(505 days)
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.
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.
The provide text describes a 510(k) premarket notification for the AirLife™ Misty Finity™ Nebulizer. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's diagnostic performance against specific acceptance criteria in the way an AI/ML medical device might.
Therefore, many of the requested categories for AI/ML device studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable to this document.
However, I can extract the acceptance criteria and performance data related to the device's functional characteristics, as presented in the document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by compliance with the USP 38 <601> standard for "Products for Nebulization – Characterization Test" and a series of ISO 10993 standards for biocompatibility. The performance data presented are the results of these characterization tests.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Misty Finity Nebulizer) |
|---|---|
| Product for Nebulization – Characterization Test (USP 38 <601>) to characterize aerosol output for common medications. | Detailed aerosol characterization using 7-stage Cascade Impaction (NGI) for Albuterol Sulfate, Budesonide Suspension, and Cromolyn Sodium at flow rates of 2 lpm and 4 lpm. Parameters reported include: - MMAD (Mass Median Aerodynamic Diameter): - Albuterol Sulfate: 3.4 ± 0.3 µm (2 lpm), 2.7 ± 0.3 µm (4 lpm) - Budesonide Suspension: 3.8 ± 0.3 µm (2 lpm), 4.2 ± 0.2 µm (4 lpm) - Cromolyn Sodium: 2.3 ± 0.3 µm (2 lpm), 3.6 ± 0.4 µm (4 lpm) - GSD (Geometric Standard Deviation): - Albuterol Sulfate: 2.8 ± 0.2 (2 lpm), 2.6 ± 0.1 (4 lpm) - Budesonide Suspension: 3.1 ± 0.2 (2 lpm), 2.4 ± 0.2 (4 lpm) - Cromolyn Sodium: 3.5 ± 0.3 (2 lpm), 2.5 ± 0.1 (4 lpm) - Particle Distribution (% mass and µg) for: - Particles (≤ 1 µm) - Particles (1-5 µm) - Particles (≤ 5 µm) - Particles (≥ 5 µm) - Calculated Time to Deliver 100% of Dose: (e.g., Albuterol sulfate: 94 ± 12 min @ 2 lpm, 104 ± 10 min @ 4 lpm for 2.5mg/3ml concentrated solution with 4ml fill volume; and other values presented in the tables for the other drugs). |
| Biocompatibility Testing (AAMI/ANSI/ISO 10993 series): - Part 1: Evaluation and Testing - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity - Part 5: Tests for In Vitro Cytotoxicity - Part 6: Tests for local effects after implantation - Part 10: Tests for Irritation and Skin Sensitization - Part 11: Tests for systemic toxicity - Part 12: Sample preparation and reference materials - Part 17: Establishment of allowable limits for leachable substances - Part 18: Chemical characterization of materials | The document explicitly states that "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" were conducted. The conclusion states that "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," implying successful compliance with these standards. Specific numerical results for each biocompatibility test are not provided in this summary. |
| Flow Rates: 2-4 LPM | 2-4 LPM |
| Maximum Fill Capacity: 10 ml | 10 ml |
| Shelf Life: Adequate | 11 months (supported by real-time aging and biocompatibility testing) |
| Useful Life: Adequate | 48 hours (supported by real-time aging and biocompatibility testing) |
| Type of Gas Source: Compressed air or oxygen | Compressed air or oxygen |
2. Sample size used for the test set and the data provenance:
Not applicable. This is a premarket notification for a medical device (nebulizer), not an AI/ML diagnostic device with a "test set" in the traditional sense. The performance data relates to the physical and functional characteristics of the nebulizer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of an AI/ML device, refers to expert labeling or definitive diagnoses. For this nebulizer, "ground truth" would be objective measurements from laboratory testing, not expert consensus on interpretations.
4. Adjudication method for the test set:
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is not an AI/ML diagnostic tool intended for human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used:
For the Performance Testing (Aerosol Characterization), the ground truth is established by the standardized methods of the USP 38 <601> using specialized laboratory equipment (7-stage Cascade Impaction - NGI) to objectively measure particle size distribution and drug delivery.
