(204 days)
No
The device description and performance studies focus on the mechanical and aerosolization properties of a nebulizer adapter, with no mention of AI or ML technologies.
Yes.
The device facilitates the aerosolization of medication for inhalation and delivers humidified respiratory gases, both of which are therapeutic functions.
No
Explanation: The device is described as a medical device accessory to facilitate aerosolization of medication or for the delivery of humidified respiratory gases. Its function is therapeutic, not diagnostic.
No
The device description clearly states it is a "single use accessory device" and mentions physical components like a "nebulizer adapter," "AirSpiral tube," and "MR290 humidification chamber." The performance studies also focus on physical characteristics and performance metrics related to aerosolization and physical integrity.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory to facilitate the aerosolization of a drug (Albuterol sulfate) for inhalation to patients. It is used for delivering humidified respiratory gases. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description reinforces that it's an accessory for delivering aerosolized solutions and humidified gases.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
The device is a medical device accessory used in the delivery of respiratory therapy, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Indications for use - AIRVO nebulizer adapter:
When used with a nebulizer:
The nebulizer adapter is a medical device accessory for single-patient use to facilitate aerosolization of Albuterol sulfate for inhalation to adult patients receiving high-flow humidified breathing gases via tracheostomy patient interface. Intended for use by healthcare professionals in hospitals or long-term care facilities.
When used without a nebulizer:
For use in hospitals and long-term care facilities, for the delivery of humidified respiratory gases to patients via nasal, tracheostomy and mask interfaces.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The Airvo Nebulizer Adapter (hereafter named "nebulizer adapter") is a single use accessory device designed to facilitate aerosolization of a physician-prescribed solution for inhalation to patients receiving high flow humidified breathing gases. The nebulizer adapter is a prescription-only accessory device, provided in a non-sterile state.
The nebulizer adapter is kitted with the AirSpiral tube and MR290 humidification chamber cleared in K162553, to be used in conjunction with Airvo series humidifiers (K131895) along with patient interfaces cleared in K162553.
The device is labelled for use with Salbutamol/ Albuterol only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
healthcare professionals in hospitals or long-term care facilities.
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 following tests were completed:
- Shelf life simulation was based on ASTM F1980-07, and ISO 291:2008(E).
- Transportation simulation was based on ISTA 2A Packaged-Products weighing 1501b (68kg) or less.
- Additional performance testing has also been completed to confirm the safety and effectiveness of the nebulizer adapter.
- Nebulizer performance testing to demonstrate that nebulizing performance is equivalent when using an Airvo nebulizer adapter to when using an Aerogen T-piece.
- Testing to verify that the Airvo system meets the requirements of ISO 80601-2-74 when used with the nebulizer adapter
- Testing to establish that the usability of the Airvo nebulizer adapter is safe and effective for its intended users, uses, and use environments.
- Testing to verify that the wear and stresses associated with the distribution of the packaged product does not cause damage to either the product or packaging.
- Testing to verify that nebulization via the Airvo nebulizer port does not adversely affect the Airvo 2 or AirSpiral tube.
- Testing to verify that the port cap will stay in place and not fall out of the nebulizer port during use with the Airvo 2 system
- Testing to measure the total volume of condensate, with the potential to reach the patient, that forms over 24 hours in an Airvo system when used with the Airvo nebulizer adapter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Respirable dose (1 - 5 µm) when nebulizing albuterol via a tracheostomy:
From 2500 µg nebule:
10 L/min - 1293.1 µg
20 L/min – 949.5 µg
30 L/min – 612.6 µg
Median Mass Aerodynamic Diameter (MMAD) when nebulizing albuterol via a tracheostomy:
10 L/min – 2.80 µm
20 L/min – 2.73 µm
30 L/min – 2.54 µm
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.
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
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
12/10/2021
Fisher & Paykel Healthcare Limited Reena Daken Regulatory Affairs Market Manager 15 Maurice Paykel Place, East Tamaki Auckland, 2013 New Zealand
Re: K211560
Trade/Device Name: Airvo Nebulizer Adapter Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: November 12, 2021 Received: November 12, 2021
Dear Reena Daken:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brandon Blakely Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211560
Device Name Airvo Nebulizer Adapter
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
Indications for use - AIRVO nebulizer adapter:
When used with a nebulizer:
The nebulizer adapter is a medical device accessory for single-patient use to facilitate aerosolization of Albuterol sulfate for inhalation to adult patients receiving high-flow humidified breathing gases via tracheostomy patient interface. Intended for use by healthcare professionals in hospitals or long-term care facilities.
When used without a nebulizer:
For use in hospitals and long-term care facilities, for the delivery of humidified respiratory gases to patients via nasal, tracheostomy and mask interfaces.
