(151 days)
No
The device description and performance studies focus on the physical components and mechanical performance of a mask, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a non-invasive accessory for channeling airflow from a PAP device, not a therapeutic device itself. It facilitates a therapy but doesn't provide it directly.
No
The AirFit F20 is described as a "non-invasive accessory used for channeling airflow...to a patient from a positive airway pressure (PAP) device." Its function is to deliver therapy, not to diagnose a condition.
No
The device description clearly outlines physical components like a mask, cushion, frame, elbow, and headgear, indicating it is a hardware device.
Based on the provided information, the AirFit F20 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to channel airflow from a PAP device to a patient. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a mask and its components used for delivering air pressure. It does not mention any components or processes related to testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical and functional performance of the mask (CO2 rebreathing, flow resistance, etc.) and biocompatibility, not on the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The AirFit F20 is an in vivo device used directly on the patient for therapeutic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
BZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth and the nose
Indicated Patient Age Range
patients weighing more than 66 lb (30 kg)
Intended User / Care Setting
single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Quattro Air (K123979)
Reference Device(s)
AirFit N10 (K132887)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and professional, reflecting the department's role in public health and welfare.
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
1
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
2
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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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 channeling
airflow (with or without supplemental oxygen) to a patient from a
positive airway pressure (PAP) device such as a continuous
positive airway pressure (CPAP) or bilevel system.
The AirFit F20 is:
to be used by patients weighing more than 66lb (30kg) 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. |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities and
Differences with the
Predicate Device | The AirFit F20 device has the following similarities to the
previously 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 previously
cleared predicated device (Quattro Air (K123979)) include mask
component 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.