AirLife Misty Finity Nebulizer

K153748 · Care Fusion · CAF · May 17, 2017 · Anesthesiology

Device Facts

• Record ID: K153748
• Device Name: AirLife Misty Finity Nebulizer
• Applicant: Care Fusion
• Product Code: CAF · Anesthesiology
• Decision Date: May 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Misty Finity is a nebulizer designed for administration of aerosolized drug to the respiratory system. Misty Finity may be used with pediatric (ages 2 years and above) and adult patients. The product is single patient use device, nonsterile and used in professional healthcare environments under a doctor's supervision and by skilled clinician.

Device Story

AirLife™ Misty Finity™ Nebulizer is a small volume pneumatic jet nebulizer for delivering aerosolized drugs to the respiratory system. Device consists of three components: top, one-piece jet, and bottom reservoir. Liquid medication is placed in the reservoir; connected to an external compressed air or oxygen source (2-4 LPM) via flexible tubing. Principle of operation: gas stream shatters liquid into particles (15-500 microns); particles impact a baffle to reduce size (<15 microns); larger particles settle via gravity/inertia to repeat nebulization; particles <5 microns are inhaled by patient. Used in professional healthcare environments by skilled clinicians under physician supervision. Single-patient use device; supports multiple treatments. Provides continuous aerosol delivery. Benefits patient by enabling targeted respiratory drug administration.

Clinical Evidence

Bench testing only. Aerosol characterization performed using 7-stage Cascade Impaction (NGI) per USP 38 <601> with three medications (Albuterol, Budesonide, Cromolyn) at 2 and 4 LPM. Metrics included MMAD, GSD, and mass distribution. Biocompatibility testing conducted per AAMI/ANSI/ISO 10993 series (cytotoxicity, sensitization, irritation, implantation, genotoxicity, extractables/leachables) for prolonged contact.

Technological Characteristics

Pneumatic jet nebulizer; 10 ml fill capacity; 2-4 LPM flow rate. Materials evaluated per AAMI/ANSI/ISO 10993-1:2009. Non-sterile, single-patient use. Mechanical operation; no software or electronic components.

Indications for Use

Indicated for pediatric (ages 2+) and adult patients requiring administration of aerosolized medication to the respiratory system.

Regulatory Classification

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.

Predicate Devices

• Uni-HEART (K943600)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 17, 2017

Carefusion/Vyaire Medical, Inc. Colleen O'Keeffe Acting Director, Regulatory Affairs 26125 Riverwoods Blvd Mettawa, IL 60045

Re: K153748

Trade/Device Name: AirLife™ Misty Finity™ Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: April 12, 2017 Received: April 17, 2017

Dear Colleen Okeeffe:

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.

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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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -S

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

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# Indications for Use

510(k) Number (if known) K153748

Device Name AirLife™ Misty FinityTM Nebulizer

#### Indications for Use (Describe)

The Misty Finity is a nebulizer designed for administration of aerosolized drug to the respiratory system. Misty Finity may be used with pediatric (ages 2 years and above) and adult patients. The product is single patient use device, nonsterile and used in professional healthcare environments under a doctor's supervision and by skilled clinician.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for Vyaire Medical. The logo is primarily blue, with the word "Vyaire" in a stylized, sans-serif font. Below "Vyaire" is the word "MEDICAL" in a smaller, sans-serif font. Above the word "Vyaire" are three curved, light blue lines that give the impression of a wave or airflow.

ne: (224) 706 -6818

# 510K Summary

#### 1. Submitter

Carefusion/Vyaire Medical, Inc. 26125 Riverwoods Blvd Mettawa, IL 60045 Phone: [phone]

Contact Person: Colleen O'Keeffe Acting Director, Regulatory Affairs

Date Prepared: May 16, 2017

#### 2. Device

| Trade name | AirLife™ Misty Finity™ Nebulizer |
|----------------------|----------------------------------|
| Common Name: | Small Volume Nebulizer |
| Classification Name: | Nebulizer 21 CFR 868.5630 |
| Regulatory Class: | II |
| Product Code: | CAF |

#### 3. Predicate Device

Uni-HEART K943600 cleared on 10/13/1994.

