(294 days)
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.
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
The provided document is a 510(k) premarket notification for a medical device (ventilator). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria for AI or a new diagnostic tool.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance derived from a test set, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, training set information, or how ground truth was established for a new AI/diagnostic device.
The document discusses:
- Device Name: Astral 100/150
- Regulation Name: Continuous Ventilator
- Predicate Device: ResMed Astral 100/150 (K133868)
- Reference Device: Respironics Trilogy 200 (K093416)
- Reason for Submission: New device (specifically, the addition of the iVAPS therapy mode).
- Non-Clinical Performance Data: Stated that design and verification activities were performed, including accuracy of ventilation, volume & pressure controls and monitoring, waveform performance, accuracy and repeatability of triggering and cycling, endurance and environmental testing, and alarm verification. It explicitly states, "All tests confirmed the product met the predetermined acceptance criteria." However, it does not list these specific acceptance criteria in a table or provide quantitative performance results against them. It also mentions side-by-side performance testing for the new therapy mode (iVAPS) and electrical changes testing.
- Conclusion: The device is substantially equivalent to the predicate and reference devices based on intended use, technological characteristics, and principles of operation. Clinical testing was not required for this submission.
In summary, this document is a 510(k) submission for a ventilator, focusing on substantial equivalence to a predicate device and not a study validating a new AI/diagnostic device with the specific criteria you've outlined.
{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 JenningsSenior Regulatory Affairs Manager |
| Official contact | Larissa D'AndreaDirector, Regulatory Government AffairsResMed Corp.9001 Spectrum Center Blvd.,San Diego CA 92123USATel: +1 858-836-6837Fax: +1 858-836-5519 |
| Proprietary name | Astral 100/150 |
| Common name | Continuous ventilator |
| Classification | 21 CFR 868.5895Primary product code CBKSecondary product code NOUClass IIVentilator, 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 | SubstantiallyEquivalent |
| Intended Use | Continuous orintermittentventilatory support | Continuous orintermittentventilatory support | Continuous orintermittentventilatory support | SubstantiallyEquivalentSame IntendedUse. andequivalentpatientpopulation asAVAPS onTrilogy |
| Invasive & non-invasive | Invasive & non-invasive | Invasive & non-invasive | ||
| Adult andPediatric (>5kg),iVAPS (>30kg) | Adult andPediatric (>5kg) | Adult andPediatric (>5kg),AVAPS (adult) | ||
| Home, institution/hospital, &portable | Home, institution/hospital, &portable | Home, institution/hospital, &portable | ||
| Intended PatientPopulation | Patients whorequiremechanicalventilation(Continuous orintermittentventilatorysupport) | Patients whorequiremechanicalventilation(Continuous orintermittentventilatorysupport) | Patients whorequiremechanicalventilation(Continuous orintermittentventilatorysupport) | SubstantiallyEquivalentIntended PatientPopulation isthe same as thepredicate, , andequivalentpatientpopulation asAVAPS onTrilogy) |
| Adult andPediatric (>5kg),iVAPS (>30kg) | Adult andPediatric (>5kg) | Adult andPediatric (>5kg),AVAPS (adult) | ||
| Therapy Modes | ||||
