(100 days)
Not Found
No
The summary describes a mechanical device (a CPAP mask) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The document describes the device as a mask that channels airflow from a positive airway pressure device; it does not describe the device itself as providing therapy.
No
The device is described as channeling airflow from a positive airway pressure device to a patient. Its intended use and description do not mention diagnosis, disease detection, or monitoring of physiological parameters. It acts as an interface for therapy.
No
The device description clearly describes 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Mirage Micro "channels airflow non-invasively to a patient from a positive airway pressure device". It's a physical device used to deliver air to the patient's respiratory system.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient.
- Intended Use: The intended use is to provide positive airway pressure, not to diagnose or detect any condition through sample analysis.
Therefore, the Mirage Micro is a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mirage Micro 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 Micro is:
- to be used by adult patients (>66lb / >30kg) for whom positive airway pressure has been prescribed.
- intended for single patient re-use in the home and the hospital/institutional environment.
Product codes
BZD
Device Description
The Mirage Micro provides seal 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 Micro is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Mirage Micro is a prescription device supplied nonsterile.
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 (>66lb / >30kg)
Intended User / Care Setting
Home and 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
Use of vented nasal 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 Mirage Micro, as was the case with the predicate devices.
The CO2 performance the new device and the predicate device are substantially equivalent.
Both the new device and the predicate are designed to operate on the same standard flow generator setting. The pressure-flow characteristics and flow impedance of both the new device and the predicate device are substantially equivalent.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the word "RESMED" in bold, black font. The letters are capitalized and evenly spaced. The font appears to be sans-serif.
:
OCT 】0 2007
510(k) SUMMARY
[As required by 21 CFFR 807.92(c)]
| Date Prepared | June 27, 2007 |
|---|---|
| Official Contact | Mr. David Thomson, |
| Senior Regulatory Affairs Manager | |
| Device Trade Name | Mirage Micro™ |
| Device Common Name/ Classification Name | Vented Nasal Mask; |
| Accessory to Noncontinuous Ventilator (IPPB) | |
| Classification | 21 CFR 868.5905, 73 BZD (Class II) |
| Predicate Devices | Ultra Mirage II Mask (K050359) |
| Meridian Nasal Mask (K050142) | |
| Description | The Mirage Micro provides seal 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 Micro is safe when used under the conditions and | |
| purposes intended as indicated in the labeling provided | |
| with the product. | |
| Mirage Micro is a prescription device supplied nonsterile. | |
| Intended Use | The Mirage Micro 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 Micro is: |
- to be used by adult patients (>66lb / >30kg) for whom
positive airway pressure has been prescribed. - intended for single patient re-use in the home and the
hospital/institutional environment. |
| Technological Characteristics comparison | Comparison with predicate Ultra Mirage II
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 over the extended
patient population.
Both the masks incorporate vent holes to provide
continuous air leak to flush out the dead space within the
mask 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 do not interfere with |
ResMed Ltd 1 Elizabeth MacArthur Drive, Bella Vista NSW 2153 Australia Tel: +61 2 8883 3114 ABN 30 003 765 142
:
1
RESMED
·
:
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-
| 1:2004) | |
|---|---|
| Both the masks have provisions for connecting oxygen | |
| and pressure sensing tubing via luer ports. | |
| Both the masks are constructed using molded plastic | |
| components and fabric headgear. All the components of | |
| both the masks are fabricated using materials deemed | |
| safe. (ref: ISO 10993-1). | |
| The main differences between Micro Mirage and Ultra | |
| Mirage II are in the number of components, 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. | |
| The predicate device can be reused by multiple patients | |
| in the hospital/institutional environment where as the new | |
| device is labeled for single patient reuse. | |
| Clinical Data | Use of vented nasal 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 Mirage Micro, as was the case | |
| with the predicate devices. | |
| Performance Data | The CO2 performance the new device and the predicate |
| device are substantially equivalent. | |
| Comparison with predicate Meridian | |
| Both the new device and the predicate are designed to | |
| operate on the same standard flow generator setting. The | |
| pressure-flow characteristics and flow impedance of both | |
| the new device and the predicate device are substantially | |
| equivalent. | |
| Substantial Equivalence | |
| Conclusion | Mirage Micro is substantially equivalent to the predicate |
| devices: |
- it has the same intended use with reduced scope
being for single patient reuse; - it has similar technological characteristics to Ultra
Mirage II; - it does not raise new questions of safety and
effectiveness; - it is at least as safe and effective as the Ultra Mirage II
and the Meridian |
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 a partial view of the Department of Health & Human Services USA logo. The logo features the department's name arranged in a circular fashion around a symbol. The symbol appears to be three stylized human profiles stacked on top of each other. The image is in black and white.
OCT 1 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ResMed Limited C/O Mr. David D' Cruz Vice President Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway California, 92064-6857
Re: K071808
Trade/Device Name: MIRAGE MICROTM Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 21, 2007 Received: September 24, 2007
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.
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
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); 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.
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) 276-0115. 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,
Sylite H. Michin Dmd
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):
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: .
- to be used by adult patients (>66lb />30kg) for whom positive airway pressure has been prescribed.
- intended for single patient re-use in the home environment and the hospital/institutional environment.
Prescription Use
AND/OR
Over-The-Counter Use
× (Part 21 CFR 801 Subpart D) Subpart C)
(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
Misi Jahlal
(Division Sign-Off) Chasion of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K071868