Who is the manufacturer of Astral 100/150?

Resmed, Ltd. filed the 510(k) submission for Astral 100/150 (K152068).

What is the FDA product code for Astral 100/150?

CBK. It is classified under 21 CFR 868.5895 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Astral 100/150?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Astral 100/150?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Astral 100/150

Q: What are the predicate devices for Astral 100/150?

ResMed Astral 100/150 (K133868).

K152068 · Resmed, Ltd. · CBK · May 13, 2016 · Anesthesiology

Device Facts

Record ID	K152068
Device Name	Astral 100/150
Applicant	Resmed, Ltd.
Product Code	CBK · Anesthesiology
Decision Date	May 13, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5895
Device Class	Class 2
Attributes	Therapeutic, Pediatric

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.

Device Story

Astral 100/150 is a microprocessor-controlled continuous ventilator. It uses a blower, valves, and pressure/flow sensors to regulate air delivery to patients via single or double-limb breathing circuits. It supports various modes including Assist/Control, SIMV, CPAP, and iVAPS (Volume Assured Pressure Support). The device is operated by clinicians or patients in home, hospital, or portable environments. It features a user interface for parameter adjustment and data display, and includes integrated battery and external power options. The iVAPS mode automatically adjusts pressure support to meet a preset alveolar minute volume target. Output includes therapeutic and technical alarms and monitored clinical data. The device assists breathing, potentially benefiting patients with respiratory insufficiency by ensuring adequate ventilation.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including verification of ventilation control parameters, waveform performance, trigger reliability, alarm verification, and electrical safety/EMC testing.

Technological Characteristics

Microprocessor-controlled blower; software-based pressure, flow, and time regulation. Materials include TPU, PC, PP, silicone, and aluminum. Connectivity includes AC/DC power and internal battery. Complies with IEC 60601-1, IEC 60601-1-2, ISO 10651-2, and ASTM F 1246-91.

Indications for Use

Indicated for patients >5kg requiring continuous or intermittent mechanical ventilation; iVAPS mode indicated for patients >30kg. Used in home, hospital, and portable settings for invasive and non-invasive ventilation.

Regulatory Classification

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.

Predicate Devices

ResMed Astral 100/150 (K133868)

Reference Devices

Respironics Trilogy 200 (K093416)

Submission Summary (Full Text)

{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.

Astral 100/150

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Astral 100/150

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