(265 days)
Not Found
No
The document describes standard CPAP device functionality and software controls, including pre-defined therapy modes and breathing pattern recognition. There is no mention of AI, ML, or adaptive learning algorithms that would adjust therapy based on real-time patient data in a way that goes beyond pre-programmed logic. The "self-adjusting" aspect likely refers to the AutoSet for Her mode, which is a pre-defined algorithm, not an AI/ML system.
Yes
The device is explicitly indicated for the "treatment of Obstructive Sleep Apnea (OSA)" and functions as a CPAP system which is a recognized therapeutic modality.
No
The device is indicated for the treatment of Obstructive Sleep Apnea (OSA) and functions as a CPAP device, delivering positive airway pressure. While it can display patient sleep data and treatment pressures and includes Cheynes Stokes Respiration (CSR) breathing pattern recognition and reporting, its primary function is therapeutic, not diagnostic.
No
The device description explicitly mentions hardware components such as a mask, tubing, humidification system, and a micro-processor controlled blower system. It also details mechanical and electrical safety testing, which are associated with hardware. While software is a key feature, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of Obstructive Sleep Apnea (OSA) by providing positive airway pressure. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a CPAP system that generates airflow to treat OSA. It measures breathing patterns and pressures, but this is for monitoring and adjusting therapy, not for diagnosing a condition based on in vitro analysis.
- Lack of In Vitro Testing: The description of performance studies includes biocompatibility, electrical safety, software validation, mechanical/acoustic testing, and a clinical study on humidifier performance. There is no mention of testing biological samples (blood, urine, tissue, etc.) or performing any in vitro analysis.
- Nature of the Device: The device is a medical device used to deliver therapy directly to the patient's airways. IVD devices are used to examine samples outside of the body to provide information for diagnosis, monitoring, or prognosis.
Therefore, the Menai self-adjusting system, including its components and associated mobile application, is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Menai system
The Menai self-adjusting system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients (female patients with mild to moderate OSA when using AfH treatment mode) weighing more than 66 lb (30 kg). It is intended for home and hospital use.
Smart Phone Application (Monte Carlo)
Monte Carlo is a mobile application for patients to remotely operate a prescribed compatible ResMed machine and transfer, and display usage and therapeutic information. Monte Carlo also allows healthcare professionals to remotely configure compatible OSA therapy devices.
Menai Full Face Mask
The Menai FFM is a non-invasive accessory used for channeling airflow to a patient from a compatible ResMed machine such as a continuous positive airway pressure (CPAP) system.
The Menai FFM is:
• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed
• intended for single-patient reuse in the home and hospital/institutional environment.
Product codes (comma separated list FDA assigned to the subject device)
BZD, MNR
Device Description
The Menai system CPAP device retains similar hardware and performance features of the predicate device(s). It is provided in a portable smaller footprint than the predicate for user convenience in the home environment. Key features include mask, tubing, humidification system, and software controls. The Menai System contains a Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O as required to maintain an "air splint" for treatment of OSA. Included is an optional humidifier component for patients who experience dryness in the upper airways such as mouth or nasal areas.
The Menai system flow generator includes CPAP, AutoSet for Her (AfH) modes. These modes and their treatment parameters are only settable by the Clinician via the Clinician accessible menu of the software. In addition to Patient and Clinician settable features, the software can display patient sleep data and treatment pressures, similar to that found on the predicate S9 Elouera (K140124). The Menai system includes Cheynes Stokes Respiration (CSR) breathing pattern recognition and reporting, this feature remains unchanged as cleared S9 Elouera (K140124).
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
Not Found
Intended User / Care Setting
Intended for home and hospital use.