#### 4. Device Description

The Misty Finity nebulizer is a small volume nebulizer designed to deliver continuous aerosolized drugs to the respiratory system over extended periods of time. The Misty Finity is a single patient use device, and may be used for multiple treatments. The nebulizer is filled with a liquid, typically respiratory medication and connected to the air source via flexible tubing operating between 2 LPM and 4 LPM. The nebulizer is disassembled and reassembled after adding the medication in the bottom (reservoir), and then the device is reassemble in a snap fit. The Misty Finity consists of three components: nebulizer top, one-piece jet, and nebulizer bottom. The Nebulizer is marketed with oxygen tubing and an adult aerosol mask. Both tubing and mask are single-use accessories. The pediatric aerosol mask can be ordered online/from the company website.

#### 5. Principal of Operation

The nebulizer works by having the fluid come into contact with the stream of gas. The gas shatters the liquid into small particles (approximately 15-500 microns in size). These particles then impact a baffle that further reduces the size of the particles (< 15 microns). The majority of larger particles settle inside the nebulizer as a result of gravity and inertia, returning the mist to liquid to repeat the nebulization process. The smaller

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Image /page/4/Picture/0 description: The image shows the logo for Vyaire Medical. The logo is in blue and features the word "Vyaire" in a stylized font. Above the word "Vyaire" are three curved lines in a lighter shade of blue. Below the word "Vyaire" is the word "MEDICAL" in a smaller, sans-serif font.

particles (<5 microns) are then administered as the patient inhales. The treatment is completed when the majority of fluid is nebulized.

#### 6. Indication for use

The Misty Finity is a nebulizer designed for administration of aerosolized drug to the respiratory system. Misty Finity may be used with pediatric (ages 2 years and above) and adult patients. The product is single patient use device, non-sterile and used in professional healthcare environments under a doctor's supervision and by skilled clinician.

## 7. Comparison of technological characteristics with the predicate device

| Element of<br>comparison | Proposed Device<br>K153748 | Predicate Device<br>K943600 | Comparison Assessment |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Misty Finity is a nebulizer<br>designed for administration of<br>aerosolized drug to the<br>respiratory system. Misty Finity<br>may be used with pediatric (ages<br>2 years and above) and adult<br>patients. The product is single<br>patient use device, non-sterile<br>and used in professional<br>healthcare environments under<br>a doctor's supervision and by<br>skilled clinician. | The proposed device is intended<br>to spray liquids in aerosol form<br>into gases that are delivered<br>directly to the patient for<br>breathing for all patients'<br>populations requiring nebulized<br>medications. | Although worded differently, the<br>indications for use (IFU)<br>statements identify the same: 1)<br>principle of operation (i.e., both<br>devices aerosolize drugs so they<br>can be delivered to the<br>respiratory system) and 2) both<br>devices are intended for all<br>populations requiring nebulized<br>medications (i.e., ages 2 years<br>and above) and adults).<br>Although not stated in the<br>predicate device IFU, both<br>devices are: 1) single use (see<br>discussion below), 2) are<br>provided non-sterile and 3) are<br>prescription products which<br>require that they are used in<br>professional healthcare<br>environments under a doctor's<br>supervision and by skilled<br>clinician. The difference in<br>verbiage in the IFU for the Misty<br>Finity Nebulizer and the<br>predicate device does not<br>present any new questions of<br>safety and effectiveness. |
| Principle of Operation | Pneumatic Jet | Pneumatic Jet | Same |
| Characteristics | | | |
| Flow rates | 2-4 LPM | 2-4 LPM | Same |
| Maximum Fill Capacity<br>(capacity of medication<br>cup) | 10 ml | 10 ml | Same |
| Shelf life | 11 months | unknown | The Shelf-life and the Useful Life |

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Image /page/5/Picture/0 description: The image shows the logo for Vyaire Medical. The logo is in blue and features the word "Vyaire" in a stylized font. Below the word "Vyaire" is the word "MEDICAL" in a smaller, sans-serif font. Above the word "Vyaire" are three curved lines in a lighter shade of blue.

