(123 days)
Not Found
No
The description focuses on the mechanical components and function of a mask for positive airway pressure, with no mention of AI or ML.
No.
This device is a mask accessory for positive airway pressure devices, not the therapeutic device itself. It channels airflow but does not provide the therapy.
No
The device is a mask that channels airflow from a positive airway pressure device to a patient. Its intended use is for therapy (CPAP/bilevel system), not for diagnosis. The performance studies mentioned also focus on physical characteristics like pressure flow and dead-space, not diagnostic accuracy.
No
The device description clearly details physical components like a mask, headgear, vent holes, and an anti-asphyxia valve, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Mirage Liberty is a mask that channels airflow from a positive airway pressure device to a patient's nose or mouth. It is a respiratory support device, not a device that analyzes biological specimens.
- Intended Use: The intended use is to provide positive airway pressure to patients, not to perform diagnostic tests on samples.
- Device Description: The description focuses on the physical components and function of the mask for delivering air, not on any analytical or diagnostic capabilities.
Therefore, the Mirage Liberty falls under the category of a medical device used for respiratory support, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Mirage Liberty channels airflow non invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system. The Mirage Liberty is to be used by adult patients (>66lb / >30kg) for whom positive airway pressure has been prescribed. The Mirage Liberty FFM is intended for single patient reuse in the home environment and/or multi-patient reuse in the hospital/institutional environment.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The Mirage Liberty FFM provides seal such that air flow from a positive pressure source is directed to the patient's nose or mouth. The mask is held in place with adjustable headgear that straps the mask to the face. Mirage Liberty FFM is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
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
single patient reuse in the home environment and/or 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)
- Use of Full Face Masks with CPAP or Bilevel therapy is Clinical Data proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the Mirage Liberty FFM, as was the case with the predicate device.
- The Pressure flow characteristics, functional dead-space, Performance Data physical dead space and flow impedance of both the new device and the predicate device are substantially equivalent.
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.
Mirage FFM Series 2 (K023244, K023284 and K023306), Mirage Swift (K042403).
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
§ 868.5905 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
Image /page/0/Picture/0 description: The image shows the word "ResMed" in bold, black letters. The font is sans-serif and slightly italicized. The letters are evenly spaced and the word is easily readable.
Ko63011
510(k) SUMMARY FEB - 2 2007 [As required by 21 CFR 807.92(c)] 25th, January, 2007 Date Prepared Official Contact Dr Lionel King, Vice-President, Global Quality Assurance and Regulatory Affairs Device Trade Name Mirage Liberty™ Full Face Mask Device Common Name/ Full Face Mask, Classification Name Accessory to Noncontinuous Ventilator (IPPB) Classification 21 CFR 868.5905, 73 BZD (Class II) Mirage FFM Series 2 (K023244, K023284 and K023306), Predicate Device Mirage Swift (K042403). Description The Mirage Liberty FFM provides seal such that air flow from a positive pressure source is directed to the patient's nose or mouth. The mask is held in place with adjustable headgear that straps the mask to the face. Mirage Liberty FFM is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Intended Use The Mirage Liberty channels airflow non invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system. The Mirage Liberty is to be used by adult patients (>66lb / >30kg) for whom positive airway pressure has been prescribed. The Mirage Liberty FFM is intended for single patient reuse in the home environment and/or multi-patient reuse in the hospital/institutional environment. Technological Comparison with predicate device, Mirage FFM Series 2: Characteristics comparison The new device and the predicate mask, provide seal via dual wall silicone interface. Both masks are offered in various sizes to ensure adequate fit range.
Both the masks incorporate vent holes in the frame to provide continuous air leak to flush out the dead space within the mask and minimize the amount of CO2 rebreathed by the patient.
ResMed Ltd 1 Elizabeth MacArthur Drive, Bella Vista NSW 2153 Australia Tel: +61 2 8884 1000 Fax: +61 2 8883 3114 ABN 30 003 765 142
1
Both the masks include built-in Anti-Asphyxia Valve which in conjunction with the vent holes allow the patient to continue to breathe fresh air in the event of positive airpressure device failure or deterioration in the therapy being administered. The design of the mask components is such that the incorporation of these vent holes do not interfere with the intended performance of the masks.
Both the masks connect to conventional air delivery hose between the mask and the positive airway-pressure source via standard conical connectors (ref: ISO 5356-1).
All the components of both the masks are fabricated using materials deemed safe. (ref: ISO 10993).
Both the masks are constructed using molded plastic components and fabric headgear, except the headgear of the new device also includes a molded plastic part.
The main differences are in the number of components, and their design, geometry and how individual components interface with each other. Both the masks are designed and constructed under ResMed's 21 CFR Part 820 compliant Quality Management System.
Comparison with predicate device, Mirage Swift:
Both the new device and the predicate device can be reused in the hospital/institutional environment. The new device is compatible with an additional method of sterilization when compared to the predicate device.
- Use of Full Face Masks with CPAP or Bilevel therapy is Clinical Data proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the Mirage Liberty FFM, as was the case with the predicate device.
- The Pressure flow characteristics, functional dead-space, Performance Data physical dead space and flow impedance of both the new device and the predicate device are substantially equivalent.
Mirage Liberty Full Face Mask (FFM) is substantially Substantial Equivalence Conclusion equivalent to the predicate devices.
ResMed Ltd 1 Elizabeth MacArthur Drive, Bella Vista NSW 2153 Australia Tel: +61 2 8883 3114 ABN 30 003 765 142
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 2 2007
ResMed Limited C/O Mr. David D' Cruz Vice President Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K063011
Trade/Device Name: Mirage Liberty™ Full Face Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: January 25, 2007 Received: January 26, 2007
Dear Mr. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number (if known): K063011
Device Name:
MIRAGE LIBERTYTM FULL FACE MASK
Indication for Use
The Mirage Liberty 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 Liberty is to be used by adult patients (>66lb />30kg) for whom positive airway pressure has been prescribed.
The Mirage Liberty FFM intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital/institutional environment.
AND/OR
Over-The-Counter Use_
X (Part 21 CFR 801 Subpart D) Subpart C)
Prescription Use
(Part 21 CFR 807
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Page 1 of 1
thory Vartak
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, Gental Devices Division of Anesthaslelogy, Dontal Devices
510(k) Number: K063011