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)
Biocompatibility Testing:
The biocompatibility evaluation for the Menai device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Tests Selected:
Component classifications for materials used according to #G95-1 are:
- Wet Air Path
- Device Category: "External communicating devices, Tissue/bone/dentin,"
- Contact Duration: "C - Permanent (>30d). "
- Skin Contact -
- Device Category "Surface devices, skin"
- Contact Duration "C Permanent (>30d)"
Biocompatibility evaluation used according to #G95-1 are;
- Wet Air Path -
- Cytotoxicity (MEM Elution) (ISO 10993-5)
- Sensitisation (Polar & Non-polar) (ISO 10993-10)
- Irritation (Polar & Non-polar) (ISO 10993-10) additional test as per #G95-1
- Genotoxicity (Polar & Non-polar) (ISO 10993-3)
- Implantation (ISO 10993-6)
- Skin Contact -
- Cytotoxicity (MEM Elution) (ISO 10993-5)
- Irritation (Polar & Non-polar) (ISO 10993-10)
- Sensitisation (Polar & Non-polar) (ISO 10993-10)
Testing the Menai system demonstrated compliance to the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995.
Electrical Safety and Electromagnetic Compatibility (EMC):
The Menai system has been tested to appropriate standards and other applicable requirements. The Menai system with integrated tubing and dedicated mask was designed and tested according to:
- IEC 60601-1:2005 amd 1 (3.1), Medical electrical equipment Part 1: General requirements for safety Medical electrical equipment - General requirements for basic safety and essential performance
- IEC 60601-1-2:2013 Ed. 4.0 Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11:2015 (Ed 2.0) Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- ISO 17510-2:2007 Sleep apnoea breathing therapy Part 2: Masks and application accessories
- IEC 62304:2006 Medical device software Software life cycle processes
- IEC 60601-1-6 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Guidance for Industry and FDA Staff, May 2005." The software for this device was considered as a "Moderate" level of concern.
Mechanical and Acoustic Testing:
Mechanical testing was carried out in accordance with mechanical and environmental requirements as set down in Environmental Testing Section (e) (6) in Reference 4.4 Reviewer Guidance for Premarket Notification Submissions, Anesthesiology and Respiratory Devices Branch, FDA, November 1993.
Acoustic testing was carried out in accordance with ISO 80601-2-70: 2015 Sleep apnoea breathing therapy -- Part 1: Sleep apnoea breathing therapy equipment and found to be compliant with these requirements.
Animal Studies:
No animal studies were performed for the Menai system.
Clinical Studies:
The key aims of the clinical study are to characterise the rate of bacterial accumulation and/or proliferation, characterize the change in impedance, and establish the replacement interval. Bio-burden outcomes showed that the humidifier component was relatively stable over the study period with no observation of unstable bioburden proliferation or accumulation. Furthermore, colony identification indicated common microbial presence to that of users and their environment with low risk pathogenicity. The impedance was shown to be relatively stable over the study duration. The clinical trial results demonstrated that the humidifier component of the Menai system performed as expected, and can be used as a single patient reuse item with a standard replacement interval.
Non-Clinical Testing:
Side-by-Side bench testing was performed to verify that the Menai system met the requirements of the Menai system Specification when compared to the predicate device S9 Elouera (K140124).
The bench testing included performance for each therapy mode which covered:
- Pressure stability
- Response to apneas
- Response to flow limitations and snore.
- Reporting of Closed Airway Detection (CAD)
A breathing machine simulates patient breathing patterns, which results in the Flow Generator responding in a manner consistent with maintaining the CPAP treatment pressure (CPAP mode) or adjusting the CPAP pressure based upon the patient's condition in real-time (self-adjusting mode). The clinical Pass/Fail requirements are traced to the Menai system Specification and to the predicate device's performance.
Bench testing for the Menai system includes Cheynes Stokes Respiration (CSR) breathing pattern recognition and reporting. Side-by-side testing using the same digitised breathing patterns was used for both predicate and Menai system. This test executes patient script file is treated as an individual scenario, which the Menai reports either: - No CSR
- CSR
- CSR + OSA
- OSA
The Menai CSR detection results are then compared to the predicate S9 Elouera (K140124). The Menai system met the predefined Clinical Pass/Fail criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
S9 Elouera (K140124), Medtronic® SULLIVAN CPAP System (K905404)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2016
ResMed Ltd. % Larissa D'andrea Director, Government and Regulatory Affairs ResMed Corp. 9001 Spectrum Center Boulevard San Diego, California 92123
Re: K160836 Trade/Device Name: Menai System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD, MNR Dated: November 11, 2016 Received: November 15, 2016
Dear Larissa D'andrea:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K160836
Device Name Menai system
Indications for Use (Describe) Menai system
The Menai self-adjusting system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients (female patients with mild to moderate OSA when using AfH treatment mode) weighing more than 66 lb (30 kg). It is intended for home and hospital use.
