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.

Device Description

The S9 Elouera retains all the same hardware and performance features of the predicate device(s). Key features include in-line power supply, fully integrated humidifier, tubing, colour LCD and simplified controls which provides improved usability. The S9 Elouera contains a Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.

The S9 Elouera flow generator includes three therapy modes. These include:

CPAP mode the device delivers a continuous positive airway pressure throughout the entire . therapy session
. AutoSet mode - the device automatically adjusts pressure in response to inspiratory flow limitation, snore and apnea.
t AutoSet for Her mode - the device automatically adjusts pressure in response to female-specific OSA characteristics.

The functional characteristics of the S9 Elouera system includes all the clinician and user friendly features of the predicate device which have been verified during usability studies in accordance with IEC 62366 Medical devices - Application of usability engineering to medical devices.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Criteria Category	Acceptance Criteria	Reported Device Performance
Clinical Efficacy (AfH Mode)	The modified AutoSet algorithm (AfH) should effectively treat female OSA patients and demonstrate non-inferiority to the standard AutoSet algorithm (predicate device S8 Aspen K091947). Outcomes of interest include Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI). No adverse events or complications should occur. The AfH algorithm should deliver therapeutic responses tailored to female OSA characteristics (slower pressure rise and decay in response to Flow Limitations).	A single-blind, randomized, cross-over non-inferiority clinical study demonstrated that the modified AutoSet algorithm (AfH) performed as expected in treating female patients. The trial showed that the AfH algorithm effectively treated female OSA patients as reflected by AHI and ODI outcomes. No adverse event or complications occurred as a result of the trial. The device incorporates modified responses to Flow Limitations, resulting in a slower pressure rise and decay when compared to the standard AutoSet algorithm, which is intended for female OSA patients.
CSR Detection and Reporting	The S9 Elouera's Cheyne-Stokes Respiration (CSR) detection and reporting feature should be equivalent to ResMed's ApneaLink Plus (K083575). This equivalence should be assessed through sensitivity and specificity compared to human scoring. The device should accurately report one of the following for each patient script file (scenario): No CSR, CSR, CSR + OSA, or OSA. A patient should be reported as having CSR once the CSR duration reaches 15 minutes. The device must meet predefined Clinical Pass/Fail criteria for CSR detection.	Side-by-side bench testing was performed using the same digitized breathing patterns. The S9 Elouera's CSR detector results were compared to human scoring, and sensitivity and specificity were assessed. The S9 Elouera met the predefined Clinical Pass/Fail criteria. In this test, a patient was reported as having CSR once the CSR duration on the Flow Generator reached 15 minutes. If it didn't reach 15 minutes, the script ran to completion.
Device Performance (General)	The S9 Elouera must meet the requirements of the S9 Elouera System Specification and the performance of the predicate devices (S8 Aspen K091947 and ApneaLink Plus K083575) for all therapy modes. This includes pressure stability, response to apneas, response to flow limitations and snore, and reporting of Closed Airway Detection (CAD). The device should provide CPAP pressure from 4-20 cmH2O.	Side-by-side bench testing verified that the S9 Elouera met the requirements of the S9 Elouera System Specification when compared to the predicate devices. This testing included performance of each therapy mode (CPAP and self-adjusting). The tests covered pressure stability, response to apneas, response to flow limitations and snore, and reporting of CAD. The breathing machine simulated patient breathing patterns, and the Flow Generator responded consistently with maintaining CPAP treatment pressure or adjusting pressure in real-time. The S9 Elouera offers a pressure range of 4-20 cmH2O for all modes.
Biocompatibility	Materials contacting the heated humidified gas pathway (permanent "external communicating devices") must pass biological tests in accordance with FDA guidance #G95-1 (ISO 10993-3 Genotoxicity, ISO 10993-5 Cytotoxicity, ISO 10993-6 Implantation, ISO 10993-10 Sensitization & Irritation). Testing for particulate matter and volatiles must demonstrate compliance to EPA requirements.	The appropriate biological tests were conducted and passed for these components, in accordance with FDA guidance #G95-1. These included ISO 10993-3 Genotoxicity, ISO 10993-5 Cytotoxicity, ISO 10993-6 Implantation, and ISO 10993-10 Sensitization & Irritation. Testing for particulate matter and volatiles demonstrated compliance to EPA requirements.
Safety and Electrical	The S9 Elouera and integrated heated humidifier must comply with IEC 60601-1:2005 (General requirements for safety and essential performance) and IEC 60601-1-2:2007 (Electromagnetic compatibility).	The S9 Elouera with integrated heated humidifier was designed and tested according to IEC 60601-1:2005 and IEC 60601-1-2:2007.
Usability	The S9 Elouera should retain clinician and user-friendly features of the predicate device, verified through usability studies in accordance with IEC 62366.	The functional characteristics of the S9 Elouera system include all the clinician and user-friendly features of the predicate device, which have been verified during usability studies in accordance with IEC 62366 Medical devices - Application of usability engineering to medical devices.

