(96 days)
The Mirage FX channels airlow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Mirage FX is:
- to be used by 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 FX 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 FX is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Mirage FX is a prescription device supplied non-sterile.
Here's an analysis of the acceptance criteria and study information for the RESMED Mirage FX Traditional 510k submission, based on the provided text:
Acceptance Criteria and Device Performance
The submission describes the Mirage FX device as "substantially equivalent" to predicate devices, meaning it meets the same safety and effectiveness standards. The specific criteria are based on the technological characteristics and performance of the predicate devices.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (Mirage FX) |
|---|---|---|
| Intended Use | Identical intended uses to predicate devices. Indicated for the same user population. | "The new device and the predicate mask have identical intended uses. Both devices are indicated for the same user population." (Comparison with predicate ComfortLite 2) |
| Technology Characteristics (Seal) | Provide a seal via a silicone interface. | "Both masks provide a seal via silicone interface." (Comparison with predicate Mirage Micro) |
| Technology Characteristics (Fit) | Offered in various sizes to ensure adequate fit over the extended patient population. | "Both the new and predicate masks are offered in various sizes to ensure adequate fit over the extended patient population." (Comparison with predicate Mirage Micro) |
| Technology Characteristics (CO2 Rebreath) | Incorporate vent holes to provide continuous air leak to flush out and minimize the amount of CO2 rebreathed by the patient, without interfering with intended performance. | "Both masks incorporate vent holes to provide continuous air leak to flush out 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." (Comparison with predicate Mirage Micro)"The CO2 performance of the Mirage FX has been demonstrated through bench testing to be substantially equivalent to the Ultra Mirage II." (Comparison with predicate Ultra Mirage II) |
| Technology Characteristics (Hose Connection) | 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 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)" (Comparison with predicate Mirage Micro) |
| Technology Characteristics (Materials) | Constructed using molded plastic and silicone components and fabric/nylon headgear. Materials deemed safe (ref: ISO 10993-1). | "Both the new and predicate devices are constructed using molded plastic and silicone components and fabric / nylon headgear. Components of the new and predicate masks are fabricated using materials deemed safe. (ref: ISO 10993-1)." (Comparison with predicate Mirage Micro) |
| Non-clinical Performance (Pressure-Flow) | Pressure-flow characteristics and flow impedance are substantially equivalent to the predicate device. | "The pressure-flow characteristics and flow impedance of the new devices was bench tested and demonstrated to be substantially equivalent to the predicate device." (Comparison with predicate Mirage Micro) |
| Non-clinical Performance (Reuse) | Reusable in home and hospital/institution environment. | "Both the new and the predicate devices can be reused in the home and hospital / institution environment." (Comparison with predicate Mirage Micro) |
| Safety and Effectiveness | Does not raise new questions of safety and effectiveness; at least as safe and effective as predicate devices. | "Mirage FX is substantially equivalent to the predicate devices...- it does not raise new questions of safety and effectiveness; - it is at least as safe and effective as the predicate devices." |
Study Information
Based on the provided text, the submission primarily relies on bench testing and comparison to predicate devices to demonstrate substantial equivalence. No clinical studies (on human subjects) are described in detail.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of patient data. The evaluation primarily involved bench testing of the device itself and comparison to physical characteristics of predicate devices.
- Data Provenance: Not applicable in the context of a clinical test set. The bench testing would have been conducted by ResMed.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth for a clinical test set (e.g., disease presence) was not established through expert review for this submission. The "ground truth" for the device's performance was established through engineering specifications and comparison to the performance of medically accepted predicate devices via bench testing.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical test set requiring expert adjudication.
-
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 MRMC study was mentioned. This device is a medical mask for positive airway pressure therapy, not an AI-assisted diagnostic or treatment device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithmic device. The "standalone" performance refers to the bench testing of the device's physical functions (e.g., pressure-flow characteristics, CO2 clearance) without a human user.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this substantial equivalence claim is effectively the established safety and effectiveness of the predicate devices and the physical/engineering standards (e.g., ISO standards, pressure-flow characteristics) achieved through bench testing. For CO2 performance, it was deemed "substantially equivalent" to the Ultra Mirage II.
