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 S9 VPAP Tx is similar to the predicate devices VPAP ST-A (K113288), VPAP ST (K102513), S9 VPAP Adapt (K113801) and S8 Aspen (K091947).

The S9 VPAP Tx provides CPAP, Auto-titrating, Bilevel, VAuto and ASV modes to treat OSA and/or respiratory insufficiency, central or mixed apneas or periodic breathing. This is achieved through the use of 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 system comprises the flow generator, patient tubing, mask (patient interface) and optional H5i humidifier.

The performance and functional characteristics of the S9 VPAP Tx includes all the clinician and user friendly features of the predicate devices, VPAP ST-A (K113288), VPAP ST (K102513), S9 VPAP Adapt (K113801) and S8 Aspen (K091947).

AI/ML Overview

Here's an analysis of the ResMed S9 VPAP Tx 510(k) submission based on the provided text, focusing on the absence of information regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of an AI/ML medical device submission.

The provided document is a 510(k) summary for the ResMed S9 VPAP Tx, a continuous ventilator. It does NOT describe an AI/ML device or any study that would typically be associated with performance criteria for an algorithmic diagnostic or prognostic tool. Instead, it describes a hardware medical device and its substantial equivalence to previously cleared predicate devices.

Therefore, many of the requested points, such as "acceptance criteria and reported device performance" related to an AI/ML algorithm, sample sizes for test sets, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this submission.

The submission focuses on demonstrating compliance with recognized standards for medical electrical equipment and biocompatibility, as well as the substantial equivalence of the new device to existing predicate devices based on intended use, operating principle, technology, and manufacturing process.

Summary regarding Acceptance Criteria and Study for ResMed S9 VPAP Tx (K123511):

This 510(k) submission is for a continuous ventilator (S9 VPAP Tx), which is a hardware medical device, not an AI/ML device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" within the context of AI/ML performance (e.g., sensitivity, specificity, AUC) is not applicable to this submission.

The document states:

"Design and Verification activities were performed on the S9 VPAP Tx as a result of the risk analysis and design requirements. All tests confirmed the product met the predetermined acceptance criteria."
"The S9 VPAP Tx has been tested to appropriate FDA consensus standards and other applicable requirements passing all test protocols."

This indicates that internal design verification and validation activities were conducted based on engineering specifications and compliance with relevant safety and performance standards for hardware medical devices. These are not performance metrics for an AI algorithm.

Addressing the specific points based on the provided text, noting irrelevance where appropriate for an AI/ML context:

A table of acceptance criteria and the reported device performance
- Not Applicable in an AI/ML context. The document does not provide a table of performance metrics (like sensitivity, specificity) for an AI/ML component. The "acceptance criteria" here refers to the passing of various engineering and safety standards.
- Relevant information from document: The device was tested according to:
  - IEC 60601-1-2:2007 (Electromagnetic compatibility)
  - IEC 60601-1:2005 (General requirements for safety and essential performance)
  - IEC 60601-1-8:2006 (Alarm systems)
  - ISO 10993 series (Biocompatibility)
- Reported Device Performance: The document states "All tests confirmed the product met the predetermined acceptance criteria" and "passing all test protocols." No specific numerical performance results (e.g., for pressure delivery accuracy, flow rates) are provided in this summary, as these would typically be detailed in the full submission, not the summary.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This device is a hardware ventilator. There is no "test set" of patient data for evaluating an AI/ML algorithm as described in the prompt. The testing involved bench testing of the physical device. The document states: "Clinical data for the S9 VPAP Tx 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." This refers to physical models or simulated patient conditions, not patient data for algorithm training/testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is not an AI/ML device. Ground truth as typically understood for AI/ML validation (e.g., expert consensus on image interpretation) is not relevant here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is not an AI/ML device.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI/ML device and therefore no MRMC study involving human readers and AI assistance was conducted or would be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a hardware ventilator, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable in an AI/ML context. The "ground truth" for this device's testing would be established by the functional specifications and performance standards (e.g., a pressure sensor correctly measures the output pressure, the device delivers a specified flow rate). The "validated patient simulation models" mentioned refer to physical or mathematical models representing patient physiology for bench testing, not clinical ground truth derived from patients for an AI.
The sample size for the training set
- Not Applicable. This device does not have a "training set" in the context of AI/ML.
How the ground truth for the training set was established
- Not Applicable. This device does not have a "training set" or associated ground truth in the context of AI/ML.

