Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on traditional microprocessor control, sensors, and pre-defined ventilation modes, with no mention of learning algorithms or adaptive capabilities beyond standard feedback loops.

Therapeutic

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

Diagnostic

No

The device is described as a ventilator that provides ventilatory support and regulates air for patients. It displays monitored clinical data and provides therapeutic and technical alarms, but its primary function is respiratory support, not diagnosing a condition.

SaMD (Software as a Medical Device)

No

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

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the device provides ventilatory support to patients. This is a direct medical intervention on a living patient, not a test performed on a sample taken from the body.
Device Description: The description details a mechanical ventilator system that delivers air to the patient. It involves pressure, flow, and time regulation of air, along with monitoring and alarms related to ventilation parameters. This is consistent with a life support device, not a diagnostic test.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.

The Astral 100/150 is a ventilator, which is a type of medical device used for respiratory support.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

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 circuit, single circuit with expiratory valve, or single circuit with intentional leak. Supplemental oxygen can be entrained at 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

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

Non-Clinical Performance 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),
accuracy and repeatability of triggering and cycling, .
endurance and environmental testing,
alarms verification.

All tests confirmed the product met the predetermined acceptance criteria. In particular non-clinical side-by-side performance testing was performed for the new therapy mode. Characteristics tested included flow, pressure and volume waveforms, ventilation control parameter accuracy, and patient trigger reliability and synchrony. As the new device included electrical changes, testing included updated third party test reports to IEC 60601-1:2005 and IEC 60601-1-2:2007 (+ additional ESD & EMI to IEC 60601-1-2 Ed 4.0).

Key Metrics

Not Found

Predicate Device(s)

ResMed Astral 100/150 (K133868)

Reference Device(s)

Respironics Trilogy 200 (K093416)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, layered on top of each other, creating a sense of depth and unity.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 13, 2016

ResMed Ltd. % Larissa D'Andrea Director, Regulatory Government Affairs ResMed Corp 9001 Spectrum Center Boulevard San Diego, California 92123

Re: K152068

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 18, 2016 Received: March 23, 2016

Dear Ms. D'andrea:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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):

Device Name: Astral 100/150

Indications for Use:

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

The iVAPS mode 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of Device Evaluation (ODE)

Page __ of __

3

510(k) Summary – Astral 100/150

Date prepared	22 April, 2016
Submitter	Peter Jennings
Senior Regulatory Affairs Manager
Official contact	Larissa D'Andrea
Director, Regulatory Government Affairs
ResMed Corp.
9001 Spectrum Center Blvd.,
San Diego CA 92123
USA
Tel: +1 858-836-6837
Fax: +1 858-836-5519
Proprietary name	Astral 100/150
Common name	Continuous ventilator
Classification	21 CFR 868.5895
Primary product code CBK
Secondary product code NOU
Class II
Ventilator, continuous, facility use
Predicate Devices	ResMed Astral 100/150 (K133868)
Reference Device	Respironics Trilogy 200 (K093416)
Reason for submission	New device

4

Indication 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 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.

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 circuit, single circuit with expiratory valve, or single circuit with intentional leak. Supplemental oxygen can be entrained at 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

Substantial Equivalence

The Astral has the following similarities to the previously cleared predicate devices:

-Same intended use
-Same scientific technology
-Same operating principle

There is no change to the intended use, scientific technology, operating principle and manufacturing process from the primary predicate device Astral 100/150 (K133868). The main change is the addition of iVAPS therapy mode As with AVAPS mode on the reference device Trilogy 200 (K093416). iVAPS is a Volume Assured Pressure Support therapy mode which adjusts pressure support to meet a preset ventilation target. As with AVAPS mode on Trilogy 200, iVAPS on Astral 100/150 is for a restricted patient weight within the continuous or intermittent ventilator support indication. Otherwise the modified Astral has changes to the main PCBA enabling addition of an alternate external battery and alternate AC power supplies.

