The Easy Care Tx 2 software is intended to be used with ResMed compatible therapy devices in a clinical environment. EasyCare Tx 2 provides therapy device setting changes and displays real-time data and treatment settings from compatible ResMed therapy devices when used together with the TxLink 2 module.

Device Description

EasyCare Tx 2 is a personal computer application designed to allow clinicians to monitor real-time data from the ResMed compatible therapy device and adjust the therapy device settings from the control room of the sleep lab.

AI/ML Overview

The device in question is the EasyCare Tx 2, a therapy titration software developed by ResMed Corp. The provided document is a 510(k) Premarket Notification summary to the FDA. The submission seeks to prove substantial equivalence to a predicate device, the EasyCare Tx System (K113780).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in a quantitative sense as might be seen for diagnostic device performance (e.g., sensitivity, specificity). Instead, it focuses on comparing the technological characteristics and intended use of the EasyCare Tx 2 with its predicate device to demonstrate substantial equivalence. The "performance" here relates to functional capabilities and parameter ranges rather than diagnostic accuracy.

Feature/Parameter	Predicate Device (EasyCare Tx - K113780)	Subject Device (EasyCare Tx 2)	Comparison/Performance Notes
Intended Use	To be used with ResMed compatible therapy devices via Tx Link; provides real-time data and treatment settings display, and can also provide therapy device setting changes remotely; intended for clinical environment.	To be used with ResMed compatible therapy devices in a clinical environment; provides therapy device setting changes and displays real-time data and treatment settings from compatible ResMed therapy devices when used together with TxLink 2 module.	Similar.
Technological Characteristics
Prescription Use	Yes	Yes	Same.
Intended Environment of Use	Hospital or Sleep Lab	Hospital or Sleep Lab	Same.
Display Type	PC	PC	Same.
Hardware Requirements	Standard PC platform with microprocessor and ancillary controllers	Standard PC platform with microprocessor and ancillary controllers	Same.
Operating System	Microsoft Windows	Microsoft Windows	Same.
Accessories	CD for downloading to PC, Tx Link	CD for downloading to PC, Tx Link 2	Similar (Tx Link vs. Tx Link 2).
Compatible Therapy Devices	BZD, MNS, MNT	BZD	Similar. EasyCare Tx 2 does not support product codes MNS and MNT.
Therapy Device Adjustments (Settings)
Adjust Device Therapy Mode	Yes	Yes	Same.
Adjust Device Therapy Settings	Yes	Yes	Same.
Available Therapy Modes	CPAP, AutoSet, AutoSet for Her, S, ST, TVAuto, ASV, ASVAuto, PAC, iVAPS	CPAP, AutoSet, AutoSet for Her, S, ST, TVAuto, ASV, ASVAuto, PAC	The PAC and iVAPS modes are no longer used and supported as they are for devices under MNS and MNT product codes, and not in scope for EasyCare Tx 2 with BZD devices.
Humidifier Control	Humidifier on/off	Humidifier on/off, level control, auto	Similar. Auto mode added for the attached therapy device optimizes humidifier temperature. EasyCare Tx 2 controls humidifier settings.
Tubing Control	Tube Temperature on/off, auto	Tube Temperature on/off, auto	Same. Therapy device optimizes tube temperature.
Ramp	0 to 45 min	5 to 45 min, off, auto	Similar. Off mode added for usability. Auto mode stops ramp when sleep detected.
Output Parameters
Pressure	-3 to 35 cm H2O	0 to 30 cm H2O	Similar. Therapy for EasyCare Tx 2 only supports OSA devices requiring lower pressure, removing the -3 cm H2O which was for a niche case in older devices. The therapy range has not changed for the relevant BZD devices.
Flow	-120 to 120 L/min	-240 to 240 L/min	Similar. Increased range due to larger data model and scalable architecture. Risks are considered by the parent therapy device.
Leak	-30 to 120 L/min	0 to 2 L/s	Similar. Leak parameters are sent from the attached therapy device in L/s. EasyCare Tx 2 allows toggling between L/s and L/min.
Respiratory Rate	6 to 35 BPM	0 to 90 BPM	Similar. Higher range supports pediatric patients using AirSense 11.
Tidal Volume	0.01 to 3 L	0 to 4 L	Similar.
Target Ventilation	0 to 30 L/min	0 to 30 L/min	Same.
Minute Ventilation	0 to 30 L/min	0 to 30 L/min	Same.
Ti (Inspiration Time)	0 to 9 seconds	0.3 to 4 seconds	Similar.
Pulse Rate	18 to 300 BPM	0 to 300 BPM	Similar. Expansion of range due to new sensor supporting increased data monitoring.
SpO₂	40 to 100%	0 to 100%	Similar. Expansion of range due to new sensor supporting increased data monitoring.

