The VPAP ADAPT SV is intended to provide non-invasive ventilatory support to treat adult patients with obstructive sleep apnea (OSA) and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

The VPAP TX is indicated for the treatment of patients weighing more than 66 lb (> 30 kg) with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. The VPAP TX is intended to be used in a clinical environment.

The S9 VPAP Tx is indicated for the treatment and titration of patients with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. CPAP, S, ST, T and PAC modes are indicated for patients weighing more than 30lb (13 kg); all other modes are indicated for patients weighing more than 66lb (30 kg). The S9 VPAP Tx is intended to be used in a clinical environment.

Device Description

The VPAP Adapt SV is identical to the predicate device VPAP Adapt SV (K051364), using a blower based positive pressure system. The device platform is identical to the VPAP Adapt SV (K051364) and contains a blower (motorfan assembly), flow and pressure sensors, and processing electronics. The blower supplies pressurized air to the patient via a mask and air tubing. The VPAP Adapt SV is a non-invasive flow generator device designed to provide adaptive servo-ventilation therapy to stabilize a patient's ventilation. The device continually measures instantaneous ventilation, and calculates a target ventilation equal to 90% of the patient's recent average ventilation (time constant 100 seconds). It then adjusts the degree of support to servo-control the patient's ventilation to at least equal the target ventilation.

The VPAP Tx is identical to the predicate device VPAP Tx (K092186), using a blower based positive pressure system. The device platform is identical to the VPAP Tx (K092186) and contains a Micro- processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency. The VPAP Tx system comprises the flow generator, patient interface) and optional humidifier.

The S9 VPAP Tx is identical to the predicate device S9 VPAP Tx (K123511), using a blower based positive pressure system. The device platform is identical to the S9 VPAP Tx (K092186) and contains a Micro- processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency. The S9 VPAP Tx comprises the flow generator, patient interface) and optional humidifier.

AI/ML Overview

This document is primarily a 510(k) summary for three ResMed devices (VPAP Adapt SV, VPAP Tx, and S9 VPAP Tx), indicating that the submission is for a labeling change to include a contraindication. It states that no further clinical testing was required to show substantial equivalence to the predicate devices because it was a labeling change only. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a performance study for a new device or software.

However, the contraindication is supported by a large-scale clinical study:

SERVE-HF Study Information (relevant to the contraindication):

Study Design: Randomized, parallel, event-driven, international multicenter study.
Sample Size: 1325 patients.
Patient Population: Chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.
Intervention: Addition of ASV (Adaptive Servo-Ventilation) to guideline-based medical management.
Outcome Investigated: Effects on survival and cardiovascular outcomes.
Finding: The addition of ASV did not improve outcomes and showed an increased risk of cardiovascular mortality despite effective control of central sleep apnea. This finding supports the need for a contraindication rather than demonstrating the device's performance against specific acceptance criteria for its intended use outside of this specific high-risk patient group.

Given the nature of the submission (a labeling change based on a clinical trial that identified a contraindication), the following points from your request cannot be directly extracted from the provided text for the device's performance meeting acceptance criteria:

A table of acceptance criteria and the reported device performance: Not available, as no new performance study was conducted. The tables provided compare characteristics of the new device to the predicate, stating they are "Equivalent," which is about substantial equivalence, not acceptance criteria performance.
Sample size used for the test set and the data provenance: For the contraindication study (SERVE-HF), the sample size was 1325 patients, from an international multicenter study. Data provenance for the device's original clearance is not detailed here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this submission's context, as it's a labeling change based on a large clinical trial, not a performance study compared to expert ground truth for a diagnostic AI.
Adjudication method: Not applicable here.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the SERVE-HF study, the "ground truth" was clinical outcomes data (survival and cardiovascular mortality).
The sample size for the training set: Not applicable, as this is a device and a labeling change, not an AI/ML algorithm development with a training set.
How the ground truth for the training set was established: Not applicable.