A comparative summary of the technological characteristics of the Astral device with the primary predicate and reference devices is presented below.

| Characteristic | Astral 100/150
(new device) | Astral 100/150
(K133868) | Trilogy 200
(K093416) | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | CBK, NOU | CBK, NOU | CBK | Substantially
Equivalent |
| Intended Use | Continuous or
intermittent
ventilatory support | Continuous or
intermittent
ventilatory support | Continuous or
intermittent
ventilatory support | Substantially
Equivalent
Same Intended
Use. and
equivalent
patient
population as
AVAPS on
Trilogy |
| | Invasive & non-
invasive | Invasive & non-
invasive | Invasive & non-
invasive | |
| | Adult and
Pediatric (>5kg),
iVAPS (>30kg) | Adult and
Pediatric (>5kg) | Adult and
Pediatric (>5kg),
AVAPS (adult) | |
| | Home, institution/
hospital, &
portable | Home, institution/
hospital, &
portable | Home, institution/
hospital, &
portable | |
| Intended Patient
Population | Patients who
require
mechanical
ventilation
(Continuous or
intermittent
ventilatory
support) | Patients who
require
mechanical
ventilation
(Continuous or
intermittent
ventilatory
support) | Patients who
require
mechanical
ventilation
(Continuous or
intermittent
ventilatory
support) | Substantially
Equivalent
Intended Patient
Population is
the same as the
predicate, , and
equivalent
patient
population as
AVAPS on
Trilogy) |
| | Adult and
Pediatric (>5kg),
iVAPS (>30kg) | Adult and
Pediatric (>5kg) | Adult and
Pediatric (>5kg),
AVAPS (adult) | |
| Therapy Modes | | | | |
| VC-CMV mode
(Volume Control

Continuous
Mandatory
Ventilation) | ACV
Patient or time
triggered. | ACV
Patient or time
triggered. | CV, AC
Patient or time
triggered. | Substantially
Equivalent
Astral
implementation
is unchanged |
| PC-CMV mode
(Pressure Control
Continuous
Mandatory
Ventilation) | PACV
Patient or time
triggered. | PACV
Patient or time
triggered. | T, PC
Patient or time
triggered. | Substantially
Equivalent
Astral
implementation
is unchanged |
| V-SIMV
(Volume -
Intermittent
Mandatory
Ventilation) | V-SIMV
Mandatory
breaths (tidal
volume) may be
time triggered or
patient triggered.
Spontaneous
breaths are
pressure support. | V-SIMV
Mandatory
breaths (tidal
volume) may be
time triggered or
patient triggered.
Spontaneous
breaths are
pressure support. | SIMV
Mandatory
breaths (tidal
volume) may be
time triggered or
patient triggered.
Spontaneous
breaths are
pressure support. | Substantially
Equivalent
Astral
implementation
is unchanged |
| P-SIMV
(Pressure -
Intermittent
Mandatory
Ventilation) | P-SIMV
Mandatory
breaths (set
pressure) may be
time triggered or
patient triggered.
Spontaneous
breaths are
pressure support. | P-SIMV
Mandatory
breaths (set
pressure) may be
time triggered or
patient triggered.
Spontaneous
breaths are
pressure support. | PC-SIMV
Mandatory
breaths (set
pressure) may be
time triggered or
patient triggered.
Spontaneous
breaths are
pressure support. | Substantially
Equivalent
Astral
implementation
is unchanged |
| CSV
(Continuous
Spontaneous
Ventilation) | PS (valved) & ST
(intentional leak)
Patient
(Spontaneous)
and Time | PS (valved) & ST
(intentional leak)
Patient
(Spontaneous)
and Time | S, S/T & T
Patient
(Spontaneous)
and Time
(Mandatory via | Substantially
Equivalent
Astral
implementation
is unchanged |
| | | | | |
| | (Mandatory via
Breathing
Frequency)
triggered. All
breaths can be
patient or time
terminated. | (Mandatory via
Breathing
Frequency)
triggered. All
breaths can be
patient or time
terminated. | (Breath Rate)
triggered. Breaths
can be patient or
time (Mandatory
breath duration is
set inspiratory
time) cycled. | |
| | CPAP
Constant positive
pressure | CPAP
Constant positive
pressure | CPAP
Constant positive
pressure | Substantially
Equivalent
Astral
implementation
is unchanged |
| | PAC
Patient
(Spontaneous)
and Time
(Mandatory via
Breathing
Frequency)
triggered. All
breaths time
cycled. | PAC
Patient
(Spontaneous)
and Time
(Mandatory via
Breathing
Frequency)
triggered. All
breaths time
cycled. | PC, S & T
Patient
(Spontaneous or
"assist") and Time
(Mandatory via
Breath Rate)
triggered. All
breaths time
cycled (or can be
configured to be). | Substantially
Equivalent
Astral
implementation
is unchanged |
| Volume
Assurance
(Adaptive control
mechanism that
can introduce a
degree of volume
assurance to
pressure-control/
pressure-support
modes) | iVAPS
Breath by breath
control of
pressure support
within given limits,
to achieve an
alveolar minute
volume target.
Indications:
Patients > 66 lbs
(30 kg).

