(103 days)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 29, 2019
Zephyr Sleep Technologies Sabina Bruehlmann Director, Technology #102, 701 64th Ave SE Calgary, Alberta, Canada T2H-2C3
Re: K191925
Trade/Device Name: MATRx Plus Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR, QCJ Dated: August 2, 2019 Received: August 5, 2019
Dear Sabina Bruehlmann:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191925
Device Name MATRx Plus
Indications for Use (Describe)
The MATRx plus is indicated for use by a lay person in the home and hospital use under the direction of a Health Care Professional (HCP).
MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep.
MATRx plus uses these recordings to produce a report for the HCP that may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.
The MATRx plus device may also be used with an automated mandibular positioner that uses feedback control to record changes in the patient's respiratory status related to repositioning of the mandible during an overnight study.
MATRx plus uses these recordings to produce a report for that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position.
The use of the device does not replace the need for follow-up testing to determine the initial and ongoing effectiveness of the therapy as recommended by clinical practice guidelines.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a large, bold, sans-serif font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the text is a stylized image of a crescent moon with a star. Below the logo is the address "#102, 701-64th Avenue SE, Calgary, AB, T2H 2C3, Canada".
K191925 Rev. October 26, 2019
Section 5 - 510k Summary - MATRx plus
| Submission Date: | July 16, 2019 |
|---|---|
| 510(k): | K191925 |
| Manufacturer Name: | Zephyr Sleep Technologies, Inc. |
| Contact Name: | Sabina Bruehlmann, PhD |
| Title: | Director, Technology |
| Postal Address: | #102, 701 64th Ave SECalgary, Alberta, CanadaT2H-2C3 |
| Phone Number: | 587-317-1976 |
| Establishment Registration Number: | 3008960597 |
| Device Proprietary Name: | MATRx plusCFR 872.5571 Closed Loop Auto TitrationDevice for Oral Appliances; |
| Classification Name: | CFR 868.2375 Ventilatory Effort Recorder |
| Classification Code: | Class II |
| Product Code: | QCJ, MNR |
| Primary Predicate: | MATRx plus (K181996) |
| Reference Device: | K190051 TD Clip;K182312 Zyppah |
Device Description:
MATRx plus is a ventilatory effort recorder and closed loop auto-titration device for oral appliances. MATRx plus is a 5-channel battery-powered respiratory pressure sensor and oximetry system. MATRx plus provides recordings of respiratory pressure, snoring, respiratory effort, pulse rate, oxygen saturation, and body position during sleep.
The device is worn on the patient's abdomen attached to a reusable effort belt and all relevant respiratory information during sleep is collected via nasal cannula, pulse
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Image /page/4/Picture/1 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the company name in a blue font, with the word "ZEPHYR" in a larger, bolder font than "Sleep Technologies." To the right of the company name is a graphic of a crescent moon with a star. Below the logo is the company's address: #102, 701-64th Avenue SE, Calgary, AB, T2H 2C3, Canada.
oximetry module, and respiratory effort sensor. The disposable plastic nasal cannula is connected to the MATRx plus recorder and fixed at the patient's nose. The cannula is dual lumen and functions to individually sample the pressure from each naris. The oximetry sensor is fixed at the patient's finger and connects directly to the device. The Recorder receives input from the sensors and wirelessly transmits the data to a bedside Tablet during the study. The Tablet is set up through a connection to the web portal by the healthcare professional (HCP) prior to deploying the device to the patient for home use. The Tablet runs the MATRx plus application and records and stores the data. The MATRx plus application on the Tablet is also used to guide the user through the set up and conduct of the study through a stepwise user interface. At the end of a recording, the Tablet advises the patient if sufficient data for analysis were recorded during the night.
During an auto-titration study, the patient wears temporary Titration Trays connected to a mandibular positioner. During the study, the device moves the mandible in response to respiratory events in order to determine if the patient is a suitable candidate for oral appliance therapy.
After recording, the MATRx plus must be returned to the HCP. The data are automatically uploaded to the secure Portal where they can be accessed and downloaded to the Data Viewer. The Data Viewer can generate a report with the recorded and analyzed data (respiratory pressure, respiratory effort, pulse rate, oxygen saturation) to aid in diagnosis (when used as a ventilatory effort recorder) or to assist the HCP in the clinical management of oral appliance therapy for patients with obstructive sleep apnea.
