DELUXE NEBULIZER

K063449 · Access Point Medical, LLC · CAF · Mar 1, 2007 · Anesthesiology

Device Facts

• Record ID: K063449
• Device Name: DELUXE NEBULIZER
• Applicant: Access Point Medical, LLC
• Product Code: CAF · Anesthesiology
• Decision Date: Mar 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The Access Point, LLC Deluxe Nebulizer is intended to provide a source of compressed air for medical purposes for use in home health care. The Deluxe Nebulizer is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.

Device Story

Deluxe Nebulizer is a home-use respiratory therapy device. It consists of a main unit, air compressor, air filters, and a handheld nebulizer kit with a mouthpiece. The device uses a non-oil lubricating, single-cylinder piston pump to compress air. This compressed air is directed through the nebulizer kit, where it atomizes medicinal liquid into a fine aerosol mist for patient inhalation. The device is operated by the patient or caregiver in a home environment. By delivering medication directly to the respiratory system, it assists in the management of respiratory disorders.

Clinical Evidence

Bench testing only. The device was verified for conformance to IEC 60601-1 (safety) and IEC 60601-1-2 (electromagnetic compatibility) and FDA guidance for nebulizers.

Technological Characteristics

Non-oil lubricating, single-cylinder piston pump compressor. Components include air filter, jet outlet, and handheld nebulizer kit (mouthpiece, T-piece, rinse tube, air hose, cup, baffle). Operates on compressed air principle. Conforms to IEC 60601-1 and IEC 60601-1-2 standards.

Indications for Use

Indicated for children and adults suffering from respiratory disorders requiring aerosolized medication therapy via a pneumatic nebulizer in a home health care setting.

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

• Medical Depot Power Neb 2 (K003344)

Submission Summary (Full Text)

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K063449

# 510(k) Summary of Safety and Effectiveness

#### Submitter Information:

Access Point Medical, LLC 3 CityPlace Drive, Suite 750 St. Louis, MO 63141 USA

MAR J 1 2007

## USA Contact:

Rick Davis Access Point Medical, LLC 3 CityPlace Drive, Suite 750 St. Louis, MO 63141- USA

Phone: [phone] Fax: [phone]

## Device Name:

Trade Name: Deluxe Nebulizer Common Name: Nebulizer (Direct Patient Interface) Classification Name: Anesthesia Conduction Kit (Reference, 21CFR, 868.5630, April 1, 2005)

## Predicate Devices:

The Deluxe Nebulizer is substantially equivalent to the Medical Depot Power Neb 2 ™ nebulizer cleared for market under 510(k) K003344. The indication for use for the Deluxe Nebulizer is identical to the Power Neb 2 TM

## Device Description:

The Deluxe Nebulizer, consist of four components. The nebulizer main unit, air compressor, air filters and nebulizer kit (hand held nebulizer with mouthpiece). The Nebulizer atomizes medicinal liquid into tiny fog droplets by compressing air. Patients inhale the compressed air for optimal internal medicinal delivery.

## Intended Use:

The Access Point, LLC Deluxe Nebulizer is intended to provide a source of compressed air for medical purposes for use in home health care. The Deluxe Nebulizer is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.

510(k) Summary

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## Technology Characteristics:

414 - 1

The Deluxe Nebulizer operation is based upon a non-oil lubricating, single-cylinder piston pump for air pressure. It is compact, simple to operate and convenient to carry. As shown in Figure 1 below, air flows through the air filter into the nebulizer's air compressor unit, out the jet outlet and then through the nebulizer.

Image /page/1/Figure/2 description: The image shows a diagram of a compressor. The diagram includes labels for the air filter, inlet, jet outlet, outlet, and compressor. The air filter is connected to the inlet, and the jet outlet is connected to the outlet.

FIGURE 1 - WORKING PRINCIPLE

The Nebulizer (Figure 4) atomizes medicinal liquid into tiny fog droplets by compressing air. Patients inhale the compressed air for optimal internal medicinal delivery.

Image /page/1/Figure/5 description: This image shows a diagram of a nebulizer, labeled as "FIGURE 4 - NEBULIZER". The diagram shows the different parts of the nebulizer, including the mouthpiece, T-piece, rinse tube, air hose, cup, and baffle. The diagram shows how the different parts of the nebulizer are connected.

510(k) Summary

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## Summary of Performance Testing

The Deluxe Nebulizer was designed to conform to the applicable sections of the following recognized consensus standards. The testing included verifying conformance to these standards and the published specifications.

| Standard<br>Guidance | Issue Date | Title |
|----------------------------|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1 | 1998 | Medical Electrical Equipment - Part 1:<br>General Requirements for Safety |
| IEC 60601-1-2 | 2001 | Medical Electrical Equipment - Part 1-2:<br>General Requirements for Safety - Collateral<br>Standard; Electromagnetic Compatibility –<br>Requirements and Tests (General) |
| FDA Document<br>Number 784 | 1993 | Reviewer Guidance for Nebulizers, Metered<br>Dose Inhalers, Spacers and Actuators |

## Conclusion:

The Deluxe Nebulizer is as safe and effective as the predicate devices when used according to the instructions in the directions for use supplied with the devices.

510(k) Summary

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 】 2007

Access Point Medical, L.L.C C/O Ms. Casey Conroy Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville. New York 11747

Re: K063449

Trade/Device Name: Deluxe Nebulizer™, Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 6, 2007 Received: February 9, 2007

Dear Ms. Conroy:

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. Conroy

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 (OS) 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,

Suresh Kumar

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: _______________________________________________________________________________________________________________________________________________________________

Device Name: Deluxe Nebulizer™, Nebulizer

Indications for use:

The Access Point, LLC Deluxe Nebulizer is intended to provide a source of compressed air for medical purposes for use in home health care. The Deluxe Nebulizer is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.

X OR Over-The-Counter___________________________________________________________________________________________________________________________________________________________ Prescription Use_ (Per 21 CFR 801.109)

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation

Wh Wh

K063419