26125 Riverwoods Blvd Mettawa, IL 60045 Phone: [phone] carefusion.com

| Element of<br>comparison | Proposed Device<br>K153748 | Predicate Device<br>K943600 | Comparison Assessment |
|--------------------------|-------------------------------------------------|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Useful life | 48 hours | unknown | of the predicate device has not<br>been published. The real-time<br>aging and Biocompatibility<br>testing of the subject device<br>support the indicated Shelf-life<br>and Useful life and do not<br>present any new questions of<br>safety and effectiveness. |
| Type of the device | Disposable<br>Single patient use<br>Non sterile | Disposable<br>Single use<br>Non sterile | The predicate device labeling<br>indicates that it is single use (i.e.,<br>used once). Misty Finity is a<br>single patient use device (i.e.,<br>the same patient may use it<br>more than once). The cleaning<br>validations of the subject device<br>support substantial equivalence<br>without posing any new<br>questions of safety and<br>effectiveness. |
| Type of gas source | Compressed air or oxygen | Compressed air or oxygen | Same |

## 8. Performance Data

The proposed device was tested to ensure compliance to the following standards:

#### 8.1 Performance Testing

| Performance Characteristic | Standard |
|---------------------------------------------------|--------------|
| Products for Nebulization – Characterization Test | USP 38 <601> |

Aerosol Characterization using 7- stage Cascade Impaction (NGI) for three common aerosolized medications 1

| | Aerosol Characteristics | 2 lpm | | 4 lpm | |
|---------------------------------------|--------------------------------------|------------|-----------------|------------|-----------------|
| Drug<br>Description | | | (mean ± 95% CI) | | (mean ± 95% CI) |
| Albuterol<br>Sulfate:<br>2.5 mg/ 3 ml | MMAD (µm) 2 | 3.4 ± 0.3 | | 2.7 ± 0.3 | |
| | GSD 3 | 2.8 ± 0.2 | | 2.6 ± 0.1 | |
| | Units | % (mass) 4 | µg 5 | % (mass) 4 | µg 5 |
| | Particles ( ≤ 1 µm) | 15.7 ± 2.9 | 523 ± 96 | 18.4 ± 2.7 | 1531 ± 184 |
| | Particles ( 1-5 um) | 46.6 ± 2.9 | 1553 ± 96 | 52.8 ± 2.0 | 4400 ± 168 |
| | Particles ( ≤ 5 µm) | 62.3 ± 3.3 | 2076 ± 109 | 71.2 ± 3.2 | 5931 ± 263 |
| | Particles ( ≥ 5 µm) | 37.7 ± 3.3 | 1258 ± 109 | 28.8 ± 3.2 | 2402 ± 263 |
| | Total Mass of Drug in Nebulizer (µg) | 3333 | | 8333 | |

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Image /page/6/Picture/0 description: The image shows the logo for Vyaire Medical. The logo is in blue and consists of the word "Vyaire" in a stylized font, with the word "MEDICAL" in smaller letters underneath. There is a light blue swoosh above the word "Vyaire".

| | Calculated Time to Deliver 100% of Dose<br>(minutes) 7,8 | 94 ± 12 | 104 ± 10 |
|-------------------------------------------|----------------------------------------------------------|------------|--------------|
| Budesonide<br>Suspension:<br>0.5 mg/ 2 ml | MMAD (µm) | 3.8 ± 0.3 | 4.2 ± 0.2 |
| | GSD | 3.1 ± 0.2 | 2.4 ± 0.2 |
| | Units | % (mass) 4 | µg 5 |
| | % Particles (≤ 1 µm) | 16.2 ± 1.4 | 162 ± 14 |
| | % Particles (1-5 μm) | 38.7 ± 1.3 | 387 ± 13 |
| | % Particles (≤ 5 µm) | 54.9 ± 1.6 | 549 ± 16 |
| | % Particles (≥ 5 μm) | 45.1 ± 1.6 | 451 ± 16 |
| | Total Mass of Drug in Nebulizer (µg) 6 | 1000 | 2500 |
| | Calculated Time to Deliver 100% of Dose<br>(minutes) 7 | 73 ± 8 | 91 ± 13 |
| Cromolyn<br>Sodium:<br>20 mg/ 2 ml | MMAD (µm) | 2.3 ± 0.3 | 3.6 ± 0.4 |
| | GSD | 3.5 ± 0.3 | 2.5 ± 0.1 |
| | Units | % (mass) 4 | µg 5 |
| | % Particles (≤ 1 µm) | 16.7 ± 2.3 | 6693 ± 924 |
| | % Particles (1-5 μm) | 51.9 ± 2.9 | 20751 ± 1152 |
| | % Particles (≤ 5 µm) | 68.6 ± 4.9 | 27444 ± 1956 |
| | % Particles (≥ 5 µm) | 31.4 ± 4.9 | 12556 ± 1956 |
| | Total Mass of Drug in Nebulizer (µg) 6 | 40000 | 100000 |
| | Calculated Time to Deliver 100% of Dose<br>(minutes) 7 | 117 ± 16 | 108 ± 10 |
| | | 14.5 ± 1 | 361 ± 24 |
| | | 40.6 ± 2.1 | 1015 ± 53 |
| | | 55.1 ± 2 | 1377 ± 50 |
| | | 44.9 ± 2 | 1123 ± 50 |
| | | 23 ± 2.4 | 22953 ± 2386 |
| | | 38.5 ± 2 | 38545 ± 1618 |
| | | 61.5 ± 3.5 | 61498 ± 3522 |
| | | 38.5 ± 3.5 | 38502 ± 3522 |

