(95 days)
No
The device description and performance studies focus on the physical design, material properties, and basic functionality of a PAP mask, with no mention of AI or ML algorithms for data analysis, control, or other functions.
Yes
The device is a mask that channels airflow from a PAP device (which is a therapeutic device) to the patient, enabling the delivery of prescribed positive airway pressure for treatment.
No
The device description indicates it is a mask that channels airflow from a PAP device, and the intended use states it is for patients for whom positive airway pressure has been prescribed. It does not mention any capabilities for detecting, analyzing, or diagnosing medical conditions.
No
The device description clearly states it is an "externally worn mask" and describes physical components like headgear and a swivel, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device "channels airflow noninvasively to a patient from a positive airway pressure (PAP) device". This describes a device used for delivering therapy, not for performing tests on samples taken from the body (which is the definition of an IVD).
- Device Description: The description details an "externally worn mask" that provides an air seal for delivering air from a PAP device. This aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on aspects like CO2 washout, pressure-flow, mechanical integrity, and cleaning/reuse. These are relevant to the function and safety of a respiratory therapy mask, not an IVD.
- Biological Tests: The biological tests mentioned (Genotoxicity, Cytotoxicity, Implantation, Sensitization, Irritation) are standard tests for biocompatibility of devices that come into contact with the body, which is consistent with a medical device, but not specifically an IVD.
In summary, the AirFit™ N10 is a medical device used for delivering positive airway pressure therapy, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The AirFit™ N10 channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.
The AirFit™ N10 is:
to be used by patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed
intended for single-patient re-use in the home environment and multipatient re-use in the hospital / institutional environment.
Product codes
BZD
Device Description
The AirFit™ N10 is an externally worn mask that provides an air seal, such that air flow from a positive pressure source is directed to the patient's nose. The mask is held in place with an adjustable headgear. It connects to a conventional PAP device air delivery hose via a standard 22mm swivel. The mask may be cleaned with mild soap.
continuous air leak to prevent rebreathing of dead space CO2
AirFit™ N10 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
Indicated Patient Age Range
66 lb/30 kg
Intended User / Care Setting
single-patient re-use in the home environment and multipatient 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)
The CO2 washout performance of the new device was tested to ensure the mask design provides adequate venting to flush out the expired CO2. The testing included physical and functional dead-space measurements. The device satisfied all predefined The new AirFit™ N10 is as safe and effective as the predicate devices:
Pressure-flow and through impedance bench test results of the new mask were also substantially equivalent to the predicate Swift FX Nano device (K123789).
Mechanical integrity performance of the new device was tested to simulated normal use and reasonable abuse scenarios. The device was also tested to demonstrate that it can withstand the effects of storage temperature, humidity and transportation shock & vibration.
Validation of cleaning and reuse was completed to establish that the device can be safely reused by a single patient, or multipatient reuse in the hospital/institutional environment following validated disinfection protocols. After 20 cycles of cleaning/disinfection in accordance with the methods described in the cleaning / disinfection quide, the device has been shown to function as intended. The device satisfied the pass/fail criteria and was shown to be substantially equivalent to the predicate devices.
Materials used in the construction of components that contact the heated humidified gas pathway are classified as permanent "external communicating devices" (with tissue/bone/dentin). The appropriate biological tests conducted and passed for these components, in accordance with FDA guidance #G95-1 were:
- ISO 10993-3 Genotoxicity, .
- ISO 10993-5 Cytotoxicity, .
- ISO 10993-6 Implantation and .
- ISO 10993-10 Sensitization .
The appropriate biological tests conducted and passed for components considered to be in permanent skin contact, in accordance with FDA guidance #G95-1, were: - ISO 10993-5 Cytotoxicity .
