(150 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 multi-patient re-use in 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 is a 510(k) summary for the ResMed Mirage Micro, a vented nasal mask. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study with acceptance criteria and a comprehensive study report. Therefore, much of the requested information regarding specific acceptance criteria, test sets, experts, and detailed study methodologies is not present in the provided text.
Here is the information that can be extracted or reasonably inferred from the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance | Comments / Context |
|---|---|---|
| Intended Use Equivalence | Same intended use as predicate device | The modified device "has the same intended use" as the predicate Mirage Micro Mask (K072940). |
| Technological Characteristics Equivalence | Similar technological characteristics to predicate device | Both devices provide seal via dual wall silicone interface, are offered in various sizes, incorporate vent holes for CO2 flushing, connect to conventional air delivery hoses via standard conical connectors, have provisions for connecting oxygen and pressure sensing tubing via luer ports, and are constructed with molded plastic components and fabric headgear using materials deemed safe. |
| Safety and Effectiveness | Does not raise new questions of safety and effectiveness; at least as safe and effective as the predicate | Stated explicitly as a conclusion for substantial equivalence. |
| CO2 Performance | Substantially equivalent to predicate device | Bench testing was used to demonstrate this. |
| Pressure-Flow Characteristics & Flow Impedance | Substantially equivalent to predicate device | Both devices are designed to operate on the same standard flow generator setting, and their pressure-flow characteristics and flow impedance are substantially equivalent. Bench testing was used to demonstrate this. |
| Material Biocompatibility | All components, including the modification to the swivel color, are fabricated using materials deemed safe (ref: ISO 10993-1). | This is a general safety criterion for medical devices. |
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."
- Sample Size for Test Set: Not specified. Since it refers to "bench testing," it would involve testing physical prototypes or samples rather than human subjects. The number of masks tested is not provided.
- Data Provenance: Bench testing results. Country of origin is not specified, but the applicant (ResMed) is a global company. Based on the submission being to the FDA, it's likely the testing was conducted in a manner consistent with US regulatory requirements, potentially in the US or by a facility accredited for such testing. The testing is prospective in the sense that it was performed to support this specific submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a bench testing study comparing the modified device to a predicate device based on physical characteristics and performance measurements (CO2, pressure-flow). There was no "ground truth" derived from expert interpretation of images or clinical outcomes in the traditional sense that would require a panel of experts.
4. Adjudication method for the test set
Not applicable, as no expert review or adjudication of clinical data was performed. The evaluation relied on objective measurements from 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 for respiratory support, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
For the performance data (CO2, pressure-flow, flow impedance), the "ground truth" would be established by the objective measurements obtained from the bench testing against predefined engineering specifications and comparison to the predicate device's performance. For biocompatibility, the ground truth refers to compliance with ISO 10993-1 standards using validated material testing methods.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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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 ThomsonRegulatory 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 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 homeenvironment and multi-patient re-use in thehospital/institutional environment. |
| TechnologicalCharacteristicscomparison | Comparison with predicate Mirage MicroThe modified device and the predicate mask, provide sealvia dual 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 that |
| the incorporation of these vent-holes does not interferewith 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 masks, including the modification to the swivel color,are fabricated using materials deemed safe. (ref: ISO10993-1). | |
| Both the modified device and the predicate 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. Bench testing is sufficient to demonstratesafety and efficacy of the Mirage Micro, as was the casewith the predicate devices. |
| Performance Data | Comparison with predicate Mirage MicroThe CO2 performance of the modified device and thepredicate device are substantially equivalent. |
| Both the modified device and the predicate are designedto operate on the same standard flow generator setting.The pressure-flow characteristics and flow impedance ofboth the modified device and the predicate device aresubstantially equivalent. | |
| Substantial EquivalenceConclusion | Modified Mirage Micro is substantially equivalent to thepredicate device:- it has the same intended use;- it has similar technological characteristics to bothpredicates;- it does not raise new questions of safety andeffectiveness;- it is at least as safe and effective as the predicate |
May 07, 2008
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May 07, 2008
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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.
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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 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
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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 Hospitalinfection Control, Denta Devices | ||
| 710(k) Number: | K081321 |
§ 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).