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.

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.

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.

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).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, keeping in mind that the document is a 510(k) summary and not a full clinical study report, so some details (like specific statistical results or full ground truth methods for all tests) may not be explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a consolidated table of acceptance criteria with numerical performance targets and reported results for all aspects of the device. Instead, it describes various tests and states that the device "met the predetermined acceptance criteria" or "demonstrated compliance."

However, we can infer some criteria and reported performance from the "Non-Clinical Testing" section for the core therapeutic performance:

Acceptance Criteria (Inferred)	Reported Device Performance
Therapeutic Performance (Bench Testing):
Pressure stability across therapy modes	Met the requirements of the Menai system Specification.
Response to apneas	Met the requirements of the Menai system Specification.
Response to flow limitations and snore	Met the requirements of the Menai system Specification.
Reporting of Closed Airway Detection (CAD)	Met the requirements of the Menai system Specification.
Cheyne-Stokes Respiration (CSR) Detection and Reporting:
CSR detection and reporting against digitized breathing patterns (vs. predicate device)	The Menai system met the predefined Clinical Pass/Fail criteria when compared to the predicate S9 Elouera (K140124) using the same digitized breathing patterns. The system reports "No CSR," "CSR," "CSR + OSA," or "OSA."
Biocompatibility Testing (Compliance to ISO 10993 and FDA G95-1 Memorandum):
Cytotoxicity (MEM Elution)	Testing demonstrated compliance.
Sensitization (Polar & Non-polar)	Testing demonstrated compliance.
Irritation (Polar & Non-polar)	Testing demonstrated compliance.
Genotoxicity (Polar & Non-polar)	Testing demonstrated compliance.
Implantation (ISO 10993-6)	Testing demonstrated compliance.
Electrical Safety and Electromagnetic Compatibility (EMC) (Compliance to various IEC standards):
Compliance to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 17510-2, IEC 62304, IEC 60601-1-6	The Menai system has been tested to appropriate standards and other applicable requirements and designed accordingly. Testing conducted according to these standards.
Software Verification and Validation (Compliance to FDA Guidance):
Software meets requirements for "Moderate" level of concern (prior to mitigation, failure could result in minor injury)	Software verification and validation testing were conducted, and documentation was provided as recommended by FDA guidance.
Mechanical and Acoustic Testing (Compliance to FDA Reviewer Guidance and ISO 80601-2-70):
Mechanical testing across environmental requirements	Carried out in accordance with mechanical and environmental requirements (FDA Reviewer Guidance)
Acoustic testing compliance to ISO 80601-2-70	Carried out in accordance with ISO 80601-2-70:2015 and found to be compliant.
Clinical Study (Humidifier Component):
Bacterial accumulation and proliferation	Humidifier component was relatively stable over the study period with no observation of unstable bioburden proliferation or accumulation. Colony identification indicated common microbial presence with low risk pathogenicity.
Change in impedance	Impedance was shown to be relatively stable over the study duration.
Establish replacement interval	Performed as expected and can be used as a single patient reuse item with a standard replacement interval.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Therapeutic Performance (Bench Testing): Not explicitly stated. It mentions "patient breathing patterns" and "digitized breathing patterns" for CSR detection, suggesting a collection of such patterns, but no number is given.
- Biocompatibility, Electrical Safety, Mechanical, Acoustic, Software V&V: These are generally conducted on device units or software builds, not "patient test sets" in the same way clinical or diagnostic studies are. The sample size for these types of tests would typically refer to the number of devices or components tested, which is not specified.
- Clinical Study (Humidifier): Not specified.
Data Provenance: The document does not specify the country of origin for any data cited.
- Therapeutic Performance (Bench Testing): Retrospective, as it used "digitized breathing patterns" and "patient script file" data.
- Clinical Study (Humidifier): Prospective for the "clinical study" focusing on bio-burden and impedance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Therapeutic Performance (Bench Testing), CSR Detection: Not specified. The "Clinical Pass/Fail criteria" were predefined, implying expert input into their establishment, but the number or qualifications of experts used to establish the ground truth for the digitized breathing patterns themselves is not mentioned. Many such patterns are often derived from polysomnography interpreted by sleep specialists, but this is not stated here.
Other Testing (Biocompatibility, Electrical, Mechanical, Software): Ground truth for these types of engineering and safety tests is established by adherence to recognized international standards and regulatory guidance, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for any specific test set. For the CSR detection, it states the Menai system's results were "compared to the predicate S9 Elouera (K140124)" and met "predefined Clinical Pass/Fail criteria." This implies a comparison to an established reference or a standard of performance, but not an independent expert adjudication process on the test cases themselves.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The device being reviewed is a noncontinuous ventilator (CPAP machine), not typically an imaging or diagnostic AI requiring an MRMC study to assess human reader improvement. The "Clinical Study" was focused on the humidifier component's characteristics (bioburden, impedance, replacement interval).

