K Number
K172875
Device Name
Astral 100/150
Manufacturer
Date Cleared
2018-04-26

(217 days)

Product Code
Regulation Number
868.5895
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation. The iVAPS mode with optional AutoEPAP is intended for patients weighing more than 66lb (30kg). The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and noninvasive ventilation.
Device Description
The Astral ventilator system uses a micro-processor controlled blower, which, along with valves and pressure and flow sensors, achieves pressure, flow and time regulation of air is directed to the patient via one of three ventilator breathing circuits; double circuit, single circuit with expiratory valve, or single circuit with intentional leak. Supplemental oxygen can be entrained at the inlet to the main turbine. The device provides both therapeutic alarms (e.g. tidal volume) and technical alarms (e.g. system fault), and a user interface allowing adjustment of clinical parameters and display of monitored clinical data. The Astral can use external AC or DC power supply and contains an integrated battery. The Astral is capable of providing the following types of ventilatory support: - Assist/Control and SIMV with either volume or pressure control - - Continuous Spontaneous Ventilation in either Pressure Support or CPAP - - -Volume Assurance and Apnea Ventilation
More Information

No
The description focuses on traditional microprocessor-controlled ventilation and a specific algorithm (AutoEPAP) which is evaluated through a clinical trial, not described as an AI/ML system. There are no mentions of AI, ML, DNN, training sets, or test sets in the provided text.

Yes
The device is a ventilator that provides continuous or intermittent ventilatory support, which is a therapeutic intervention for patients requiring mechanical ventilation.

No

The device is a ventilator used for providing ventilatory support to patients. While it monitors clinical data and provides therapeutic alarms, its primary function is therapeutic (providing ventilation), not diagnostic.

No

The device description clearly outlines hardware components such as a micro-processor controlled blower, valves, pressure and flow sensors, and an integrated battery, indicating it is a physical medical device with embedded software, not a software-only device.

Based on the provided information, the Astral 100/150 device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
  • Astral 100/150 Function: The Astral 100/150 is a ventilator. Its function is to provide mechanical ventilation to patients who require breathing support. It directly interacts with the patient's respiratory system to assist with breathing.
  • Lack of Diagnostic Testing: The description of the Astral 100/150 does not mention any capabilities for performing tests on biological samples for diagnostic purposes. It focuses on delivering air and monitoring respiratory parameters.

Therefore, the Astral 100/150 falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.

The iVAPS mode with optional AutoEPAP is intended for patients weighing more than 66lb (30kg).

The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and noninvasive ventilation.

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

CBK, NOU

Device Description

The Astral ventilator system uses a micro-processor controlled blower, which, along with valves and pressure and flow sensors, achieves pressure, flow and time regulation of air is directed to the patient via one of three ventilator breathing circuits; double circuit, single circuit with expiratory valve, or single circuit with intentional leak. Supplemental oxygen can be entrained at the inlet to the main turbine. The device provides both therapeutic alarms (e.g. tidal volume) and technical alarms (e.g. system fault), and a user interface allowing adjustment of clinical parameters and display of monitored clinical data. The Astral can use external AC or DC power supply and contains an integrated battery.

The Astral is capable of providing the following types of ventilatory support:

  • Assist/Control and SIMV with either volume or pressure control -
  • Continuous Spontaneous Ventilation in either Pressure Support or CPAP -
  • -Volume Assurance and Apnea Ventilation

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 11lb (5kg)
iVAPS mode: patients weighing more than 66lb (30kg)
Adult and Pediatric (>5kg), iVAPS (>30kg)

Intended User / Care Setting

home, institution/hospital and portable applications

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:
Design and Verification activities were performed on the Astral as a result of the risk analysis and product requirements. Performance testing included:

  • accuracy of ventilation,
  • volume & pressure controls and monitoring, -
  • waveform performance (flow, pressure, volume),
  • alarms verification. -
    All tests confirmed the product met the predetermined acceptance criteria. In particular bench testing for the AutoEPAP feature included characterization of the ventilator's response to a breathing machine that simulates patients flow limitations and apneas.