Smart Phone Application (Monte Carlo)
Monte Carlo is a mobile application for patients to remotely operate a prescribed compatible ResMed machine and transfer, and display usage and therapeutic information. Monte Carlo also allows healthcare professionals to remotely configure compatible OSA therapy devices.
Menai Full Face Mask
The Menai FFM is a non-invasive accessory used for channeling airflow to a patient from a compatible ResMed machine such as a continuous positive airway pressure (CPAP) system.
The Menai FFM is:
• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed
· intended for single-patient reuse in the home and hospital/institutional environment.
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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3
510(k) Summary – Menai system
| Required | By section 807.92 (c) |
|---|---|
| Date Prepared | |
| Owners Name | 15 Dec 2016 |
| ResMed Ltd | |
| 1 Elizabeth Macarthur Drive | |
| Bella Vista, NSW 2153, Australia | |
| Submitter | Greg Dockar, Senior Regulatory Affairs Manager. |
- 61 2 8884 2157 (Phone)
- 61 2 8884 2004 (FAX)
GregD@resmed.com.au |
| Official Contact | Ms Sheila Bruschi – Senior Manager, Regulatory Affairs
ResMed Corp.
9001 Spectrum Center Boulevard,
San Diego, CA 92123
+1 858-836-5934 (Phone) or +1 (858) 836 5519 (FAX) |
| Product Codes | 73 BZD
73 MNR |
| Class | II |
| Classification Reference | (21 CFR 868.5905 Product code 73 BZD)
(21 CFR 868.2375 Product code 73 MNR) |
| Common/Usual Name | Non continuous ventilator (IPPB)
Breathing Frequency Monitor |
| Proprietary Name | Menai system |
| Predicate Device(s) | S9 Elouera (K140124)
Medtronic® SULLIVAN CPAP System (K905404) |
| Reason for submission | New Device |
4
DEVICE DESCRIPTION
The Menai system CPAP device retains similar hardware and performance features of the predicate device(s). It is provided in a portable smaller footprint than the predicate for user convenience in the home environment. Key features include mask, tubing, humidification system, and software controls. The Menai System contains a Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O as required to maintain an "air splint" for treatment of OSA. Included is an optional humidifier component for patients who experience dryness in the upper airways such as mouth or nasal areas.
The Menai system flow generator includes CPAP, AutoSet for Her (AfH) modes. These modes and their treatment parameters are only settable by the Clinician via the Clinician accessible menu of the software. In addition to Patient and Clinician settable features, the software can display patient sleep data and treatment pressures, similar to that found on the predicate S9 Elouera (K140124). The Menai system includes Cheynes Stokes Respiration (CSR) breathing pattern recognition and reporting, this feature remains unchanged as cleared S9 Elouera (K140124).
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate devices.
- » Same intended use
- A Similar operating principle
- Similar technologies A
As a result of the Risk Analysis review and design input requirements, Verification activities were performed on the Menai system. All tests confirmed the product met the predetermined acceptance criteria.
INDICATION FOR USE
Menai system
Indication for Use
The Menai self-adjusting system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients (female patients with mild to moderate OSA when using AfH treatment mode) weighing more than 66 lb (30 kq).
It is intended for home and hospital use.
Software Application (Monte Carlo)
Indication for Use
Monte Carlo is a mobile application for patients to remotely operate a prescribed compatible ResMed machine and transfer, analyze and display usaqe and therapeutic information. Monte Carlo allows healthcare professionals to remotely configure compatible OSA therapy devices.
Menai Full Face Mask
Indication for Use
The Menai FFM is a non-invasive accessory used for channelling airflow to a patient from a compatible ResMed machine such as a continuous positive airway pressure (CPAP) system.
The Menai FFM is:
- to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed
- intended for single-patient reuse in the home and hospital/institutional environment.
