HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5

K072163 · 3A Health Care S.R.L. · CAF · Mar 6, 2008 · Anesthesiology

Device Facts

• Record ID: K072163
• Device Name: HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5
• Applicant: 3A Health Care S.R.L.
• Product Code: CAF · Anesthesiology
• Decision Date: Mar 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The intended use of the Happyneb II, Happyneb III, Speedy, Nebby Plus and the Myneb is to spray liquids in aerosol form into gases that are delivered directly to adult or pediatric patients who have been prescribed inhalation therapy or medication. Each of these nebulizers must be used exclusively with their own nebulizer and mouthpiece. The nebulizers Happyneb II, Happyneb III, Speedy, and the Nebby Plus are intended to be used primarily by patients in the home care market, although they may also be used by trained hospital staff personnel as well. The Myneb model is intended to be used only in home health care. The Happyneb II, Happyneb III, Speedy, Nebby Plus and the Myneb are intended for multiple use, are non-sterile and for use with pharmaceutical products which are under physician prescription.

Device Story

Family of five nebulizer systems (Happyneb II, Happyneb III, Speedy, Nebby Plus, Myneb) designed to convert liquid medication into aerosol for inhalation. Four models (Happyneb II, Happyneb III, Speedy, Nebby Plus) utilize AC power; one model (Myneb) utilizes a DC motor with rechargeable battery and external charger. Systems use Fasterjet or Nebjet nebulizers to deliver aerosolized medication. Intended for home care use by patients, with AC models also suitable for use by trained hospital staff. Devices are non-sterile and intended for multiple use. Operation involves connecting the compressor to the specific nebulizer and mouthpiece to deliver prescribed pharmaceutical products. Clinical benefit is the effective delivery of aerosolized medication to the respiratory tract.

Clinical Evidence

Bench testing only. Performance evaluated per FDA 'Reviewer guidance for nebulizers, metered dose inhalers, spacers and actuators' (1993). Results demonstrate equivalent performance parameters (MMAD, GSD, FPF, PFD) compared to predicate devices. No clinical data required.

Technological Characteristics

Compressor-based nebulizer systems. AC-powered (4 models) or DC-powered with rechargeable battery (1 model). Plastic housings. Uses Fasterjet or Nebjet nebulizers. Non-sterile, multiple-use devices. No software or electronic algorithms.

Indications for Use

Indicated for adult and pediatric patients requiring aerosolized inhalation therapy or medication 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

• Healthdyne, Inc NEBULIZER SYSTEM (K922623)
• Invacare - PRO, COMPACT and PORTABLE DESKTOP (K042483)
• Salter Labs - Salter Aire Compressor (K992285)
• Medical Industries Sport-Neb (K964078)
• Salter Labs 8900 nebulizer (K870027)
• Medic-Aid Sidestream Nebulizer (K991725)
• Pari LC STAR nebulizer (K963924)

Submission Summary (Full Text)

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CONFIDENTIAL

K072163

## 510(k) Summary for the 3A Healthcare nebulizers: Happyneb II, Happyneb III, Speedy, Nebby Plus and the Myneb

This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

## 1. General Information

| Submitter: | 3A Health Care S.r.l.<br>via Marziale Cerutti 90/F<br>25017 - Lonato (BS)<br>Italy<br>Simone Abate |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell<br>O'Connell Regulatory Consultants, Inc.<br>5 Timber Lane<br>North Reading, MA 01864<br>Telephone:<br>978-207-1245 |
| Consultant: | Guido Bonapace<br>ISENET<br>Via Calindri, 50<br>40068 - S.Lazzaro di Savena (BO)<br>Italy<br>Telephone:<br>[phone]<br>Fax:<br>[phone]<br>Email: [e-mail] |
| Summary Preparation Date: | July 24, 2007 |
| 2. Names | Device Name: The families of Happyneb III<br>Happyneb III, Speedy, Nebby Plus and<br>Myneb |
| Classification Name: | Nebulizer<br>Regulation number: 868.5630<br>Product Code: CAF |

