The S10 Kirra is indicated to provide CPAP and Bi-level therapy for the treatment of obstructive sleep apnea (OSA) in patients (female patients with mild to moderate OSA when using AfH treatment mode) weighing more than 66 lb (30 kg). ASV and ASVAuto modes are also indicated for the treatment of central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use.

Device Description

The S10 Kirra is a prescription only Positive Airway Pressure (PAP) ventilator device intended to treat individuals that are diagnosed with sleep apnea conditions. The S10 Kirra uses a micro-processor controlled blower, along with pressure and flow sensors, to achieve pressure, flow and time regulation of air delivery. It includes optional humidification, with air delivery to the patient via heated or non-heated breathing circuits. The device provides both therapeutic (e.g. tidal volume) and technical data (e.g. system fault), and a user interface allowing adjustment of device parameters. The device uses an external AC power supply, and allows the addition of low flow supplemental oxygen.

AI/ML Overview

The provided text describes the S10 Kirra, a non-continuous ventilator, and its substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer all parts of your request about acceptance criteria and a specific study proving the device meets them.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices (S9 Greenhills, S9 Wanda, S9 Elouera), rather than detailing a new study with acceptance criteria for a novel device.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document states:
"Verification confirmed the S10 Kirra met the predetermined acceptance criteria as defined in the relevant compliance standards and as defined in the system verification protocols."

However, it does not provide a table listing specific acceptance criteria values and the reported performance for each criterion. It broadly mentions areas of testing:

Pressure performance
Breath events (flow limitations, snore, apneas)
Response to periodic breathing
Humidification

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

This information is not available in the provided text. The document refers to "verification bench testing" and "comparative predicate testing" but does not specify sample sizes for test sets or data provenance (country of origin, retrospective/prospective).

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 available. The document focuses on bench testing and comparison to predicate devices, not human expert evaluations for ground truth.

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

This information is not available. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed 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

The document explicitly states:
"Clinical performance data is not required as the subject device uses established therapeutic technology and bench testing is sufficient to demonstrate substantial equivalence."

Therefore, no MRMC comparative effectiveness study was done as the device relies on established technology, and its performance was evaluated through non-clinical bench testing.

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

The entire non-clinical data section describes performance of the device itself (hardware and software), which can be considered a standalone performance assessment in a bench testing environment. The listed performance areas (pressure, breath events, humidification) are intrinsic to the device's function.

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

For the non-clinical bench testing, the "ground truth" would be established by engineering specifications, compliance standards, and the performance characteristics of the predicate devices. The tests evaluate if the S10 Kirra performs according to these pre-defined, measurable engineering and physiological parameters. It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for clinical evaluations.

8. The sample size for the training set

This information is not applicable/available. The S10 Kirra is a medical device (ventilator) with microprocessor control, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's "training" involves design, engineering, and calibration to meet its specifications, rather than data-driven model training.

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

This information is not applicable/available for the same reason as point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

December 18, 2020

ResMed Pty Ltd % Sheila Bruschi Director, Regulatory Affairs ResMed Corp 9001 Spectrum Center Boulevard San Diego, California 92123

Re: K203126

Trade/Device Name: S10 Kirra Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: October 16, 2020 Received: October 19, 2020

Dear Sheila Bruschi:

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

{1}------------------------------------------------

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,

for Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K203126

Device Name S10 Kirra

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the ResMed logo. The logo features a curved line made up of a series of colored dots, transitioning from blue to red. Below the line is the word "ResMed" in a bold, sans-serif font.

510(k) Summary

	[As required by 21 CFR 807.92(c)]
Date Prepared:	16 December 2020
Company Name/Owner:	ResMed Pty Ltd1 Elizabeth Macarthur DriveBella Vista, NSW, 2153 Australia
Prepared and Submitted by:	Mr Peter JenningsSenior Regulatory Affairs ManagerTel: +612 8884 1000Fax: +612 8884 2004peter.jennings@resmed.com.au
Official Contact:	Ms Sheila BruschiDirector, Regulatory AffairsResMed Corp.9001 Spectrum Center BlvdSan Diego CA 92123 USATel: +1 858 836 5934Fax: +1 858 836 5519sheila.bruschi@resmed.com
Device Trade Name:	S10 Kirra
Device Common Name:	Non continuous ventilator (IPPB)
Classification:	21 CFR 868.5905, BZD (Class II)
Product Code:	BZD
Predicate Device(s):	S9 Greenhills (K140279)S9 Wanda (K140159)S9 Elouera (K140124)
Reference Device(s):	VPAP Adapt (K133801)
Reason for Submission:	New Device

Device Description:

{4}------------------------------------------------

S10 Kirra Traditional 510(k)

Image /page/4/Picture/1 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 line of dots is the word "ResMed" in a bold, sans-serif font.

heated or non-heated breathing circuits. The device provides both therapeutic (e.g. tidal volume) and technical data (e.g. system fault), and a user interface allowing adjustment of device parameters. The device uses an external AC power supply, and allows the addition of low flow supplemental oxygen.

