Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a software application for monitoring and adjusting therapy device settings, with no mention of AI, ML, or related concepts.

Therapeutic

No
The device, "EasyCare Tx 2 software," is a personal computer application that allows clinicians to monitor real-time data and adjust settings of compatible ResMed therapy devices. It does not directly provide therapy; rather, it is a tool for managing therapy devices.

Diagnostic

No

This device is described as software that allows clinicians to monitor real-time data and adjust settings of therapy devices. It does not provide a diagnosis, but rather facilitates the management of existing therapy. The "Indications for Use" mention "therapy device setting changes" and displaying "real-time data and treatment settings," which are functions related to therapy management, not diagnosis. The performance studies also do not mention any diagnostic metrics.

SaMD (Software as a Medical Device)

Yes

The device is described as a "personal computer application" and the performance studies focus solely on "Software verification and validation," indicating it is a software-only medical device that interacts with hardware (therapy devices and the TxLink 2 module) but is not itself a hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to be used with therapy devices to change settings and display real-time data. This is related to managing a patient's therapy, not performing diagnostic tests on biological samples.
Device Description: The description focuses on monitoring and adjusting therapy device settings in a clinical environment.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The EasyCare 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.

Product codes (comma separated list FDA assigned to the subject device)

BZD

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

clinicians, clinical environment, control room of the sleep lab, Hospital or Sleep Lab

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
Clinical tests were not required to demonstrate the safety and effectiveness of EasyCare Tx 2.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

EasyCare Tx System (K113780)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

AirSense 11, K203126

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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)

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.

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 Corp
9001 Spectrum Center Boulevard
San Diego, CA 92123, US
Official Contact:	Prerana Gurubasavaraj
Senior Regulatory Affairs Specialist
ResMed Corp
9001 Spectrum Center Boulevard
San Diego, CA 92123, US
prerana.gurubasavaraj@resmed.com
Device Trade Name:	EasyCare Tx 2
Device Common Name:	Therapy titration software
Classification and
Classification Name:	II
Noncontinuous 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 Predicate

Device:	EasyCare Tx System (K113780)
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.
Indication For Use:	The EasyCare 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.
Intended Use Comparison	EasyCare Tx	EasyCare Tx 2
	(K113780)
	EasyCare Tx is intended to be	The EasyCare Tx 2 software is
	used with ResMed compatible
therapy devices via the Tx Link.	intended to be used with
ResMed compatible therapy
	EasyCare Tx provides real-time	devices in a clinical
	data and treatment settings
display, and can also provide	environment. EasyCare Tx 2
provides therapy device setting
changes and displays real-time
data and treatment settings

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| therapy device setting changes
remotely.

EasyCare Tx is intended to be
used in a clinical environment. | from compatible ResMed
therapy devices when used
together with the TxLink 2
module. |

---------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------

| Technological
Characteristics Comparison | EasyCare Tx
(K113780) | EasyCare Tx 2 | Discussion | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
(User PC) | Standard PC
platform with
microprocessor
and ancillary
controllers | Standard PC
platform with
microprocessor
and ancillary
controllers | Same | |
| Operating
System (User
PC) | Microsoft
Windows | Microsoft
Windows | Same | |
| Accessories | CD for
downloading
to PC
Tx Link | CD for
downloading
to PC
Tx Link 2 | Same | |
| Compatible
Therapy
Devices | BZD
MNS
MNT | BZD | Same
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 | CPAP | Same | |
| | AutoSet | AutoSet | The PAC and
¡VAPS modes
are no longer
used and
supported as
they are for
devices under | |
| | AutoSet for
Her | AutoSet for
Her | | |
| | S | S | | |
| | ST | ST | | |
| | TVAuto | TVAuto | the MNS and
MNT product
codes, and | |
| | ASV | ASV | not in scope
for EasyCare
Tx 2 with BZD
devices. | |
| | ASVAuto | ASVAuto | | |
| | PAC
¡VAPS | PAC | | |
| Humidifier
Control | Humidifier
on/off | Humidifier
on/off, level
control, auto | Similar | |
| | | | Auto mode in
the attached
ResMed
therapy
device
optimizes the
humidifier
temperature
to ensure
rainout does
not occur as
ambient
temperature
varies during
the night.
EasyCare Tx 2
controls the
humidifier
settings on
the ResMed
compatible
therapy
device. | |
| Tubing Control | Tube
Temperature
on/off, auto | Tube
Temperature
on/off, auto | Same
ResMed
therapy
device
optimizes the
tube
temperature
to ensure
rainout does
not occur as
ambient | |
| | | | temperature varies during the night. | |
| Ramp | 0 to 45 min | 5 to 45 min,
off, auto | Similar