6. Standalone Performance Study (Algorithm Only)

Yes, standalone performance was implicitly studied for the core therapeutic functions and CSR detection:

Therapeutic Performance (Bench Testing): "A breathing machine simulates patient breathing patterns, which results in the Flow Generator responding in a manner consistent with maintaining the CPAP treatment pressure... or adjusting the CPAP pressure..." This indicates the algorithm's performance in responding to simulated physiological conditions.
CSR Detection 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." This is a standalone test of the algorithm's ability to detect and report these patterns.

7. Type of Ground Truth Used

Therapeutic Performance (Bench Testing): The ground truth for these tests would be the expected or ideal physiological response to the simulated breathing patterns, as defined by the device's specification and comparison to the predicate device's known performance. This is essentially an engineering-defined "ground truth."
CSR Detection and Reporting: The ground truth for this was established by the "same digitized breathing patterns" used for both the predicate and new device, which were likely derived from actual patient data previously interpreted and labeled, forming the "patient script files." This would be closer to an "expert consensus" or "polysomnography-derived" ground truth for the underlying physiological events.
Clinical Study (Humidifier): Laboratory analysis (for bacterial accumulation/proliferation) and direct measurement (for impedance).

8. Sample Size for the Training Set

The document does not provide details about a training set for any algorithms. This is a 510(k) summary, often focused on verification and validation against pre-defined requirements and predicate devices, rather than the developmental aspects of AI/ML algorithms which would typically involve training sets. While there's a "Software Verification and Validation Testing" section, it focuses on general software lifecycle processes rather than machine learning specifics.

9. How Ground Truth for the Training Set Was Established

Since no training set details are provided, the method for establishing its ground truth is also not described.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K160836

Device Name Menai system

Indications for Use (Describe) Menai system

Smart Phone Application (Monte Carlo)

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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510(k) Summary – Menai system

Required	By section 807.92 (c)
Date PreparedOwners Name	15 Dec 2016ResMed Ltd1 Elizabeth Macarthur DriveBella 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 AffairsResMed Corp.9001 Spectrum Center Boulevard,San Diego, CA 92123+1 858-836-5934 (Phone) or +1 (858) 836 5519 (FAX)
Product Codes	73 BZD73 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

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DEVICE DESCRIPTION

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

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.

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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.	EquivalentSoftware application - similar functionality to LCD and keypad operation with S9 Elouera (K140124).
Indication for use	FFM Quattro LTThe 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.	EquivalentSimilar 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	EquivalentThese 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 ofoperation	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 whenusing the software- similarfunctionality to LCD and keypadoperation with S9 Elouera(K140124).
CSRDetection andReporting	Yes	Yes	Equivalent
SystemComponents	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	EquivalentSimilar components, sametreatment options. Humidifiercomponent similar to additionalpredicate Medtronic® Sullivan NasalCPAP System (K905404).

Characteristics between the predicate and new device

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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.

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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).

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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.

Regulation Number and Section

§ 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).