(28 days)
Not Found
No
The device description focuses on the physical components of a CPAP mask and headgear, with the only change being the color of the headgear fabric. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a mask component for a positive airway pressure device, not a therapeutic device itself.
No
The device is a non-invasive accessory for positive airway pressure devices (CPAP/bilevel systems) that channels airflow; it is not described as performing any diagnostic function.
No
The device description explicitly states it is constructed using molded plastic components and fabric headgear, indicating it is a physical hardware device, not software only.
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 non-invasively from a positive airway pressure device to a patient. This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the physical components of a mask and headgear used for delivering air. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on the equivalence of the modified device to a predicate device in terms of function and safety for delivering air, not on diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any such function.
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 multipatient re-use in the hospital/institutional environment.
Product codes
BZD
Device Description
The headgear colour of the modified device has changed. The color of the outer layer of the fabric is being changed from dark blue to tan. All other aspects of the device remain unchanged.
The modified Mirage Micro is safe when used under the conditions and purposes intended as indicated in the labelling provided with the product.
The modified Mirage Micro is a prescription device supplied nonsterile.
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 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 have provisions for connecting oxygen and pressure sensing tubing via luer ports.
Both 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).
Both the modified device and the previously cleared device can be reused in the hospital / institution environment.
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
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 The change does not require bench testing as the change has no effect on the technological characteristics when used with a compatible ResMed flow generator.
Performance Data: The headgear 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 perform the same function.
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
Image /page/0/Picture/0 description: The image shows the word "RESMED" in bold, black letters. The letters are capitalized and slightly slanted to the right. The font is sans-serif and the letters are closely spaced together.
Special 510(k) SUMMARY [As required by 21 CFR 807 92(c)]
| Date Prepared | March 8, 2011 |
|---|---|
| Official Contact | David D'Cruz |
| Vice President, US Medical & Regulatory Affairs | |
| 9001 Spectrum Center Blvd., | |
| San Diego | |
| CA 92123 | |
| Device Trade Name | Mirage Micro TM |
| 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 headgear colour of the modified device has changed. The |
| color of the outer layer of the fabric is being changed from dark blue | |
| to tan. All other aspects of the device remain unchanged. |
The modified Mirage Micro is safe when used under the conditions
and purposes intended as indicated in the labelling provided with the
product.
The modified 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 multipatient re-use in the hospital/institutional
environment. |
| Technological Characteristics Comparison | Comparison with predicate Mirage Micro
The headgear colour of the modified device has changed. The
colour of the outer layer of the fabric is being changed from dark blue
to tan. All other aspects of the device remain unchanged.
The following technological details are outlined below are provided
for completeness only. |
1
RESMED
Mirage Micro
Special 510K
| | 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 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 have provisions for connecting oxygen and pressure
sensing tubing via luer ports. |
| | Both 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). |
| | Both the modified device and the previously cleared 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 The change does not require bench testing as the
change has no effect on the technological characteristics when
used with a compatible ResMed flow generator. |
| Performance Data | Comparison with predicate Mirage Micro |
| | The headgear 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 perform the same function. |
| | As the outer layer of the headgear fabric does not come in to
contact with the patient under normal use conditions, ISO 10993-1
is not applicable in this situation. |
| Substantial
Equivalence
Conclusion | The modified Mirage Micro is substantially equivalent to the
previously cleared 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 previously cleared
- Mirage Micro (K072940). |
9
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Resmed Limited C/O Mr. David D`Cruz Resmed Corporation (2183969) 9001 Spectrum Center Boulevard San Diego, California 92123
MAR 1 6 2011
Re: K110444
Trade/Device Name: Mirage Micro ** Regulation Number: 21 CFR 868,5905 Regulation Name: Noncontinuos Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 9, 2011 Received: March 11, 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 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); 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.
lf 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/ucm115809.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.
Anthony D. Winter
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and dental devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Mirage Micro ™
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 ainway pressure has been prescribed.
-
intended for single patient re-use in the home environment and multi-patient reuse in the hospital/institutional environment.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subparl C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schütthers
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 1 of 1
11/0444 510(k) Number: _______________________________________________________________________________________________________________________________________________________________ 17