The acceptance criteria here are implicitly met by demonstrating that the EasyCare Tx 2 has similar intended use and technological characteristics to the predicate device, and that any differences do not raise new questions of safety or effectiveness. The "reported device performance" are the parameter ranges and functional capabilities described for EasyCare Tx 2.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "Non-clinical verification and validation testing completed for EasyCare Tx 2 demonstrated that the device met all intended performance requirements. Testing included: Software verification and validation."

It also mentions: "The verification testing performed with EasyCare Tx 2 was software verification and validation against the non-functional requirements and end-to-end functional testing."

This indicates that the "test set" consisted of various software testing scenarios (unit, integration, system, performance, usability tests) to verify functionality and non-functional requirements. However, no specific sample size (e.g., number of data points, cases, or patients) for a test set is provided, nor is the data provenance (country of origin, retrospective/prospective) for any specific clinical data mentioned. The testing described is primarily software-centric, not based on a dataset of patient outcomes.

3. 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 information is not provided. The testing described is software verification and validation, which typically involves engineering and quality assurance professionals, not clinical experts establishing ground truth in the context of medical image analysis or similar diagnostic tasks.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided. Given the nature of the software verification and validation, adjudication methods typical for clinical or image-based studies are not relevant here.

5. 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 MRMC comparative effectiveness study was done. This device is a software application for clinicians to monitor and adjust therapy device settings, not a diagnostic AI intended to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a human-in-the-loop software. Its purpose is to allow clinicians to monitor and adjust therapy settings. The "performance" is the software correctly displaying data and applying setting changes, not standalone diagnostic accuracy. The testing performed was "software verification and validation against the non-functional requirements and end-to-end functional testing," indicating validation of its functional integrity, not standalone diagnostic capability.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the software verification and validation, the "ground truth" would be the defined software requirements and expected behavior based on engineering specifications and design documents. For example, if a setting is changed from X to Y, the ground truth is that the software should correctly register and apply that change to the therapy device and display it accurately. It's not a clinical ground truth like pathology or outcome data.

8. The sample size for the training set

This information is not applicable/not provided. The EasyCare Tx 2 is described as therapy titration software, not an AI/ML model that would require a "training set" in the context of learning from data to make predictions or classifications. The software's functionality is based on programming and engineering, not machine learning.

9. How the ground truth for the training set was established

This information is not applicable/not provided as there is no mention of a machine learning training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

September 27, 2024

ResMed Corp Prerana Gurubasavaraj Senior Regulatory Affairs Specialist 9001 Spectrum Center Blvd San Diego, California 92123

Re: K241939

Trade/Device Name: EasyCare Tx 2 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: July 1, 2024 Received: July 2, 2024

Dear Prerana Gurubasavaraj:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Rachana Visaria -S

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241939

Device Name EasyCare Tx 2

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary 1

[As required by 21 CFR 807.921(c)]

Date of Submission:	July 1, 2024
Company Name/Owner:	ResMed Corp9001 Spectrum Center BoulevardSan Diego, CA 92123, US
Official Contact:	Prerana GurubasavarajSenior Regulatory Affairs SpecialistResMed Corp9001 Spectrum Center BoulevardSan Diego, CA 92123, USprerana.gurubasavaraj@resmed.com
Device Trade Name:	EasyCare Tx 2
Device Common Name:	Therapy titration software
Classification andClassification Name:	IINoncontinuous Ventilator (IPPB)
Product Code:	BZD

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Image /page/5/Picture/0 description: The image shows the ResMed logo. The logo features a curved line made of dots that transition in color from blue to red. Below the line of dots, the text "ResMed" is written in a bold, sans-serif font.

