(60 days)
No
The document describes a standard PAP ventilator device with microprocessor control and sensors, but there is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as "intended to provide CPAP and Bi-level therapy for the treatment of obstructive sleep apnea (OSA)" and "a prescription only Positive Airway Pressure (PAP) ventilator device intended to treat individuals that are diagnosed with sleep apnea conditions". The word "therapy" and "treat" directly indicate a therapeutic purpose.
No
Explanation: The device description states its purpose is to provide therapy for diagnosed sleep apnea conditions, not to diagnose them. It delivers therapeutic data (e.g., tidal volume) and technical data (e.g., system fault) but does not analyze patient data for diagnostic purposes.
No
The device description explicitly states it is a "Positive Airway Pressure (PAP) ventilator device" and details hardware components like a "micro-processor controlled blower," "pressure and flow sensors," and "optional humidification." This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. The description of the S10 Kirra clearly states it is a PAP ventilator device that delivers air to the patient's airway. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use is for treating sleep apnea conditions. This is a therapeutic device, not a diagnostic one that analyzes samples to identify a disease or condition.
- The device description focuses on air delivery, pressure and flow regulation, and humidification. These are all functions related to respiratory support, not in vitro analysis.
Therefore, the S10 Kirra is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
BZD
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.
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
patients weighing more than 66 lb (30 kg)
Intended User / Care Setting
Home and hospital use.
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 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
S9 Greenhills (K140279), S9 Wanda (K140159), S9 Elouera (K140124)
Reference Device(s)
VPAP Adapt (K133801)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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)
Device Name S10 Kirra
Indications for Use (Describe)
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.
| 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
| [As required by 21 CFR 807.92(c)] | |
|---|---|
| Date Prepared: | 16 December 2020 |
| Company Name/Owner: | ResMed Pty Ltd |
| 1 Elizabeth Macarthur Drive | |
| Bella Vista, NSW, 2153 Australia | |
| Prepared and Submitted by: | Mr Peter Jennings |
| Senior Regulatory Affairs Manager | |
| Tel: +612 8884 1000 | |
| Fax: +612 8884 2004 | |
| peter.jennings@resmed.com.au | |
| Official Contact: | Ms Sheila Bruschi |
| Director, Regulatory Affairs | |
| ResMed Corp. | |
| 9001 Spectrum Center Blvd | |
| San Diego CA 92123 USA | |
| Tel: +1 858 836 5934 | |
| Fax: +1 858 836 5519 | |
| sheila.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:
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
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:
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.
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 Greenhills
K140279 | Predicate device:
S9 Wanda
K140159 | Predicate device:
S9 Elouera
K140124 | Subject device:
S10 Kirra | Substantially
Equivalent? |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Positive airway
pressure support
for sleep apnea
Patients >66 lb
(>30kg)
Home and Hospital | Positive airway
pressure support
for sleep apnea
Patients >66 lb
(>30kg)
Home and Hospital | Positive airway
pressure support
for sleep apnea
Patients >66 lb
(>30kg)
Home and Hospital | Positive airway
pressure support
for sleep apnea
Patients >66 lb
(>30kg)
Home and Hospital | YES |
| Indications for
Use
Statement | The S9 Greenhills is
indicated for the
treatment of
patients weighing
more than 66 lb (30
kg) with obstructive
sleep apnea (OSA),
central and/or
mixed apneas, or
periodic breathing.
It is intended for
home and hospital
use | The S9 WANDA
VPAP ST is indicated
for the treatment of
Obstructive Sleep
Apnea (OSA) in
patients weighing
more than 66 lb (30
kg).
It is intended for
use in the hospital
and home | The S9 Elouera self-
adjusting device is
indicated 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). | 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 | YES
S10 Kirra
includes a
combined IFU
statement
within the
Intended Use of
the predicate
devices.
Disease states
treated by each
therapy mode
are unchanged |
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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 Greenhills
K140279 | Predicate device:
S9 Wanda
K140159 | Predicate device:
S9 Elouera
K140124 | Subject device:
S10 Kirra | Substantially
Equivalent? | | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | The humidifier is
intended for single
patient use in the
home environment
and re-use in a
hospital /
institutional
environment. | | It is intended for
home and hospital
use | 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. | from the
predicates. | | |
| Environment
of Use | Home Healthcare
Environment,
Professional
Healthcare Facilities | Home Healthcare
Environment,
Professional
Healthcare Facilities | Home Healthcare
Environment,
Professional
Healthcare Facilities | Home Healthcare
Environment
(including aircraft),
Professional
Healthcare Facilities | YES
S10 Kirra and
predicate
devices for use
in same
environments.
