ResScan is intended to augment the standard follow-up care of patients by providing transfer of machine and therapeutic information, including the ability to remotely change settings. It is intended to be used by Clinicians in conjunction with ResMed compatible flow generators, 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), 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. Summary of additional features from the ResScan (K050775): ResMed compatible flow generators include, S8 series flow generators (73 BZD), VPAP Bilevel devices (73 MNS) and Stellar (73 MNT). Display/reporting of additional modes such as S, ST, ASV, iVAPS & PAC. Additional Windows Vista (64 bit) and Windows 7 (32 & 64 bit), and added support for remote settings via removable media - SD cards and USB sticks. Added support for display of alarm events. Added the capability to generate patient compliance reports based on US CMS guidelines both on a per patient basis and across all patient data.

AI/ML Overview

This document describes the regulatory submission for the ResScan device, an adjunct to patient care that allows clinicians to transfer machine and therapeutic information and remotely change settings on ResMed compatible flow generators.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative format for the ResScan device. Instead, it describes a more general approach to verification.

Acceptance Criteria Category	Description/Reported Performance
Functional Verification	End-to-end testing confirmed 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.
Design Input Specifications	Performance testing of ResScan has been conducted using End bench testing methodology to demonstrate that the modified ResScan performs to design input specifications. ResScan device met the predetermined pass/fail criteria as defined in the ResScan System Verification Report.
Safety and Effectiveness	The modified ResScan has not altered the safety and effectiveness when used for patient compliance management as an adjunct with ResMed flow generators. The inclusion of new features was assessed within the risk analysis, and no additional safety risks were found.
Regulatory Compliance	Complies with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and FDA Off-the-Shelf Software Use in Medical Devices (September 9, 1999).
Substantial Equivalence	Demonstrated substantial equivalence to the predicate device (ResScan, K050775) based on similar intended use, same operating principle, same technologies, and same manufacturing process.

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

Sample Size for Test Set: Not explicitly stated. The document refers to "End bench testing methodology" and "testing activities" performed as a result of risk analysis and design requirements. This suggests a rigorous internal testing process, but the specific number of test cases or "samples" is not quantified.
Data Provenance: The testing appears to be internal "bench testing" and "Verification activities" conducted by ResMed Ltd, Australia. There is no mention of external data, clinical data, or country of origin for a specific "test set" in the context of patient data.

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

The document describes a "Non-Clinical Testing" approach involving "predetermined pass/fail criteria" and "design input specifications." This implies that the ground truth for testing was established by the design and engineering teams at ResMed based on the device's functional requirements.
The document does not mention the use of external "experts" (e.g., radiologists, clinicians) to establish ground truth for a test set, as this was not a clinical study involving interpretation of patient data. The ground truth was based on the device's technical specifications and expected performance.

4. Adjudication Method for the Test Set

An adjudication method is not applicable or mentioned. The testing described is verification testing against predetermined design inputs and pass/fail criteria, not a study involving human reviewers assessing output and requiring a consensus mechanism.

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

No MRMC study was done. 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." Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.

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

Yes, a standalone performance study was done for the device's functionality. The described "End bench testing methodology" and "Verification activities" represent a standalone evaluation of the ResScan software's ability to:
- Successfully transfer settings between flow generators and ResScan.
- Receive data captured by the flow generator.
- Perform to design input specifications.
- Meet predetermined pass/fail criteria.
- The "algorithm" here refers to the software's functionality in handling data transfer and settings, rather than an AI-driven interpretive algorithm.

7. Type of Ground Truth Used

The ground truth used for the non-clinical testing was design input specifications and predetermined pass/fail criteria. This refers to the functional requirements and expected behavior of the software, not clinical outcomes, pathology, or expert consensus on patient data.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here. ResScan is a software device for data transfer and settings management, not a machine learning or AI algorithm that requires a training set in the conventional sense. The development likely involved standard software engineering practices (coding, unit testing, integration testing, system testing) rather than data-driven machine learning model training.

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

Not applicable, as there was no training set for a machine learning model. The "ground truth" for the device's development and verification was its design specifications and functional requirements as established by ResMed's engineering and product development teams.

Summary

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ResMed

510(k) Summary - ResScan

[As required by 21 CFR 807.92 (c)]

u113815

Date Prepared	22nd February 2012
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 BZD
Common/Usual Name	Non continuous ventilator (IPPB)
Proprietary Name	ResScan
Predicate Device(s)	ResScan (K050775)

New Device

Reason for submission

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Image /page/1/Picture/0 description: The image shows the word "RESMED" in all capital letters. The font is bold and sans-serif. The letters are black against a white background.

Indication for Use

ResScan is intended to augment the standard follow-up care of patients by providing transfer of machine and therapeutic information, including the ability to remotely change settings.

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

Substantial Equivalence

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

A Similar intended use
A Same operating principle
Same technologies A
A 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. The modified ResScan has not altered the 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 quidance 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)

Non-Clinical Testing:

Performance testing of ResScan has been conducted using End bench testing methodology to demonstrate that the modified ResScan performs to design input specifications.

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

Clinical Testing:

Clinical testing was not deemed necessary as indentified 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.

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) 入
Create and print reports >

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RESMED

Uses Removal Media or PC direct connection as the interface between the flow generator ➤ and ResScan
Support for Data Card Reader

Summary of additional features from the ResScan (K050775):

ResMed compatible flow generators include, S8 series flow generators (73 BZD), VPAP Bilevel devices (73 MNS) and Stellar (73 MNT).
Display/reporting of additional modes such as S, ST, ASV, iVAPS & PAC. 入
Additional Windows Vista (64 bit) and Windows 7 (32 & 64 bit), and added support for remote A settings via removable media - SD cards and USB sticks.
Added support for display of alarm events.
Added the capability to generate patient compliance reports based on US CMS guidelines both on a per patient basis and across all patient data.

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 the features.

Conclusion

The modified ResScan is substantially equivalent to the predicate device, ResScan (K050775).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

Re: K113815

Trade/Device Name: ResScan Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: BZD, MNS, MNT Dated: February 23, 2012 Received: February 27, 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 Federal Register.

MAR 2 7 2012

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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

Enclosure

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RESMED

Indication for Use

510(k) Number (if known):

Device Name: ResScan

Indication for Use

ResScan is intended to augment the standard follow-up care of patients by providing transfer of machine and therapeutic information, including the ability to remotely change settings.

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

L. Shuler

(Division Sign-Off) " ivision of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K113815

AND/OR Over-The-Counter Use_ Prescription Use __ x (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (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

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).