Detailed Study Information:

2. Sample Sizes Used for the Test Set and Data Provenance:

Clinical Testing (AfH Mode): Not explicitly stated how many patients were in the "single-blind, randomized, cross-over non-inferiority study." Given the context of a 510(k) summary, specific sample sizes are often omitted in this section but would be detailed in the full submission.
- Data Provenance: Not explicitly stated, though ResMed is an Australian company, so studies could be international or domestic to Australia. The submission is to the FDA, implying relevance to the US market. The study design (clinical trial) implies prospective data collection.
Non-Clinical Testing (CSR Detection):
- Sample Size: The text mentions "patient script files," with each treated as an "individual scenario." The exact number of these scenarios (test cases for CSR) is not provided.
- Data Provenance: The text describes the use of "digitised breathing patterns." This suggests a retrospective dataset of breathing patterns, potentially derived from real patient data or generated synthetically to simulate various conditions. The origin of these patterns (e.g., country) is not specified.

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

Clinical Testing (AfH Mode):
- Number of Experts: Not specified. Clinical trials typically involve medical professionals (e.g., pulmonologists, sleep specialists) to diagnose OSA, monitor patients, and interpret results, but the experts specifically for ground truth establishment in this context (e.g., AHI/ODI scoring) are not quantified beyond the general conduct of a clinical trial.
- Qualifications: "Medical professionals" (implied for a clinical trial) are involved in patient assessment and data collection/interpretation.
Non-Clinical Testing (CSR Detection):
- Number of Experts: Not specified. The text refers to "human scoring" as the comparator for the CSR detector. This implies one or more human experts scored the breathing patterns.
- Qualifications: Not specified. These would likely be sleep specialists or trained sleep technologists with expertise in scoring sleep-disordered breathing events, including Cheyne-Stokes Respiration.

4. Adjudication Method for the Test Set:

Clinical Testing (AfH Mode): Not specified. Standard clinical trial practices for outcomes like AHI and ODI often involve blinded scoring by certified sleep technologists, potentially with adjudication processes for discrepancies, but this is not detailed in the summary.
Non-Clinical Testing (CSR Detection): Not specified. The text only mentions comparison to "human scoring." It doesn't indicate if multiple human scorers were used or if an adjudication process was in place.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was implicitly NOT conducted for the device performance itself.
- The primary clinical study for the AfH mode was a non-inferiority clinical trial comparing two device algorithms (AfH vs. standard AutoSet) in human patients, not a multi-reader study comparing human performance with and without AI assistance.
- The CSR detection testing involved bench testing against human scoring as ground truth, but not for assessing the improvement of human readers using the device.
Effect Size of Human Readers Improvement with AI vs. without AI: Not applicable, as an MRMC comparative effectiveness study involving human readers' performance with AI assistance was not described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, for the CSR Detection feature, a standalone evaluation was performed.
- The description of "Side-by-side testing using the same digitised breathing patterns was used. This test executes patient script files. Each patient script file is treated as an individual scenario, which the S9 Elouera reports either: No CSR, CSR, CSR + OSA, OSA. The S9 Elouera CSR detector results are then compared to human scoring where sensitivity and specificity are assessed." This clearly indicates an assessment of the algorithm's performance independent of a human operator, using human scoring as the ground truth.
For the main therapeutic algorithms (CPAP, AutoSet, AfH), these are inherently "standalone" in their operation. They automatically adjust pressure based on detected events. Their efficacy is evaluated in clinical trials (as described for AfH) where the device alone provides therapy.

7. The Type of Ground Truth Used:

Clinical Testing (AfH Mode): The ground truth for treatment effectiveness (non-inferiority) was established by patient outcomes data (AHI and ODI) collected during a clinical trial, likely based on polysomnography or other clinically accepted methods of measuring these indices.
Non-Clinical Testing (CSR Detection): The ground truth for the CSR detection algorithm was established by expert consensus / human scoring of the "digitised breathing patterns."

