The VPAP Tx is indicated for the treatment and titration of patients weighing more than 66 Ib (> 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.

Device Description

The modified VPAP Tx device has a similar operating principle, and the same technology and manufacturing process as the VPAP Tx (K092186). The hardware (electromechanical operation and materials) also remain unchanged from the predicate VPAP Tx (K092186). The therapy modes contained in the predicate VPAP Tx (K092186) provides CPAP, Auto-titrating, Bilevel, VAuto and ASV modes to treat OSA and/or respiratory insufficiency, central or mixed apneas or periodic breathing in patients weighing more than 66 lb. The device contains a micro-processor controlled blower system that generates as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency, central or mixed apneas or periodic breathing.

The change to the modified VPAP Tx device includes the addition of the ASVAuto therapy mode. The modified VPAP Tx system comprises the flow generator, patient tubing, mask (patient interface) and optional HumidAire 2i humidifier.

The performance and functional characteristics of the modified VPAP Tx includes all the clinician and user friendly features of the predicate device VPAP Tx (K092186).

AI/ML Overview

Here's an analysis of the provided text regarding the VPAP Tx device, focusing on acceptance criteria and study details.

It's important to note that the provided text describes a 510(k) premarket notification for a medical device. This process aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new safety and effectiveness through extensive, de novo clinical trials with predefined acceptance criteria for the new device's performance against a specific disease outcome. The "acceptance criteria" here refer more to meeting design specifications and demonstrating non-inferiority to the predicate device in terms of performance.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria & Test Categories	Reported Device Performance
Non-Clinical Testing:
- Performance to design input specifications (via Side-by-Side bench testing compared to predicate device K092186)	- "The VPAP Tx met the predetermined pass/fail criteria as defined in the VPAP Tx System Verification Report."
- ASVAuto algorithm performance to specification (via closed-loop and open-loop test scripts from patient models, including Adaptive servo-ventilation tests and EPAP response tests)	- "The bench test results demonstrated that the VPAP Tx met the predetermined pass/fail criteria."
Clinical Testing:
- Non-inferiority of Enhanced ASV in suppressing respiratory events compared to predicate ASV treatment for central sleep apnea/periodic breathing.	- "Enhanced ASV is clinically non-inferior in terms of suppressing respiratory events in patients who are treated for central sleep apnea/periodic breathing." (Implied acceptance based on the study objective and the overall 510(k) clearance)
- Absence of complications or adverse events during the clinical trial.	- "There were no complications or adverse events recorded, as a result of this clinical trial."
Compliance:
- Adherence to applicable regulations and guidance documents (e.g., FDA Guidance for Ventilators, FDA Guidance for Software in Medical Devices, IEC 60601-1-2, IEC 60601-1).	- "The VPAP Tx complies with the applicable requirements." (Explicitly stated for the listed standards.)

Study Details:

Sample size used for the test set and the data provenance:
- Test Set Sample Size (Clinical Trial): 21 subjects.
- Data Provenance: Not explicitly stated, but it's a clinical trial comparing the enhanced device to a predicate, conducted by ResMed. It can be inferred as prospective, as it "documented the outcome" of the new feature. The country of origin is not specified, but ResMed Ltd is in Australia and ResMed Corp in the USA.
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):
- This document does not specify the number or qualifications of experts used to establish a "ground truth" for the clinical trial test set. The clinical trial focused on comparing the suppression of respiratory events between two ASV treatments, rather than evaluating an algorithm's performance against a manually adjudicated ground truth in a diagnostic context. The assessment of "respiratory events" would likely rely on standard polysomnography scoring, which itself involves trained technologists and/or physicians, but these details are not provided here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. The clinical trial compared the outcomes of two different therapy modes (Enhanced ASV vs. Predicate ASV). The evaluation of respiratory events would typically follow established sleep study scoring guidelines, but the specific adjudication method for event scoring is not detailed.
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:
- No, an MRMC comparative effectiveness study involving human readers/interpreters with and without AI assistance was not performed. This study directly compared the performance of an "Enhanced ASV" algorithm (a software change) to a "predicate ASV" treatment in suppressing respiratory events in patients. It's a comparison of device performance, not an assessment of human reader improvement with AI.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the clinical trial essentially evaluated the "Enhanced ASV" algorithm as a standalone component within the device, comparing its therapeutic effect to the predicate ASV. The "Enhanced ASV" is described as a software change (ASVAuto algorithm), and its performance was directly assessed in suppressing respiratory events. The overall device operation (including the software) is independent once initiated.
- The non-clinical bench testing also directly evaluated the ASVAuto algorithm alone ("ResMed conducted extensive bench testing using both closed-loop and open-loop test scripts from patient models designed to verify that the ASVAuto algorithm in the VPAP Tx performs to specification.").
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The term "ground truth" isn't directly applicable in the same way as it might be for a diagnostic AI device. In this context, the "ground truth" for evaluating the clinical effectiveness of ASV treatments would be the quantification of respiratory events (e.g., apneas, hypopneas, periodic breathing occurrences) as measured by standard clinical methods (presumably polysomnography or similar monitoring) in patients receiving treatment. The study's objective was to demonstrate non-inferiority in suppressing these events.
The sample size for the training set:
- Not applicable / Not provided. This document describes a 510(k) submission for a device featuring an "ASVAuto algorithm" (a software change). It does not provide details about the development or training of this algorithm, including any potential "training set" of data that might have been used to develop the algorithm itself prior to verification and clinical testing. The focus is on the verification of the enhanced algorithm's performance.
How the ground truth for the training set was established:
- Not applicable / Not provided. As mentioned above, details about the algorithm's development/training, and therefore the establishment of ground truth for any training data, are not included in this regulatory summary.