1 Performance data using Cascade Impactor (NGI) per USP 35 <1601> chilled to 5 °C with an extraction flow of 15 \/min for three commonly aerosolized medications. Values represent the Mean and 95% confidence interval of the mean.

2 MMAD is Mass Median Aerodynamic Diameter.

3 GSD is Geometric Standard Deviation.

4 Values are the percent (by mass) of drug substance delivered in the specified range of aerosol particles.

్ Values are the total drug mass in nebulizer, multiplied by the % (mass) for each micron range. This assumes 100% dose delivery and represents the theoretical maximum drug mass for a given micron range.

otal Mass of Drug in Nebulizer is the mass of drug substance placed in the nebulizer cap for dose listed. At the drug concentrations specified, these drug masses equate to a 4 ml fill volume for 2 lpm, and a 10 ml fill volume for 4 lpm.

7 Calculated by dividing the Total Mass of Drug in Nebulizer, by the Drug Delivery Rate. This is a theoretical calculation which assumes 100% dose delivery.

8 Calculated time to deliver 100% of 3 ml dose of Albuterol sulfate at 2.5 mg/3 ml concentration:

- 68 minutes @ 2 lpm ●
- 30 minutes @ 4 lpm .

The aerosol characterization testing with the adult and pediatric face mask demonstrated that the proposed device performance is equivalent to the predicate device.

#### 8.2 Biocompatibility

Tests for an externally communicating, tissue by way of gas path and direct mucosal contact with prolonged contact (greater than 24 hours but less than 30 days): Cytotoxicity, Sensitization, Irritation, Muscle Implantation, Genotoxicity and Extractables/Leachables.

| Performance Characteristic | Standard |
|----------------------------------------------------------------------------|----------------------------|
| Biological Evaluation of Medical Devices—Part 1:<br>Evaluation and Testing | AAMI/ANSI/ISO 10993-1:2009 |

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Image /page/7/Picture/0 description: The image shows the logo for Vyaire Medical. The logo is blue and features the word "Vyaire" in a stylized font. Below the word "Vyaire" is the word "MEDICAL" in a smaller, sans-serif font. Above the word "Vyaire" are three curved lines in a lighter shade of blue.

| Performance Characteristic | Standard |
|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Biological evaluation of medical devices – Part 3: Tests<br>for genotoxicity, carcinogenicity and reproductive<br>toxicity | AAMI/ANSI/ISO 10993-3:2009 (R2014) |
| Biological Evaluation of Medical Devices-Part 5: Tests<br>for In Vitro Cytotoxicity | AAMI/ANSI/ISO 10993-5:2009 (R2014) |
| Biological evaluation of medical devices - Part 6: Tests<br>for local effects after implantation | AAMI/ANSI/ISO 10993-6:2009 (R2014) |
| Biological Evaluation of Medical Devices-Part 10: Tests<br>for Irritation and Skin Sensitization. | AAMI/ANSI/ISO 10993-10:2010<br>(R2014) |
| Biological evaluation of medical devices – Part 11:<br>Tests for systemic toxicity | AAMI/ANSI/ISO 10993-11:2006<br>(R2010) |
| Biological evaluation of medical devices – Part 12:<br>Sample preparation and reference materials | AAMI/ANSI/ISO 10993-12: 2012 |
| Biological Evaluation of Medical Devices Part 17:<br>Establishment of allowable limits for leachable<br>substances | AAMI/ANSI/ISO 10993-17:2002 |
| Biological Evaluation of Medical Devices Part 18:<br>Chemical characterization of materials | AAMI/ANSI/ISO 10993-18:2005 |

#### 9. Conclusion

The non-clinical data demonstrate that the Misty Finity nebulizer is as safe and as effective as the predicate and therefore substantially equivalent to the predicate device.