(123 days)
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.
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. 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. 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. 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.
This document concerns the ResMed Mirage Liberty™ Full Face Mask, a medical device. The submission primarily relies on demonstrating substantial equivalence to predicate devices rather than a standalone study with specific acceptance criteria as defined for an AI/CADe device.
Therefore, the requested information elements related to AI/CADe clinical study design (sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, specific ground truth types like pathology or outcomes data) are not applicable to this 510(k) summary, as it is for a physical medical device.
The study described is a comparison to predicate devices, and the 'acceptance criteria' are essentially the demonstration of substantial equivalence through bench testing.
Here's the information that can be extracted or deduced from the provided text:
1. Table of "Acceptance Criteria" and Reported Device Performance
Since this is a substantial equivalence submission for a physical device, the "acceptance criteria" are not framed as quantitative metrics for accuracy, sensitivity, or specificity as they would be for an AI/CADe device. Instead, the acceptance is based on demonstrating that the new device is functionally equivalent to existing legally marketed predicate devices.
| Acceptance Criterion (Demonstrating Substantial Equivalence via Bench Testing) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Provide seal via dual wall silicone interface | Both the new device and predicate mask provide seal via dual wall silicone interface. |
| Offer various sizes to ensure adequate fit range | Both masks are offered in various sizes to ensure adequate fit range. |
| Incorporate vent holes for continuous air leak (CO2 washout) | Both masks incorporate vent holes in the frame to provide continuous air leak to flush out dead space and minimize rebreathing CO2. |
| Include built-in Anti-Asphyxia Valve | Both masks include built-in Anti-Asphyxia Valve for breathing fresh air during positive air pressure device failure. |
| Connect to conventional air delivery hose via standard conical connectors | Both masks connect to conventional air delivery hose via standard conical connectors (ISO 5356-1). |
| Fabricated using materials deemed safe (ISO 10993) | All components of both masks are fabricated using materials deemed safe (ISO 10993). |
| Compatible with CPAP or Bilevel therapy | Use of Full Face Masks with CPAP or Bilevel therapy is clinically proven and accepted. |
| Pressure flow characteristics | Substantially equivalent to predicate device. |
| Functional dead-space | Substantially equivalent to predicate device. |
| Physical dead space | Substantially equivalent to predicate device. |
| Flow impedance | Substantially equivalent to predicate device. |
| Reusability in hospital/institutional environment | Both new and predicate devices can be reused in hospital/institutional environment. |
| Sterilization compatibility (new device has additional method) | New device is compatible with an additional method of sterilization compared to predicate. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of an AI/CADe test set. The submission refers to "bench testing" of the physical device and a comparison of its characteristics to predicate devices. The exact number of units or test conditions used for this bench testing is not specified.
- Data Provenance: Not specified, but generally, bench testing would be conducted in a laboratory environment, likely by the manufacturer (ResMed Ltd, Australia).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The ground truth for this device is based on established engineering and physiological requirements for respiratory masks and the performance of predicate devices. Expert consensus in the clinical interpretation sense (e.g., radiologists reviewing images) is not relevant here. The clinical efficacy of FFM with CPAP/Bilevel therapy is stated as "Clinical Data proven technology and is well accepted by the medical community."
4. Adjudication method for the test set
- Not Applicable. There is no "test set" in the sense of clinical cases requiring adjudication. The assessment is a direct comparison of physical and functional characteristics.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a physical medical device (a mask), not an AI/CADe system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (a mask), not an AI/CADe system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is implicitly based on:
- Engineering standards: e.g., ISO 5356-1 for connectors, ISO 10993 for material safety.
- Physiological requirements: Effective CO2 washout, proper seal, anti-asphyxia mechanism.
- Performance of legally marketed predicate devices: The "substantial equivalence" framework means the predicate devices' performance serves as the benchmark.
- Accepted medical practice: "Use of Full Face Masks with CPAP or Bilevel therapy is Clinical Data proven technology and is well accepted by the medical community."
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is for a physical device, not an AI/CADe system using machine learning.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set.
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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
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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
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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.
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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
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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
§ 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).