- ISO 10993-10 Sensitization and Irritation
Use of vented nasal masks with CPAP or Bilevel therapy is Clinical Data proven technology and is well accepted by the medical community. Clinical data was not relied upon to demonstrate Substantial Equivalence to predicate devices. Bench testing alone is sufficient.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Swift FX Nano (K123789), Ultra Mirage II (K050359), SleepNet Mojo (K060273)
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
DEC 2 0 2013
RESMED
AirFit™ N10 Traditional 510(k)
| | 510(k) SUMMARY
[As required by 21 CFR 807.92(c)] |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | September 16th, 2013 |
| Owner's Name | 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 | Mr. Jim Cassi
Vice President - Quality Assurance Americas
ResMed Corp.
9001 Spectrum Center Blvd
San Diego CA 92123 USA
Tel: +1 858 836 6081
Fax: +1 858 836 5519
jim.cassi@resmed.com.au |
| Device Trade Name | AirFit™ N10 |
| Device Common Name | Vented Nasal Mask |
| Classification &
Classification Name | 21 CFR 868.5905, 73 BZD (Class II)
Noncontinuous Ventilator (IPPB) |
| Legally Marketed
Predicate Devices | Swift FX Nano (K123789)
Ultra Mirage II (K050359)
SleepNet Mojo (K060273) |
| Intended Use | The AirFit™ N10 channels airflow noninvasively to a patient from
a positive airway pressure (PAP) device such as a continuous
positive airway pressure (CPAP) or bilevel device.
The AirFit™ N10 is:
to be used by patients (> 66 lb/30 kg) for whom positive
airway pressure has been prescribed
intended for single-patient re-use in the home environment
and multipatient re-use in the hospital / institutional
environment. |
| Reason for Submission | New Device |
| Device Description | The AirFit™ N10 is an externally worn mask that provides an air
seal, such that air flow from a positive pressure source is directed
to the patient's nose. The mask is held in place with an adjustable
headgear. It connects to a conventional PAP device air delivery
hose via a standard 22mm swivel. The mask may be cleaned with
mild soap. |
| | continuous air leak to prevent rebreathing of dead space CO2
AirFit™ N10 is a prescription device supplied non-sterile. |
| Intended Use comparison | Comparison with predicate Swift FX Nano (K123789)
The new device and the predicate Swift FX Nano mask have
identical intended uses. Both are intended to be used with
Positive Air Pressure therapy equipment and for the same
identical patient population. |
| Technological
Characteristics
comparison | Comparison with predicate Swift™ FX Nano (K123789)
Similarities:
The new device and the predicate mask, provide a seal via a
silicone interface. Both devices incorporate a silicone cushion that
seals around the patient's nose. Both masks are offered in
multiple sizes to ensure adequate fit over the extended patient
population. |
| | Both masks connect to a conventional air delivery hose between
the mask and the positive airway-pressure source via standard
22mm conical connectors (ref: ISO 5356-1:2004). |
| | Both masks are constructed using molded plastic and silicone
components and fabric / nylon headgear. All the components of
both masks are fabricated using materials deemed safe. (ref. ISO
10993-1). |
| | In addition, development of the AirFit™ N10 device complies with
ISO 14971:2007, Medical devices - Application of risk
management to medical devices. |
| | Both the new mask and the predicate device are designed to
operate on the same Pillows, Mirage or Swift ResMed flow
generator settings. The pressure-flow characteristics and flow
impedance of both devices are identical. |
| | Both the new mask and the predicate device can be reused in the
home and hospital / institution environment. |
| | The main differences with the new device are:
(a) The headgear fixes to the mask at 4 attachment points.
(b) Magnets are incorporated in the headgear clip design to
improve usability.
(c) Mask reassembly is made simpler through parts integration. |
| | (d) The exhaust port design is of a diffused vent type.
Comparison with predicate SleepNet Mojo (K060273)
Both devices incorporate magnets in the headgear clip design.