8. The Sample Size for the Training Set:

Not provided. The summary focuses on the validation/testing of the device's algorithms. It does not mention the training phase or the size of any training datasets used to develop the AutoSet or AfH algorithms or the CSR detector. This information is typically proprietary to the manufacturer and not always included in 510(k) summaries unless explicitly requested by the FDA for specific types of AI/ML devices depending on their risk and adaptive capabilities.

9. How the Ground Truth for the Training Set Was Established:

Not provided. Since the training set size is not mentioned, the method for establishing its ground truth is also absent from the summary.

Summary

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	510(k) Summary - S9 Elouera	K140124MAY 1 2 2014
Required	By section 807.92 (c)
Date PreparedOwners Name	12th May, 2014ResMed Ltd1 Elizabeth Macarthur DriveBella Vista, NSW 2153, Australia
Submitter	Greg Dockar+ 61 2 8884 2157 (Phone)+ 61 2 8884 2004 (FAX)GregD@resmed.com.au
Official Contact	Mr Jim Cassi - Vice President - Quality Assurance AmericasResMed Corp.9001 Spectrum Center Boulevard,San Diego, CA 92123+ 1 (858) 836 6081 (Phone)+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	S9 Elouera
Predicate Device(s)	S8 Aspen (K091947)ApneaLink Plus (K083575)
Reason for submission	New Device

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Indication for Use

It is intended for home and hospital use.

Substantial Equivalence

The new device has the following similarities to the previously cleared predicate devices.

Similar intended use Same
operating principle Similar
technologies
Same manufacturing process

The S9 Elouera retains all the same operating/technologies/manufacturing characteristics cleared in the S8 Aspen (K091947). The S9 Elouera includes an additional treatment mode called AutoSet for Her (AH). AutoSet for Her mode is based on key aspects of ResMed's AutoSet algorithm and delivers therapeutic responses tailored to the characteristics of female OSA patients. These include modified responses to Flow Limitations resulting in a slower pressure rise and decay when compared to standard AutoSet algorithm.

These changes have been fully tested within the clinical trial as shown in the "Clinical Testing" section of this 510(k) summary.

The S9 Elouera includes Cheyne-Stokes Respiration (CSR) breathing pattern recognition and reporting, this feature is equivalent to ResMed's ApneaLink Plus (K083575).

Design and Verification activities were performed on the S9 Elouera device as a result of the risk analysis and design requirements. All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that the new device has not altered the safety and effectiveness of CPAP treatment. The S9 Elouera complies with the applicable requirements referenced in the FDA guidance documents:

FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
FDA Draft Guidance for Industry and FDA Staff Design Considerations for Devices Intended for Home Use- Document Issued on: December 12, 2012
FDA Draft Guidance for Industry and FDA Staff Radio Frequency Wireless Technology in Medical Devices - Document Issued on: August 13, 2013
Reviewer Guidance for Premarket Notification Submissions, ARDB, CDRH, FDA, November 1993.

Clinical Testing:

A clinical trial demonstrated that the modified AutoSet algorithm performed as expected in treating female patients in a single-blind, randomised, cross-over non-inferiority study comparing the efficacy of the new AfH algorithm when compared to the standard AutoSet algorithm cleared in the S8 Aspen (K091947). The trial showed that the AfH algorithm effectively treated female OSA patients as reflected by the apneahypopnea index (AHI) and oxygen desaturation index (ODI) outcomes.

No adverse event or complications occurred as a result of the trial.

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Non-Clinical Testing:

Side-by-Side bench testing was performed to verify that the S9 Elouera met the requirements of the S9 Elouera System Specification when compared to the predicate devices (S8 Aspen (K091947) and Apneal.ink Plus (K083575)).

This bench testing included testing the performance of each therapy mode which included:

Pressure stability
A Response to apneas
Response to flow limitations and snore. >
Reporting of Closed Airway Detection (CAD) A

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 S9 Elouera System Specification and to the predicate device's performance.

The S9 Elouera also includes an optional pulse oximeter accessory which is used to confirm apneas when linked with the apnea events.

Bench testing for the S9 Elouera includes Chevnes Stokes Respiration (CSR) breathing pattern recognition and reporting, this feature is equivalent to ResMed's ApneaLink Plus (K083575). Side-by-side testing using the same digitised breathing patterns was used. This test executes patient script files. Each patient script file is treated as an individual scenario, which the S9 Elouera reports either:

No CSR CSR > CSR + OSA > OSA
The S9 Elouera CSR detector results are then compared to human scoring where sensitivity and specificity are assessed. The S9 Elouera met the predefined Clinical Pass/Fail criteria.

