(505 days)
Not Found
No
The 510(k) summary describes a mechanical nebulizer and its performance characteristics related to aerosol delivery. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a nebulizer designed for the administration of aerosolized drugs to the respiratory system, which is a therapeutic function.
No
The device is described as a nebulizer designed for the administration of aerosolized drugs to the respiratory system, which is a therapeutic function, not a diagnostic one. The performance studies and key metrics evaluate drug delivery characteristics rather than diagnostic accuracy.
No
The device description clearly outlines physical components (nebulizer top, one-piece jet, nebulizer bottom, tubing, mask) and describes a mechanical function (delivering aerosolized drugs). There is no mention of software as the primary or sole component.
Based on the provided information, the Misty Finity device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration of aerosolized drug to the respiratory system. This is a therapeutic purpose, delivering medication to a patient's body.
- Device Description: The description details a nebulizer that creates an aerosol from liquid medication for inhalation. This is a drug delivery device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The performance studies focus on the aerosol characteristics of drug delivery, not on analyzing biological samples.
In summary, the Misty Finity is a medical device used for drug delivery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications 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, nonsterile and used in professional healthcare environments under a doctor's supervision and by skilled clinician.
Product codes
CAF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
respiratory system
Indicated Patient Age Range
pediatric (ages 2 years and above) and adult patients
Intended User / Care Setting
professional healthcare environments under a doctor's supervision and by skilled clinician.
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)
Performance Testing:
- Standard: USP 38 (Products for Nebulization – Characterization Test)
- Method: Aerosol Characterization using 7-stage Cascade Impaction (NGI) for three common aerosolized medications (Albuterol Sulfate, Budesonide Suspension, Cromolyn Sodium). Values represent the Mean and 95% confidence interval of the mean.
- Key Results:
- Albuterol Sulfate (2.5 mg/3 ml):
- 2 lpm: MMAD 3.4 ± 0.3 µm, GSD 2.8 ± 0.2, Particles (= 5 µm) 37.7 ± 3.3% (1258 ± 109 µg). Calculated Time to Deliver 100% of Dose: 94 ± 12 minutes (and 68 minutes calculated for a smaller dose).
- 4 lpm: MMAD 2.7 ± 0.3 µm, GSD 2.6 ± 0.1, Particles (= 5 µm) 28.8 ± 3.2% (2402 ± 263 µg). Calculated Time to Deliver 100% of Dose: 104 ± 10 minutes (and 30 minutes calculated for a smaller dose).
- Budesonide Suspension (0.5 mg/2 ml):
- 2 lpm: MMAD 3.8 ± 0.3 µm, GSD 3.1 ± 0.2, Particles (= 5 µm) 45.1 ± 1.6% (451 ± 16 µg). Calculated Time to Deliver 100% of Dose: 73 ± 8 minutes.
- 4 lpm: MMAD 4.2 ± 0.2 µm, GSD 2.4 ± 0.2, Particles (= 5 µm) 44.9 ± 2% (1123 ± 50 µg). Calculated Time to Deliver 100% of Dose: 91 ± 13 minutes.
- Cromolyn Sodium (20 mg/2 ml):
- 2 lpm: MMAD 2.3 ± 0.3 µm, GSD 3.5 ± 0.3, Particles (= 5 µm) 31.4 ± 4.9% (12556 ± 1956 µg). Calculated Time to Deliver 100% of Dose: 117 ± 16 minutes.
- 4 lpm: MMAD 3.6 ± 0.4 µm, GSD 2.5 ± 0.1, Particles (= 5 µm) 38.5 ± 3.5% (38502 ± 3522 µg). Calculated Time to Deliver 100% of Dose: 108 ± 10 minutes.
- Albuterol Sulfate (2.5 mg/3 ml):
- The aerosol characterization testing with the adult and pediatric face mask demonstrated that the proposed device performance is equivalent to the predicate device.
Biocompatibility Testing:
- 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.
- Standards: AAMI/ANSI/ISO 10993-1:2009, AAMI/ANSI/ISO 10993-3:2009 (R2014), AAMI/ANSI/ISO 10993-5:2009 (R2014), AAMI/ANSI/ISO 10993-6:2009 (R2014), AAMI/ANSI/ISO 10993-10:2010 (R2014), AAMI/ANSI/ISO 10993-11:2006 (R2010), AAMI/ANSI/ISO 10993-12: 2012, AAMI/ANSI/ISO 10993-17:2002, AAMI/ANSI/ISO 10993-18:2005.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MMAD (Mass Median Aerodynamic Diameter), GSD (Geometric Standard Deviation), % (mass) of drug substance delivered in specified range of aerosol particles, µg (total drug mass in nebulizer for each micron range), Calculated Time to Deliver 100% of Dose.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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.
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 ( |
Aerosol Characterization using 7- stage Cascade Impaction (NGI) for three common aerosolized medications 1
| Aerosol Characteristics | 2 lpm | 4 lpm | |||
|---|---|---|---|---|---|
| Drug | |||||
| Description | (mean ± 95% CI) | (mean ± 95% CI) | |||
| Albuterol | |||||
| Sulfate: | |||||
| 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 |
6
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
(minutes) 7,8 | 94 ± 12 | 104 ± 10 |
|-------------------------------------------|----------------------------------------------------------|------------|--------------|
| Budesonide
Suspension:
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 |
| Cromolyn
Sodium:
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 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 |
7
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 | |
| for genotoxicity, carcinogenicity and reproductive | |
| toxicity | AAMI/ANSI/ISO 10993-3:2009 (R2014) |
| Biological Evaluation of Medical Devices-Part 5: Tests | |
| for In Vitro Cytotoxicity | AAMI/ANSI/ISO 10993-5:2009 (R2014) |
| Biological evaluation of medical devices - Part 6: Tests | |
| for local effects after implantation | AAMI/ANSI/ISO 10993-6:2009 (R2014) |
| Biological Evaluation of Medical Devices-Part 10: Tests | |
| for 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 leachable | |
| substances | 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.