentage it was exactly") |
| Mean target accuracy difference |
Ask a specific question about this device
(103 days)
|
| Device Proprietary Name: | MATRx plus
CFR 872.5571
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.
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.
Here's a breakdown of the acceptance criteria and study information for the MATRx Plus device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance for the MATRx Plus (K191925) is based on demonstrating substantial equivalence to its predicate devices (K181996 and DEN170090), rather than explicit numerical acceptance criteria for clinical performance. The focus is on showing that the minor changes to the new MATRx Plus device do not alter its safety or effectiveness compared to the predicate MATRx Plus devices. Therefore, the "acceptance criteria" are implied by the performance of the predicate device and the demonstration that the subject device meets the same performance standards.
| Feature/Performance Aspect | Acceptance Criterion (Implied by Predicate) | Reported Device Performance (Subject Device) | Discussion of Differences/Equivalence |
|---|---|---|---|
| Intended Use | Identical to predicate device | Identical to predicate device | Identical |
| Patient Population | Adults (Identical to predicate) | Adults (Identical to predicate) | Identical |
| Environment of Use | Deployed from clinics/hospitals, unsupervised in home/clinic, analyzed from physician's office (Identical to predicate) | Deployed from clinics/hospitals, unsupervised in home/clinic, analyzed from physician's office (Identical to predicate) | Identical |
| Outcome | 1) Data to assist in diagnosis of sleep disordered breathing; 2) Identifying patients with mild to moderate sleep apnea for whom an oral appliance is a suitable therapy (Identical to predicate). | 1) Data to assist in diagnosis of sleep disordered breathing; 2) Identifying patients with mild to moderate sleep apnea for whom an oral appliance is a suitable therapy (Identical to predicate). | Identical |
| Oximeter Sensor | Masimo SET 2040, 1 Hz sampling frequency (Predicate performance) | Masimo SET 2040D, 1 Hz sampling frequency (Functionally identical) | Functionally identical; oximeters have same technology and performance standards. Substantially equivalent. |
| Airflow Signal Alert | Predicate: Airflow signal absent for 90s alert | Subject Device: Airflow signal absent for 120s alert | 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. |
| Mandibular Positioner Actuator Material | Acetal resin or anodized stainless steel (Predicate) | Acetal resin, anodized stainless steel, or anodized aluminum (Subject Device) | Identical aside from addition of anodized aluminum actuator. Mandibular positioner function is not affected by change to actuator material. Substantially equivalent. |
| Titration Trays Use Duration | Predicate: 24 hours | Subject Device: 6 nights (maximum duration allowed by tablet software) | The Titration Trays themselves are unchanged from the predicate. Additional biocompatibility and performance testing (in reference device K190051) demonstrated suitability for longer use. This change increases allowable test duration without changing tray design, thus substantially equivalent. |
| Titration Trays Fitting Personnel | Predicate: Qualified dentist or dental professional | Subject Device: Trained healthcare professional | The change to fitting of Titration Trays is supported by reference devices (e.g., Zyppah K182312) which are OTC oral appliances fitted by untrained individuals. Since a non-HCP fitting for an oral appliance has been cleared as safe and effective, the subject device's trays can similarly be fitted by a non-healthcare professional. Substantially equivalent. |
| Recorder Dimensions/Weight | 6.30 x 7.90 x 6.60 cm, 230 g (Predicate) | 11.0 x 8.0 x 3.5 cm, 166 g (Subject Device) | Subject device is smaller and lighter than predicate. Substantially equivalent. (Implies performance maintained) |
| Mandibular Positioner Dimensions/Weight | 5.2 x 5.7 x 2.8 cm, 80 g (Predicate) | 5.2 x 5.5 x 2.6 cm, 80 g (Subject Device) | Subject device is slightly smaller than predicate and the same weight. New design has been tested to ensure it meets the same performance criteria as predicate device. Substantially equivalent. |
| Battery Amperage | 5V - 2A medical grade wall power supply (Predicate) | 5V - 1A medical grade wall power supply (Subject Device) | Decrease in amperage leads to slightly increased charging time (5 h vs 4 h). Device is usable at 85% charge. Deemed negligible. Substantially equivalent. |
| Study Setup and Management | Setup on device software and transferred to Device via internet (Predicate) | Setup on device software and transferred to Device via internet. HCP may start new study directly on Tablet. HCP may opt to set up a study containing both study types (basic sleep study preceding or following auto-titration study). | HCP may continue to set up study in web Portal and load on Tablet or can alternatively start the study directly on the Tablet. No new functionality introduced (just change of function location). Addition of option for HCP to set up multiple studies for one patient removes the need for the device to be returned to the HCP between studies. Study types remain the same. Addition of risk that is mitigated by Tablet software. Substantially equivalent. |
| Reprocessing Instructions | (Original instructions) | Simplified instructions for reprocessing | No changes to reprocessing requirements. New instructions have been validated for cleaning and low-level disinfection. Substantially equivalent. |
| Biocompatibility | All body contacting components previously cleared | All body contacting components previously cleared. Titration Trays cleared for use up to 29 nights (in K190051) – allowed test duration changed from 3 to 6 nights. | Change to auto-titration test duration supported by biocompatibility testing on file for reference device (K190051). Substantially equivalent. |
| Other (Respiratory Effort, Position, Snoring, Data Collection, Processor, Indicators, Recording Time, Internal Memory, Battery Cover, Data Display, Data Reporting/Analysis - Indices Generated) | Identical to predicate | Identical to predicate | Identical |
| Safety Testing | Tested to IEC 60601-1, IEC 80601-2 | Tested to IEC 60601-1, IEC 80601-2 | Testing performed as necessary for subject device to demonstrate updated standards as predicate devices. Substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical performance testing was not required for the changes made to the subject device." This means there was no new clinical test set used for this specific 510(k) submission (K191925) to demonstrate the device meets acceptance criteria. The clearance relies on the existing clinical data and performance of the predicate devices (K181996 and DEN170090).
