ASTRAL VENTILATOR

K133868 · Resmed, Ltd. · CBK · Jun 4, 2014 · Anesthesiology

Device Facts

• Record ID: K133868
• Device Name: ASTRAL VENTILATOR
• Applicant: Resmed, Ltd.
• Product Code: CBK · Anesthesiology
• Decision Date: Jun 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 5kg (11 lb) who require mechanical ventilation. 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 ventilator; uses blower, valves, and pressure/flow sensors to regulate air delivery. Inputs: air via double circuit, single circuit with expiratory valve, or single circuit with intentional leak; supplemental oxygen entrainment at turbine inlet. Outputs: therapeutic/technical alarms, monitored clinical data on LCD screen. Used in home, hospital, and portable settings; operated by clinicians or patients. Provides Assist/Control, SIMV (volume/pressure), Continuous Spontaneous Ventilation (Pressure Support/CPAP), Volume Assurance, and Apnea Ventilation. Healthcare providers adjust clinical parameters via user interface; output assists in managing patient respiratory needs; benefits include continuous or intermittent ventilatory support for patients >5kg.

Clinical Evidence

No clinical data. Bench testing only. Verification activities included accuracy of ventilation volume and pressure controls, waveform performance (flow, pressure, volume), triggering/cycling accuracy and repeatability, endurance, environmental testing, and alarm verification. Side-by-side performance testing against predicates confirmed equivalent flow, pressure, and volume waveforms, and patient trigger reliability.

Technological Characteristics

Microprocessor-controlled blower; pressure, flow, and time regulation. Interfaces: double limb, single limb with expiratory valve, or single limb with intentional leak. Power: AC, DC, and internal battery. User interface: LCD screen, hard keys, LED indicators. Standards: ASTM F 1246-91, ASTM F 1100-90, ISO 10651-2, IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for patients >5kg (11 lb) requiring mechanical ventilatory support; suitable for home, hospital, and portable use; supports both 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

• Respironics Trilogy 200 (K093416)
• Pulmonetic LTV 1200 (K060647)

Submission Summary (Full Text)

{0}------------------------------------------------

# JUN 0 4 2014

# 510(k) Summary - Astral

Date prepared

Official contact

Submitter

4 April 2014

Peter Jennings Senior Regulatory Affairs Manager

Jim Cassi V.P., Quality Assurance Americas ResMed Corp. 9001 Spectrum Center Blvd., San Diego CA 92123 USA Tel: [phone] Fax: [phone]

Astral 100/150

Continuous ventilator

Proprietary name

Common name

Classification

21 CFR 868.5895 Primary product code CBK Secondary product code NOU Class II Ventilator, continuous, facility use

Respironics Trilogy 200 (K093416) Pulmonetic LTV 1200 (K060647)

Predicate Devices

Reason for submission

New device

{1}------------------------------------------------

#### Intended Use

The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 5kg (11 lb) who require mechanical ventilation. 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 delivery. 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 and technical alarms, 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
- ー 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 ﺖ
- Similar performance specifications -

A comparative summary of the technological characteristics of the Astral device with the primary predicate Trilogy 200 (K093416) is presented below.

| Characteristic | Astral (new device) | Trilogy 200 (K093416) | Comparison |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Continuous or intermittent<br>ventilatory support | Continuous or intermittent<br>ventilatory support | Substantially Equivalent<br>Intended use the same as<br>predicate |
| | Invasive & non-invasive | Invasive & non-invasive | |
| | Adult and Pediatric (>5kg) | Adult and Pediatric (>5kg) | |
| | Home, institution/hospital, &<br>portable | Home, institution/hospital, &<br>portable | |
| Therapy Modes<br>Supplementary<br>Features | ACV<br>PACV<br>V-SIMV<br>P-SIMV<br>PS & S/T<br>CPAP<br>PAC<br>SV<br>Sigh<br>Apnea Ventilation<br>Manual Breath | CV, AC<br>T & PC<br>SIMV<br>PC-SIMV<br>S, S/T & T<br>CPAP<br>PC<br>AVAPS<br>Sigh<br>Apnea Rate | Substantially Equivalent<br>Equivalent modes can be<br>configured to deliver the<br>same therapy.<br>Apnea Ventilation &<br>Manual Breath<br>substantially equivalent to<br>LTV 1200 (K060647) |
| Ventilation<br>Control<br>Parameters | Pressure Range<br>Tidal Volume<br>Respiratory Rate<br>Rise Time<br>Timed Inspiration<br>Sensitivity | Pressure Range<br>Tidal Volume<br>Respiratory Rate<br>Rise Time<br>Timed Inspiration<br>Sensitivity | Substantially Equivalent<br>Astral provides equivalent<br>range and equivalent or<br>improved accuracy to the<br>predicate device |

