The Galapagos app is intended for patients who are prescribed a compatible ResMed S10 platform device to simulate therapy prior to using their device with their prescribed settings. It is an optional software accessory to allow patients to acclimate to their therapy device.

Device Description

Galapagos is a mobile interface where the patient can control the device through pre-determined, scaled inspiratory pressures to help them adjust to pressure and mask fit prior to starting their prescribed therapy. In addition, Galapagos may also be used as a communication pathway using the mobile Bluetooth connection to the compatible flow generator in order to send and receive data.

AI/ML Overview

The provided text is a 510(k) summary for the device "Galapagos," a mobile application. It details the device's indications for use, its comparison to a predicate device (Monte Carlo), and the testing performed to demonstrate substantial equivalence.

However, the document states: "Clinical tests were not required to demonstrate the safety and effectiveness of Galapagos."

This crucial statement means that the acceptance criteria and study proving the device meets those criteria were not based on clinical performance studies like those typically conducted for AI/ML medical devices (e.g., MRMC studies, standalone performance with reader ground truth). Instead, the assessment for this device relied on non-clinical verification and validation testing to demonstrate that it met its intended performance requirements and was substantially equivalent to a previously cleared predicate device.

Therefore, I cannot provide the information requested in points 1-9 as they pertain to clinical performance studies and AI/ML model validation, which were explicitly not conducted for Galapagos. The acceptance criteria and "proof" of meeting them for Galapagos are primarily based on software verification and validation, and bench testing, rather than human-in-the-loop or standalone AI performance.

The document highlights the following non-clinical testing for Galapagos:

Software verification and validation
Predicate testing (which involved bench tests against nonfunctional requirements and end-to-end functional testing, comparing Galapagos to the Monte Carlo device).

The "acceptance criteria" here is therefore the successful completion of these non-clinical tests and the demonstration of substantial equivalence based on differences not impacting safety or efficacy.

To directly address your request based on the provided text, but acknowledging the limitations:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied from the document): The device must successfully pass software verification and validation, and non-clinical performance bench tests including end-to-end functional testing and predicate testing (demonstrating substantial equivalence to Monte Carlo without raising new questions of safety or efficacy).
- Reported Device Performance: "Non-clinical verification and validation testing completed for Galapagos demonstrated that the device met all intended performance requirements." And "The predicate testing conducted with Galapagos to the predicate Monte Carlo device (K160836) demonstrate substantial equivalence to the technology and operating principle of the devices."
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as clinical data was not used for performance evaluation. The "test set" would refer to the scenarios and inputs used during software/bench testing, the details of which are not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance was not established due to the absence of clinical testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 study was done, as clinical tests were not required. The device is a "mobile interface where the patient can control the device" and an "optional software accessory to allow patients to acclimate to their therapy device," not an AI/ML diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of typical AI/ML standalone performance studies. Bench and software tests were done, but these are not the same as standalone diagnostic performance of an AI algorithm on patient data.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for clinical ground truth. The "ground truth" for the non-clinical testing would be the expected functional behavior and performance characteristics derived from design specifications and predicate device equivalence.
The sample size for the training set: Not applicable, as this device does not appear to be an AI/ML model that learns from a training set of data. It's a software application controlling a medical device.
How the ground truth for the training set was established: Not applicable.

Summary

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January 17, 2021

ResMed Corp Rose Malonzo Regulatory Affairs Specialist 9001 Spectrum Center Blyd San Diego, California 92123

Re: K200565

Trade/Device Name: Galapogos Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 18, 2020 Received: December 18, 2020

Dear Rose Malonzo:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).

Sincerely,

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

Enclosure

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Indications for Use

510(k) Number (if known) K200565

Device Name Galapagos

Indications for Use (Describe)

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)

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Galapagos
Traditional 510(k)
Traditional 510(k)
K200565

510(k) SUMMARY
[As required by 21 CFR 807.92(c)]

Date of Submission:	13 January 2021
Company Name/Owner:	ResMed Corp9001 Spectrum Center BlvdSan Diego, CA 92123USA
Official Contact:	Rose MalonzoSpecialist, Regulatory AffairsTel: 858-285-5670rose.malonzo@resmed.com
Device Trade Name:	Galapagos
Device Common Name:	Ventilator, Non-Continuous (Respirator)
Classification andClassification Name:	IINoncontinuous ventilator (IPPB) (21 CFR 868.5905)
Product Code:	73 BZD
Predicate Device:	Monte Carlo (mobile application in the Menai System)K160836
Device Description:	Galapagos is a mobile interface where the patient can control thedevice through pre-determined, scaled inspiratory pressures to helpthem adjust to pressure and mask fit prior to starting theirprescribed therapy.
	In addition, Galapagos may also be used as a communicationpathway using the mobile Bluetooth connection to the compatibleflow generator in order to send and receive data.
Indications For Use:	The Galapagos app is intended for patients who are prescribed acompatible ResMed S10 platform device to simulate therapy prior tousing their device with their prescribed settings. It is an optionalsoftware accessory to allow patients to acclimate to their therapydevice.

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Image /page/4/Picture/0 description: The image shows the logo for ResMed. The logo consists of a series of colored dots arranged in a curved line, transitioning from blue to red. Below the dots is the word "ResMed" in a bold, sans-serif font. The dots are arranged in a wave-like pattern, with the blue dots on the left and the red dots on the right.

Non-clinical testing

Non-clinical verification and validation testing completed for Galapagos demonstrated that the device met all intended performance requirements. Testing included:

Software verification and validation
Predicate testing .

The non-clinical performance bench tests performed with Galapagos include testing against the nonfunctional requirements and end-to-end functional testing. The predicate testing conducted with Galapagos to the predicate Monte Carlo device (K160836) demonstrate substantial equivalence to the technology and operating principle of the devices.