The device is intended to be used on adult patients, upon referral from their healthcare provider.
The device is not to be used as an apnea monitor or in a life supporting or life sustaining situation and must not be used in the vicinity of an MRI device.
Indications for Use:
The MATRx plus is indicated for use by a lay person in the home and hospital use under the direction of a Health Care Professional (HCP).
MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep.
MATRx plus uses these recordings to produce a report for the HCP that may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.
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Image /page/5/Picture/1 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a large, bold, blue font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the text is a blue graphic of curved lines and a star. Below the logo is the address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada".
The MATRx plus device may also be used with an automated mandibular positioner that uses feedback control to record changes in the patient's respiratory status related to repositioning of the mandible during an overnight study.
MATRx plus uses these recordings to produce a report for the HCP that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position.
The use of the device does not replace the need for follow-up testing to determine the initial and ongoing effectiveness of the therapy as recommended by clinical practice guidelines.
Technology:
The MATRx plus subject device is an updated version of the predicates cleared in DEN170090 and K181996. Minor changes have been made to device hardware to make the Recorder and mandibular positioner components slightly smaller and lighter, and to software to provide the healthcare professional with additional option for test set up and study workflow. The Titration Trays used during an auto-titration study can now be used for up to 6 nights and can be fit by a trained healthcare professional.
Comparison to Predicate Devices:
The MATRx plus subject device is substantially equivalent to the MATRx plus device (K181996 and DEN170090;), manufactured by Zephyr Sleep Technologies, Inc. The following tables provide a detailed comparison of the MATRx plus technological characteristics in comparison of the intended use for the predicates.
| Trade Name | MATRx plus | Proposed MATRx plus | Discussion of Differences |
|---|---|---|---|
| 510k Number | K181996/DEN170090 | -- | |
| Manufacturer | Zephyr Sleep Technologies,Inc. | Zephyr Sleep Technologies,Inc. | |
| Indications forUse | The MATRx plus is indicatedfor use by a lay person in thehome and hospital use underthe direction of a Health CareProfessional (HCP). | The MATRx plus is indicatedfor use by a lay person in thehome and hospital use underthe direction of a Health CareProfessional (HCP). | Identical |
| MATRx plus records thefollowing data: patientrespiratory nasal airflow,snoring, blood oxygensaturation, pulse, respiratoryeffort and body position duringsleep. | MATRx plus records thefollowing data: patientrespiratory nasal airflow,snoring, blood oxygensaturation, pulse, respiratoryeffort and body position duringsleep. | ||
| MATRx plus uses these | MATRx plus uses these | ||
| Trade Name | MATRx plus | Proposed MATRx plus | Discussion of Differences |
| 510k Number | K181996/DEN170090 | -- | |
| Manufacturer | Zephyr Sleep Technologies,Inc. | Zephyr Sleep Technologies,Inc. | |
| recordings to produce a reportfor the HCP that may aid in thediagnosis of sleep disorderedbreathing for adult patients. | recordings to produce a reportfor the HCP that may aid inthe diagnosis of sleepdisordered breathing for adultpatients. | ||
| The MATRx plus device mayalso be used with an automatedmandibular positioner that usesfeedback control to recordchanges in the patient'srespiratory status related torepositioning of the mandibleduring an overnight study. | The MATRx plus device mayalso be used with anautomated mandibularpositioner that uses feedbackcontrol to record changes inthe patient's respiratory statusrelated to repositioning of themandible during an overnightstudy. | ||