-
The sample size for the training set
- Not applicable. This device does not involve machine learning algorithms that require a "training set."
-
How the ground truth for the training set was established
- Not applicable. This device does not involve machine learning algorithms.
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RESMED
Mirage FX Traditional 510k
510(k) SUMMARY [As required by 21 CFR 807.92(c)] Sept 17", 2010 Date Prepared DEC 2 8 2010 Submitter Mr. Kim Kuan Lee Official Contact Mr. David D'Cruz, V.P., US Medical & Regulatory Affairs 9001 Spectrum Center Blvd San Diego CA 92123 USA Tel: (858) 836-5984 Mirage™ FX Device Trade Name Device Common Name/ Vented Nasal Mask; Classification Name Accessory to Noncontinuous Ventilator (IPPB) 21 CFR 868.5905, 73 BZD (Class II) Classification Predicate Devices Mirage Micro Nasal Mask (K072940) Ultra Mirage II Nasal Mask (K050359) ComfortLite 2 (K082558) Description The Mirage FX 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 FX is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Mirage FX is a prescription device supplied non-sterile. Intended Use Comparison with predicate ComfortLite 2 The Mirage FX 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 FX is: to be used by patients (> 66 lb/30 kg) for whom positive ● airway pressure has been prescribed intended for single-patient reuse in the home environment . and multi-patient reuse in the hospital/institutional environment. The new device and the predicate mask have identical intended uses. Both devices are indicated for the same user population. Technological & non Comparison with predicate Mirage Micro clinical performance The new device and the predicate mask provide a seal via characteristics silicone interface. Both the new and predicate masks are offered in various sizes to ensure adequate fit over the extended patient population. Both masks incorporate vent holes to provide continuous air leak to flush out and minimize the amount of CO2 rebreathed
17 September, 2009
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RESMED
| by the 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 the new and predicate devices are constructed usingmolded plastic and silicone components and fabric / nylonheadgear. Components of the new and predicate masks masksare fabricated using materials deemed safe. (ref: ISO 10993-1). | |
| The pressure-flow characteristics and flow impedance of thenew devices was bench tested and demonstrated to besubstantially equivalent to the predicate device. | |
| Both the new and the predicate devices can be reused in thehome and hospital / institution environment. | |
| The main differences between Mirage FX and the predicateMirage Micro is in the number of components, theirdesign/geometry and how individual components interface witheach other. Both masks are designed and constructed underResMed's 21 CFR Part 820 compliant Quality ManagementSystem. | |
| Non clinical performanceData | Comparison with predicate Ultra Mirage IIThe CO2 performance of the Mirage FX has been demonstratedthrough bench testing to be substantially equivalent to the UltraMirage II. |
| Clinical Data | Use of vented nasal masks with CPAP or Bilevel therapy isproven technology and is well accepted by the medicalcommunity. Bench testing is sufficient to demonstrate safetyand efficacy of the Mirage FX, as was the case with thepredicate devices. |
| Substantial EquivalenceConclusion | Mirage FX is substantially equivalent to the predicate devices:- it has the same, intended use and is indicated for the sameuser population;- it has similar technological characteristics to the predicates;- it does not raise new questions of safety and effectiveness;- it is at least as safe and effective as the predicate devices. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Mr. David D'Cruz V.P. US Medical & Regulatory Affairs ResMed, Limited 9001 Spectrum Center Boulevard San Diego, California 92123
DEC 2 8 2010
Re: K102746
Trade/Device Name: Mirage™ FX Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BDZ Dated: December 20, 2010 Received: December 22, 2010
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.
If 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/ReportalProblem/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,
for
Anthony 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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Mirage FX Traditional 510k
Indication for Use
510(k) Number (if known): Mirage™ FX Device Name: Indication for Use
DEC 2 8 2010
The Mirage FX channels airlow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Mirage FX is:
- to be used by 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.
Over-The-Counter Use_ AND/OR Prescription Use X (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (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
17 September, 2010
ing J. D'Souza
Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devicgs
$10(k) Number: K102746
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).