| VC-CMV mode(Volume Control- ContinuousMandatoryVentilation) | ACVPatient or timetriggered. | ACVPatient or timetriggered. | CV, ACPatient or timetriggered. | SubstantiallyEquivalentAstralimplementationis unchanged |
| PC-CMV mode(Pressure Control- ContinuousMandatoryVentilation) | PACVPatient or timetriggered. | PACVPatient or timetriggered. | T, PCPatient or timetriggered. | SubstantiallyEquivalentAstralimplementationis unchanged |
| V-SIMV(Volume -IntermittentMandatoryVentilation) | V-SIMVMandatorybreaths (tidalvolume) may betime triggered orpatient triggered.Spontaneousbreaths arepressure support. | V-SIMVMandatorybreaths (tidalvolume) may betime triggered orpatient triggered.Spontaneousbreaths arepressure support. | SIMVMandatorybreaths (tidalvolume) may betime triggered orpatient triggered.Spontaneousbreaths arepressure support. | SubstantiallyEquivalentAstralimplementationis unchanged |
| P-SIMV(Pressure -IntermittentMandatoryVentilation) | P-SIMVMandatorybreaths (setpressure) may betime triggered orpatient triggered.Spontaneousbreaths arepressure support. | P-SIMVMandatorybreaths (setpressure) may betime triggered orpatient triggered.Spontaneousbreaths arepressure support. | PC-SIMVMandatorybreaths (setpressure) may betime triggered orpatient triggered.Spontaneousbreaths arepressure support. | SubstantiallyEquivalentAstralimplementationis unchanged |
| CSV(ContinuousSpontaneousVentilation) | PS (valved) & ST(intentional leak)Patient(Spontaneous)and Time | PS (valved) & ST(intentional leak)Patient(Spontaneous)and Time | S, S/T & TPatient(Spontaneous)and Time(Mandatory via | SubstantiallyEquivalentAstralimplementationis unchanged |
| (Mandatory viaBreathingFrequency)triggered. Allbreaths can bepatient or timeterminated. | (Mandatory viaBreathingFrequency)triggered. Allbreaths can bepatient or timeterminated. | (Breath Rate)triggered. Breathscan be patient ortime (Mandatorybreath duration isset inspiratorytime) cycled. | ||
| CPAPConstant positivepressure | CPAPConstant positivepressure | CPAPConstant positivepressure | SubstantiallyEquivalentAstralimplementationis unchanged | |
| PACPatient(Spontaneous)and Time(Mandatory viaBreathingFrequency)triggered. Allbreaths timecycled. | PACPatient(Spontaneous)and Time(Mandatory viaBreathingFrequency)triggered. Allbreaths timecycled. | PC, S & TPatient(Spontaneous or"assist") and Time(Mandatory viaBreath Rate)triggered. Allbreaths timecycled (or can beconfigured to be). | SubstantiallyEquivalentAstralimplementationis unchanged | |
| VolumeAssurance(Adaptive controlmechanism thatcan introduce adegree of volumeassurance topressure-control/pressure-supportmodes) | iVAPSBreath by breathcontrol ofpressure supportwithin given limits,to achieve analveolar minutevolume target.Indications:Patients > 66 lbs(30 kg).SV (SafetyVolume)Breath by breathcontrol ofpressure supportwithin given limits,to achieve a tidalvolume target. | SV (SafetyVolume)Breath by breathcontrol ofpressure supportwithin given limits,to achieve a tidalvolume target. | AVAPSBreath by breathcontrol ofpressure supportwithin given limits,to achieve a tidalvolume target.Indications: Adultpatients | SubstantiallyEquivalent toTrilogy K093416for iVAPSimplementation.All modesadjust thepressuresupport, withinpractitioner-determinedlimits, to meetthe presetventilationtarget. |
| SupplementaryFeatures | SighApnea VentilationManual Breath | SighApnea VentilationManual Breath | SighApnea Ventilation | SubstantiallyEquivalentAstralimplementationis unchanged |
| VentilationControlParameters | ||||
| Pressure Range[cmH20] | IPAP: 4-50EPAP: 2-25 sCPAP: 3-20PEEP: Off, 3 to 20 | IPAP: 4-50EPAP: 2-25 sCPAP: 3-20PEEP: Off, 3 to 20 | IPAP: 4-50EPAP: 0-25CPAP: 4-20 | SubstantiallyEquivalent |
