AKITA2 APIXNEB

K072019 · Activaero America, Inc. · CAF · Nov 5, 2007 · Anesthesiology

Device Facts

• Record ID: K072019
• Device Name: AKITA2 APIXNEB
• Applicant: Activaero America, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Nov 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The AKITA2 APIXNEB is a nebulizer system that will be used with patients for whom doctors have prescribed medication for nebulization in the home care, nursing home, subacute institution, or hospital environment. The AKITA2 APIXNEB is intended for patients 3 years and older who can coordinate breathing.

Device Story

AKITA2 APIXNEB is an electronic nebulizer system for aerosolizing liquid medications. System comprises an electrically powered compressor and a nebulizer handset (based on Pari eFlow technology) using a piezoelectric-vibrated perforated stainless steel membrane. Device operates by nebulizing medication only during the inhalation phase, guided by patient-specific breathing patterns stored on 'Smart Cards'. Used in home, nursing home, sub-acute, or hospital environments by patients 3 years and older. Healthcare providers program delivery parameters onto Smart Cards to control inhalation flow and timing. Output is a controlled aerosol mist; device optimizes drug delivery based on individual breathing patterns, potentially improving therapeutic efficacy and patient compliance.

Clinical Evidence

Bench testing only. Performance evaluations included flow performance, trigger pressure, on/off performance, nebulization time, time lag, timing parameters, life-time testing, cleaning performance, and smart card functionality. Additional testing included VOC/PM2.5 emissions, electrical safety, EMC, EMI, and mechanical/environmental testing. No clinical data provided.

Technological Characteristics

System includes an electrically powered compressor and a piezoelectric-vibrated perforated stainless steel membrane nebulizer handset. Features include inhalation-synchronized nebulization and programmable Smart Card interface for patient-specific breathing patterns. Operates on AC power. Designed for single-patient, multi-use. Software-controlled delivery parameters.

Indications for Use

Indicated for patients 3 years and older capable of coordinating breathing, requiring prescribed nebulized medication (excluding pentamidine) in home, nursing home, sub-acute, 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

• I-neb Insight (K052941)
• ProDose (K030747)
• eFlow™ (K033833)
• AutoNeb (K935693)

Submission Summary (Full Text)

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K072019

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 3 18-Sep-07

| 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: | AKITA² APIXNEB | NOV - 5 200 |
| Common/Usual Name: | Nebulizer systems | |
| Classification Name: | Nebulizer (Direct Patient Interface)<br>CAF - 868.5630 | |
| Predicate Devices: | I-neb Insight -- K052941 -- Profile / Respironics<br>ProDose - K030747 - Profile / Respironics<br>eFlow™ - K033833 - Pari<br>AutoNeb -- K935693 - Vortran | |

### Device Description

The AKITA? APIXNEB nebulizer and the handset together constitute a single patient, 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 AKITA2 . APIXNEB nebulizer handset.
- . A nebulizer handset based upon the PARI e-Flow™, K033833, which uses piezoelectric vibration of a perforated stainless steel membrane (head) for the aerosol generation.
- . Single patient use, reusable
- Nebulization only during inhalation phase .
- . Smart Card series for defined patient breathing patterns

### Indications for Use

The AKITA2 APIXNEB 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, sub-acute institution, or hospital environment.

## Patient Population

The AKITA2 APIXNEB 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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#### Non-Confidential Summary of Safety and Effectiveness

Page 2 of 3 18-Sep-07

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

For substantial equivalence the predicate comparisons included:

- . General Attributes
- o Indications for Use
- ্ Patient Population
- o Environments of use
- Vortran AutoNeb K935693, I-neb K052941and Prodose AAD System -O K030747
- . Nebulizer performance

.

.

- Particle characterization ্ত
- Pari eFlow™ K033833 o
- Nebulization during inhalation
- Vortran AutoNeb K935693, I-neb K052941and Prodose AAD System o K030747
- Delivery based upon breathing patterns .
- 1-neb K052941and Prodose AAD System K030747 0
- . Algorithm to program breathing patterns
- I-neb K052941and Prodose AAD System K030747 ্ত
- in vitro data Activaero 0
- Controlled inhalation flow
- I-neb K052941 ୍
- . Use of programmable disc (Smart cards) for setting nebulization and delivery parameters
- O Prodose AAD System K030747 and I-neb K052941

For safety and effectiveness testing included:

- Performance of the AKITA2 APIXNEB system .
- Flow performance o
- o Trigger Pressure performance
- o On/Off performance
- Nebulization Time performance 0
- Time lag performance o
- Timing Parameters o
- Life Time test O
- Cleaning performance 0
- o Smart Card performance
- Inhalation / Exhalation resistance
- . VOC and PM25 testing
- Electrical safety, EMC, EMI, Mechanical and environmental testing ●

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## Non-Confidential Summary of Safety and Effectiveness

Page 3 of 3 18-Sep-07

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# Differences Between Other Legally Marketed Predicate Devices

The AKITA2 APIXNEB 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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Image /page/3/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Activaero America, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creck Court, # 102 Bonita Springs, Florida 34134

NOV - 5 2007

Rc: K072019

Trade/Device Name: AKITA2 APIXNEB Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: September 18, 2007 Received: September 20, 2007

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 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.

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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); 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 [phone]. Also, please note the regulation cntitled. "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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Neil R. Ogden

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

Enclosure

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## Indications for Use Statement

Page 1 of 1

510(k) Number: K072019 (To be assigned)

AKITA2 APIXNEB Device Name:

Indications for Use:

The AKITA2 APIXNEB is a nebulizer system that will be used with patients for whom doctors have prescribed medication for nebulization in the home care, nursing home, subacute institution, or hospital environment.

The AKITA2 APIXNEB 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)

*(Division Sign-Off)*

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: KC)72016