| MATRx plus uses theserecordings to produce a reportfor the HCP that can be used toprospectively identify patientswith mild to moderateobstructive sleep apnea whomay be suitable for therapywith an oral appliance and torecommend a targetmandibular position.The use of the device does notreplace the need for follow-uptesting to determine the initialand ongoing effectiveness ofthe therapy as recommendedby clinical practice guidelines. | MATRx plus uses theserecordings to produce a reportfor the HCP that can be usedto prospectively identifypatients with mild to moderateobstructive sleep apnea whomay be suitable for therapywith an oral appliance and torecommend a targetmandibular position.The use of the device does notreplace the need for follow-uptesting to determine the initialand ongoing effectiveness ofthe therapy as recommendedby clinical practice guidelines. | ||
| PatientPopulation | Adults | Adults | Identical |
| Environment ofUse | Deployed from clinics,hospitalsUsed unsupervised in the homeor clinicAnalyzed from physician'soffice | Deployed from clinics,hospitalsUsed unsupervised in thehome or clinicAnalyzed from physician'soffice | Identical |
| Outcome | 1) Data to assist in thediagnosis of sleep disorderedbreathing (K181996);2) Identifying patients withmild to moderate sleep apneafor whom an oral appliance is | 1) Data to assist in thediagnosis of sleep disorderedbreathing;2) Identifying patients withmild to moderate sleep apnea | Identical |
| Trade Name | MATRx plus | Proposed MATRx plus | Discussion ofDifferences |
| 510k Number | K181996/DEN170090 | -- | |
| Manufacturer | Zephyr Sleep Technologies,Inc. | Zephyr Sleep Technologies,Inc. | |
| a suitable therapy(DEN170090). | for whom an oral appliance isa suitable therapy. | ||
| Contra-indications | The device is not to be used asan apnea monitor or in a lifesupporting or life sustainingsituation. | The device is not to be used asan apnea monitor or in a lifesupporting or life sustainingsituation. | Identical |
| The device is not to be used bypersons under the age of 18. | The device is not to be used bypersons under the age of 18. | ||
| The MATRx plus is MRunsafe. | The MATRx plus is MRunsafe. | ||
| In auto-titration study mode,the device is not recommendedfor use in patients who: haveloose teeth or advancedperiodontal disease; have fulldentures or dental implants. | In auto-titration study mode,the device is not recommendedfor use in patients who: haveloose teeth or advancedperiodontal disease; have fulldentures or dental implants. |
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Image /page/6/Picture/0 description: The image contains the text "K191925" and "Rev. October 26, 2019". The text is arranged in two lines, with "K191925" on the top line and "Rev. October 26, 2019" on the bottom line. The text is in a clear, sans-serif font and is easily readable.
Image /page/6/Picture/1 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a large, sans-serif font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the text is a graphic of a crescent moon with a star above it. Below the logo is the address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada".
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| Proprietary Name | MATRx plus | Proposed MATRx plus subject device | Discussion of Differences |
|---|---|---|---|
| 510(k) Number | DEN170090/K181996 | ||
| Manufacturer | Zephyr Sleep Technologies, Inc. | Zephyr Sleep Technologies, Inc. | |
| Sensors | |||
| PulseOximeter | Third party oximeter sensor (Masimo SET 2040) attaches to patient worn recorder, measures degree of oxygen saturation of the blood and pulse rate. Sampling frequency of 1 Hz. | Third party oximeter sensor (Masimo SET 2040D) attaches to patient worn recorder, measures degree of oxygen saturation of the blood and pulse rate. Sampling frequency of 1 Hz. | Functionally identical; oximeters have same technology and performance standards. Substantially equivalent. |
| Airflow | Dual channel nasal cannula attaches to patient worn recorder; records pressure and translates to airflow and snoring. Sampling frequency of 350 Hz. In auto-titration mode, an alert will notify the user | Dual channel nasal cannula attaches to patient worn recorder; records pressure and translates to airflow and snoring. Sampling frequency of 350 Hz. In auto-titration mode, an alert will notify the user | No changes to airflow collection or analysis. Change to airflow alert in auto-titration study mode has no effect on data collected or test outcome. Substantially equivalent. |
| Proprietary Name | MATRx plus | Proposed MATRx plussubject device | Discussion ofDifferences |
| 510(k) Number | DEN170090/K181996 | ||
| Manufacturer | Zephyr SleepTechnologies, Inc.if the airflow signal hasbeen absent for 90 s. | Zephyr SleepTechnologies, Inc.if the airflow signal hasbeen absent for 120 s. | |
