Astral 100/150

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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) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K172875 # 510(k) SUMMARY [As required by 21 CFR 807.92(c)] - April 26, 2018 1. Date prepared ## 2. Applicant information | Company Name/<br>Owner | ResMed Ltd<br>1 Elizabeth Macarthur Drive<br>Bella Vista NSW 2153 Australia | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Name | Peter Jennings<br>Senior Regulatory Affairs Manager<br>Tel: + 61 2 8884 2232<br>Fax: + 61 2 8884 2004<br>peter.jennings@resmed.com.au | | Correspondent Details/<br>Official Contact | Miss Sheila Bruschi<br>Director, Regulatory Affairs<br>ResMed Corp.<br>9001 Spectrum Center Blvd<br>San Diego CA 92123 USA<br>Tel: +1 858 836 5934<br>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) | | {4}------------------------------------------------ ## 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:<br>Astral 100/150<br>(K152068) | Subject Device:<br>Astral 100/150 | Substantially<br>Equivalent? | |----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product code | CBK, NOU | CBK, NOU | YES | | Intended Use | Continuous or intermittent<br>ventilatory support<br><br>Invasive & non-invasive<br><br>Adult and Pediatric (>5kg)<br><br>Home, institution/hospital, &<br>portable | Continuous or intermittent<br>ventilatory support<br><br>Invasive & non-invasive<br><br>Adult and Pediatric (>5kg)<br><br>Home, institution/hospital, &<br>portable | YES | | Intended Patient<br>Population | Patients who require mechanical<br>ventilation (Continuous or<br>intermittent ventilatory support)<br><br>Adult and Pediatric (>5kg),<br>iVAPS (>30kg) | Patients who require mechanical<br>ventilation (Continuous or<br>intermittent ventilatory support)<br><br>Adult and Pediatric (>5kg),<br>iVAPS (>30kg) | YES | | Therapies | | | | | Modes | ACV<br>PACV<br>V-SIMV<br>P-SIMV<br>PS & ST<br>CPAP<br>PAC<br>iVAPS (fixed manual EPAP) | ACV<br>PACV<br>V-SIMV<br>P-SIMV<br>PS & ST<br>CPAP<br>PAC<br>iVAPS (optional AutoEPAP) | YES<br>Clinical and bench data for<br>AutoEPAP on the subject<br>Astral device demonstrate it<br>is substantially equivalent to<br>manual EPAP.<br>Moreover, AutoEPAP in<br>iVAPS mode has been<br>cleared in the reference<br>device K161492.<br>PS & ST with intentional leak<br>have the same functionality<br>and clinical intent. | | Supplementary<br>Therapy<br>Features | SV (Safety Volume)<br>Sigh<br>Apnea Ventilation<br>Manual Breath | SV (Safety Volume)<br>Sigh<br>Apnea Ventilation<br>Manual Breath | YES<br>SV on therapy modes with<br>leak circuits has the same<br>clinical intent and functional<br>implementation as SV on<br>equivalent therapy modes<br>with valved circuits. | | Ventilation Control Parameters | | | | | Pressure Range<br>[cmH2O] | IPAP: 4-50<br>EPAP: 2-25 s<br>CPAP: 3-20<br>PEEP: Off, 3 to 20<br>Accuracy: ±(0.5 + 5% of target) | IPAP: 4-50<br>EPAP: 2-25 s<br>CPAP: 3-20<br>PEEP: Off, 3 to 20<br>Accuracy: ±(0.5 + 5% of target) | YES | | Tidal Volume<br>[mL] | 100-2500 (adult)<br>50-500 (pediatric)<br><br>Accuracy ± 12 ml or 10%<br>whichever is greater. (Valved<br>Circuits) | 100-2500 (adult)<br>50-500 (pediatric)<br><br>Accuracy ± 12 ml or 10%<br>whichever is greater. (Valved<br>Circuits) | YES | | Respiratory<br>Rate<br>(Breathing<br>Frequency)<br>[bpm] | 2-50 (adult)<br>5-80 (pediatric)<br><br>Accuracy ±2% | 2-50 (adult)<br>5-80 (pediatric)<br><br>Accuracy ±2% | YES | | Characteristic | Predicate Device:<br>Astral 100/150<br>(K152068) | Subject Device:<br>Astral 100/150 | Substantially<br>Equivalent? | | Rise Time | Min-900 msec | Min-900 msec | YES | | Timed<br>Inspiration | 0.2 to 5 seconds | 0.2 to 5 seconds | YES | | Sensitivity | Accuracy ±(20 ms +5% of<br>setting) | Accuracy ±(20 ms +5% of<br>setting) | | | Sensitivity | Inspiratory<br>Flow controlled<br>0.5 to 15l/min | Inspiratory<br>Flow controlled<br>0.5 to 15l/min | YES | | Technology & Design | | | | | Operating<br>Principle | Micro-processor controlled<br>blower as air source | Micro-processor controlled<br>blower as air source | YES | | Technology | Software based pressure, flow<br>and time regulation with<br>secondary volume target | Software based pressure, flow<br>and time regulation with<br>secondary volume target | YES | | Material contact<br>status | Permanent contact duration,<br>indirect dry airpath<br>patientcontacting materials | Permanent contact duration,<br>indirect dry airpath<br>patientcontacting materials | YES | | Circuit<br>Interfaces | Vented & Non-vented<br>Invasive & Non-invasive | Vented & Non-vented<br>Invasive & Non-invasive | YES | | Circuit Types | Double limb<br>Single limb with expiratory valve<br>Single limb with intentional leak | Double limb<br>Single limb with expiratory valve<br>Single limb with intentional leak | YES | | User Interface | LCD screen, soft keys, mute<br>button & LED indicators. | LCD screen, soft keys, mute<br>button & LED indicators. | YES | | System<br>Components | Ventilator | Ventilator | YES | | | Mask, invasive patient interface | Mask, invasive patient interface | | | | Air tubing, air filter, optional<br>antibacterial filter | Air tubing, air filter, optional<br>antibacterial filter | | | | Optional humidifier/ HME,<br>oximeter, nebuliser | Optional humidifier/ HME,<br>oximeter, nebuliser | | | Power | AC, DC and Internal Battery | AC, DC and Internal Battery | YES | | Supplemental<br>Oxygen | Labeled for use with<br>supplemental oxygen | Labeled for use with<br>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.