EFLOW ELECTRONIC INHALER/NEBULIZER

K033833 · Pari Innovative Manufacturers, Inc. · CAF · May 5, 2004 · Anesthesiology

Device Facts

• Record ID: K033833
• Device Name: EFLOW ELECTRONIC INHALER/NEBULIZER
• Applicant: Pari Innovative Manufacturers, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: May 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The eFlow™ is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients.

Device Story

Handheld, single-patient use, reusable electronic nebulizer; aerosolizes prescribed medications for inhalation. Input: liquid medication in capped cup. Operation: ultrasonic/piezoelectric vibration generates aerosol; two-valve system provides breath-enhanced delivery. Power: 4 AA batteries, DC adapter, or AC adapter. Used in clinical or home settings by patients or caregivers. Output: aerosolized medication for patient inhalation. Benefit: efficient delivery of prescribed respiratory medication.

Clinical Evidence

No clinical data; bench testing only. Performance metrics (MMAD, RF, TOR) compared to predicate devices showed comparable or superior results. Safety/EMC testing met EN/IEC 60601-1, DIN EN 60601-2, and UL 1431 standards.

Technological Characteristics

Electronic nebulizer using ultrasonic/piezoelectric vibration. Features two-valve system for breath-enhanced delivery. Power: 4 AA batteries, DC, or AC adapter. Single-patient use, reusable. Meets EN/IEC 60601-1, DIN EN 60601-2, and UL 1431 safety/EMC standards.

Indications for Use

Indicated for adult and pediatric patients prescribed medication for nebulization.

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

• AeroNeb IITM Portable Nebulizer (K992381)
• AcroNebTM Portable Nebulizer (K003022/970010)
• PARI LC Star® nebulizer (K963924)

Submission Summary (Full Text)

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KO33833

eFlow™ Electronic Nebulizer 510(k) Submission 510(k) Summary

MAY - 5 2004

## Submitter Information

| Name: | PARI Innovative Manufacturers, Inc. |
|----------------|--------------------------------------------------|
| Address: | 2943 Oaklake Blvd.<br>Midlothian, Virginia 23112 |
| Phone Number: | 804-639-7235 x235 |
| FAX Number: | 804-639-7244 |
| Contact Name: | Lawrence Weinstein |
| Date Prepared: | August 14, 2003 |

#### Device Name

| Common Name: | Electronic Nebulizer |
|----------------------|--------------------------------------|
| Proprietary Name: | eFlow™ |
| Classification Name: | Nebulizer (Direct Patient Interface) |

# Legally Marketed Predicate Device

| Manufacturer | Device | 510(k) Number |
|-------------------------------------|---------------------------------|----------------|
| AeroGen Inc | AeroNeb IITM Portable Nebulizer | K992381 |
| AeroGen Inc | AcroNebTM Portable Nebulizer | K003022/970010 |
| PARI Innovative Manufacturers, Inc. | PARI LC Star® nebulizer | K963924 |

#### Device Description

The PARI eFlow™ is a small, single patient use, reusable electronic nebulizer for the inhalation treatment of aerosol medications. It is a hand-held device containing a capped medication cup that can be filled by the user. Power input is provided by cither 4 AA batteries, a DC adapter or an AC adapter. Alternate power cords/plugs/adapters allow use in any country.

#### Intended Use

The eFlow™ is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients.

# Technological Characteristics Compared to Predicate Device

eFlow, LC Star and Aeroneb are all nebulizers used to aerosolize medication for inhalation. I.C Star is a compressor driven jet nebulizer while elilow and Aeroneb use ultrasonic/piezoelectric vibration to generate the aerosol.

eFlow makes use of similar/identical materials for the nebulizer, as compared to the LC Star and also uses a similar two valve system to provide breath enhanced aerosol delivery.

## Non-clinical Test Summary

EFlow was tested to compare performance to the predicate devices, including:

- MMAD: eFlow MMAD is comparable to or lower than prodicate devices. ●
- RI: eFlow RF is comparable to or greater than predicate devices. ●
- TOR: eFlow TOR is comparable to or greater than predicate devices. .
- Safety/EMC: eFlow meets the requirements of EN/IEC 60601-1, DIN EN 60601-2 and U'L 1431. .

# Clinical Performance Summary

Clinical testing was not completed/is not required to show substantial equivalence.

#### Conclusions from Testing

eFlow meets performance requirements and raises no new issues of safety or effectiveness.

PARI Confidential por and the Market Millian Market Mark Mark Mark Page 42719 Market Page

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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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2004

Pari Innovative Manufacturers C/O Mr. Robert Mosenkis CITECH 5200 Butler Pike Plymouth Meeting, PA 19462

Re: K033833

Trade/Device Name: eFlow Electronic Inhaler/Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: April 20, 2004 Received: April 21, 2004

Dear Mr. Mosenkis:

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. Mosenkis

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 vour 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/dsma/dsmamain.html.

Sincerely vours.

Chris

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): ____________________________________________________________________________________________________________________________________________________ K033833

Device Name: _eFlowTM Electronic Nebulizer

Indications for Use:

The cFlow is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The cFlow is intended for adult and pediatric patients.

Prescription Usc XXX (Part 21 CFR 801 Subpart D)

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AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Aulialion

(Division Slan-Off) Division of Assethesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K0538