| Respiratory Effort | Respiratory effortchannel to measure therespiratory effort usingan inductance principle.Third-party belt (SleepSense, K042253).Sampling frequency of25 Hz. | Respiratory effortchannel to measure therespiratory effort usingan inductance principle.Third-party belt (SleepSense, K042253).Sampling frequency of25 Hz. | Identical |
| Position | Channel to determinebody position of thepatient during sleep by3D axis accelerometer. | Channel to determinebody position of thepatient during sleep by3D axis accelerometer. | Identical |
| Snoring | Nasal airflow fluctuationenvelope signal (between10 and 70 Hz).Set threshold. | Nasal airflow fluctuationenvelope signal (between10 and 70 Hz).Set threshold. | Identical |
| MandibularPositioner | Small, lightweight,motorized positionerattached to temporaryTitration Trays.Mandibular positioner isheld in place by theTitration Trays, which fitfirmly to the dentition.The mandibularpositioner consists of onesealed rod with a doubleseal design. Themandibular positioner ismade from acrylonitrilebutadiene styrene (ABS).The actuator rod materialis made from acetal resinor anodized stainlesssteel.Digital transfer ofmandibular position,sound, and acceleration.Powered by 14 V(hardware configurable). | Small, lightweight,motorized positionerattached to temporaryTitration Trays.Mandibular positioner isheld in place by theTitration Trays, which fitfirmly to the dentition.The mandibularpositioner consists of onesealed rod with a doubleseal design. Themandibular positioner ismade from acrylonitrilebutadiene styrene (ABS).The actuator rod materialis made from acetalresin, anodized stainlesssteel, or anodizedaluminum.Digital transfer ofmandibular position,sound, and acceleration.Powered by 14 V(hardware configurable). | Identical aside fromaddition of anodizedaluminum actuator.Mandibular positionerfunction is not affectedby change to actuatormaterial. Substantiallyequivalent. |
| Proprietary Name | MATRx plus | Proposed MATRX plussubject device | Discussion ofDifferences |
| 510(k) Number | DEN170090/K181996 | ||
| Manufacturer | Zephyr SleepTechnologies, Inc. | Zephyr SleepTechnologies, Inc. | |
| Digital signal isconverted from analogueon the MP board. | Digital signal isconverted from analogueon the MP board. | ||
| Mandibular positioningis constrained to theanterior/posteriordirection and uses aprotrusive step size of0.2 to 0.3 mm. A 5 sdelay is imposed by thesoftware. | Mandibular positioningis constrained to theanterior/posteriordirection and uses aprotrusive step size of0.2 to 0.3 mm. A 5 sdelay is imposed by thesoftware. | ||
| The maximum force thatthe mandibularpositioner can apply is70 N. The position isheld by the linearactuator and measuredby the software. | The maximum force thatthe mandibularpositioner can apply is70 N. The position isheld by the linearactuator and measuredby the software. | ||
| The mandibularpositioner requiresreprocessing betweenpatients. | The mandibularpositioner requiresreprocessing betweenpatients. | ||
| Titration Trays | Maxillary andmandibular U-shapedtrays with two walls toreceive impressionmaterial. Full arch thatencapsulates the incisorsand canines, narrower atthe front and lower wallheight on inner surface.The trays have slits inthe tray base to promoteflexibility. The trays areavailable in 2 sizes toaccommodate the incisorregion, medium andlarge. | Maxillary andmandibular U-shapedtrays with two walls toreceive impressionmaterial. Full arch thatencapsulates the incisorsand canines, narrower atthe front and lower wallheight on inner surface.The trays have slits inthe tray base to promoteflexibility. The trays areavailable in 2 sizes toaccommodate the incisorregion, medium andlarge. | The Titration Trays usedin the subject device areunchanged from thoseused in the predicatedevice.Additionalbiocompatibility andperformance testing weredemonstrated for theidentical Titration Traysin a reference device(K190051). Therefore,the allowed test durationhas been increased tothat allowed by thedevice software (6nights). As the traysthemselves areunchanged, the devicesare substantially |
| Proprietary Name | MATRx plus | Proposed MATRx plus subject device | Discussion of Differences |
| 510(k) Number | DEN170090/K181996 | ||
| Manufacturer | Zephyr SleepTechnologies, Inc. | Zephyr SleepTechnologies, Inc. | |