Clinical testing

Clinical tests were not required to demonstrate the safety and effectiveness of Galapagos.

Substantial Equivalence

The subject and predicate device have similar intended use, technology, and operating principle.

The differences between the subject Galapagos device and the previously cleared predicate Monte Carlo app (K160836) are:

Galapagos can deliver temporary pre-determined therapy settings, whereas Monte Carlo ● delivers the patient's prescribed therapy settings.
. Galapagos is an optional accessory intended for use by patients to control the compatible flow generator (pre-determined therapy settings), whereas Monte Carlo is a required component of the flow generator device intended as the patient's user interface to control the device, as well as for clinicians to remotely configure the device (i.e., change prescribed therapy settings).
Via the mobile bluetooth connection and HTTP proxy function, Galapagos is an additional . communication pathway to Machine Cloud Service (MCS) of AirView (K151901) to the compatible flow generator in order to send and receive data, similarly to the CAM (cellular) module within the compatible ResMed S10 device. This is considered a non-medical device MDDS function.

Characteristic	Predicate device:Monte Carlo	Subject Device:Galapagos	Substantial Equivalence
	Manufacturer:ResMed Ltd	Manufacturer:ResMed Corp
	510(k) Number:K160836	510(k) Number:K200565
Indications forUse	Monte Carlo is a mobileapplication for patients toremotely operate a prescribedcompatible ResMed machineand transfer, analyze anddisplay usage and therapeuticinformation. Monte Carlo alsoallows healthcareprofessionals to remotelyconfigure compatible OSAtherapy devices.	The Galapagos app isintended for patientswho are prescribed acompatible ResMedS10 platform device tosimulate therapy prior tousing their device withtheir prescribedsettings. It is an optionalsoftware accessory toallow patients toacclimate to theirtherapy device.	Difference in the indications foruse does not impact the safety orefficacy of the subject devicesince the subject devicefunctionality is a limited subset ofthe predicate.
Characteristic	Predicate device:Monte Carlo	Subject Device:Galapagos	Substantial Equivalence
	Manufacturer:ResMed Ltd	Manufacturer:ResMed Corp
	510(k) Number:K160836	510(k) Number:K200565
RegulationNumber	21 CFR §868.5905	21 CFR §868.5905	Yes. Identical.
ClassificationName	Noncontinuous ventilator (IPPB)	Noncontinuousventilator (IPPB)	Yes. Identical.
FDA ProductCode	73 BZD	73 BZD	Yes. Identical.
Prescription Use	Yes	Yes	Yes. Identical.
IntendedEnvironment ofUse	Hospital/home	Hospital/Home	Yes. Identical.
PatientContacting	No, Monte Carlo is software.	No, Galapagos issoftware.	Yes. Identical.
Display Type	Smartphone display	Smartphone display	Yes. Identical.
Therapy DeviceConnectionRequirement	Yes. Monte Carlo app must beconnected to a compatibletherapy device for usage.	Yes. Galapagos appmust be connected to acompatible therapydevice for usage.	Yes. Identical.
Mask InformationRequirement	Yes. Monte Carlo app requirespatient to provide mask typefor usage.	Yes. Galapagos apprequires patient toprovide mask type forusage.	Yes. Identical.
Performance Testing - Patient Use
DisplaysUsage andTherapeuticValues	Yes.	No.	Difference in limited functionalityof the subject device does notimpact the safety or efficacy of theGalapagos app.The Galapagos app is notintended to alter treatmentsettings.
TreatmentSettings	Ramp time, EPR On/Off	Not available
PerformanceTesting - ClinicalUse	Same as Patient Use features.	Clinician access notavailable for Galapagos.	Difference in limited functionalityof the subject device does notimpact the safety or efficacy of theGalapagos app.
Device Control	Yes. Monte Carlo can controlthe connected therapy device.	Yes. Galapagos cancontrol the connectedtherapy device.	Yes. Galapagos has limiteddevice control capabilities as itdelivers temporary pre-determinedtherapy settings, whereas MonteCarlo delivers the patient'sprescribed therapy settings.
CommunicationPathways	Bluetooth and HTTPS(cellular or wireless internetconnection)	Bluetooth and HTTPS(cellular or wirelessconnection)	Yes. Identical.
Characteristic	Predicate device:Monte CarloManufacturer:ResMed Ltd510(k) Number:K160836	Subject Device:GalapagosManufacturer:ResMed Corp510(k) Number:K200565	Substantial Equivalence
Device data toappcommunicationpathway	Device data transfers directlyto Monte Carlo app.	Device data transfers toMachine Cloud Service(MCS) via Galapagos.	Inclusion of MCS in the datapathway does not impact thesafety or efficacy of the subjectdevice.
App DownloadAvailability	Apple App Store	Google Play Store	Difference in mobile app storeavailability does not impact thesafety or efficacy of Galapagos.
Therapy SettingsChanges	Yes	No	Difference in limited functionalityof the subject device does notimpact the safety or efficacy of theGalapagos app.The Galapagos app is notintended to alter treatmentsettings.
Adjust ComfortSettings	Yes	No	Difference in limited functionalityof the subject device does notimpact the safety or efficacy of theGalapagos app.The Galapagos app is notintended to alter treatmentsettings.
Level of Concern	Moderate	Moderate	Yes. Identical.

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Galapagos Traditional 510(k) K200565

Substantial Equivalence Conclusion

Galapagos has a similar intended use, technology, and operating principle as the predicate device. The differences in the intended use and technology between the subject and predicate devices do not impact or raise new questions of safety or efficacy. The non-clinical performance data provided in this submission supports the determination that Galapagos is substantially equivalent to the predicate Monte Carlo device (K160836).

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).