(70 days)
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.
Here's an analysis of the provided text regarding the Aeroneb Go Nebulizer, matching the requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list "acceptance criteria" with specific quantitative thresholds. Instead, it states that performance evaluations were conducted and demonstrated "substantial equivalence" to predicate devices. The performance evaluations focused on "nebulizer delivery characterization, electrical, mechanical, and EMC safety."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Nebulizer delivery characterization meets standards of predicate devices. | The Aeroneb Go nebulizer was found to be "substantially equivalent to the other legally marketed devices in performance" after non-clinical performance tests comparing it to the Aeroneb Portable Nebulizer System, the Pari LC Star, and the Omron MicroAir. |
| Electrical safety meets relevant standards. | "Successful tests demonstrated the device consistently performed within its design parameters." (Implies compliance with electrical safety, as it was a stated evaluation area). |
| Mechanical safety meets relevant standards. | "Successful tests demonstrated the device consistently performed within its design parameters." (Implies compliance with mechanical safety, as it was a stated evaluation area). |
| EMC safety meets relevant standards. | "Successful tests demonstrated the device consistently performed within its design parameters." (Implies compliance with EMC safety, as it was a stated evaluation area). |
| Consistent performance within design parameters. | "The successful tests demonstrated the device consistently performed within its design parameters." |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "non-clinical performance tests." It does not specify a sample size for the test set. It also does not provide information about the data provenance (e.g., country of origin, retrospective/prospective), as these were non-clinical, likely bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This section is not applicable. The verification did not involve human interpretation or expert-established ground truth in the way a diagnostic imaging study would. The performance was assessed against technical specifications and comparison to predicate devices.
4. Adjudication Method for the Test Set
This section is not applicable. There was no need for adjudication as the testing involved objective measurements and comparisons to predicate device performance.
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
This section is not applicable. The device is a nebulizer, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is applicable in the sense that the device's performance was assessed independently of human interaction for its core function (aerosolizing solutions). The "standalone" performance is the focus of the non-clinical tests.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation was established by:
- Technical specifications/design parameters: The device was tested to ensure it performed consistently within its intended design.
- Comparison to predicate devices: The performance metrics (likely particle size distribution, nebulization rate, etc.) were compared against those of already-approved predicate nebulizers. The FDA guidance for nebulizers (October 1, 1993) also likely served as a reference for expected performance characteristics.
8. The Sample Size for the Training Set
This section is not applicable as this is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as this is not an AI/machine learning device that requires a training set.
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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.
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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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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)
§ 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).