(57 days)
No
The summary describes a physical medical device (a mask for positive airway pressure) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on physical characteristics and CO2 clearance, not algorithmic performance.
No.
The device is a mask that channels airflow from a positive airway pressure device to a patient. It is an accessory to a therapeutic device (CPAP or bilevel system), not a standalone therapeutic device itself.
No
The device is a mask for delivering positive airway pressure, not for diagnosing conditions.
No
The device description clearly describes a physical mask and headgear, which are hardware components, not software.
Based on the provided information, the Mirage Micro is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Mirage Micro Function: The description clearly states that the Mirage Micro "channels airflow non-invasively to a patient from a positive airway pressure device." It is a mask used for delivering air pressure for respiratory therapy.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is purely mechanical, facilitating the delivery of air.
Therefore, the Mirage Micro falls under the category of a respiratory therapy device, 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 environment and multi-patient re-use in 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
Nose, Face
Indicated Patient Age Range
Adult patients (>66lb / >30kg)
Intended User / Care Setting
Home environment and 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)
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:
Comparison with predicate Mirage Micro
The CO2 performance of 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Mirage Micro Mask (K071808), Mirage Quattro Mask (K063122)
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
RESMED
Mirage Micro Traditional 510k
| 510(k) SUMMARY
| [As required by 21 CFR 807.92(c)] | ||
|---|---|---|
| Date Prepared | October 15, 2007 | |
| Official Contact | Mr. David Thomson, | |
| Senior Regulatory Affairs Manager | DEC 1 3 2007 | |
| 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 | Mirage Micro Mask (K071808) | |
| Mirage Quattro Mask (K063122) | ||
| 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
environment and multi-patient re-use in the
hospital/institutional environment. | |
| Technological
Characteristics
comparison | Comparison with predicate Mirage Micro
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
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). | |
| | Comparison with predicate Mirage Quattro
Both the new device and the predicate device can be
reused in the hospital / institution environment. | |
| 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 | Comparison with predicate Mirage Micro | |
| | The CO2 performance of 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. | |
| Substantial Equivalence
Conclusion | New Mirage Micro is substantially equivalent to the
predicate 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 Mirage Quattro. | |
October 15, 2007
1
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
DEC 1 3 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: K072940
Trade/Device Name: Mirage MicroTM Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: October 15, 2007 Received: October 17, 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.
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
RESMED
Mirage Micro Traditional 510k
Indication for Use
| 510(k) Number (if known): | ||
|---|---|---|
| Device Name: | MIRAGE MICROTM | |
| 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 multi-patient reuse in the ﯿ hospital/institutional environment.
| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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
K072940October 15, 2007