(151 days)
The AirFit F20 is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous pressure (CPAP) or bilevel system.
The AirFit F20 is:
• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed
• intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment.
The AirFit F20 is an externally placed vented mask covering the mouth and the nose of the patient. It provides a seal such that pressure from a positive pressure source is directed to the patient's nose and/or mouth. The mask connects via a standard conical connector to a conventional air delivery hose, which in turn connects to the positive pressure source. The mask is held in place with an adjustable headgear that straps the mask to the face. The AirFit F20 mask system comprises four subassemblies: cushion, frame, elbow and headgear. The elbow incorporates the vent array and anti-asphyxia valve safety features. The cushion and headgear are available in various sizes to fit a wide patient population.
AirFit F20 is a prescription device supplied non-sterile.
The provided document is a 510(k) summary for the ResMed AirFit F20, a non-invasive accessory for CPAP/bilevel systems. It focuses on demonstrating substantial equivalence to a predicate device (Quattro Air K123979) rather than presenting a study to prove acceptance criteria for a new, unique device performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable or not explicitly detailed as one might find in a study specifically designed to establish novel performance claims.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a direct table of specific acceptance criteria values alongside numerical performance results for the AirFit F20. Instead, it states that the device was designed and tested in accordance with ISO 17510-2: Sleep apnoea breathing therapy - Part 2: Masks and application accessories, and that testing confirmed the new device met "predetermined acceptance criteria" and its performance is "substantially equivalent" to the predicate.
| Acceptance Criteria Category (Derived from ISO 17510-2 and testing) | Reported Device Performance |
|---|---|
| CO2 Rebreathing | Met predetermined acceptance criteria; demonstrated performance substantially equivalent to Quattro Air (K123979). |
| AAV performance | Met predetermined acceptance criteria for activation/deactivation, inspiratory/expiratory resistance, inadvertent activation/deactivation, and response to extreme humidification; demonstrated performance substantially equivalent to Quattro Air (K123979). |
| Total Mask Flow | Met predetermined acceptance criteria; demonstrated performance substantially equivalent to Quattro Air (K123979). |
| Flow Resistance | Met predetermined acceptance criteria; demonstrated performance substantially equivalent to Quattro Air (K123979). |
| Through Impedance | Met predetermined acceptance criteria; demonstrated performance substantially equivalent to Quattro Air (K123979). |
| Mechanical Integrity & Performance | Verified to simulated normal and reasonable abuse scenarios (home cleaning, multi-patient reuse, transportation, storage); met predetermined acceptance criteria. |
| Biocompatibility | Met predetermined acceptance criteria in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12, and ISO 10993-17 for new materials. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The testing appears to be primarily bench/non-clinical and biocompatibility. For bench testing of physical characteristics like flow, rebreathing, and resistance, samples would typically consist of a certain number of manufactured units of the AirFit F20. The specific number is not provided.
- Data Provenance: The testing was non-clinical (bench testing) and focused on material and functional performance. It does not involve human patient data in the context of clinical outcomes. The manufacturer, ResMed Ltd., is based in Australia, and the submission was made to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable in the context of this 510(k) submission. The "ground truth" for the non-clinical tests (e.g., CO2 rebreathing, flow resistance) is established by measurement against predefined engineering specifications and international standards (like ISO 17510-2). These are objective physical measurements, not subjective expert interpretations that require "ground truth" establishment by multiple experts with specific qualifications like radiologists.
4. Adjudication Method for the Test Set
- Not applicable. Since the tests are objective physical measurements against standards and predicate performance, there is no need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states: "Clinical data was not relied upon to demonstrate substantial equivalence to the predicate device. Bench testing demonstrates that the new AirFit F20 device performs in an equivalent manner and is as safe and as effective as the predicate device." MRMC studies apply to imaging or diagnostic devices where human readers interpret results, which is not the case for this device.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance Study
- Yes, indirectly. The non-clinical data presented (CO2 rebreathing, AAV performance, total mask flow, flow resistance, through impedance, mechanical integrity, biocompatibility) represents testing of the device's inherent physical and functional performance, essentially "standalone" in a bench setting without human interaction influencing the core functional measurements. However, it's not an "algorithm" in the typical sense for AI, but rather the performance of the physical mask.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical tests is based on:
- International Standards: Specifically, ISO 17510-2: Sleep apnoea breathing therapy - Part 2: Masks and application accessories.
- Engineering Specifications: Predetermined acceptance criteria derived from the standard and design requirements.
- Predicate Device Performance: Demonstrating substantial equivalence to the performance characteristics of the legally marketed predicate device (Quattro Air (K123979)).
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical device (mask), not an AI/algorithm-based diagnostic system that requires a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no AI training set for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2016
ResMed Ltd. % Larissa D'Andrea Director, Government & Regulatory Affairs ResMed Corp. 9001 Spectrum Center Boulevard San Diego, California 92123
Re: K153563
Trade/Device Name: AirFit F20 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (Ippb) Regulatory Class: Class II Product Code: BZD Dated: April 8, 2016 Received: April 11, 2016
Dear Larissa D'Andrea:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name AirFit F20
Indications for Use (Describe)
The AirFit F20 is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous pressure (CPAP) or bilevel system.