| 14 mm (20 mm range).Incisor edge-to-edge ismarked by the zeroposition on the trayscale. | 14 mm (20 mm range).Incisor edge-to-edge ismarked by the zeroposition on the trayscale. | The change to the fittingof the Titration Trays issupported by referencedevices such as theZyppah (K182312),which is an over-the-counter oral appliance(LRK) that is fitted bythe patient - an untrainedindividual. Since thecreation and use of acustom oral appliance bya patient withoutdirection from an HCPhas been cleared as safeand effective forapplying a protrusiverepositioning duringsleep, the subjectdevice's Titration Trayscan similarly be fitted bya non-healthcareprofessional. The subjectdevice is substantiallyequivalent in this mannerto the reference device. | |
| The mounting bracket isintegral with the trays,manufactured from asingle mold design. Thetrays are verticallyconstrained byinterconnection betweenthe two mountingbrackets. | The mounting bracket isintegral with the trays,manufactured from asingle mold design. Thetrays are verticallyconstrained byinterconnection betweenthe two mountingbrackets. | ||
| The Titration Trays aresingle patient, multi-useand are not reprocessed. | The Titration Trays aresingle patient, multi-useand are not reprocessed. | ||
| Titration Trays can beused for 24 hours. | Titration Trays can beused for 6 nights, i.e., themaximum durationallowed by the Tabletsoftware. | ||
| The Titration Trays arefit by a qualified dentistor dental professional. | The Titration Trays arefit by a trained healthcareprofessional. | ||
| Other channels | None | None | Identical |
| Method ofconnection to thepatient | Plastic tubing andcannula for pressuresensing; belts forrespiratory effort; probesorFlexi Wrap for oximetry;touch proof electrodecables; belts forattaching of device andclip straps to secureposition of device.The device is worn onthe patient's chest. | Plastic tubing andcannula for pressuresensing; belts forrespiratory effort; probesorFlexi Wrap for oximetry;touch proof electrodecables; belts forattaching of device andclip straps to secureposition of device.The device is worn onthe patient's chest. | Identical |
| Device Design | |||
| Sensor Connection | Sensors (airflow,oximeter, effort belt,mandibular positioner | Sensors (airflow,oximeter, effort belt,mandibular positioner | Identical |
| Proprietary Name | MATRx plus | Proposed MATRx plussubject device | Discussion ofDifferences |
| 510(k) Number | DEN170090/K181996 | ||
| Manufacturer | Zephyr SleepTechnologies, Inc.(during auto-titrationstudy) are attached to abody worn recorder unit. | Zephyr SleepTechnologies, Inc.(during auto-titrationstudy) are attached to abody worn recorder unit. | |
| RecorderDimensions/Weight | 6.30 x 7.90 x 6.60 cm230 g | 11.0 x 8.0 x 3.5 cm166 g | Subject device is smallerand lighter thanpredicate. Substantiallyequivalent. |
| MandibularPositionerDimensions/Weight | 5.2 x 5.7 x 2.8 cm80 g | 5.2 x 5.5 x 2.6 cm80 g | Subject device is slightlysmaller than predicateand the same weight.New design has beentested to ensure it meetsthe same performancecriteria as predicatedevice. Substantiallyequivalent. |
| Data collection | All sensors connectdirect to recorder.Study data are wirelesslytransferred (Bluetooth)from Recorder to tabletand stored on the tabletuntil study conclusion.Data are wirelesslycollected via device toweb portal at the end ofthe study. | All sensors connectdirect to recorder.Study data are wirelesslytransferred (Bluetooth)from Recorder to tabletand stored on the tabletuntil study conclusion.Data are wirelesslycollected via device toweb portal at the end ofthe study. | Identical |
| Processor | Recorder microprocessorsystem (ARM CortexM4 based, STM32F407,168 MHz) processes thepatient's data (1MB).Tablet minimumrequirements: 1.33 GHzprocessor, 1 GB RAM.The MATRx plusincludes a Tablet to storethe data and guide userinteractions. | Recorder microprocessorsystem (ARM CortexM4 based, STM32F407,168 MHz) processes thepatient's data (1MB).Tablet minimumrequirements: 1.33 GHzprocessor, 1 GB RAM.The MATRx plusincludes a Tablet to storethe data and guide userinteractions. | Identical |
| Indicators | Via Tablet Userinterface:Test StartedTest Paused | Via Tablet Userinterface:Test StartedTest Paused | Identical |
| OximetryConnectionEffort Sensor | Additional feedbackprovided to the MATRxplus user to help | Additional feedbackprovided to the MATRxplus user to help | Identical |
| Proprietary Name | MATRx plus | Proposed MATRx plussubject device | Discussion ofDifferences |
| 510(k) Number | DEN170090/K181996 | ||
| Manufacturer | Zephyr SleepTechnologies, Inc. | Zephyr SleepTechnologies, Inc. | |
| Recording Time | 6 x 8 hours. The totalnumber of study hours inthe MATRx plus is setby the software. Internalmemory is > 100 hours. | 6 x 8 hours. The totalnumber of study hours inthe MATRx plus is setby the software. Internalmemory is > 100 hours. | Identical |
