The S9 VPAP Adapt is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The S9 VPAP Adapt is intended for home and hospital use.

The AirCurve 10 ASV device is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.

The VPAP Adapt is indicated for the treatment of patients weighing more than 66lb (30kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The VPAP Adapt is intended for home and hospital use.

Device Description

The S9 VPAP Adapt is identical to the predicate device S9 VPAP Adapt (K102586), using a blower based positive pressure system with an integrated heated humidfier and heater controller. The device platform is identical to the S9 VPAP Adapt (K102586) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmHJO 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 VPAP ADAPT is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventilation during sleep. The device continually measures instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average. It then adjusts the degree of pressure support to servo-control the patient's ventilation to at least equal the target ventilation.

The VPAP Adapt is identical to the predicate device (K113801), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is identical to the VPAP Adapt (K113801) and contains a Micro-processor controlled blower system that qenerates controlled positive airway pressure between 3-25 cmH2O 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 VPAP Adapt is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV) 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. It then adjusts the degree of pressure support to servo-control the patient's ventilation to at least equal the target ventilation.

The AirCurve 10 ASV is identica to the predicate device, S9 Greenhills (K140279), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is identical to the S9 Greenhills (K140279) 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 AirCurve 10 ASV 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for several ResMed devices (S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV). The submission is a labeling change only to include a contraindication related to Adaptive Servo-Ventilation (ASV) therapy.

Therefore, the acceptance criteria and device performance information typically associated with a medical device study (e.g., diagnostic accuracy metrics like sensitivity, specificity, AUC) are not applicable or provided in this document. The purpose of this 510(k) is to demonstrate substantial equivalence to predicate devices based on the absence of changes to the device's fundamental safety and effectiveness despite the new contraindication.

The study referenced, SERVE-HF, is not a study proving the device meets acceptance criteria in the traditional sense of validating a device's performance metrics. Instead, it is a clinical trial that informed the contraindication for the ASV therapy provided by the devices.

Here's an breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

As this submission is for a labeling change and asserts that the "new device has not altered the safety and effectiveness" compared to the predicate, traditional performance acceptance criteria (e.g. sensitivity, specificity for a diagnostic device) are not detailed as they were not required to be re-evaluated for the 510(k). The "acceptance criteria" here implicitly refer to demonstrating that the device itself (hardware, underlying software logic for therapy delivery) remains functionally identical and equally safe and effective as its predicate before the new contraindication.

The document essentially states:

Characteristic/Criterion	Predicate Device Performance	New Device Performance	Comments	Acceptance
Intended Use	Identical to predicate	Identical to predicate	Only labeling change to include contraindication	Met
Location of Use	Hospital/Home	Hospital/Home	Equivalent	Met
Pressure Range	4-20 cm H2O (CPAP), 3-25 cm H2O (ASV/ASVAuto)	4-20 cm H2O (CPAP), 3-25 cm H2O (ASV/ASVAuto)	Equivalent	Met
RAMP Settings	User selected "Off" to 45 min, Max Ramp time set by clinician	User selected "Off" to 45 min, Max Ramp time set by clinician	Equivalent	Met
System Components	Flow generator, humidifier, mask, air/heated tubing	Flow generator, humidifier, mask, air/heated tubing	Equivalent	Met
Power Supply	100-240V, 50-60Hz	100-240V, 50-60Hz	Equivalent	Met
Weight	1.7lb (S9/VPAP), 2.5lb (AirCurve 10)	1.7lb (S9/VPAP), 2.5lb (AirCurve 10)	Equivalent	Met
Dimensions	Specified for each device	Identical for each device	Equivalent	Met
Supplemental Oxygen Use	Labeled for use with	Labeled for use with	Equivalent	Met
Contraindication	Not present	Added: ASV therapy contraindicated in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced LVEF (≤ 45%) and moderate to severe predominant central sleep apnea.	Based on SERVE-HF study findings, which showed increased risk of cardiovascular mortality.	Met (labeling update implemented)

The justification for substantial equivalence for all three devices (S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV) explicitly states:

"Same intended use"
"Same operating principle"
"Similar technologies"
"Same manufacturing process"

And crucially: "As this was a labelling change only, no further clinical testing was required to show substantial equivalence to the predicate device..."

