The S9 WANDA VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). It is intended for use in the hospital and home.

Device Description

S9 WANDA VPAP ST System is similar to the predicate device (S9 VPAP ST (K102513)). Key features include: inline power supply; integrated humidifier; tubing; colour LCD; and simple controls. The S9 WANDA VPAP ST contains a Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 3-25 cmHzO as required to maintain an "air splint" for treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier. The S9 WANDA VPAP ST flow generator includes the same therapy modes as the S9 VPAP ST system (K102513) predicate device. These base therapy modes include: CPAP and CPAP with expiratory pressure relief (EPR) modes the device delivers a continuous positive airway pressure throughout the therapy session Bilevel mode the flow generator augments any breath initiated by the patient by detecting the onset of inspiration or expiration and delivering the set Inspiratory Positive Airway Pressure (IPAP) and Expiratory Positive Airway Pressure (EPAP) VAuto mode - the mean air-way pressure (between IPAP and EPAP) will alter based upon breathing events The functional characteristics of the S9 WANDA VPAP ST 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

Acceptance Criteria and Study for S9 WANDA VPAP ST

The submission for the S9 WANDA VPAP ST primarily relied on bench testing to demonstrate substantial equivalence to its predicate device, the S9 VPAP ST (K102513). Therefore, the "acceptance criteria" discussed below primarily refer to the performance standards met during these bench tests, which were deemed sufficient to prove a similar level of safety and effectiveness to the predicate. No clinical studies are mentioned.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with specific quantitative thresholds for each test. Instead, it states that "All tests confirmed the product met the predetermined acceptance criteria" and that these criteria were "traced to the S9 WANDA VPAP ST System Specification and to the predicate device's performance."

However, the "Characteristics (differences) between predicate and new device" and "Flow Generator comparison" sections provide some comparative performance data, which can be interpreted as demonstrating the device's fulfillment of implied acceptance criteria based on equivalence to the predicate.

Characteristic	Predicate S9 VPAP ST (K102513) Performance	S9 WANDA VPAP ST Performance	Acceptance Criteria (Implied)	Met/Not Met (as per document)
Intended Use	Treatment of Obstructive Sleep Apnea (OSA) in patients weighing > 66 lb (30 kg), for hospital and home use.	Treatment of Obstructive Sleep Apnea (OSA) in patients weighing > 66 lb (30 kg), for hospital and home use.	Equivalent to Predicate	Met (Explicitly stated "Equivalent")
Operating System/Controller	Micrium uC/OS-II Software/digital	Microchip: STM32F405ZG micro-controller with ARM 32-bit Cortex™-M4 CPU Software/digital	Updated micro in line with latest technologies appropriate for processing power needed, maintaining functional equivalence.	Met (Explicitly stated "Equivalent")
Flow Generator Weight	1.7 lb	2.5 lb	Biologically Equivalent (accounts for integrated humidifier)	Met (Explicitly stated "Equivalent")
Dimensions H x 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	Biologically Equivalent (accounts for integrated humidifier, larger width)	Met (Explicitly stated "Equivalent")
Data Transfer Medium	SD Card	SD Card, Wireless	Equivalent to Predicate (Wireless data transfer equivalent to EasyCare Online (K132371))	Met (Explicitly stated "Equivalent")
Humidifier Output (for > 8 hours)	12.7 mg/L @ 20cm H2O (50 L/min)	12.0 mg/L @ 20cm H2O (50 L/min)	Not clinically significant difference compared to predicate.	Met (Explicitly stated "The difference is not clinically significant and acceptance criteria was met (refer to bench testing (section 18)).")
Pressure Stability	Not explicitly quantified but implied performance of predicate.	Demonstrated in bench testing.	Equivalent to Predicate	Met (Stated "This performance testing demonstrate successful implementation of therapy modes into the S9 WANDA VPAP ST")
Response to Apneas	Not explicitly quantified but implied performance of predicate.	Demonstrated in bench testing.	Equivalent to Predicate	Met (Stated "This performance testing demonstrate successful implementation of therapy modes into the S9 WANDA VPAP ST")
Response to Flow Limitations & Snore	Not explicitly quantified but implied performance of predicate.	Demonstrated in bench testing.	Equivalent to Predicate	Met (Stated "This performance testing demonstrate successful implementation of therapy modes into the S9 WANDA VPAP ST")
Reporting of Closed Airway Detection (CAD)	Not explicitly quantified but implied performance of predicate.	Demonstrated in bench testing.	Equivalent to Predicate	Met (Stated "This performance testing demonstrate successful implementation of therapy modes into the S9 WANDA VPAP ST")

