The S9 Greenhills is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep annea (OSA), central and/or mixed apneas, or periodic breathing.

It is intended for home and hospital use.

The hunidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.

Device Description

The S9 Greenhills is similar to the predicate device(s), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is identical to the S9 VPAP Adapt (K113801) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmH2O. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.

The S9 Greenhills is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV mode) or (ASVAuto mode) to stabilize a patient's ventilation during sleep. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average minute ventilation. It then adjusts the degree of pressure support to servo-control the patilation to at least equal the target ventilation. The same is true for ASVAuto mode except the EPAP is adjusted to address any obstructive apneas detected.

Therapy modes contained in the S9 Greenhills are CPAP, ASV, and ASVAuto and unchanged from the S9 VPAP Adapt (K102586). They are:

. CPAP mode - the device delivers a continuous positive airway pressure throughout the entire therapy session;
ASV mode the device automatically adjusts pressure support in response to the . patient's recent average minute ventilation; and
ASVAuto mode the device automatically adjusts pressure support in response to . the patient's recent average minute ventilation and EPAP level for OSA events.

The functional characteristics of the S9 Greenhills 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

The provided 510(k) summary for the ResMed S9 Greenhills device describes its acceptance criteria and the study conducted to demonstrate its performance. However, it's important to note that this submission focuses on demonstrating substantial equivalence to a predicate device, not on proving overall clinical effectiveness from scratch. Therefore, the "study" is primarily comparative bench testing, and some of the requested information (like human reader performance with/without AI assistance, or expert consensus for ground truth on a large test set) is not applicable or not provided in this type of submission.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide a direct table of specific numerical acceptance criteria with corresponding performance metrics like a typical clinical trial report. Instead, it states that "All tests (predicate bench testing) confirmed the product met the predetermined acceptance criteria." and "Side-by-Side bench testing was performed to verify that the S9 Greenhills met the predetermined pass/fail requirements of the S9 Greenhills System Specification when compared to the predicate devices."

The key performance characteristics compared, which inherently define the acceptance criteria for substantial equivalence, are:

Characteristic	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (S9 Greenhills)
Indication for Use	Treatment of patients > 66 lb (30 kg) with OSA, central/mixed apneas, or periodic breathing. Intended for home and hospital use.	Same as predicate.
Location of Use	Hospital/Home	Same as predicate.
Pressure Range & Modes	CPAP: 4-20 cm H2OASV: 3-25 cm H2OASVAuto: 3-25 cm H2O	Same as predicate.
RAMP Settings	User selected "Off" to 45 minutes in 5-minute increments. Max ramp time at clinician's discretion.	Same as predicate.
System Components	Flow generator, integrated humidifier (H5i), mask, air tubing, heated tubing.	Flow generator, humidifier, mask, air tubing, heated tubing. (Note: Humidifier is now integrated and contributes to overall weight/dimensions).
Power Supply	100-240V, 50-60Hz	Same as predicate.
Flow Generator Weight	1.7 lb (for flow generator unit only)	2.5 lb (includes humidifier internal to the Flow Generator, so combined weight). Accepted as equivalent due to inclusion of humidifier.
Dimensions H x W x D	Flow generator unit: 3.4 x 5.5 x 6.0 inches	Flow generator unit: 4.5 x 9.6 x 6.0 inches. Accepted as equivalent and accounts for inclusion of the humidifier with larger width.
Supplemental Oxygen	Labeled for use with supplemental oxygen.	Same as predicate.
Therapy Mode Performance	Consistent with maintaining CPAP treatment pressure (CPAP mode), adjusting PS (ASV mode), adjusting PS and EPAP (ASVAuto mode) based on patient condition. (Traced to S9 Greenhills System Specification and predicate device's performance). Specific quantitative acceptance criteria are not detailed in this section.	"S9 Greenhills met the predetermined pass/fail requirements of the S9 Greenhills System Specification when compared to the predicate devices." Implies performance consistent with the predicate across therapy modes.

