(57 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 document is a 510(k) summary for the ResMed Mirage Micro Traditional, a vented nasal mask, seeking substantial equivalence to predicate devices. It is not a study that proves the device meets acceptance criteria in the way typically seen for AI/ML-based medical devices or diagnostics. Instead, it demonstrates substantial equivalence through comparisons of technological characteristics and performance data via bench testing.
Therefore, many of the requested fields (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of submission.
Here's a breakdown of the available information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state formal "acceptance criteria" with numerical thresholds in the sense of a diagnostic device. Instead, it relies on demonstrating substantial equivalence to predicate devices through comparative performance and technological characteristics. The "reported device performance" is essentially a statement of equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| CO2 performance substantially equivalent to predicate device. | "The CO2 performance of the new device and the predicate device are substantially equivalent." |
| Pressure-flow characteristics and flow impedance substantially equivalent to predicate device. | "The pressure-flow characteristics and flow impedance of both the new device and the predicate device are substantially equivalent." |
| Operation on the same standard flow generator setting as predicate device. | "Both the new device and the predicate are designed to operate on the same standard flow generator setting." |
| Provision of seal via dual wall silicone interface. | "The new device and the predicate mask, provide seal via dual wall silicone interface." |
| Incorporation of vent holes for continuous air leak. | "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." |
| Connection to conventional air delivery hose via 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)." |
| Provisions for connecting oxygen and pressure sensing tubing. | "Both the masks have provisions for connecting oxygen and pressure sensing tubing via luer ports." |
| Construction using molded plastic components and fabric headgear with safe materials. | "Both the 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)." |
| Intended use matching predicate devices. | "it has the same intended use;" |
| Technological characteristics similar to predicate devices. | "it has similar technological characteristics to both predicates:" |
| Does not raise new questions of safety and effectiveness. | "it does not raise new questions of safety and effectiveness:" |
| At least as safe and effective as predicate devices. | "it is at least as safe and effective as the predicate devices Mirage Micro and Mirage Quattro." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not applicable. The submission refers to "bench testing" and "comparison with predicate" rather than a clinical trial or a test set of data points in the context of an AI/ML device.
- Data provenance: Not applicable. Bench testing is typically performed in a laboratory setting. No country of origin for clinical data is mentioned as none was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. Ground truth establishment by experts is not described as part of this bench testing for a mechanical device.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. This concept is relevant for expert disagreement resolution in diagnostic studies, not for mechanical device 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
- MRMC study: No. This is a medical device, not an AI/ML diagnostic.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This is a medical device, not an AI/ML diagnostic.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not explicitly stated as "ground truth" in the AI/ML sense. The performance of the new device was compared against the performance of the predicate devices (Mirage Micro K071808 and Mirage Quattro K063122) through bench testing parameters like CO2 performance, pressure-flow characteristics, and flow impedance. The "truth" is based on the established safety and efficacy of the predicate devices.
8. The sample size for the training set
- Sample size for training set: Not applicable. This is a medical device, not an AI/ML system.
9. How the ground truth for the training set was established
- Ground truth for training set establishment: Not applicable. This is a medical device, not an AI/ML system.
Summary of the Study (as described in the 510(k) Summary):
The submission for the Mirage Micro Traditional nasal mask relies on a bench testing study to demonstrate substantial equivalence to its predicate devices (Mirage Micro Mask K071808 and Mirage Quattro Mask K063122).
The core of the "study" involved:
- Comparison of Technological Characteristics: Detail how the new device's design, materials, and features are similar to the predicates. This includes aspects like the dual-wall silicone interface, vent hole design, standard connectors, luer ports, and biocompatible materials.
- Performance Data Comparison (Bench Testing): Direct comparison of the new device's performance against the predicate Mirage Micro regarding:
- CO2 performance: Stated as "substantially equivalent."
- Pressure-flow characteristics: Stated as "substantially equivalent."
- Flow impedance: Stated as "substantially equivalent."
- Operation on standard flow generator settings: Stated as designed to operate on the same settings.
The conclusion drawn from this comparison and bench testing is that the new Mirage Micro is substantially equivalent because it shares the same intended use, similar technological characteristics, does not raise new questions of safety and effectiveness, and is at least as safe and effective as the predicate devices. Clinical data was deemed unnecessary as "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..."
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RESMED
Mirage Micro Traditional 510k
| 510(k) SUMMARY[As required by 21 CFR 807.92(c)] | ||
|---|---|---|
| Date Prepared | October 15, 2007 | |
| Official Contact | Mr. David Thomson,Senior Regulatory Affairs Manager | DEC 1 3 2007 |
| 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 | Mirage Micro Mask (K071808)Mirage Quattro Mask (K063122) | |
| 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 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 the | |
| mask 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 withthe 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). | ||
| Comparison with predicate Mirage QuattroBoth the new 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 Micro | |
| The CO2 performance of the new device and thepredicate device are substantially equivalent. | ||
| Both 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 | New Mirage Micro is substantially equivalent to thepredicate devices:- 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 predicatedevices Mirage Micro and Mirage Quattro. |
October 15, 2007
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
DEC 1 3 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: K072940
Trade/Device Name: Mirage MicroTM Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: October 15, 2007 Received: October 17, 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.
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 Traditional 510k
Indication for Use
| 510(k) Number (if known): | ||
|---|---|---|
| Device Name: | MIRAGE MICROTM | |
| 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 multi-patient reuse in the ﯿ hospital/institutional environment.
| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
Page 1 of 1
K072940October 15, 2007
§ 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).