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" for validating the device's technical performance in the current submission. The SERVE-HF study, which informed the contraindication, acted as the primary data provenance.

Sample Size (SERVE-HF): 1325 patients
Data Provenance (SERVE-HF): "randomized, parallel, event-driven, international multicenter study." This implies a prospective, multi-country study. Specific countries are not detailed in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this 510(k) submission, as it's a labeling change based on a clinical trial (SERVE-HF) rather than a de novo device performance study requiring expert ground truth in a test set. The SERVE-HF study's outcomes (survival and cardiovascular events) were the 'ground truth' for establishing the contraindication, validated via standard clinical trial methodologies rather than expert consensus on individual cases for a device's performance.

4. Adjudication method for the test set

Not applicable. For the SERVE-HF study, clinical trial protocols would typically include adjudication methods for primary and secondary outcomes, often by an independent committee. This level of detail is not present in the 510(k) summary.

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 device is a therapeutic ventilator, not an AI-assisted diagnostic tool.

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

Not applicable. This is a therapeutic device. The "algorithm" for ASV therapy operates as part of the device's function, not as a standalone diagnostic. The SERVE-HF study assessed the clinical outcome of the therapy delivered by such devices.

7. The type of ground truth used

The "ground truth" for the new contraindication derived from the outcomes data of the SERVE-HF study. These outcomes included "survival and cardiovascular outcomes" rather than expert consensus, pathology, or specific diagnostic accuracy.

8. The sample size for the training set

Not applicable. The SERVE-HF study's data was used to establish a clinical contraindication for the device's therapy, not to train a machine learning model. The device itself (S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV) is established technology, and the 510(k) asserts its functional identity to predicate devices.

9. How the ground truth for the training set was established

Not applicable, as no training set for a machine learning model is described. The "ground truth" for the contraindication came from the clinical trial results of the SERVE-HF study: patients randomized to ASV therapy (compared to optimal medical management alone) showed an increased risk of cardiovascular mortality.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often used as a symbol of medicine. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

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

September 9, 2016

ResMed Ltd c/o Ms. Larissa D'andrea Director, Government and Regulatory Affairs ResMed Corp 9001 Spectrum Center Boulevard San Diego, California 92123

Re: K160822

Trade/Device Name: S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: August 10, 2016 Received: August 11, 2016

Dear Ms. 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. Isting 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

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 below.

510(k) Number (if known)

Device Name S9 VPAP ADAPT

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

FORM FDA 3881 (8/14)

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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 below.

510(k) Number (if known)

Device Name AirCurve 10 ASV

Indications for Use (Describe)

The AirCurve 10 ASV device is indicated for the treatment of patients weighing more than 66 Ib (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use. The humidifier 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)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."

{4}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name VPAP Adapt

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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."

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510(k) Summary – S9 VPAP Adapt

Required	By Section 807.92 (c)
Date Prepared	18 March, 2016
Owners Name	ResMed Ltd1 Elizabeth Macarthur DriveBella Vista, NSW 2153, Australia
Submitter	Jasjit Baveja+ 61 2 8884 1518 (Phone)+ 61 2 8884 2000 (FAX)Jasjit.baveja@resmed.com.au
Official Contact	Larissa D'AndreaDirector, Government & Regulatory AffairsResMed Corp9001 Spectrum Center BoulevardSan Diego, CA 92123+1 858 836 6837 (Phone)+1 858 836 5519 (Fax)Larissa.D'Andrea@resmed.com
Product codes	73 BZD
ClassClassification ReferenceCommon/Usual NameProprietary Name	21 CFR 868.5905, Product Code 73 BZDNon continuous ventilator (IPPB)S9 VPAP Adapt
Predicate device(s)	S9 VPAP Adapt (K102586)

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Reason for submission

This 510(k) is being submitted as a labelling chanqe for the following contraindication:

ASV therapy is contraindicated in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.