In this test, a patient is reported as having CSR once the CSR duration on the FG reaches a value of 15 mins. Once the CSR duration of 15 mins is met, the scenario is complete and the next scenario in the feature file can begin. Should the CSR duration fail to reach 15 mins, the patient script file will run to completion, before the scenario is completed and moves on to the next one. The S9 Elouera met the predefined Clinical Pass/Fail criteria.

Materials used in the construction of components that contact the heated humidified gas pathway are classified as permanent "external communicating devices" (with tissue/bone/dentin). The appropriate biological tests conducted and passed for these components, in accordance with FDA guidance #G95-1 were:

ISO 10993-3 Genotoxicity, .
ISO 10993-5 Cytotoxicity, .
ISO 10993-6 Implantation and ●
ISO 10993-10 Sensitization & Irritation. .

Testing for particulate matter and volatiles demonstrated compliance to EPA requirements.

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The S9 Elouera has been tested to appropriate standards and other applicable requirements. The S9 Elouera with integrated heated humidifier was designed and tested according to:

IEC 60601-1:2005. Medical electrical equipment Part 1: General requirements for safety Medical electrical equipment - General requirements for basic safety and essential performance
IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

Device Description

The S9 Elouera flow generator includes three therapy modes. These include:

CPAP mode the device delivers a continuous positive airway pressure throughout the entire . therapy session
. AutoSet mode - the device automatically adjusts pressure in response to inspiratory flow limitation, snore and apnea.
t AutoSet for Her mode - the device automatically adjusts pressure in response to female-specific OSA characteristics.

Characteristics between predicate and new device

Characteristic	Predicate Device S8 Aspen (K091947)	New device S9 Elouera	Comments
Indication for use	The S8 Aspen self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg).The S8 Aspen self-adjusting system is intended for home and hospital 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.	EquivalentName change and reduced patient population from predicate regarding AfH mode.
Location of use (primary)	Hospital/Home	Hospital/Home	Equivalent
Performance
Pressure range	4-20 cm H2O (all modes) EPR +3 cm H2O (all modes)	4-20 cm H2O (all modes) EPR +3 cm H2O (all modes)	Equivalent

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ResMed

S9 Elouera Traditional 510(k) Submission May 2014

Rampfeatures	User selected as "Off" to 45 minutes in 5 minute increments Max Ramp time set at clinician's discretion	User selected as "Off" to 45 minutes in 5 minute increments Max Ramp time set at clinician's discretion	Equivalent
Modes ofoperation	CPAP Mode (Fixed-pressure) AutoSet Mode (maximum to 20cm H2O with CAD) CPAP and AutoSet with EPR (maximum to 20cm H2O with CAD)	CPAP Mode (Fixed-pressure) AutoSet Mode (maximum to 20cm H2O with CAD) CPAP, AutoSet with EPR(maximum to 20cm H2O with CAD) AutoSet for Her (AfH) (maximum to 20cm H2O with CAD)	Equivalent:Addition of AfH treatment mode.Clinical testing demonstrated thatthis new mode is substantiallyequivalent to the AutoSet mode.

Characteristic	Predicate Device S8 Aspen(K091947)	New device S9 Elouera	Comments
SystemComponents	Flow generator Integrated humidifier(HumidAire 4i Plus) Mask, air tubing and heatedtubing	Flow generator Humidifier Mask, air tubing and heatedtubing	Equivalent

Characteristic	Predicate Device ApneaLink Plus(K083575)	New device S9 Elouera	Comments
CSRDetection andReporting	Scoring of apnea events such asObstructive Sleep Apnea (OSA) andCheyne-Stokes Respiration (CSR).	Scoring of apnea events such asObstructive Sleep Apnea(OSA) and Cheyne-StokesRespiration (CSR).	Equivalent

Conclusion

The S9 Elouera is substantially equivalent to the predicate devices (S8 Aspen K091947) and ApneaLink Plus (K083575) and is as safe and as effective as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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May 12, 2014

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Resmed Corporation Mr. Jim Cassi Vice President, Quality Assurance Americas 9001 Spectrum Center Blvd. San Diego. CA 92123

Re: K140124

Trade/Device Name: S9 Elouera Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD, MNR Dated: April 7, 2014 Received: April 9, 2014

Dear Mr. Cassi:

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.

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Page 2 - Mr. Cassi

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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" (21CFR 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/Reportally/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

ManFDAiner-S

Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140124

Device Name S9 Eloucra

Indications for Use (Describe)

The S9 Elovera self-adjusting device is indicated for the treatment of Obstructive Sleep Apnea (OSA) in 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.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (1/14)

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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).