| Internal memory | 48 hours | 48 hours | Identical |
| Battery Cover | Tamper-proof andlocked. MATRx plusbattery is recharged andis not replaceable by theuser. | Tamper-proof andlocked. MATRx plusbattery is recharged andis not replaceable by theuser. | Identical |
| Study Set up and Management | |||
| Patient Set up | Set up on devicesoftware and transferredto Device via internet | Set up on devicesoftware and transferredto Device via internet.HCP may start a newstudy for a patientpreviously created in theweb Portal.HCP may opt to set up astudy containing bothstudy types (i.e., basicsleep study preceding orfollowing auto-titrationstudy). | HCP may continue to setup the study in the webPortal and load on Tabletor can alternatively startthe study directly on theTablet. No newfunctionality introduced(just change of functionlocation).Addition of option forHCP to set up multiplestudies for one patientremoves the need for thedevice to be returned tothe HCP betweenstudies. Study typesremain the same.Addition of risk that ismitigated by Tabletsoftware.Substantially equivalent. |
| Data Storage and | Data are stored and | Data are stored and | Identical |
| Access | accessible via database.Database is located onmanufacturer's secureinternet accessibleserver. Copies aredownloaded locally foranalysis. | accessible via database.Database is located onmanufacturer's secureinternet accessibleserver. Copies aredownloaded locally foranalysis. | |
| Design - Data Viewer (PC Application) | |||
| Data Display | MNR function: Realtime waveformsdisplayed for allchannels; autoscored 4% | MNR function: Realtime waveformsdisplayed for allchannels; autoscored 4% | Identical |
| Proprietary Name | MATRx plus | Proposed MATRx plus subject device | Discussion of Differences |
| 510(k) Number | DEN170090/K181996 | ||
| Manufacturer | Zephyr SleepTechnologies, Inc. | Zephyr SleepTechnologies, Inc. | |
| desaturation and 4% or3% apnea-hypopneaevents are temporallydisplayed in relation tothe airflow, oxygen,pulse rate, and othersignals. Summary dataare calculated.QCJ function: Realtime data displayed forall channels: mandibularprotrusion, autoscored4% oxygen desaturationevents, airflow, oxygen,pulse rate, respiratoryeffort. | desaturation and 4% or3% apnea-hypopneaevents are temporallydisplayed in relation tothe airflow, oxygen,pulse rate, and othersignals. Summary dataare calculated.QCJ function: Realtime data displayed forall channels: mandibularprotrusion, autoscored4% oxygen desaturationevents, airflow, oxygen,pulse rate, respiratoryeffort. | ||
| DataReporting/Analysis | MNR function: Datarelated to patientrespiratory nasal airflow,snoring, blood oxygensaturation, pulse,respiratory effort andbody position can beanalyzed/displayed bySoftware and a reportcan be generatedautomatically. Thefollowing indices aregenerated from theMATRX plus software:ODI (4% and 3%), AHI(4% and 3%), AI (4%and 3%), averagesaturation, minimumsaturation, maximumsaturation, minimumpulse rate, maximumpulse rate, average pulserate.QCJ function: A reportis generated thatprovides: 1) raw data ofoxygen saturation,airflow, body position,respiratory effort, andmandibular position | MNR function: Datarelated to patientrespiratory nasal airflow,snoring, blood oxygensaturation, pulse,respiratory effort andbody position can beanalyzed/displayed bySoftware and a reportcan be generatedautomatically. Thefollowing indices aregenerated from theMATRX plus software:ODI (4% and 3%), AHI(4% and 3%), AI (4%and 3%), averagesaturation, minimumsaturation, maximumsaturation, minimumpulse rate, maximumpulse rate, average pulserate.QCJ function: A reportis generated thatprovides: 1) raw data ofoxygen saturation,airflow, body position,respiratory effort, andmandibular position | Identical |
| Proprietary Name | MATRx plus | Proposed MATRx plussubject device | Discussion ofDifferences |
| 510(k) Number | DEN170090/K181996 | ||
| Manufacturer | Zephyr SleepTechnologies, Inc.night test; 2) a display ofthe oxygen desaturationevents detected by thedevice, as calculated bythe previously-clearedsleep recorder(K181996); anassessment of whetherthe patient is predicted toachieve an oxygendesaturation index (ODI)of less than 10 per hourwith a third-party customoral appliance; 4) aprotrusive position that ispredicted to beefficacious to achieve thedesired therapeuticsuccess criterion (ODI < $10 h^{-1}$ ) | Zephyr SleepTechnologies, Inc.night test; 2) a display ofthe oxygen desaturationevents detected by thedevice, as calculated bythe previously-clearedsleep recorder(K181996); anassessment of whetherthe patient is predicted toachieve an oxygendesaturation index (ODI)of less than 10 per hourwith a third-party customoral appliance; 4) aprotrusive position that ispredicted to beefficacious to achieve thedesired therapeuticsuccess criterion (ODI < $10 h^{-1}$ ) | |