In conclusion, the ResMed S9 VPAP Tx 510(k) submission is for a conventional medical device (ventilator) and does not contain information pertinent to the performance criteria or studies typically associated with AI/ML-enabled devices. The "predetermined acceptance criteria" and "test protocols" refer to engineering and safety standards, not AI algorithm performance metrics.

Summary

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ResMed

KIZ3SI | S9 VPAP Tx Traditional 510(k) Submission | Nov 2012

510(k) Summary - S9 VPAP Tx

MAR 2 1 2013

Date Prepared	16 March 2013
Submitter	Nicole GaddiRegulatory Affairs ManagerResMed Ltd, Australia
Official Contact	Mr. Jim CassiV.P., Quality Assurance AmericasResMed Corp9001 Spectrum Center BoulevardSan Diego, CA 92123USATel: (858) 836 6081Fax: (858) 836 5519
Classification Reference	21 CFR 868.5895
Product Code	73 MNS
Common/Usual Name	Ventilator, continuous, non-life-supporting
Proprietary Name	S9 VPAP Tx
Predicate Device(s)	ResMed, VPAP ST-A (K113288) - PrimaryResMed, VPAP ST (K102513) - SecondaryResMed, S9 VPAP Adapt (K113801) - SecondaryResMed, S8 Aspen (K091947) - Secondary
Reason for submission	New Device

Page 21

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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.

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

Design and Verification activities were performed on the S9 VPAP Tx as a result of the risk analysis and design requirements. All tests confirmed the product met the predetermined acceptance criteria. Clinical data for the S9 VPAP Tx 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. The new device complies with the applicable requirements referenced in the FDA guidance documents:

FDA Draft Reviewer Guidance for Ventilators (July 1995)
人 FDA Guidance for the Content of Premarket Submissions for Software in Medical Devices (May 11, 2005)

Non-Clinical Testing:

The S9 VPAP Tx has been tested to appropriate FDA consensus standards and other applicable requirements passing all test protocols. The S9 VPAP Tx without the optional 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 60601-1:2005. Medical electrical equipment Part 1: General requirements for safety Medical electrical equipment - General requirements for basic safety and essential performance
IEC 60601-1-8:2006. Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Materials have been tested in accordance with FDA Guidance documents (G95-1), and ISO 10993 series as defined for "external communicating device", Tissue/Bone/Dentin, contact duration "C"."

Device Description

The S9 VPAP Tx is similar to the predicate devices VPAP ST-A (K113288), VPAP ST (K102513), S9 VPAP Adapt (K113801) and S8 Aspen (K091947).

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The S9 VPAP Tx system comprises the flow generator, patient tubing, mask (patient interface) and optional H5i humidifier.

Conclusion

The S9 VPAP Tx is substantially equivalent to the previously cleared 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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, creating a sense of unity and support.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6 Silver Spring, MD 20993-0002

March 21, 2013

Mr. Jim Cassi Vice President, Quality Assurance Americas ResMed Corporation 9001 Spectrum Center Boulevard SAN DIEGO CA 92123

Re: K123511

Trade/Device Name: S9 VPAP Tx Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: February 15, 2013 Received: February 19, 2013

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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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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/7 description: The image contains the words "Kwame Ulmer" in bold, black font on the left side of the image. To the right of the names is a logo that contains the letters "EDA". The letters in the logo are outlined in black.

for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indication for Use

માટડ કા 510(k) Number (if known):

Device Name: S9 VPAP Tx

Indication for Use

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

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(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)	Albert E. Moyal
	S	for LS
Page 1 of 1	(Division Sign-Off)
	Division of Anesthesiology, General HospitalInfection Control, Dental Devices
510(k) Number:	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).