Clinical data:
Clinical trial data is provided to demonstrate that the AutoEPAP algorithm performed as expected in maintaining upper airway patency in patients with respiratory failure or respiratory insufficiency. The data relates to a multi-center, single-blind, randomized, cross-over clinical trial comparing AutoEPAP algorithm in iVAPS therapy mode with manual EPAP titration in iVAPS therapy mode.

The trial demonstrated that for the primary outcome Oxygen Desaturation Index (ODI4%) as a measure of upper airway obstruction, the iVAPS with AutoEPAP algorithm is non-inferior to iVAPS with manual EPAP.

No serious adverse events or complications related to the study device were recorded.

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

Oxygen Desaturation Index (ODI4%) as a measure of upper airway obstruction, the iVAPS with AutoEPAP algorithm is non-inferior to iVAPS with manual EPAP.

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.

ResMed Astral 100/150 (K152068)

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.

ResMed Juno VPAP ST-A (K161492)

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

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).

0

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

April 26, 2018

ResMed Ltd % Sheila Bruschi Senior Manager, Regulatory Affairs, ResMed Corp Resmed Corp (Registration Number: 3007573469) 9001 Spectrum Center Boulevard San Diego, California 92123

Re: K172875

Trade/Device Name: Astral 100/150 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK, NOU Dated: March 29, 2018 Received: March 30, 2018

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

1

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K172875

Device Name Astral 100/150

Indications for Use (Describe)

The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 111b (5kg) who require mechanical ventilation.

The iVAPS mode with optional AutoEPAP is intended for patients weighing more than 66lb (30kg).

The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and noninvasive ventilation.

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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K172875

510(k) SUMMARY

[As required by 21 CFR 807.92(c)]

  • April 26, 2018 1. Date prepared

2. Applicant information

| Company Name/
Owner | ResMed Ltd
1 Elizabeth Macarthur Drive
Bella Vista NSW 2153 Australia |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name | Peter Jennings
Senior Regulatory Affairs Manager
Tel: + 61 2 8884 2232
Fax: + 61 2 8884 2004
peter.jennings@resmed.com.au |
| Correspondent Details/
Official Contact | Miss 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

3. Device details and substantial equivalence claim [807.92(a)(3)]

Trade/Device Names Astral 100/150
Device Common Name Continuous ventilator
Regulation Number 21 CFR 868.5895
Regulation Name Anesthesiology devices, Continuous Ventilator
Requlatory Class Class II
Product Code Primary product code CBK
Secondary product code NOU
Predicate Device ResMed Astral 100/150 (K152068)
Reference Device ResMed Juno VPAP ST-A (K161492)

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4. Indications For Use

The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.

The iVAPS mode with optional AutoEPAP is intended for patients weighing more than 66lb (30kg).

The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and non-invasive ventilation.

5. Device description

The Astral ventilator system uses a micro-processor controlled blower, which, along with valves and pressure and flow sensors, achieves pressure, flow and time regulation of air is directed to the patient via one of three ventilator breathing circuits; double circuit, single circuit with expiratory valve, or single circuit with intentional leak. Supplemental oxygen can be entrained at the inlet to the main turbine. The device provides both therapeutic alarms (e.g. tidal volume) and technical alarms (e.g. system fault), and a user interface allowing adjustment of clinical parameters and display of monitored clinical data. The Astral can use external AC or DC power supply and contains an integrated battery.