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

Sample Size for Test Set: Not applicable as no human-subject clinical test set was used. The study relied on bench testing using a "breathing machine" and the device itself.
Data Provenance: The bench testing was performed by ResMed Ltd., an Australian company. The testing is therefore attributed to the manufacturer's internal testing procedures. The data would be considered prospective in relation to the submission, as it was specifically generated for the purpose of demonstrating substantial equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. The "ground truth" for the bench testing was established by comparing the S9 WANDA VPAP ST's performance to the "S9 WANDA VPAP ST System Specification" and the "predicate device's performance." These are engineering specifications and previously established performance metrics, not expert human interpretations of data.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no human "test set" requiring adjudication. The assessment was based on objective measurements against engineering specifications and comparison to the predicate device's measured performance during bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The submission explicitly states "Bench testing alone is sufficient to demonstrate Substantial Equivalence."
Effect Size of Human Readers with/without AI Assistance: Not applicable, as no human-in-the-loop study with AI assistance was conducted.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: Yes, in a sense. The "bench testing" represents a standalone performance evaluation of the device's algorithms and hardware without a human operator directly influencing its core therapeutic function during the test. The "breathing machine" simulates patient input, and the device's response is objectively measured. This is not "algorithm only" in the modern sense of a software-as-a-medical-device (SaMD) study, but rather the performance of the integrated device's therapeutic functions.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the bench testing was based on:
- Engineering Specifications: The S9 WANDA VPAP ST System Specification defined the expected performance.
- Predicate Device Performance: Direct comparison to the measured performance of the legally marketed S9 VPAP ST (K102513) further served as a "ground truth" for demonstrating equivalence. This is an objective, measured ground truth.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a hardware-based medical device with integrated software that controls its mechanical functions (like pressure generation and response to breathing patterns). It does not employ machine learning or AI models that require a separate "training set" of data in the way modern AI/ML devices do. The software development likely involved traditional engineering verification and validation.

9. How Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there was no training set in the context of machine learning. The device's operational parameters and control logic were developed through engineering design process, adhering to established medical device standards (e.g., IEC 60601-1, IEC 62304) and based on the predicate device's proven functionality.

Summary

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JUN 1 7 2014

510(k) Summary - S9 WANDA VPAP ST

Required By section 807.92 (c)

16th June, 2014

Date Prepared Owners Name

ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista, NSW 2153, Australia Submitter Greg Dockar + 61 2 8884 2157 (Phone) + 61 2 8884 2004 (FAX)

GregD@resmed.com.au

Official Contact

Mr Jim Cassi - Vice President - Quality Assurance Americas ResMed 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 Product code 73 BZD)

Product Code 73 BZD

Class ll

Common/Usual Name

Non continuous ventilator (IPPB).

Proprietary Name S9 WANDA VPAP ST

Predicate Device(s)

S9 VPAP ST (K102513)

Reason for submission

New Device

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Indication for Use

・・

The S9 WANDA VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). It is intended for use in the hospital and home.

Substantial Equivalence

The new device has the following similarities to the previously cleared predicate device ((S9 VPAP ST (K102513)),

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

The S9 WANDA VPAP ST retains the same operating/technologies/manufacturing characteristics cleared in the S9 VPAP ST (K102513). The main differences between the S9 WANDA VPAP ST and the predicate device (S9 VPAP ST) include: the interface of the flow generator with the humidifier: updated operating system: minor material changes; and the addition of wireless data transfer.

Design and Verification activities were performed on the S9 WANDA VPAP ST device as a result of the risk analysis and design requirements. All tests confirmed the product met the predetermined acceptance criteria. The S9 WANDA VPAP ST 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 document "Radio Frequency Wireless Technology in Medical Devices Guidance for . Industry and Food and Drug Administration Staff" - Document Issued on: August 13, 2013
Reviewer Guidance for Premarket Notification Submissions, ARDB, CDRH, FDA, November 1993. .

Clinical Testing

Bench testing alone is sufficient to demonstrate Substantial Equivalence. Treatment algorithms remain unchanged from the predicate device (K102513).

Non-Clinical Testing

Side-by-Side bench testing was performed to verify that the S9 WANDA VPAP ST met the requirements of the S9 WANDA VPAP ST System Specification, and compare the results to the predicate device [(S9 VPAP ST (K102513)].

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

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

A breathing machine simulates patient breathing patterns, which results in the Flow Generator responding to provide the therapy mode pressure. The clinical Pass/Fail requirements are traced to the S9 WANDA VPAP ST System Specification and to the predicate device's performance.