SV (Safety
Volume)
Breath by breath
control of
pressure support
within given limits,
to achieve a tidal
volume target. | SV (Safety
Volume)
Breath by breath
control of
pressure support
within given limits,
to achieve a tidal
volume target. | AVAPS
Breath by breath
control of
pressure support
within given limits,
to achieve a tidal
volume target.
Indications: Adult
patients | Substantially
Equivalent to
Trilogy K093416
for iVAPS
implementation.
All modes
adjust the
pressure
support, within
practitioner-
determined
limits, to meet
the preset
ventilation
target. |
| Supplementary
Features | Sigh
Apnea Ventilation
Manual Breath | Sigh
Apnea Ventilation
Manual Breath | Sigh
Apnea Ventilation | Substantially
Equivalent
Astral
implementation
is unchanged |
| Ventilation
Control
Parameters | | | | |
| Pressure Range
[cmH20] | IPAP: 4-50
EPAP: 2-25 s
CPAP: 3-20
PEEP: Off, 3 to 20 | IPAP: 4-50
EPAP: 2-25 s
CPAP: 3-20
PEEP: Off, 3 to 20 | IPAP: 4-50
EPAP: 0-25
CPAP: 4-20 | Substantially
Equivalent |
| | Accuracy: ±(0.5 | Accuracy: ±(0.5 | Accuracy: greater | |
| | + 5% of target) | + 5% of target) | of 2cmH2O or 8%
of setting | |
| Tidal Volume
[mL] | 100-2500 (adult)
50-500 (pediatric) | 100-2500 (adult)
50-500 (pediatric) | 50-2000 | Substantially
Equivalent |
| | Accuracy ± 12 ml
or 10% whichever
is greater. (Valved
Circuits) | Accuracy ± 12 ml
or 10% whichever
is greater. (Valved
Circuits) | Accuracy: greater
of 15mL or 10% of
setting (Active
Circuits) | |
| Respiratory Rate
(Breathing
Frequency)
[bpm] | 2-50 (adult)
5-80 (pediatric)
Accuracy ±2% | 2-50 (adult)
5-80 (pediatric)
Accuracy ±2% | 1-60
Accuracy ±1 bpm
or 10% of setting | Substantially
Equivalent |
| Rise Time | Min-900 msec | Min-900 msec | 1-6 (nominal
values) | Substantially
Equivalent |
| Timed Inspiration | 0.2 to 5 seconds
Accuracy ±(20 ms
+5% of setting) | 0.2 to 5 seconds
Accuracy ±(20 ms
+5% of setting) | 0.3 to 5 seconds
Accuracy ±100ms | Substantially
Equivalent |
| Sensitivity | Inspiratory
Flow controlled
0.5 to 15l/min | Inspiratory
Flow controlled
0.5 to 15l/min | Inspiratory &
Expiratory
Flow controlled | Substantially
Equivalent |
| Technology &
Design | | | | |
| Operating
Principle | Micro-processor
controlled blower
as air source | Micro-processor
controlled blower
as air source | Micro-processor
controlled blower
as air source | Substantially
Equivalent
Same operating
principle |
| Technology | Software based
pressure, flow and
time regulation
with secondary
volume target | Software based
pressure, flow and
time regulation
with secondary
volume target | Software based
pressure, flow and
time regulation
with secondary
volume target | Substantially
Equivalent
Same
technology |
| Material contact
status | Permanent
contact duration,
indirect dry air-
path patient-
contacting
materials | Permanent
contact duration,
indirect dry air-
path patient-
contacting
materials | Permanent
contact duration,
indirect dry air-
path patient-
contacting
materials | Substantially
Equivalent
Status
unchanged from
K133868 |
| Materials | Various materials,
including:
• Thermoplastic
Polyurethane
(TPU)
• Polycarbonate
(PC) and PC
blends
• Polypropylene
(PP)
• Silicone
• Aluminium | Various materials,
including:
• Thermoplastic
Polyurethane
(TPU)
• Polycarbonate
(PC) and PC
blends
• Polypropylene
(PP)
• Silicone
• Aluminium | Proprietary
information | Substantially
Equivalent
Materials
unchanged from
K133868 |
| Circuit Interfaces | Vented & Non-
vented | Vented & Non-
vented | Vented & Non-
vented | Substantially
Equivalent |
| | Invasive & Non-
invasive | Invasive & Non-
invasive | Invasive & Non-
invasive | |
| 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 | Single limb with
expiratory valve
with proximal flow
& pressure
sensing
Single limb with
expiratory valve
Single limb with
intentional leak | Substantially
Equivalent
Same circuit
types |
| User Interface | LCD screen, keys
& LED indicators | LCD screen, keys
& LED indicators | LCD screen, hard
keys & LED
indicators | Substantially
Equivalent |
| Power | AC, DC, &
Internal battery | AC, DC, &
Internal battery | AC, DC, &
Internal battery | Substantially
Equivalent |
| System
Components | Ventilator
Mask, invasive
patient interface
Air tubing, air
filter, optional
antibacterial filter
Optional external
humidifier or HME | Ventilator
Mask, invasive
patient interface
Air tubing, air
filter, optional
antibacterial filter
Optional external
humidifier or HME | Ventilator
Mask, invasive
patient interface
Air tubing, air
filter, optional
antibacterial filter
Optional external
humidifier or HME | Substantially
Equivalent |
| Supplemental
Oxygen | Labeled for use
with supplemental
oxygen
Optional oxygen
sensor | Labeled for use
with supplemental
oxygen
Optional oxygen
sensor | Labeled for use
with supplemental
oxygen | Substantially
Equivalent |