Legally Marketed PredicateDevice:	EasyCare Tx System (K113780)
Device Description:	EasyCare Tx 2 is a personal computer application designed to allowclinicians to monitor real-time data from the ResMed compatibletherapy device and adjust the therapy device settings from thecontrol room of the sleep lab.
Indication For Use:	The EasyCare Tx 2 software is intended to be used with ResMedcompatible therapy devices in a clinical environment. EasyCare Tx 2provides therapy device setting changes and displays real-time dataand treatment settings from compatible ResMed therapy deviceswhen used together with the TxLink 2 module.
Intended Use Comparison	EasyCare Tx	EasyCare Tx 2
	(K113780)
	EasyCare Tx is intended to be	The EasyCare Tx 2 software is
	used with ResMed compatibletherapy devices via the Tx Link.	intended to be used withResMed compatible therapy
	EasyCare Tx provides real-time	devices in a clinical
	data and treatment settingsdisplay, and can also provide	environment. EasyCare Tx 2provides therapy device settingchanges and displays real-timedata and treatment settings

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therapy device setting changesremotely.EasyCare Tx is intended to beused in a clinical environment.	from compatible ResMedtherapy devices when usedtogether with the TxLink 2module.
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TechnologicalCharacteristics Comparison	EasyCare Tx(K113780)	EasyCare Tx 2	Discussion
PrescriptionUse	Yes	Yes	Same
IntendedEnvironment ofUse	Hospital orSleep Lab	Hospital orSleep Lab	Same
Display Type	PC	PC	Same
HardwareRequirements(User PC)	Standard PCplatform withmicroprocessorand ancillarycontrollers	Standard PCplatform withmicroprocessorand ancillarycontrollers	Same
OperatingSystem (UserPC)	MicrosoftWindows	MicrosoftWindows	Same
Accessories	CD fordownloadingto PCTx Link	CD fordownloadingto PCTx Link 2	Same
CompatibleTherapyDevices	BZDMNSMNT	BZD	SameEasyCare Tx 2does notsupportproductcodes MNSand MNT
Therapy Device Adjustments (Settings)
Adjust DeviceTherapy Mode	Yes	Yes	Same
Adjust DeviceTherapySettings	Yes	Yes	Same
AvailableTherapy Modes	CPAP	CPAP	Same
	AutoSet	AutoSet	The PAC and¡VAPS modesare no longerused andsupported asthey are fordevices under
	AutoSet forHer	AutoSet forHer
	S	S
	ST	ST
	TVAuto	TVAuto	the MNS andMNT productcodes, and
	ASV	ASV	not in scopefor EasyCareTx 2 with BZDdevices.
	ASVAuto	ASVAuto
	PAC¡VAPS	PAC
HumidifierControl	Humidifieron/off	Humidifieron/off, levelcontrol, auto	Similar
			Auto mode inthe attachedResMedtherapydeviceoptimizes thehumidifiertemperatureto ensurerainout doesnot occur asambienttemperaturevaries duringthe night.EasyCare Tx 2controls thehumidifiersettings onthe ResMedcompatibletherapydevice.
Tubing Control	TubeTemperatureon/off, auto	TubeTemperatureon/off, auto	SameResMedtherapydeviceoptimizes thetubetemperatureto ensurerainout doesnot occur asambient
			temperature varies during the night.
Ramp	0 to 45 min	5 to 45 min,off, auto	SimilarRamp is inthe attachedResMedtherapydevice. Inauto mode,the rampstops as soonas sleep isdetected toensure thepatientobtains thebest therapyoutcome.Off mode wasadded forusabilitypurposesinstead oframping to 0in thepredicate.
Output Parameters1
Pressure	-3 to 35 cmH2O	0 to 30 cm H2O	SimilarTherapyrange has notchanged.
			-3cm H₂O waspreviouslyused to coveran extremelyniche case,whichpresentedlittle clinicalbenefit inAirSense 10and wassubsequentlyremoved inAirSense 11.The reductionin pressure isbased on thefact that thatEasyCare Tx 2only supportsOSA deviceswhich requirea lowertherapypressure.

