The S9 Cronulla for Her self-adjusting system is indicated for the treatment of mild to moderate obstructive sleep apnea (OSA) in female patients weighing more than 66 lb (30 kg).

The S9 Cronulla for Her self-adjusting system is intended for home and hospital use.

Device Description

The 'S9 Cronulla for Her' contains a Micro-processor controlled blower (flow generator) 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 (standard, or heated), mask (patient interface) and humidifier. The 'S9 Cronulla for Her' System (S9 Cronulla for Her with HumidAire 5i) retains all the same hardware and performance features of the predicate device. Key features include in-line power supply, HumidAire 5i, tubing (heated and standard options) and colour LCD for better user interface.

The 'S9 Cronulla for Her' 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.
AutoSet for Her mode -- the device automatically adjusts pressure in response female-specific OSA characteristics.

The functional characteristics of the S9 Cronulla for Her 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

This document describes the regulatory submission for the ResMed S9 Cronulla for Her, a non-continuous ventilator (IPPB) designed for the treatment of mild to moderate obstructive sleep apnea (OSA) in female patients. The submission aims to demonstrate substantial equivalence to a predicate device, the S8 Aspen (K091947), by incorporating a new treatment mode called AutoSet for Her (AfH).

Here's an analysis based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide a formal table of specific, quantitative acceptance criteria for the clinical trial, nor does it explicitly list corresponding "reported device performance" against those criteria. Instead, it describes the primary endpoints and outcomes as "met" and generally discusses improvements and lack of significant differences.

However, based on the text, the implicit acceptance criteria for the clinical trial were demonstrating non-inferiority or efficacy in treating female OSA patients, with key outcomes being Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI). The non-clinical testing had "predetermined acceptance criteria" for pressure stability, response to apneas, and response to flow limitations and snore, which were reportedly met.

Acceptance Criteria (Implied/Stated)	Reported Device Performance
Clinical Trial:
Primary endpoints met (non-inferiority for AHI and ODI)	The primary endpoints were met, showing the AfH algorithm effectively treated female OSA patients as reflected by AHI and ODI outcomes.
Effective treatment of female OSA patients (AHI, ODI outcomes)	AfH algorithm effectively treated female OSA patients as reflected by AHI and ODI outcomes.
Effect on sleep parameters (e.g., flow limitation)	Flow limitation was significantly decreased with the AfH algorithm compared to the standard AutoSet algorithm.
Other sleep parameters (e.g., REM sleep, RERAs)	No other statistically significant results were found in these parameters, but there were improvements in REM sleep percentage and RERAs.
Subjective feedback ("above average" ratings)	No significant differences between AfH and standard AutoSet algorithms; all outcomes' median subjective ratings remained "above average."
No adverse events or complications	No adverse event or complications occurred.
Non-Clinical Testing:
Software change does not affect safety and effectiveness	Verification activities were performed to verify this, and bench testing confirmed the product met predetermined acceptance criteria.
Compliance with S9 Cronulla System Specification	Side-by-side bench testing verified that the S9 Cronulla for Her met the requirements, and it met the predefined Clinical Pass/Fail criteria.
Performance of therapy modes (Pressure stability, response to events)	Bench testing (using a breathing machine to simulate patient breathing patterns) demonstrated the Flow Generator responded in a manner consistent with maintaining CPAP or adjusting pressure based on the patient's condition for CPAP and self-adjusting modes, and met predefined Clinical Pass/Fail criteria for pressure stability, response to apneas, and response to flow limitations and snore.
Compliance with IEC 60601-1-2:2007 (EMC)	The device was designed and tested according to this standard.
Compliance with IEC 60601-1:2005 (Safety)	The device was designed and tested according to this standard.
Successful Software Regression Testing	Software regression testing was conducted.

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

Sample Size: The document does not specify the exact sample size for the clinical trial. It refers to "female OSA patients" without providing a number.
Data Provenance: The clinical trial was a "single-blind, randomised, cross-over non-inferiority study." It does not explicitly state the country of origin, but ResMed Ltd is based in Australia, and their official contact for the submission is in the US, suggesting a multinational context or at least compliance with international standards. The study design is prospective.