The Astral is capable of providing the following types of ventilatory support:

  • Assist/Control and SIMV with either volume or pressure control -
  • Continuous Spontaneous Ventilation in either Pressure Support or CPAP -
  • -Volume Assurance and Apnea Ventilation

6. Predicate Comparison

The Astral 100/150 has the same intended use and similar indications, technological characteristics, and principles of operation as the previously cleared predicate Astral 100/150 (K152068). The main change to the subject 510(k) is the addition of the optional AutoEPAP feature to the iVAPS therapy mode. The purpose of EPAP (Expiratory Positive Airway Pressure) is to maintain upper airway patency. The iVAPS mode in the predicate device includes an EPAP feature which is a manually titrated fixed EPAP. The optional AutoEPAP feature automatically adjusts the EPAP pressure in response to flow limitation (partial obstruction of the upper airway) or apnea (complete obstruction of the upper airway), within pre-set limits determined by the prescribing physician. Whether EPAP is set to manual or automatic, the operating range of EPAP is the same, and the therapeutic effect is the same, i.e. maintenance of an open upper airway. The AutoEPAP feature has been previously cleared on the reference device Juno VPAP ST-A (K161492). The AutoEPAP feature is not intended for invasive use. Other technological differences between the subject device and the predicate device are:

    1. Extending the Safety Volume supplementary feature to leak circuits (cleared in K152068 on valved circuits)
  • Duplication of ST mode as PS mode (with leak circuit) to enable clinician preference on 2) PEEP/EPAP terminology

5

| Characteristic | Predicate Device:
Astral 100/150
(K152068) | Subject Device:
Astral 100/150 | Substantially
Equivalent? |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | CBK, NOU | CBK, NOU | YES |
| Intended Use | Continuous or intermittent
ventilatory support

Invasive & non-invasive

Adult and Pediatric (>5kg)

Home, institution/hospital, &
portable | Continuous or intermittent
ventilatory support

Invasive & non-invasive

Adult and Pediatric (>5kg)

Home, institution/hospital, &
portable | YES |
| Intended Patient
Population | Patients who require mechanical
ventilation (Continuous or
intermittent ventilatory support)

Adult and Pediatric (>5kg),
iVAPS (>30kg) | Patients who require mechanical
ventilation (Continuous or
intermittent ventilatory support)

Adult and Pediatric (>5kg),
iVAPS (>30kg) | YES |
| Therapies | | | |
| Modes | ACV
PACV
V-SIMV
P-SIMV
PS & ST
CPAP
PAC
iVAPS (fixed manual EPAP) | ACV
PACV
V-SIMV
P-SIMV
PS & ST
CPAP
PAC
iVAPS (optional AutoEPAP) | YES
Clinical and bench data for
AutoEPAP on the subject
Astral device demonstrate it
is substantially equivalent to
manual EPAP.
Moreover, AutoEPAP in
iVAPS mode has been
cleared in the reference
device K161492.
PS & ST with intentional leak
have the same functionality
and clinical intent. |
| Supplementary
Therapy
Features | SV (Safety Volume)
Sigh
Apnea Ventilation
Manual Breath | SV (Safety Volume)
Sigh
Apnea Ventilation
Manual Breath | YES
SV on therapy modes with
leak circuits has the same
clinical intent and functional
implementation as SV on
equivalent therapy modes
with valved circuits. |
| Ventilation Control Parameters | | | |
| Pressure Range
[cmH2O] | IPAP: 4-50
EPAP: 2-25 s
CPAP: 3-20
PEEP: Off, 3 to 20
Accuracy: ±(0.5 + 5% of target) | IPAP: 4-50
EPAP: 2-25 s
CPAP: 3-20
PEEP: Off, 3 to 20
Accuracy: ±(0.5 + 5% of target) | YES |
| Tidal Volume
[mL] | 100-2500 (adult)
50-500 (pediatric)

Accuracy ± 12 ml or 10%
whichever is greater. (Valved
Circuits) | 100-2500 (adult)
50-500 (pediatric)

Accuracy ± 12 ml or 10%
whichever is greater. (Valved
Circuits) | YES |
| Respiratory
Rate
(Breathing
Frequency)
[bpm] | 2-50 (adult)
5-80 (pediatric)