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Characteristic | Predicate Device- S9 Elouera
(K140124) | New device- Menai System | Comments |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | The S9 Elouera self-adjusting device is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients (female patients with mild to moderate OSA when using AfH treatment mode) weighing more than 66 lb (30 kg). It is intended for home and hospital use. | The Menai self-adjusting system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients (female patients with mild to moderate OSA when using AfH treatment mode) weighing more than 66 lb (30 kg). It is intended for home and hospital use. | Equivalent |
| Location of use (primary) | Hospital/Home | Hospital/Home | Equivalent |
| Indication for use | — | Monte Carlo is a mobile application for patients to remotely operate a prescribed compatible ResMed machine and transfer, analyze and display usage and therapeutic information. Monte Carlo also allows healthcare professionals to remotely configure compatible OSA therapy devices. | Equivalent
Software application - similar functionality to LCD and keypad operation with S9 Elouera (K140124). |
| Indication for use | FFM Quattro LT
The Quattro LT channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Quattro LT is:
• to be used by adult patients (>66 lb / >30kg) for whom positive airway pressure has been prescribed
• intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment. | The Menai FFM is a non-invasive accessory used for channelling airflow to a patient from a compatible ResMed machine such as a continuous positive airway pressure (CPAP) system.
The Menai FFM is:
• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed
• intended for single-patient reuse in the home and hospital/institutional environment. | Equivalent
Similar intended Use, reduced feature, same patient population and compatibility with a CPAP Machine. |
| Performance | | | |
| Pressure range | • 4-20 cm H2O (CPAP Mode)
• 4-20 cm H2O (AutoSet Mode)
• 4-20 cm H2O (AutoSet AfH Mode)
• EPR +3 cm H2O (all modes) | • 4-20 cm H2O (CPAP Mode)
• 4-20 cm H2O (AutoSet Mode)
• 4-20 cm H2O (AutoSet AfH Mode)
• EPR +3 cm H2O (all modes) | Equivalent:
These features are enabled when using the software- similar functionality to LCD and keypad operation with S9 Elouera (K140124). |
| Ramp features | • User selected as "Off" to 45 minutes in 5 minute increments | • User selected as "Off" to 45 minutes in 5 minute increments | Equivalent
These features are enabled when using the software- similar functionality to LCD and keypad operation with S9 Elouera (K140124). |
| Characteristic | Predicate Device- S9 Elouera
(K140124) | New device- Menai System | Comments |
| Modes of
operation | CPAP Mode (Fixed-pressure) with CAD AutoSet/AfH Mode (maximum to 20cm H2O with CAD) CPAP and AutoSet with EPR (maximum to 20cm H2O with CAD) | CPAP Mode (Fixed-pressure) with CAD AutoSet/AfH Mode (maximum to 20cm H2O with CAD) CPAP and AutoSet with EPR (maximum to 20cm H2O with CAD) | Equivalent:
These features are enabled when
using the software- similar
functionality to LCD and keypad
operation with S9 Elouera
(K140124). |
| CSR
Detection and
Reporting | Yes | Yes | Equivalent |
| System
Components | Flow generator Integrated humidifier Mask, air tubing and heated tubing Graphic User Interface Plug Pack | Flow generator Optional Humidifier component Mask and air tubing Graphic User Interface (SPA) Plug Pack | Equivalent
Similar components, same
treatment options. Humidifier
component similar to additional
predicate Medtronic® Sullivan Nasal
CPAP System (K905404). |
Characteristics between the predicate and new device
6
PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the Menai device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Tests Selected
Component classifications for materials used according to #G95-1 are:
- -Wet Air Path
- Device Category: "External communicating devices, Tissue/bone/dentin," O
- o Contact Duration: "C - Permanent (>30d). "
- Skin Contact -
- Device Category "Surface devices, skin" O
- Contact Duration "C Permanent (>30d)" O
Biocompatibility evaluation used according to #G95-1 are;
- Wet Air Path -
- Cytotoxicity (MEM Elution) (ISO 10993-5) O
- Sensitisation (Polar & Non-polar) (ISO 10993-10) O
- Irritation (Polar & Non-polar) (ISO 10993-10) additional test as per #G95-1 O
- Genotoxicity (Polar & Non-polar) (ISO 10993-3) O
- o Implantation (ISO 10993-6)
- Skin Contact -
- Cytotoxicity (MEM Elution) (ISO 10993-5) O
- Irritation (Polar & Non-polar) (ISO 10993-10) O
- Sensitisation (Polar & Non-polar) (ISO 10993-10) O
Testing the Menai system demonstrated compliance to the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995.