| Components inPatient contact | Recorder and Sensors(nasal cannula, pulseoximeter, effort belt,mandibular positioner,Titration Trays) | Recorder and Sensors(nasal cannula, pulseoximeter, effort belt,mandibular positioner,Titration Trays) | Identical |
| Biocompatibility | All body contactingcomponents previouslycleared | All body contactingcomponents previouslycleared.Titration Trays are nowcleared for use for up to29 nights (cleared inK190051) – change toallowable test durationfrom 3 to 6 nights. | Change to auto-titrationtest duration supportedby biocompatibilitytesting on file forreference device(K190051).Substantially equivalent. |
| Reprocessing | Patient contacting andindirectly contactingcomponents arereprocessed | Patient contacting andindirectly contactingcomponents arereprocessed. Simplifiedinstructions forreprocessing have beenrevalidated. | No changes toreprocessingrequirements. Newinstructions have beenvalidated for cleaningand low-leveldisinfection.Substantially equivalent. |
| Safety Testing | Tested to: IEC 60601-1,IEC 80601-2 | Tested to: IEC 60601-1,IEC 80601-2 | Testing performed asnecessary for subjectdevice to demonstrate |
| Proprietary Name | MATRx plus | Proposed MATRx plus subject device | Discussion of Differences |
| 510(k) NumberManufacturer | DEN170090/K181996Zephyr SleepTechnologies, Inc. | Zephyr SleepTechnologies, Inc. | updated standards as predicate devices.Substantially equivalent. |
| Patient isolation | Device has no galvanicconnections to mains asit is a battery-operateddevice. Notpossible to connectauxiliary devices to thedevice | Device has no galvanicconnections to mains asit is a battery-operateddevice. Notpossible to connectauxiliary devices to thedevice | Identical |
| Battery Powered | Internally powered:single cell rechargeableLi-Ion battery(3.7 V).The battery is notreplaceable by the user.The battery is charged bya 5V - 2A medical grade(double insulated) wallpower supply connectedwith a standard barrelpower jack. The batterywas safety tested forcompliance to IEC62133:2012 | Internally powered:single cell rechargeableLi-Ion battery(3.7 V).The battery is notreplaceable by the user.The battery is charged bya 5V - 1A medical grade(double insulated) wallpower supply connectedwith a standard barrelpower jack. The batterywas safety tested forcompliance to IEC62133:2012 | Decrease in amperage ofbattery. Subject devicebattery has a slightlyincreased charging timefrom that of predicatedevices (5 h for fullcharge instead of 4 h).The device remainsusable upon reaching85% charge. Change isdeemed negligible.Substantially equivalent. |
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Image /page/8/Picture/0 description: The image contains text that indicates a revision date. The text "Rev. October 26, 2019" is present, suggesting that a document or file was revised on that date. The image also contains the text "K191925".
Image /page/8/Picture/1 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. The address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada" is printed below the company name.
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Image /page/9/Picture/0 description: The image displays the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a large, sans-serif font, with the words "Sleep Technologies" in a smaller font underneath. The address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada" is printed below the company name.
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Image /page/10/Picture/0 description: The image contains the alphanumeric string "K191925" on the top line. The second line of the image contains the text "Rev. October 26, 2019". The text is left-aligned and the font is sans-serif.
Image /page/10/Picture/1 description: The image shows the logo for Zephyr Sleep Technologies. The logo includes the company name in a stylized font, with the word "ZEPHYR" in large, bold letters and "Sleep Technologies" in a smaller font underneath. To the right of the company name is a graphic of three curved lines with a star above them. Below the logo is the company's address: #102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada.
