AERONEB II, MODEL APN 200

K992831 · Aerogen, Inc. · CAF · Aug 25, 2000 · Anesthesiology

Device Facts

• Record ID: K992831
• Device Name: AERONEB II, MODEL APN 200
• Applicant: Aerogen, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Aug 25, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AeroNeb™ II Portable Nebulizer is intended for breath-triggered nebulization of aerosolized medications prescribed by a physician.

Device Story

AeroNeb™ II is a battery-operated, hand-held portable nebulizer. It utilizes piezoelectric vibration aerosol generator technology to convert liquid medication into an aerosol for inhalation. The device is breath-triggered, ensuring medication delivery is synchronized with patient inhalation. It is intended for use in clinical or home settings under physician prescription. The healthcare provider uses the device to administer prescribed aerosolized medications to patients. The device benefits patients by providing a portable, efficient method for medication delivery. Operation involves the patient inhaling through the device, which triggers the nebulization process.

Clinical Evidence

Bench testing only. Performance evaluations included nebulizer delivery characterization, electrical safety, and EMC safety, conducted in accordance with FDA CDRH Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (1993).

Technological Characteristics

Battery-operated, hand-held form factor. Utilizes piezoelectric vibration aerosol generator technology. Materials are identical to the predicate device. Performance testing conducted per FDA CDRH 1993 guidance for nebulizers.

Indications for Use

Indicated for patients requiring aerosolized medication delivery via breath-triggered nebulization as prescribed by a physician.

Regulatory Classification

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.

Predicate Devices

• FPT Nebulizer (K970010)

Submission Summary (Full Text)

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### Section 2 Page 4 of 4 JUN AeroNeb™ II Portable Nebullzer 510(K) Premarket Notification

## SMDA 510(k) Summary of Safety and Effectiveness

- (1) Submitter's Name / Contact Person:
AeroGan™ Inc. 1310 Orleans Drive Sunnyvala, CA 94089

Contact Person:

Traci V. A. Edwards Director, Quality Assurance & Regulatory Affairs Tel .: [phone] Fax: [phone] E-mall; tedwards @ aerogen.com

Date prepared:

August 23, 2000

(2) Name of device:

Trade Name: Common Name: Classification Name:

AeroNebTM II Portable Nebulizer Nebulizer Nebulizer, 21 CFF1 5868.5630

(3) Identification of predicate device:

| Manufacturer<br>I wall a manufacture to the manufacture manufacturer in the manufacturer and consistence and the contraction of the comments of the comments of the contribution of the commen | Device | 510(k) Number |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|---------------|
| Fluld Propulsion Technologies | FPT Nebulizer | K970010 |

#### (4) Description of the device:

The AeroNeb™ II is a battery operated hand-held portable nebulizer using the same materials and piezoelectric vibration aerosol generator technology as the predicate device.

#### (5) A statement of the intended use of the device:

The AeroNeb™ II Portable Nebulizer is intended for breath-triggered nebulization of aerosolized medications prescribed by a physician.

#### (6) Predicate Device Comparison;

The AeroNeb™ II Portable Nebulizer Is a smaller portable version of the FPT Nebulizer,

The AeroNeb™ II Portable Nebullzer is substantially equivalent to similar features in the predicate device and has the same intended use and technological characteristics as the predicate device. Non-clinical performance tests were conducted comparing AeroNeb™ II to the FPT Nebulizer and are summarized in the submission.

The performance evaluations including nebulizer delivery characterization, electrical, 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, is as safe and effective, and performs as well as, or better than, the predicate device

AeroGen Inc.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2000

Ms. Traci V. A. Edwards AeroGen, Inc. 1310 Orleans Drive Sunnyvale, CA 94089

K992831 Re: AeroNeb™ II Portable Nebulizer Regulatory Class: II (two) Product Code: 73 CAF Dated: August 11, 2000 Received: August 14, 2000

Dear Ms. Edwards:

We have reviewed your Section 510(k) notification of intent to market we have reviewed your boose and we have determined the device is the device forcioned and it a the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encrosure) to regarif mariese pay 28, 1976, the enactment date of the Incelstate Commerce proble of to devices that have been reclassified redical bevree famonakenos, is one of the Federal Food, Drug, and In acturation with oneous therefore, market the device, subject to the general controls provisions of the Act. The general controls the general controlo provisions quirements for annual registration, provisions of thes, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special It your device ID enemarket Approval), it may be subject to such ednerold) or crais. Existing major regulations affecting your device additionar concease - Enederal Regulations, Title 21, Parts 800 can be roa substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set with the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS ocheral regaration on Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in assumptions. Italiae of Ottion, FDA may publish further announcements regaratory acouvere in the Federal Register. Please note: this concerning your as remarket notification submission does not affect any response co your have under sections 531 through 542 of the Act obrigation you major the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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# Page 2 - Ms. Traci V. A. Edwards

This letter will allow you to begin marketing your device as described This letter will allow you co begin mirroans from of substantial
in your 510(k) premarket notification. www.stated modicato device in your 310(K) premaired notifications and the marketed predicate device equivalence of your device of a regioned device to proceed to the market.

. If you desire specific advice for your device on our labeling If you desire specific advice for for for for for in vitro regulation (21 CM fart our and the Office of Compliance at diagnostic devices), predoc ochool on the promotion and [phone]. AdditIonally) 10- quosect the Office of Compliance at
advertising of your device, please contact later antitled [phone]. Also, please note the regulation entitled, [phone]. "AI30, premarket notification" (21 CR 807.97).
"Misbranding by reference to premarket notification" (21 CER 807.97) "Misbranding by relerence to premarked instituties under the Act may Other general information of Small Manufacturers Assistance at its internet be obtained from the Dribico. I ---------------------------------------------------------------------------------------------------------------------------------------------coll free namber (ovefda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours, ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 1 Page 7 of 11 A EROGEN AeroNeb™ II Portable Nebullzer 510(K) Promarket Notification

510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________

Device Name: AeroGen™ Inc. AeroNeb™ II Portable Nebullzer

Indications For Use:

The AeroNeb™ II Portable Nebulizer is intended for breath-triggered nebulization of aerosolized medications prescribed by a physician.

fe

Division of Cardioyascular & Respiratory Devices
510(k) Number KY 1 28 3 /

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEGORD)

Concurrence of CDRH, Office of Device Evaluation (ODB)

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use

(Optional Format 1-2-96)