(14 days)
This device is intended to be used to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using the Airlife™ Misty Finity™ Large Volume Continuous Nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used in either a hospital, nursing homes, extended care facilities or outpatient clinics.
The nebulizer is a single patient use device, which is filled with a fluid, typically respiratory medication and connected to an air source via flexible tubing. The nebulizer works by having the fluid come into contact with the steam of gas. The gas shatters the liquid into small particles. These particles then impact a baffle that further reduces the size of the particles. The majority of the 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 particles are then administered as the patient inhales. The treatment is completed when the majority of fluid is nebulized.
This document describes the Airlife™ Misty Finity™ Large Volume Continuous Nebulizer.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are based on performance evaluation, specifically cascade impaction and output rate testing. The performance of the proposed device (Airlife™ Misty Finity™ Large Volume Continuous Nebulizer) was compared to the predicate device (Westmed Heart Continuous Large Volume Nebulizer).
| Characteristic | Acceptance Criteria (Substantial Equivalence to Predicate) | Reported Device Performance (Airlife™ Misty Finity™) |
|---|---|---|
| Cascade Impaction Parameters | Performance "substantially equivalent" to the predicate device across: | "Test results found the performance of the Misty Finity substantially equivalent to the predicate device." |
| Median Mass Aerodynamic Diameter (MMAD) | Substantially equivalent to predicate | Tested and found substantially equivalent to predicate. |
| Geometric Standard Deviation (GSD) | Substantially equivalent to predicate | Tested and found substantially equivalent to predicate. |
| Deposited Drug Masses (total within impactor) | Substantially equivalent to predicate | Tested and found substantially equivalent to predicate. |
| Deposited Drug Masses (at each stage) | Substantially equivalent to predicate | Tested and found substantially equivalent to predicate. |
| Deposited Drug Masses (between 0.4 - 4.7 microns) | Substantially equivalent to predicate. Specifically, `%0.4 - 4.7 microns was calculated by summing the drug masses deposited onto stages 3-7 and dividing by the total mass collected in the impactor." This implies a target range or equivalency to the predicate's performance in this critical particle size range for effective drug delivery to the lungs. | Tested and found substantially equivalent to predicate. The calculation method was performed for the proposed device, demonstrating its performance in this critical range. |
| Output Rate Testing | Substantially equivalent to predicate | Tested and found substantially equivalent to predicate. |
| Biological Qualification Safety Tests (ISO 10993-1) | Materials used must be found "similar to the predicate" and "acceptable for the intended use." | "All materials used in the fabrication... were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1... and were found similar to the predicate." "These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the "test set" in terms of the number of nebulizers tested or the number of cascade impaction runs. It only states that "Performance evaluation... consisted of cascade impaction and output rate testing."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that this is a 510(k) submission for a new device, the testing would inherently be prospective, conducted by the manufacturer, Cardinal Health Corporation (McGaw Park, IL, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device submission. The "ground truth" for a nebulizer's performance in this context is established through objective, standardized physical testing (cascade impaction, output rate) against a well-defined predicate device, rather than expert interpretation of medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. For a physical device performance study, the results are derived from objective measurements, not subjective human evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance
This information is not applicable. This is a submission for a medical device (a nebulizer), not an AI algorithm or a diagnostic tool that involves human readers interpreting data. Therefore, an MRMC study or AI-assisted human performance evaluation is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation in this 510(k) submission is based on objective physical measurements obtained through standardized laboratory tests (cascade impaction and output rate testing). The performance of the proposed device is then compared directly against the performance of the predicate device (Westmed Heart Continuous Large Volume Nebulizer) under the same test conditions. The predicate device's established performance serves as the benchmark for "substantial equivalence." Additionally, biological qualification safety tests (ISO 10993-1) provide ground truth on material biocompatibility.
8. The Sample Size for the Training Set
This information is not applicable. "Training set" refers to data used to train machine learning algorithms. This device is a physical medical device and does not involve AI or machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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(JUN 1 0 2004
Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of several curved lines, and the text "CardinalHealth" is written in a simple, sans-serif font.