7
Electrical Safety and Electromagnetic Compatibility (EMC)
The Menai system has been tested to appropriate standards and other applicable requirements. The Menai system with integrated tubing and dedicated mask was designed and tested according to:
-
IEC 60601-1:2005 amd 1 (3.1), Medical electrical equipment Part 1: General requirements for safety Medical electrical equipment - General requirements for basic safety and essential performance
- IEC 60601-1-2:2013 Ed. 4.0 Medical Electrical Equipment Part 1-2: General requirements for basic safety A and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11:2015 (Ed 2.0) Medical electrical equipment -- Part 1-11: General requirements for basic A safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- ISO 17510-2:2007 Sleep apnoea breathing therapy Part 2: Masks and application accessories
- IEC 62304:2006 Medical device software Software life cycle processes A
- IEC 60601-1-6 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Guidance for Industry and FDA Staff, May 2005." The software for this device was considered as a "Moderate" level of concern, since prior to mitigation of hazards, failure of the Software Device result in Minor Injury, either to a user of the device since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Mechanical and Acoustic Testing
Mechanical testing was carried out in accordance with mechanical and environmental requirements as set down in Environmental Testing Section (e) (6) in Reference 4.4 Reviewer Guidance for Premarket Notification Submissions, Anesthesiology and Respiratory Devices Branch, FDA, November 1993.
Acoustic testing was carried out in accordance with ISO 80601-2-70: 2015 Sleep apnoea breathing therapy -- Part 1: Sleep apnoea breathing therapy equipment and found to be compliant with these requirements.
Animal Studies
No animal studies were performed for the Menai system.
Clinical Studies:
The key aims of the clinical study are to characterise the rate of bacterial accumulation and/or proliferation, characterize the change in impedance, and establish the replacement interval. Bio-burden outcomes showed that the humidifier component was relatively stable over the study period with no observation of unstable bioburden proliferation or accumulation. Furthermore, colony identification indicated common microbial presence to that of users and their environment with low risk pathogenicity. The impedance was shown to be relatively stable over the study duration. The clinical trial results demonstrated that the humidifier component of the Menai system performed as expected, and can be used as a single patient reuse item with a standard replacement interval.
Non-Clinical Testing:
Side-by-Side bench testing was performed to verify that the Menai system met the requirements of the Menai system Specification when compared to the predicate device S9 Elouera (K140124).
8
The bench testing included performance for each therapy mode which covered:
- Pressure stability A
- Response to apneas A
- Response to flow limitations and snore. A
- Reporting of Closed Airway Detection (CAD) ♪
A breathing machine simulates patient breathing patterns, which results in the Flow Generator responding in a manner consistent with maintaining the CPAP treatment pressure (CPAP mode) or adjusting the CPAP pressure based upon the patient's condition in real-time (self-adjusting mode). The clinical Pass/Fail requirements are traced to the Menai system Specification and to the predicate device's performance.
Bench testing for the Menai system includes Cheynes Stokes Respiration (CSR) breathing pattern recognition and reporting. Side-by-side testing using the same digitised breathing patterns was used for both predicate and Menai system. This test executes patient script file is treated as an individual scenario, which the Menai reports either:
- No CSR A
- » CSR
- CSR + OSA A
- OSA A
The Menai CSR detection results are then compared to the predicate S9 Elouera (K140124). The Menai system met the predefined Clinical Pass/Fail criteria.
CONCLUSION
The Menai system is substantially equivalent to the predicate devices S9 Elouera (K140124) and Medtronic® SULLIVAN CPAP System (K905404) and is as safe and as effective as the predicate device.