Indications for Use:

It is intended for home and hospital use.

Substantial Equivalence:

The subject and predicate devices have the same intended use and the following similarities:

. Similar Indications for Use
. Same operating principle
. Similar technological characteristics

The S10 Kirra combines the PAP therapy modes of the predicate devices S9 Greenhills (K140279), S9 Elouera (K140124) and S9 Wanda (K140159) in a new flow generator system. There are only minor differences between the S10 Kirra and the predicate devices including new materials and the addition of Bluetooth technology.

Characteristic	Predicate device:S9 GreenhillsK140279	Predicate device:S9 WandaK140159	Predicate device:S9 EloueraK140124	Subject device:S10 Kirra	SubstantiallyEquivalent?
Intended Use	Positive airwaypressure supportfor sleep apneaPatients >66 lb(>30kg)Home and Hospital	Positive airwaypressure supportfor sleep apneaPatients >66 lb(>30kg)Home and Hospital	Positive airwaypressure supportfor sleep apneaPatients >66 lb(>30kg)Home and Hospital	Positive airwaypressure supportfor sleep apneaPatients >66 lb(>30kg)Home and Hospital	YES
Indications forUseStatement	The S9 Greenhills isindicated for thetreatment ofpatients weighingmore than 66 lb (30kg) with obstructivesleep apnea (OSA),central and/ormixed apneas, orperiodic breathing.It is intended forhome and hospitaluse	The S9 WANDAVPAP ST is indicatedfor the treatment ofObstructive SleepApnea (OSA) inpatients weighingmore than 66 lb (30kg).It is intended foruse in the hospitaland home	The S9 Elouera self-adjusting device isindicated for thetreatment ofObstructive SleepApnea (OSA) inpatients (femalepatients with mildto moderate OSAwhen using AfHtreatment mode)weighing more than66 lb (30 kg).	The S10 Kirra isindicated to provideCPAP and Bi-leveltherapy for thetreatment ofobstructive sleepapnea (OSA) inpatients (femalepatients with mildto moderate OSAwhen using AfHtreatment mode)weighing more than	YESS10 Kirraincludes acombined IFUstatementwithin theIntended Use ofthe predicatedevices.Disease statestreated by eachtherapy modeare unchanged

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for ResMed. The logo consists of the word "ResMed" in a bold, sans-serif font. Above the word, there is a curved line made up of a series of dots that transition in color from blue to red. The dots are arranged in a wave-like pattern.

Characteristic	Predicate device:S9 GreenhillsK140279	Predicate device:S9 WandaK140159	Predicate device:S9 EloueraK140124	Subject device:S10 Kirra	SubstantiallyEquivalent?
	The humidifier isintended for singlepatient use in thehome environmentand re-use in ahospital /institutionalenvironment.		It is intended forhome and hospitaluse	66 lb (30 kg). ASVand ASVAutomodes are alsoindicated for thetreatment ofcentral and/ormixed apneas, orperiodic breathing.It is intended forhome and hospitaluse.	from thepredicates.
Environmentof Use	Home HealthcareEnvironment,ProfessionalHealthcare Facilities	Home HealthcareEnvironment,ProfessionalHealthcare Facilities	Home HealthcareEnvironment,ProfessionalHealthcare Facilities	Home HealthcareEnvironment(including aircraft),ProfessionalHealthcare Facilities	YESS10 Kirra andpredicatedevices for usein sameenvironments.Specific use onaircraft basedon referencedevice K133801testingmethods.
Therapies
TherapyModes	CPAPASVASVAuto	CPAP---VAutoS, ST, T	CPAPAutoSetAutoSet for Her(AfH)	CPAPASVASVAutoAutoSetAutoSet for Her(AfH)VAutoS, ST, T	YESS10 Kirra hassame therapymodes aspredicates
PressureRange	4-20 cm H2O(CPAP)3-25 cm H2O (ASV,ASVAuto)	4-20 cm H2O(CPAP)4-25 cm H2O(VAuto)3-25 cm H2O (S, ST,T)	4-20 cm H2O (CPAP,AutoSet, AutoSetfor Her)	4-20 cm H2O (CPAP,AutoSet, AutoSetfor Her)4-25 cm H2O(VAuto)3-25 cm H2O (S, ST,T, ASV, ASVAuto)	YESS10 Kirra hasidenticalpressure rangeforcorrespondingmodes.
ComfortFeatures		Expiratory PressureRelief (EPR)Easybreathe	Expiratory PressureRelief (EPR)	Expiratory PressureRelief (EPR)Easybreathe	YES
Technology & DesignSystem
Components	Flow GeneratorIntegratedHumidifierAir TubingMask	Flow GeneratorIntegratedHumidifierAir TubingMask	Flow GeneratorIntegratedHumidifierAir TubingMask	Flow GeneratorIntegratedHumidifierAir TubingMask	YES

{6}------------------------------------------------

Image /page/6/Picture/1 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.