Summary in relation to your request:

The document describes a labeling change for three continuous ventilators (VPAP Adapt SV, VPAP Tx, S9 VPAP Tx). This change is to add a contraindication for ASV therapy 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 directly supported by findings from the SERVE-HF study, a large-scale, randomized, parallel, event-driven, international multicenter study involving 1325 patients. The study found that adding ASV to guideline-based medical management in this specific patient population did not improve outcomes and led to an increased risk of cardiovascular mortality. The "ground truth" for the SERVE-HF study was clinical outcomes data (survival and cardiovascular outcomes).

The document explicitly states that no further clinical testing was required for this 510(k) submission because it was only a labeling change, and the device itself (its operating principle, technology, manufacturing process) remains substantially equivalent to its respective predicate devices (K051364, K092186, K123511). Therefore, there are no new acceptance criteria or device performance data against them presented in this document for the device's efficacy in its cleared indications.

Summary

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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 Regulatory Affairs ReMed Corps 9001 Spectrum Center Boulevard San Diego, California 92123

Re: K161487

Trade/Device Name: VPAP Adapt SV, VPAP Tx, S9 VPAP Tx Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: MNS 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. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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 VPAP Adapt SV

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."

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Indications for Use

Expiration Date: January 31, 2017 See PRA Statement below.

Form Approved: OMB No. 0910-0120

510(k) Number (if known)

Device Name VPAP Tx

Indications for Use (Describe)

The VPAP TX is intended to be used in a clinical 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.

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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Indications for Use

510(k) Number (if known)

Device Name S9 VPAP Tx

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.

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 – VPAP Adapt SV

Required	By Section 807.92 (c)
Date Prepared	18 May, 2016
Owners Name	ResMed Ltd1 Elizabeth Macarthur Drive BellaVista, 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 Affairs ResMedCorp9001 Spectrum Center Boulevard SanDiego, CA 92123+1 858 836 6837 (Phone)+1 858 836 5519 (Fax)Larissa.D'Andrea@resmed.com
Product codes	73 MNS
ClassClassification ReferenceCommon/Usual NameProprietary Name	II21 CFR 868.5895, Product Code 73 MNSVentilator, Continuous, Non-Life SupportingVPAP Adapt SV
Predicate device(s)	VPAP Adapt SV (K051364)

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Reason for submission

This 510(k) is being submitted as a labelling change 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 VPAP ADAPT SV is intended to provide non-invasive ventilatory support to treat adult patients with obstructive sleep apnea (OSA) and Respiratory caused by central and/or mixed apneas and periodic breathing.

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 providing non- invasive ventilatory support for treatment for patients with Obstructive Sleep Apnoea (OSA) and respiratory insufficiency caused by central and/or mixed apneas, and periodic breathing. The new device complies with the applicable requirements referenced in the FDA guidance documents:

FDA Draft Reviewer Guidance for Ventilators (July 1995)
FDA Reviewer Guidance for Premarket Notification Submissions (November 1993)
FDA Reviewer's and Industry, Guidance for the content of premarket submissions for software contained in medical devices, May 1998

As this was a labelling change only, no further clinical testing was required to show substantial equivalence to the predicate device VPAP Adapt SV (K051364)

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

Device description

The VPAP Adapt SV is a non-invasive flow generator device designed to provide adaptive servo-ventilation therapy to stabilize a patient's ventilation. The device continually measures instantaneous ventilation, and calculates a target ventilation equal to 90% of the patient's recent average ventilation (time constant 100 seconds). It then adjusts the degree of support to servo-control the patient's ventilation to at least equal the target ventilation.

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Therapy modes contained in the VPAP Adapt SV are

CPAP mode;
Auto Servo Ventilation (ASV) ●

Therapy modes come from the predicate VPAP Adapt SV (K051364).