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

This information is not provided in the submission. The clinical trial was a direct comparison of two algorithms in patients, with outcomes (AHI, ODI, sleep parameters) likely derived from polysomnography (PSG) data, which is objectively measured. The "ground truth" here would thus be the objective physiological measurements of OSA, rather than an expert interpretation of, for example, medical images.

4. Adjudication Method for the Test Set

This information is not explicitly provided. Given the nature of objective physiological measurements (AHI, ODI) as primary endpoints in a clinical trial, a complex adjudication method by multiple experts is less common than for subjective assessments or image interpretation. The study was single-blind, randomized, and cross-over.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission describes a clinical trial comparing two algorithms for a medical device (a ventilator), not an AI algorithm assisting human readers in interpreting medical data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the clinical trial directly compared the performance of two algorithms: the new AutoSet for Her algorithm (AfH) against the standard AutoSet algorithm (predicate device's algorithm). This is a standalone comparison of the algorithms' effectiveness in treating OSA in female patients, without direct human intervention in the algorithm's diagnostic or therapeutic decision-making process. The device operates automatically based on these algorithms.

7. The Type of Ground Truth Used

The ground truth for the clinical trial was objective physiological measurements related to obstructive sleep apnea, specifically:

Apnea-Hypopnea Index (AHI)
Oxygen Desaturation Index (ODI)
Other sleep parameters (e.g., flow limitation, REM sleep percentage, RERAs)

This data is typically derived from polysomnography (PSG), which directly measures these physiological events.

8. The Sample Size for the Training Set

The submission does not specify a "training set" size. The "AutoSet for Her" mode is an additional treatment software mode based on specific OSA characteristics in females. While algorithms are typically developed using data, the document does not detail the development or training process for this particular algorithm beyond stating it's a "modified AutoSet algorithm." The focus of the clinical trial is on validating its performance, not on describing its development data.

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

This information is not provided as the submission focuses on the clinical validation of the device and its new mode, not the detailed development of the algorithm itself. It's implied that the algorithm was designed to respond to "female-specific OSA characteristics," suggesting that development would have been based on clinical understanding and data related to these characteristics, likely derived from sleep studies and medical research.

Summary

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K132606

JAN 1 3 2014

Required	By section 807.92 (c)
Date Prepared	10th Jan, 2014
Owners Name	ResMed Ltd1 Elizabeth Macarthur DriveBella Vista, NSW 2153, Australia
Submitter	Greg Dockar+ 61 2 8884 2157 (Phone)+ 61 2 8884 2000 (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)
Classification Reference	21 CFR 868.5905 (Class II)
Product Code	73 BZD
Common/Usual Name	Non continuous ventilator (IPPB).
Proprietary Name	S9 Cronulla for Her
Predicate Device(s)	S8 Aspen (K091947)

510(k) Summary – S9 Cronulla for Her

Reason for submission

New Device

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Indication for Use

The S9 Cronulla for Her self-adiusting system is indicated for the treatment of mild to moderate obstructive sleep apnea (OSA) in female patients weighing more than 66 lb (30 kg).

The S9 Cronulla for Her self-adjusting system 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
Same technologies ●
. Same manufacturing process

The S9 Cronulla for Her retains all the same operating/technologies/manufacturing characteristics as the S8 Aspen (K091947). The S9 Cronulla for Her includes an additional treatment mode (software) called AutoSet for Her (AfH) which provides equivalent responses to apneas, snore and flattening breathing events for females in comparison to standard AutoSet mode. The S9 Cronulla for Her is indicated for a subset of the patient population when compared to the predicate S8 Aspen (K091947). Therefore this difference (subset) does not affect safety and effectiveness which remains unchanged from the predicate (K091947).

Design and Verification activities were performed on the S9 Cronulla for Her System 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 Cronulla for Her complies with the applicable requirements referenced in the FDA guidance documents:

. FDA Draft Reviewer Guidance for Ventilators (July 1995)
. 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

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 to the standard AutoSet algorithm (K091947).

The primary endpoints were met in the AfH clinical trial. The trial showed that the AfH algorithm effectively treated female OSA patients as reflected by the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) outcomes. Furthermore, investigation of sleep parameters showed that flow limitation was significantly decreased with the AfH algorithm compared to the standard AutoSet algorithm. Whilst no other statistically significant results were found in these parameters, there were the following improvements:

. REM sleep percentage
RERAs .