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

Sample Size for Test Set: The document refers to "Side-by-Side bench testing" using "a breathing machine simulates patient breathing patterns." No specific number of simulated patient breathing patterns or cases are quantified.
Data Provenance: The testing is described as "bench testing" and is therefore synthetic data generated by a breathing machine, not human patient data. There is no country of origin of data or retrospective/prospective designation in the clinical sense, as it is a bench study.

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

This information is not applicable and not provided. The "ground truth" for this bench testing is the expected performance of a well-functioning CPAP/ASV device, primarily benchmarked against the predicate device's known performance characteristics. The tests verify engineering specifications, not clinical diagnoses that would require expert consensus.

4. Adjudication Method for the Test Set

Not applicable. This was a bench test against predetermined engineering specifications and comparison to predicate device performance. No human adjudication of clinical outcomes or images was involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a ventilation device, not a diagnostic imaging device using AI to assist human readers. Therefore, an MRMC study comparing AI-assisted vs. non-AI-assisted human reader performance is not relevant to this submission.

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

The device itself is a standalone medical device that delivers therapy based on internal algorithms and sensor inputs. The "bench testing" described evaluates the performance of these algorithms and the device's hardware independently. While not explicitly framed as an "algorithm only" study in the AI context, the bench tests verify the device's automated functioning.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this study is primarily:

Engineering Specifications: Predetermined pass/fail criteria from the "S9 Greenhills System Specification."
Predicate Device Performance: The known and established performance of the S9 VPAP Adapt (K113801) is used as the benchmark for comparison, establishing "substantial equivalence." The "breathing machine simulates patient breathing patterns" to test the device's response against expected physiological responses.

8. The Sample Size for the Training Set

Not applicable. This medical device primarily uses control algorithms based on established physiological principles and engineered specifications, not machine learning algorithms that require a distinct "training set" of data in the AI sense.

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

Not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device. The device's operating principles and algorithms are based on established medical science for respiratory support.

Summary

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长140279

JUL 3 1 2014

510(k) Summary

Required	By section 807.92 (c)
Date Prepared	31st July, 2014
Owners Name	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	Mr Jim Cassi - Vice President - Quality Assurance Americas
	ResMed Corp.
	9001 Spectrum Center Boulevard,
	San Diego, CA 92123
	+ 1 (858) 836 6081 (Phone)
	+ 1 (858) 836 5519 (FAX)

Product Code	73 BZD
ClassClassification Reference	II(21 CFR 868.5905 Product code 73 BZD)
Common/Usual Name	Non continuous ventilator (IPPB).
Proprietary Name	S9 Greenhills
Predicate Device(s)	S9 VPAP Adapt (K113801)
Reason for submission	New Device.

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Indication for Use

The S9 Greenhills is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep annea (OSA), central and/or mixed apneas, or periodic breathing.

It is intended for home and hospital use.

Substantial Equivalence

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

t Same intended use
t Same operating principle
t Similar technologies
Same manufacturing process .

Design and Verification activities were performed on the S9 Greenhills System as a result of the risk analysis and design requirements. "All tests (predicate bench testing) confirmed the product met the predetermined acceptance criteria. ResMed has determined that the new device has not altered the safety and effectiveness of CPAP/Bilevel treatment for patients with Obstructive Sleep Apnoea (OSA), central and/or mixed apneas, or periodic breathing who weigh more than 66 Ib (>30 kg).

Predicate bench testing and clinical studies were used to show substantial equivalence between the S9 VPAP Adapt (K113801) and S9 Greenhills.

The new device 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:

Clinical testing is not required, bench testing alone is sufficient to demonstrate the product remains substantially equivalent to the predicate device S9 VPAP Adapt (K113801).

Non-Clinical Testing:

Side-by-Side bench testing was performed to verify that the S9 Greenhills met the predetermined pass/fail requirements of the S9 Greenhills System Specification when compared to the predicate devices [S9 VPAP Adapt (K113801)]. This bench testing included testing the performance of each therapy mode which included:

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

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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 pressure support (PS) in (ASV mode) and adjusting the pressure support (PS) and EPAP in (ASVAuto mode) based upon the patient's condition. The clinical Pass/Fail requirements are traced to the S9 Greenhills System Specification and to the predicate device's performance

The S9 Greenhills has been tested to appropriate FDA consensus standards and other applicable requirements passing all test protocols. The S9 Greenhills with and without the integrated heated humidifier was designed and tested according to:

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 Notifications, ARDB, CDRH, FDA, 。 November 1993.

