(28 days)
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.
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.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Same intended use as the predicate device (Mirage Micro Mask K072940). | The modified Mirage Micro has the same intended use: channeling airflow non-invasively to adult patients from a positive airway pressure device (CPAP or bilevel system), for single-patient re-use at home and multi-patient re-use in hospital/institutional environments. |
| Similar technological characteristics to the predicate device. | The only change is the headgear color (from dark blue to tan). All other aspects (vent holes, connectors, provisions for oxygen/pressure sensing, construction materials, re-use capability) remain identical to the predicate device. |
| Does not raise new questions of safety and effectiveness. | The change in headgear color is asserted not to affect technological characteristics when used with a compatible ResMed flow generator, and the outer layer of the fabric does not come into contact with the patient, therefore not requiring ISO 10993-1. This implies no new safety or effectiveness concerns. |
| At least as safe and effective as the previously cleared Mirage Micro (K072940). | Due to the cosmetic nature of the change (headgear color) and the assertion that it does not affect the device's function or patient contact, the device is considered substantially equivalent in safety and effectiveness to the predicate. |
| Bench testing not required as the change has no effect on technological characteristics when used with a compatible ResMed flow generator. | No bench testing was performed due to the nature of the change. This implicitly serves as an acceptance criterion being met by the product's unchanged functional aspects. |
| The headgear color change (from dark blue to tan) does not affect performance. | The document states, "The headgear colour of the modified device has changed... All other aspects of the device remain unchanged." and "The headgear performance of the modified device and the previously cleared device are substantially equivalent." This indicates the color change did not impact performance. |
| All components are fabricated using materials deemed safe (ref: ISO 10993-1). | "All the components of both the masks are fabricated using materials deemed safe. (ref: ISO 10993-1)." This implies that while the outer layer of the headgear fabric doesn't come into patient contact, other components still adhere to this standard, ensuring overall safety. |
| Design of vent-holes does not interfere with the intended performance of the masks. | "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." This characteristic is maintained from the predicate. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This document is for a Special 510(k) for a minor device modification (headgear color change). No new clinical or performance test data was generated with a specific test set. The submission relies on a comparison to the predicate device and the assertion that the change is cosmetic and does not impact performance.
- Data Provenance: Not applicable for a new test set. The basis for substantial equivalence is the prior clearance of the predicate device (Mirage Micro Mask K072940) and the established safety and effectiveness of vented nasal masks with CPAP/Bilevel therapy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No new ground truth was established for a test set as part of this Special 510(k) submission.
4. Adjudication method for the test set:
- Not applicable. No test set requiring adjudication was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a passive medical device (a mask); it does not involve AI or human readers for interpretation. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a passive medical device and does not involve any algorithms or software-driven performance that would require standalone testing.
7. The type of ground truth used:
- The ground truth for the safety and effectiveness of the device is based on the prior clearance and established performance of the predicate device (Mirage Micro Mask K072940). The current submission argues that the modified device is substantially equivalent because the change is purely cosmetic (headgear color) and does not alter the fundamental design, materials, or intended use that were proven safe and effective by the predicate.
8. The sample size for the training set:
- Not applicable. This device is a passive medical device, and this submission is for a minor modification. It does not involve machine learning or AI, and therefore no training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set involved, no ground truth needed to be established for it.
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Special 510(k) SUMMARY [As required by 21 CFR 807 92(c)]
| Date Prepared | March 8, 2011 |
|---|---|
| Official Contact | David D'CruzVice President, US Medical & Regulatory Affairs9001 Spectrum Center Blvd.,San DiegoCA 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. Thecolor of the outer layer of the fabric is being changed from dark blueto tan. All other aspects of the device remain unchanged.The modified Mirage Micro is safe when used under the conditionsand purposes intended as indicated in the labelling provided with theproduct.The modified Mirage Micro is a prescription device suppliednonsterile. |
| Intended Use | The Mirage Micro channels airflow non-invasively to a patient froma positive airway pressure device such as a continuous positiveairway pressure (CPAP) or bilevel system.The Mirage Micro is:- to be used by adult patients (>66lb / >30kg) for whompositive airway pressure has been prescribed.- intended for single patient re-use in the home environmentand multipatient re-use in the hospital/institutionalenvironment. |
| Technological Characteristics Comparison | Comparison with predicate Mirage MicroThe headgear colour of the modified device has changed. Thecolour of the outer layer of the fabric is being changed from dark blueto tan. All other aspects of the device remain unchanged.The following technological details are outlined below are providedfor completeness only. |
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RESMED
Mirage Micro
Special 510K
| Both the masks incorporate vent holes to provide continuous air leakto flush out the dead space within the mask and minimize the amountof CO2 rebreathed by the patient. The design of the maskcomponents is such that the incorporation of these vent-holes doesnot interfere with the intended performance of the masks.Both masks connect to a conventional air delivery hose between themask and the positive airway-pressure source via standard conicalconnectors (ref: ISO 5356-1:2004) | |
|---|---|
| Both masks have provisions for connecting oxygen and pressuresensing tubing via luer ports. | |
| Both masks are constructed using molded plastic components andfabric headgear. All the components of both the masks are fabricatedusing materials deemed safe. (ref: ISO 10993-1). | |
| Both the modified device and the previously cleared device can bereused in the hospital / institution environment. | |
| Clinical Data | Use of vented nasal masks with CPAP or Bilevel therapyis proven technology and is well accepted by the medicalcommunity The change does not require bench testing as thechange has no effect on the technological characteristics whenused with a compatible ResMed flow generator. |
| Performance Data | Comparison with predicate Mirage Micro |
| The headgear performance of the modified device and thepreviously cleared device are substantially equivalent. | |
| Both the modified device and the previously cleared device aredesigned to perform the same function. | |
| As the outer layer of the headgear fabric does not come in tocontact with the patient under normal use conditions, ISO 10993-1is not applicable in this situation. | |
| SubstantialEquivalenceConclusion | The modified Mirage Micro is substantially equivalent to thepreviously 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
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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.
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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
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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
§ 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).