Flow	-120 to 120L/min	-240 to 240L/min	SimilarRisksassociated
			with theincrease inflow as anoutputparameterare ultimatelyconsidered bythe parenttherapydevice.EasyCare Tx 2uses a largerdata modelwith scalablearchitectureto achievethe greaterrange.
Leak	-30 to 120L/min	0 to 2 L/s	SimilarLeakparametersare sent fromthe attachedResMedtherapydevice in L/s.EasyCare Tx 2allows theoption totogglebetween L/sand L/min.
RespiratoryRate	6 to 35 BPM	0 to 90 BPM	Similar
			The subjectdevice'shigher rangesupportspediatricpatients usingthe AirSense11.
Tidal Volume	0.01 to 3 L	0 to 4 L	Similar
TargetVentilation	0 to 30 L/min	0 to 30 L/min	Same
MinuteVentilation	0 to 30 L/min	0 to 30 L/min	Same
Ti (InspirationTime)	0 to 9 seconds	0.3 to 4seconds	Similar
Pulse Rate	18 to 300 BPM	0 to 300 BPM	Similar
	SpO₂	40 to 100%	0 to 100%	Similar
				Expansion of range on pulse rate and SpO₂ – the new sensor that is utilised for EasyCare Tx 2 now supports an increased range of data monitoring.
¹Easycare Tx 2 does not contain any PAP device information and receives data packets from AirSense 11 flow generators that contain the range for each parameter.
Submission Reason:	New Device
Non-clinical testing:	Non-clinical verification and validation testing completed for EasyCare Tx 2 demonstrated that the device met all intended performance requirements. Testing included:
	Software verification and validation
	The following FDA guidance were conformed to:
	Content of Premarket Submissions for Device Software Functions: June 2023
	Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: September 2023

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Image /page/9/Picture/0 description: The image contains the text "EasyCare Tx 2". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "EasyCare" on the first line and "Tx 2" on the second line.

Image /page/9/Picture/3 description: The image shows the logo for ResMed. The logo consists of the company name "ResMed" in a bold, sans-serif font, positioned below a curved line of colored dots. The dots transition in color from blue on the left to red on the right, creating a gradient effect.

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Clinical Testing	The verification testing performed with EasyCare Tx 2 was softwareverification and validation against the non-functional requirementsand end-to-end functional testing. The predicate testing conductedwith EasyCare Tx 2 to the predicate EasyCare Tx System device(K113780) demonstrate substantial equivalence to the technologyandoperating principle of the devices.Clinical tests were not required to demonstrate the safety andeffectiveness of EasyCare Tx 2.
Substantial Equivalence	The subject device has similar features and interfaces as the devicecleared in K113780. The main differences between ResMed'sEasyCare Tx System and the EasyCare Tx 2 include:
	1. Compatible therapy devices are not hardcoded into theEasyCare Tx 2 software, and EasyCare Tx 2 can receive datapackets from the compatible flow generators (e.g., AirSense11, K203126).2. EasyCare Tx 2 contains all the same therapy settings andoutput parameters as the predicate, but has updated featuresfor auto modes, up-to-date therapy settings, and extendedranges.3. The EasyCare Tx 2 is only for use with compatible ResMeddevices, including the updated TxLink™ 2. EasyCare Tx 2 is notreverse compatible with EasyCare Tx or TxLink™.4. The EasyCare Tx 2 introduces secure communicationinitialization via CSR, implements code-signing for the installer,and enhances the certificate generation and use process.
	The subject device has the same intended use and similartechnological characteristics as the predicate device (K113780).EasyCare Tx 2 has undergone performance testing to ensure thedevice is as safe and effective as the predicate, and it can beconcluded that the subject device does not raise new issues of safetyor effectiveness compared to the predicate device. The similarindications for use, technological characteristics, and performancecharacteristics for the proposed EasyCare Tx 2 are assessed to besubstantially equivalent to the predicate device.

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Substantial Equivalence Conclusion:

The EasyCare Tx 2 is substantially equivalent to the predicate EasyCare Tx System (K113780):

It has similar intended use
. It has similar technological characteristics
. It has similar operating principles
The differences do not raise any new questions of safety . or effectiveness
. It is at least as safe and as effective as the predicate device

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).