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## 3. Predicate Devices

The 3A Health Care nebulizers Happyneb II, Happyneb III, Speedy, Nebby Plus and the Myneb, with their own nebulizers, Fasterjet and Nebjet, are substantially equivalent to a combination of the following devices:

- Healthdyne, Inc NEBULIZER SYSTEM K922623
- > Invacare - PRO, COMPACT and PORTABLE DESKTOP - K042483
- V Salter Labs - Salter Aire Compressor - K992285
- Medical Industries Sport-Neb (K964078)

for compressors, and

- Salter Labs 8900 nebulizer K870027 >
- > Medic-Aid Sidestream Nebulizer - K991725
- > Pari LC STAR nebulizer - K963924

for nebulizers.

### 4. Device Description

The family of 3A Health Care nebulizers include 5 different devices: 4 are AC powered devices (Happyneb II, Happyneb III, Speedy, Nebby Plus) and one model (Myneb) with a DC motor, a rechargeable battery pack and an external charger/power supplier.

The 4 AC compressors (Happyneb II, Happyneb III, Speedy, and Nebby Plus) have different plastic housings. There are three different types of electrical motors for AC models and one type for the DC model (Myneb). The 5 models of compressors are designed to use two nebulizers, the Fasterjet and Nebjet.

### 5. Indications for Use

The intended use of the Happyneb II, Happyneb III, Speedy, Nebby Plus and the Myneb is to spray liquids in aerosol form into gases that are delivered directly to adult or pediatric patients who have been prescribed inhalation therapy or medication. Each of these nebulizers must be used exclusively with their own nebulizer and mouthpiece.

The nebulizers Happyneb II, Happyneb III, Speedy, and the Nebby Plus are intended to be used primarily by patients in the home care market, although they may also be used by trained hospital staff personnel as well. The Myneb model is intended to be used only in home health care.

The Happyneb II, Happyneb III, Speedy, Nebby Plus and the Myneb are intended for multiple use, are non-sterile and for use with pharmaceutical products which are under physician prescription.

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## 6. Performance Data

The non clinical performance bench tests performed by 3A Health Care Srl, have been executed as requested in "Reviewer guidance for nebulizers, metered dose inhalers, spacers and actuators" issued in October 1993, and demonstrate that 3A Health Care nebulizers have the same effectiveness as their predicate devices because they have equivalent performance parameters (MMAD, GSD, FPF and PFD). Therefore, clinical data are not required.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### MAR - 6 2008

3A Health Care S.r.l. C/O Ms. Maureen O'Connell Regulatory Consultant O'Connell Regulatory Consultants, Incorporated 5 Timber Lane North Reading, Massachusetts 01864

Re: K072163

Trade/Device Name: Happyneb II, Happyneb III, Speedy, Nebby Plus and the Myneb Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: January 23, 2008 Received: January 28, 2008

Dear Ms. O'Connell:

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 -- Ms. O'Connell

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

Sincerely yours.

Snyte Y. Michael Omd.

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

510(k) Number (if known):

Device Name: Happyneb II, Happyneb III, Speedy, Nebby Plus and the Myneb

Indications for Use:

The intended use of the Happyneb II. Happyneb III. Speedy, Nebby Plus and the Myneb is to spray liquids in aerosol form into gases that are delivered directly to adult or pediatric patients who have been prescribed inhalation therapy or medication. Each of these devices must be used exclusively with their own nebulizer and mouthpiece.

The devices Happyneb II, Happyneb III, Speedy, and the Nebby Plus are intended to be used primarily by patients in the home care market, although they may also be used by trained hospital staff personnel as well. The Myneb model is intended to be used only in home health care.

The Happyneb II, Happyneb III. Speedy, Nebby Plus and the Myneb are intended for multiple use, are non-sterile and for use with pharmaceutical products which are under physician prescription.

Prescription Use >< (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mui Muly

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

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