Characteristic	Predicate device:S9 GreenhillsK140279	Predicate device:S9 WandaK140159	Predicate device:S9 EloueraK140124	Subject device:S10 Kirra	SubstantiallyEquivalent?
OperatingPrinciple	Micro-processorcontrolled brush-less centrifugalblower as air sourceto provide splintingof patient airway	Micro-processorcontrolled brush-less centrifugalblower as air sourceto provide splintingof patient airway	Micro-processorcontrolled brush-less centrifugalblower as air sourceto provide splintingof patient airway	Micro-processorcontrolled brush-less centrifugalblower as air sourceto provide splintingof patient airway	YES
Materials	Various materials,including:PolymersPlasticsStainless steel	Various materials,including:PolymersPlasticsStainless steel	Various materials,including:PolymersPlasticsStainless steel	Various materials,including:PolymersPlasticsStainless steel	YESSubstantiallyequivalentmaterialsverified forreprocessingand BioC.Same basematerial.
DataConnectivity	SD card, CellularWireless	SD card, CellularWireless	SD card, CellularWireless	SD card, CellularWireless, BluetoothWireless	YESBluetooth is analternatewirelesstechnologyoption toprovide thesame datatransfercapabilities ascellular.
Humidification
Humidifier	Integratedthermostaticallycontrolled heatedhumidifier withdetachable waterchamber	Integratedthermostaticallycontrolled heatedhumidifier withdetachable waterchamber	Integratedthermostaticallycontrolled heatedhumidifier withdetachable waterchamber	Integratedthermostaticallycontrolled heatedhumidifier withdetachable waterchamber	YES
OperatingPrinciple	Water is heated bya heater plate tocreate warm andmoist air within thewater chamber.Airflow from thedevice is passedthrough the heatedwater chamber,which moistens andwarms the air.	Water is heated bya heater plate tocreate warm andmoist air within thewater chamber.Airflow from thedevice is passedthrough the heatedwater chamber,which moistens andwarms the air.	Water is heated bya heater plate tocreate warm andmoist air within thewater chamber.Airflow from thedevice is passedthrough the heatedwater chamber,which moistens andwarms the air.	Water is heated bya heater plate tocreate warm andmoist air within thewater chamber.Airflow from thedevice is passedthrough the heatedwater chamber,which moistens andwarms the air.	YES
Humidifieroutput	12.0mg/L @ 20cmH2O (50 L/min)	12.0mg/L @ 20cmH2O (50 L/min)	12.0mg/L @ 20cmH2O (50 L/min)	12.6mg/L @ 20cmH2O (50 L/min)	YES
Heated Tubetemperaturesettings	60-86 °F(16-30 °C)	60-86 °F(16-30 °C)	60-86 °F(16-30 °C)	60-86 °F(16-30 °C)	YES
Characteristic	Predicate device:S9 GreenhillsK140279	Predicate device:S9 WandaK140159	Predicate device:S9 EloueraK140124	Subject device:S10 Kirra	SubstantiallyEquivalent?
Heated Tubetemperaturecutout	106 °F (41 °C)	106 °F (41 °C)	106 °F (41 °C)	106 °F (41 °C)	YES

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for ResMed. The logo consists of a curved line of dots that transitions from blue to red. Below the line of dots is the word "ResMed" in a bold, sans-serif font.

Non-Clinical Data:

. Verification bench testing for S10 Kirra comprises system verification and comparative sideby-side predicate testing. Verification confirmed the S10 Kirra met the predetermined acceptance criteria as defined in the relevant compliance standards and as defined in the system verification protocols.
. Comparative predicate testing supports the determination that the S10 Kirra is substantially equivalent to the predicate devices (S9 Greenhills (K140279), S9 Wanda (K140159), S9 Elouera (K140124)). Verification bench testing included testing the performance of the therapy modes and therapy functions including:
- o Pressure performance
- Breath events including flow limitations, snore and apneas o
- Response to periodic breathing O
- Humidification O

The S10 Kirra was designed and tested in accordance with the applicable requirements in relevant FDA consensus standards including:

. IEC 60601-1:2005+AMD1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
. IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
. IEC 60601-1-11:2015, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
ISO 80601-2-70, Medical Electrical Equipment – Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
ISO 80601-2-74, Medical Electrical Equipment – Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
. ISO 10993-1:2018 – Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
. ISO 18562-1:2017 – Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for ResMed. The logo consists of a curved line of colored dots that transition from blue to red. Below the dots is the word "ResMed" in a bold, sans-serif font.

Clinical Data:

Clinical performance data is not required as the subject device uses established therapeutic technology and bench testing is sufficient to demonstrate substantial equivalence.

Substantial Equivalence Conclusion:

The S10 Kirra has the same intended use and similar indications and technological characteristics as the predicate devices. The differences in the technological characteristics between the predicate devices and subject device do not impact or raise new questions of safety or efficacy. Non-clinical performance data supports the determination that the subject device is substantially equivalent to the predicate devices.

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).