This contraindication is supported by SERVE-HF, which was a randomized, parallel, event-driven, international multicenter study in 1325 patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF≤45%) and moderate to severe predominant central sleep apnea. The study investigated the effects of adding ASV to guideline-based medical management on survival and cardiovascular outcomes. The addition of ASV did not improve outcomes and showed an increased risk of cardiovascular mortality despite effective control of central sleep apnea.

Intended Use

The S9 VPAP Adapt is indicated for the treatment of patients weighing more than 66 lb (30kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The S9 VPAP Adapt is intended for home and hospital use.

Substantial Equivalence

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

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

ResMed has determined that the new device has not altered the safety and effectiveness of CPAP treatment for patients with Obstructive Sleep Apnoea (OSA), central and/or mixed appeas, or periodic breathing who weigh more than 66 lb (>30 kg). The new device complicable requirements referenced in the FDA guidance documents:

. FDA Reviewer Guidance for Premarket Notification Submissions (November 1993)
FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)

As this was a labelling change only, no further clinical testing was required to show substantial equivalence to the predicate device S9 VPAP Adapt (K102586)

The new device is as safe and effective as the predicate device.

Device description

The S9 VPAP ADAPT is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventilation during sleep. The device continually measures instantaneous ventilation,

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and calculates a target ventilation based on to the patient's recent average. It then adjusts the degree of pressure support to servo-control the patient's ventilation to at least equal the target ventilation. Therapy modes contained in the S9 VPAP Adapt are:

. CPAP mode;
CPAP with EPR .
Auto Servo Ventilation (ASV) ●

Therapy modes come from the predicate S9 VPAP Adapt (K102586).

The functional characteristics of the S9 VPAP Adapt system include all the clinician and user friendly features of the predicate device.

Characteristic	S9 VPAP Adapt (K102586)	New Device (S9 VPAP Adapt )	Comments
Indication foruse	The S9 VPAP Adapt is indicatedfor the treatment of patientsweighing more than 66 lb (30kg)with obstructive sleep apnea(OSA), central and/or mixedapneas, or periodic breathing.The S9 VPAP Adapt is intendedfor home and hospital use.	The S9 VPAP Adapt is indicatedfor the treatment of patientsweighing more than 66 lb (30kg)with obstructive sleep apnea(OSA), central and/or mixedapneas, or periodic breathing.The S9 VPAP Adapt is intendedfor home and hospital use.	EquivalentOnly labeling changeto includecontraindication
Location of use	Hospital/Home	Hospital/Home	Equivalent
Pressure Range and Treatment Modes
	4-20 cm H2O (CPAP)3-25 cm H2O (ASV)	4-20 cm H2O (CPAP)3-25 cm H2O (ASV)	Equivalent:
RAMP Settings	> User selected as "Off" to 45minutes in 5 minuteincrements> Max Ramp time set atclinician's discretion	> User selected as "Off" to 45minutes in 5 minuteincrements> Max Ramp time set atclinician's discretion	Equivalent
SystemComponents	> Flow generator> Integrated humidifier (5i)> Mask, air tubing and heatedtubing	> Flow generator> Integrated humidifier (5i)> Mask, air tubing and heatedtubing	Equivalent
Power supply	100-240V, 50-60Hz	100-240V, 50-60Hz	Equivalent
Flow generatorweight	1.7lb	1.7lb	Equivalent
Dimensions H xW x D (inches)	Flow generator unit:3.4 x 5.5 x 6.0	Flow generator unit:3.4 x 5.5 x 6.0	Equivalent

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Characteristic	S9 VPAP Adapt (K102586)	New Device (S9 VPAP Adapt )	Comments
Supplementaloxygen	Labeled for use withsupplemental oxygen	Labeled for use with supplementaloxygen	Equivalent

Conclusion

The S9 VPAP Adapt is substantially equivalent to the predicate device, S9 VPAP Adapt (K102586).

