(70 days)
The Mirage Echo channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system. The Mirage Echo is: to be used by adult patients (> 66 lb/30 kg) 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 Mirage Echo provides an interface 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 Echo is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Mirage Echo is a prescription device supplied non-sterile.
Here's an analysis of the Mirage Echo Traditional 510k, based on the provided text, focusing on acceptance criteria and supporting studies.
Based on the provided information, the 510(k) submission for the Mirage™ Echo nasal mask describes a comparative study against predicate devices (Mirage Micro and Ultra Mirage II Mask) to demonstrate substantial equivalence, rather than a study with explicit, quantitative acceptance criteria for device performance as one might see for an AI algorithm.
The core of the "study" is a set of comparisons and assertions of substantial equivalence, relying on bench testing and the existing clinical acceptance of similar technology.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a traditional 510(k) for a medical device (nasal mask), the "acceptance criteria" are primarily established implicitly by demonstrating substantial equivalence to predicate devices, focusing on safety, performance characteristics, and intended use. The performance is reported as "substantially equivalent" to the predicates.
| Acceptance Criteria (Implied from Substantial Equivalence to Predicates) | Reported Device Performance (Mirage Echo) |
|---|---|
| Safety: Materials deemed safe (ref: ISO 10993-1). | All components are fabricated using materials deemed safe (ref: ISO 10993-1). |
| Intended Use: Channels airflow noninvasively from a PAP device to adult patients (> 66 lb/30 kg) for single-patient home reuse and multipatient hospital/institutional reuse. | Same intended use as predicates. Channels airflow noninvasively to a patient from a PAP device (CPAP/bilevel system), for adult patients (> 66 lb/30 kg), for single-patient home reuse and multipatient hospital/institutional reuse. |
| Technological Characteristics: | |
| - Provides a seal via silicone interface. | Provides a seal via silicone interface. |
| - Offered in various sizes for adequate fit. | Offered in various sizes to ensure adequate fit. |
| - Incorporates vent holes for continuous air leak to flush CO2 and minimize rebreathing without interfering with performance. | Incorporates vent holes to provide continuous air leak to flush out and minimize the amount of CO2 rebreathed. The design ensures vents do not interfere with intended performance. |
| - Connects to conventional air delivery hose via standard conical connectors (ISO 5356-1:2004). | Connects to a conventional air delivery hose via standard conical connectors (ref: ISO 5356-1:2004). |
| - Constructed using molded plastic and silicone components. | Constructed using molded plastic and silicone components. |
| - Operates on the same ResMed flow generator settings. | Designed to operate on the same ResMed flow generator settings. |
| - Substantially equivalent pressure-flow characteristics and flow impedance. | Pressure-flow characteristics and flow impedance of both the new device and the predicate device are substantially equivalent. |
| - Can be reused in home and hospital/institution environment. | Can be reused in the home and hospital/institution environment. |
| - CO2 performance is substantially equivalent. | The CO2 performance of the new device and the predicate device are substantially equivalent. |
| Effectiveness: At least as safe and effective as the predicate devices and does not raise new questions of safety and effectiveness. | Asserted to be at least as safe and effective and does not raise new questions of safety and effectiveness. "Use of vented nasal masks with CPAP or Bilevel therapy is Clinical Data proven technology and is well accepted by the medical community." "Bench testing is sufficient to demonstrate safety and efficacy of the Mirage ECHO, as was the case with the predicate device." |
2. Sample Size for the Test Set and Data Provenance
The provided text does not mention a "test set" in the context of clinical data or patient-specific evaluation. The performance data refers to bench testing. Therefore, information regarding:
- Sample size for the test set
- Data provenance (e.g., country of origin, retrospective/prospective)
is not applicable as no clinical test set data is described. The submission relies on "bench testing" and comparison of technical specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. Since no clinical test set data is described, there's no mention of experts establishing a ground truth for such a set. The "ground truth" for this type of submission is typically derived from established engineering principles, international standards (e.g., ISO), and the performance of legally marketed predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable. No clinical test set data is described that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, potentially with AI assistance. The Mirage Echo is a medical device (nasal mask) for therapy delivery, not a diagnostic tool requiring interpretation.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not done, nor would it be relevant for this type of device. The Mirage Echo is a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context is established through bench testing results, adherence to international standards (e.g., ISO 10993-1 for biocompatibility, ISO 5356-1:2004 for connectors), engineering specifications, and the established performance and safety profile of legally marketed predicate devices. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this submission, as it focuses on demonstrating substantial equivalence in physical and functional characteristics.