{2}------------------------------------------------

| Operating<br>Principle | | | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology | Micro-processor controlled<br>blower as air source | Micro-processor controlled<br>blower as air source | Substantially Equivalent<br>Same operating principle |
| | 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 | Substantially Equivalent<br>Same technology |
| Circuit<br>Interfaces | Vented & Non-vented<br>Invasive & Non-invasive | Vented & Non-vented<br>Invasive & Non-invasive | Substantially Equivalent |
| Circuit Types | Double limb<br>Single limb with expiratory<br>valve<br>Single limb with intentional<br>leak | Active Flow<br>Active PAP<br>Passive | Substantially Equivalent<br>Double limb (Astral) &<br>Active Flow (Trilogy 200)<br>both measure expiratory<br>flow. Double limb also on<br>LTV 1200 (K060647) |
| User Interface | LCD screen, hard keys & LED<br>indicators | LCD screen, hard keys & LED<br>indicators | Substantially Equivalent |
| Power | AC, DC, & Internal battery | AC, DC, & Internal battery | Substantially Equivalent |
| System<br>Components | Ventilator<br>Mask, invasive patient<br>interface<br>Air tubing, air filter, optional<br>antibacterial filter<br>Optional external humidifier or<br>HME | Ventilator<br>Mask, invasive patient<br>interface<br>Air tubing, air filter, optional<br>antibacterial filter<br>Optional external humidifier or<br>HME | Substantially Equivalent |

#### Non-Clinical Performance Data

Design and Verification activities were performed on the Astral as a result of the risk analysis and product requirements. 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, and alarms verification. All tests confirmed the product met the predetermined acceptance criteria. In particular non-clinical side-by-side performance testing was performed for each therapy mode and supplementary feature. Characteristics tested included flow, pressure and volume waveforms, ventilation control parameter accuracy, and patient trigger reliability and synchrony, supporting the claim that the Astral is substantially equivalent to the predicate devices.

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

- FDA Draft Reviewer Guidance for Ventilators (July 1995) -
- 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
- ASTM F 1100-90 (1997) Standard Specification for Ventilators intended for use in -Critical Care
- ISO 10651-2:2004. Lung ventilators for medical use Part 2: Home care ventilators for ventilator-dependent 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.

{3}------------------------------------------------

### Conclusion

The indications for use, technological characteristics, and principles of operation are similar to the predicate devices. Performance data supports the claim that the new device is as safe and as effective as the predicate devices. Thus the data in this submission supports the claim of substantial equivalence to the identified predicate devices.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WQ66-G609 Silver Spring, MD 20993-0002

# June 4, 2014

ResMed Corporation Mr. Jim Cassi V.P. of Quality Assurance Americas 9001 Spectrum Center Blvd. San Diego, CA 92123

Re: K133868

Trade/Device Name: Astral 100/150 Regulation Number: 21 CFR 868.5895 Regulation Name: Ventilator, continuous, facility use Regulatory Class: II Product Code: CBK. NOU Dated: April 4, 2014 Received: April 7, 2014

#### Dear Mr. Cassi;

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. Iisting 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.

{5}------------------------------------------------

Page 2 - Mr. Cassi

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary STRUNner -S

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

{6}------------------------------------------------

## 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 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)

Image /page/6/Picture/13 description: The image shows the letters "FDA" in a stylized, blocky font. The letters are arranged horizontally, with "F" on the left, "D" in the middle, and "A" on the right. The letters are composed of thick, angular lines, giving them a bold and somewhat abstract appearance. The image is in black and white.

Anya C. Harry -S 2014.06.04 03:21:15 -04'00'

Page __ of _