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Image /page/11/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo includes the company name in a stylized font, with the word "ZEPHYR" in large, bold letters and "Sleep Technologies" in smaller letters underneath. The address "#102, 701-64th Avenue SE, Calgary, AB, T2H 2C3, Canada" is printed below the company name.
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Image /page/12/Picture/0 description: The image contains the text "K191925" and "Rev. October 26, 2019". The text is arranged in two lines, with "K191925" on the top line and "Rev. October 26, 2019" on the bottom line. The text is in a simple, sans-serif font and is black in color. The background of the image is white.
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Image /page/13/Picture/0 description: The image shows a logo with a blue, stylized crescent shape and a small star above it. The text "Technologies" is written in a sans-serif font below the crescent shape. The logo appears to be for a technology company or organization. The color scheme is simple, with a focus on blue and white.
Sleep Te #102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada
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Image /page/14/Picture/0 description: The image contains the text "K191925" on the top line. The second line of text says "Rev. October 26, 2019". The text is black and the background is white. The text is centered.
Image /page/14/Picture/1 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a large, bold, blue font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the text is a graphic of a crescent moon with a star above it. Below the logo is the address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada".
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Image /page/15/Picture/0 description: The image contains the logo for Zephyr Sleep Technologies. The logo has the word "ZEPHYR" in large blue font, with the words "Sleep Technologies" in a smaller font below it. To the right of the words is a graphic of a crescent moon with a star above it. Below the logo is the address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada".
Testing Summary: Non-clinical:
The subject device was tested to the following standards:
IEC 60601-1: 2005 3rd ed. + A1:2012. General Requirements for Basic Safety and Essential Performance.
IEC 60601-1-2: 2014. Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
IEC 60601-1-6: 2010. AMDI:2003. Medical Electrical Equipment – Part 1-6: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability.
IEC 62366: 2007. Medical Devices – Part 1: Application of usability engineering to medical devices.
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Image /page/16/Picture/1 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the company name in a blue font, with the word "ZEPHYR" in a larger, bolder font than "Sleep Technologies." To the right of the company name is a graphic of a crescent moon and a star. Below the logo is the company's address: #102, 701-64th Avenue SE, Calgary, AB, T2H 2C3, Canada.
IEC 60601-1-10: 2007.Medical Electrical Equipment - Part 1-10: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers. IEC 60601-1-11: 2015.Medical Electrical Equipment - Part 1-10: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements of Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.
IEC 62304: 2006 186 Ed. + A1:2015. Medical Device Software - Software life cycle processes.
IEC 80601-2-61:2011 Medical electrical equipment -- Medical Electrical Equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
IEC 62133 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
EN 62311:2008 Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields (0 Hz - 300 GHz)
EN 300 328/1 1.8.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE
Directive
EN 301 489-1 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements
EN 301 489-17 ElectroMagnetic Compatibility (EMC)
standard for radio equipment and services; Part 17: Specific conditions for Broadband Data Transmission Systems
FCC Part 15B Equipment authorization of unintentional radiators
FCC Part 2.1091, 15.247 Radiofrequency radiation exposure evaluation: mobile devices, Operation within the bands 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz.
Reprocessing validation was completed on the new device hardware and new, simpler reprocessing instructions.
Performance bench testing was completed to demonstrate that the subject device's mandibular positioner and oximeter meet the same performance criteria as those cleared in the predicate (cleared in DEN170090).
All materials in contact with the mucosal membrane were assessed and tested in accordance with ISO 10993-1 and the associated FDA guidance, Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices – Part 1 Evaluation
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Image /page/17/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a large, sans-serif font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the text is a graphic of curved lines and a star. Below the logo is the address "#102, 701-64th Avenue SE, Calgary, AB, T2H 2C3, Canada".
and Testing within a Risk Management Process" issued June 16, 2016. Specifically, the following tests were performed:
ISO 10993-5: 2009 Biological Evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
IOS 10993-10: 2010 Biological Evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
Clinical:
Clinical performance testing was not required for the changes made to the subject device.
Conclusion:
The conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the legally marketed MATRx plus predicate devices cleared under DEN170090 and K181996.
§ 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).