For the Biocompatibility Testing, the ground truth is established by standardized laboratory tests adhering to various AAMI/ANSI/ISO 10993 standards, employing validated biological and chemical assays.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device requiring a training set. The performance data is derived from physical and chemical testing of the device itself.
9. How the ground truth for the training set was established:
Not applicable.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
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 (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,
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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: (224) 706-6818
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 ofcomparison | Proposed DeviceK153748 | Predicate DeviceK943600 | Comparison Assessment |
|---|---|---|---|
| Indications for Use | The Misty Finity is a nebulizerdesigned for administration ofaerosolized drug to therespiratory system. Misty Finitymay be used with pediatric (ages2 years and above) and adultpatients. The product is singlepatient use device, non-sterileand used in professionalhealthcare environments undera doctor's supervision and byskilled clinician. | The proposed device is intendedto spray liquids in aerosol forminto gases that are delivereddirectly to the patient forbreathing for all patients'populations requiring nebulizedmedications. | Although worded differently, theindications for use (IFU)statements identify the same: 1)principle of operation (i.e., bothdevices aerosolize drugs so theycan be delivered to therespiratory system) and 2) bothdevices are intended for allpopulations requiring nebulizedmedications (i.e., ages 2 yearsand above) and adults).Although not stated in thepredicate device IFU, bothdevices are: 1) single use (seediscussion below), 2) areprovided non-sterile and 3) areprescription products whichrequire that they are used inprofessional healthcareenvironments under a doctor'ssupervision and by skilledclinician. The difference inverbiage in the IFU for the MistyFinity Nebulizer and thepredicate device does notpresent any new questions ofsafety and effectiveness. |
| Principle of Operation | Pneumatic Jet | Pneumatic Jet | Same |
| Characteristics | |||
| Flow rates | 2-4 LPM | 2-4 LPM | Same |
| Maximum Fill Capacity(capacity of medicationcup) | 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: (224) 706 -6818 carefusion.com
| Element ofcomparison | Proposed DeviceK153748 | Predicate DeviceK943600 | Comparison Assessment |
|---|---|---|---|
| Useful life | 48 hours | unknown | of the predicate device has notbeen published. The real-timeaging and Biocompatibilitytesting of the subject devicesupport the indicated Shelf-lifeand Useful life and do notpresent any new questions ofsafety and effectiveness. |
| Type of the device | DisposableSingle patient useNon sterile | DisposableSingle useNon sterile | The predicate device labelingindicates that it is single use (i.e.,used once). Misty Finity is asingle patient use device (i.e.,the same patient may use itmore than once). The cleaningvalidations of the subject devicesupport substantial equivalencewithout posing any newquestions of safety andeffectiveness. |
| 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 | |||
|---|---|---|---|---|---|
| DrugDescription | (mean ± 95% CI) | (mean ± 95% CI) | |||
| AlbuterolSulfate: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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| Calculated Time to Deliver 100% of Dose(minutes) 7,8 | 94 ± 12 | 104 ± 10 | |
|---|---|---|---|
| BudesonideSuspension: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(minutes) 7 | 73 ± 8 | 91 ± 13 | |
| CromolynSodium: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(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: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: Testsfor genotoxicity, carcinogenicity and reproductivetoxicity | AAMI/ANSI/ISO 10993-3:2009 (R2014) |
| Biological Evaluation of Medical Devices-Part 5: Testsfor In Vitro Cytotoxicity | AAMI/ANSI/ISO 10993-5:2009 (R2014) |
| Biological evaluation of medical devices - Part 6: Testsfor local effects after implantation | AAMI/ANSI/ISO 10993-6:2009 (R2014) |
| Biological Evaluation of Medical Devices-Part 10: Testsfor Irritation and Skin Sensitization. | AAMI/ANSI/ISO 10993-10:2010(R2014) |
| Biological evaluation of medical devices – Part 11:Tests for systemic toxicity | AAMI/ANSI/ISO 10993-11:2006(R2010) |
| Biological evaluation of medical devices – Part 12:Sample preparation and reference materials | AAMI/ANSI/ISO 10993-12: 2012 |
| Biological Evaluation of Medical Devices Part 17:Establishment of allowable limits for leachablesubstances | AAMI/ANSI/ISO 10993-17:2002 |
| Biological Evaluation of Medical Devices Part 18: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.
§ 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).