(100 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 and the hospital/institutional environment.
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.
The provided text describes the 510(k) summary for the ResMed Mirage Micro™ nasal mask. This document outlines the device's characteristics and its substantial equivalence to predicate devices, rather than a clinical study demonstrating the device meets specific acceptance criteria through comprehensive performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, and ground truth establishment are not present in this regulatory submission for a nasal mask. The submission emphasizes "bench testing" and "proven technology" for substantial equivalence.
Here's an analysis based on the information available and not available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific numerical targets. Instead, it relies on a comparison to predicate devices, asserting "substantial equivalence" in key performance characteristics relevant to its function as a nasal mask for PAP therapy.
| Performance Characteristic (Implied "Acceptance Criteria") | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Seal (adequate for airflow from positive pressure source) | "The Mirage Micro provides seal such that airflow from a positive pressure source is directed to the patient's nose." |
| Fit (over extended patient population) | "Both masks are offered in various sizes to ensure adequate fit over the extended patient population." (Compared to Ultra Mirage II) |
| CO2 Rebreathing / Vent Holes (minimize CO2 rebreathing and flush dead space) | "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." (Compared to Ultra Mirage II) "The CO2 performance the new device and the predicate device are substantially equivalent." |
| Connection to Air Delivery Hose (standard conical connectors) | "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)" (Compared to Ultra Mirage II) |
| Oxygen/Pressure Sensing Ports (luer ports) | "Both the masks have provisions for connecting oxygen and pressure sensing tubing via luer ports." (Compared to Ultra Mirage II) |
| Biocompatibility of Materials (fabricated using safe materials) | "All the components of both the masks are fabricated using materials deemed safe. (ref: ISO 10993-1)." (Compared to Ultra Mirage II) |
| Pressure-Flow Characteristics / Flow Impedance | "The pressure-flow characteristics and flow impedance of both the new device and the predicate device are substantially equivalent." (Compared to Meridian) |
| Safety and Efficacy | "Bench testing is sufficient to demonstrate safety and efficacy of the Mirage Micro, as was the case with the predicate devices." (Clinical data section explicitly states this) |
| Intended Use (adult patients, single patient reuse, home/hospital environment) | "Same intended use with reduced scope being for single patient reuse" (compared to predicate Ultra Mirage II for multi-patient use in hospital/institutional environment) |
2. Sample size used for the test set and the data provenance
The document explicitly states: "Bench testing is sufficient to demonstrate safety and efficacy of the Mirage Micro, as was the case with the predicate devices." This indicates that the primary performance evaluation was conducted via bench testing, meaning in a laboratory setting, rather than with human subjects in a clinical trial.
- Sample size: Not specified for bench tests. For physical component characteristics, it would likely involve a sample of manufactured masks.
- Data provenance: Bench test data, not explicitly described as from a specific country, but linked to internal testing by ResMed Ltd (Australia). The data provenance is retrospective in the sense that it's based on internal validation for product development.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As the evaluation was based on bench testing and comparison to predicate devices, there was no "ground truth" derived from expert interpretation of clinical data in the traditional sense. The "ground truth" for performance would be the specifications and validated behavior of the predicate devices and general knowledge of CPAP mask function.
4. Adjudication method for the test set
Not applicable. No expert adjudication method is described, as it was bench testing.
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
Not applicable. This device is a medical mask, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical mask, not an algorithm. Its "standalone" performance refers to its physical and functional characteristics on a bench.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance is based on engineering specifications, material safety standards (ISO 10993-1), recognized international standards for connectors (ISO 5356-1:2004), and the established performance characteristics of the predicate devices. It’s not clinical ground truth like pathology or expert consensus on patient data.
8. The sample size for the training set
Not applicable. This is a physical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved for this device.
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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.
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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 apositive pressure source is directed to the patient's nose.The mask is held in place with adjustable headgear thatstraps the mask to the face.Mirage Micro is safe when used under the conditions andpurposes intended as indicated in the labeling providedwith the product.Mirage Micro is a prescription device supplied nonsterile. |
| Intended Use | The Mirage Micro channels airflow non-invasively to apatient from a positive airway pressure device such as acontinuous positive airway pressure (CPAP) or bilevelsystem.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 and thehospital/institutional environment. |
| Technological Characteristics comparison | Comparison with predicate Ultra Mirage IIThe new device and the predicate mask, provide seal viadual wall silicone interface. Both masks are offered invarious sizes to ensure adequate fit over the extendedpatient population.Both the masks incorporate vent holes to providecontinuous air leak to flush out the dead space within themask and minimize the amount of CO2 rebreathed by thepatient. The design of the mask components is such thatthe 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
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RESMED
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the intended performance of the masks.
| Both the masks connect to conventional air delivery hosebetween the mask and the positive airway-pressuresource via standard conical connectors (ref: ISO 5356-1:2004) | |
|---|---|
| Both the masks have provisions for connecting oxygenand pressure sensing tubing via luer ports. | |
| Both the masks are constructed using molded plasticcomponents and fabric headgear. All the components ofboth the masks are fabricated using materials deemedsafe. (ref: ISO 10993-1). | |
| The main differences between Micro Mirage and UltraMirage II are in the number of components, theirdesign/geometry and how individual components interfacewith each other. Both the masks are designed andconstructed under ResMed's 21 CFR Part 820 compliantQuality Management System. | |
| The predicate device can be reused by multiple patientsin the hospital/institutional environment where as the newdevice is labeled for single patient reuse. | |
| Clinical Data | Use of vented nasal masks with CPAP or Bilevel therapyis proven technology and is well accepted by the medicalcommunity. Bench testing is sufficient to demonstratesafety and efficacy of the Mirage Micro, as was the casewith the predicate devices. |
| Performance Data | The CO2 performance the new device and the predicatedevice are substantially equivalent.Comparison with predicate MeridianBoth the new device and the predicate are designed tooperate on the same standard flow generator setting. Thepressure-flow characteristics and flow impedance of boththe new device and the predicate device are substantiallyequivalent. |
| Substantial EquivalenceConclusion | Mirage Micro is substantially equivalent to the predicatedevices:- it has the same intended use with reduced scopebeing for single patient reuse;- it has similar technological characteristics to UltraMirage II;- it does not raise new questions of safety andeffectiveness;- it is at least as safe and effective as the Ultra Mirage IIand the Meridian |
ResMed Ltd 1 Elizabeth MacArthur Drive, Bella Vista NSW 2153 Australia Tel: +61 2 8883 3114 ABN 30 003 765 142
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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.
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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); 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
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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
§ 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).