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)
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3
510(k) Summary
As Required by 21 CFR 807.92(c)
SUBMITTER I.
| Company Name and Address | Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place
East Tamaki
Auckland 2013, New Zealand
Telephone: +64 9 574 0100 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Reena Daken
Regulatory Affairs Manager
Telephone: +64 9 574 0100
Email: reena.daken@fphcare.co.nz |
| Date Prepared | 10 December 2021 |
SUBJECT DEVICE II.
| Name of Device | Airvo Nebulizer Adapter |
|---|---|
| Common/Usual Name | Airvo Nebulizer Adapter |
| Classification Name | Nebulizer (Direct Patient Interface) |
| Class II (21 CFR §868.5630) | |
| Product Code | CAF |
III. PREDICATE DEVICE
Aeroneb Solo Nebulizer System / Aeroneb Solo Adapter (K133360)
DEVICE DESCRIPTION IV.
The Airvo Nebulizer Adapter (hereafter named "nebulizer adapter") is a single use accessory device designed to facilitate aerosolization of a physician-prescribed solution for inhalation to patients receiving high flow humidified breathing gases. The nebulizer adapter is a prescription-only accessory device, provided in a non-sterile state.
The nebulizer adapter is kitted with the AirSpiral tube and MR290 humidification chamber cleared in K162553, to be used in conjunction with Airvo series humidifiers (K131895) along with patient interfaces cleared in K162553.
The device is labelled for use with Salbutamol/ Albuterol only.
4
INDICATIONS FOR USE V.
Indications for use - AIRVO nebulizer adapter:
When used with a nebulizer:
The nebulizer adapter is a medical device accessory for single-patient use to facilitate aerosolization of Albuterol sulfate for inhalation to adult patients receiving high-flow humidified breathing gases via tracheostomy patient interface. Intended for use by healthcare professionals in hospitals or long-term care facilities.
When used without a nebulizer:
For use in hospitals and long-term care facilities, for the delivery of humidified respiratory gases to patients via nasal, tracheostomy and mask interfaces.
VI. NON-CLINICAL PERFORMANCE DATA
The following tests were completed:
- Shelf life simulation was based on ASTM F1980-07, and ISO 291:2008(E). ●
- Transportation simulation was based on ISTA 2A Packaged-Products weighing 1501b (68kg) or less.
- . Additional performance testing has also been completed to confirm the safety and effectiveness of the nebulizer adapter.
- O Nebulizer performance testing to demonstrate that nebulizing performance is equivalent when using an Airvo nebulizer adapter to when using an Aerogen T-piece.
- Testing to verify that the Airvo system meets the requirements of ISO 80601-2-74 when used O with the nebulizer adapter
- Testing to establish that the usability of the Airvo nebulizer adapter is safe and effective for O its intended users, uses, and use environments.
- O Testing to verify that the wear and stresses associated with the distribution of the packaged product does not cause damage to either the product or packaging.
- Testing to verify that nebulization via the Airvo nebulizer port does not adversely affect the o Airvo 2 or AirSpiral tube.
- Testing to verify that the port cap will stay in place and not fall out of the nebulizer port during O use with the Airvo 2 system
- Testing to measure the total volume of condensate, with the potential to reach the patient, that O forms over 24 hours in an Airvo system when used with the Airvo nebulizer adapter.
The Airvo Nebulizer Adapter has been tested to applicable requirements of the following standards:
- ISO 80601-2-74 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- . ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications, Part 1: Evaluation and testing within a risk management process.
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COMPARISON OF TECHNOLOGICAL CHARATCERISTICS WITH THE PREDICATE DEVICE VII.
| Feature/Function | Subject Device
Nebulizer Adapter | Predicate Device
Aerogen T-piece (cleared as part of Aerogen
Solo system K133360) | Comments |
|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code
Device Classification
Classification Panel | CAF
Class II (21 CFR §868.5630)
Anesthesiology | CAF
Class II (21 CFR §868.5630)
Anesthesiology | Identical |
| Intended Use | Used for attaching a nebulizer system to
a breathing circuit to allow the delivery
of nebulized medication | Used for attaching a nebulizer system to a breathing
circuit to allow the delivery of nebulized
medication | Identical |
| Indications for Use | Indications for use - AIRVO nebulizer
adapter:
When used with a nebulizer:
The nebulizer adapter is a medical
device accessory for single-patient use
to facilitate aerosolization of Albuterol
sulfate for inhalation to adult patients
receiving high-flow humidified
breathing gases via tracheostomy patient
interface. Intended for use by healthcare
professionals in hospitals or long-term
care facilities.
When used without a nebulizer:
For use in hospitals and long-term care
facilities, for the delivery of humidified
respiratory gases to patients via nasal,
tracheostomy and mask interfaces. | As the Aerogen T-piece was cleared as part of the
Aerogen Solo system K133360, it does not have its
own Indications for Use statement.
The Indications for Use statement of the Aerogen
Solo system is:
The Aerogen Solo Nebulizer System is a portable
medical device for single patient use that is
intended to aerosolize physician-prescribed
solutions for inhalation to patients on and off
ventilation or other positive pressure breathing
assistance. | Equivalent to predicate
Both, the subject device and predicate have the same
general intended use: to be used with an Aerogen
Solo nebulizer to introduce nebulized drug into
respiratory breathing circuit, however, only
Salbutamol/Albuterol can be delivered through this
adapter. |
| Availability | Prescription use.
