(156 days)
AirFit N20 (K161978)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a respiratory mask, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The AirFit N20 is an accessory (mask) for a PAP device, which is used for therapeutic purposes, but the mask itself does not deliver therapy.
No
Explanation: The device is a respiratory mask used to channel airflow from a PAP device to a patient. Its function is to deliver positive airway pressure, not to diagnose a condition.
No
The device description clearly outlines physical components (headgear, frame, cushion, elbow/short tube) and describes it as an externally placed vented respiratory mask, indicating it is a hardware device.
Based on the provided information, the AirFit N20 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- AirFit N20 Function: The AirFit N20 is a respiratory mask that channels airflow from a PAP device to a patient's airway. It is an external device used for delivering therapy, not for analyzing biological specimens.
- Intended Use: The intended use clearly states it's for channeling airflow non-invasively for positive airway pressure therapy.
- Device Description: The description details a mask, headgear, frame, cushion, and elbow/short tube – components for delivering air, not for analyzing samples.
Therefore, the AirFit N20 falls under the category of a respiratory support device, not an IVD.
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 AirFit N20 is an externally placed vented respiratory mask covering the patient's nose. It provides a seal such that pressure from a positive air pressure (PAP) source is directed to the patient's airway non-invasively via the nose. The mask connects to the positive pressure source through a conventional air tubing via a standard conical connector. The mask is held in place with adjustable head straps.
The AirFit N20 comprises 4 subassemblies: headgear, frame, cushion and elbow/short tube. The exhaust port is incorporated into the elbow/short tube assembly. The cushion and headgear are available in various sizes to fit a wide patient population.
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
Nose, 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
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)
Verification and validation testing has demonstrated that the expansion of the multi-patient reuse reprocessing claims do not affect intended performance of the mask nor raise new questions of safety or effectiveness.
Non clinical testing included:
Bioburden efficacy tests which demonstrated that the subject device meets the same cleaning and microbicidal bioburden efficacy performance as the predicate device. Performance tests before and after the additional reprocessing claims to demonstrate that the subject device continues to meet the same performance specifications as the predicate device. These included Mask Pressure-Flow tests per ISO 17510:2015 and relevant mask mechanical integrity tests such as visual inspection, assembly integrity, headgear connection integrity, simulated body weight crush test and free fall drop test. Residual toxicity testing which demonstrated that the subject device remains safe after reprocessing. This was demonstrated using the appropriate Cytotoxicity biocompatibility tests, performed in accordance with ISO 10993-5:2009.
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.
AirFit N20 (K161978)
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.
Not Found
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/2 description: The image is a black and white 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 coiled around it. The caduceus is a symbol of medicine and healing. The logo also includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2017
ResMed Ltd % Sheila Bruschi Senior Manager, Regulatory Affairs. ResMed CORP. ResMed Corp (Registration Number: 3007573469) 9001 Spectrum Center Boulevard San Diego, California 92123
Re: K171212
Trade/Device Name: AirFit N20 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: August 28, 2017 Received: August 30, 2017
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
1
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 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 (DICE) 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 (DICE) 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,
Tara A. Ryan -S
for
Tina Kiang, PhD 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
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)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| Date Prepared | September 28, 2017 |
|---|---|
| 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 (K161978) |
| Device Description | The AirFit N20 is an externally placed vented respiratory mask |
| covering the patient's nose. It provides a seal such that pressure from | |
| a positive air pressure (PAP) source is directed to the patient's airway | |
| non-invasively via the nose. The mask connects to the positive | |
| pressure source through a conventional air tubing via a standard | |
| conical connector. The mask is held in place with adjustable head | |
| straps. |
The AirFit N20 comprises 4 subassemblies: headgear, frame, cushion
and elbow/short tube. The exhaust port is incorporated into the
elbow/short tube assembly. The cushion and headgear are available
in various sizes to fit a wide patient population.
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
Submission reason Expansion of reprocessing claims
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 subiect AirFit N20 and the previously cleared predicate AirFitN20 (K161978) device.
The subiect and predicate devices have identical intended use and are based on the same technological elements as follows:
- . Silicone elastomer cushions 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 foam padded fabric headgear and clips.
- An elbow and short tube assembly delivers the treatment pressure from the PAP device tubing to the cushion and the patient's airway.
- Exhaust ports flush out CO2. ●
- . 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 swivel for connection to the PAP delivery hose.
- . Multiple size offerings to allow for adequate mask fit over the intended 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
The main difference between the subject AirFit N20 and the previously cleared predicated device AirFit N20 (K161978) is:
- High level chemical disinfection claims (Alconox cleaning followed by Cidex OPA disinfection) were added to the diffused elbow and diffused short tube assemblies.
- . High level thermal disinfection claims (Alconox cleaning followed by Hot Water disinfection (90°C, 1 min) were added to the multihole elbow and short tube assembly.
These differences do not affect substantial equivalence claim to the predicate device because non-clinical testing below demonstrates that the subject device has equivalent performance to and is as safe as the predicate device.
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| Non-clinical data | Verification and validation testing has demonstrated that the
expansion of the multi-patient reuse reprocessing claims do not affect
intended performance of the mask nor raise new questions of safety
or effectiveness. |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Non clinical testing included:
Bioburden efficacy tests which demonstrated that the subject
device meets the same cleaning and microbicidal bioburden
efficacy performance as the predicate device. Performance tests before and after the additional
reprocessing claims to demonstrate that the subject device
continues to meet the same performance specifications as
the predicate device. These included Mask Pressure-Flow
tests per ISO 17510:2015 and relevant mask mechanical
integrity tests such as visual inspection, assembly integrity,
headgear connection integrity, simulated body weight crush
test and free fall drop test. Residual toxicity testing which demonstrated that the subject
device remains safe after reprocessing. This was
demonstrated using the appropriate Cytotoxicity
biocompatibility tests, performed in accordance with ISO
10993-5:2009. |
| Substantial
Equivalence
Conclusion | The subject AirFit N20 is substantially equivalent to the previously
predicate AirFit N20 device (K161978):
it has the same intended use it has the same technological characteristics it has the same 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 |