(83 days)
Not Found
Not Found
No
The summary describes a non-invasive airflow channel for positive airway pressure devices, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is described as channeling airflow from a positive airway pressure device (CPAP or bilevel system) to a patient for whom positive airway pressure has been prescribed, which is a therapeutic intervention.
No
Explanation: The device is described as channeling airflow from a positive airway pressure device, indicating a therapeutic or enabling function for treatment (CPAP/bilevel system), not for diagnosing medical conditions.
No
The device description and intended use clearly describe a physical medical device (a mask) used for channeling airflow, not a software-only device.
Based on the provided information, the Mirage Micro is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the device as channeling airflow noninvasively to a patient from a positive airway pressure device. This is a therapeutic function, not a diagnostic one.
- Lack of Diagnostic Activity: IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. The Mirage Micro does not perform any such examination of specimens.
- Device Description (Not Found): While the description is missing, the intended use clearly points away from diagnostic activity.
- Other Sections: The absence of information related to image processing, AI/ML, imaging modality, anatomical site, training/test sets, performance studies, and key metrics further supports that this is not a diagnostic device. These sections are typically relevant for devices that perform analysis or interpretation, which is characteristic of many IVDs.
In summary, the Mirage Micro is a device used for delivering positive airway pressure, which is a form of therapy, not a diagnostic procedure.
N/A
Intended Use / Indications for Use
The Mirage Micro channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Mirage Micro is:
- to be used by adult patients (>66lb / >30kg) for whom positive airway pressure has been prescribed.
- to be reused in the home environment and multi-patient reuse in the hospital/institutional environment.
Product codes
BZD
Device Description
Mirage Micro Model 16333 (S), 16334 (M&L), 16335 (LW&XL)
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
adult patients (>66lb / >30kg)
Intended User / Care Setting
Home environment and multi-patient reuse in the hospital/institutional environment.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 emblem featuring three curved lines, resembling an abstract representation of the human form or a symbol of health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ResMed, Limited C/O Mr. David D'Cruz Vice President, US Medical-and Regulatory Affairs ResMed, Corporation 9001 Spectrum Center Boulevard San Diego, California 92123
JUN - 9 2010
Re: K100772
Trade/Device Name: Mirage Micro Model 16333 (S), 16334 (M&L), 16335 (LW&XL) Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinous Ventilator Regulatory Class: II Product Code: BZD Dated: May 11, 2010 Received: May 14, 2010
Dear Mr. D'Cruz:
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.
1
Page 2- Mr. D'Cruz
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 (QS) 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Mirage Micro Special 510k
Indication for Use
510(k) Number (if known):
Device Name:
Mirage Micro™
Indication for Use
The Mirage Micro channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Mirage Micro is:
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﻘﻘﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﻘﻘﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ
ge Micro is.
to be used by adult patients (>66lb / >30kg) for whom positive airway pressure has been prescribed. l
- (o be asou by addit patient re-use in the home environment and multi-patient reuse in the hospital/institutional environment.
| Prescription Use
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(Part 21 CFR 807 Subpart C) |
|-------------------------------------------------|--------|-----------------------------------------------------|
| X | | |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K 100772 |
| Mar, 2010 | Page 1 of 1 |