(122 days)
No
The device description and performance studies focus on the mechanical and material properties of a respiratory mask, with no mention of AI or ML.
No
The device is a non-invasive vented respiratory mask that channels airflow from a PAP device and is not a therapeutic device itself.
No
The device is a non-invasive vented respiratory mask used to channel airflow for PAP therapy. It does not perform any diagnostic functions.
No
The device description clearly outlines physical components (mask, headgear, frame, cushion, elbow/short tube) and the performance studies focus on mechanical integrity, biocompatibility, and reprocessing, all related to hardware. There is no mention of software as a component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to channel airflow non-invasively to a patient from a PAP device. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a respiratory mask that provides an air seal and connects to a PAP device. This is a physical device used for delivering air pressure, not for analyzing biological samples.
- Lack of Diagnostic Activity: There is no mention of the device being used to test or analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the physical and functional aspects of the mask (CO2 rebreathing, flow resistance, mechanical integrity, biocompatibility, reprocessing), not on the accuracy or reliability of diagnostic results.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is designed to deliver therapy to the body.
N/A
Intended Use / Indications for Use
The AirFit N20 channels airflow non-invasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.
The AirFit N20 is:
- to be used by patients weighing more than 66 lb (30 kg) 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The modified ResMed AirFit N20 is a non-invasive vented respiratory mask that provides a silicone air seal around the patient's nose and upper lip. The mask is held in place with adjustable head straps. Air flow from a positive air pressure (PAP) source is directed to the patient's airway non-invasively. It connects to a conventional PAP device air delivery hose via a standard 22mm swivel.
The modified AirFit N20 comprises 4 subassemblies: headgear, frame, cushion and elbow/short tube. The exhaust port is incorporated into the elbow/short tube assembly. For home use, the mask may be cleaned in warm soapy water.
The AirFit N20 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
patient's nose and upper lip, patient's airway
Indicated Patient Age Range
patients weighing more than 66 lb (30 kg)
Intended User / Care Setting
single patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment. Prescription Use.
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 modified AirFit N20 was designed and tested in accordance with ISO 17510:2015: Medical devices – Sleep apnoea breathing therapy Masks and application accessories.
The scope of non-clinical testing conducted to support the substantial equivalence claim of modified AirFit N20 to the previously cleared predicate AirFit N20 device included:
- CO2 rebreathing
- Total mask flow
- Flow resistance
- Through impedance
Mechanical integrity performance of the new device was verified by testing to simulated normal use and reasonable abuse scenarios including:
- home cleaning for single patient reuse
- reprocessing for multi-patient reuse
- transportation
- storage
Biocompatibility evaluation was conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-12 on modified components that were manufactured using new materials with patient exposure classifications of permanent external communicating device (tissue) and /or permanent skin contact. Predication on the predicate AifFit N20 device (K153673) and other reference devices was relied upon where the modified components were manufactured using previously cleared predicate materials.
Validation of reprocessing included a combination of cleaning efficacy testing, disinfection efficacy testing and predication based on previously validated Master Components. Post disinfection and sterilization performance testing and residual toxicity evaluation were also completed to demonstrate functional performance of the modified device.
Verification confirmed that the modified device met the predetermined acceptance criteria and the performance is substantially equivalent to the previously cleared predicate AirFit N20 (K153673).
Clinical Data: Clinical data was not relied upon to demonstrate Substantial Equivalence to the predicate device. Bench testing demonstrates that the modified AirFit N20 mask device performs in an equivalent manner and is as safe and as effective as the previously cleared predicate AirFit N20 device (K153673).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K031047, K032433, K132013, K132887
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2016
ResMed Ltd % Sheila Bruschi Senior Manager, Regulatory Affairs, ResMed Corp. ResMed Corp. 9001 Spectrum Center Boulevard San Diego, California 92123
Re: K161978
Trade/Device Name: AirFit N20 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: October 17, 2016 Received: October 18, 2016
Dear Sheila Bruschi:
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
Tina Kiang, Ph.D. Acting 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 N20
Indications for Use (Describe)
The AirFit N20 channels airflow non-invasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.
The AirFit N20 is:
· to be used by patients weighing more than 66 lb (30 kg) 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) SUMMARY
[As required by 21 CFFR 807.92(c)]
| Date Prepared | Nov 16th, 2016 |
|---|---|
| Company Name / | |
| Owner | ResMed Ltd |
| 1 Elizabeth Macarthur Drive | |
| Bella Vista, NSW, 2153 Australia | |
| Prepared & submitted | |
| by | Mr. Kim Kuan LEE |
| Senior Regulatory Affairs Manager | |
| Tel: + 61 2 8884 2232 | |
| Fax: + 61 2 8884 2004 | |
| kim.lee@resmed.com.au | |
| Official Contact | Miss Sheila Bruschi |
| Senior Manager, Regulatory Affairs | |
| ResMed Corp. | |
| 9001 Spectrum Center Blvd | |
| San Diego CA 92123 USA | |
| Tel: +1 858 836 5934 | |
| Fax: +1 858 836 5519 | |
| sheila.bruschi@resmed.com | |
| Device Trade Name | AirFit N20 |
| Device Common Name | Vented Nasal Mask |
| Classification & | |
| Classification Name | 21 CFR 868.5905, 73 BZD (Class II) |
| Accessory to Noncontinuous Ventilator (IPPB) | |
| Legally Marketed | |
| Predicate Devices | AirFit N20 (K153673) |
| Device Description | The modified ResMed AirFit N20 is a non-invasive vented respiratory |
| mask that provides a silicone air seal around the patient's nose and | |
| upper lip. The mask is held in place with adjustable head straps. Air | |
| flow from a positive air pressure (PAP) source is directed to the | |
| patient's airway non-invasively. It connects to a conventional PAP | |
| device air delivery hose via a standard 22mm swivel. |
The modified AirFit N20 comprises 4 subassemblies: headgear,
frame, cushion and elbow/short tube. The exhaust port is
incorporated into the elbow/short tube assembly. For home use, the
mask may be cleaned in warm soapy water.