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510(k) Summary – VPAP Adapt

Required	By Section 807.92 (c)
Date Prepared	18 March, 2016
Owners Name	ResMed Ltd1 Elizabeth Macarthur DriveBella Vista, NSW 2153, Australia
Submitter	Jasjit Baveja+ 61 2 8884 1518 (Phone)+ 61 2 8884 2000 (FAX)Jasjit.baveja@resmed.com.au
Official Contact	Larissa D'AndreaDirector, Government & Regulatory AffairsResMed Corp9001 Spectrum Center BoulevardSan Diego, CA 92123+1 858 836 6837 (Phone)+1 858 836 5519 (Fax)Larissa.D'Andrea@resmed.com
Product codes	73 BZD
ClassClassification ReferenceCommon/Usual NameProprietary Name	21 CFR 868.5905, Product Code 73 BZDNon continuous ventilator (IPPB)VPAP Adapt
Predicate device(s)	VPAP Adapt (K113801)

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Reason for submission

This 510(k) is being submitted as a labelling chanqe for the following contraindication:

Indication for Use

The VPAP Adapt is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The VPAP Adapt is intended for home and hospital use

Substantial Equivalence

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

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

ResMed has determined that the new device has not altered the safety and effectiveness of CPAP treatment for patients with Obstructive Sleep Apnoea (OSA), central and/or mixed apneas, or periodic breathing who weigh more than 66 lb (>30 kg). The new device complicable requirements referenced in the FDA guidance documents:

FDA Reviewer Guidance for Premarket Notification Submissions (November 1993) ●
FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May ● 11, 2005)

As this was a labelling change only, no further clinical testing was required to show substantial equivalence to the predicate device VPAP Adapt (K113801).

The new device is as safe and effective as the predicate device.

Device Description

The VPAP Adapt is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventilation during sleep. The device continually measures the patient's instantaneous ventilation, and

{11}------------------------------------------------

calculates a target ventilation based on to the patient's recent average. It then adjusts the degree of pressure support to servo-control the patient's ventilation to at least equal the target ventilation.

Therapy modes contained in the VPAP Adapt are

СРАР .
ASV ●
ASVAuto .

The CPAP and ASV therapy modes come from the VPAP Adapt (K113801).

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

Characteristic	VPAP Adapt (K113801)	New Device (VPAP Adapt)	Comments
Indication foruse	The VPAP Adapt is indicated forthe treatment of patientsweighing more than 66 lb (30kg) with obstructive sleep apnea(OSA), central and/or mixedapneas, or periodic breathing. Itis intended for home andhospital use.	The 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.	EquivalentOnly labeling change toinclude contraindication
Location of use	Hospital/Home	Hospital/Home	Equivalent
Pressure Range and Treatment Modes
	4-20 cm H2O (CPAP)3-25 cm H2O (ASV)3-25 cm H2O (ASVAuto)	4-20 cm H2O (CPAP)3-25 cm H2O (ASV)3-25 cm H2O (ASVAuto)	Equivalent:
RAMP Settings	> User selected as "Off" to 45minutes in 5 minuteincrements> Max Ramp time set atclinician's discretion	> User selected as "Off" to 45minutes in 5 minuteincrements> Max Ramp time set atclinician's discretion	Equivalent
SystemComponents	> Flow generator> Integrated humidifier (5i)> Mask, air tubing and heatedtubing	> Flow generator> Integrated humidifier (5i)> Mask, air tubing and heatedtubing	Equivalent
Power supply	100-240V, 50-60Hz	100-240V, 50-60Hz	Equivalent
Flow generatorweight	1.7lb	1.7lb	Equivalent
Dimensions H xW x D (inches)	Flow generator unit:3.4 x 5.5 x 6.0	Flow generator unit:3.4 x 5.5 x 6.0	Equivalent
Characteristic	VPAP Adapt (K113801)	New Device (VPAP Adapt)	Comments
Supplementaloxygen	Labeled for use withsupplemental oxygen	Labeled for use with supplementaloxygen	Equivalent

{12}------------------------------------------------

Conclusion

The VPAP Adapt is substantially equivalent to the predicate devices, VPAP Adapt (K113801).