Device Description

Therapy modes contained in the S9 Greenhills are CPAP, ASV, and ASVAuto and unchanged from the S9 VPAP Adapt (K102586). They are:

. CPAP mode - the device delivers a continuous positive airway pressure throughout the entire therapy session;
ASV mode the device automatically adjusts pressure support in response to the . patient's recent average minute ventilation; and
ASVAuto mode the device automatically adjusts pressure support in response to . the patient's recent average minute ventilation and EPAP level for OSA events.

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The functional characteristics of the S9 Greenhills system includes all the clinician and user friendly features of the predicate device.

Characteristic	S9 VPAP Adapt with H5i(K113801)	New Device (S9 Greenhills)	Comments
Indication foruse	The $9 VPAP Adapt is indicated forthe treatment of patients weighingmore than 66 lb (30 kg) withobstructive sleep apnea (OSA),central and/or mixed apneas, orperiodic breathing. It is intended forhome and hospital use.	The S9 Greenhills is indicated for thetreatment of patients weighing morethan 66 lb (30 kg) with obstructivesleep apnea (OSA), central and/ormixed apneas, or periodic breathing.lt is intended for home and hospitaluse.	EquivalentName change only, samepatient population aspredicate
Location ofuse	Hospital/Home	Hospital/Home	Equivalent
ﺷ	Pressure Range and Treatment Modes4-20 cm HzO (CPAP)3-25 cm H2O (ASV)3-25 cm HzO (ASVAuto)	4-20 cm H2O (CPAP)3-25 cm H2O (ASV)3-25 cm H2O (ASVAuto)	Equivalent:
RAMPSettings	User selected as "Off" to 45>minutes in 5 minute incrementsMax Ramp time set at clinician's入discretion	User selected as "Off" to 45Aminutes in 5 minute incrementsMax Ramp time set at clinician'sAdiscretion	Equivalent
SystemComponents	Flow generator>Integrated humidifier (5i)AMask, air tubing and heatedAtubing	Flow generatorAHumidifier>Mask, air tubing and heatedAtubing	Equivalent
Power supply	100-240V, 50-60Hz	100-240V, 50-60Hz	Equivalent
Flowqeneratorweight	1.7lb	2.5lb	EquivalentIncludes humidifierinternal to the FlowGenerator (combinedweight of humidifier andFlow Generator)
Dimensions Hx W x D(inches)	Flow generator unit:3.4 x 5.5 x 6.0	Flow generator unit:4.5 x 9.6 x 6.0	EquivalentAccounts for inclusion ofthe humidifier with largerwidth
Supplementaloxygen	Labeled for use with supplementaloxygen	Labeled for use with supplementaloxygen	Equivalent

Conclusion

The S9 Greenhills is substantially equivalent to the predicate device, S9 VPAP Adapt (K113801).

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract eagle design with three parallel lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

July 31, 2014

ResMed Corp. C/O Mr. Jim Cassi Vice President Quality Assurance Americas 9001 Spectrum Center Boulevard San Diego, CA 92123

Re: K140279

Trade/Device Name: S9 Greenhills Regulation Number: 21 CFR 868.5905 Regulation Name: Non continuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: June 20, 2014 Received: June 25, 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 10 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/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 vours.

Mary S. Runner -S

Erin I. Keith, M.S. Division 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)

K140270

Device Name S9 Greenhills

Indications for Use (Describe)

The S9 Greenhills is indicated for the treatment of patients weighing more than 66 Ib (30 kg) with obstructive sleep appea (OSA), central and/or mixed apneas, or periodic breathing.

It is intended for home and hospital use.

The hunidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.

Type of Use (Select one or both, as applicable)

[X] 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 2014.07.31 09:55:56 -04'00'

FORM FDA 3881 (1/14)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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).