(185 days)
Airlife Misty Nebulizer
Not Found
No
The description details a mechanical nebulizer that uses gas flow and baffles to create aerosolized medication. There is no mention of any computational or learning components.
Yes
The device is used to nebulize specific drugs for inhalation by a patient, which directly relates to treating or managing a medical condition.
No
Explanation: The device, the Airlife Misty Nebulizer, is a pneumatic nebulizer designed to administer medication to patients by nebulizing specific drugs for inhalation. Its purpose is drug delivery, not diagnosis.
No
The device description clearly describes a physical nebulizer that uses gas to aerosolize liquid medication. This is a hardware device, not software.
Based on the provided information, the Airlife Misty Nebulizer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, in order to provide information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
- Airlife Misty Nebulizer Function: The description clearly states that the nebulizer is used to nebulize specific drugs for inhalation by a patient. It delivers medication directly to the patient's respiratory system. It does not examine specimens from the body to provide diagnostic information.
- Intended Use: The intended use is for administering medical aerosol products to a patient, not for diagnostic testing.
Therefore, the Airlife Misty Nebulizer falls under the category of a therapeutic medical device, specifically a drug delivery device, rather than an IVD.
N/A
Intended Use / Indications for Use
The Airlife Misty Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. The patient population includes infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used in either a hospital or homecare environment.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
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 stream 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.
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
infant, pediatric and adult patients.
Intended User / Care Setting
physician or healthcare professional; hospital or homecare environment.
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)
All materials used in the fabrication of the Airlife® Misty Max 10 TM Nebulizer were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". Comparative testing was performed using the proposed, predicate and Pari-LC with regards to particle size distribution testing. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Airlife Misty Nebulizer
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.
Not Found
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
MAY = 1 2003
Image /page/0/Picture/1 description: The image shows the word "Allegiance" in a stylized font. To the left of the word is a graphic of a plus sign made up of small circles. The word is in all capital letters and is in bold.
a Cardinal Health company
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESSS
Submitter:
Allegiance Healthcare Corporation 1500 Waukegan Road MPWM McGaw Park, IL 60085
| Regulatory Affairs Contact: | Sharon Nichols |
|---|---|
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | April, 2003 |
| Common Name: | Airlife ® Misty Max 10™ Nebulizer |
| Classification: | Class II per 21CFR § 868.5630 |
| Predicate Device: | Airlife Misty Nebulizer |
| Description: | 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 stream 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. |
1
Image /page/1/Picture/0 description: The image shows the logo for Allegiance, a Cardinal Health company. The logo features a stylized cross made of small dots to the left of the word "Allegiance" in a bold, italicized font. Below the company name is the text "a Cardinal Health company" in a smaller, non-italicized font.
SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Intended Use: | The Airlife Misty Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. The patient population includes infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used in either a hospital or homecare environment. |
|---|---|
| Substantial Equivalence: | Airlife ® Misty Max 10 TM Nebulizer is substantially equivalent to the Airlife® Misty-Neb Nebulizer in that: - the intended use is the same - the performance attributes are similar |
| Summary of testing: | All materials used in the fabrication of the Airlife® Misty Max 10 TM Nebulizer were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". Comparative testing was performed using the proposed, predicate and Pari-LC with regards to particle size distribution testing. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use. |
2
Image /page/2/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 an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing the wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY = 1 2003
Ms. Sharon Nichols Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building WM McGaw Park, Illinois 60085
Re: K023602
Trade/Device Name: Airlife® Misty Max 10™ Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: March 31, 2003 Received: April 1, 2003
Dear Ms. Nichols:
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 Federal Register.
3
Page 2 - Ms. Nichols
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance 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 Division of 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.
Susa Runner
Susan Runner, DDS, MA Interim 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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a Cardinal Health company
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
Page 1 of 1
510(k) Number (if known):
Device Name:
Indications For Use:
Airlife®Misty Max 10™ Nebulizer
The Airlife Misty Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. The patient population includes infant, pediatric and adult patients. It's use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used in either a hospital or homecare environment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
or
Over-The Counter Use
SAHutchinson
n of Anesthesiology, General Hospital,
510(k) Number: K023602