Ramp is in
the attached
ResMed
therapy
device. In
auto mode,
the ramp
stops as soon
as sleep is
detected to
ensure the
patient
obtains the
best therapy
outcome.

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Image /page/7/Picture/0 description: The image shows the ResMed logo. The logo consists of a series of blue to red dots arranged in a curved line above the word "ResMed" in a bold, sans-serif font. The dots transition in color from blue on the left to red on the right, creating a visual gradient.

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Image /page/8/Picture/0 description: The image shows the ResMed logo. The logo features a curved line made of connected circles that transition in color from blue to red. Below the line is the word "ResMed" in a bold, sans-serif font.

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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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Image /page/10/Picture/2 description: The image shows the ResMed logo. The logo consists of a curved line of dots that transition in color from blue to red. Below the dots is the company name, "ResMed", in a bold, sans-serif font.

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Image /page/11/Picture/2 description: The image shows the logo for ResMed. The logo consists of a curved line of dots that transition in color from blue to red. Below the dots is the word "ResMed" in a bold, sans-serif font.

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Image /page/12/Picture/0 description: The image shows the logo for ResMed. The logo consists of a curved line of dots that transition in color from blue to red. Below the dots is the word "ResMed" in a bold, sans-serif font.

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Image /page/13/Picture/2 description: The image contains the ResMed logo. The logo features a curved line made up of a series of dots that transition in color from blue to purple to red. Below the line of dots is the word "ResMed" in a bold, sans-serif font.

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| Clinical Testing | The verification testing performed with EasyCare Tx 2 was software
verification and validation against the non-functional requirements
and end-to-end functional testing. The predicate testing conducted
with EasyCare Tx 2 to the predicate EasyCare Tx System device
(K113780) demonstrate substantial equivalence to the technology
andoperating principle of the devices.
Clinical tests were not required to demonstrate the safety and
effectiveness of EasyCare Tx 2. |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence | The subject device has similar features and interfaces as the device
cleared in K113780. The main differences between ResMed's
EasyCare Tx System and the EasyCare Tx 2 include: |
| | 1. Compatible therapy devices are not hardcoded into the
EasyCare Tx 2 software, and EasyCare Tx 2 can receive data
packets from the compatible flow generators (e.g., AirSense
11, K203126).

EasyCare Tx 2 contains all the same therapy settings and
output parameters as the predicate, but has updated features
for auto modes, up-to-date therapy settings, and extended
ranges.
The EasyCare Tx 2 is only for use with compatible ResMed
devices, including the updated TxLink™ 2. EasyCare Tx 2 is not
reverse compatible with EasyCare Tx or TxLink™.
The EasyCare Tx 2 introduces secure communication
initialization 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 similar
technological characteristics as the predicate device (K113780).
EasyCare Tx 2 has undergone performance testing to ensure the
device is as safe and effective as the predicate, and it can be
concluded that the subject device does not raise new issues of safety
or effectiveness compared to the predicate device. The similar
indications for use, technological characteristics, and performance
characteristics for the proposed EasyCare Tx 2 are assessed to be
substantially 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