(150 days)
Not Found
No
The summary describes a physical mask for CPAP/bilevel systems and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is a mask that channels airflow from a positive airway pressure device to the patient; it does not directly provide therapeutic action itself.
No
The device description indicates it is a mask that channels airflow from a positive airway pressure device to the patient's nose. Its purpose is to deliver therapy, not to diagnose a condition.
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 (like blood, urine, tissue) to provide information about a person's health.
- Mirage Micro Function: The description clearly states that the Mirage Micro is a mask that channels airflow non-invasively to a patient from a positive airway pressure device. It is a physical interface for delivering therapy, not for analyzing biological samples.
- Intended Use: The intended use is for delivering positive airway pressure for patients with prescribed therapy, not for diagnostic testing.
Therefore, the Mirage Micro falls under the category of a medical device used for therapy delivery, not an IVD.
N/A
Intended Use / Indications 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 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
Not Found
Indicated Patient Age Range
adult patients (>66lb / >30kg)
Intended User / Care Setting
single patient re-use in the home environment and multi-patient 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)
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 of the modified device and the predicate device are substantially equivalent. Both the modified 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 modified device and the predicate device are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Mirage Micro Mask (K072940)
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
OCT 0 9 2008
RESMED
Mirage Micro
Special 510k
| Special 510(k) SUMMARY
| [As required by 21 CFR 807.92(c)] | |
|---|---|
| Date Prepared | May 07, 2008 |
| Official Contact | David Thomson |
| Regulatory Affairs Director | |
| 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 Device | Mirage Micro Mask (K072940) |
| 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 modified 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 does 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 masks, including the modification to the swivel color,
are fabricated using materials deemed safe. (ref: ISO
10993-1). |
| | Both the modified 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 modified device and the
predicate device are substantially equivalent. |
| | Both the modified 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 modified device and the predicate device are
substantially equivalent. |
| Substantial Equivalence
Conclusion | Modified Mirage Micro is substantially equivalent to the
predicate device:
- 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 |
May 07, 2008
- .
1
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May 07, 2008
・・
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2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 9 2008
ResMed Limited C/O Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K081321
Trade/Device Name: Mirage MicroTM Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 19, 2008 Received: October 2, 2008
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
Th. Samuels-Send me for//
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 Special 510k
Indication for Use
| 510(k) Number (if known): | K08- |
|---|---|
| Device Name: | MIRA |
| Indication for Use |
1321 age Micro™
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. י
- intended for single patient re-use in the home environment and multi-patient reuse 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)
| Division Sign-Off) | Page 1 of 1 | |
|---|---|---|
| Division of Anesthesioloov: General Hospital | ||
| infection Control, Denta Devices | ||
| 710(k) Number: | K081321 |