Therefore, details like sample size, data provenance (country of origin, retrospective/prospective) for a new clinical test set are not provided for this submission. The original predicate devices would have undergone such studies, but that information is not detailed here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no new clinical performance testing was conducted for this submission, there's no mention of experts establishing ground truth for a new test set. For the predicate devices, it's assumed appropriate medical experts (likely sleep specialists/physicians) would have been involved in establishing ground truth for their respective clinical studies.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical performance testing was performed.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
Not applicable, as no new clinical performance testing was performed, and the device is a diagnostic/therapeutic aid, not an AI interpretation system requiring MRMC for reader improvement.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
The regulatory submission focuses on the safety and performance changes of a medical device hardware and software update, not on a standalone algorithm's performance in a traditional AI sense. The device does perform automated data processing (e.g., auto-scoring of events, calculating indices), which represents an "algorithm only" component. The performance of these algorithmic aspects is implicitly validated through the equivalence to the predicate devices and their prior clearance. For example, the document states: "autoscored 4% desaturation and 4% or 3% apnea-hypopnea events," indicating an algorithm operating on the collected data.
7. The Type of Ground Truth Used
For the predicate devices, the ground truth for diagnosing sleep-disordered breathing and assessing oral appliance efficacy would have been established through methods standard in sleep medicine, likely including:
- Expert Consensus: Interpretation of polysomnography (PSG) data by board-certified sleep physicians.
- Outcomes Data: Demonstrating clinical benefit (e.g., reduction in AHI, improvement in ODI) with the oral appliance therapy guided by the device.
For this specific 510(k) (K191925), the ground truth for demonstrating equivalence rests on the technical performance of the modified components meeting the standards and identical functional outcomes of the previously cleared predicate. For example, performance bench testing was completed to demonstrate the mandibular positioner and oximeter meet the same performance criteria as the predicate.
8. The Sample Size for the Training Set
Not applicable, as this submission did not involve the development or re-training of a new AI model with a distinct training set. The device is an updated version of existing hardware and software, with the core analytical algorithms presumably carried over from the predicate.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as #8. For the original development of the algorithms in the predicate device, ground truth would have been established through expert-labeled sleep study data.
Ask a specific question about this device
(245 days)
.
NEW REGULATION NUMBER: 21 CFR 872.5571
CLASSIFICATION: Class II
PRODUCT CODE: QCJ
BACKGROUND
Product Code: QCJ Device Type: Auto titration device for oral appliances Class: II Regulation: 21 CFR 872.5571
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.
This De Novo request is for an expanded indication (new intended use) for use 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 device is an automated temporary oral appliance that manipulates the mandible through multiple protrusion levels during an overnight sleep study in the home. The device uses the same interface as the MATRx plus Home Sleep Apnea Test, also from Zephyr Sleep Technologies, cleared under product code MNR, regulation 21 CFR 868.2375, cleared in K163665. These components include the recorder, tablet, oximeter, effector belt, and nasal cannula. The MATRx plus device for a titration study includes a mandibular positioner to determine an optimal titration position based on inputs of airflow and an oxygen desaturation index (ODI) of less than 10 events per hour. The device analyses the collected information and generates a report to assist the Healthcare Provider in the clinical management of oral appliance therapy for patients with mild to moderate obstructive sleep apnea. From this report, patients may be informed on the future efficaciousness of oral appliance (OA) therapy.
Specifically, the clinical management may be assisted by this type of oral appliance assessment study by prospectively identifying patients that are expected to achieve therapeutic success with oral appliance therapy. The oral appliance assessment study also includes the provision of a recommended target protrusive setting for the mandible through use of a legally marketed intraoral appliance (regulated under 21 CFR 872.5570, product code LQZ). The target protrusive setting is the amount of mandibular protrusion where the patient is expected to achieve efficacious therapy with the intraoral appliance and is used by the HCP to more effectively complete the titration process.
