MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER

K072670 · Pari Innovative Manufacturers, Inc. · CAF · Dec 13, 2007 · Anesthesiology

Device Facts

• Record ID: K072670
• Device Name: MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER
• Applicant: Pari Innovative Manufacturers, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Dec 13, 2007
• Decision: SESE
• Submission Type: Special
• 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 electronic nebulizer for aerosol medication delivery; single-patient use; reusable. Input: liquid medication in capped cup. Operation: electronic nebulization; powered by AA batteries or AC/DC adapter. Output: aerosolized medication for inhalation. New control unit features LCD for visual status monitoring and out-of-range parameters; communicates one-way; does not control nebulization process. Used by patients in home or clinical settings. Healthcare providers use status indicators to monitor treatment. Benefits: portable, ergonomic delivery of prescribed aerosolized drugs.

Clinical Evidence

Bench testing only. Software verification and validation performed per PARI SOP PV 02 70014. Electromagnetic compatibility and electrical safety testing conducted per IEC 60601-1-2, CAN/CSA C22.2 NO 601.1-M90, and UL 1431. Environmental stress testing performed per IEC/EN/DIN 60068-2-3, 60068-2-6, 60068-2-14, 60068-2-29, 60068-2-64, and 60068-2-78.

Technological Characteristics

Handheld electronic nebulizer. Power: 4 AA batteries or AC/DC adapter. Interface: LCD for status display (one-way communication). Connectivity: wired connection cord. Software: firmware for control unit interface. Standards: IEC 60601-1-2, CAN/CSA C22.2 NO 601.1-M90, UL 1431, IEC/EN/DIN 60068 series.

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

• eFlow® Electronic Nebulizer (K033833)

Submission Summary (Full Text)

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# SECTION 5: PREMARKET NOTIFICATION 510(K) SUMMARY STATEMENT

#### 1. Submitter Information

| Name: | PARI Innovative Manufacturers, Inc |
|-------------------------------|------------------------------------------------------------|
| Address: | 2943 Oak Lake Boulevard<br>Midlothian, Virginia 23112-3998 |
| Phone: | 804-639-7235 x810 |
| FAX: | 804-639-7244 |
| Contact Name: | James L. McIntire Jr. |
| Date Prepared: | August 2, 2007 |
| Device Name | |
| Common Name: | Nebulizer |
| Proprietary Name: | eFlow® Electronic Nebulizer |
| Classification Name: | Nebulizer (Direct Patient Interface) |
| Classification Regulation No: | 868.5630 |
| Classification Panel: | Anesthesiology |
| Product Code: | CAF |

## 3. Device Description

2.

The PARI eFlow® Electronic Nebulizer 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 either four AA batteries or a DC or AC adapter. Alternate power cords/plugs/adapters allow its use in any country.

## 4. Intended Use

The eFlow is a handheld nebulizer that will be used with patients for whom doctors have rno or to would ation for nebulization. The eFlow is intended for adult and pediatric patients.

## 5. Device Modification Summary

The device modification involves the addition of a new control unit and connection cord to those which are already part of the FDA-cleared device. These components will not replace the present control unit or connection cord. Rather, they represent additional device options.

The new control unit features a liquid crystal display (LCD) that visually displays the nebulization status and out-of-range parameters. It performs the same function as the audiovisual interfaces (light

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emitting diodes (LEDs) and audio tones) present in both the FDA-cleared control units. All of these audiovisual interfaces, including the LCD, communicate one-way, and do not control any aspects of the nebulization process.

Modifications to the FDA-cleared device are thus confined to the new control unit and connection cord. However, incorporating the LCD in the new control unit has had a "snowball" effect, and resulted in the following: (1) added ergonomics of the LCD interface; (2) a redesigned control unit and connectivity, (3) software and firmware; and, (4) labeling.

#### 6. Summary of Testing

The new, optional control unit underwent the following evaluations:

- Software verification and validation testing performed to the applicable requirements of k PARI SOP PV 02 70014 Version 00 (Release Software 678*).
- Electromagnetic compatibility and electrical safety testing for the intended operational . environment was performed to the applicable requirements of: IEC 60601-1-2; CAN/CSA C22.2 NO 601.1-M90; UL 1431, and;
- Stress testing for the intended operational environment was performed to the applicable 피 requirements of IEC/EN/DIN 60068-2-3, 60068-2-6, 60068-2-14, 60068-2-29, 60068-2-64 and 60068-2-78.

Testing demonstrated that the modifications to the new, optional control unit do not affect the performance of the eFlow Electronic Nebulizer, and raise no new issues of safety or effectiveness.

## 7. Substantial Equivalence

The new control unit and connection cord are an addition to the present eFlow®. Modifications to the device are confined to these new components, and involve the following: (1) added ergonomics of the device user interface (the LCD); (2) redesign of the control unit and the connection cord to accommodate the LCD. (3) software and firmware to accommodate the feature; and (4) labeling (IFU change to describe the LCD).

The addition of the modified unit does not affect the intended use, or alter the fundamental scientific technology of the legally-marketed PARI eFlow . Additionally, there is no change to the legally-marketed device's: (1) materials; (2) performance specifications; (3) dimensional specifications: (4) environmental specifications: (5) energy sources; or; (6) packaging.

Based upon the criteria set forth in 21 CFR 807.87, and under the New 510(k) Paradigm, we believe that the modifications to the eFlow® device are substantially equivalent to the eFlow® Electronic Nebulizer, previously determined to be substantially equivalent on May 5, 2004 in 510k No. K033833.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2007

PARI Innovative Manufacturers, Incorporated C/O Mr. Jay Y. Kogoma Senior Staff Engineer Intertek Testing Services 2307 East Eurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K072670

Trade/Device Name: eFlow® Electronic Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: November 30, 2007 Received: December 3, 2007

Dear Mr. Kogoma:

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. Kogoma

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,

Ching-Lin, Ph.D.

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:

eFlow® Electronic Nebulizer

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

Murt Tholl

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
|-------------------------------------------------|---|

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)