Characteristic	VPAP Adapt SV (K051364)	New Device (VPAP Adapt SV)	Comments
Indication foruse	The VPAP ADAPT is intended toprovide non-invasive ventilatorysupport to treat adult patients withobstructive sleep apnea (OSA)and Respiratory Insufficiencycaused by central and/or mixedapneas and periodic breathing.	The VPAP ADAPT is intended toprovide non-invasive ventilatorysupport to treat adult patients withobstructive sleep apnea (OSA) andRespiratory Insufficiency caused bycentral and/or mixed apneas andperiodic breathing.	EquivalentOnly labeling change toinclude contraindication
Location of use	Hospital/Home	Hospital/Home	Equivalent
Pressure Range and Treatment Modes	4-13 cm H2O (CPAP)4-25 cm H2O (ASV)	4-13 cm H2O (CPAP)4-25 cm H2O (ASV)	Equivalent
RAMPSettings	Feature enables a slowincrease in the patient airflowto allow the patient to fallasleep before the devicedelivers the full pressure; thetimer may be set to 0 – 45minute delay periods, in 5-minutes increments	Feature enables a slowincrease in the patient airflowto allow the patient to fallasleep before the devicedelivers the full pressure; thetimer may be set to 0 - 45minute delay periods, in 5-minutes increments	Equivalent
Flow generatoroperating system	Nucleus Plus	Nucleus Plus	Equivalent
Motor Type	Brush-less low voltage DC	Brush-less low voltage DC	Equivalent
Fan Type	Centrifugal	Centrifugal	Equivalent
ElectronicController	Servo-control loop	Servo-control loop	Equivalent
Power supply	100-240V, 50-60Hz	100-240V, 50-60Hz	Equivalent

Conclusion

The VPAP Adapt SV is substantially equivalent to the predicate device, VPAP Adapt SV (K051364).

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510(k) Summary -VPAP Tx
Required	By Section 807.92 (c)
Date Prepared	18 May, 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 MNS
ClassClassification ReferenceCommon/Usual NameProprietary Name	II21 CFR 868.5895, Product Code 73 MNSVentilator, Continuous, Non-Life SupportingVPAP Tx
Predicate device(s)	VPAP Tx (K092186)

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Reason for submission

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

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 quideline-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.

Indication for Use

The VPAP Tx is indicated for the treatment of patients weighing more than 66 lb (> 30 kq) with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing. The VPAP Tx is intended to be used in a clinical environment.

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 treatment for patients with obstructive Sleep Apnoea (OSA), respiratory insufficiency 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 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 Off-the-Shelf Software Use in Medical Devices (September 9,1999)

As this was a labelling change only, no further clinical testing was required to show substantial equivalence to the predicate device VPAP Tx (K092186).

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

Device Description

The VPAP Tx system comprises the flow generator, patient interface) and optional humidifier.

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Therapy modes contained in the VPAP Tx are:

СРАР
· Auto-titrating
Bi-level
VAuto
. ASV

These modes come from the VPAP Tx (K092186).

Characteristic	VPAP Tx (K092186)	New Device (VPAP Tx)	Comments
Indication foruse	The VPAP Tx is indicated for thetreatment of patients weighingmore than 66 lb (> 30 kg) withobstructive sleep apnea (OSA),respiratory insufficiency, central ormixed apneas, or periodicbreathing.The VPAP Tx is intended to beused in a clinical environment.	The VPAP Tx is indicated for thetreatment of patients weighing morethan 66 lb (> 30 kg) with obstructivesleep apnea (OSA), respiratoryinsufficiency, central or mixedapneas, or periodic breathing.The VPAP Tx is intended to be usedin a clinical environment.	EquivalentOnly labeling change toinclude contraindication
Location of use	Hospital/Home	Hospital/Home	Equivalent
Pressure Range and Treatment Modes
	4-20 cm H2O (CPAP)	4-20 cm H2O (CPAP)	Equivalent:
	4-20 cm H2O (Autoset)	4-20 cm H2O (Autoset)
	3-30 cm H2O (Bilevel)	3-30 cm H2O (Bilevel)
	4-25 cm H2O (VAuto)4-25 cm H2O (ASV)	4-25 cm H2O (VAuto)4-25 cm H2O (ASV)
Flow generatoroperating system	ResMed proprietary 'FG Engine'using Diamond architecture	ResMed proprietary 'FG Engine'using Diamond architecture	Equivalent
Motor Type	Brush-less low voltage DC	Brush-less low voltage DC	Equivalent
Fan Type	Centrifugal	Centrifugal	Equivalent
ElectronicController	Servo-control loop	Servo-control loop	Equivalent
Power supply	100-240V, 50-60Hz	100-240V, 50-60Hz	Equivalent