The AirFit F20 is:
• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed • intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY [As required by 21 CFR 807.92(c)] Date Prepared May 4, 2016 Company Name / Owner ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia Submitter Name Ms. Johanna Wright Senior Regulatory Affairs Manager ResMed Ltd Tel: +612 8884 1000 Fax: +612 8884 2004 johanna.wright@resmed.com.au Official Contact Ms Larissa D'Andrea Director, Government & Regulatory Affairs ResMed Corp 9001 Spectrum Center Blvd San Diego CA 92123 USA Tel: +1 858 836 6837 Fax: +1 858 836 5519 Larissa.D'Andrea@resmed.com Device Trade Name AirFit F20 Device Common Name Vented Full Face Mask Noncontinuous Ventilator (IPPB) (21 CFR 868.5905, Classification Name Product Code BZD) Predicate Device Quattro Air (K123979) Reference Device AirFit N10 (K132887) Device Description The AirFit F20 is an externally placed vented mask covering the mouth and the nose of the patient. It provides a seal such that pressure from a positive pressure source is directed to the patient's nose and/or mouth. The mask connects via a standard conical connector to a conventional air delivery hose, which in turn connects to the positive pressure source. The mask is held in place with an adjustable headgear that straps the mask to the face. The AirFit F20 mask system comprises four subassemblies: cushion, frame, elbow and headgear. The elbow incorporates the vent array and anti-asphyxia valve safety features. The cushion and headgear are available in various sizes to fit a wide patient population.
AirFit F20 is a prescription device supplied non-sterile.
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| Intended Use | The AirFit F20 is a non-invasive accessory used for channelingairflow (with or without supplemental oxygen) to a patient from apositive airway pressure (PAP) device such as a continuouspositive airway pressure (CPAP) or bilevel system.The AirFit F20 is:to be used by patients weighing more than 66lb (30kg) forwhom positive airway pressure therapy has been prescribed intended for single-patient reuse in the home environment andmulti-patient reuse in the hospital/institutional environment. |
|---|---|
| Similarities andDifferences with thePredicate Device | The AirFit F20 device has the following similarities to thepreviously cleared predicated device (Quattro Air (K123979): same intended use same operating principle similar design and materials which incorporates: a silicone interface providing a seal around the nose and the mouth; vent holes providing continuous air leak to flush out and minimize the amount of CO2 re-breathed by the patient; anti-asphyxia valves (AAV) to enable the patient to breathe fresh air in the event that airflow from the flow generator is impeded; elbow which connects to a conventional air delivery hose via standard conical connector; molded plastic and silicone components and polyamide/polyurethane/polyester headgear - all deemed biologically safe (ref: ISO 10993-1); Both masks are offered in various sizes to ensure adequate fit over the extended patient population. similar performance i.e both masks operate on the same flow generator settings and have similar pressure-flow characteristics and flow impedance. same operating environments i.e reuse in the home and hospital / institution environments similar manufacturing processes |
| The main differences between the AirFit F20 and the previouslycleared predicated device (Quattro Air (K123979)) include maskcomponent design and geometry:The AirFit F20 frame incorporates an upper arm positioned under the eyes whilst the Quattro Air frame includes a forehead support. The AirFit F20 vent array is located on the elbow assembly, whereas the Quattro Air vent array is located on the cushion assembly. For sealing performance, the AirFit F20 silicone cushion employs a novel feature to anchor and stabilise the interface compared with the traditional Quattro Air silicone cushion design. | |
| Verification and validation testing has demonstrated that these |
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differences do not raise new questions of safety or effectiveness.
Non-Clinical Data The AirFit F20 was designed and tested in accordance with ISO 17510-2: Sleep apnoea breathing therapy - Part 2: Masks and application accessories.
The scope of non-clinical testing conducted to support the substantial equivalence claim of AirFit F20 with the predicate device included:
- CO2 rebreathing ●
- . AAV performance (activation/deactivation, inspiratory /expiratory resistance, inadvertent activation/deactivation, response to extreme humidification)
- . Total mask flow
- Flow resistance ●
- Through impedance ●
Mechanical integrity and performance of the new device was also verified to simulated normal and reasonable abuse scenarios including: home cleaning; multi-patient reuse; transportation and storage.
Biocompatibility testing was conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12 and ISO 10993-17 on new materials used in the manufacture of the AirFit F20 with patient exposure classifications permanent external communicating device (tissue) and /or permanent skin contact.
Testing confirmed that the new device met the predetermined acceptance criteria and the performance of the AirFit F20 is substantially equivalent to Quattro Air (K123979).
Clinical Data Clinical data was not relied upon to demonstrate substantial equivalence to the predicate device. Bench testing demonstrates that the new AirFit F20 device performs in an equivalent manner and is as safe and as effective as the predicate device.
Substantial Equivalence The new AirFit F20 is substantially equivalent to the predicate Conclusion device:
- it has the same intended use -
- it has similar technological characteristics
- it has similar performance characteristics
- the difference do not raise any new questions of safety or effectiveness
- it is at least as safe and as effective as the predicate device.
§ 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).