Summary

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MAY 2 5 2012

RESMED

ﺎ

VPAP Tx Traditional 510(k) Premarket Notification

Revised 510(k) Summary – VPAP Tx[As required by 21 CFR 807.92 (c)]
Date Prepared	14 December 2011
Submitter	Nicole GaddiRegulatory Affairs ManagerResMed Ltd, Australia
Official Contact	Mr. David D'CruzV.P., Clinical & Regulatory AffairsResMed Corp9001 Spectrum Center BoulevardSan Diego, CA 92123USATel: (858) 836 5984Fax: (858) 836 5522
Classification Reference	21 CFR 868.5895
Product Code	73 MNS
Common/Usual Name	Ventilator, continuous, non-life-supporting
Proprietary Name	VPAP Tx
Predicate Device(s)	VPAP Tx (K092186)
Reason for submission	New Device

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Indication For Use

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

Substantial Equivalence

The modified VPAP Tx device has the following similarities to the previously cleared predicate devices.

ﺮ Similar intended use
» Similar operating principle
راز Same technologies
Same manufacturing process 产

The change to the Indication For Use statement is a minor change to include the words "and titration", this minor change has been done for clarity only. Design and Verification activities were performed on the modified VPAP Tx as a result of the risk analysis and design requirements. Endurance testing was not repeated as the change relates to the inclusion of ASVAuto (software change only) and therefore. the test report D251-178 remains valid as supplied in the VPAP Tx (K092186) submission, and is held on file at ResMed. As the VPAP Tx device is technologically identical to the VPAP Tx (K092186), predicate therapy performance verification was directly applicable to the modified VPAP Tx device. ResMed has determined that the modified VPAP Tx device has not altered the safety and effectiveness of treatment for patients with respiratory insufficiency or Obstructive Sleep Apnoea (OSA) who weigh more than 66 Ib (>30 kg).

The VPAP Tx complies with the applicable requirements:

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)
A 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

Non-Clinical Testing

Performance testing of VPAP Tx has been conducted using Side-by-Side bench testing methodology to demonstrate that the modified VPAP Tx performs to design input specifications when compared to the VPAP Tx (K092186) clinical trial device. The VPAP Tx met the predetermined pass/fail criteria as defined in the VPAP Tx System Verification Report.

ResMed conducted extensive bench testing using both closed-loop and open-loop test scripts from patient models designed to verify that the ASVAuto algorithm in the VPAP Tx performs to specification. These tests included Adaptive servo-ventilation tests for the ASV functionality, and EPAP response tests to Flow Limitation, Snore and Apnea events for the auto-adjusting EPAP component. The bench test results demonstrated that the VPAP Tx met the predetermined pass/fail criteria.

Clinical Testing

There were 21 subjects who completed the trial, which documented the outcome of Enhanced ASV when compared to the predicate ASV treatment, and to demonstrate the Enhanced ASV is clinically non-inferior in terms of suppressing respiratory events in patients who are treated for central sleep apnealperiodic breathing.

There were no complications or adverse events recorded, as a result of this clinical trial.

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Device Description

The performance and functional characteristics of the modified VPAP Tx includes all the clinician and user friendly features of the predicate device VPAP Tx (K092186).

Conclusion

The modified VPAP Tx is substantially equivalent to the previously cleared predicate device VPAP Tx (K092186).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

MAY 25 2012

Re: K113714

Trade/Device Name: VPAP Tx Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: May 16, 2012 Received: May 24, 2012

Dear Mr. D'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 Eederal Register.

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Page 2- Mr. D'Cruz

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Nh 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

Indication for Use

510{k) Number (if known):

Device Name: VPAP Tx

Indication for Use

The VPAP Tx is indicated for the treatment and titation of patients weighing more than 66 ib (> 30 kg) with obstructive sleep apnea (OSA), respiratory in the abudinant and atradon of patients welgining more than

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

-L. Schultes

(Division Sign-Off) Division of Anesthasiology, General Hospital Infection Control, Dental Devices

K-113714 510(k) Number:

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)

14 December 2011

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).