8. Sample Size for the Training Set
This information is not applicable. The Mirage Echo is a physical medical device, not an AI algorithm that undergoes a "training set" process.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As it's not an AI algorithm, there is no "training set" or ground truth for such a set.
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Mirage Echo Traditional 510k
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RESMED
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| 510(k) SUMMARY [As required by 21 CFR 807.92(c)] | ||
|---|---|---|
| Date Prepared | February 20th, 2009 | |
| Official Contact | Mr. Steven Lubke,Director, Regulatory Affairs | MAY - 6 2009 |
| Device Trade Name | Mirage™ Echo | |
| 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 (K071808, K072940, K081321)Ultra Mirage II Mask (K050359) | |
| Description | The Mirage Echo provides an interface such that airflow from apositive pressure source is directed to the patient's nose. Themask is held in place with adjustable headgear that straps themask to the face. | |
| Mirage Echo is safe when used under the conditions andpurposes intended as indicated in the labeling provided with theproduct | ||
| Mirage Echo is a prescription device supplied non-sterile. | ||
| Intended Use | The Mirage Echo channels airflow noninvasively to a patientfrom a positive airway pressure (PAP) device such as acontinuous positive airway pressure (CPAP) or bilevel system.The Mirage Echo is:to be used by adult patients (> 66 lb/30 kg) for whompositive airway pressure has been prescribedintended for single-patient re-use in the home environmentand multipatient re-use in the hospital/institutionalenvironment. | |
| TechnologicalCharacteristicscomparison | Comparison with predicate Mirage MicroThe new device and the predicate mask, provide a seal viasilicone interface. Both masks are offered in various sizes toensure adequate fit over the extended patient population. | |
| Both masks incorporate vent holes to provide continuous airleak to flush out and minimize the amount of CO2 rebreathed bythe patient. The design of the mask components is such thatthe incorporation of these vent-holes does not interfere with theintended performance of the masks. | ||
| Both masks connect to a conventional air delivery hosebetween the mask and the positive airway-pressure source viastandard conical connectors (ref: ISO 5356-1:2004) | ||
| Both masks are constructed using molded plastic and silicone | ||
| February 20, 2009 | 19 |
February 20, 2009
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RESMED Mirage Echo Traditional 510k components and fabric / nylon headgear. All the components of both the masks are fabricated using materials deemed safe. (ref: ISO 10993-1). Both the new device and the predicate are designed to operate on the same ResMed flow generator settings. The pressureflow characteristics and flow impedance of both the new device and the predicate device are substantially equivalent. Both the new device and the predicate device can be reused in the home and hospital / institution environment. The main differences between Mirage ECHO and the Mirage Micro is in the number of components, their design/geometry and how individual components interface with each other. Both masks are designed and constructed under ResMed's 21 CFR Part 820 compliant Quality Management System. Use of vented nasal masks with CPAP or Bilevel therapy is Clinical Data proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the Mirage ECHO, as was the case with the predicate device. Comparison with predicate Ultra Mirage II Performance Data The CO2 performance of the new device and the predicate device are substantially equivalent. Substantial Equivalence Mirage Echo is substantially equivalent to the predicate Conclusion devices: 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 predicate devices Mirage Micro and Ultra Mirage 11
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
MAY - 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs Resmed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K090490 Trade/Device Name: Mirage™ Echo Regulation Number: 868.5905 Regulatory Class: II Product Code: BZD Dated: February 20, 2009 Received: February 25, 2009
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 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.
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Page 2- D'Cruz
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) 276-0100. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 yours,
Svantner
Susan Runner, D.D.S., M.A. Acting 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 Echo Traditional 510k
Indication for Use
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510(k) Number (if known):
Mirage™ Echo
Device Name: Indication for Use
The Mirage Echo channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Mirage Echo is:
- to be used by adult patients (> 66 lb/30 kg) 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.
| 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)
Page 1 of 1
| February 20, 2009 | 17 |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General HospitalInfection Control, Dental Devices | |
| 510(k) Number: | K090990 |
§ 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).