{13}------------------------------------------------

510(k) Summary – AirCurve 10 ASV

Required	By Section 807.92 (c)
Date Prepared	18 March, 2016
Owners Name	ResMed Ltd1 Elizabeth Macarthur DriveBella Vista, NSW 2153, Australia
Submitter	Jasjit Baveja+ 61 2 8884 1518 (Phone)+ 61 2 8884 2000 (FAX)Jasjit.baveja@resmed.com.au
Official Contact	Larissa D'AndreaDirector, Government & Regulatory AffairsResMed Corp9001 Spectrum Center BoulevardSan Diego, CA 92123+1 858 836 6837 (Phone)+1 858 836 5519 (Fax)Larissa.D'Andrea@resmed.com
Product codes	73 BZD
Class	II
Classification Reference	21 CFR 868.5905, Product Code 73 BZD
Common/Usual Name	Non continuous ventilator (IPPB)
Proprietary Name	AirCurve 10 ASV
Predicate device(s)	S9 Greenhills (K140279)

{14}------------------------------------------------

Reason for submission

This 510(k) is being submitted as a labelling chanqe for the following contraindication:

Indication for Use

Substantial Equivalence

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

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

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 lb (>30 kg).

The new device complies with the applicable requirements referenced in the FDA quidance 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. .

As this was a labelling change only, no further clinical testing was required to show substantial equivalence to the predicate device S9 Greenhills (K140279).

The new device is as safe and effective as the predicate device.

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Device Description

The AirCurve 10 ASV 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 AirCurve 10 ASV are CPAP, ASV, and ASVAuto. 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 AirCurve 10 ASV 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.

The functional characteristics of the system include all the clinician and user friendly features of the predicate device S9 Greenhills (K140279).

Characteristic	S9 Greenhills (K140279)	New Device (AirCurve 10 ASV)	Comments
Indication foruse	The S9 Greenhills is indicatedfor the treatment of patientsweighing more than 66 lb (30kg) with obstructive sleepapnea (OSA), central and/ormixed apneas, or periodicbreathing. It is intended forhome and hospital use. Thehumidifier is intended for singlepatient use in the homeenvironment and re-use in ahospital/institutionalenvironment.	The AirCurve 10 ASV device isindicated for the treatment ofpatients weighing more than 66 lb(30 kg) with obstructive sleep apnea(OSA), central and/or mixedapneas, or periodic breathing. It isintended for home and hospital use.The humidifier is intended for singlepatient use in the homeenvironment and re-use in ahospital/institutional environment.	EquivalentMarketed name changeonlyOnly labeling change toinclude contraindication
Location of use	Hospital/Home	Hospital/Home	Equivalent

{16}------------------------------------------------

Characteristic	S9 Greenhills (K140279)	New Device (AirCurve 10 ASV)	Comments
Pressure Range and Treatment Modes
	4-20 cm H2O (CPAP)	4-20 cm H2O (CPAP)	Equivalent:
	3-25 cm H2O (ASV)	3-25 cm H2O (ASV)
	3-25 cm H2O (ASVAuto)	3-25 cm H2O (ASVAuto)
RAMP Settings	User selected as "Off" to45 minutes in 5 minuteincrementsMax Ramp time set atclinician's discretion	User selected as "Off" to 45minutes in 5 minute incrementsMax Ramp time set atclinician's discretion	Equivalent
System Components	Flow generatorHumidifierMask, air tubing andheated tubing	Flow generatorHumidifierMask, air tubing and heatedtubing	Equivalent
Power supply	100-240V, 50-60Hz	100-240V, 50-60Hz	Equivalent
Flow generatorweight	2.5lb	2.5lb	Equivalent
Dimensions H xW x D (inches)	Flow generator unit:4.5 x 9.6 x 6.0	Flow generator unit:4.5 x 9.6 x 6.0	Equivalent
Supplementaloxygen	Labeled for use withsupplemental oxygen	Labeled for use with supplementaloxygen	Equivalent

Conclusion

The AirCurve 10 ASV is substantially equivalent to the predicate device, S9 Greenhills (K140279).

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).