(Part 21 CFR 801 Subpart D) | Prescription use.
(Part 21 CFR 801 Subpart D) | Identical |
| Feature/Function | Subject Device
Nebulizer Adapter | Predicate Device
Aerogen T-piece (cleared as part of Aerogen
Solo system K133360) | Comments |
| Application | Nebulization within a humidified high
flow therapy system | Nebulization within a non-specific breathing
support system | Equivalent to predicate.
The subject device functions within a subset of the
predicate device. |
| Environment of Use | Hospital | Hospital | Identical |
| Connection to breathing circuit | Airvo nebulizer adapter has proprietary
connectors | T-piece with 22mm ISO medical tapers (Male
inlet and Female outlet) | The subject device is proprietary to the Airvo system
while the predicate is a T-piece able to be connected
to any breathing circuit. |
| Nebulizer port orientation when
attached to a humidification
chamber | Nebulizer port at 15° above horizontal | Nebulizer port at 15° above horizontal | Identical |
| Position in circuit | Wet side of humidification chamber in
single-limb circuit | End of inspiratory limb in a dual-limb circuit or
dry side of humidification chamber in a single-
limb circuit | The subject device functions within a subset of the
predicate device (subject device has no dual-limb
configuration). Comparative testing done on the
two systems shows equivalence between the drug
delivery to the patient on both systems, when
predicate is tested with "dry side of humidification
chamber" nebulizer positioning as per predicate
Instructions For Use. |
| Sterility | Device not provided sterile | Device not provided sterile | Identical |
| Reusability | Single use | Single use | Identical |
| Maximum duration of use with
nebulized drugs | 7 days continuous use | 7 days continuous use | Identical |
| Shelf life | 3 years | Not specified | Shelf life is not specified for the predicate |
| Feature/Function | Subject Device | Predicate Device | Comments |
| | Nebulizer Adapter | Aerogen T-piece (cleared as part of Aerogen
Solo system K133360) | |
| Flow path gas flow range when
nebulizing albuterol via a
tracheostomy | 10 – 30 L/min | Not defined | Flow range is not defined for predicate device |
| Flow path gas pressure range | Less than 25 cm H2O | Less than 90 cm H2O | The subject device's pressure range is within the
pressure range of the predicate |
| On-label Drugs for Delivery | Salbutamol/Albuterol only | General purpose nebulizer | The on-label drugs for use with the subject device is
a subset of the drugs for use on the predicate device. |
| Respirable dose (1 - 5 µm)
when nebulizing albuterol via a
tracheostomy | From 2500 µg nebule:
10 L/min - 1293.1 µg | From 2500 µg nebule:
10 L/min - 1339.3 µg | Equivalent to predicate |
| | 20 L/min – 949.5 µg | 20 L/min – 991.8 µg | |
| | 30 L/min – 612.6 µg | 30 L/min – 624.4 µg | |
| | | When nebulizer placed on dry side of
humidification chamber | |
| Median Mass Aerodynamic
Diameter (MMAD) when
nebulizing albuterol via a
tracheostomy | 10 L/min – 2.80 µm | 10 L/min - 2.55 µm | Equivalent to predicate |
| | 20 L/min – 2.73 µm | 20 L/min - 2.63 µm | |
| | 30 L/min – 2.54 µm | 30 L/min – 2.59 µm | |
| | | When nebulizer placed on dry side of
humidification chamber | |
| Compatibility with Tracheal
Patient Interface | Yes, Trache patient interface (OPT970) | Yes, when patient intubated through a trachea
interface | Equivalent to predicate |
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7
8
VIII. ACCESSORIES
| Port Cap Open and Nebulizer Fitted | Port Cap Closed |
|---|---|
| When the Port Cap is OPEN, and an Aerogen Solo | |
| nebulizer is fitted and used to deliver nebulized | |
| albuterol, the Airvo Nebulizer Adapter will be | |
| compatible with the following patient interface: | |
| ● | |
| OPT970 tracheostomy interface | When the Port Cap is CLOSED, and only |
| warmed/humidified air/oxygen mixtures are delivered | |
| to the patient WITHOUT nebulized medication, the | |
| Airvo Nebulizer Adapter will be compatible with the | |
| following patient interfaces: | |
| ● OPT970 tracheostomy interface | |
| ● OPT942/OPT944/OPT946 Nasal Cannulas | |
| ● OPT316/OPT318 Nasal Cannulas | |
| ● OPT980 Mask Interface Adapter |
CONCLUSIONS IX.
The comparison of features, performance, and intended use demonstrate that the Airvo nebulizer adapter is substantially equivalent to the predicate Aerogen T-piece (K133360). In addition, performance testing of the nebulizer adapter was completed to determine that the differences between the subject device and the predicate device do not raise new questions of safety or effectiveness. These tests demonstrate substantial equivalence of the nebulizer adapter to the predicate device.