The use of the MATRx plus device for an oral appliance assessment study does not replace the clinical titration process or the need for follow-up testing to determine the initial and ongoing therapy as recommended by clinical practice guidelines.
The MATRx plus test identifies patients as suitable for intraoral therapy if a mandible protrusion level can be found where the patient has an oxygen desaturation index (ODI) of less than 10 events per hour with a 4% desaturation criterion.
Here's a structured breakdown of the acceptance criteria and the study that proves the MATRx plus device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Clinical Endpoints
| Acceptance Criteria Category | Specific Acceptance Criteria (Effectiveness, Safety, Usability) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Effectiveness | 1. Predictive Accuracy (Primary Endpoint): Sensitivity and specificity statistically significant to reject the null hypothesis that sensitivity ≤0.6. | Sensitivity: 94.2% (95% CI: 0.86 – 1.00) |
| Specificity: 75.0% (95% CI: 0.40 – 1.00) | ||
| 2. Target Protrusive Position (Secondary Endpoint): Statistically significant to reject the null hypothesis that target accuracy ≤0.6. | Identification of Efficacious Target Protrusion: 86.3% of participants were correctly predicted as responders and successfully provided with an effective target protrusion. | |
| Safety | No significant safety concerns reported by coordinator, dentist, or participant. | No significant safety concerns reported. Adverse events were temporary discomfort (in teeth, joint, jaw, minor gum irritations, temporary bite changes, soreness in teeth) that resolved within a few hours. |
| Only minor discomfort reported on post-study questionnaires. | Temporary discomfort reported (resolved within hours). | |
| No software failure resulting in injury. | No software failure reported that resulted or could result in injury. | |
| No movement beyond full retrusion and maximum protrusion set values. | No movement beyond full retrusion and maximum protrusion set values reported. | |
| Usability | Accurate prediction for OA therapy and effective titration level demonstrated by actual use testing (setup, placement, use, removal by participant in home). | Human factors assessment conducted as part of the clinical trial showed participants and providers evaluated for comprehension-based tasks. The study supported usability. |
Bench Performance Testing
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (as stated in the document) |
|---|---|---|
| Mandibular Positioner, Accuracy Data | (i) Device will be able to send a position feedback signal to the controller that reports a new position within 0.5mm of the actual physical position of the trays/mandible; and the accuracy will be maintained under expected clinical loads. (ii) The mandibular positioner will be able to physically endure the use life of the device under normal operating load without failure and maintain the accuracy. Simulated use life testing was conducted based on days of single patient use, movements per patient use, and approximated number of insertion and removal cycles per patient use. | The data provided showed each test was passed according to its pre-specified acceptance criteria. |
| Mandibular Positioner, Force Limit Test | Mandibular positioner will be incapable of applying a force that could induce serious injury under a worst-case fault scenario of 70 Newtons. | The data provided showed each test was passed according to its pre-specified acceptance criteria. |
| Device Force Limitation Simulation | (i) Demonstrate the ability of users to voluntarily stall the mandibular positioner in a fault position (i.e., full stroke speed). (ii) Demonstrate that without voluntary action to resist the force, the trays dislodge from their seated position on the teeth prior to injury or maximum force (i.e., 70N). | The data provided showed each test was passed according to its pre-specified acceptance criteria. |
| Impression Material Breakage | Demonstrate the ability of the impression material used to form the temporary oral appliance to maintain integrity over the use life of the temporary oral appliance. | The data provided showed each test was passed according to its pre-specified acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Clinical Study: The document provides "49" for "Successful Identification of Responders" and "2" for "Failure to Identify Responders" in the "Predictive Success Category," and "3" for "Successful Identification of Responders" and "6" for "Failure to Identify Responders" in the "Predictive Failure Category." This totals 49 + 2 + 3 + 6 = 60 participants in the mild to moderate OSA population for the effectiveness endpoints.
- Human Factors: 15 patients were recruited for each study.
- Data Provenance: The MATRx plus is by Zephyr Sleep Technology, located in Calgary, Alberta, Canada. The clinical study was conducted in a clinical setting (dental professional's office for deployment, home environment for use). The study is prospective, as it involved recruiting participants, conducting the MATRx plus study, and then following up with custom oral appliance therapy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts:
- Effectiveness Ground Truth (Oral Appliance Outcome): While not explicitly stated how many individual experts reviewed each case, the process involved a "Sleep Health professional" reviewing baseline HSAT data and a "licensed dentist" conducting intraoral exams and subjective interviews post-study. The final determination of "successful treatment with an oral appliance" (ODI
Ask a specific question about this device
Page 1 of 1