Specific use on
aircraft based
on reference
device K133801
testing
methods. | | |
| Therapies | | | | | | | |
| Therapy
Modes | CPAP
ASV
ASVAuto | CPAP
VAuto
S, ST, T | CPAP
AutoSet
AutoSet for Her
(AfH) | CPAP
ASV
ASVAuto
AutoSet
AutoSet for Her
(AfH)
VAuto
S, ST, T | YES
S10 Kirra has
same therapy
modes as
predicates | | |
| Pressure
Range | 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, AutoSet
for Her) | 4-20 cm H2O (CPAP,
AutoSet, AutoSet
for Her)
4-25 cm H2O
(VAuto)
3-25 cm H2O (S, ST,
T, ASV, ASVAuto) | YES
S10 Kirra has
identical
pressure range
for
corresponding
modes. | | |
| Comfort
Features | | Expiratory Pressure
Relief (EPR)
Easybreathe | Expiratory Pressure
Relief (EPR) | Expiratory Pressure
Relief (EPR)
Easybreathe | YES | | |
| Technology & Design
System | | | | | | | |
| Components | Flow Generator
Integrated
Humidifier
Air Tubing
Mask | Flow Generator
Integrated
Humidifier
Air Tubing
Mask | Flow Generator
Integrated
Humidifier
Air Tubing
Mask | Flow Generator
Integrated
Humidifier
Air Tubing
Mask | YES | | |
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| Characteristic | Predicate device:
S9 Greenhills
K140279 | Predicate device:
S9 Wanda
K140159 | Predicate device:
S9 Elouera
K140124 | Subject device:
S10 Kirra | Substantially
Equivalent? |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating
Principle | Micro-processor
controlled brush-
less centrifugal
blower as air source
to provide splinting
of patient airway | Micro-processor
controlled brush-
less centrifugal
blower as air source
to provide splinting
of patient airway | Micro-processor
controlled brush-
less centrifugal
blower as air source
to provide splinting
of patient airway | Micro-processor
controlled brush-
less centrifugal
blower as air source
to provide splinting
of patient airway | YES |
| Materials | Various materials,
including:
Polymers
Plastics
Stainless steel | Various materials,
including:
Polymers
Plastics
Stainless steel | Various materials,
including:
Polymers
Plastics
Stainless steel | Various materials,
including:
Polymers
Plastics
Stainless steel | YES
Substantially
equivalent
materials
verified for
reprocessing
and BioC.
Same base
material. |
| Data
Connectivity | SD card, Cellular
Wireless | SD card, Cellular
Wireless | SD card, Cellular
Wireless | SD card, Cellular
Wireless, Bluetooth
Wireless | YES
Bluetooth is an
alternate
wireless
technology
option to
provide the
same data
transfer
capabilities as
cellular. |
| Humidification | | | | | |
| Humidifier | Integrated
thermostatically
controlled heated
humidifier with
detachable water
chamber | Integrated
thermostatically
controlled heated
humidifier with
detachable water
chamber | Integrated
thermostatically
controlled heated
humidifier with
detachable water
chamber | Integrated
thermostatically
controlled heated
humidifier with
detachable water
chamber | YES |
| Operating
Principle | Water is heated by
a heater plate to
create warm and
moist air within the
water chamber.
Airflow from the
device is passed
through the heated
water chamber,
which moistens and
warms the air. | Water is heated by
a heater plate to
create warm and
moist air within the
water chamber.
Airflow from the
device is passed
through the heated
water chamber,
which moistens and
warms the air. | Water is heated by
a heater plate to
create warm and
moist air within the
water chamber.
Airflow from the
device is passed
through the heated
water chamber,
which moistens and
warms the air. | Water is heated by
a heater plate to
create warm and
moist air within the
water chamber.
Airflow from the
device is passed
through the heated
water chamber,
which moistens and
warms the air. | YES |
| Humidifier
output | 12.0mg/L @ 20cm
H2O (50 L/min) | 12.0mg/L @ 20cm
H2O (50 L/min) | 12.0mg/L @ 20cm
H2O (50 L/min) | 12.6mg/L @ 20cm
H2O (50 L/min) | YES |
| Heated Tube
temperature
settings | 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 Greenhills
K140279 | Predicate device:
S9 Wanda
K140159 | Predicate device:
S9 Elouera
K140124 | Subject device:
S10 Kirra | Substantially
Equivalent? |
| Heated Tube
temperature
cutout | 106 °F (41 °C) | 106 °F (41 °C) | 106 °F (41 °C) | 106 °F (41 °C) | YES |
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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
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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.