AEROMIST LT, MODEL HCS15004

K031686 · Medline Industries, Inc. · BTI · Jan 21, 2004 · Anesthesiology

Device Facts

• Record ID: K031686
• Device Name: AEROMIST LT, MODEL HCS15004
• Applicant: Medline Industries, Inc.
• Product Code: BTI · Anesthesiology
• Decision Date: Jan 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.6250
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Aesomist LT nebulizer compressor is an AC-powered air compressor intended to provide a source of compressed air for medical purposes for health care use. This device must be 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

The Aeromist LT is an AC-powered air compressor; provides compressed air to a pneumatic nebulizer; converts liquid medication into a fine aerosol mist for inhalation. Used in healthcare settings for respiratory therapy; operated by clinicians or patients. Output is a continuous stream of compressed air; enables delivery of aerosolized drugs to the patient's airways. Benefits include effective administration of respiratory medications.

Clinical Evidence

Bench testing only.

Technological Characteristics

AC-powered air compressor; portable form factor; intended for use with pneumatic nebulizers. No specific materials or software algorithms described.

Indications for Use

Indicated for children and adults suffering from respiratory disorders requiring aerosolized medication therapy via a pneumatic nebulizer.

Regulatory Classification

Identification

A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, possibly representing people or services provided by the department.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2004

Ms. Andrea Haferkamp Corporate Director of Regulatory Affairs Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060-4486

Re: K031686

Trade/Device Name: Medline Aeromist LT Nebulizer Compressor Regulation Number: 868.6250 Regulation Name: Portable Air Compressor Regulatory Class: II Product Code: BTI Dated: October 17, 2003 Received: October 27, 2003

Dear Ms. Haferkamp:

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, thereforc, 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.

{1}------------------------------------------------

Page 2 – Ms. Andrea Haferkamp

Please be advised that FDA' s issuance of a substantial equivalence determination does not mean that FDA has made a dctermination that your device complies with other requirements mean that I Dring 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/dsma/dsmamain.html.

Sincerely yours,

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known): KO31686

Device Name:

Aeromist LT Nebulizer Compressor

Indications For Use:

The Aesomist LT nebulizer compressor is an AC-powered air compressor intended to provide a source of compressed air for medical purposes for health care use. This device must be 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.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO MOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page: 1 of

Division of Anesthesiology, General Hospital,
Infection Control, Devices

510(k) Number: K031686