ResScan is intended to augment the standard follow-up care of patients by providing transfer of machine and therapeutic information. This includes the ability to remotely change settings in non-life support devices only.

It is intended to be used by Clinicians in conjunction with ResMed compatible therapy devices, using ResMed's proprietary communications protocol.

Device Description

The performance and functional characteristics of ResScan includes all the user friendly features of the predicate device.

ResScan allows the clinician to:

Download and view patient and machine data from ResMed flow generators
Store patient details
Set machine parameters (Using Removal Media or PC direct connection), non-life support devices only.
Create and print reports
Uses Removal Media or PC direct connection as the interface between the flow generator and ResScan
Support for Data Card Reader

AI/ML Overview

The provided document describes a 510(k) submission for the ResScan device, which is a software intended to augment patient follow-up care by transferring machine and therapeutic information and allowing remote changes to settings in non-life support devices. This submission aims to demonstrate substantial equivalence to a predicate device, also named ResScan (K113815).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) with corresponding reported device performance values. Instead, it discusses "predetermined acceptance criteria" in the context of verification testing.

The acceptance criteria appear to be qualitative and focused on successful communication and data transfer. The reported device performance is that these criteria were met.

Feature/Test	Acceptance Criteria (Implied)	Reported Device Performance
Settings Transfer (End-to-End Testing)	Settings successfully transferred between flow generator and ResScan	"All tests confirmed the product met the predetermined acceptance criteria."
Data Capture & Transmission (End-to-End Testing)	Data captured by flow generator sent to ResScan	"All tests confirmed the product met the predetermined acceptance criteria."
Removable Media Functionality (Non-Clinical)	ResScan can receive patient usage, device settings, therapy summary data, detailed signal data, and device log information from flow generator via removable media.	"All tests confirmed the product met the predetermined acceptance criteria." (Specific mention: "ResScan met the predetermined pass/fail criteria as defined in the ResScan System Verification Report.")

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

The document describes "End-to-End bench testing" and "non-clinical verification activities." These refer to laboratory or bench testing rather than testing with patient data or in a clinical setting.

Sample Size for Test Set: Not applicable in the context of patient data. The "test set" would consist of various configurations, data types, and scenarios used in the bench testing. No numerical sample size for these test cases is provided.
Data Provenance: Not applicable as the testing was non-clinical/bench testing. The document states that ResScan "only obtains patient and machine information from therapeutic devices for which clinical trials have already been conducted, or compared with previous predicate comparison test results." This implies reliance on data generated by the therapeutic devices themselves, not data specifically collected for ResScan's performance evaluation.

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

Number of Experts: Not applicable. Given that the testing was end-to-end bench testing of data transfer and settings changes, the "ground truth" would be established by the expected behavior of the system and direct observation/validation during engineering testing. There is no mention of human experts defining ground truth for this type of technical performance evaluation.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The testing described is technical verification (e.g., "end-to-end testing to confirm that settings were successfully transferred," "data captured by the flow generator was sent"). Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation or diagnostic tasks where expert consensus is needed to resolve discrepancies in human assessments of often ambiguous data. Here, the outcome of a test case (e.g., "was the setting changed correctly?") is expected to be binary and objectively verifiable.

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

Was it done?: No. The document explicitly states: "Clinical testing was not deemed necessary as identified in the Risk Analysis, as ResScan only obtains patient and machine information from therapeutic devices for which clinical trials have already been conducted, or compared with previous predicate comparison test results. Accordingly no clinical testing is required."
Effect size of human readers with vs. without AI assistance: Not applicable, as no MRMC study was conducted. ResScan is a data management and setting adjustment software, not an AI-assisted diagnostic or interpretation tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was it done?: Yes, in essence. The "end-to-end bench testing" described is a standalone performance test of the software's ability to correctly transfer data and settings. The performance evaluated is the software's internal functionality. While it is ultimately used by clinicians, the testing described focuses on the software's direct interaction with the flow generators and its own data processing capabilities, without evaluating a human-in-the-loop task.

7. Type of Ground Truth Used

Type of Ground Truth: Expected System Behavior/Technical Specification Adherence.
- For settings transfer: The ground truth is whether the new setting was correctly applied to the flow generator as initiated by ResScan.
- For data capture and transmission: The ground truth is whether the data generated by the flow generator was accurately received and stored by ResScan.
- This is established by comparing the software's output/actions against the design specifications and expected functional behavior, not against pathology, outcomes data, or expert consensus in a clinical diagnostic sense.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This document describes a software system that manages data and settings, and interfaces with medical devices. It is not an AI/machine learning model that typically requires a distinct "training set" for model development. The software capabilities are likely developed through traditional software engineering paradigms, not statistical learning from a large dataset.

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

How Ground Truth for Training Set Was Established: Not applicable, as there isn't a "training set" in the machine learning sense. The "ground truth" for developing the software (e.g., for unit and integration testing) would be derived from functional requirements, design specifications, and communication protocols.

Summary

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KI40.054

RESMED

MAY 1 6 2014

ResScan Traditional 510(k)

510(k) SUMMARY

[As required by 21 CFR 807.92(c)]

Date Prepared	15 April 2014
Submitter Name	Nicole Gaddi
Official Contact	Mr. Jim CassiVice President - Quality Assurance Americas9001 Spectrum Center BlvdSan Diego CA 92123 USATel: (858) 836 6081
Device Trade Name	ResScan
Device Common Name	Continuous Ventilator
Classification/s &Classification Name/s	21 CFR 868.5905, 73 BZD (Class II)Non continuous ventilator (IPPB)21 CFR 868.5895, 73 MNS (Class II)Continuous Ventilator21 CFR 868.5895, 73 MNT (Class II)Continuous Ventilator21 CFR 868.5895, 73 CBK (Class II)Ventilator, continuous, facility use
Legally MarketedPredicate DeviceReason for Submission	ResScan (K113815)New Device

Indication for Use

It is intended to be used by Clinicians in conjunction with ResMed compatible therapy devices, using ResMed's proprietary communications protocol.