The clips are self-locating and they also provide audible and
tactile feedback to indicate successful mechanical engagement. |
| Non-clinical testing and
performance data
comparison | The CO2 washout performance of the new device was tested to
ensure the mask design provides adequate venting to flush out
the expired CO2. The testing included physical and functional
dead-space measurements. The device satisfied all predefined |
・
16" Sept 2013
1
2
the predicate Ultra Mirage II device (K050359).
Pressure-flow and through impedance bench test results of the new mask were also substantially equivalent to the predicate Swift FX Nano device (K123789).
Mechanical integrity performance of the new device was tested to simulated normal use and reasonable abuse scenarios. The device was also tested to demonstrate that it can withstand the effects of storage temperature, humidity and transportation shock & vibration.
Validation of cleaning and reuse was completed to establish that the device can be safely reused by a single patient, or multipatient reuse in the hospital/institutional environment following validated disinfection protocols. After 20 cycles of cleaning/disinfection in accordance with the methods described in the cleaning / disinfection quide, the device has been shown to function as intended. The device satisfied the pass/fail criteria and was shown to be substantially equivalent to the predicate devices.
Materials used in the construction of components that contact the heated humidified gas pathway are classified as permanent "external communicating devices" (with tissue/bone/dentin). The appropriate biological tests conducted and passed for these components, in accordance with FDA guidance #G95-1 were:
- ISO 10993-3 Genotoxicity, .
- ISO 10993-5 Cytotoxicity, .
- ISO 10993-6 Implantation and .
- ISO 10993-10 Sensitization .
The appropriate biological tests conducted and passed for components considered to be in permanent skin contact, in accordance with FDA guidance #G95-1, were:
- ISO 10993-5 Cytotoxicity .
- ISO 10993-10 Sensitization and Irritation
Use of vented nasal masks with CPAP or Bilevel therapy is Clinical Data proven technology and is well accepted by the medical community. Clinical data was not relied upon to demonstrate Substantial Equivalence to predicate devices. Bench testing alone is sufficient.
Substantial Equivalence Conclusion
- it has the same intended use; -
devices:
· .
-
it has identical technological characteristics to the predicate devices;
The new AirFit™ N10 is as safe and effective as the predicate -
the new device did not raise any new questions of safety . or effectiveness:
-
it is at least as safe and effective as the predicate devices.
.
3
Image /page/3/Picture/1 description: The image shows a logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a symbol. The symbol is a stylized depiction of an eagle or bird with outstretched wings. The text is in a bold, sans-serif font, and the symbol is in black. The overall design is simple and clean, with a focus on conveying a sense of authority and trustworthiness.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-00002
December 20, 2013
ResMed Limited Mr. Jim Cassi Vice President - Quality Assurance Americas 9001 Spectrum Center Boulevard SAN DIEGO CA 92123
Re: K132887
Trade/Device Name: AirFit N10™ Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Non-continuous Ventilator (Respirator) Regulatory Class: Class II Product Code: BZD Dated: November 15, 2013 Received: November 18, 2013
Dear Mr. Cassi:
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
4
Page 2 - Mr. Cassi
:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/8 description: The image contains a signature or logo on the left side, which is stylized and difficult to decipher. To the right of the signature, there is text that reads "Tejashri Purohit-Sheth, M.D.," followed by "Clinical Deputy Director" and "DAGRID." The word "FOR" is located in the bottom right corner of the image.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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RESMED
Airft N10 Traditional 510(k)
Indication for Use
610(k) Number (if known): K 152887 ALFR™ N10 Device Name: indication for Ung
The AirFil® N10 channels airflow noninvasively to a patient from a positive airway pressure (PAP) deelse such as a continuous positive airway pressure (CPAP) or bilevel device.
The Abfil™ NHO iss
- to be used by patients (> 66 ib/30 kg) for whom positive streay pressure has been presenthed .
- intended for single-patient re-use in the home environment and multipatient re-use in the . hospitalinstitutional environment.
AND/OR Over-The-Counter Use Presoription Use X (Pert 21 OFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
:
Anya C. Harry -S 2013.12.20 14:34:22 -05'00'