(70 days)
No
The device description and performance studies focus on the physical interface and airflow mechanics, with no mention of AI or ML.
No
The device is described as an interface that channels airflow from a positive airway pressure (PAP) device to the patient's nose, rather than actively providing therapy itself. It is an accessory to therapeutic devices like CPAP or bilevel systems.
No
Explanation: The device, Mirage Echo, is described as an interface that channels airflow from a positive airway pressure (PAP) device to a patient's nose. Its purpose is to deliver therapy, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical mask and headgear, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to channel airflow noninvasively to a patient from a PAP device. This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on providing an interface for airflow to the nose. This is a physical interface for delivering therapy.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
- Bench Testing: The performance studies rely on bench testing to demonstrate safety and efficacy related to airflow and CO2 performance, which are relevant to the device's function in delivering PAP therapy, not for diagnostic purposes.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The Mirage Echo channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Mirage Echo is:
- to be used by adult patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed .
- . intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.
Product codes
BZD
Device Description
The Mirage Echo provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face.
Mirage Echo is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product
Mirage Echo 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
patient's nose
Indicated Patient Age Range
adult patients (> 66 lb/30 kg)
Intended User / Care Setting
single-patient re-use in the home environment and multipatient re-use 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 Mirage ECHO, as was the case with the predicate device.
The CO2 performance of the new device and the predicate device are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K071808, K072940, K081321, K050359
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
Mirage Echo Traditional 510k
.
RESMED
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.
| 510(k) SUMMARY [As required by 21 CFR 807.92(c)] | ||
|---|---|---|
| Date Prepared | February 20th, 2009 | |
| Official Contact | Mr. Steven Lubke, | |
| Director, Regulatory Affairs | MAY - 6 2009 | |
| Device Trade Name | Mirage™ Echo | |
| Device Common Name/ | ||
| Classification Name | Vented Nasal Mask; | |
| Accessory to Noncontinuous Ventilator (IPPB) | ||
| Classification | 21 CFR 868.5905, 73 BZD (Class II) | |
| Predicate Devices | Mirage Micro (K071808, K072940, K081321) | |
| Ultra Mirage II Mask (K050359) | ||
| Description | The Mirage Echo provides an interface such that airflow from a | |
| positive pressure source is directed to the patient's nose. The | ||
| mask is held in place with adjustable headgear that straps the | ||
| mask to the face. | ||
| Mirage Echo is safe when used under the conditions and | ||
| purposes intended as indicated in the labeling provided with the | ||
| product | ||
| Mirage Echo is a prescription device supplied non-sterile. | ||
| Intended Use | The Mirage Echo channels airflow noninvasively to a patient | |
| from a positive airway pressure (PAP) device such as a | ||
| continuous positive airway pressure (CPAP) or bilevel system. | ||
| The Mirage Echo is: | ||
| to be used by adult patients (> 66 lb/30 kg) for whom | ||
| positive airway pressure has been prescribed | ||
| intended for single-patient re-use in the home environment | ||
| and multipatient re-use in the hospital/institutional | ||
| environment. | ||
| Technological | ||
| Characteristics | ||
| comparison | Comparison with predicate Mirage Micro | |
| The new device and the predicate mask, 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 vent holes to provide continuous air | ||
| leak 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 vent-holes does not interfere with the | ||
| intended performance of the masks. | ||
| 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 molded plastic and silicone | ||
| February 20, 2009 | 19 |
February 20, 2009
:
、
19
:
1
RESMED Mirage Echo Traditional 510k components and fabric / nylon headgear. All the components of both the masks are fabricated using materials deemed safe. (ref: ISO 10993-1). Both the new device and the predicate are designed to operate on the same ResMed flow generator settings. The pressureflow characteristics and flow impedance of both the new device and the predicate device are substantially equivalent. Both the new device and the predicate device can be reused in the home and hospital / institution environment. The main differences between Mirage ECHO and the Mirage Micro is in the number of components, their design/geometry and how individual components interface with each other. Both masks are designed and constructed under ResMed's 21 CFR Part 820 compliant Quality Management System. Use of vented nasal 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 ECHO, as was the case with the predicate device. Comparison with predicate Ultra Mirage II Performance Data The CO2 performance of the new device and the predicate device are substantially equivalent. Substantial Equivalence Mirage Echo is substantially equivalent to the predicate Conclusion devices: it has the same intended use; it has similar technological characteristics to both .
predicates;
- it does not raise new questions of safety and effectiveness;
- it is at least as safe and effective as the predicate devices Mirage Micro and Ultra Mirage 11
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
MAY - 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs Resmed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K090490 Trade/Device Name: Mirage™ Echo Regulation Number: 868.5905 Regulatory Class: II Product Code: BZD Dated: February 20, 2009 Received: February 25, 2009
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 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.
3
Page 2- D'Cruz
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0100. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Svantner
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
RESMED
Mirage Echo Traditional 510k
Indication for Use
.
510(k) Number (if known):
Mirage™ Echo
Device Name: Indication for Use
The Mirage Echo channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Mirage Echo is:
- to be used by adult patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed .
- . intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use
(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)
Page 1 of 1
| February 20, 2009 | 17 |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K090990 |