Device Description

The performance and functional characteristics of ResScan includes all the user friendly features of the predicate device.

ResScan allows the clinician to:

Download and view patient and machine data from ResMed flow generators A
Store patient details A
Set machine parameters (Using Removal Media or PC direct connection), non-life support A devices only.
メ Create and print reports
. Uses Removal Media or PC direct connection as the interface between the flow generator and ResScan
大 Support for Data Card Reader

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Substantial Equivalence

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

入 Similar intended use
Same operating principle
Same technologies ★
Same manufacturing process

Design and Verification activities were performed on ResScan as a result of the risk analysis and design requirements. Verification testing included end-to-end testing to confirm that settings were successfully transferred between the flow generator and ResScan, and data captured by the flow generator was sent to ResScan. All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that the new device is substantially equivalent to the predicate device and any changes do not raise new questions of safety and effectiveness when used for patient compliance management as an adjunct with ResMed flow generators. The new device 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 Off-the-Shelf Software Use in Medical Devices (September 9, 1999)

Feature	ResScan predicate(K113815)	ResScan (modified)	Comments
Intended Use	ResScan™ is intended toaugment the standard follow-up care of patients byproviding transfer of machine and therapeutic information,including the ability to remotely change settings.It is intended to be used byClinicians in conjunction withResMed compatible flowgenerators, using ResMed'sproprietary communications protocol.	ResScan™ is intended toaugment the standardfollow-up care of patients byproviding transfer ofmachine and therapeuticinformation. This includesthe ability to remotelychange settings in non-lifesupport devices only.It is intended to be used byClinicians in conjunctionwith ResMed compatibletherapy devices, usingResMed's proprietarycommunications protocol.	Equivalent:Remote setting changefunctionality is notapplicable to ResMedCBK therapy devices.
Location of use	• Hospital	• Hospital	Equivalent
Functionality	• Display of therapy data• Generate reports• Settings management• Patient management	• Display of therapy data• Generate reports• Settings management• Patient management	Equivalent:Remote setting changefunctionality onlyapplies to non-lifesupport devices
Compatibleflow generators	• Resmed compatibletherapy devices (73 BZD,73 MNS and 73 MNT )	• Resmed compatibletherapy devices (73 BZD,73 MNS, 73 MNT and 73CBK )	Equivalent:Remote setting changefunctionality onlyapplies to non-lifesupport devices

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Feature	ResScan predicate(K113815)	ResScan (modified)	Comments
Communicationmedium	• Serial connection• Removable medium	• Serial connection• Removable medium	Equivalent:Serial connection onlyapplies to non-lifesupport devices
Patientinformation	• Mask Leak• AHI• Pressure• Minute Ventilation• Respiratory rate	• Mask Leak• AHI• Pressure• Minute Ventilation• Respiratory rate	Equivalent
Changeablesettings	• Start Pressure• Set Pressure• Ramp time• Setting time	• Start Pressure• Set Pressure• Ramp time• Setting time	Equivalent:Remote setting changefunctionality onlyapplies to non-lifesupport devices

Non-Clinical Testing

Design and non-clinical verification activities were performed on ResScan as a result of the updated risk analysis and design requirements. Verification testing included End-to-End bench testing to verify that ResScan, using only Removable Media, can receive patient usage, device settings, therapy summary data, detailed signal data and device log information from the flow generator (data). All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that the new version of ResScan is substantially equivalent to the predicate device, ResScan (K113815).

ResScan met the predetermined pass/fail criteria as defined in the ResScan System Verification Report.

Clinical Testing

Clinical testing was not deemed necessary as identified in the Risk Analysis, as ResScan only obtains patient and machine information from therapeutic devices for which clinical trials have already been conducted, or compared with previous predicate comparison test results. Accordingly no clinical testing is required.

Summary of additional features from the ResScan (K113815)

ResMed compatible therapy devices include, e.g. VPAP Bilevel devices (73 MNS).
Life support therapy device (73 CBK). A
Display/reporting of multiple therapy programs for life support therapy devices. メ
Display/reporting of additional modes such as ASVAuto, ACV, PACV, V-SIMV, P-SIMV, & PS. A
A Support for Windows Remote Desktop Environments.

The inclusion of these features has been assessed within the risk analysis and no additional safety risks have been found as a result of the inclusion of these features.

Conclusion

The modified ResScan is as safe and as effective as the predicate device, ResScan (K113815) and is deemed substantially equivalent to the predicate device, ResScan (K113815).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and three horizontal lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

Public Health Service

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

May 16, 2014

Resmed Corporation Mr. Jim Cassi Vice President, Quality Assurance Americas 9001 Spectrum Center Blvd. San Diego, CA 92123

Re: K140054

Trade/Device Name: ResScan Regulation Number: 21 CFR 868.5905 Regulation Name: Non-continuous Ventilator Regulatory Class: II Product Code: BZD, MNS, MNT, CBK Dated: April 16, 2014 Received: April 18, 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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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 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/McdicalDevices/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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

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

DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K140054

Device Name ResScan

Indications for Use (Describe)

ResScan is intended to augment the standard follow-up care of patients by providing transfer of machine and thermation. This includes the ability to remotely change settings in non-life support devices only.

It is intended to be used by Clinicians in conjunction with ResMed compatible therapy devices, using

ResMed's proprietary communications protocol.

Type of Use (Select one or both, as applicable)

[x] 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.

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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).