The AirFit N20 is a prescription device supplied non-sterile. |
| Intended Use | The AirFit N20 channels airflow non-invasively to a patient from a
positive airway pressure (PAP) device such as a continuous positive
airway pressure (CPAP) or bilevel device.
The AirFit N20 is:
• to be used by patients weighing more than 66 lb (30 kg) 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. |
4
Device modifications Submission reason
Comparison of technological characteristics with the previously cleared predicate AirFit N20 device
Delivering treatment pressure generated from a positive airway device (PAP) device to the patient's airway is the technological principle of both the modified AirFit N20 and the previously cleared predicate AirFitN20 (K153673) device.
The modified and predicate devices are based on the following same technological elements:
- Soft silicone elastomer cushions are used to achieve an air seal ● around the patient's nose and upper lip.
- . The cushion is held in place using a polymeric frame
- The frame is strapped to the patient's head using a four point foam padded fabric headgear that employ self- aligning tactile magnetic clips.
- A flexible and extensible elbow and short tube assembly delivers the treatment pressure from the PAP device tubing to the cushion and the patient's airway.
- Exhaust ports are built into the elbow to continuously flush out and minimize the amount of CO2 rebreathed by the patient.
- . The masks can be disassembled for cleaning and reprocessing in accordance with the labelling.
- Use of polymeric construction materials for the pneumatic and structural components and foam padded fabrics for the head strap.
- . Use of ISO 5356-1 compliant 22mm diameter swivel for connection to the PAP delivery hose.
- Multiple size offering to ensure adequate mask fit over the . extended patient population.
- Similar performance i.e. both masks have similar operating . pressure range, pressure flow and flow impedance characteristics and operate on the same "Pillows, Mirage or Swift" ResMed flow generator settings.
- . Same operating environments i.e. reuse in the home and hospital / institution environments
- . Similar manufacturing processes
The following technological differences exist between the modified AirFit N20 and the previously cleared predicate AirFit N20 (K153673) are:
- The modified AirFit N20 design incorporates an optional multi-. hole integrated elbow/short tube; the previously cleared AirFit N20 only has a diffused elbow/short tube assembly.
- . Headgear fabric materials were modified.
- Exhaust port vent geometries modifications were made to the . diffused elbow.
- . Reprocessing claims expanded to include other components. In the predicate device only the cushion was labelled for reprocessing.
Verification and validation testing has demonstrated that these differences do not affect intended performance of the modified mask nor raise new questions of safety or effectiveness.
5
| Non-clinical data | The modified AirFit N20 was designed and tested in accordance with
ISO 17510:2015: Medical devices – Sleep apnoea breathing therapy
Masks and application accessories.
The scope of non-clinical testing conducted to support the substantial
equivalence claim of modified AirFit N20 to the previously cleared
predicate AirFit N20 device included:
• CO2 rebreathing
• Total mask flow
• Flow resistance
• Through impedance |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Mechanical integrity performance of the new device was verified by
testing to simulated normal use and reasonable abuse scenarios
including:
• home cleaning for single patient reuse
• reprocessing for multi-patient reuse
• transportation
• storage |
| | Biocompatibility evaluation was conducted in accordance with
ISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-12 on
modified components that were manufactured using new materials
with patient exposure classifications of permanent external
communicating device (tissue) and /or permanent skin contact.
Predication on the predicate AifFit N20 device (K153673) and other
reference devices was relied upon where the modified components
were manufactured using previously cleared predicate materials.
Reference devices include Mirage Vista Mask (K031047), Mirage
Swift (K032433), AirFit P10 (K132013) and AirFit N10 (K132887). |
| | Validation of reprocessing included a combination of cleaning efficacy
testing, disinfection efficacy testing and predication based on
previously validated Master Components. Post disinfection and
sterilization performance testing and residual toxicity evaluation were
also completed to demonstrate functional performance of the modified
device. |
| | Verification confirmed that the modified device met the predetermined
acceptance criteria and the performance is substantially equivalent to
the previously cleared predicate AirFit N20 (K153673). |
| Clinical Data | Clinical data was not relied upon to demonstrate Substantial
Equivalence to the predicate device. Bench testing demonstrates that
the modified AirFit N20 mask device performs in an equivalent
manner and is as safe and as effective as the previously cleared
predicate AirFit N20 device (K153673). |
| Substantial
Equivalence
Conclusion | The modified AirFit N20 is substantially equivalent to the previously
predicate AirFit N20 device (K153673):
• it has the same intended use
• it has similar technological characteristics
• it has similar performance characteristics
• the differences do not raise any new questions of safety or
effectiveness
• it is at least as safe and as effective as the predicate device |