(74 days)
Not Found
No
The device description and performance studies focus on the physical components and airflow mechanics of a CPAP mask, with no mention of AI or ML technologies.
No.
The device is a mask that channels airflow from a positive airway pressure device to the patient; it does not itself provide therapy.
No
The device description indicates it is an interface (mask) that channels airflow from a positive airway pressure device to the patient; it does not mention any function related to diagnosing a condition or disease.
No
The device description clearly states it is a mask and headgear system, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Mirage Quattro is a mask that channels airflow from a positive airway pressure device to a patient's nose and mouth. Its function is to deliver therapy, not to analyze biological samples.
- Intended Use: The intended use clearly states it's for channeling airflow for positive airway pressure therapy. There is no mention of testing or analyzing samples.
- Device Description: The description focuses on the physical interface and how it connects to a positive pressure source.
- Lack of IVD-related information: The document does not mention any aspects related to sample collection, analysis, reagents, or diagnostic results.
Therefore, the Mirage Quattro is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mirage Quattro 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 Quattro is to be used by adult patients (>66lb />30kg) for whom positive airway pressure has been prescribed.
The Mirage Quattro is intended for single patient re-use 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 Quattro provides an interface such that airflow from a positive pressure source is directed to the patient's nose and mouth. The mask is held in place with adjustable headgear that straps the mask to the face.
The Mirage Quattro is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
The Mirage Quattro is a prescription device supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Adult patients (>66lb />30kg)
Intended User / Care Setting
Single patient re-use 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)
Bench testing is sufficient to demonstrate safety and efficacy of the modified Mirage Quattro, as was the case with the previously cleared Mirage Quattro device.
The CO2 performance of the modified device and the previously cleared device are substantially equivalent. Both the modified device and the previously cleared device are designed to operate on the same flow generator settings as specified in the User Guide. The only difference is an extension in the therapy pressure range from 4-20cmH2O to 4-40cmH2O. Verification testing of the modified device did not raise any new questions of safety and efficacy.
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 Quattro™ (K063122)
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
RESMED
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参考文献
Special 510(k): Device Mirage Quattro
Special 510(k): Device Modification
5. 510(k) SUMMARY
K 113127
[As required by 21 CFR 807.92]
| Date Prepared | 18 October, 2011 |
|---|---|
| Submitter | Ms. Tracey Bullivant, |
| Regulatory Affairs Manager | |
| Official Contact | Mr. David D'Cruz, |
| V.P., US Medical & Regulatory Affairs | |
| 9001 Spectrum Center Blvd | |
| San Diego CA 92123 USA | |
| Tel: (858) 836-5984 | |
| Device Trade Name | Mirage Quattro™ |
| Device Common | |
| Name/ Classification | |
| Name | Vented Full Face Mask; |
| Accessory to Noncontinuous Ventilator (IPPB) | |
| Classification | 21 CFR 868.5905, 73 BZD (Class II) |
| Predicate Device | Mirage Quattro™ (K063122) |
| Description | The Mirage Quattro provides an interface such that airflow from a |
| positive pressure source is directed to the patient's nose and mouth. | |
| The mask is held in place with adjustable headgear that straps the | |
| mask to the face. | |
| The Mirage Quattro is safe when used under the conditions and | |
| purposes intended as indicated in the labeling provided with the | |
| product. | |
| The Mirage Quattro is a prescription device supplied non-sterile. | |
| Intended Use | The Mirage Quattro 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 Quattro is to be used by adult patients (>66lb />30kg) | |
| for whom positive airway pressure has been prescribed. | |
| The Mirage Quattro is intended for single patient re-use in the home | |
| environment and/or multi-patient reuse in the hospital/institutional | |
| environment. | |
| Comparison of | |
| Technological | |
| Characteristics | Comparison with previously cleared Mirage Quattro |
| The modified device and the previously cleared mask both provide a | |
| seal via silicone interface. Both masks are offered in various | |
| sizes to ensure adequate fit over the extended patient population. | |
| Both masks incorporate vents to provide continuous air flow to flush | |
| out and minimize the amount of CO2 rebreathed by the patient. The | |
| design of the mask components is such that the incorporation of | |
| these vents does not interfere with the intended performance of the | |
| masks. Both masks also contain an anti-asphyxia valve (AAV) to | |
| enable the patient to breathe fresh air in the event that airflow from | |
| the flow generator is impeded. | |
| Both masks connect to a conventional air delivery hose between the | |
| mask and the positive airway-pressure source via standard conical | |
| connectors (ref: ISO 5356-1:2004). | |
| Both masks are constructed using moulded plastic and silicone | |
| components and fabric / nylon headgear. All the components of both | |
| masks are fabricated using materials deemed safe (ISO10993-1). | |
| Both the modified device and the previously cleared device are | |
| designed to operate on the same Full Face ResMed flow generator | |
| settings. The pressure-flow characteristics and flow impedance of | |
| both the modified device and the predicate device are identical. | |
| Both the modified device and the previously cleared device can be | |
| reused in the home and hospital / institution environment. | |
| Clinical Data | Use of vented masks with CPAP or Bilevel therapy is proven |
| technology and is well accepted by the medical community. Bench | |
| testing is sufficient to demonstrate safety and efficacy of the | |
| modified Mirage Quattro, as was the case with the previously | |
| cleared Mirage Quattro device. | |
| Performance Data | Comparison with previously cleared Mirage Quattro |
| The CO2 performance of the modified device and the previously | |
| cleared device are substantially equivalent. Both the modified device | |
| and the previously cleared device are designed to operate on the | |
| same flow generator settings as specified in the User Guide. The | |
| only difference is an extension in the therapy pressure range from | |
| 4-20cmH2O to 4-40cmH2O. Verification testing of the modified | |
| device did not raise any new questions of safety and efficacy. | |
| Substantial | |
| Equivalence | |
| Conclusion | The modified Mirage Quattro is as safe and effective as the |
| previously cleared Mirage Quattro device: |
- it has the same intended use:
- it has identical technological characteristics to the
previously cleared device; - the modified device did not raise any new questions of
safety or effectiveness; - it is at least as safe and effective as the previously
Cleared Mirage Quattro (K063122). |
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure embracing the world. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN - 6 2012
ResMed Limited C/O Mr. David D'Cruz Vice President, US Medical Regulatory Affairs ResMed Corporation 9001 Spectrum Center Boulevard San Diego, California 92123
Re: K113127
Trade/Device Name: MIRAGE QUATTRO™ FULL FACE MASK Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: December 2, 2011 Received: December 7, 2011
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 Eederal Register.
3
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/ ucm 1 1 5809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Division Director --Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): Device Name: Indication for Use
MIRAGE QUATTRO™ FULL FACE MASK
The Mirage Quattro 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 Quattro is to be used by adult patients (>66lb />30kg) for whom positive airway pressure has been prescribed.
The Mirage Quattro is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital/institutional environment.
Over-The-Counter Use AND/OR Prescription Use X (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) air 21 OF N 60 Four D)
(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_
L. Schulthis
(Division Sian-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113127