(70 days)
Not Found
No
The description focuses on the mechanical vibration mechanism for aerosolization and does not mention any AI or ML components.
Yes.
The device is intended to aerosolize physician-prescribed solutions for inhalation, indicating its use in administering medication for therapeutic purposes.
No
The device is a nebulizer intended to aerosolize physician-prescribed solutions for inhalation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details hardware components (OnQ™ Aerosol Generator, aperture plate, vibrational element, AC Power Controller, Battery Powered Controller, batteries) and physical mechanisms (vibration, micropumping) for aerosolizing medication. This is a hardware device with potential embedded software for control, but not a software-only medical device.
Based on the provided information, the Aeroneb Go nebulizer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to aerosolize physician-prescribed solutions for inhalation. This is a drug delivery device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the mechanism for creating an aerosol for inhalation. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
The Aeroneb Go nebulizer is a medical device used for drug delivery via inhalation.
N/A
Intended Use / Indications for Use
The Aeroneb Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.
Product codes
CAF
Device Description
The Aeroneb Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.
The Aeroneb Go nebulizer uses the OnQ™ Aerosol Generator, which is comprised of a unique dome shaped aperture plate containing over 1,000 precision-formed tapered holes surrounded by a vibrational element. When energy is applied, the aperture plate vibrates approximately 100,000 times per second. This rapid vibration causes each aperture to act as a micropump, drawing liquid through the holes to form consistently sized droplets.
The Aeroneb Go nebulizer is lightweight, compact and silent. The device can be powered with the AC Power Controller or with the Battery Powered Controller that uses three "AA" disposable batteries.
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
pediatric and adult patients
Intended User / Care Setting
Not Found
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)
Non-clinical performance tests were conducted comparing Aeroneb Go nebulizer to the Aeroneb Portable Nebulizer System, the Pari LC Star and the Omron MicroAir. Results demonstrated that the Aeroneb Go nebulizer was substantially equivalent to the other legally marketed devices in performance.
Evaluation of performance included nebulizer delivery characterization, electrical, mechanical, and EMC safety, were based on those suggested in the FDA CDRH - REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS issued on: October 1, 1993.
The successful tests demonstrated the device consistently performed within its design parameters and is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K970010/K003022, K963924, K923024
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
NOV 2 1 2003
Image /page/0/Picture/1 description: The image shows the logo for Aerogen. The logo consists of the word "Aerogen" in a sans-serif font, with a stylized graphic above it. The graphic appears to be an abstract representation of airflow or a wing-like shape, composed of two curved lines that converge to a point on the right side.
SMDA Non-confidential 510(k) Summary
(1) Submitter's name / Contact person:
Aerogen, Inc. 2071 Stierlin Court Mountain View, CA 94043 USA
Contact person: Nancy E. Isaac Vice President, Regulatory Affairs and Quality Tel .: (650) 864-7493 Fax: (650) 864-7350
Date prepared: August 2003
(2) Name of device:
| Trade name: | Aeroneb® Go Nebulizer |
|---|---|
| Common name: | Nebulizer |
| Classification name: | Nebulizer, 21 CFR §868.5630 |
(3) Identification of predicate device:
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| Aerogen, Inc. | Aeroneb® Portable Nebulizer System | K970010/ |
| K003022 | ||
| Pare Holding Co. | Pari LC Star™ Reusable Nebulizer | K963924 |
| Omron Healthcare, Inc. | Omron MicroAir® Portable Ultrasonic Nebulizer | K923024 |
(4) Description of the device:
The Aeroneb Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.
The Aeroneb Go nebulizer uses the OnQ™ Aerosol Generator, which is comprised of a unique dome shaped aperture plate containing over 1,000 precision-formed tapered holes surrounded by a vibrational element. When energy is applied, the aperture plate vibrates approximately 100,000 times per second. This rapid vibration causes each aperture to act as a micropump, drawing liquid through the holes to form consistently sized droplets.
1
The Aeroneb Go nebulizer is lightweight, compact and silent. The device can be powered with the AC Power Controller or with the Battery Powered Controller that uses three "AA" disposable batteries.
(5) A statement of the intended use of the device:
The Aeroneb Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.
(6) Predicate device comparison:
The Aeroneb Go nebulizer is substantially equivalent to similar features in the predicate devices and has the same intended use and technological characteristics as the predicate devices.
Non-clinical performance tests were conducted comparing Aeroneb Go nebulizer to the Aeroneb Portable Nebulizer System, the Pari LC Star and the Omron MicroAir. Results demonstrated that the Aeroneb Go nebulizer was substantially equivalent to the other legally marketed devices in performance.
(7) Performance evaluations:
Evaluation of performance included nebulizer delivery characterization, electrical, mechanical, and EMC safety, were based on those suggested in the FDA CDRH - REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS issued on: October 1, 1993.
The successful tests demonstrated the device consistently performed within its design parameters and is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved lines that resemble a human figure or a symbol representing health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2003
Aerogen, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313
Re: K032849
Trade/Device Name: Aeroneb Go Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: November 6, 2003 Received: November 7, 2003
Dear Mr. Job:
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 vour 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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Page 2 - Mr. Mark Job
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 (OS) 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.
Ches
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
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Image /page/4/Picture/0 description: The image shows the word "Aerogen" in a simple, sans-serif font. Above the word is a stylized graphic consisting of two horizontal lines that are angled upwards and converge towards the right, creating a sense of forward movement. The logo is clean and minimalist, with a focus on the company name and a symbolic representation of its brand.
Section 1 Aeroneb® Go Nebulizer Premarket Notification 510(k)
510(k) Number (if known): _K 032849
Device Name: Aeroneb® Go Nebulizer
Indications for Use:
The Aeroneb Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.
signature
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental D
510(k) Number: K032847
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANTOHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over the Counter Use_
Optional Format 1-2-96)