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.

Device Description

S9 VPAP ST System (S9 VPAP ST with H5i) 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, both hardware and firmware come from the S8 Aspen with H4i Plus (K091947) and contains a micro-processor controlled blower system that generates 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 S9 VPAP ST contains treatment modes that come from earlier versions of ResMed Bilevel devices, these modes are known as Spontaneous (S Mode), Timed (T Mode), Spontaneous/Timed (S/T Mode) and VAuto Mode. Therapy modes come from the VPAP Tx system (K092186), VPAP ST (K080131) for S, S/T, T and VAuto and CPAP Mode comes from the S8 Aspen (K091947).

AI/ML Overview

This document is a 510(k) summary for the ResMed S9 VPAP ST, a non-continuous ventilator intended for the treatment of Obstructive Sleep Apnea (OSA). It outlines the device's substantial equivalence to predicate devices and the non-clinical testing performed.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria in a table format with specific performance metrics and their corresponding values for each test. Instead, it broadly states that "All bench tests confirmed the predetermined acceptance criteria." The performance is generally reported as meeting these criteria through various tests against predicate devices.

Acceptance Criteria Category	Reported Device Performance
Bench Tests (General)	Confirmed predetermined acceptance criteria.
Specific Bench Tests	Pressure, Flattening, Snore, Hypopnea, and Apnea tests passed against predicate devices using common protocols.
Compliance with Standards	Passed all test protocols for:
IEC 60601-1-2:2007 (EMC)	Met requirements.
IEC 60601-1:1988 Ed 2 (Basic Safety)	Met requirements.
ISO 17510-1:2007 (Sleep Apnea Therapy)	Met requirements.
ISO 8185:2007 (Respiratory Humidifiers)	Met requirements.
Safety and Effectiveness	"Analysis of comparison of design, function and features of the predicate devices... together with the results of testing demonstrates that the S9 VPAP ST to be substantially equivalent to the predicate devices in terms of meeting performance criteria and function as intended."

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

The document indicates that clinical data for the S9 VPAP ST is not required. Therefore, there is no human patient test set as the device's safety and effectiveness were established through comparison to predicate devices and bench testing.

Sample Size: Not applicable for a human test set. Bench tests were performed on the device itself.
Data Provenance: Not applicable for patient data. The tests were non-clinical (bench testing) and likely performed internally by ResMed.

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

As no clinical data was required and testing was done non-clinically, there was no expert adjudication process to establish ground truth for a patient test set. The "ground truth" for the non-clinical tests would have been the specifications and performance characteristics of the predicate devices and relevant engineering standards.

4. Adjudication Method for the Test Set

Not applicable, as there was no patient test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data for the S9 VPAP ST is not required as the predicate devices have been subjected to clinical trial requirements or validated patient simulation models have been used during the bench testing phases."

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

The S9 VPAP ST is a physical medical device (a ventilator), not a software algorithm providing diagnostic or treatment recommendations. Therefore, the concept of "standalone performance" in the context of an algorithm's without-human-in-the-loop performance is not directly applicable. The device itself performs its intended function (delivering positive airway pressure). Its performance was evaluated through non-clinical bench testing.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was based on:

The performance specifications and established safety/effectiveness of the predicate devices.
Engineering parameters and requirements defined by international standards (IEC, ISO) and internal design requirements.
Validated patient simulation models used during bench testing.

8. The Sample Size for the Training Set

The device is a hardware-based medical device with integrated software, not a machine learning algorithm that undergoes a "training phase" with a distinct "training set" of data in the typical AI/ML sense. Therefore, no specific sample size for a training set is applicable or mentioned. Its design and functionality are based on established engineering principles and prior device iterations, not statistical learning from a dataset.

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

As there is no "training set" in the context of machine learning, this question is not applicable. The device's functionality and "knowledge" are engineered into its design, operating principles, and firmware, validated against industry standards and predicate device performance.

Summary

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510(k) Summary -- S9 VPAP ST 513

JAN - 5 2011

20th Nov, 2010 Date Prepared

Mr David D'Cruz - V.P., US Medical & Regulatory Affairs Official Contact ResMed Corp. 9001 Spectrum Center Boulevard, San Diego, CA 92123

Tel: (858) 836-5984

Classification Reference	21 CFR 868.5905
Product Code	73 BZD
Common/Usual Name	Non continuous ventilator (IPPB).
Proprietary Name	S9 VPAP ST .
Predicate Device(s)	VPAP ST (K080131).S8 Aspen with H4i Plus (K091947)VPAP Tx (K092186)
Reason for submission	New Device

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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.

Substantial Equivalence

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

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

Design and Verification activities were performed on the S9 VPAP ST System as a result of the risk analysis and design requirements. All bench tests confirmed the predetermined acceptance criteria, this included Pressure, Flattening, Snore, Hypopnea and Apnea tests against the predicate devices using common protocols for both devices. Clinical data for the S9 VPAP ST is not required as the predicate devices have been subjected to clinical trial requirements or validated patient simulation models have been used during the bench testing phases. ResMed has determined that the new device has not altered the safety and effectiveness of CPAP treatment for patients with Obstructive Sleep Apnoea (OSA) who weigh more than 66 Ib (>30 kg). 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)

Non-Clinical Testing:

This device has been tested to appropriate ISO and IEC standards and other applicable requirements passing all test protocols. The S9 VPAP ST with and without the integrated heated humidifier (H5)) was designed and tested according to:

IEC 60601-1-2:2007. Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
IEC 60601-1:1988 Ed 2, Medical electrical equipment Part 1: General requirements for safety
ISO 17510-1: 2007. Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment
ISO 8185:2007, Respiratory tract humidifiers for medical use -- Particular requirements for > respiratory humidification systems

Device Description

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Therapy modes contained in the S9 VPAP ST are CPAP. CPAP with EPR, Spontaneous, Spontaneous with Easybreathe, Spontaneous/Timed, Timed, and VAuto.

The functional characteristics of the S9 VPAP ST system includes all the clinician and user friendly features of the predicate devices.

Statement of Safety and Effectiveness

Analysis of comparison of design, function and features of the VPAP Tx system (K092186), VPAP ST (K080131) for S. S/T. T and VAuto and CPAP Mode from the S8 Aspen (K091947) together with the results of testing demonstrates that the S9 VPAP ST to be substantially equivalent to the predicate devices in terms of meeting performance criteria and function as intended.

Conclusion

The S9 VPAP ST is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol resembling an abstract caduceus or a series of flowing lines, possibly representing health and human services.

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

ResMed Limited C/O Mr. David D' Cruz Vice President Clinical & Regulatory Affairs ResMed Corporation 9001 Spectrum Center Boulevard San Diego, California 92123

JAN - 5 2011

Re: K102513

Trade/Device Name: S9 VPAP ST Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: December 13, 2010 Received: December 15, 2010

Dear Mr. Cruz:

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. D' Cruz

Enclosure

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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ResMed	S9 VPAP ST Traditional 510(k) Submission	Aug 2010
Indication for Use
510(k) Number (if known):	K102513
Device Name: S9 VPAP ST	JAN - 5 2011
Indication for Use

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

Prescription Use	X	AND/OR
------------------	---	--------

Over-The-Counter Use_____

(Part 21 CFR 801 Subpart D)

で

(Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number:	K102513

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).