1500 Waukegan Road
McGaw Park, Illinois 60085-6787
847.473.1500 FAX: 847.785.2461
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Airlife™ Misty Finity™ Large Volume Continuous Nebulizer
| Manufacturer: | Cardinal Health Corporation1300 Waukegan RoadMcGaw Park, IL 60085 |
|---|---|
| Regulatory Affairs Contact: | Lavenia Ford1500 Waukegan Road MPWMMcGaw Park, IL 60085 |
| Telephone: | (847) 785-3323 |
| Date Summary Prepared: | March, 2004 |
| Trade Name: | Airlife™ Misty Finity™ Large Volume Continuous Nebulizer |
| Classification: | Class II per 21CFR § 868.5630 |
| Classification Name: | Nebulizer |
| Predicate Device: | Westmed Heart Continuous Large Volume Nebulizer |
| Description: | The nebulizer is a single patient use device, which isfilled with a fluid, typically respiratory medication andconnected to an air source via flexible tubing. Thenebulizer works by having the fluid come into contactwith the steam of gas. The gas shatters the liquid intosmall particles. These particles then impact a baffle thatfurther reduces the size of the particles. The majority ofthe larger particles settle inside the nebulizer as a resultof gravity and inertia, returning the mist to liquid torepeat the nebulization process. The smaller particlesare then administered as the patient inhales. Thetreatment is completed when the majority of fluid isnebulized. |
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Image /page/1/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic of several curved lines above the company name. The text "CardinalHealth" is written in a simple, sans-serif font.
1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Airlife™ Misty Finity™ Large Volume Continuous Nebulizer
This device is intended to be used to spray liquids in Intended Use: aeroso! form into gases that are delivered directly to the patient for breathing. It's use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using the Airlife™ Misty Finity™ Large Volume Continuous Nebulizer. This product is a single patient use, nonsterile prescriptive device and is designed to be used in either a hospital, nursing homes, extended care facilities or outpatient clinics.
Substantial Equivalence: Airlife™ Misty Finity™ Large Volume Continuous Nebulizer is substantially equivalent to the Westmed Heart Continuous Large Volume Nebulizer All materials used in the fabrication of the Airlife™ Misty Summary of testing: Finity™ Large Volume Continuous Nebulizer were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices"and were found similar to the predicate. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use. Note Table below:
| Characteristic | (Proposed Cardinal) AirLife Misty Finity Large Volume Continuous Nebulizer | (Predicate WestMed) Heart Large Volume Continuous Nebulizer K963910 |
|---|---|---|
| Intended Use | This device is intended to be used to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing | Same |
| Type of Device | Disposable, Sold Non-Sterile, Single Patient Use | Same |
| Type of Air Source | Compatible with compressed air systems | Same |
| Nebulizer Flow Rates | 10 lpm | 10 or 15 lpm |
| Maximum Fill Capacity | 240 ml | Same |
| Patient Population | Infant, Pediatric and Adult | Same |
| Accessories | Aerosol Masks, Tubing | Same |
| Materials | Thermo Plastics | Same |
| Manufacturing Process | Plastic Molding | Same |
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SMDA REQUIREMENTS (continued)
Summary of Testing:
"Performance evaluation of the proposed and predicated devices consisted of cascade impaction and output rate testing. Cascade impaction was conducted at a flow rate of 28.3 L/min, evaluating MMAD, GSD and deposited drug masses (total within impactor, at each stage and between 0.4 - 4.7 microns). Three different drug classes were tested; beta-agonist bronchodilator. anti-cholinergic bronchodilator and anti-inflammatory drugs. Test results found the performance of the Misty Finity substantially equivalent to the predicate device."
Test Description and Performance Summary - Particle Size "%0.4 - 4.7 microns was calculated by summing the drug masses deposited onto stages 3-7 and dividing by the total mass collected in the impactor."
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three horizontal lines that curve and merge into a single line at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
(JUN 1 0 2004
Cardinal Health C/O Mr. Ned Devine Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K041418
Trade/Device Name: Airlife Misty Finity Large Volume Continuous Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated on Submission: May 27, 2004 Date Received in ODE: May 27, 2004
Dear Mr. Devine:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Eederal Register.
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Page 2 - Mr. Devine
Please be advised that FDA's issuance of a substantial equivalence determination does not Flease be auvrsod that I Dr. o tosmination that your device complies with other requirements Incall that I DA nas made a deceminations administered by other Federal agencies. of the Act of any I ederal bates and squirements, including, but not limited to: registration You must comply with and the reseling (21 CFR Part 801); good manufacturing practice allu listing (21 CF R Part 807), abstitus (QS) regulation (21 CFR Part 820); and if requirements as set form in the quadistion control provisions (Sections 531-542 of the Act); applications and cleculity letter will allow you to begin marketing your device as described 21 CFR 1000-1030. This leaser manufication. The FDA finding of substantial equivalence in your bection 916(i) predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specificatives for your at (301) 594-4646. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overnit our Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K041418 510(k) Number (if known)
Device Name: Misty Finity™ Large Volume Continuous Nebulizer
Indications for Use:
This device is intended to be used to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Its use is indicated whenever a physician or healthcare professional administers or inaloutu medical aerosol products to a patient using a Continuous Large Volume Nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used under medical supervision in hospitals, nursing homes, extended care facilities or outpatient clinics.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K041418 |
|---|---|
| ---------------- | --------- |
§ 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).