(166 days)
Not Found
No
The description focuses on traditional microprocessor-controlled ventilation mechanics and does not mention AI or ML.
Yes
The "Device Description" section states that the Astral device provides "both therapeutic and technical alarms."
No
The device is described as providing ventilatory support for patients requiring mechanical ventilation, which is a therapeutic function. While it displays "monitored clinical data," its primary function is not to diagnose a condition but rather to provide life support.
No
The device description clearly outlines hardware components such as a micro-processor controlled blower, valves, pressure and flow sensors, and an integrated battery, indicating it is a physical medical device with embedded software, not a software-only device.
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 "continuous or intermittent ventilatory support for patients". This is a therapeutic function, directly supporting a patient's breathing.
- Device Description: The description details a mechanical ventilator system that delivers air to the patient. This is a life-support device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro testing, or providing information for diagnosis based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health. The Astral 100/150 is a device that acts upon the body to provide respiratory support.
N/A
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 Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and non-invasive ventilation.
Product codes (comma separated list FDA assigned to the subject device)
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 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
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
patients weighing more than 5kg (11 lb)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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: +1 858-836-6081 Fax: +1 858-836-5519
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 | ||
| ventilatory support | Continuous or intermittent | ||
| ventilatory support | Substantially Equivalent | ||
| Intended use the same as | |||
| predicate | |||
| Invasive & non-invasive | Invasive & non-invasive | ||
| Adult and Pediatric (>5kg) | Adult and Pediatric (>5kg) | ||
| Home, institution/hospital, & | |||
| portable | Home, institution/hospital, & | ||
| portable | |||
| Therapy Modes | |||
| Supplementary | |||
| Features | ACV | ||
| PACV | |||
| V-SIMV | |||
| P-SIMV | |||
| PS & S/T | |||
| CPAP | |||
| PAC | |||
| SV | |||
| Sigh | |||
| Apnea Ventilation | |||
| Manual Breath | CV, AC | ||
| T & PC | |||
| SIMV | |||
| PC-SIMV | |||
| S, S/T & T | |||
| CPAP | |||
| PC | |||
| AVAPS | |||
| Sigh | |||
| Apnea Rate | Substantially Equivalent | ||
| Equivalent modes can be | |||
| configured to deliver the | |||
| same therapy. | |||
| Apnea Ventilation & | |||
| Manual Breath | |||
| substantially equivalent to | |||
| LTV 1200 (K060647) | |||
| Ventilation | |||
| Control | |||
| Parameters | Pressure Range | ||
| Tidal Volume | |||
| Respiratory Rate | |||
| Rise Time | |||
| Timed Inspiration | |||
| Sensitivity | Pressure Range | ||
| Tidal Volume | |||
| Respiratory Rate | |||
| Rise Time | |||
| Timed Inspiration | |||
| Sensitivity | Substantially Equivalent | ||
| Astral provides equivalent | |||
| range and equivalent or | |||
| improved accuracy to the | |||
| predicate device |
2
| Operating
| Principle | |||
|---|---|---|---|
| Technology | Micro-processor controlled | ||
| blower as air source | Micro-processor controlled | ||
| blower as air source | Substantially Equivalent | ||
| Same operating principle | |||
| 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 | |||
| Circuit | |||
| Interfaces | Vented & Non-vented | ||
| Invasive & Non-invasive | Vented & Non-vented | ||
| Invasive & Non-invasive | Substantially Equivalent | ||
| Circuit Types | Double limb | ||
| Single limb with expiratory | |||
| valve | |||
| Single limb with intentional | |||
| leak | Active Flow | ||
| Active PAP | |||
| Passive | Substantially Equivalent | ||
| Double limb (Astral) & | |||
| Active Flow (Trilogy 200) | |||
| both measure expiratory | |||
| flow. Double limb also on | |||
| LTV 1200 (K060647) | |||
| User Interface | LCD screen, hard keys & LED | ||
| indicators | LCD screen, hard keys & LED | ||
| indicators | Substantially Equivalent | ||
| Power | 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 | 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 (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" (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 (800) 638-2041 or (301) 796-7100 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'
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