Conclusion

The VPAP Tx is substantially equivalent to the predicate device, VPAP Tx (K092186).

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510(k) Summary – S9 VPAP Tx

Required	By Section 807.92 (c)
Date Prepared	18 May, 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 & Requlatory 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 MNS
ClassClassification ReferenceCommon/Usual NameProprietary Name	21 CFR 868.5895, Product Code 73 MNSVentilator, Continuous, Non-Life SupportingS9 VPAP Tx
Predicate device(s)	S9 VPAP Tx (K123511)

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Reason for submission

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

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 quideline-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.

Indication for Use

The S9 VPAP Tx is intended to be used in a clinical environment.

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 treatment for patients with Obstructive Sleep Apnoea (OSA), central and/or mixed apneas, or periodic breathing who weigh more than 66 lb (>30 kq).

The new device 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)

As this was a labelling change only, no further clinical testing was required to show substantial equivalence to the predicate device S9 VPAP Tx (K123511).

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

Device Description

The S9 VPAP Tx comprises the flow generator, patient interface) and optional humidifier.

Therapy modes contained in the VPAP Tx are

. СРАР
. Auto-titrating
o Bi-level
o VAuto
ASV

These modes come from the S9 VPAP Tx (K123511).

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

Characteristic	S9 VPAP Tx (K123511)	New Device (S9 VPAP Tx)	Comments
Indication foruse	The S9 VPAP Tx is indicatedfor the treatment and titration ofpatients with obstructive sleepapnea (OSA), respiratoryinsufficiency, central or mixedapneas, or periodic breathing.CPAP, S, ST, T and PACmodes are indicated forpatients weighing more than30lb (13 kg); all other modesare indicated for patientsweighing more than 66lb (30kg).The S9 VPAP Tx is intended tobe used in a clinicalenvironment.	The S9 VPAP Tx is indicated forthe treatment and titration ofpatients with obstructive sleepapnea (OSA), respiratoryinsufficiency, central or mixedapneas, or periodic breathing.CPAP, S, ST, T and PAC modesare indicated for patientsweighing more than 30lb (13 kg);all other modes are indicated forpatients weighing more than66lb (30 kg).The S9 VPAP Tx is intended tobe used in a clinicalenvironment.	EquivalentOnly labeling changeto includecontraindication
Location of use	Hospital/Home	Hospital/Home	Equivalent
Pressure Range and Treatment Modes	4-20 cm H2O (CPAP)3-30 cm H2O (Bi-level)3-25 cm H2O (VAuto)3-30 cm H2O (ASV)3-30 cm H2O (ASVAuto)	4-20 cm H2O (CPAP)3-30 cm H2O (Bi-level)3-25 cm H2O (VAuto)3-30 cm H2O (ASV)3-30 cm H2O (ASVAuto)	Equivalent:
Flow generatoroperating system	Micrium uC/OS-II Software/digital	Micrium uC/OS-II Software/digital	Equivalent
Motor Type	Brush-less low voltage DC	Brush-less low voltage DC	Equivalent
Fan Type	Multiple impeller axial motor	Multiple impeller axial motor	Equivalent
Electronic Controller	Servo-control loop	Servo-control loop	Equivalent
Power supply	100-240V, 50-60Hz	100-240V, 50-60Hz	Equivalent

Conclusion

The S9 VPAP Tx is substantially equivalent to the predicate device, S9 VPAP Tx (K123511).

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).