5

6

7

8

Non-Clinical Performance 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), ●
accuracy and repeatability of triggering and cycling, .
endurance and environmental testing,
alarms verification.

All tests confirmed the product met the predetermined acceptance criteria. In particular non-clinical sideby-side performance testing was performed for the new therapy mode. Characteristics tested included flow, pressure and volume waveforms, ventilation control parameter accuracy, and patient trigger reliability and synchrony. As the new device included electrical changes, testing included updated third party test reports to IEC 60601-1:2005 and IEC 60601-1-2:2007 (+ additional ESD & EMI to IEC 60601-1-2 Ed 4.0). There was no change to cleaning procedures or materials from the predicate device so no additional testing was conducted in these areas. This suite of tests supports the claim that the Astral is substantially equivalent to the predicate device.

9

Human Factors/Usability Engineering evaluations were performed on the Astral in order to mitigate risks associated with users performing tasks incorrectly or failing to perform tasks which could result in serious harm. Human Factors/Usability Engineering testing was performed for the clearance of the predicate Astral device (K133868). Additional Human Factors/Usability Engineering testing was performed for iVAPS implementation, disconnection alarm and external battery.

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

FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical -Devices (May 11, 2005)
ASTM F 1246-91 (2005) Standard Specification for Electrically Powered Home Care Ventilators -
-ISO 10651-2:2004. Lung ventilators for medical use - Part 2: Home care ventilators for ventilatordependent patients
IEC 60601-1:2005 Medical electrical equipment. Part 1: General requirements for basic safety and essential performance.
-IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: Electromagnetic compatibility -Requirements and tests

Clinical testing was not required.

Conclusion

The intended use, technological characteristics, and principles of operation are similar to the predicate and reference devices. Non-clinical performance data supports the claim that the new device is substantially equivalent to the predicate and reference devices. The primary modification of the inclusion of iVAPS therapy mode remains within the previously cleared indications for use for VAPS therapy. Thus the data in this submission supports the claim of substantial equivalence to the identified predicate and reference devices.