(133 days)
Not Found
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 technologies.
Yes.
The device is a mask that channels airflow from a positive airway pressure (PAP) device to a patient who has been prescribed positive airway pressure. It is used in conjunction with PAP devices like CPAP or bilevel devices for therapeutic purposes, specifically for patients weighing more than 66 lb (30 kg) for whom positive airway pressure has been prescribed.
No
The device is a mask that channels airflow from a PAP device; it does not perform any diagnostic function.
No
The device description clearly outlines physical components (headgear, frame, cushion, elbow/short tube) and describes non-software related testing (CO2 rebreathing, flow resistance, mechanical integrity, biocompatibility).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The AirFit N20 is a respiratory mask that delivers air non-invasively to a patient's airway from a PAP device. It is a physical interface for delivering therapy, not for analyzing biological samples.
- Intended Use: The intended use clearly states it "channels airflow non-invasively to a patient." There is no mention of analyzing any biological samples.
- Device Description: The description focuses on the physical components of the mask and how it connects to a PAP device.
- Performance Studies: The performance studies focus on mechanical integrity, CO2 rebreathing, flow resistance, and biocompatibility – all related to the physical function and safety of the mask in delivering air. There are no studies related to analyzing biological samples.
Therefore, the AirFit N20 is a medical device used for respiratory therapy, but it does not meet the definition of an In Vitro Diagnostic device.
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:
- o 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
BZD
Device Description
The 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 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
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)
Non-clinical data: The AirFit N20 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 N20 to the predicate 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 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 N20 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 N20 is substantially equivalent to the predicate AirFit N10 (K132887).
Clinical Data: Clinical data was not relied upon to demonstrate Substantial Equivalence to predicate devices. Bench testing demonstrates that the new AirFit N20 mask 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)
AirFit N10 (K132887)
Reference Device(s)
Not Found
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 2, 2016
ResMed Ltd. % Larissa D'Andrea Director, Government and Regulatory Affairs ResMed Corp 9001 Spectrum Center Boulevard San Diego, California 92123
Re: K153673
Trade/Device Name: AirFit N20 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: March 23, 2016 Received: March 25, 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153673
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:
- o 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)
区 Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (Part 21 CFR 807 Subpart C)
CONTINUE ON ANOTHER PAGE IF NEEDED)
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FORM FDA 3881 (8/14)
3
510(k) SUMMARY
[As required by 21 CFFR 807.92(c)]
| Date Prepared | December 17th, 2015 |
|---|---|
| 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 Larissa D'Andrea |
| Director, Government and 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 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 N10 (K132887) |
| Device Description | The 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 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
Submission reason New Device
Similarities and differences with the predicate device
- predicate AirFit N10 (K132887): . same intended use
- same operating principle ●
- . similar construction materials and design that incorporate:
The AirFit N20 has the following similarities to the previously cleared
- A silicone elastomer cushion interface that provides air a. seal around the patient's nose and upper lip.
- b. The use of a multi-hole vent array to continuously flush out and minimize the amount of CO2 rebreathed by the patient.
- A multiple size offering to ensure adequate mask fit over C. the extended patient population.
- Use of a 4 attachment point head strap that employ self-ರ. aligning tactile magnetic clips.
- A flexible and extensible short tube to mechanically e. decouple the mask from the conventional PAP device air delivery hose to enhance stability and air seal.
- f. A 22 mm diameter ISO 5356-1 fully rotatable (360°) conical swivel for connection to the delivery hose.
- The use of molded polymeric plastic and silicone air seal g. components and foam padded fabric headgear deemed safe (ref: ISO 10993-1).
- . 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 main differences between the AirFit N20 and the previously cleared predicate AirFit N10 (K132887) include mask component design and geometry:
- The AirFit N20 design incorporates an integrated elbow/short tube ● that is detachable from the frame to enhance usability: the AirFit N10 short tube is permanently moulded to the frame.
- . The AirFit N20 plastic frame arms incorporate permanently overmoulded foam padded soft fabrics to enhance patient comfort and usability; the AirFit N10 mask is supplied with fabric soft sleeves that can be fitted to the plastic arms.
- For sealing performance, the AirFit N20 silicone cushions employ . a novel feature to anchor and stabilise the interface: the AirFit N10 cushions employ the traditional dual wall design.
- . The AirFit N20 exhaust port is located on the elbow component whereas the AirFit N10 exhaust port is located on the frame component.
Verification and validation testing has demonstrated that these differences do not affect intended performance of the mask nor raise new questions of safety or effectiveness.
- Non-clinical data The AirFit N20 was designed and tested in accordance with ISO 17510-2: Sleep apnoea breathing therapy - Part 2: Masks and application accessories.
5
The scope of non-clinical testing conducted to support the substantial equivalence claim of AirFit N20 to the predicate 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 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 N20 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 N20 is substantially equivalent to the predicate AirFit N10 (K132887). Clinical Data Clinical data was not relied upon to demonstrate Substantial Equivalence to predicate devices. Bench testing demonstrates that the new AirFit N20 mask device performs in an equivalent manner and is as safe and as effective as the predicate device. Substantial The new AirFit N20 is substantially equivalent to the predicate device: Equivalence it has the same intended use -Conclusion 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