Accuracy ±2% | 2-50 (adult)
5-80 (pediatric)

Accuracy ±2% | YES |
| Characteristic | Predicate Device:
Astral 100/150
(K152068) | Subject Device:
Astral 100/150 | Substantially
Equivalent? |
| Rise Time | Min-900 msec | Min-900 msec | YES |
| Timed
Inspiration | 0.2 to 5 seconds | 0.2 to 5 seconds | YES |
| Sensitivity | Accuracy ±(20 ms +5% of
setting) | Accuracy ±(20 ms +5% of
setting) | |
| Sensitivity | Inspiratory
Flow controlled
0.5 to 15l/min | Inspiratory
Flow controlled
0.5 to 15l/min | YES |
| Technology & Design | | | |
| Operating
Principle | Micro-processor controlled
blower as air source | Micro-processor controlled
blower as air source | YES |
| Technology | Software based pressure, flow
and time regulation with
secondary volume target | Software based pressure, flow
and time regulation with
secondary volume target | YES |
| Material contact
status | Permanent contact duration,
indirect dry airpath
patientcontacting materials | Permanent contact duration,
indirect dry airpath
patientcontacting materials | YES |
| Circuit
Interfaces | Vented & Non-vented
Invasive & Non-invasive | Vented & Non-vented
Invasive & Non-invasive | YES |
| Circuit Types | Double limb
Single limb with expiratory valve
Single limb with intentional leak | Double limb
Single limb with expiratory valve
Single limb with intentional leak | YES |
| User Interface | LCD screen, soft keys, mute
button & LED indicators. | LCD screen, soft keys, mute
button & LED indicators. | YES |
| System
Components | Ventilator | Ventilator | YES |
| | Mask, invasive patient interface | Mask, invasive patient interface | |
| | Air tubing, air filter, optional
antibacterial filter | Air tubing, air filter, optional
antibacterial filter | |
| | Optional humidifier/ HME,
oximeter, nebuliser | Optional humidifier/ HME,
oximeter, nebuliser | |
| Power | AC, DC and Internal Battery | AC, DC and Internal Battery | YES |
| Supplemental
Oxygen | Labeled for use with
supplemental oxygen | Labeled for use with
supplemental oxygen | YES |

6

7. Non Clinical data

Design and Verification activities were performed on the Astral as a result of the risk analysis and product requirements. Performance testing included:

  • accuracy of ventilation,
  • volume & pressure controls and monitoring, -
  • waveform performance (flow, pressure, volume),
  • alarms verification. -

All tests confirmed the product met the predetermined acceptance criteria. In particular bench testing for the AutoEPAP feature included characterization of the ventilator's response to a breathing machine that simulates patients flow limitations and apneas.

The Astral was designed and tested in accordance with the applicable requirements in relevant FDA guidance documents and international standards including:

7

  • FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical -Devices (May 11, 2005)
  • -ISO 80601-2-72:2015, Medical Electrical Equipment – Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
  • 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: Electromagnetic compatibility -- Requirements and tests

8. Clinical data

Clinical trial data is provided to demonstrate that the AutoEPAP algorithm performed as expected in maintaining upper airway patency in patients with respiratory failure or respiratory insufficiency. The data relates to a multi-center, single-blind, randomized, cross-over clinical trial comparing AutoEPAP algorithm in iVAPS therapy mode with manual EPAP titration in iVAPS therapy mode.

The trial demonstrated that for the primary outcome Oxygen Desaturation Index (ODI4%) as a measure of upper airway obstruction, the iVAPS with AutoEPAP algorithm is non-inferior to iVAPS with manual EPAP.

No serious adverse events or complications related to the study device were recorded.

9. Substantial Equivalence Conclusion

The indications for use, technological characteristics, and principles of operation are similar to the predicate device. Clinical data and non-clinical performance data supports that the subject device is substantially equivalent to the predicate device.