| 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 | SubstantiallyEquivalent |
| Accuracy ± 12 mlor 10% whicheveris greater. (ValvedCircuits) | Accuracy ± 12 mlor 10% whicheveris greater. (ValvedCircuits) | Accuracy: greaterof 15mL or 10% ofsetting (ActiveCircuits) | ||
| Respiratory Rate(BreathingFrequency)[bpm] | 2-50 (adult)5-80 (pediatric)Accuracy ±2% | 2-50 (adult)5-80 (pediatric)Accuracy ±2% | 1-60Accuracy ±1 bpmor 10% of setting | SubstantiallyEquivalent |
| Rise Time | Min-900 msec | Min-900 msec | 1-6 (nominalvalues) | SubstantiallyEquivalent |
| Timed Inspiration | 0.2 to 5 secondsAccuracy ±(20 ms+5% of setting) | 0.2 to 5 secondsAccuracy ±(20 ms+5% of setting) | 0.3 to 5 secondsAccuracy ±100ms | SubstantiallyEquivalent |
| Sensitivity | InspiratoryFlow controlled0.5 to 15l/min | InspiratoryFlow controlled0.5 to 15l/min | Inspiratory &ExpiratoryFlow controlled | SubstantiallyEquivalent |
| Technology &Design | ||||
| OperatingPrinciple | Micro-processorcontrolled bloweras air source | Micro-processorcontrolled bloweras air source | Micro-processorcontrolled bloweras air source | SubstantiallyEquivalentSame operatingprinciple |
| Technology | Software basedpressure, flow andtime regulationwith secondaryvolume target | Software basedpressure, flow andtime regulationwith secondaryvolume target | Software basedpressure, flow andtime regulationwith secondaryvolume target | SubstantiallyEquivalentSametechnology |
| Material contactstatus | Permanentcontact duration,indirect dry air-path patient-contactingmaterials | Permanentcontact duration,indirect dry air-path patient-contactingmaterials | Permanentcontact duration,indirect dry air-path patient-contactingmaterials | SubstantiallyEquivalentStatusunchanged fromK133868 |
| Materials | Various materials,including:• ThermoplasticPolyurethane(TPU)• Polycarbonate(PC) and PCblends• Polypropylene(PP)• Silicone• Aluminium | Various materials,including:• ThermoplasticPolyurethane(TPU)• Polycarbonate(PC) and PCblends• Polypropylene(PP)• Silicone• Aluminium | Proprietaryinformation | SubstantiallyEquivalentMaterialsunchanged fromK133868 |
| Circuit Interfaces | Vented & Non-vented | Vented & Non-vented | Vented & Non-vented | SubstantiallyEquivalent |
| Invasive & Non-invasive | Invasive & Non-invasive | Invasive & Non-invasive | ||
| Circuit Types | Double limbSingle limb withexpiratory valveSingle limb withintentional leak | Double limbSingle limb withexpiratory valveSingle limb withintentional leak | Single limb withexpiratory valvewith proximal flow& pressuresensingSingle limb withexpiratory valveSingle limb withintentional leak | SubstantiallyEquivalentSame circuittypes |
| User Interface | LCD screen, keys& LED indicators | LCD screen, keys& LED indicators | LCD screen, hardkeys & LEDindicators | SubstantiallyEquivalent |
| Power | AC, DC, &Internal battery | AC, DC, &Internal battery | AC, DC, &Internal battery | SubstantiallyEquivalent |
| SystemComponents | VentilatorMask, invasivepatient interfaceAir tubing, airfilter, optionalantibacterial filterOptional externalhumidifier or HME | VentilatorMask, invasivepatient interfaceAir tubing, airfilter, optionalantibacterial filterOptional externalhumidifier or HME | VentilatorMask, invasivepatient interfaceAir tubing, airfilter, optionalantibacterial filterOptional externalhumidifier or HME | SubstantiallyEquivalent |
| SupplementalOxygen | Labeled for usewith supplementaloxygenOptional oxygensensor | Labeled for usewith supplementaloxygenOptional oxygensensor | Labeled for usewith supplementaloxygen | SubstantiallyEquivalent |
{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.
§ 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).