AKITA JET

K090730 · Activaero America, Inc. · CAF · Nov 13, 2009 · Anesthesiology

Device Facts

• Record ID: K090730
• Device Name: AKITA JET
• Applicant: Activaero America, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Nov 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The AKITA JET is a nebulizer system that will be used with patients for whom doctors have prescribed medication (except pentamidine) for nebulization in the home care, nursing home, subacute institution, or hospital environment.

Device Story

AKITA JET is an electronic nebulizer system for aerosolizing liquid medications. System comprises an electrically powered compressor and a nebulizer handset (based on PARI LC Sprint). Device operates by delivering aerosol only during the inhalation phase, guided by patient-specific breathing patterns programmed via Smart Cards. Used in home, nursing home, subacute, or hospital settings; operated by patients or clinicians. Smart Cards set inspiration and nebulization parameters to control inhalation flow. By synchronizing delivery with patient breathing, the device optimizes medication deposition, potentially improving therapeutic outcomes for patients capable of coordinating their breathing.

Clinical Evidence

Bench testing only. Performance was validated through cascade impactor testing for particle characterization, electrical safety, EMC/EMI testing, and environmental testing. No clinical trial data was required or provided.

Technological Characteristics

Electronic nebulizer system; compressor-driven; handset based on PARI LC Sprint. Features programmable Smart Cards for setting inspiration and nebulization timing. Controls inhalation flow and synchronizes nebulization with inhalation phase. Electrical power source. Multi-use design for home and clinical environments.

Indications for Use

Indicated for patients 3 years and older who can coordinate breathing, prescribed nebulized medication (excluding pentamidine) in home, nursing home, subacute, or hospital settings.

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

• AKITA 2 APIXNEB (K072019)
• LC Sprint nebulizer (K060399)
• AutoNeb (K935693)

Submission Summary (Full Text)

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K090730

510(k) Summary Page 1 of 2 8-Sep-09

NOV 1 8 2009

| Activaero America, Inc.<br>P.O. Box 351<br>Dublin, OH 43017-9684 | Tel - [phone]<br>Fax - [phone] |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Official Contact: | William Zimlich - CEO |
| Proprietary or Trade Name: | AKITA JET |
| Common/Usual Name: | Nebulizer systems |
| Classification Name: | Nebulizer (Direct Patient Interface)<br>CAF - 868.5630 |
| Predicate Devices: | AKITA 2 APIXNEB - K072019 - Activaero<br>LC Sprint nebulizer - K060399 - PARI<br>AutoNeb - K935693 - Vortran |

#### Device Description

The AKITA JET nebulizer and the AKITA JET nebulizer handset together constitute a multi-use, electronic nebulizer system designed to aerosolize liquid medications. The system includes and features:

- An electrically powered compressor which provides an air flow to the AKITA JET ● nebulizer handset.
- . A nebulizer handset based upon the PARI LC Sprint, K060399
- Single patient, multi-use in the home setting .
- . Multiple patient, multi-use in the hospital and clinical settings
- .
- . Nebulization only during inhalation phase
- Smart Card series for defined patient breathing patterns .

#### Indications for Use

The AKITA JET is a nebulizer system that will be used with patients for whom doctors have prescribed medication (except pentamidine) for nebulization in the home care, nursing home, subacute institution, or hospital environment.

#### Patient Population

The AKITA JET is intended for patients 3 years and older who can coordinate breathing.

#### Environment of Use

Home care, nursing home, sub-acute institution, or hospital

#### Contraindications

None

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# 510(k) Summary Page 2 of 2 8-Sep-09

To demonstrate substantial equivalence as well as safety and effectiveness a series of performance tests were done.

The predicate comparison is broken into several categories:

- . General Attributes
- o Indications for Use
- o Patient Population
- o Environments of use
- Nebulizer performance
- ಂ Particle characterization
- PARI LC Sprint Reusable Nebulizer K060399 o
- . Delivery during inhalation
- Activaero AKITA2 APIXNEB K072019, Vortran AutoNeb K935693 o
- Delivery based upon breathing patterns . Activaero AKITA2 APIXNEB K072019 o
- . Algorithm to program breathing patterns
- Activaero AKITA2 APIXNEB K072019 ಂ
- . Controlled inhalation flow
- Activaero AKITA2 APIXNEB K072019 O
- Use of programmable Smart Cards for setting inspiration and nebulization time .
- Activaero AKITA2 APIXNEB K072019 o

For safety and effectiveness testing included:

- Performance of the AKITA JET system via Cascade Impactor testing ●
- . VOC, PM2 < and Ozone testing
- Electrical safety, EMC, EMI, Mechanical and environmental testing .

## Differences Between Other Legally Marketed Predicate Devices

The AKITA JET system is viewed as substantially equivalent to the predicates.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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## 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" around the perimeter. Inside the circle is an abstract symbol of an eagle or bird-like figure, with stylized wings and body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Activaero America, Incorporated C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

NOV 1 8 2009

Re: K090730 Trade/Device Name: Akita Jet Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: November 6, 2009

Received: November 9, 2009

Dear Mr. Dryden:

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 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.

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## Page 2- Mr. Dryden

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting Division 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 Statement

Page 1 of 1

510(k) Number:

K090730 (To be assigned)

Device Name: AKITA JET

Indications for Use:

The AKITA JET is a nebulizer system that will be used with patients for whom doctors have prescribed medication (except pentamidine) for nebulization in the home care, nursing home, subacute institution, or hospital environment.

Patient Population

The AKITA JET is intended for patients 3 years and older who can coordinate breathing.

Prescription Use XX (Part 21 CFR 801 Subpart D)

or

Over-the-counter use (21 CFR 807 Subpart C)

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

L. Schultheis

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

. 510(k) Number: K090730