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Subjective feedback also showed no significant differences between the AfH and standard AutoSet algorithms with all outcomes' median subjective ratings remaining "above average".

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

Non-Clinical Testing:

Verification activities were performed to verify that the software change to include an additional treatment mode ('AutoSet for Her') did not affect the safety and effectiveness of the subject device.

Side-by-Side bench testing was performed to verify that the S9 Cronulla for Her with H5i humidifier and heated tubing met the requirements of the S9 Cronulla System Specification, and compare the results to the predicate device (S8 Aspen with H4i Plus humidifier and heated tubinq (K091947)). This bench testing included testing the performance of each therapy mode which included:

. Pressure stability
. Response to apneas
. Response to flow limitations and snore.

A breathing machine was used to simulate patient breathing patterns resulting 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 Cronulla for Her System Specification and to the predicate device's performance. The S9 Cronulla for Her met the predefined Clinical Pass/Fail criteria.

The S9 Cronulla for Her with and without the integrated heated humidifier (H5i) was designed and tested according to:

. 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 ،
IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for safety . Medical electrical equipment - General requirements for basic safety and essential performance

Software regression testing was also conducted.

Device Description

The 'S9 Cronulla for Her' flow generator includes three therapy modes. These include:

. CPAP mode - the device delivers a continuous positive airway pressure throughout the entire therapy session

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AutoSet mode the device automatically adjusts pressure in response to inspiratory flow . limitation, snore and apnea.
AutoSet for Her mode -- the device automatically adjusts pressure in response female-specific ● OSA characteristics.

Characteristics between predicate and modified device

	Characteristic Predicate Device S8 Aspen (K091947)	Modified device S9 Cronulla for Her	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 Cronulla for Her self-adjusting system is indicated for the treatment of mild to moderate obstructive sleep apnea (OSA) in female patients weighing more than 66 lb (30 kg).The S9 Cronulla for Her self-adjusting system is intended for home and hospital use.	EquivalentOnly name change- and reduced patient population from predicate
Location of use (primary)	Hospital/Home	Hospital/Home	Equivalent
Performance
Pressure range	4-20 cm H2O (CPAP Mode) EPR +3 cm H2O4-20 cm H2O (AutoSet Mode) EPR +3 cm H2O	4-20 cm H2O (CPAP Mode) EPR +3 cm H2O4-20 cm H2O (AutoSet Mode) EPR +3 cm H2O4-20 cm H2O (AutoSet AfH Mode) EPR +3 cm H2O	Equivalent:Addition of treatment mode indicated for females
Ramp	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 of operation	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) AutoSet for Her (AfH) (maximum to 20cm H2O with CAD) CPAP, AutoSet with EPR(maximum to 20cm H2O with CAD)	Equivalent:Addition of treatment mode indicated for females
System Components	Flow generator Integrated humidifier (HumidAire 4i Plus) Mask, air tubing and heated tubing	Flow generator Integrated humidifier (H5i) Mask, air tubing and heated tubing	EquivalentName change only from predicate (K091947)- same performance

Conclusion

Based on the clinical and non-clinical results, the S9 Cronulla for Her is substantially equivalent to the Predicate device (S8 Aspen K091947).

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Public Health Service

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

January 13, 2014

ResMed Corporation Mr. Jim Cassi Vice President - Quality Assurance Americas 9001 Spectrum Center Boulevard San Diego, CA 92123

Re: K132606

Trade/Device Name: ResMed™ S9 Cronulla for Her Regulation Number: 21 CFR 868.5905 Regulation Name: Non-continuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 5, 2013 Received: December 9, 2013

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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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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/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 Small Manufacturers, International and Consumer Assistance 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 yours,

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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

Enclosure

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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) K132606

Davice Name S9 Cronulla for Her

Indications for Use (Describe)

The S9 Crowle for Her self-adjusting system is indicated for the treatment of mild to moderate obstructive sleep apress (OSA) in female patients weighing more than 66 lb (30 kg).

The S9 Cronulla for Her self-adjusting system is intended for home and hospital usc.

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.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Anya C. Harry -S 2014.01.10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16:06:27 -05'00'

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).