This performance testing demonstrate successful implementation of therapy modes into the S9 WANDA VPAP ST

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Standards Testing

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

IEC 60601-1:2005. Medical electrical equipment Part 1: General requirements for safety Medical . electrical equipment - General requirements for basic safety and essential performance
IEC 60601-1-11 Edition 1.0: 2010, Medical electrical equipment Part 1-11: General . requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. (General)
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 62304:2006 Medical device software Software life cycle processes ●
IEC 62366:2007 Medical devices Application of usability engineering to medical devices .
ISO 8185:2007 Respiratory tract humidifiers for medical use -- Particular requirements for . respiratory humidification systems
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing in the . risk management process

Biocompatibility Testing

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

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

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

Device Description

The S9 WANDA VPAP ST flow generator includes the same therapy modes as the S9 VPAP ST system (K102513) predicate device. These base therapy modes include:

CPAP and CPAP with expiratory pressure relief (EPR) modes the device delivers a continuous positive . airway pressure throughout the therapy session
Bilevel mode the flow generator augments any breath initiated by the patient by detecting the onset of . inspiration or expiration and delivering the set Inspiratory Positive Airway Pressure (IPAP) and Expiratory Positive Airway Pressure (EPAP)
. VAuto mode - the mean air-way pressure (between IPAP and EPAP) will alter based upon breathing events

The functional characteristics of the S9 WANDA VPAP ST 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.

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Characteristics (differences) between predicate and new device

Characteristic	Predicate S9 VPAP ST (K102513)	New Device (S9 WANDA VPAP ST)	Comments
Indication for use	The S9 VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The S9 VPAP ST is intended for use in the hospital and home.	The S9 WANDA VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). It is intended for use in the hospital and home.	EquivalentSimplified - Intent of IFU remains unchanged
Performance
Flow Generator operating system/controller	Micrium uC/OS-IISoftware/digital	Microchip:STM32F405ZG micro-controller with ARM 32-bit Cortex™-M4 CPUSoftware/digital	Equivalent:Updated micro in line with latest technologies for micro-controller chip-sets and CPU appropriate for processing power needed for this device.
Flow generator weight	1.7lb	2.5lb	EquivalentIncludes humidifier internal to the Flow Generator (combined weight of humidifier and flow generator)
Dimensions H x 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 of the humidifier with larger width
Data transfer medium	SD Card	SD CardWireless	Equivalent:Wireless data transfer is equivalent to EasyCare Online (K132371). EasyCare Online is indicated for compatibility with ResMed therapy devices

「

Flow Generator comparison

Characteristic	Predicate S9 VPAP ST with H5i (K102513)	S9 WANDA VPAP ST Humidifier	Comments
Indication for use	Indicated for thehumidification of the airdelivered from ResMedcompatible CPAP therapydevices	—	Equivalent:Humidifier is completelyintegrated- separate manual isno longer required. Relevantinformation is included in theUser Guide. Refer to Appendix I
Humidifier Performance
Humidifier output formore than 8 hours	12.7mg/L @ 20cm H2O (50L/min)	12.0mg/L @ 20cm H2O (50L/min)	Equivalent:The difference is not clinicallysignificant and acceptance criteriawas met (refer to bench testing(section 18)).
Size	96 mm (H) x 145 mm (W) x153 mm (L)	N/A	EquivalentHumidifier is now internal to theTherapy Device
Weight	0.55 kg (including Dockingstation)	N/A	EquivalentHumidifier is now internal to theTherapy Device

The differences between the predicate [(S9 VPAP ST (K102513)] and S9 WANDA VPAP ST does not raise new questions of safety or effectiveness. .

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Conclusion

제조사 : 2017-04-09 10:00:00 :

September 19.

. . . . . . . .

) : ・

・

The S9 WANDA VPAP ST is substantially equivalent to the predicate device [(S9 VPAP ST (K102513)].

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Flealth Service

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

June 17, 2014

ResMed Ltd. Jim Cassi Vice President, Quality Assurance Americas 9001 Spectrum Center Blvd. San Diego, CA 92123

Re: K140159

Trade/Device Name: S9 WANDA VPAP ST Regulation Number: 21 CFR 868.5905 Regulation Name: Non Continuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: May 6, 2014 Received: May 12, 2014

Dear Mr. Cassi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Cassi

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

Teiashri Purohit-Sheth, M.D. Clinical Deputy Director

Teiashri Purohit-Sheth, M.D. DAGRID/ODE/CDRH FOR

. .

Erin I. Keith, M.S. 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)

Device Name S9 WANDA VPAP ST

Indications for Use (Describe)

The S9 WANDA VPAP ST is indicated for the treatment of Obstructive Sleep Apies (OSA) in patients weighing more than 66 Ib (30 kg). It is intended for use in the hospital and home.

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
	2014.06.16
	21:57:14 -04'00'
FORM FDA 3881 (1/14)	Page 1 of 2	PSC Publishing Services (301) 443-6740

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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).